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Tetra Bio-Pharma Inc. — Annual Report 2020
Feb 25, 2021
46241_rns_2021-02-24_9c113b28-ab4b-4627-a581-5a555842af74.pdf
Annual Report
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TETRA BIO-PHARMA INC.
Annual Information Form For the year ended November 30, 2020
February 24, 2021
Table of Contents
MEANINGS OF CERTAIN REFERENCES .................................................................................................. 3 FORWARD-LOOKING STATEMENTS ......................................................................................................... 3 CORPORATE STRUCTURE ........................................................................................................................ 6 GENERAL DEVELOPMENT OF THE BUSINESS ..................................................................................... 13 DESCRIPTION OF THE BUSINESS .......................................................................................................... 21 COMPETITION ........................................................................................................................................... 30 DIVIDENDS ................................................................................................................................................. 31 REGULATORY OVERVIEW ....................................................................................................................... 31 RISK FACTORS .......................................................................................................................................... 33 CAPITAL STRUCTURE .............................................................................................................................. 35 PRIOR SALES ............................................................................................................................................ 38 ESCROWED SECURITIES ........................................................................................................................ 39 DIRECTORS AND MANAGEMENT ........................................................................................................... 39 PROFILE OF THE BOARD AND MANAGEMENT ..................................................................................... 41 SECURITY HOLDINGS OF THE DIRECTORS AND OFFICERS.............................................................. 43 CEASE TRADE ORDERS, BANKRUPTCIES, PENALTIES AND SANCTIONS ....................................... 44 CONFLICTS OF INTEREST ....................................................................................................................... 44 AUDIT AND RISK COMMITTEE INFORMATION ...................................................................................... 45 LEGAL PROCEEDINGS AND REGULATORY ACTIONS ......................................................................... 46 INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS .................................... 46 TRANSFER AGENT AND REGISTRAR ..................................................................................................... 48 MATERIAL CONTRACTS ........................................................................................................................... 48 INTERESTS OF EXPERTS ........................................................................................................................ 48 ADDITIONAL INFORMATION .................................................................................................................... 49 SCHEDULE A ........................................................................................................................................... A-1
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MEANINGS OF CERTAIN REFERENCES
In this annual information form ("AIF"), references to the "Corporation", "Tetra", "we", "us", "our" or "its" are references to Tetra Bio-Pharma Inc. References to "management" in this AIF mean the persons acting in the capacities of Tetra's Chief Executive Officer and Chief Regulatory Officer, Chief Financial Officer, Chief Operating Officer, Chief Scientific Officer, and Chief Commercial Officer. Any statements in this AIF made by or on behalf of management are made in such persons' capacities as officers of Tetra and not in their personal capacities. In this AIF, unless the context suggests otherwise, the term "Corporation" includes the Corporation's predecessors.
This AIF may contain company names, product names, trade names, trademarks and service marks of other organizations, all of which are the property of their respective owners.
The term "cannabis" has the meaning given to the term "cannabis" in the Cannabis Act (SC 2018, c.16) (the "Cannabis Act").
FORWARD-LOOKING STATEMENTS
Certain statements in this AIF may constitute "forward-looking information" or "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"), which are based upon the Corporation's current internal expectations, estimates, projections, assumptions and beliefs. Forward-looking statements are identified by the use of terms and phrases such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan", "predict", "project", "will", "would", and similar terms and phrases, including references to assumptions. Such information may involve, but is not limited to, comments with respect to strategies, expectations, planned operations or future actions.
Forward-looking statements are necessarily based on estimates and assumptions made by management in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as factors that management believe are appropriate. Forward-looking statements in this AIF include, but are not limited to: statements with respect to the anticipated impacts of the current COVID-19 crisis on the Corporation's business, including its clinical trials, and the measures that the Corporation may put in place to address such impacts; the commercialization of Tetra’s assets developed from its intellectual property; the expected size and value of the addressable markets for the Corporation’s drug candidates; the Corporation’s expectations regarding its pre-clinical and clinical trial results; the development, manufacturing and commercialization of the Corporation’s drug candidates; the anticipated health benefits of Tetra’s drug candidates; the anticipated penetration of the Corporation’s drug candidates in foreign markets; the anticipated timelines for regulatory approvals of the Corporation’s drug candidates; the Corporation’s expectations regarding funding for its pipeline of drug candidates; the Corporation’s potential and planned acquisitions and the benefits that are expected to result therefrom; and potential fluctuations in operating results.
Such statements reflect Tetra's current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions using data from publicly available governmental sources as well as from market research and industry analysis and on assumptions based on data and knowledge of the industry which Tetra believes to be reasonable, but are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Although generally indicative of relative market positions, market shares and performance characteristics, such data is inherently imprecise. While Tetra is not aware of any misstatement regarding any industry or government data presented herein, the medical cannabis industry involves risks and uncertainties that are subject to change based on various factors. Many factors could cause Tetra's actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-
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looking statements. In making the forward looking statements included in this AIF, the Corporation has made various material assumptions, including, but not limited to: (i) the Corporation's ability to obtain funding for its operations, including funding for clinical trials research and to manufacture the active pharmaceutical ingredients used in the research; (ii) the enrollment in, completion of and obtaining positive results from clinical trials; (iii) obtaining and maintaining regulatory approvals; (iv) the Corporation's ability to develop and commercialize, or otherwise monetize, its drug candidates and develop new drugs; (v) the Corporation's and competitor's costs of production and operation; (vi) the availability of financing on reasonable terms; (vii) the safety and efficacy of the Corporation’s drug candidates and any new drugs; (viii) the assumption that Tetra's current good relationships with its collaborators, suppliers, joint venture partners and other third parties will be maintained; (ix) the Corporation’s ability to enter into collaboration agreements for the licensing, development and ultimate commercialization of its product candidates; (x) the Corporation's ability to attract and retain skilled staff within the specialized scientific and managerial nature of the Corporation's business; (xi) the Corporation's ability to protect patents and other proprietary rights including trade secrets; (xii) the Corporation's ability to integrate acquired or licensed products into the Corporation's existing pipeline; (xiii) Health Canada maintaining its policy to expedite the review of a drug product shown to improve the outcome of life-threatening conditions, such as COVID-19; (xiv) the Corporation’s ability to manage the impacts and effects of the COVID-19 pandemic; (xv) the Corporation’s ability to complete and successfully integrate its planned acquisitions, and to fully realize the benefits of such acquisitions; (xvi) the ability of the Corporation’s products to penetrate various geographical markets; (xvii) the ability of the Corporation to continue to conduct clinical trials in the ordinary course; (xviii) our ability to source and maintain licenses from third-party owners; (xix) the assumption that the public perception of the Corporation’s products and technology will remain favorable and accepted by the medical profession as a treatment option for patients; (xx) the assumption that the anticipated market for Tetra's potential products and technologies will continue to exist and expand; (xxi) Tetra’s ability to advertise and promote its technologies and products effectively and efficiently; (xxii) Tetra's ability to protect its networks equipment, IT systems and software against damage; (xxiii) Tetra’s ability to maintain adequate insurance coverage at commercially reasonable rates; (xxiv) Tetra’s ability to maintain adequate disclosure controls, procedures and internal controls policies; and (xxv) Tetra’s ability to continue to comply with applicable laws in all material respects.
Although the Corporation believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct.
The forward-looking statements in this document involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements or industry results to be materially different from any future results, performance or achievements or industry results expressed or implied by such forward-looking information or financial outlook. The factors which could cause results to differ from current expectations include, but are not limited to: (i) Tetra’s drug candidates contain substances related to cannabis, which may generate public controversy, (ii) the Corporation is subject to all of the business risks and uncertainties associated with any early-stage enterprise, including undercapitalization, cash shortages, limitation with respect to personnel, financial and other resources, and lack of revenues; (iii) Tetra’s future operations are dependent upon obtaining financing; (iv) Tetra may not be able to manage its future growth; (v) the anticipated markets for the Corporation’s products and technologies may not exist or expand; (vi) changes in laws and regulations may adversely affect the Corporation; (vii) the risks associated with acquisitions, dispositions or other strategic transactions; (viii) Tetra may not be able to generate sufficient revenue and the Corporation may not be able to achieve or sustain profitability; (ix) the Corporation’s drug candidates may fail for a number of reasons; (x) we may have difficulty enrolling or maintaining the enrollment of patients in any clinical trials conducted for our drugs, which may result in the delay or cancellation of such trials; (xi) the Corporation’s reliance on preclinical testing and clinical trials; (xii) the potential effects and impacts of the COVID-19 pandemic on the Corporation’s business and operations; (xiii) the vulnerability of results of planned clinical trials; (xiv) the Corporation’s reliance on regulatory approvals and the risks of noncompliance with applicable laws; (xv) the Corporation’s reliance on contract manufacturing organizations; (xvi) Tetra may not be able to successfully market its drugs; (xvii) the Corporation may be unable to identify, discover or license drug candidates; (xviii) the possibility that none of our drug candidates under development will successfully
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gain market approval from the FDA, Health Canada or other regulatory authorities; (xix) delays in clinical testing; (xx) negative results from clinical trials or studies of others and adverse safety events; (xxi) the inability of the Corporation to develop enhancements to its existing products and services or acceptable new products and services that keep pace with rapidly changing developments; (xxii) competition; (xxiii) reliance on key personnel; (xxiv) employee misconduct or other improper activities; (xxv) our reliance on the success of collaboration agreements; (xxvi) Tetra may not be able to protect its intellectual property; (xxvii) changes in patent laws; (xxviii) the risk of third-party claims for infringement; (xxix) Tetra’s inability to protect its trade secrets; (xxx) we may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary for our drug candidates; (xxxi) Tetra's insurance may be insufficient to cover losses that may occur as a result of Tetra's operations; (xxxii) deficiencies in disclosure controls and procedures and internal controls over financial reporting; (xxxiii) legal proceedings; (xxxiv) the Corporation’s reliance on information technology systems and the risks of damaging cyberattacks; (xxxv) conflicts of interest; (xxxvi) the Corporation’s failure to comply with anti-bribery legislation; (xxxvii) the failure of our information technology systems; (xxxviii) product liability lawsuits; (xxxix) clinical trial liability; (xl) the risks posed by internal expansion; (xli) the volatility and fluctuation of the market price of the common shares of the Corporation (the "Common Shares"); (xlii) holders of warrants have no rights as shareholders until such holders acquire warrant shares; (xliii) no assurance can be given that an active or liquid trading market for the Common Shares will be sustained; (xliv) the possible future dilution of our common shareholders; (xlv) the subordination of shareholders to our lenders; (xlvi) the senior ranking of future offerings of debt and equity securities to that of Common Shares; (xlvii) the negative impact of future sales of Common Shares by officers and directors on the market price for the Common Shares; (xlviii) the limited market for our securities; (xlix) our unlisted warrants; (l) our limited operating history; (li) the fact that there is no assurance of the Corporation's future profitability; (lii) the risks associated with our revenue generation and liquidity levels; (liii) the fact that we do not currently pay dividends; and (liv) fluctuations in foreign currency exchange rates.
For additional information with respect to risks and uncertainties, readers should carefully review and consider the risk factors presented in this AIF and in the section entitled "Risk Factors" of the management’s discussion and analysis of Tetra for the twelve months ended November 30, 2020 (the "Annual MD&A"), which section is incorporated herein by reference. The Annual MD&A is available on SEDAR at www.sedar.com and on Tetra’s website at www.tetrabiopharma.com under the "Investors" section. The information contained in this AIF identifies additional factors that could affect the operating results and performance of Tetra. Shareholders and prospective investors are urged to carefully consider those factors.
Readers are cautioned that the preparation of financial statements in accordance with International Financial Reporting Standards ("IFRS") requires Tetra's management to make certain judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses. The forwardlooking statements contained herein are expressly qualified in their entirety by this cautionary statement. Forward-looking statements reflect management's current beliefs and are based on information currently available to Tetra.
The forward-looking statements are made as at the date of this AIF (or in the case of information contained in a document incorporated by reference herein, as of the date of such document), and Tetra assumes no obligation to publicly update or revise such forward-looking information to reflect new information, subsequent or otherwise, except as may be required by applicable securities laws.
DATE OF INFORMATION
The information in this AIF is presented as of February 24, 2021, unless otherwise indicated.
PRESENTATION OF FINANCIAL INFORMATION
Unless otherwise indicated, all references to "$" or "dollars" are to Canadian dollars, which is Tetra's functional currency, and all references to "U.S.$" or "USD$" are to U.S. dollars. The financial year end of
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all entities within Tetra's corporate structure is November 30. Tetra's financial statements are prepared in accordance with IFRS.
THIRD-PARTY INFORMATION
Market and industry data contained in this AIF were obtained from third-party sources, such as government or other industry publications and reports, journals, studies and publications, websites and other publicly available information or based on estimates derived from same and management's knowledge of, and experience in, the pharmaceutical industry, markets and economies in which the Corporation operates. Government and industry publications and reports generally indicate that information has been obtained from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information. The Corporation believes that the industry, market and economic data presented throughout this AIF is accurate and, with respect to data prepared by the Corporation or on the Corporation’s behalf, that the Corporation’s opinions, estimates and assumptions are currently appropriate and reasonable, but there can be no assurance as to the accuracy or completeness thereof. Further, certain of these organizations are participants in, or advisors to participants in, the pharmaceutical industry, and they may present information in a manner that is more favourable to the industry than would be presented by an independent source. Actual outcomes may vary materially from those forecast in such reports or publications, and the prospect for material variation can be expected to increase as the length of the forecast period increases. While the Corporation believes this data to be reliable, the Corporation has not independently verified any of the data from third-party sources referred to in this AIF, analyzed or verified the underlying studies or surveys relied upon or referred to by such sources, or ascertained the underlying industry. Market, economic, industry data and other assumptions relied upon by such sources are subject to variations and cannot be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties inherent in any statistical survey.
CORPORATE STRUCTURE
Tetra Bio-Pharma Inc.
Tetra was incorporated under the name Mazorro Resources Inc. ("Mazorro") under the Canada Business Corporations Act (the "CBCA") on May 17, 2007. On December 29, 2014, GrowPros MMP Inc. completed ‐ an amalgamation transaction with Mazorro and 9048073 Canada Inc., a wholly owned subsidiary of Mazorro incorporated, to effect the amalgamation. As a result of a share exchange in connection with the amalgamation, control of the combined companies passed to the former shareholders of GrowPros MMP Inc., which for accounting purposes was deemed to be the acquirer. As part of the amalgamation agreement, Mazorro changed its name to "GrowPros Cannabis Ventures Inc." Tetra's head office is located at 2316 St. Joseph Blvd., Orleans, Ontario, K1C 1E8 and its principal place of business is located at 365 rue St-Jean, Suite 122, Longueuil, QC J4H 2X7.
On September 28, 2016, the Corporation formally changed its name from GrowPros Cannabis Ventures Inc. to Tetra's current name. The Common Shares were listed for trading on the Canadian Securities Exchange ("CSE") under the symbol "TBP" and the OTCQB[®] Venture Market ("OTCQB") under the symbol "TBPMF".
On August 16, 2017, the Common Shares were delisted from the CSE and were listed for trading on the TSX Venture Exchange ("TSXV") under the symbol "TBP" and the OTCQB under the symbol "TBPMF". On August 4, 2020, the Corporation completed its graduation to the Toronto Stock Exchange ("TSX") and the Common Shares and the Corporation’s listed warrants began trading on the TSX under the symbols "TBP", "TBP.WT", "TBP.WT.A" and "TBP.WT.B". In connection with the Corporation’s graduation to the TSX, concurrently, the Common Shares and the Corporation's listed warrants were voluntarily delisted from the TSXV. The Common Shares continue to trade on the OCTQB market under the symbol "TBPMF".
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The Corporation has three active subsidiaries: PhytoPain Pharma Inc., Tetra Bio-Pharma Europe Ltd. and Panag Pharma Inc.
The following chart illustrates, as of November 30, 2020, the Corporation's corporate structure, describing the Corporation's active subsidiaries:
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(1)
Tetra Bio-Pharma Inc.
100%
PhytoPain Pharma Inc. Panag Pharma Inc.(4)
("PhytoPain")(2) Tetra Bio-Pharma Europe Ltd. [(3)] ("Panag")
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(1) Incorporated under the CBCA.
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(2) Incorporated under the CBCA and whose principal activity is drug discovery and drug development.
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(3) Incorporated under the Companies Act (Malta) and whose principal activity is European market
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authorizations and clinical trials.
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(4) Incorporated under the Companies Act (Nova Scotia) and whose principal activity is discovery and development of patent protected molecules and compounds.
On August 30, 2019, the Corporation incorporated 2714140 Ontario Inc. ("HempCo") as a wholly owned subsidiary for the purpose of divesting the Corporation's Hemp Energy Drink ("HED") business, previously operated by Tetra Natural Health. See "Discontinued Operations – Lumiera and HempCo" below for additional information. During the year ended November 30, 2020, the Corporation completed the divestiture of its subsidiary called Lumiera Health Innovations Inc. ("Lumiera"), which contained the Corporation’s natural products business segment, following a proposed strategic reorganization of the Corporation’s ongoing business. On August 17, 2020 the Corporation entered into a share exchange agreement for the sale of Lumiera to Mondias Natural Products ("Mondias") (the "Lumiera Transaction"). The Lumiera Transaction was completed on October 27, 2020. See "Discontinued Operations – Lumiera and HempCo " below for additional information. On January 23, 2020, an inactive subsidiary of the ‐ Corporation named Grow Pros Agro Tek Inc. was dissolved. As at the date of this AIF, the Corporation also has two inactive subsidiaries, being Minerra Mazorro s.r.l. de c.v. and HempCo, both of which the Corporation intends to dissolve in the future.
In the final quarter of fiscal year 2020, Tetra incorporated a wholly owned subsidiary, Tetra Bio-Pharma Europe Ltd. in Valletta, Malta. The Maltese subsidiary will lead the regulatory filings with the Europe Medicines Agency ("EMA") for all of Tetra's investigational new drugs and European-based clinical trial operations as well as Orphan drug designation applications. This includes accelerating the marketing authorization application for QIXLEEF™ in Europe and performing the Phase III PLENITUDE© trial. Having multiple venues to advance its clinical trials and regulatory activities will enable Tetra to access fast track marketing authorizations. For several indications that have unmet medical needs, health authorities such as Health Canada, the Food and Drug Administration ("FDA") and the EMA are taking
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the necessary measures to expedite the granting of marketing authorizations based on the approvals in other recognized jurisdictions.
On February 3, 2021, Tetra announced the creation of a wholly owned subsidiary called ENJOUCA Inc. Jurisdictions differ greatly in terms of regulatory requirements surrounding medical cannabis, which means that in some territories, QIXLEEF™ can be commercialized as a medical cannabis product. As a result, Tetra's strategy is to launch QIXLEEF™ under the trademark ENJOUCA™ as a medical cannabis product within those territories using its robust clinical package. ENJOUCA™ branded products will be distributed through existing medical cannabis channels. For other jurisdictions, QIXLEEF™ will remain a prescription drug product and commercialized to the major global markets. As a prescription drug, QIXLEEF™ will be available by prescription only, through pharmacies. See "Description of Business – Advanced Cancer Pain: QIXLEEF™: PLENITUDE[©] Target Intended Uses" below for additional information on QIXLEEF™.
Shared ventures
The Corporation has entered into agreements to form shared ventures to develop and commercialize drugs and wellness supplements.
| SHARED VENTURE | PRINCIPAL ACTIVITIES |
|---|---|
| CB2 Therapeutics Inc. | Development and commercialization of medicines and wellness |
| supplements for management of chronic inflammatory conditions | |
| MAKScientific, LLC | Access to novel new molecules securing patented new drug |
| candidates |
CB2 Therapeutics Inc.
At the end of the fiscal year 2019, the Corporation announced it signed an agreement with Thorne Research Inc. and Onegevity Health LLC to form a shared venture named CB2 Therapeutics Inc. ("CB2 Therapeutics"), a corporation focused on leveraging the power of the endocannabinoid system using innovative multi-omics and multi-targeted therapeutic options in the management of chronic inflammatory conditions.
CB2 Therapeutics has been structured as a shared venture using the intellectual property of the three companies on a royalty-free license to develop and commercialize a global product for chronic inflammatory conditions with high unmet needs or that are poorly served with existing therapies. In addition, as part of the agreement, CB2 Therapeutics would also commercialize wellness supplements in the USA through its partnership with Thorne.
In the final quarter of fiscal year 2020, CB2 Therapeutics made great strides towards its pipeline development. The current pipeline of products includes a cannabis prebiotic, a medical food, and two products for the treatment of bowel conditions. For the cannabis residue prebiotic, a provisional patent was filed in July 2020 for Post-Treated Cannabis Plant Residue as Prebiotic. In addition, a dedicated commercial supplier was found and a contractual agreement for development was signed. On the medical food and drug development side, key relationships have been formed with an Italian contract manufacturer to develop an exclusive phytosome, one of the lipid-based vesicular delivery systems.
CB2 Therapeutics will look to establish an agreement that will provide rights to global markets. CB2 Therapeutics has entered a development agreement granting the rights to study and develop a
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formulation using phytosome technology targeted at enhancing oral delivery of a terpene-based compound that acts on the cannabinoid type II receptor. Additionally, CB2 Therapeutics is in the final steps of a co-development agreement to include exclusive use of the phytosome in medical foods. The pharmacokinetic and toxicology study of the phytosome has been designed and is set to begin in the first quarter of 2021, subject to the Corporation obtaining sufficient financing to begin such study within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information.
CB2 Therapeutics granted Thorne an exclusive licence to manufacture, distribute, market and sell the prebiotic in both human and animal markets. Thorne will collaborate with CB2 Therapeutics to obtain approval by the FDA in the USA. CB2 Therapeutics will retain the right to sell the prebiotic for other applications, such as in conventional foods and medical foods, and in territories or markets not served by Thorne. Thorne will pay CB2 Therapeutics a royalty based on the aggregate annual net sales of the prebiotic. Thorne will pay for the costs involved in developing and implementing the manufacturing commercial process. This cost will be disclosed to CB2 Therapeutics and will be deducted from the royalty payments.
During fiscal 2021, CB2 Therapeutics will focus on the optimization of the manufacturing process and raw material specifications and will then focus on making a submission to the FDA to allow commercialization of the prebiotic.
MAKScientific, LLC
Tetra entered into a co-development agreement with MAKScientific, LLC ("MAKScientific") in January of 2020. MAKScientific is a recognized global leader in endocannabinoid research and development. This agreement will provide a pipeline for next generation pharmacology research of prescription drugs. To date, Tetra has completed an evaluation of MAKScientific compounds in a primary cell-based assay relevant to idiopathic pulmonary fibrosis and testing their effectiveness on ocular pain & inflammation. Tetra will be granted an exclusive license to use the results to initiate a clinical drug development pathway.
Equity Method Investment
To mitigate risk in the research and development program as well as to advance its novel leading drug compounds, the Corporation, in the year ended November 30, 2020, made investments in Targeted Pharmaceuticals, LLC ("Targeted") and TALLC Corporation Inc. ("TALLC"). Using HU-308, TALLC will develop a series of therapeutics to create new intellectual property, such as enantiomeric blend for ophthalmic products.
| SHARED | PRINCIPAL ACTIVITIES | PRINCIPAL |
|---|---|---|
| VENTURE | AREAS | |
| Targeted | Research collaboration with Targeted | ARDS-003 |
| Pharmaceuticals, | and George Mason University’s |
|
| LLC. | National Center for Biodefense and | |
| Infectious Diseases to evaluate | ||
| Tetra’s ARDS-003 with and without | ||
| antiviral drugs to prevent and treat | ||
| SARS-COV-2 in animals. | ||
| TALLC | Development of fast onset, long | Ocular |
| Corporation Inc. | duration, and an alternative to opioid | Market |
| medications and NSAID1 drugs for | ||
| ocular pain and dry eye disease | ||
| market using Tetra’s key asset HU- |
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Targeted Pharmaceuticals, LLC
During the year ended November 30, 2020, Tetra entered into agreements with Targeted to acquire a minority stake of up to 20% of the issued and outstanding units of membership interest of Targeted. Targeted is a Delaware limited liability Corporation operating in the biopharmaceutical industry that holds a license to certain intellectual property owned by George Mason Research Foundation Inc. in several areas, including antivirals and autophagy[1] modulators and cancer, a key mechanism by which cells degrade and remove damaged intracellular components.
Under the terms of the agreements, Tetra initially subscribed, on August 26, 2020, for 5,500,000 units of membership interest representing 10% of the total interest in Targeted for a cash consideration of USD $250,000. On October 22, 2020, upon obtaining regulatory approval from TSX, Tetra acquired an additional 10% stake in Targeted in the form of 5,500,000 additional units of membership interest in exchange for 1,994,360 Common Shares of an equivalent value of $328,550 (corresponding to USD $250,000 based on Canadian exchange rate on October 22, 2020, of $1.00 equal to USD$1.3134) resulting in an aggregate 20% stake in Targeted now owned by Tetra.
Acquiring a minority stake in Targeted allowed Tetra to enter into a research collaboration agreement with Targeted for performing preclinical studies at George Mason University’s National Center for Biodefence and Infectious Diseases ("NCBID"). The execution of this partnership agreement is a strategic milestone for Tetra that will enable the Corporation to further accelerate the development of its leading drug, ARDS003.
George Mason University's NCBID is one of the 13 national centers of biodefence and infectious diseases in the United States. The center is a recognized institute which conducts pioneering research on infectious diseases including diagnostic, therapeutics, and vaccine development. The research collaboration will allow the evaluation of ARDS-003, with and without antiviral drugs, to prevent and treat SARS-CoV-2 infection in animals. Under the leadership of Dr. Lance Liotta, Principal Investigator for Targeted, and Professor at the George Mason University, ARDS-003 will be studied in SARS-CoV-2 infected animals to further understand its potential as a preventive and therapeutic medicine. This research will be performed by Dr. Liotta's team at the Biocontainment Laboratory-George Mason University NCBID.
In late 2020, Tetra and the scientists working for Targeted designed studies to learn more about the potential benefits of ARDS-003 in animal models. These models involve Sars-CoV-2 infected animals. Studies of ARDS-003 in these models are expected to provide Tetra with data on ARDS-003 in the prevention of acute respiratory distress in animals infected with the virus responsible for COVID-19. This research is expected to be completed in the first half of fiscal 2021, subject to the Corporation obtaining sufficient financing to complete such research within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information.
Tetra has entered into a non-binding term sheet with Targeted and holders of membership interests of Targeted pursuant to which Tetra would acquire the residual 80% stake in Targeted, subject to a number of conditions. The term sheet contemplates a purchase price of approximately USD $9,250,000, to be paid (i) USD $3,000,000 in cash and (ii) USD $6,250,000 in Common Shares. In addition, during the 10year period following closing, certain milestone payments would be payable by Tetra to the sellers upon the achievement of certain pre-established drug development and commercialization milestones, such milestones and milestone payments to be mutually agreed upon between the parties prior to the
1 Targeting autophagy is a means to promote cancer cell death in chemotherapy-resistant tumors, with autophagy inhibition being a prime target during later stage tumour progression.
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execution of a definitive purchase agreement. As part of the transaction, Tetra would commit to a minimum funding of U.S. $500,000 to pursue the intellectual property portfolio of Targeted.
Completion of the proposed transaction is conditioned upon the satisfaction of customary closing conditions, including, without limitation, completion of satisfactory due diligence, the negotiation and execution of a definitive purchase agreement and the satisfaction of the conditions negotiated therein, including, without limitation, the approval of the Board of Directors of Tetra (the "Board"), and the approval by the TSX of the listing of the Common Shares to be issued in connection with the proposed transaction.
As of the date of this AIF, the parties are in advanced stages of negotiation and it is anticipated that the definitive purchase agreement with respect to this acquisition will be executed by the parties in the near term. However, there can be no assurance that any definitive purchase agreement will be entered into and if so, on what terms, or that this or any other transaction with Targeted will be approved or consummated.
TALLC Corporation Inc.
On January 8, 2020, the Corporation formed TALLC, a joint venture with Altus Formulations ("Altus") to develop a series of therapeutics using HU-308 to create new intellectual property for ophthalmic products. As of the date of this AIF, Tetra had contributed $1,250,000 and now owns 50% of TALLC while Altus owns the remaining 50%. With initial funding provided from Altus and Tetra, TALLC’s immediate focus is to develop TA-A001, a non-opioid, non-steroidal small molecule that selectively activates CB2 receptors mediating the human anti-inflammatory response. Combined with TALLC’s novel SmartCelle[TM] nanotechnology, TA-A001 is expected to provide fast onset, long duration and can be an alternative to opioid medications and NSAID[2] drugs in the multibillion-dollar ocular pain and dry eye disease market[3] .
TALLC has combined TA-A001 with its SmartCelle[TM] nanotechnology to create TALLC Formulation TAP2005. Preclinical studies have indicated this formulation was 12 times more efficacious than the conventionally formulated drug used as a control, supporting the hypothesis that SmartCelle[TM] increases corneal access. Additionally, TALLC is working on several studies to determine the analgesic and antiinflammatory effects of increasing doses of formulations of TA-A001 in a corneal hyperalgesia model. TALLC also began discussions to explore the value of TA-A001 and TA-A002, a topical treatment, in treating the glaucoma and dry-eye disease. TALLC continues to focus on its lead indication, the orphan disease keratoconus and is expected to shortly submit its application for orphan drug status.
During the year ended November 30, 2020, TALLC continued to make significant progress in the preclinical evaluation of its formulations and mostly recovered from the delays it experienced due to the COVID-19 pandemic. On July 7, 2020, United Kingdom Intellectual Property Office granted TALLC patent, GB2561009, for its novel SmartCelle[TM] nanotechnology. It is the first in the series of SmartCelle[TM] "smart micelle" patents and is a critical addition to TALLC’s growing patent portfolio. The North American and European applications are now under review and are proceeding as expected. SmartCelle[TM] nanotechnology is expected to allow delivery of highly insoluble molecules and is designed to provide improved access to cornea and the back of the eye. The novel SmartCelle[TM] TA-A001 formulation had already demonstrated potency in models of ocular pain and inflammation and was transferred for manufacturing to Dalton Pharma Services, a contract development and manufacturing organization.
Discontinued Operations: Lumiera and HempCo
During the years ended November 30, 2019 and November 30, 2020, the Corporation reclassed its two non-core businesses, the natural health business operated by its former subsidiary Lumiera and the
2 Nonsteroidal anti-inflammatory drugs (NSAID) are members of a drug class that reduces pain, decreases fever, prevents blood clots, and in higher doses, decreases inflammation.
3Global Ophthalmic Drugs Market Size Report, 2021-2028. Source: https://www.grandviewresearch.com/industry- - - analysis/ophthalmic therapeutics drug market/segmentation
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hemp energy drink ("HED") business operated by HempCo as assets held for sale. In the year ended November 30, 2020, the Corporation completed the divestiture of its former subsidiary Lumiera.
Lumiera
Pursuant to the terms of an amended share exchange agreement dated October 23, 2020, Mondias acquired Lumiera for a purchase price of $1,300,000. The purchase price was satisfied by the issuance of 16,250,000 common shares in the capital of Mondias ("Mondias Shares") using a stock price of $0.08 per Mondias Share, with 14,625,000 Mondias Shares received by Tetra and 1,625,000 received by minority shareholders of Lumiera. As part of this transaction, Tetra assigned all intellectual property rights previously held in its AWAYE™ and TERPACAN™ brands to Lumiera.
In connection with the Lumiera Transaction, Mondias, Tetra and AIP Asset Management Inc. ("AIP") agreed to amend the $2,000,000 convertible debt facility entered into between Lumiera and AIP on August 27, 2020 into a $3,000,000 non-convertible debt facility (the "Amended Note") of which $2,000,000 million has been drawn. The Amended Note bears interest at a rate equal to 15% per year and is guaranteed by a first-ranking hypothec granted over the universality of assets of Mondias and Lumiera. In addition, the Corporation agreed to guarantee the obligations of Lumiera under the facility. In the event that AIP calls on the guarantee for Tetra to honour the obligations under the facility, Tetra is entitled to either pay in cash or elect to issue its own Common Shares in lieu of a cash payment, subject to the TSX's prior approval. The Amended Note will come to maturity on February 27, 2022.
Hempco
The Corporation also had the intention of divesting its HempCo subsidiary or the HED assets when during the year ended November 30, 2019, it reclassified the HED assets as held for sale and transferred them to HempCo, a wholly-owned subsidiary of Tetra.
In connection with this transfer, the Corporation had secured financing from AIP in the amount of $2,000,000 through the issuance of convertible notes (the "Convertible Notes") to support ongoing operations of the HED business until the successful monetization of the HED business through a spin-off or other type of liquidity event (each a "Liquidity Event").
As of November 30, 2020, after two unsuccessful attempts to complete a Liquidity Event, management determined that the fair value less costs to sell for substantially all the assets was nil, and a loss was recognized in the statement of loss, as part of discontinued operations.
On February 16, 2021, the Corporation entered into a note purchase agreement for an aggregate amount of up to $3,000,000 with AIP. The notes carry a 15% annual interest with interest payment made monthly and is secured by a general security agreement over all of the assets of Tetra and its subsidiaries. This note purchase agreement was entered into to refinance the $2,000,000 convertible debenture previously incurred by HempCo and to cure all breaches under such convertible debenture.
Please refer to the annual audited financial statements of the Corporation for the year ended November 30, 2020 for additional information on discontinued operations. A copy of the annual audited financial statements of the Corporation for the year ended November 30, 2020 can be found under the Corporation’s profile on www.sedar.com. and on Tetra’s website at www.tetrabiopharma.com under the "Investors" section.
GrowPros MMP
On February 22, 2018, the Corporation entered into an agreement to sell all the shares of its subsidiary "GrowPros MMP Inc." to North Bud Farms Inc. ("North Bud") for gross proceeds of $350,000, as well as 15,500,000 common shares of North Bud (the "GrowPros MMP Transaction"). This sale was contingent upon North Bud completing a listing transaction and becoming a publicly traded company. As at August
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31, 2018, the conditions of the agreement were completed and consequently the sale and transaction were recorded.
The completion of the GrowPros MMP Transaction resulted in the Corporation disposing of its medical marijuana production business division in order to focus its activities on its core business, the drug development and the clinical trials of its pharmaceutical business candidates.
On August 31, 2018, the Board approved the distribution of a dividend-in-kind consisting of the 15,500,000 common shares of North Bud (each, a "North Bud Share") received by Tetra as part of the GrowPros MMP Transaction, on a pro rata basis based on the Corporation's 152,961,631 outstanding Common Shares held on the record date as of August 29, 2018, representing 0.101233 North Bud Share per Common Share. 15,500,000 North Bud Shares were delivered to Tetra's shareholders subsequent to August 31, 2018. The dividend-in-kind was paid on or September 12, 2018.
GENERAL DEVELOPMENT OF THE BUSINESS
Three Year History
This section describes how the Corporation’s business has developed over the last three completed financial years.
Financial Year Ending November 30, 2018
On March 5, 2018, Tetra completed a bought deal financing with Echelon Wealth Partners Inc. ("Echelon") pursuant to which it sold 11,500,000 units of the Corporation at a price of $1.00 per unit for gross proceeds of $11,500,000. Each unit consisted of one Common Share and one Common Share purchase warrant. Each warrant entitles the holder thereof to acquire one full Common Share at a price of $1.30, for a period of 36 months following closing of such bought deal financing.
On March 29, 2018, Tetra completed a non-brokered private placement of 4,292,000 units of the Corporation at a price of $1.00 per unit for aggregate gross proceeds of $4,292,000. Each unit consisted of one Common Share and one non-transferable Common Share purchase warrant. Each warrant entitles the holder thereof to acquire one full Common Share at a price of $1.30 per share for a period of 36 months following closing of such non-brokered private placement.
On April 3, 2018, Mr. Guy Chamberland, M.Sc., Ph.D., an accomplished drug developer and the then Chief Scientific Officer of Tetra, was appointed Chief Executive Officer of Tetra.
On June 1, 2018, Tetra completed the listing of its previously issued 11,500,000 Common Share purchase warrants on the TSXV.
On June 5, 2018, Mr. Ofer Yifrach-Stav was hired as Vice President Pharmaceutical Compliance and Quality.
On July 16, 2018, Tetra entered into a co-development agreement with Storz & Bickel to use a specialized medical device known as the Mighty Medic, in combination with its QIXLEEF[TM] prescription drug. The agreement allows Tetra to effectively bring QIXLEEF[TM] to patients suffering from fibromyalgia and other chronic pain conditions, significantly expanding the market potential for QIXLEEF[TM] .
On September 13, 2018, Health Canada re-classified the inhalation pipe device used in the delivery of its QIXLEEF[TM] cannabis drug to a Class 2 Medical Device with the impact that, if QIXLEEF[TM] is approved by Health Canada, the Corporation anticipates that both the prescription drug and the inhalation device will be covered by private and provincial public insurance plans.
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On November 20, 2018, Tetra signed a binding proposal for exclusive access to a Health Canada licensed facility (i.e., Drug Establishment License; DEL) that enables the Corporation to produce cannabis and cannabinoid drug products for Tetra's and Panag's development activities including the ocular drug formulations. Quantum Pharma, owned by Dr. Peter Ford, was the good manufacturing practice ("GMP") manufacturing division of Ford's Family Pharmacy and Wellness Centre.
On November 30, 2018, Tetra completed a private placement of units with Aphria Inc. ("Aphria") for 6,900,000 units of the Corporation, with each unit being comprised of one Common Share and one Common Share purchase warrant, at a price of $1.03 per unit for gross proceeds of $7,107,000. Each warrant entitles Aphria to purchase one full Common Share at a price of $1.29 per Common Share for a period of 36 months following the closing of such private placement.
Financial Year 2019 Ending November 30, 2019
On December 11, 2018, Tetra entered into a non-exclusive supply agreement for GMP-Grade tetrahydrocannabinol ("THC")[4] with U.S.-based Rhodes Technologies Inc. in connection with several drug development activities including Tetra's cannabinoid-derived products PPP002, PPP003, and PPP004, as well as for discovery phase projects.
On December 18, 2018, Tetra filed a patent application with the Canadian Intellectual Property Office for its QIXLEEF[TM] drug product. The patent application covers methods of fabrication and composition of matter. The patent application has been open to public inspection since June 18, 2020 and has not been granted yet.
On February 20, 2019, Tetra temporarily suspended its phase III clinical program due to impurities found in its QIXLEEF[TM] investigational drug being administered to patients.
On March 4, 2019, Tetra completed the first double-blind, randomized and placebo-controlled phase II clinical trial of cannabis oil capsules. The trial evaluated the safety and efficacy of different doses and ratios of medical cannabis oil, for the treatment of uncontrolled chronic pain in cancer and non-cancer patients.
On April 9, 2019, Tetra resumed its phase III clinical program in advanced cancer pain patients.
On April 11, 2019, Tetra entered into a collaboration agreement with Ovensa Inc. to evaluate TRIOZAN, a proprietary nanomedicine platform for targeted delivery of cannabinoids to brain tumour cells.
On May 1, 2019, Tetra acquired 100% of the issued and outstanding common shares of Panag, a Canadian-based biotechnology corporation focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Refer to " Interest of Management and Others in Material Transactions – Panag Transaction " for additional information.
On May 2, 2019, Panag was authorized by the Veterinary Drugs Directorate ("VDD") of Health Canada, to conduct a pilot clinical study to evaluate the tolerability and potential efficacy of its PPP-003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals. Refer to " PPP – 003v (HU-308v) – Veterinary Market" below for additional information.
On June 17, 2019, Tetra announced that the Phase II clinical study design and the quality and toxicology requirements for initiating trials in patients in the U.S. had been confirmed by the FDA and that the FDA had agreed that it was acceptable to evaluate the safety and efficacy of PPP003 Ophthalmic Solution for the treatment of the signs and symptoms of painful dry eye. See "Description of the Business – Ophthalmology – PPP-003 (HU-308): Ocular formulations" below for additional information on PPP003.
4 For additional information on THC, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2731700/.
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On July 12, 2019, Tetra completed a short form prospectus offering for 26,833,332 units of the Corporation, including the exercise in full of the over-allotment option granted to a syndicate of agents led by Echelon, with each unit being comprised of one Common Share and one Common Share purchase warrant, at a price of $0.30 per unit for gross proceeds of $8,050,000. Each warrant entitles the holder thereof to purchase one full Common Share at a price of $0.40 per Common Share for a period of 36 months following the closing of such offering.
On August 2, 2019, Tetra completed a non-brokered private placement in which some of the Corporation's directors, officers, consultants and employees, as well as certain of their associates, purchased an aggregate of 870,100 units of the Corporation at a price of $0.30 per unit for aggregate gross proceeds of $261,030, with each unit being comprised of one Common Share and one Common Share purchase warrant. Each warrant entitles the holder thereof to purchase one full Common Share at an exercise price of $0.40 per Common Share for a period of 36 months following the closing of such non-brokered private placement.
On October 22, 2019, the Corporation entered into the CB2 Therapeutics shared venture agreement with Thorne Research Inc. and Onegevity Health, LLC. Refer to " Corporate Structure – Shared Ventures – CB2 Therapeutics " for additional information.
On November 25, 2019, the FDA authorized the advancement of the Corporation's clinical trial for its investigational therapeutic QIXLEEF™ for the treatment of uncontrolled pain in advanced cancer patients called PLENITUDE[©] . See "Description of Business – Advanced Cancer Pain: QIXLEEF™: PLENITUDE[©] Target Intended Uses" below for additional information on QIXLEEF™.
Financial Year Ending November 30, 2020
On December 2, 2019, the Corporation announced that it had signed a definitive co-development and commercialization agreement with Alternavida S.A. de C.V. ("Alternavida") for the clinical development, marketing and distribution of CAUMZ™ in Mexico.
On December 4, 2019, the Corporation announced it had received the FDA Orphan Drug Designation ("ODD") for THC in the treatment of hepatocellular carcinoma.
On December 16, 2019, the Corporation announced the entering into of a definitive agreement with Azevedos Indústria Farmacêutica, S.A. ("Azevedos") for the marketing and distribution of CAUMZ[TM] (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. In return, Azevedos will be responsible for registering the product, manufacturing, as well as all marketing and distribution in Portugal.
On January 13, 2020, the Corporation received a favourable letter of advice from the FDA for QIXLEEF™. The letter provided scientific guidance on the Corporation's quality file including aspects such as reporting of volatile organic compounds contained in the drug product. It provided further insight into the January 26, 2017 Type B meeting with the FDA with regards to the requirements for drug approval for a non-serious condition such as uncontrolled pain as a second-or third-line therapy. See "Description of Business – Advanced Cancer Pain: QIXLEEF™: PLENITUDE[©] Target Intended Uses" below for additional information on QIXLEEF™.
On January 30, 2020, Tetra received a favourable letter from the FDA following a Type B meeting with the FDA for its drug-device combination product CAUMZ[TM] . See "Description of the Business – Advanced " Cancer Pain and Cancer Cachexia: CAUMZ[TM] below for additional information on CAUMZ[TM] .
On February 6, 2020, Tetra entered into a definitive manufacturing agreement with Vitiprints LLC, for the commercial scale production of CAUMZ™ and HCC011. This agreement further protects CAUMZ™ and HCC011 with four additional patents on manufacturing know-how. The manufacturing technology licensed from Vitiprints LLC allows Tetra to manufacture cannabinoid drugs for inhalation and does not involve the
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use of other ingredients. This is critical for ensuring the safety and tolerability of CAUMZ™ in patients. See "Description of the Business – Advanced Cancer Pain and Cancer Cachexia: CAUMZ[TM] " below for additional information on CAUMZ[TM] .
On February 13, 2020, Tetra completed a short form prospectus offering for 29,245,300 units of the Corporation, with each unit being comprised of one Common Share and one Common Share purchase warrant, at a price of $0.53 per unit for gross proceeds of $15,500,009. Each warrant entitles the holder thereof to purchase one full Common Share at a price of $0.75 per Common Share for a period of 36 months following the closing of such offering. In consideration of the services provided in connection with the offering, Tetra also paid Echelon, as sole underwriter and sole book runner, a cash fee equivalent to 7% of the gross proceeds from the offering in addition to 2,047,171 underwriter's warrants, each of which entitles the holder thereof to acquire one full Common Share by paying an exercise price of $0.75 for a period of 36 months from the date of closing of the offering.
On February 20, 2020, the Corporation announced the initiation of its clinical trial for its synthetic cannabinoid therapy for the treatment of ophthalmic eye pain in the veterinary setting. The Health Canada approved trial is designed to evaluate the safety, tolerability and potential efficacy of PPP003, the Corporation’s synthetic cannabinoid therapy, to ameliorate symptoms of ocular pain and inflammation in companion animals. See "Description of the Business – Ophthalmology – PPP-003v (HU-308v) – Veterinary Market" below for additional information on PPP003.
On February 24, 2020, Tetra announced that it had received FDA’s authorization to proceed with QIXLEEF™’s clinical trial PLENITUDE[©] in the U.S. Following a Type B meeting, the FDA confirmed areas where Tetra could obtain a waiver for some of the nonclinical safety requirements based on the target patient population. This confirmation was critical as it confirms Tetra’s understanding of the regulatory requirements. This FDA authorized clinical trial to assess the clinical impact of QIXLEEF™ in advanced cancer patients with uncontrolled pain. A successful PLENITUDE[©] clinical program will allow Tetra to commercialize the world’s first dried flower botanical cannabinoid drug product for the treatment of pain in patients with an advanced refractory cancer. See "Description of Business – Advanced Cancer Pain: QIXLEEF™: PLENITUDE[©] Target Intended Uses" below for additional information on the PLENITUDE[© ] clinical program.
On February 25, 2020, the Corporation announced its first indication for CAUMZ™. To ensure minimal time to market, the Corporation intends for CAUMZ™ to first target cancer cachexia patients that have an incurable and malignant cancer that is refractory to treatment. CAUMZ™ is designed to prolong survival and improve quality of life and the patient's day-to-day functioning.
On February 25, 2020, the FDA confirmed that CAUMZ™ would be eligible for waivers of some of the standard nonclinical toxicology studies.
On February 27, 2020, Tetra entered into a co-development definite agreement with MAKScientific. This agreement provides Tetra with access to novel patented new molecules with CB1 and CB2 agonist or antagonist properties. In the long term, this agreement secures patented new drug candidates for Tetra to develop after CAUMZ[TM] and QIXLEEF[TM] receive marketing approval. Under this agreement, MAKScientific will develop new molecules that will be screened by Tetra for potential efficacy in various indications including cancer, pain and inflammation as well as other potential targets of interest to Tetra. See "Corporate Structure – Shared Ventures – MAKScientific, LLC" above for additional information.
On March 5, 2020, Tetra announced that Echelon exercised its over-allotment option granted under the short form prospectus offering of February 13, 2020, and purchased an additional 4,386,795 units of the Corporation, with each unit being comprised of one Common Share and one Common Share purchase warrant, at a price of $0.53 per unit for gross proceeds of $2,325,001. Further, Echelon received, in consideration for its services rendered in relation with the offering, 307,075 additional underwriter's warrants, each of which entitles the holder thereof to acquire one full Common Share by paying an exercise price of $0.75 for a period of 36 months from the date of closing of the offering.
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On March 6, 2020, Tetra announced the engagement of Alpha Bronze LLC, an investor relation, management consulting and financial communications firm, to implement and execute a comprehensive investor relations and communications program.
On March 26, 2020, Tetra announced the results of a survey conducted among US and Canadian patients and physicians which validated the primary endpoint of the SERENITY© pivotal trial. The results confirm that the primary endpoint in the SERENITY© clinical trial of cancer cachexia is accurate.
On May 22, 2020, the Corporation completed a public offering deal for aggregate gross proceeds of $9,149,660. A total of 35,191,000 units were sold at a price of $0.26 per unit. Each unit consists of one Common Share and one transferable Common Share purchase warrant, with a whole warrant entitling the holder to purchase one full Common Share at a price of $0.32 per Common Share for a period of 36 months following the closing date.
On June 3, 2020, Tetra announced the launch of TALLC, a new corporation incorporated under the Business Corporations Act (Québec) focused on the development of TA-A001 a non-opioid, non-steroidal small molecule that selectively activates CB2 receptors mediating the human anti-inflammatory response. See "Corporate Structure – Equity Method Investment – TALLC Corporation Inc." above for additional information on TALLC.
On June 4, 2020, Tetra and Storz & Bickel, a subsidiary of Canopy Growth Corporation, a world-leading diversified cannabis, hemp and cannabis device company, announced that they have finalized a definitive commercial sales agreement for the sale of the Mighty Medic device as part of the CAUMZ[TM] -kit drugdevice combination product. See "Description of the Business – Advanced Cancer Pain and Cancer Cachexia: CAUMZ[TM] " below for additional information on the Mighty Medic device.
On June 5, 2020, Tetra announced the long-awaited resumption of its QIXLEEF[TM] - PLENITUDE© clinical trial, the signing of a definitive commercial sales agreement for the sale of the Mighty Medic device as part of the CAUMZ[TM] -kit drug device and the reassessed timeline to initiate CAUMZ[TM] -REBORN© clinical trial. See "Description of Business – Advanced Cancer Pain: QIXLEEF™: PLENITUDE[©] Target Intended Uses" and "Description of the Business – Advanced Cancer Pain and Cancer Cachexia: CAUMZ[TM] " below for additional information.
On June 22, 2020, Tetra announced Greg Drohan’s resignation from the Board.
On June 25, 2020, Tetra announced the grant of an aggregate of 1,535,583 stock options to certain officers, consultants, and employees of the Corporation. Each option is exercisable into one Common Share of the Corporation at a price of $0.21 per Common Share. The options vested on grant and will expire on June 24, 2023. See "Capital Structure – Market for Securities – Prior Sales" below for additional information.
On July 9, 2020 , Tetra appointed Steve Edgett as a strategic advisor to the CEO and the Board with a mandate to advise on strategic and capital markets aspects of the Corporation’s activities and to aid in the advancement of Tetra’s key programs: ARDS-003, QIXLEEF[TM] and CAUMZ[TM] .
On July 16, 2020 , Tetra announced the FDA’s favourable review of the Corporation’s Pre-Investigational New Drug application for ARDS-003. The review was conducted within the framework of the Coronavirus Treatment Acceleration Program. FDA’s positive review confirms that the rodent and nonrodent species can be used in the nonclinical toxicology study and will provide a relevant assessment of the safety profile of the new drug (ARDS-003) prior to first-in-human trials. This path is expected to result in decreased costs to run the drug development program assuming that the Corporation is able to leverage the toxicology reports for ARDS-003 and the PPP-003 ocular, although the Corporation is not yet able to measure the potential cost savings. The FDA also provided detailed feedback on the proposed Phase I and Phase II clinical trial protocols. As the FDA also stated that no additional nonclinical safety studies would be required, Tetra is planning to initiate its study in COVID-19 patients in parallel to conducting the Phase I trial in healthy volunteers once it has completed its regulatory process, subject to the Corporation
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obtaining sufficient financing to initiate such study and trial within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information. Also refer to "Description of Business – Inflammation: ARDS-003 Treatment of Sepsis and Covid-19" below for additional information on ARDS-003.
On August 6, 2020 , Tetra announced that it had received support from Malta Enterprise, the national economic development agency of the Government of Malta, to open its European office in Malta. The Corporation has created a wholly owned subsidiary called Tetra Bio-Pharma Europe Ltd. to expand its clinical and regulatory activities as well as its future commercial operations for QIXLEEF[TM] . See "Corporate Structure – Tetra Bio-Pharma Inc." above for additional information on Tetra Bio-Pharma Europe Ltd.
On August 4, 2020 , Tetra completed its graduation to the TSX following which the Corporation’s Common Shares and listed warrants began trading on the TSX under the symbols "TBP", "TBP.WT", "TBP.WT.A" and "TBP.WT.B". In connection with the Corporation’s graduation to the TSX, the Corporation’s Common Shares and listed warrants were voluntarily delisted from the TSXV on August 4, 2020.
On August 17, 2020 , subsequent to the signing of the binding letter of intent announced on July 23, 2020, Tetra and Mondias entered into a Share Exchange Agreement ("SEA") pursuant to which Mondias agreed to acquire all of the issued and outstanding shares of Lumiera. This transaction closed on October 27, 2020. See "Discontinued Operations – Lumiera and HempCo" above for additional information.
On August 18, 2020 , Tetra awarded a contract to Dalton Pharma Services for the manufacturing of its HU-308 molecule, the active pharmaceutical ingredient ("API") and its intravenous, sterile, finished drug product ARDS-003. Pursuant to the agreement, Dalton Pharma Services will manufacture, by using current good manufacturing practices ("cGMP"), the HU-308 molecule, and will test and release batches according to agreed specifications. See "Description of Business – Inflammation: ARDS-003 Treatment of Sepsis and Covid-19" below for additional information on ARDS-003.
On August 27, 2020, Tetra announced it had completed on schedule a cannabidiol ("CBD") metabolites study in humans who were administered QIXLEEF[TM] . The data emphasized that QIXLEEF[TM] has a safe, well tolerated profile and rapid and high degree of absorption favouring higher efficacy at a lower dose, compared to oral administration. Defining THC and CBD metabolites in blood is a critical step for the FDA and Health Canada to characterize the safety profile of the drug product in patients consuming cannabis.
On September 2, 2020, Tetra announced that it had initiated the in-life phase of QIXLEEF[TM] clinical trial having overcome major hurdles including securing GMP grade cannabis drug product from Aphria Inc., a Health Canada licensed producer of medical cannabis products.
On September 4, 2020, Tetra announced the appointment of Dania Scott as Senior Vice President – Commercial Strategy. She is the lead executive responsible for the global commercialization of QIXLEEF[TM] .
On September 11, 2020, Tetra announced the appointment of Jean-François Boily, CPA, CA, as Chief Financial Officer and member of the Corporation’s executive team. Mr. Boily took over from Sabino Di Paola, CPA, CA who joined Tetra in 2019 and resigned in September 2020.
On September 17, 2020, Tetra announced the appointment of Ms. Dale Weil and Dr. Brent Norton to the Board. The Corporation also announced the appointment of Dr. Graham Wood, Ph.D., as Chief Operating Officer and the appointment of Steeve Neron as Chief Commercial Officer, who transitioned from his previous role as Tetra’s Chief Operating Officer.
On September 30, 2020, Tetra announced that it obtained exclusive Canadian rights from a USA strategic partner to commercialize Dronabinol Soft Gel capsule. The exclusivity rights come with the
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Dronabinol data pack, which enabled Tetra to submit a New Drug Submission ("NDS") application in December 2020. Tetra's first DIN for the THC-based prescription drug was submitted in December 2020.
On October 7, 2020, Tetra provided an update on its commercial strategy to bring innovative therapies to patients suffering from chemotherapy induced nausea and vomiting ("CINV"). In the year ended November 30, 2020, Tetra submitted a marketing application to obtain a prescription DIN for the Dronabinol Soft Gel capsule Canadian exclusive rights. Tetra expects approval in the first half of 2021.
On October 21, 2020, Tetra announced the acquisition of exclusive global technology rights of Adversa® from IntelGenx. Adversa® is a Mucoadhesive Delivery Technology to be used in Tetra’s PPP-002 (Dronabinol) drug candidate. Tetra plans to file a 502(b)(2) application in the US to obtain a DIN for a THC-based prescription drug in early 2022, subject to the Corporation obtaining sufficient financing to file such application within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information. Tetra will use this acquisition for a cannabinoid derived medicine for patients experiencing CINV.
On November 2, 2020, Tetra announced the acquisition of 14,625,000 Mondias Shares in connection with the completion of the divesture of Lumiera to Mondias, which Tetra previously announced on October 27, 2020. See "Discontinued Operations – Lumiera and HempCo" above for additional information.
On December 2, 2020, Tetra announced that it completed Investigational New Drug ("IND") enabling toxicology, clearing the way for human clinical trials for its novel drug candidate ARDS-003, a synthetic cannabinoid-derived therapeutic aimed at preventing and treating the serious and life-threatening inflammatory response that is associated with COVID-19, sepsis, septic shock, and others.
On December 16, 2020, Tetra announced it conducted a Type B meeting with the FDA for an inhaled THC-based innovative drug for the treatment of CINV. This new drug will be part of Tetra's global commercialization strategy to maintain a lead position in the treatment of CINV in patients with cancer who have failed to respond adequately to conventional anti-vomiting treatments. This inhaled THC drug, along with the Dronabinol Adversa® drug product, will target global markets.
On December 30, 2020, Tetra announced the filing of a NDS for REDUVO™, Dronabinol Soft Gel capsules, in Canada. This new submission would provide Tetra with its first DIN for a THC-based prescription drug targeting patients suffering from CINV. REDUVO™ will be indicated in AIDS-related anorexia associated with weight loss and severe nausea, and vomiting associated with cancer chemotherapy.
Recent Developments
On January 29, 2021, Tetra announced the FDA has cleared the IND application for QIXLEEF[TM] , allowing Tetra to initiate its REBORN1©[TM] Clinical trial for patients with cancer. REBORN1©[TM] is a 10-week openlabel randomized study to evaluate the effect of inhaled QIXLEEF[TM] compared to morphine sulfate immediate release, to improve fast onset of pain relief for advanced cancer pain.
On February 3, 2021, Tetra announced the creation of a new wholly owned subsidiary called ENJOUCA Inc. See "Corporate Structure – Tetra Bio-Pharma Inc." for addition information on ENJOUCA Inc.
On February 3, 2021, Tetra announced the closing of its previously disclosed non-brokered private placement of units of the Corporation. A total of 11,085,064 units were issued by the Corporation at a price of $0.17 per unit for aggregate gross proceeds of approximately $1,885,000. Each unit consists of one Common Share and one full Common Share purchase warrant of the Corporation. Each warrant entitles the holder thereof to acquire one Common Share on payment of $0.21 to the Corporation for a period of 24 months from the closing of such non-brokered private placement, expiring on February 3, 2023, subject to adjustment in certain circumstances. The offering was conducted with a group of
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strategic investors including Dr. Michael Nashat, a co-founder and former President and Chief Executive Officer of TerrAscend Corp. Dr. Nashat is also a co-founder of OnPharm Independent Pharmacy Group, one of the largest independent non-banner groups in Canada and the managing partner of RxInfinity Inc.
Management Update on COVID-19 Pandemic
The Corporation continues to adapt and navigate through a period of widespread uncertainty. The pandemic provided Tetra with a silver lining – a new drug candidate which our scientists, associated with Dalhousie University, had been studying for over 12 years. ARDS-003 is a new molecular entity formulated as a sterile injectable nano-emulsion containing the drug common name HU-308. This novel therapeutic intervention treats hyperinflammatory states including those seen in viral infections such as COVID-19, as well as other disease-states associated with dysregulation of the immune system and elevated levels of inflammatory cytokines, such as sepsis. The Corporation chose to fast-track ARDS-003 drug development program as it will benefit from FDA’s expedited review under the framework of the Coronavirus Treatment Acceleration Program.
Management believes that under an accelerated timeline, it is possible that the submission of marketing application, for conditional approval by Health Canada could be ready during the fourth quarter of fiscal 2021, subject to the Corporation obtaining sufficient financing to submit such marketing application within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information. This estimated accelerated timeline is based on Health Canada's policy to expedite the review of a drug product shown to improve the outcome of life-threatening conditions, such as COVID-19.
It should be noted that the active molecule in ARDS-003 (HU-308) is also being studied to improve inflammation and pain in certain diseases such as uveitis, painful dry eye, and other painful ocular conditions. This drug program is called PPP-003. Both ARDS-003 and PPP-003 have the same active substance, which represents a great advantage to accelerate the PPP-003 drug development by leveraging the data collected in the clinical development of ARDS-003.
Regarding drug candidate QIXLEEF[TM] , both Phase II and Phase III clinical trials are expected to be conducted from USA-based private clinics which are less affected by the pandemic. The Phase III trial is also expected to be performed in Europe. The Phase II trial is expected to be completed in 2021, Phase III trial in early 2022 and the new drug application ("NDA") submitted in 2022, subject to the Corporation obtaining sufficient financing to complete such clinical trials within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information.
While CAUMZ[TM] – SERENITY© and HCC-011 drug development programs remain part of Tetra’s priorities, current and prospective investors are cautioned that these programs have experienced and are expected to have additional delays. To mitigate this risk, the Corporation re-established its priorities to fast-track the development of ARDS-003, advance QIXLEEF[TM ] - PLENITUDE[©] and CAUMZ[TM] – REBORN[©] .
The Corporation's re-established short-term objectives are:
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ARDS-003 for treatment of sepsis and prevention of Acute Respiratory Distress Syndrome ("ARDS");
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Reduvo[TM] portfolio for chemotherapy-induced nausea and vomiting
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QIXLEEF[TM] for advanced uncontrolled cancer pain;
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QIXLEEF[TM] (REBORN1[©] ) for fast pain relief in breakthrough pain;
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CAUMZ[TM] (REBORN[©] ) for fast pain relief in breakthrough pain; and
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Ensure readiness of PPP-003 to initiate trial in patients with a co-development partner.
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DESCRIPTION OF THE BUSINESS
General Description
Tetra is a biopharmaceutical pioneer in immunomodulator drug discovery and development aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Tetra’s evidence-based scientific approach has enabled us to develop a pipeline of drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what we do, Tetra is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
The Corporation has a robust pipeline of multi patented formulations and drug delivery systems with a unique portfolio of assets in early research and development phase to advanced stage clinical programs. The Corporation develops drug candidates based on clinical trials authorized in Canada by Health Canada, in the United States by the FDA, and in Europe by the EMA. Tetra's products have the potential to serve many unmet medical needs of patients in the U.S., Canada, Europe, and Japan.
A successful biopharmaceutical company requires a pipeline of patent protected molecules, formulations, and various delivery systems that can become its next generation therapeutics. As Tetra continues its focus as a "pure play" biopharmaceutical company, the Corporation’s intention is to grow rapidly into a fully vertically integrated pharmaceutical company whereby Tetra Bio-Pharma Inc., the parent company, will be responsible for the development and commercialization of the novel drugs developed by its two wholly owned subsidiaries, PhytoPain Pharma Inc. and Panag Pharma Inc.
The Corporation develops drugs that adhere to Canadian, USA and European prescription drug regulations. The initial focus is in the therapeutic areas of inflammation, oncology, ophthalmology, and pain in humans through a robust pipeline using multiple delivery systems. The secondary focus is veterinary ophthalmology. To distinguish itself, the Corporation’s business model is supported by three key pillars:
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Clinical trials: Clinical trials are regulated by the drug registration authorities of each country and are an essential component of Tetra's drug development programs. Pioneering research initiatives form the cornerstone upon which the Corporation is built.
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Patented formulations and delivery systems: The Corporation has both granted patents and filed patent applications. In the ophthalmic space, Tetra has patents issued and further patents have been filed. A separate family of patents has been filed to protect the delivery of cannabis derived drugs via inhalation. The Corporation uses advanced medical devices, formulations and delivery systems to optimize patient care.
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Pharmaceutical quality: Quality is at the forefront of what the Corporation does. Tetra is dedicated to providing exceptional pharmaceutical products to ensure efficacy and safety.
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After the mycotoxin incident which occurred in the first quarter of 2019, Tetra no longer had any drug candidates in a clinical trial after terminating all trials involving drug products derived from cannabis. To rapidly create clinical stage drug candidates, Tetra accelerated the preclinical development of its 2[nd] generation inhalation drug therapy, CAUMZ[TM] asset, and initiated the manufacturing of the HU-308 API of PPP-003 in a GMP compliant facility. In parallel, Tetra continued to developed methods to improve the quality of QIXLEEF[TM] . The 2019 advancements allowed Tetra, in 2020, to develop ARDS-003 from its HU-308 API and complete the clinical trial enabling nonclinical safety studies for HU-308, required by the FDA and Health Canada, to allow initiation of clinical trials in humans. In addition, after receiving the raw material supply for QIXLEEF[TM] in the fourth quarter of 2020, Tetra was able to launch the treatment phase of the PLENITUDE[©] clinical trial.
For the fiscal year 2021, Tetra expects to complete the activities mentioned in the below table. These planned activities were developed based on estimates and assumptions made by management in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as factors that management believe are appropriate. Refer to the section entitled "Caution Regarding Forward-Looking Statements" for cautionary statements regarding our estimates and assumptions. Tetra is in constant communication with its vendors and partners monitoring COVID-19 and its impact on current projects. Based on the Corporation's core competencies, Tetra is aiming to complete the following:
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Inflammation: ARDS-003 Treatment of Sepsis and COVID-19
Tetra’s drug candidate, ARDS-003, is an optimized sterile nano-emulsion of a synthetic compound that meets pharmaceutical quality standards for an intravenously administered drug. This new therapeutic is aimed at preventing and treating the serious, life-threatening inflammatory response associated with COVID-19 and sepsis.
On October 20, 2020, the Corporation announced it completed preclinical studies demonstrating an antiinflammatory effect of its new drug, ARDS-003, in an animal model of lung injury known as "induced pulmonary fibrosis". Pulmonary fibrosis occurs when lung tissue is scarred, often as a result of extreme or prolonged inflammation. This scarring results in a stiffening of lung tissue that may lead to respiratory problems and, in extreme cases, respiratory failure. The results of Tetra’s preclinical studies demonstrate that ARDS-003 reduces levels of key inflammatory markers, such as the cytokine interleukin 6 (IL-6), and proinflammatory cytokines (TNFα, IL-1β). Importantly, this anti-inflammatory effect was reflected in reduced fibrosis measures when the lung tissue was analyzed after 20 days of treatment.
To further confirm that a comparable effect may occur in humans, ARDS-003 was studied using models of inflammation in human lung cells and was similarly found to reduce the activation of fibrosis-associated inflammatory pathways. Together, these results present positive evidence for the use of ARDS-003 as an experimental therapeutic treatment for patients with severe inflammatory disorders caused by COVID-19.
Further, on October 22, 2020, the Corporation announced that it signed a research collaboration agreement with Targeted Pharmaceutical to evaluate our ARDS-003 at the George Mason University's NCBID. As a result, ARDS-003 is being evaluated in Sars-CoV-2 infected animals to further understand its potential as a preventive and therapeutic medicine. The research team will gain tremendous knowledge on the role which a cytokine release modulating drug may play in COVID-19 infections, which the Corporation hopes will generate additional new intellectual property for the Corporation.
The NCBID is a leading institute conducting pioneering research on infectious diseases including diagnostic, therapeutic, and vaccine development. The NCBID at the George Mason University focuses on host-pathogen interactions using proteomics and nanotechnology. NCBID manages the Biomedical Research Lab, one of thirteen Regional Biocontainment Laboratories in the USA 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 biological threat agents.
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On December 2, 2020, the Corporation announced it completed IND-enabling toxicology. Successful completion of the non-clinical safety studies is required to submit a Clinical Trial Application ("CTA") in Canada and an IND in the USA for ARDS-003 for a Phase I study in humans. The non-clinical safety data demonstrate that the API and the sterile injectable drug product ARDS-003 are both safe for use in humans. The toxicology program was designed to meet the international standards established by the International Council for Harmonisation for enabling a first-in-human clinical trial and included general toxicology in two species, specific studies to assess toxicity in major organ systems (cardiovascular, respiratory, nervous system) and genotoxicity.
The clinical trial enabling regulatory process is different for a Sars-CoV-2 indication. Regulatory agencies in Canada and the USA have reduced the CTA/IND review periods to approximately 10 days. This period does not allow the agencies to review the nonclinical safety package of a new molecular entity. Therefore, prior to submitting the CTA/IND request, the Corporation must first provide the nonclinical safety data in a pre-CTA/IND format.
Once human studies are launched, the research and development team will continue to advance the nonclinical safety studies to ensure readiness for an eventual Phase II trial. Completion of these nonclinical safety studies is required to support a new drug submission/application in Canada/USA. The nonclinical studies include longer term repeat dose toxicology, as well as developmental, fertility, and early embryonic toxicology.
The Corporation believes that this drug will play a significant role in addressing the needs of the antiinflammatory drug markets. Though, as with any new drug candidate, ARDS-003 has not yet been shown to be effective in the prevention or treatment of inflammatory conditions.
Chemotherapy Induced Nausea and Vomit Reduvo[TM] Adversa[®]
The Corporation has a portfolio of potential drug products that target chemotherapy-induced nausea and vomiting. The portfolio includes the following three products: Reduvo™ soft get capsule, Reduvo™ Adversa® mucoadhesive tablet, and Reduvo™ inhaled THC-based product.
As previously announced, the Corporation signed a definitive agreement to acquire the Canadian exclusive rights to Dronabinol soft gel capsules with a USA-based strategic partner. Dronabinol soft gel capsules are prescribed for the treatment of HIV-related anorexia associated with weight loss and CINV. The agreement comes with a complete Dronabinol Data Pack. On December 30, 2020, the Corporation submitted its first NDS for the Reduvo™ soft gel capsules to Health Canada to obtain approval and a DIN for the prescription drug.
Furthermore, the Corporation entered into an amended and restated license agreement with IntelGenx Corp., a Canadian leader in pharmaceutical films, to acquire additional worldwide exclusive rights for the mucoadhesive delivery technology for its PPP-002 drug candidate. Tetra is planning to file a 505(b)(2) application in the USA in 2022, subject to the Corporation obtaining sufficient financing to file such application within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information. This new technology, namely the Reduvo™ Adversa® mucoadhesive tablet, will offer more flexibility to patients who are experiencing issues associated with swallowing soft gel capsules. While the indication of CINV will remain the same as for the soft gel, this new technology is expected to limit the first-pass metabolism, improve bioavailability, as well as reduce gastro-intestinal exposure and related side-effects, and finally enhance product stability. Data indicate that the side-effect profile may be lessened without affecting efficacy. Finally, on October 7, 2020, the Corporation announced that it is working on a third drug candidate to add to its CINV portfolio, an inhaled THC formulation using its Mighty Medic® - dosing capsule kit intellectual property. This is the same technology used by Tetra for both CAUMZ™ and QIXLEEF™.
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Advanced Cancer Pain: QIXLEEF™: PLENITUDE[©] Target Intended Uses
QIXLEEF™ is a botanical drug product with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The product is inhaled through a medical device (vaporizer) and will be first indicated in advanced cancer patients with inadequately controlled pain.
As an addition to standard end-of-life care, QIXLEEF[TM] aims to improve quality of life and help reduce the pain of adult terminal cancer patients. PLENITUDE[©] , a Phase II clinical trial cleared by the FDA, is a 4- week trial to evaluate the safety and effectiveness of inhaled QIXLEEF[TM] on uncontrolled cancer pain in 78 adult patients with symptoms related to advanced, incurable cancer, and uncontrolled cancer-related pain. In order to prevent regulatory delays, this clinical trial has been divided into two segments PLENITUDE[©] to be completed in the United States, and PLENITUDE2[©] to be completed in Europe. On September 2, 2020, the Corporation announced that it has initiated the in-life Phase II of the clinical trial operations.
In August 2020, Tetra announced that it had a first meeting with the Malta Medicines Authority which resulted in clarifications and the identification of milestones necessary to complete a clinical trial application compliant with the requirements of both local and European Authorities. Tetra intends to submit the PLENITUDE2[©] clinical trial application in the EU in early 2021, subject to the Corporation obtaining sufficient financing to submit such application within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information. The trial will be performed in Europe to expand the claims associated with the prescription of QIXLEEF™.
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Advanced Cancer Pain and Cancer Cachexia: CAUMZ[TM]
CAUMZ[TM] is synthetic drug product which is inhaled through a medical device (vaporizer). The drug products in the CAUMZ[TM] category include:
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I. REBORN©: treatment of breakthrough pain;
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II. SERENITY©: treatment of cancer cachexia; and
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III. Fibromyalgia.
CAUMZ[TM] will be studied in two indications using the clinical trials called: REBORN[©] and SERENITY[©]
REBORN© is designed to assess the safety and efficacy of CAUMZ™ and demonstrate its ability to reduce the use of opioids in patients suffering from breakthrough pain. SERENITY[©] is designed to evaluate the efficacy of CAUMZ™ to improve health-related quality of life of patients with uncontrolled symptoms related to advanced cancer. Tetra has prioritized accelerating the REBORN[©] clinical trial over the development of SERENITY© to focus on speed-to-market and at a lower clinical development cost.
The REBORN© clinical trial was designed with two parts. REBORN1© is aimed at testing the hypothesis and helping to determine the required sample size to demonstrate superiority. REBORN2[©] is aimed at comparing the speed of onset of pain relief to that of a fast release morphine formulation. This trial will
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first be performed with QIXLEEF™ and subsequently with CAUMZ™. The outcome of this study will scientifically apply to both drugs through Tetra’s bridging[5] strategy.
As the Corporation continues to advance CAUMZ™ and QIXLEEF™ towards the ultimate milestone of marketing approval, Tetra plans to initiate Phase III and NDA-filing enabling toxicology for both drugs. In addition, Tetra plans to initiate research studying the interactions between the active medicinal ingredients which is required for the NDA of a drug-drug combination product and a trial in patients with advanced cancer.
Lastly, to accelerate CAUMZ™ in 2021, Tetra entered into a manufacturing agreement with a USA-based drug manufacturer for the manufacturing and scale-up of CAUMZ™. With this agreement in place, the Corporation can supply the GMP pharmaceutical CAUMZ™ for its clinical trials and future scale-ups will ensure readiness for the projected marketing in 2023 or 2024, subject to the Corporation obtaining sufficient financing to complete such clinical trials and future scale-ups within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information.
The Mighty Medic is a first battery-powered, Class 2 medical vaporizer device, approved by Health Canada. Mighty Medic vaporizer has been used in Tetra's research with CAUMZ™ and QIXLEEF™ including Phase I clinical trials and is being used in the SERENITY[©] , REBORN[©] and PLENITUDE[©] clinical trials.
As at the date of this AIF, further development on fibromyalgia treatments remains a secondary focus for the Corporation and will be revisited following further advancements with CAUMZ[TM] .
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The SERENITY© clinical trial will evaluate the efficacy of CAUMZ[TM] to improve health-related quality of life of patients with uncontrolled symptoms related to advanced cancer, cachexia, and incurable malignancy secondary endpoints. Cachexia is defined as "multifactorial syndrome characterized by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment". 50% to 80% of cancer patients experience cachexia during their disease[6] . The most intense symptoms reported by the cachectic patients are lack of appetite, fatigue, diminution of well-being, sleep, and increase in pain.
The goal of the trial is to:
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assess the effect of CAUMZ[TM] to improve on cancer pain and pain management; symptom burden; functional and nutritional status; and
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evaluate the effect of CAUMZ[TM] on safety and tolerability; patient confusion and illness understanding; modification in amount and type of concomitant medications; treatment satisfaction for caregivers; pharmacoeconomic impact.
Tetra has prioritized accelerating REBORN© over the development of SERENITY© to focus on speed- tomarket. As at the date of this AIF, no significant progress has been made on SERENITY© as the Corporation has focused on the development of ARDS-003 and QIXLEEF[TM] .
Ophthalmology – PPP-003 (HU-308): Ocular formulations
5 Bridging strategy: scientific approach used to demonstrate to regulators that patients receive the same medicinal ingredients using either QIXLEEF or CAUMZ.
6 Source : Josep M. Argilés, PhD Nefertiti Campos, PhD José M. Lopez-Pedrosa, PhD Ricardo Rueda, MD, PhD Leocadio Rodriguez-Mañas, PhD. Https://www.jamda.com/Article/S1525-8610(16)30113-X/Abstract.
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In the fourth quarter of 2020, the Corporation completed several nonclinical toxicology studies for the ARDS-003 and PPP-003 drug development programs, in which HU-308 is the API. Results from these studies will support further Phase I and Phase II trials in ophthalmic disease patient populations. The Corporation will be required to assess the local tolerance of the eye product formulation (e.g., administration-site allergic or other reactions) and the degree of systemic absorption in animals. The Corporation expects to launch its ophthalmic drug program in 2021.
Depending on its financing in 2021, Tetra may decide to initiate a proof-of-concept Phase II trial in proliferative vitreoretinopathy or uveitis patients. A prove-of-concept trial is a smaller trial and involves a lower budget. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See " Forward-Looking Statements " and " Risk Factors " for additional information.
PPP-003v (HU-308v) – Veterinary Market
In partnership with a veterinary ophthalmological team, Tetra initiated a Phase II clinical trial in domestic dogs, as a proof-of-concept for its PPP-003v drug candidate for eye pain. This study involves domestic pets and not laboratory animals with a goal of providing pet owners with an alternative ophthalmic pain medication for indolent corneal ulcers. Completion of enrollment was planned by April 30, 2020, however, since the COVID-19 measures restricted the ability of owners to bring their pets to the veterinary clinic for trial procedures, this impacted Tetra's ability to complete enrollment as projected by May 1, 2020. An Experimental Studies Certificate ("ESC") is granted for a period of one year under the veterinary drug regulations, therefore all study-related activities, i.e., treatment and follow-ups, must be completed within that 1-year period. As a result of the COVID-19 enrollment halt, Tetra proactively submitted a renewal for the ESC to complete enrollment once COVID-19 restrictions are lifted. On April 30, 2020, Health Canada's VDD granted the ESC for an additional year. When enrollment halted due to COVID-19, 50% of the study subjects had completed the treatment and follow-up phase of the clinical trial. None of the subjects in the study had medication-related adverse effects. The safety and tolerability profile of the PPP-003v ocular drug product was part of the new ESC application for study renewal as well as new data regarding the sterility.
As a result of the ongoing COVID-19 pandemic, the Corporation has experienced delays in launching its clinical trials for PPP-003 pending availability of clinical sites and the necessary financing to complete the trials. Tetra will submit a subsequent renewal for the ESC in order to allow it to pursue its clinical trials after the expiry of the ESC granted by Health Canada's VDD on April 30, 2020. Assuming that the Corporation remains able to enroll companion animals in the study, the Corporation expects to complete the trial in early 2022, subject to the Corporation obtaining sufficient financing to complete such trial within the anticipated timeline. There can be no assurance that the Corporation will be able to secure additional financing on reasonable terms or at all. See "Forward-Looking Statements" and "Risk Factors" for additional information.
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Biopharmaceutical Products Pipeline
The table below summarizes all clinical/regulatory works we are currently performing on all our product assets:
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Patents
Tetra currently holds 8 patents registered in Europe, Australia, Canada and the US listed in the table below. These patents cover pharmaceutical compositions for use in the treatment of inflammation and/or pain.
Tetra/Panag Patents
| Patent Title | Country/ Region | Application No. (Patent No.) |
Filing Date (Issue Date) |
|---|---|---|---|
| Compositions for Treatment of Ocular Inflammation and Pain |
United States | 61/906,694 | November 20, 2013 (January 24, 2020) |
| Compositions and Methods for Treatment of Ocular Inflammation Pain |
PCT | PCT/CA2014/000841 | November 20, 2014 |
| Canada | 2,931,039 | May 18, 2016 | |
| Europe Regional Phase |
14864137.6 3071193 |
June 20, 2016 (August 28, 2020) |
|
| United States Reg (CIP) |
14/722,991 (9,549,906) | May 27, 2015 (January 24, 2017) |
|
| PCT | PCT/CA2016/050603 | May 27, 2016 | |
| Australia National Phase |
2016268872 | December 21, 2017 |
|
| Canada National Phase |
2,986,588 | December 21, 2017 | |
| Europe Regional Phase |
16799004.3 | December 21, 2017 | |
| Topical Liposome Compositions Containing Phenolic Anti-Inflammatory Agents and Their Methods of Preparation |
Patent Cooperation Treaty (PCT) |
WO 2014/085914 Al | December 6, 2013 |
| (December 12, 2014) |
|||
| USA |
9775789 B2 | December 6, 2013 (October 3, 2017) |
|
| Methods for Treatment of Interstitial Cystitis | US Provisional | 62/586,516 | November 15, 2017 |
| US Regular | 16/190,450 | November 14, 2018 |
|
| Patent Cooperation Treaty (PCT) | CA2018/051438 | November 14, 2018 |
|
| Europe | 18878853.3 | June 19, 2019 | |
| Australia | 2018367945 | June 26, 2019 | |
| Canada | 3048926 | June 28, 2019 | |
| Japan | 2019-542098 | July 30, 2019 |
|
| South Korea | 10-2019-7023798 | August 13, 2019 |
|
| Post-treated Cannabis Plant Residue as Prebiotic |
US Provisional | 63046915 | July 1, 2020 |
| Topical Liposomal Flavonoid and Cannabinoid Compositions for Treating and Prevention Various Skin Disorders |
Canada | PCT/CA2020051231 | September 11, 2020 |
| Methods, Processes, and Compositions for Improved Preparation of HU308 and HU433 |
US Provisional | 63082986 | September 24, 2020 |
| Cannabis Compositions and Methods | Canada | 3,027,876 | September 24, 2020 |
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Principal Products or Services
The Corporation is currently devoting its resources to research and development. Upon successful completion of clinical trials and approval of the Corporation's prescription drugs, the Corporation plans to:
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Enter into licensing agreements with pharmaceutical companies in various regions of the world for the commercialization of its prescription drugs. Entering into such agreements will be dependent on regulatory approval of various regulatory bodies such as Health Canada's Therapeutic Products Directorate ("TPD"), the FDA, and other such entities. Through these licensing agreements, Tetra expects to generate revenues from one or a combination of the following: (i) upfront payments for the right to exclusively commercialize a product in a specific territory where such product(s) will have been approved, (ii) royalties on the sales of licensed product(s), (iii) milestone payments on the sales of licensed product(s), and (iv) commercial milestones.
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Commercialize, on its own, via partnerships and/or through reseller(s), such drugs that will be aimed towards the pharmacies, and any other channels where such drugs will be permitted to be sold by local authorities.
Competition
The pharmaceutical industry is highly competitive and subject to rapid change. The industry continues to expand and evolve as an increasing number of competitors and potential competitors enter the market. Many of these competitors and potential competitors have substantially greater financial, technological, managerial and research and development resources and experience than the Corporation. Some of these competitors and potential competitors have more experience than the Corporation in the development of pharmaceutical drugs, including validation procedures and regulatory matters. Other companies working in cannabinoid research may develop drugs targeting the same diseases that the Corporation is focused on that are competitive or superior to Tetra's drug candidates. In addition, there are non-FDA approved cannabis/cannabinoid preparations being made available from companies in the medical cannabis industry, which may be competitive to Tetra's drugs. If Tetra is unable to compete successfully, its commercial opportunities will be reduced and Tetra's business, results of operations and financial conditions may be materially harmed.
Compared to the Corporation, many of its competitors may have significantly greater financial, technical and human resources at their disposal. As a result of these factors, competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before the Corporation, which may limit the Corporation's ability to develop or commercialize its drug candidates. Competitors may also develop drugs that are safer, more effective, more widely used and less expensive, and may also be more successful in manufacturing and marketing their products. These advantages could materially impact the Corporation's ability to develop and commercialize its drugs successfully.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
Employees
As of November 30, 2020, Tetra had 33 employees.
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DIVIDENDS
Other than the dividend-in-kind of the North Bud Shares which was paid on September 12, 2018, the Corporation has not paid dividends on its Common Shares to date and it currently intends to retain its future earnings, if any, to fund the development and growth of its business. See "Risk Factors – Risks Related to the Corporation's Securities – No Paid Dividends" below for additional information.
REGULATORY OVERVIEW
Tetra’s operations are subject to a variety of laws, regulations, guidelines and policies relating to the manufacture, import, export, management, packaging/labelling, advertising, sale, transportation, distribution, storage and disposal of its drug candidates but also including laws and regulations relating to drugs, controlled substances, health and safety, the conduct of its operations and the protection of the environment. While, to the knowledge of management, Tetra is currently in material compliance with all such laws, any changes to such laws, regulations, guidelines and policies due to matters beyond the control of Tetra may adversely affect its operations.
The Corporation is required to comply with the requirements of the various regulatory agencies (such as the TPD of Health Canada) in jurisdictions where the Corporation intends to register its drugs as prescription drugs, as well as its non-prescription drug products. Any entity planning to commercialize pharmaceutical drugs is required to follow and adhere to key regulatory requirements and paths for prescription drugs, as well as non-prescription drugs. Clinical trials or clinical studies are performed to evaluate the safety and efficacy of new products (drug or medical devices) or for a new intended use of an already approved product. Health Canada and the FDA are involved in the regulation of the sale (distribution) and importation of unapproved drugs for use in human clinical trials.
Clinical trials fall under the responsibility of each jurisdiction's specific regulatory body:
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Health Canada:
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Controlled substances, botanical and synthetic drugs: the TPD; and
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oMedical devices: Medical Device Bureau. -
FDA:
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Controlled substances, botanical and synthetic drugs: the Center for Drug Evaluation and Research; and
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Medical devices: Center for Devices and Radiological Health.
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EMA[7] :
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Controlled substances, botanical and synthetic drugs; and
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oMedical devices.
In order to be able to initiate a clinical trial in humans, an investigational product must conform to the requirements defined by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and any country-specific requirements.
The Corporation performs research to understand the dose response and frequency of administration as well as the pharmacodynamics response. This data, along with the safety data, is used to define the dose range that can be tested in humans.
The general phases of drug development are:
- Discovery and lead selection;
7 The respective agency varies by country.
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Preclinical (nonclinical) pharmacology and toxicology;
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Phase 1: safety testing in healthy human volunteers;
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Phase 2: dose finding to define the potential efficacious dose and frequency of administration;
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Phase 3: trials performed to demonstrate the safety and efficacy of the product in the intended patient population and usually involve several hundred to several thousand participants. These trials are the key studies used to obtain marketing approval. In a lifethreatening indication, regulators can accept a single Phase 3 trial under the condition that the Corporation performs a Phase 4 trial as a post-marketing requirement; and
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Phase 4: also known as post-marketing trials. Trials are performed either as a commitment for marketing approval, as part of the pharmacovigilance for a product, or as part of the marketing promotion for a new drug.
Each clinical trial phase can only be initiated after having received authorization[8] from the applicable regulatory authority.[9] This includes Phases 1, 2, 3 and Expanded Access. A Phase 4 trial only requires approval from the regulatory authority if the use of the drug is not part of the marketing approval intended use. Discovery and toxicology phases do not require approval by regulatory authorities.
During the drug development process, the Corporation prepares a study report. In Canada, once the last study required for the submission is released, the NDS application is completed and submitted to the TPD. After submitting the NDS application, the file undergoes a screening process prior to being accepted for review. The TPD has 45 calendar days from receipt to complete the screening review process. If granted a Priority Review or applications accepted for consideration under the Notice of Compliance/conditional policy, the screening period is reduced to 25 calendar days. Submission review will cease upon issuance of the Qualifying Notice. The target for the average time to reach first decision on a NDS application is 300 calendar days. The FDA has a similar review process for NDAs.
The Cannabis Act passed into law on October 17, 2018. As a result, cannabis is no longer a controlled substance under the Controlled Drugs and Substances Act (Canada), but is subject to the Cannabis Act and the Cannabis Regulations enacted under the Cannabis Act.
However, human and veterinary drugs containing cannabis (including phytocannabinoids) continue to be regulated as prescription drugs. Health Canada has amended both the human and veterinary prescription drug lists to include:
- Phytocannabinoids produced by, or found in, the cannabis plant and substances that are duplicates of such phytocannabinoids.[10]
Pre-clinical studies and clinical trial authorizations from Health Canada continue to be required for drugs containing cannabis and some cannabinoid molecules. In addition, a research license under the Cannabis Regulations enacted under the Cannabis Act is now required in lieu of an exemption pursuant to Section 56 of the Controlled Drugs and Substances Act (Canada) to conduct research activities with cannabis.
The production of drugs containing cannabis is subject to a valid cannabis drug license issued pursuant to the Cannabis Act.
8 Authorization typically is a no objection to the proposed clinical trial. Each country has its own regulatory framework involving a review process to ensure the safety and wellbeing of human subjects. Canada issues a No Objection Letter whereas in the USA a clinical trial goes into effect after a 30-calendar day review period unless otherwise indicated by the FDA.
9 The clinical trial enabling regulatory process is different for a Sars-CoV-2 indication. Regulatory agencies in Canada and the USA are committed to review the CTA/IND in a timely and efficient manner to accelerate the drug development. Therefore, prior to submitting the CTA/IND request, the Corporation must first provide the nonclinical safety data in a pre-IND/CTA format irrespective of a prior successful meeting with the agency.
10 Health Canada. Notice of Amendment: Prescription Drug List (PDL): Phytocannabinoids. Online at: https://www.canada.ca/en/health-canada/services/drugs ‐ health ‐ products/drug ‐ products/prescriptiondruglist/notice ‐ prescription ‐ drug ‐ list ‐ 2018 ‐ 10 ‐ 17.html
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RISK FACTORS
A discussion of the risks to which Tetra is subject is presented in the section entitled "Risk Factors" of the Annual MD&A, which section is incorporated herein by reference. In addition to the risk factors discussed in the Annual MD&A, please refer to the discussion below relating to the risks associated with an investment in the securities of Tetra. The Annual MD&A is available on SEDAR at www.sedar.com and on Tetra’s website at www.tetrabiopharma.com under the "Investors" section. See the section entitled "Forward-Looking Statements" on page 3 of this AIF for a discussion of risks associated with forwardlooking statements.
Risks Related to the Corporation’s Securities
Volatile Market Price of the Common Shares
The market price for securities of biopharmaceutical companies, including the Corporation’s, has historically been volatile and subject to wide fluctuations in response to various factors, many of which are beyond the Corporation’s control, which may affect the ability of the Corporation’s shareholders to sell their securities at an advantageous price. The Corporation’s failure to meet expectations, downward revision in securities analysts' estimates, adverse changes in general market conditions or economic trends, acquisitions, dispositions, industry-related developments, results of drug development or commercialization, changes in government regulations or other material public announcements by Tetra or its competitors, along with a variety of additional factors may affect market fluctuations. The market price of the Common Shares may decline even if the Corporation’s operating results, underlying asset values or prospects have not changed. There can be no assurance that continuing fluctuations in price and volume will not occur.
Financial markets have at times historically experienced significant price and volume fluctuations that have particularly affected the market prices of equity securities of companies and that have often been unrelated to the operating performance, underlying asset values or prospects of such companies. Accordingly, the market price of the Common Shares may decline even if the Corporation’s operating results, underlying asset values or prospects have not changed. There can be no assurance that continuing fluctuations in price and volume will not occur. If such increased levels of volatility and market turmoil continue, the Corporation’s operations could be adversely impacted and the trading price of the Common Shares may be materially adversely affected.
Holders of Warrants Have No Rights as a Shareholder
Until a holder of warrants acquires Common Shares underlying such warrants upon exercise of such warrants, such holder will have no rights with respect to the Common Shares underlying such warrants. Upon exercise of such warrants, such holder will be entitled to exercise the rights of a holder of Common Shares common only as to matters for which the record date occurs after the exercise date.
No Assurance of Active or Liquid Market
No assurance can be given that an active or liquid trading market for the Common Shares will be sustained. If an active or liquid market for the Common Shares fails to be sustained, the prices at which such shares trade may be adversely affected and holders of Common Shares may be unable to sell their investment on satisfactory terms. Whether or not the Common Shares will trade at lower prices depends on many factors, including the liquidity of the Common Shares, prevailing interest rates and the markets for similar securities, general economic conditions and the Corporation’s financial condition, historic financial performance and prospects. Other factors unrelated to the Corporation’s performance that may have an effect on the price and liquidity of the Corporation’s securities include the extent of the analytical coverage, lessening in trading volume and general market interest in the Corporation’s securities, the size of the Corporation’s public float and any event resulting in a delisting of the securities. Moreover, the issuance by the Corporation of Common Shares on the exercise of options under the Corporation’s
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incentive compensation plans and upon the exercise of outstanding warrants and the subsequent resale of such Common Shares in the public market could also adversely affect the prevailing market price.
Dilution
The Corporation may issue additional securities in the future, including pursuant to acquisitions completed from time to time, which may dilute a shareholder's holdings in the Corporation. The Corporation’s articles permit the issuance of an unlimited number of Common Shares, and shareholders will have no preemptive rights in connection with such further issuance. The directors of the Corporation have discretion to determine the price and the terms of further issuances subject to applicable securities laws and stock exchange rules. Moreover, additional Common Shares will be issued by the Corporation on the exercise of options or other compensation securities issued under the Corporation’s incentive compensation plans and upon the exercise of outstanding warrants.
Subordination of Common Shareholders to Tetra’s Lenders
In the event of bankruptcy, liquidation or reorganization of Tetra, holders of its debt and its trade creditors will generally be entitled to payment of their claims from the assets of Tetra before any assets are made available for distribution to Tetra or shareholders. The Common Shares are effectively subordinated to the debt and other obligations of Tetra.
Senior Ranking of Future Offerings of Debt or Equity Securities
If Tetra decides to issue debt or equity securities in the future ranking senior to the Common Shares or otherwise incur additional indebtedness, it is possible that these securities or indebtedness will be governed by an indenture or other instrument containing covenants restricting Tetra's operating flexibility and limiting Tetra's ability to pay dividends to shareholders. Additionally, any convertible or exchangeable securities that Tetra issues in the future may have rights, preferences and privileges, including with respect to dividends, more favourable than those of the Common Shares and may result in dilution to shareholders. Because Tetra's decision to issue debt or equity securities in any future offering or otherwise incur indebtedness will depend on market conditions and other factors beyond Tetra's control, Tetra cannot predict or estimate the amount, timing or nature of Tetra's future offerings or financing, any of which could reduce the market price of the Common Shares and dilute the value of the Common Shares.
Future Sales of Common Shares by Officers and Directors
Subject to compliance with applicable securities laws, directors and officers of Tetra and their affiliates may sell some or all of their Common Shares in the future. No prediction can be made as to the effect, if any, such future sales of Common Shares may have on the market price of the Common Shares prevailing from time to time. However, the future sale of a substantial number of Common Shares by the directors and officers of Tetra and their affiliates, or the perception that such sales could occur, could adversely affect prevailing market prices for the Common Shares.
Limited Market for Securities
The Corporation’s Common Shares are listed on the TSX, and on the OTCQB; however, there can be no assurance that an active and liquid market for the Corporation will develop or be maintained and an investor may find it difficult to resell any securities of the Corporation.
Unlisted Warrants
Other than the Common Share purchase warrants listed on the TSX, Tetra's outstanding share purchase warrants are not listed on any exchange and the Corporation does not intend to list its outstanding warrants on any exchange. Investors may be unable to sell Tetra's unlisted outstanding share purchase
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warrants at the prices desired or at all. There is no existing trading market for Tetra's unlisted outstanding share purchase warrants and there can be no assurance that a liquid market will develop or be maintained for such warrants, or that an investor will be able to sell any of such warrants at a particular time (if at all). To the extent warrants are exercised, the number of warrants outstanding will decrease, resulting in a diminished liquidity for the remaining warrants. A decrease in the liquidity of the warrants may cause, in turn, an increase in the volatility associated with the price of the warrants. If any secondary market trading of the warrants becomes illiquid, an investor may have to exercise such warrants to realize value. The liquidity of the trading market in Tetra's unlisted outstanding share purchase warrants and the sale price, if any, for such warrants, may be adversely affected by, among other things:
-
changes in the overall market for the warrants;
-
changes in the Corporation’s financial performance or prospects;
-
the prospects for companies in the industry generally;
-
the number of holders of the warrants; and
-
the interest of securities dealers in making a market for the warrants.
No Paid Dividends
Other than the dividend-in-kind of the North Bud Shares which was paid on September 12, 2018, the Corporation has not paid dividends on its Common Shares to date and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of the Common Shares will be your sole source of gain for the foreseeable future. Consequently, in the foreseeable future, you will likely only experience a gain from your investment in the Common Shares if the price of the Common Shares increases.
Fluctuations in Foreign Currency Exchange Rates
Tetra is subject to foreign currency risk. The strengthening or weakening of the Canadian or U.S. dollar versus other currencies will impact the translation of the Corporation’s expenses and net revenues generated in these foreign currencies into Canadian and US dollars. The Corporation imports certain products from foreign countries, and so may become forced to pay higher rates for these products as a result of the weakening of the Canadian or U.S. dollar.
CAPITAL STRUCTURE
Common Shares
The authorized share capital of the Corporation consists of an unlimited number of Common Shares, each with no par value.
As at November 30, 2020, the Corporation had 283,826,966 Common Shares outstanding.
The holders of the common shares are entitled:
-
a) To vote at all meetings of shareholders, except meetings at which only holders of a specified class of shares are entitled to vote;
-
b) To receive any dividend declared by the Corporation on the Common Shares; and
-
36 -
-
c) Subject to the rights, privileges, restrictions and conditions attaching to any other class of shares of the Corporation, to receive the remaining property of the Corporation upon dissolution, liquidation or winding-up of the Corporation.
Options
As at November 30, 2020, the Corporation had 5,385,583 stock options (the "Options") issued and outstanding.
The Corporation originally adopted a 10% rolling stock option plan (the "SOP"), which was most recently approved by the shareholders of the Corporation at the annual meeting of shareholders held on June 20, 2019.
Further to a review of the SOP and a desire to increase flexibility of granting different types of long-term incentive compensation securities to non-executive directors, officers, employees and consultants of the Corporation, the Board approved, as of May 4, 2020, a new omnibus equity incentive compensation plan dated effective as of August 13, 2020 (the "Omnibus Incentive Plan"), which was approved by the shareholders of the Corporation at the annual meeting of shareholders held on June 5, 2020.
The Omnibus Incentive Plan serves as the successor to the SOP. Consequently, effective as of August 13, 2020, the SOP became a legacy plan and no further awards will be granted under the SOP; however, all options previously granted under the SOP will remain outstanding in accordance with their existing terms and reduce the number of Common Shares reserved for issuance to participants under the Omnibus Incentive Plan by a corresponding amount.
The SOP provided for the grant of stock options to directors, officers, employees and consultants of the Corporation as an incentive to serve the Corporation in attaining its goal of improved shareholder value. Under the Omnibus Incentive Plan, employees, directors, officers and consultants of the Corporation and its affiliates are eligible to receive stock options, restricted share units, deferred share units and performance share units. The Omnibus Incentive Plan will remain in effect, subject to the right of the board of directors of the Corporation to amend or terminate the Omnibus Incentive Plan at any time, until the tenth (10th) anniversary of the effective date of the Omnibus Incentive Plan.
The above descriptions of the SOP and the Omnibus Incentive Plan are qualified in its entirety by the full text of these plans. A more detailed summary of the SOP and the Omnibus Incentive Plan is provided in the Corporation’s management information circular dated May 4, 2020, which is available on SEDAR at www.sedar.com, and the full text of the Omnibus Incentive Plan is attached thereto as Schedule A.
In connection with the graduation of the Corporation from the TSXV to the TSX, the Corporation intends to review and amend, if required, the Omnibus Incentive Plan to ensure that such plan meets the guidelines set out in the TSX Company Manual.
Warrants
As at November 30, 2020, the Corporation had 126,325,222 warrants to purchase Common Shares, issued and outstanding.
As at November 30, 2020, there were:
-
16,597,001 warrants, expiring March 5, 2021 and March 29, 2021, entitling the holder thereof, to acquire one full Common Share in exchange for $1.30 per warrant;
-
6,900,000 warrants, expiring November 30, 2021, entitling the holder thereof, to acquire one full Common Share in exchange for $1.29 per warrant;
-
37 -
-
1,654,078 warrants, expiring July 12, 2021, entitling the holder thereof to acquire one full Common Share in exchange for $0.40 per warrant;
-
2,463,370 warrants, expiring May 22, 2022, entitling the holder thereof, to acquire one full Common Share in exchange for $0.26 per warrant;
-
26,833,332 warrants, expiring July 12, 2022, entitling the holder thereof to acquire one full Common Share in exchange for $0.40 per warrant;
-
700,100 warrants, expiring August 2, 2022, entitling the holder thereof to acquire one full Common Share in exchange for 0.40$ per warrant;
-
31,292,471 warrants, expiring February 13, 2023, entitling the holder thereof to acquire one full Common Share in exchange for $0.75 per warrant;
-
4,693,871 warrants, expiring February 13, 2023, entitling the holder thereof to acquire one full Common Share in exchange for 0.75$ per warrant; and
-
35,191,000 warrants, expiring May 22, 2023, entitling the holder thereof, to acquire one full Common Share in exchange for $0.32 per warrant.
Constraints
There are no constraints imposed on the ownership of securities of Tetra to ensure a certain level of Canadian ownership of Tetra.
Ratings
Tetra has not requested, nor to management's knowledge has Tetra received, any ratings from any rating organizations in respect of any of Tetra's securities.
Market for Securities
On August 4, 2020, the Corporation completed its graduation to the TSX and the Common Shares and the Corporation’s listed warrants began trading on the TSX under the symbol "TBP". In connection with the graduation, the Common Shares were voluntarily delisted from the TSXV.
The following table sets out the price range and trading volume of the Common Shares, as reported by the TSXV and TSX during the most recently completed financial year:
| Period | **Price Range ** | **Price Range ** | Total Volume |
|---|---|---|---|
| High ($) | Low($) | ||
| TSXV Month ended December 31, 2019 Month ended January 31, 2020 Month ended February 28, 2020 Month ended March 31, 2020 Month ended April 30, 2020 Month ended May 31, 2020 Month ended June 30, 2020 |
$0.61 $0.69 $0.59 $0.42 $0.37 $0.35 $0.24 |
$0.42 $0.40 $0.31 $0.20 $0.23 $0.21 $0.20 |
26,949,447 33,211,367 26,038,990 19,609,826 14,380,417 31,161,657 20,713,945 |
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| Month ended July 31, 2020 | $0.26 | $0.19 | 17,261,430 |
|---|---|---|---|
| TSX | |||
| Month ended August 31, 2020 | $0.23 | $0.17 | 9,858,437 |
| Month ended September 30, | $0.20 | $0.14 | 9,947,858 |
| 2020 | |||
| Month ended October 31, 2020 | $0.18 | $0.15 | 8,628,725 |
| Month ended November 30, | $0.22 | $0.17 | 12,101,102 |
| 2020 |
PRIOR SALES
The following tables summarize details of the following securities that are not listed or quoted on a marketplace issued by Tetra, during the most recently completed financial year end.
Options
Pursuant to Tetra's Amended and Restated Stock Option Plan , during the most recently completed financial year, Tetra issued the following Options exercisable for Common Shares :
| Date of Issuance |
Number of Options(1) |
Exercise Price |
Expiry Date | Grant Date Fair Value |
|---|---|---|---|---|
| January 29, 2020 |
1,000,000 | $0.50 | May 26, 2021 | $424,621 |
| February 18, 2020 |
200,000 | $0.42 | February 18, 2023 |
$49,457 |
| June 24, 2020 | 1,535,583 | $0.21 | June 24, 2023 | $191,050 |
| July 6, 2020 | 350,000 | $0.20 | July 6, 2025 | $59,770 |
Notes:
(1) Vested and non-vested.
Warrants
During the most recently completed financial year, Tetra issued the following warrants:
| Date of Issuance |
Number of Warrants |
Exercise Price |
Expiry Date | Grant Date Fair Value |
|---|---|---|---|---|
| February 13, 2020 |
29,245,300(1) | $0.75 | February 13, 2023 |
$4,724,054 |
| February 13, 2020 |
2,047,171(2) | $0.75 | February 13, 2023 |
$330,683 |
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| March 5, 2020 |
4,386,795(3) | $0.75 | February 13, 2023 |
$708,608 |
|---|---|---|---|---|
| March 5, 2020 |
307,076(4) | $0.75 | February 13, 2023 |
$49,603 |
| May 22, 2020 |
35,191,000(5) | $0.32 | May 22, 2023 |
$2,902,972 |
| May 22, 2020 |
2,463,370(6) | $0.26 | May 22, 2022 |
$195,265 |
Notes:
-
(1) Warrants issued in connection with the prospectus offering on a bought deal basis completed on February 13, 2020.
-
(2) Warrants issued to the underwriters in connection with a prospectus offering on a bought deal basis completed on February 13, 2020.
-
(3) Warrants issued in connection with the exercise of the overallotment option granted to the underwriters in connection with the prospectus offering on a bought deal basis completed on February 13, 2020.
-
(4) Warrants issued to underwriters in connection with the exercise of the overallotment option granted to the underwriters in connection with the prospectus offering on a bought deal basis completed on February 13, 2020.
-
(5) Warrants issued in connection with the public overnight marketed offering completed on May 22, 2020.
-
(6) Warrants issued to agents in connection with the public overnight marketed offering completed on May 22, 2020.
ESCROWED SECURITIES
As at November 30, 2020, none of the securities of the Corporation were in escrow or subject to a contractual restriction on transfer.
DIRECTORS AND MANAGEMENT
The members of the Board (each of whom has been appointed to hold office until the close of Tetra's next annual general meeting) and management of Tetra currently consist of the following individuals:
| Name | Position and Residence |
Principal Occupation During the Last Five Years |
Date First Appointment as Director or Officer |
Number of Voting Securities |
% of Voting Securities |
|---|---|---|---|---|---|
| BILL CHELIAK(1)(3) |
Chairman of the Board, Director Pembroke, ON |
CEO, Panag (2015-2019) President and Interim CEO, Chelation Partners (2013-present) |
July 10, 2017 | 1,549,300 Common Shares |
0.55% of Common Shares |
| CARL MERTON(1)(2) |
Director Belle River, ON |
CFO of Aphria (2015 – present) |
June 22, 2017 |
Nil | Nil |
| BRENT NORTON(1)(4)(5) |
Director Toronto, ON |
Venture Partner at Lumira Ventures |
August 18, 2020 |
Nil | Nil |
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| (2016 – present) | |||||
|---|---|---|---|---|---|
| DALE WEIL(1)(3)(5) |
Director Montreal, QC |
Executive Director at West Island Palliative Care Center (2010–present) |
August 14, 2020 |
Nil | Nil |
| GUY CHAMBERLAND |
CEO and Chief Regulatory Officer Boucherville, QC |
CEO and Chief Regulatory Officer of Tetra Director of Tetra Natural Health |
April 6, 2018 | 5,126,436 Common Shares |
1.81% of Common Shares |
| JEAN- FRANÇOIS BOILY |
CFO Montreal, QC |
CFO of Tetra VP Finance at Acasti Pharma (2018- 2020) Director of Finance & IT at Innovaderm Research Inc. (2014-2018) |
September 1, 2020 |
Nil | Nil |
| STEEVE NÉRON |
CCO Terrebonne, QC |
COO of Tetra (2018- 2020) Senior Portfolio Manager at Valeant (2013-2018) |
November 5, 2018 |
70,100 Common Shares |
0.02% of Common Shares |
| MELANIE KELLY |
CSO Halifax, NS |
Chief Scientific Officer of Tetra and of Panag |
November 11, 2019 |
2,707,288 Common Shares |
0.95% of Common Shares |
| GRAHAM WOOD |
COO MONTREAL, QC |
COO of Tetra CSO at Neptune Wellness Solutions (2019 – 2020) Chief R&D Officer at Altasciences (2018- 2019) Executive VP, phase 1 clinical development (2015-2017) |
September 21, 2020 |
Nil | Nil |
Note:
(1) Independent director under National Instrument 58-101 – Disclosure of Corporate Governance Practices .
(2) Chair of the Audit Committee.
(3) Member of the Audit Committee.
(4) Chair of the Compensation and Governance Committee.
(5) Member of the Compensation and Governance Committee.
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PROFILE OF THE BOARD AND MANAGEMENT
Tetra Bio-Pharma Inc.
Bill Cheliak, Chairman and Director
Dr. W.M. (Bill) Cheliak was CEO of MedBiome, a Canadian based start-up focussed on developing therapeutics to modulate the function of the microbiome in specific disease conditoins. As well, he served as CEO of Panag Pharma, a Canadian based biotechnology company focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation, prior to the acquisition of Panag by Tetra. He is also co-founder and Interim CEO to Chelation Partners, a private company developing a technology to enhance the efficacy of antibiotics. Dr. Cheliak has over 20 years of experience as an entrepreneur having helped establish companies in a wide variety of life science fields, including vaccines, human genetics, oncology, neurology and anti-infective drug development and clinical research organization services. He brings extensive deal making experience with the pharmaceutical industry. He currently serves as a Director for Solarvest (SVS). Dr. Cheliak was Vice Chair of the Government of Canada's Networks Centres Excellence (NCE) Standing Selection Committee and Chair of the NCE Monitoring Committee until September 2018.
Carl Merton, Director
Mr. Merton has over 25 years of financial and business experience, including over 10 years' experience as a CFO for public companies involved in the capital markets. Beginning with 12 years combined with Ernst & Young and KPMG, he transitioned from the audit stream into financial advisory work, as a Business Valuator, Forensic Accountant and Corporate Finance functions. After leaving KPMG, Mr. Merton joined Atlas Tube Inc., as Vice-President, Special Projects. After assisting in the sale of Atlas Tube, Mr. Merton became the CFO of Reko International Group Inc. In December 2014, Mr. Merton was elected by shareholders as a member of the inaugural board of directors of Aphria. Approximately one year later, Mr. Merton resigned as a member of the board of Aphria and joined Aphria as its CFO. In his role as CFO, Mr. Merton is responsible for communication with all stakeholders and is a member of the executive management team responsible for the strategic direction of Aphria, as well as leading all acquisition discussions, budgeting, financing, financial reporting and internal controls. Mr. Merton is a Chartered Professional Accountant, a Chartered Accountant and is a Fellow of the Canadian Institute of Chartered Business Valuators (the "CICBV"). He holds a B.Comm. Hon. in Sports Administration from Laurentian University and has served as a past Chair of both the CICBV and the International Association of Professional Business Valuators.
Brent Norton, Director
Dr. Brent Norton holds his medical doctorate degree from McGill University, an MBA from Ivey Business School at Western University and was granted the ICD.D designation by the Institute of Corporate Directors following the completion of the Directors Education Program at the Rotman School of Business in Toronto. With over 25 years of experience in the life sciences industry, Dr. Norton has used his crossfunctional knowledge to develop strategy, raise capital and build important relationships in the academic and business community. Operationally, he has built R&D and commercial operations, led transactions with AstraZeneca, Eli Lilly, L’Oreal, Parke Davis/Pfizer and others, and taken products through the FDA to global out-licensing with Johnson & Johnson. His contributions to five companies have allowed early investors the opportunity to crystallize investment gains of over $2.5B and their products have positively impacted hundreds of thousands of lives. Brent is currently a Venture Partner with Lumira Ventures and has recently been appointed to the Board of Directors and the Research & Innovation committee of the prestigious Association of Faculties of Medicine of Canada.
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Dale Weil, Director
Dale Weil brings close to 35 years of business development experience, much of which was acquired while working at McKesson Canada, a diversified healthcare company and the largest pharmaceutical distributor in the country. At McKesson Canada, Ms. Weil held various leadership positions, most recently as Senior Advisor to the President. Ms. Weil holds a Bachelor’s degree in Marine Biology and a Master’s degree in Business Administration, both from McGill University. Additionally, Dale received the ICD.D designation from the Institute of Corporate Directors. The ICD.D designation represents a lifelong commitment to excellence in the boardroom, a desire to stay current, and to be a more effective director. In January 2020, Dale was appointed as the Executive Director of the West Island Palliative Care Centre, an initiative that she has been involved with since 2010.
Guy Chamberland, Director, Chief Executive Officer and Chief Regulatory Officer
Dr. Guy Chamberland, M.Sc., Ph.D., Master Herbalist, has been Chief Scientific Officer & Regulatory Affairs of Tetra from June 2016 until April 2018 when he was appointed Chief Executive Officer. He is also Chief Regulatory Officer of Tetra since October 15, 2018 and previously joined Tetra as Chief Scientific Officer in April 2016. He has been Vice President of Regulatory Affairs & Product Development at Biotanika Health Group Inc. since March 2007. He served as Vice President of Clinical & Regulatory Affairs at Victhom Laboratory Inc. from 2005 to 2007. He developed a specialty in regulatory affairs (drugs, biologics, medical device, combination products, botanicals). He works closely with physicians and naturopathic physicians in these clinical areas. He spent 6 years as the Co-Chair and member of Health Canada's Expert Advisory Committee for Veterinary Natural Health Products and Low Risk VHP. He was the Program Director of MDS Pharma Services. Dr. Chamberland has over 7 years' experience in the development of clinical research protocols for botanical medicines and the management of these clinical studies in the areas of anxiety, sleep, pain, depression, inflammation and wound healing. He has over 26 years' experience in the development of new drugs in the pharmaceutical industry (Canada and USA). He was a member of the Investment Committee of Fonds Bionovation for 7 years. Since 2007, Dr. Chamberland developed an expertise in botanical medicine and gave lectures and continuing education workshops for health professionals (physicians, naturopathic physicians, chiropractors, etc.) on the use of plants in the treatment of pain, anxiety, insomnia, wound healing etc. He got three patents (Patent granted on the synergy of phyto-ingredients and antifungal agents.). He is the Professor of Botanical Medicine and Principles of clinical research at the Ecole d'Enseignement Superieur de Naturopathie du Quebec (EESNQ) and French language equivalent of the Canadian College of Naturopathic Medicine (CCNNM). He earned a diploma in Proficiency in Herbal Prescription from the Australian College of Phytotherapy, a Certified Herbalist from the Dominion College of Canada and a Master Herbalist diploma from the Dominion College of Canada. Dr. Chamberland received a B.Sc. in Agriculture from McGill University, an M.Sc. in Veterinary anatomy and physiology and a Ph.D. in Biomedical Sciences (toxicology) from the University of Montreal.
Jean-Francois Boily, Chief Financial Officer
Before joining Tetra Bio-Pharma, Mr. Boily served as Vice-President and Financial Officer at Acasti Pharma Inc., a dual-listed (TSX-V & Nasdaq) biopharmaceutical innovator focused on the research and development of prescription drugs using Omega-3 fatty acids derived from krill oil for treatment of hypertriglyceridemia. Prior to Acasti, Mr. Boily served as a Director of Finance & Information Technology at Innovaderm Research Inc., a North American contract research organization (CRO) specialized in dermatology. Working closely with the President and founder, Mr. Boily undertook a vast financial, IT and growth mandate and increased revenues and profits over 25%. Formerly, Mr. Boily was a Director of Finance at Teva Canada Innovation where he oversaw and reported on the financial conduct of all clinical R&D activities and managing branded product launches in the therapeutic areas of central nervous system (CNS), respiratory, oncology and pain care. Mr. Boily holds a Bachelor of Science in Accounting from HEC Montreal and is a Quebec-Chartered Public Accountant (CPA).
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Steeve Néron, Chief Commercial Officer
Mr. Néron has more than three decades of experience in the pharmaceutical industry where challenging the reimbursement landscape factored prominently in his role, with demonstrated success in numerous therapeutic sectors including cardiology, rheumatology, endocrinology, women’s health, asthma/COPD, OTC and dermatology. Prior to joining the Corporation, he occupied a senior marketing position at Bausch Health Canada. Steeve has held various marketing, sales, finance, material management and business development positions and has worked to launch or rejuvenate numerous market-leading pharmaceutical brands including Aerius™ (antihistamine), Altace™ (hypertension), Ezetrol™ (cholesterol), Eliquis™ (anti-coagulant), Lodalis™ (cholesterol) and Contrave™ (Obesity). Mr. Néron holds a Bachelor’s degree in Business Administration (BBA) in Marketing from Université du Québec in Chicoutimi (QC).
Melanie Kelly, Ph. D., Chief Scientific Officer
Dr. Kelly is a Professor in Pharmacology, Anesthesia, Pain Management and Perioperative Medicine and Ophthalmology and Visual Science at Dalhousie University in Halifax with expertise in preclinical and clinical research design, novel drug development, medical cannabis and cannabinoid drugs. A respected research professional with a Doctor of Philosophy (PhD) focused on drug discovery and molecular pharmacology, Dr. Kelly has significant research experience in the field of G protein coupled receptors and ion channels. She is considered to be an expert in the cannabinoid drug development space. Dr. Kelly’s current research addresses the pharmacology of the endocannabinoid system and lipid signalling, with a specific focus on ocular immunopharmacology. She is the Executive Director of the International Cannabinoid Research Society (ICRS) and a member of the Board of Directors of the Canadian Consortium for Investigation of Cannabinoids (CCIC).
Graham Wood, Chief Operating Officer
Dr. Graham Wood joined the Corporation in September 2020 as Chief Operating Officer, to lead the regulated drug development activities. Dr. Wood has over twenty years of drug development experience. Most recently he was Chief Scientific Officer at Neptune Wellness, where he leads product development and clinical research activities. Prior to that, he was Chief R&D Officer at Altasciences where he was responsible for developing innovative nonclinical and clinical techniques and overseeing the clinical pharmacology study designs. He was also Chief Executive Officer at Manna Research, which he grew from a single clinical research site to the largest family practice site network in Canada. As President at Cetero Research, he was responsible for the early and late stage clinical development conducted at the Cetero facilities in Toronto and Miami. He holds a PhD in Neurology and Neurosurgery from McGill University and worked as Fellow at the National Institute of Health.
SECURITY HOLDINGS OF THE DIRECTORS AND OFFICERS
As at the date of this AIF, as a group, the directors and executive officers of Tetra beneficially own, or exercise control or direction over, directly or indirectly, a total of 9,473,124 Common Shares, representing approximately 3.34% of the currently issued and outstanding Common Shares (excluding the Common Shares issuable upon the exercise of the aggregate of 1,415,000 Options or of the aggregate of 288,800 warrants held by the directors and executive officers of Tetra).
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CEASE TRADE ORDERS, BANKRUPTCIES, PENALTIES AND SANCTIONS
No director or executive officer of Tetra is, as at the date of this AIF, or has been, within 10 years before the date of this AIF, a director, chief executive officer or chief financial officer of any corporation (including Tetra) that:
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i. was subject to an order (as defined below) that was issued while the director or executive officer was acting in the capacity as director, chief executive officer or chief financial officer; or
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ii. was subject to an order that was issued after the director or executive officer ceased to be a director, chief executive officer or chief financial officer and which resulted from an event that occurred while that person was acting in the capacity as director, chief executive officer or chief financial officer.
No director or executive officer of Tetra, and to the best of the knowledge of Tetra, no shareholder holding a sufficient number of Tetra's securities to affect materially the control of Tetra:
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i. is, as at the date of this AIF, or has been within 10 years before the date of this AIF, a director or executive officer of any corporation (including Tetra) that, while that person was acting in that capacity, or within a year of that person ceasing to act in that capacity, became bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency or was subject to or instituted any proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or trustee appointed to hold its assets; or
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ii. has, within the 10 years before the date of this AIF, become bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency, or become subject to or instituted any proceedings, arrangement or compromise with creditors, or had a receiver, receiver manager or trustee appointed to hold the assets of the director, executive officer or shareholder.
No director or executive officer of Tetra, and to the best of the knowledge of Tetra, no shareholder holding a sufficient number of Tetra's securities to affect materially the control of Tetra, has been subject to:
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i. any penalties or sanctions imposed by a court relating to securities legislation or by a securities regulatory authority or has entered into a settlement agreement with a securities regulatory authority; or
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ii. any other penalties or sanctions imposed by a court or regulatory body that would likely be considered important to a reasonable investor in making an investment decision with respect to Tetra.
For the purposes of (i) above, "order" means a cease trade order, an order similar to a cease trade order; or an order that denied the relevant corporation access to any exemption under securities legislation, that was in effect for a period of more than 30 consecutive days.
CONFLICTS OF INTEREST
Except as otherwise described elsewhere in this AIF, there are currently no other existing or potential material conflicts of interests between Tetra and any of its directors and officers other than those otherwise set out herein.
Carl Merton, other than through his employment position at Aphria, has no other existing or potential material conflict of interests. Aphria is a critical supplier in the Corporation’s supply chain.
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AUDIT AND RISK COMMITTEE INFORMATION
Charter of the Audit Committee
The full text of the current Audit Committee's Charter is attached as Schedule A to this AIF.
Composition of the Audit Committee
The current members of the Audit Committee are Carl Merton, Dale Weil and Bill Cheliak, all of whom are financially literate within the meaning of National Instrument 52-110 – Audit Committee (" NI 52-110 "). Each member of the Audit Committee is independent .
Relevant Education and Experience
See the respective biographies of each member of the Audit Committee in " Directors and Management – Profile of the Board and Management " for a description of the experience that is relevant to the performance of their responsibilities as Audit Committee members.
Reliance on Certain Exemptions
At no time since the commencement of the Corporation's financial year ended November 30, 2020 has the Corporation relied on the exemption provided under section 2.4 of NI 52-110 ( De Minimis Non-Audit Services ) or an exemption from NI 52-110, in whole or in part, granted under Part 8 of NI 52-110 ( Exemptions ).
Audit Committee Oversight
At no time since the commencement of the Corporation's financial year ended November 30, 2020 was a recommendation of the audit committee to nominate or compensate an external auditor not adopted by the Board.
Pre-Approval Policies and Procedures
Tetra's audit committee has adopted specific policies and procedures for the engagement of non-audit services as described in the audit committee's charter attached hereto as Schedule A.
External Auditor Service Fees
The aggregate fees billed by Tetra's external auditors in each of the last two financial years for audit fees are as follows:
| Financial Year Ending |
Audit Fees |
Audit- Related Fees |
Tax Fees | All Other Fees |
|---|---|---|---|---|
| November 30, 2020(1) |
$74,671 | $71,015 | $7,000 | $187,172(2) |
| November 30, 2019 |
$96,077 | $134,000 | $16,000 | $5,290 |
(1) Includes fees up to February 17, 2021.
(2) Includes fees related to the graduation of the Common Shares from TSX-V to TSX, and fees related to assets dispositions undertaken by the Corporation.
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" Audit Fees " are the aggregate fees billed by the Corporation's external auditor for services provided for the audit of Tetra's annual financial statements.
" Audit-Related Fees " are the aggregate fees billed for assurance and related services by the Corporation's external auditor that are reasonably related to the performance of the audit or review of the Corporation's financial statements.
" Tax Fees " are the aggregate fees billed by Tetra's external auditor for tax compliance, tax advice and tax planning services.
" All Other Fees " are the aggregate fees billed by Tetra's external auditor for products and services not included in the other categories of fees described above.
LEGAL PROCEEDINGS AND REGULATORY ACTIONS
Tetra was not involved in any legal proceedings during the year ended November 30, 2020 that had, or could have, a material adverse effect on Tetra. Moreover, to the knowledge of Tetra's management, Tetra is not currently involved in any outstanding, threatened or pending litigation that could have a material adverse effect on Tetra.
To the knowledge of Tetra, during the financial year ended November 30, 2020, there were no: (i) penalties or sanctions imposed against Tetra by a court relating to securities legislation or by a securities regulatory authority; (ii) any other penalties or sanctions imposed by a court or regulatory body against Tetra that would likely be considered important to a reasonable investor in making an investment decision; or (iii) settlement agreements Tetra entered into before a court relating to securities legislation or with a securities regulatory authority.
INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS
Other than as described elsewhere in this AIF, there are no material interests, direct or indirect, of any anticipated or current director or executive officer of the Corporation, any shareholder that beneficially owns, or controls or directs (directly or indirectly) more than 10% of any class or series of the Corporation’s outstanding voting securities, or any associate or affiliate of any of the foregoing persons, in any transaction within the three years before the date hereof that has materially affected or is reasonably expected to materially affect the Corporation or a subsidiary of the Corporation.
PhytoPain Transaction
On March 19, 2018, pursuant to a share purchase agreement (the "PhytoPain Purchase Agreement"), Tetra completed the acquisition of the remaining 20% interest in PhytoPain from entities controlled by André Rancourt, former Chairman of the Board, and Guy Chamberland, who is currently Chief Executive Officer and Chief Regulatory Officer of the Corporation (collectively, the "Sellers"), whereby Tetra acquired from the Sellers all of the issued and outstanding common shares of PhytoPain currently held by the Sellers (representing 20% of the issued and outstanding shares of Phytopain) (the "PhytoPain Transaction") for an aggregate purchase price of $12,425,089 composed of:
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(a) a cash payment of $248,000;
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(b) promissory notes in the principal aggregate amount of $2,236,696 payable to the Sellers in accordance with the terms of the PhytoPain Purchase Agreement;
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(c) the issuance of 2,485,218 Common Shares at the closing of the PhytoPain Transaction; and
-
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(d) the issuance of 7,455,653 Common Shares to an escrow agent designated by the parties, to be held in escrow and released in accordance with a specified milestone schedule based on corporate objectives. All Common Shares were released from escrow and distributed to the Sellers as of November 30, 2020.
The PhytoPain Transaction constituted a "related party transaction" within the meaning of Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101"). Upon completion of the PhytoPain Transaction, PhytoPain became a wholly-owned subsidiary of Tetra. A complete and detailed description of the PhytoPain Transaction is contained in the material change report of the Corporation dated March 29, 2018, a copy of which is available on SEDAR (www.sedar.com) under the Corporation's profile.
Panag Transaction
On May 1, 2019, Tetra completed the acquisition of Panag (the "Panag Transaction"), pursuant to a share purchase agreement (the "Panag Agreement") between the Corporation and the shareholders of Panag (the "Vendors"). Pursuant to the Panag Agreement, Tetra acquired 100% of the issued and outstanding common shares of Panag held by the Vendors in consideration for, in aggregate:
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(a) $3,000,000 in cash; and
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(b) the issuance of 16,304,348 Common Shares at a price of $0.552 per Common Share.
The terms of the Panag Transaction also provide for the payment by Tetra to the Vendors of an aggregate amount of up to $15,000,000 in cash in milestone payments upon the achievement of operational targets associated with marketing approvals and commercialization of both human and veterinary drug products by the FDA and the EMAs. Tetra has also committed itself to fund Panag's research in an amount no less than $1,200,000 annually for a period of ten years after the closing date of the Panag Transaction, all as more fully described in the management proxy and information circular of the Corporation dated March 20, 2019.
Two of the Vendors, W.M. (Bill) Cheliak and Gregory Drohan, were non-arm's length parties to Tetra within the meaning of the rules of the TSXV. Dr. Cheliak is the Chairman of the Board and Mr. Drohan was at the time a director of the Corporation. The Panag Transaction constituted a "related party transaction" within the meaning of MI 61-101. The Corporation relied upon the exemptions from valuation and minority approval set out in Sections 5.5(a) and 5.7(1)(a), respectively, of Part 5 of MI 61-101. The facts supporting reliance on the formal valuation exemption stated in Sections 5.5(a) and 5.7(1)(a) of MI 61-101 were as follows: at the time the Panag Transaction was agreed to, neither the fair market value of the subject matter of, nor the fair market value of the consideration for, the Panag Transaction, insofar as it involved interested parties, exceeded 25% of the Corporation's market capitalization.
The Panag Transaction did not constitute a "Significant Acquisition" for the Corporation pursuant to Part 8 of National Instrument 51-102 - Continuous Disclosure Obligations . A complete and detailed description of the Panag Transaction is contained in the material change report of the Corporation dated February 11, 2019 and in the management proxy and information circular of the Corporation dated March 20, 2019, copies of which are available on SEDAR (www.sedar.com) under the Corporation's profile.
Private Placement
On August 2, 2019, Tetra completed a non-brokered private placement in which some of the Corporation's directors, officers, consultants and employees, as well as certain of their associates, purchased an aggregate of 870,100 units of the Corporation at a price of $0.30 per unit for aggregate gross proceeds of $261,030, with each unit being comprised of one Common Share and one Common Share purchase warrant. Each warrant entitles the holder thereof to purchase one full Common Share at
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an exercise price of $0.40 per Common Share for a period of 36 months following the closing of such non-brokered private placement. Certain directors and senior officers of the Corporation or of its subsidiaries subscribed for units as part of the private placement, constituting a "related party transaction" within the meaning of MI 61-101 and Policy 5.9 of the TSXV. The non-brokered private placement was completed in reliance on (i) an available exemption from the formal valuation requirement of MI 61-101 provided in paragraph (a) of Section 5.5 of MI 61-101 and (ii) an available exemption from the minority shareholder approval requirement of MI 61-101 provided in paragraph (a) of Section 5.7(1) of MI 61-101. Neither the fair market value of the units issued nor the consideration paid for the units pursuant to the portion of the private placement subscribed for by related parties of the Corporation exceeded 25% of the Corporation's market capitalization.
TRANSFER AGENT AND REGISTRAR
The transfer agent and registrar for the Common Shares is Computershare Trust Corporation of Canada located at 1500 Robert-Bourassa Boulevard, Montreal, QC, H3A 3S8.
MATERIAL CONTRACTS
The following are material contracts of Tetra required to be filed on SEDAR pursuant to National Instrument 51-102 – Continuous Disclosure Obligations :
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a) Supply Agreement with Aphria Inc. effective November 1, 2016 for raw materials to be used in QIXLEEF[TM] only;
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b) Research and Development funding agreement with the University of New Brunswick ("UNB") signed on May 2, 2017 and amended on January 18, 2019 to establish a Health Research Chair in Cannabis at UNB;
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c) Share purchase agreement with the shareholders of Panag effective January 30, 2019, setting the terms for the acquisition by Tetra of all of the issued and outstanding shares in the capital of Panag;
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d) Joint venture agreement signed with Altus Formulations Inc. on January 8, 2020, setting the terms for the development of a series of cannabinoid-receptor targeted therapeutics;
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e) Development, scale up, and GMP manufacturing agreements signed with Dalton Pharma Services on December 17, 2018 and April 11, 2019 setting the terms for the manufacturing of drug substance HU-308;
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f) Warrant Indenture with Computershare Trust Corporation of Canada dated July 12, 2019 providing for the issue of Common Share purchase warrants;
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g) Warrant indenture with Computershare Trust Corporation of Canada dated February 13, 2020, providing for the issue of Common Share purchase warrants; and
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h) Warrant indenture with Computershare Trust Corporation of Canada dated May 22, 2020, providing for the issue of Common Share purchase warrants.
INTERESTS OF EXPERTS
McGovern Hurley LLP are the auditors of the Corporation and have confirmed that they are independent with respect to the Corporation within the meaning of the relevant rules and related interpretations prescribed by the relevant professional bodies in Canada and any applicable legislation or regulation.
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ADDITIONAL INFORMATION
Additional information relating to Tetra may be found on SEDAR at www.sedar.com. Additional information, including directors' and officers' remuneration and indebtedness, principal holders of Tetra's securities, and securities authorized for issuance under equity compensation plans, if applicable, is contained in Tetra's management information circular dated May 12, 2020, a copy of which has been filed on SEDAR and is available at www.sedar.com under the Corporation's profile. Additional financial information is provided in Tetra's audited consolidated financial statements and management's discussion and analysis for Tetra's most recently completed financial year, copies of which have been filed on SEDAR and are also available at www.sedar.com under the Corporation's profile.
SCHEDULE A
TETRA BIO-PHARMA INC.
AUDIT COMMITTEE CHARTER
This charter (the " Charter ") sets forth the purpose, composition, responsibilities and authority of the Audit Committee (the " Committee ") of the Board of Directors (the " Board ") of Tetra Bio-Pharma Inc. (" Tetra ").
1.0 Purpose
The purpose of the Committee is to assist the Board in fulfilling its oversight responsibilities with respect to:
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financial reporting and disclosure requirements;
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ensuring that an effective risk management and financial control framework has been implemented and tested by management of Tetra;
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external and internal audit processes;
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Tetra’s systems of internal accounting and financial controls; and
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public disclosure items such as quarterly press releases, financial-oriented investor relations materials and other public reporting requirements.
2.0
Composition and Membership
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(a) The Board will appoint the members (" Members ") of the Committee. The Members will be appointed to hold office until the next annual general meeting of shareholders of Tetra or until their successors are appointed. The Board may remove a Member at any time and may fill any vacancy occurring on the Committee. A Member may resign at any time and a Member will automatically cease to be a Member upon ceasing to be a director. The Board will fill vacancies on the Committee by appointment from among qualified directors of the Board. Members must have suitable experience and must be familiar with auditing and financial matters.
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(b) The Committee will consist of at least three directors. Each Member will meet the criteria for independence and financial literacy established by applicable laws and the rules of any stock exchanges upon which Tetra's securities are listed, including National Instrument 52-110 − Audit Committees (as it may be amended or replaced from time to time, " NI 52-110 "), subject to any exceptions permitted under NI 52-110. All Members will meet the criteria for independence established by the aforementioned laws and rules. ln addition, each director will be free of any relationship which could, in the view of the Board, be reasonably expected to interfere with the exercise of a Member's independent judgment. In order to ensure independence requirements as prescribed by NI 52-110, Tetra shall not enter into any arrangement with any Member under which a Member is entitled to receive, directly or indirectly, any consulting, advisory or other compensatory fee from Tetra or any of its related parties or subsidiaries, other than as remuneration for acting in his or her capacity as a member of the Board or any Board committee, or as a part-time chair or vice-chair of the Board or any Board committee.
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112879666
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(c) The Board will appoint one of the Members to act as the chairman of the Committee (the " Chairman "). The Members shall elect a secretary of the Committee (the " Secretary ") who will be the secretary of all meetings and will maintain minutes of all meetings and deliberations of the Committee. If the Members so decide, the Committee may appoint another person who may, but need not, be a Member to act as the secretary of that meeting.
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(d) Subject to applicable law, the Committee may delegate any or all of its functions to any of its independent Members or any independent sub-set thereof, from time to time as it sees fit. Between meetings, the Chairman, or any Member designated for such purpose by the Committee, may, if required in the circumstance, exercise any power delegated by the Committee on an interim basis. The Chairman or other designated Member will promptly report to the other Members in any case in which this interim power is exercised.
3.0 Meetings
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(a) Meetings of the Committee will be held at such times and places as the Chairman may determine, but in any event not less than four (4) times per year, and such meetings shall correspond with Tetra’s reporting cycle or more frequently as circumstances require. Twenty-four (24) hours advance notice of each meeting will be given to each Member orally, by telephone, by facsimile or email, unless all Members are present and waive notice, or if those absent waive notice before or after a meeting. Members may attend all meetings either in person or by telephone, video or other electronic means.
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(b) At the request of the external auditors of Tetra, the Chief Executive Officer or the Chief Financial Officer of Tetra or any Member, the Chairman will convene a meeting of the Committee. Any such request will set out in reasonable detail the business proposed to be conducted at the meeting so requested.
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(c) The Chairman, if present, will act as the chairman of meetings of the Committee. If the Chairman is not present at a meeting of the Committee, the Members in attendance may select one of the Members to act as chairman of the meeting.
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(d) A majority of Members will constitute a quorum for a meeting of the Committee. If a vacancy exists on the Committee, the remaining Members may exercise all of their powers so long as there is a quorum. Each Member will have one vote and decisions of the Committee will be made by an affirmative vote of the majority. For greater certainty, during a meeting of the Committee held by telephone, video or other electronic means, any member may vote by telephone, video or other electronic means, as applicable. The Chairman will not have a deciding or casting vote in the case of an equality of votes. Powers of the Committee may also be exercised by written resolutions signed by all Members. For greater certainty, a resolution may be signed by a Member by electronic means, including by a Member authorizing, via email communication, the corporate secretary of Tetra (or such officer holding an equivalent or more senior position) to affix the electronic signature of such Member to the written resolution.
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(e) The Committee may invite from time to time such persons as it sees fit to attend its meetings and to take part in the discussion and consideration of the affairs of the Committee. The Committee may meet in camera without members of management in attendance for a portion of each meeting of the Committee, as the Committee deems appropriate.
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(f) ln advance of every regular meeting of the Committee, the Chairman, with the assistance of the Secretary, will prepare and distribute to the Members and others as deemed appropriate by the Chairman, an agenda of matters to be addressed at the meeting
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together with appropriate briefing materials. The Committee may require officers and employees of Tetra to produce such information and reports as the Committee may deem appropriate in order for it to fulfill its duties.
- (g) Minutes of meetings of the Committee must accurately reflect the significant discussions and the decisions of the Committee. Minutes of Committee meetings shall be recorded and maintained by the Secretary, or any other person acting in such capacity, and subsequently presented to the Committee for approval.
4.0 Duties and Responsibilities
The duties and responsibilities of the Committee as they relate to the following matters, are as follows:
4.1 Financial Reporting and Disclosure
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(a) review and recommend to the Board for approval, the audited annual financial statements, including the auditors' report thereon, the quarterly financial statements, management discussion and analysis, annual and interim press releases announcing financial results (if any), financial reports, and any guidance with respect to earnings per share to be given, prior to the public disclosure of such information, with such documents to indicate whether such information has been reviewed by the Board or the Committee;
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(b) review and recommend to the Board for approval, where appropriate, financial information contained in any prospectuses, annual information forms, annual report to shareholders, management proxy circular, material change disclosures of a financial nature and similar disclosure documents prior to the public disclosure of such information;
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(c) review with management of Tetra, and with external auditors, significant accounting principles and disclosure issues and alternative treatments under International Financial Reporting Standards (" IFRS "), with a view to gaining reasonable assurance that financial statements are accurate, complete and present fairly Tetra's financial position and the results of its operations in accordance with IFRS, as applicable;
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(d) seek to ensure that adequate procedures are in place for the review of Tetra's public disclosure of financial information extracted or derived from Tetra's financial statements, Tetra’s disclosure controls and procedures and periodically assess the adequacy of those procedures and recommend any proposed changes to the Board for consideration;
4.2
Internal Controls and Audit
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(a) review the adequacy and effectiveness of Tetra's system of internal control and management information systems through discussions with management and the external auditor to ensure that Tetra maintains (i) the necessary books, records and accounts in sufficient detail to accurately and fairly reflect Tetra's transactions, (ii) effective internal control over financial reporting, and (iii) adequate processes for assessing the risk of material misstatement of the financial statement and for detecting control weaknesses or fraud. From time to time the Committee shall assess whether it is necessary or desirable to establish a formal internal audit department having regard to the size and stage of development of Tetra at any particular time;
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(b) satisfy itself that management has established adequate procedures for the review of Tetra's disclosure of financial information extracted or derived directly from Tetra's financial statements;
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(c) satisfy itself, through discussions with management, that the adequacy of internal controls, systems and procedures has been periodically assessed in order to ensure compliance with regulatory requirements and recommendations;
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(d) review and discuss Tetra's major financial risk exposures and the steps taken to monitor and control such exposures, including the use of any financial derivatives and hedging activities;
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(e) review, and in the Committee's discretion make recommendations to the Board regarding, the adequacy of Tetra's risk management policies and procedures with regard to identification of Tetra's principal risks and implementation of appropriate systems and controls to manage such risks including an assessment of the adequacy of insurance coverage maintained by Tetra;
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(f) recommend the appointment, or if necessary, the dismissal of the head of Tetra's internal audit process;
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(g) periodically review Tetra’s policies and procedures for reviewing and approving or ratifying related-party transactions;
4.3 External Audit
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(a) recommend to the Board a firm of external auditors to be nominated for appointment as the external auditor of Tetra;
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(b)
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ensure the external auditors report directly to the Committee on a regular basis;
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(c) review the independence, qualifications and performance of the external auditors, including a written report from the external auditors respecting their independence and consideration of applicable auditor independence standards;
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(d) review and recommend to the Board the fee, scope and timing of the audit and other related services rendered by the external auditors;
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(e)
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review the audit plan of the external auditors prior to the commencement of the audit;
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(f) establish and maintain a direct line of communication with Tetra's external and internal auditors;
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(g) meet in camera with only the auditors, with only management, and with only the Members of the Committee at every Committee meeting where, and to the extent that, such parties are present and the Committee deems appropriate;
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(h) oversee the performance of the external auditors who are accountable to the Committee and the Board as representatives of the shareholders, including the lead partner of the independent auditors' team;
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(i) oversee the work of the external auditors appointed by the shareholders of Tetra with respect to preparing and issuing an audit report or performing other audit, review or attest services for Tetra, including the resolution of issues between management of Tetra and the external auditors regarding financial disclosure;
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(j) review the results of the external audit and the report thereon including, without limitation, a discussion with the external auditors as to the quality of accounting principles used, any alternative treatments of financial information that have been discussed with
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management of Tetra, the ramifications of their use as well as any other material changes. Review a report describing all material written communication between management and the auditors such as management letters and schedule of unadjusted differences;
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(k) review any material written communications between senior executives of Tetra and the external auditors and any significant disagreements between the senior executives and the external auditors;
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(l) discuss with the external auditors their perception of Tetra's financial and accounting personnel, records and systems, the cooperation which the external auditors received during their course of their review and availability of records, data and other requested information and any recommendations with respect thereto;
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(m) discuss with the external auditors their perception of Tetra's identification and management of risks, including the adequacy or effectiveness of policies and procedures implemented to mitigate such risks;
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(n) review the reasons for any proposed change in the external auditors which is not initiated by the Committee or Board and any other significant issues related to the change, including the response of the incumbent auditors, and enquire as to the qualifications of the proposed auditors before making its recommendations to the Board;
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(o) review annually a report from the external auditors in respect of their internal qualitycontrol procedures, any material issues raised by the most recent internal quality-control review, or peer review of the external auditors, or by any inquiry or investigation by governmental or professional authorities, within the preceding five years, respecting one or more independent audits carried out by the external auditors, and any steps taken to deal with any such issues;
4.4 Associated Responsibilities
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(a) monitor and periodically review Tetra's Whistleblower Policy and associated procedures for:
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(i) the receipt, retention and treatment of complaints received by Tetra’s regarding accounting, internal accounting controls or auditing matters;
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(ii) the confidential, anonymous submission by directors, officers and employees of Tetra of concerns regarding questionable accounting or auditing matters;
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(iii) any violations of any applicable law, rule or regulation that relates to corporate reporting and disclosure, or violations of Tetra’s Code of Business Conduct & Ethics;
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(b) review the public disclosure regarding the Committee required from time to time by NI 52110;
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(c) inform the Board of matters that may significantly impact the financial condition or affairs of the business of Tetra;
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(d) review and approve Tetra's hiring policies regarding employees and partners, and former employees and partners, of the present and former external auditors of Tetra; and
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(e) review and monitor the implementation of Tetra’s Code of Business Conduct and Ethics.
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4.5 Non-Audit Services
- (a) pre-approve all non-audit services to be provided to Tetra or any subsidiary entities by its external auditors or by the external auditors of such subsidiary entities. The Committee may delegate to one or more of its Members the authority to pre-approve non-audit services but pre-approval by such Member or Members so delegated shall be presented to the full Committee at its first scheduled meeting following such pre- approval.
5.0 Oversight Function
While the Committee has the responsibilities and powers set forth in this Charter, it is not the duty of the Committee to plan or conduct audits or to determine that Tetra's financial statements are complete and accurate or comply with IFRS and other applicable requirements. These are the responsibilities of management and the external auditors. The Committee, the Chairman and any Members identified as having accounting or related financial expertise are members of the Board, appointed to the Committee to provide broad oversight of the financial, risk and control related activities of Tetra, and are specifically not accountable or responsible for the day to day operation or performance of such activities. Although the designation of a Member as having accounting or related financial expertise for disclosure purposes is based on that individual's education and experience, which that individual will bring to bear in carrying out his or her duties on the Committee, such designation does not impose on such person any duties, obligations or liability that are greater than the duties, obligations and liability imposed on such person as a member of the Committee and Board in the absence of such designation. Rather, the role of a Member who is identified as having accounting or related financial expertise, like the role of all Members, is to oversee the process, not to certify or guarantee the internal or external audit of Tetra's financial information or public disclosure. This Charter is not intended to change or interpret the constating documents of Tetra or applicable law or stock exchange rule to which Tetra is subject, and this Charter should be interpreted in a manner consistent with all such applicable laws and rules. The Board may, from time to time, permit departures from the terms of this Charter, either prospectively or retrospectively to the extent permitted under applicable law and listing standards. This Charter is not intended to give rise to civil liability on the part of Tetra or its directors or officers to shareholders, security holders, customers, suppliers, competitors, employees or other persons, or to any other liability whatsoever on their part.
6.0 Reporting
The Chairman will report to the Board at each Board meeting on the Committee's activities since the last Board meeting. The Committee will annually review and approve the Committee's report to the Board. The minutes of each meeting of the Committee will be available to the members of the Board, at their request.
7.0 Access to Information and Authority
The Committee will be granted unrestricted access to all information regarding Tetra that is necessary or desirable to fulfill its duties and all directors, officers and employees will be directed to cooperate as requested by the Members. The Committee has the authority to retain, at Tetra's expense, independent legal, financial and other advisors, consultants and experts, to assist the Committee in fulfilling its duties and responsibilities, including sole authority to retain and to approve any such firm's fees and other retention terms without prior approval of the Board. The Committee also has the authority to communicate directly with internal and external auditors.
The Committee shall at least annually evaluate its own performance and report to the Board on such evaluation.
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8.0 Review of Charter
The Committee will annually review and assess the adequacy of this Charter and recommend any proposed changes to the Board for consideration.
Dated: February 22, 2021 Approved by: Board of Directors
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