ANTIBE THERAPEUTICS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS

Year Ended March 31, 2022

Dated: June 29, 2022

MANAGEMENT'S DISCUSSION AND ANALYSIS

INTRODUCTION

The following management's discussion and analysis (this "MD&A") of the operating results and financial position of Antibe Therapeutics Inc. ("Antibe" or the "Company") is for the three and twelve month period ended March 31, 2022 ("Q4 2022" and "Q4 2022 YTD" respectively) and for the comparative periods, the three and twelve month period ended March 31, 2021 ("Q4 2021" and "Q4 2021 YTD" respectively) and should be read in conjunction with the Company's most recent audited consolidated financial statements (the "2022 Audited FS") and the notes thereto for the twelve months ended March 31, 2022. The Company's accounting policies and estimates used in the preparation of the 2022 Audited FS are considered appropriate in the circumstances, but are subject to judgments and uncertainties inherent in the financial statement process. The Company's financial data have been prepared in accordance with International Financial Reporting Standards ("IFRS"), as issued by the International Accounting Standards Board, and are presented in Canadian dollars unless otherwise noted herein.

Additional information relating to the Company is available under the Company's System for Electronic Document Analysis and Retrieval ("SEDAR") profile at www.sedar.com.

The Company's financial data are presented in thousands of Canadian dollars unless otherwise noted herein.

This MD&A was approved by the Company's Board of Directors on June 29, 2022.

FORWARD-LOOKING STATEMENTS

Certain statements in this MD&A about the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements or any other future events or developments constitute forward- looking statements. The words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate and reasonable in the circumstances.

Many factors could cause the Company's actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements. The purpose of the forward-looking statements is to provide readers with a description of management's expectations regarding, among other things, the Company's financial performance and research and development plans and may not be appropriate for other purposes. Readers should not place undue reliance on forward-looking statements.

Furthermore, unless otherwise stated, the forward-looking statements are made as of the date of this MD&A, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. New factors emerge from time to time, and it is not possible for the Company to predict which factors may arise. In addition, the Company cannot assess the impact of each factor on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Without limitation, this MD&A may contain forward-looking statements pertaining to the following:

  • the Company's research and development plans (including the persons expected to oversee, coordinate and participate in such plans), business model, focus, strategic objectives and growth strategy;
  • the Company's current and future capital requirements and the need for additional financing;
  • the continuation of the Company as a going concern;
  • the payment of dividends;
  • the Company's plans for Citagenix;

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  • the Company's expectations regarding net losses and revenue generation; and
  • the Company's expectations regarding increases in research and development costs and general and administrative expenses.

With respect to forward-looking statements, assumptions have been made regarding, among other things:

  • the Company's future research and development plans proceeding substantially as currently envisioned;
  • expected research and development tax credits;
  • future expenditures to be incurred by the Company;
  • research and development and operating costs;
  • the Company's ability to find partners in the pharmaceutical industry;
  • additional sources of funding, including the Company's ability to obtain funding from partners;
  • the impact of competition on the Company;
  • the Company being able to obtain financing on acceptable terms; and
  • the Company's ability to license and/or obtain for sale new and innovative regenerative medicine products.

Because the factors discussed in this MD&A could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by the Company, readers should not place undue reliance on any such forward-looking statements. These statements are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate, among other factors, to:

  • The Company's research and development activities not achieving the desired outcomes;
  • the Company's history of operating losses;
  • the Company's ability to obtain additional capital in the future to conduct operations, research and development activities and develop its products;
  • the availability of tax credits;
  • the Company's ability to find partners in the pharmaceutical industry;
  • the Company's ability to license its products on terms and conditions acceptable to the Company;
  • the Company's ability to compete against other companies and research institutions with greater financial and other resources;
  • the Company's ability to secure and maintain adequate protection for its intellectual property;
  • the Company's ability (or the ability of the Company's partners) to obtain regulatory approvals for the Company's products;
  • the Company's ability to attract and retain key personnel;
  • the Company's ability to expand its regenerative medicine business into additional products and markets;
  • the potential impact of the COVID-19 crisis on the Company's operations.

The Company's actual results could differ materially from those discussed in the following MD&A.

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COMPANY OVERVIEW

Antibe is a clinical stage biotechnology company leveraging its proprietary hydrogen sulfide ("H2S") platform to develop next-generation safer therapies to address inflammation arising from a wide range of medical conditions. The Company's current pipeline includes therapies that seek to overcome the gastrointestinal ("GI") ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs ("NSAIDs"). Antibe's lead drug, otenaproxesul, is in development for the treatment of acute and chronic pain. The Company's second pipeline drug is a GI-sparing alternative to ketoprofen. The Company's next target is inflammatory bowel disease ("IBD"), a condition long in need of safer, more effective therapies.

The Company's overall strategy is to monetize otenaproxesul and its drug pipeline at the optimal time through partnering or mergers and acquisitions ("M&A") activity. Antibe's primary regulatory focus is to obtain United States Food and Drug Administration ("U.S. FDA") approval for otenaproxesul given that the United States is the world's largest pharmaceutical market. The Company has also engaged a European regulatory consulting agency to develop a strategy for European Market Area ("EMA") approval. Upon the conclusion of this mandate, the Company plans on identifying the optimal path for seeking regulatory approval for otenaproxesul in Europe.

On November 12, 2020, the Company completed its graduation to the Toronto Stock Exchange ("TSX") and the Company's Common Shares ("the Common Shares") began trading on the TSX under the symbol "ATE". Concurrently, the Common Shares were voluntarily delisted from the TSX Venture Exchange. The Common Shares will continue to trade on the OTCQX market under the symbol "ATBPF".

On December 1, 2020, the Company completed a share consolidation of the Company's issued and outstanding common shares on the basis of one (1) new common share for every ten (10) common shares issued and outstanding. All common shares, options, restricted share units ("RSUs"), warrants and per share amounts have been restated to give retrospective effect to the share consolidation, unless otherwise noted.

On June 3, 2021, the Company completed a transaction with Holdings by way of a three-corner amalgamation. Pursuant to the transaction, the Company acquired full ownership of Holdings' patent portfolio, eliminating the royalty liability on future revenues. In consideration, Antibe issued an aggregate of 5,873,092 common shares in the capital of the Company to acquire all of the issued and outstanding shares of Holdings.

On August 3, 2021, the Company announced that it had placed its absorption, metabolism and excretion ("AME") study of otenaproxesul on a required pause because a pre-specified safety threshold was exceeded. Thereafter, the Company completed a scientific and strategic review leading to the launch of an acute pain program for otenaproxesul; clinical studies commenced in calendar Q1 2022. The Company continues to investigate alternative dosing regimens as a potential path forward for chronic indications.

On May 2, 2022, following the end of Antibe's 2022 fiscal year, the Company announced the signing of a binding agreement to sell its subsidiary, Citagenix Inc. The $6.5 million transaction involves a guaranteed $3.5 million, divided into four equal payments over three years, the first of which will be received at closing. The remaining $3 million is subject to Citagenix achieving sales milestones over the three-year period following closing. The transaction will close no later than 180 days following the signing of this binding agreement.

On May 25, 2022, following the end of Antibe's 2022 fiscal year, the Company announced the appointment of Robert E. Hoffman, a Director of Antibe, as the new Chair of its Board of Directors. The Company also created two corporate Vice Chair positions to recognize the contributions of Walt Macnee, the outgoing Chair, and Dr. John L. Wallace, Chief Scientific Officer and Director since he founded the Company. As Vice Chairs, they will provide ongoing counsel to the Company on key business initiatives while also both continuing to serve on its Board of Directors. Dr. Wallace is also taking the opportunity to return to his vocation as a research scientist, with a continued focus on enriching the Company's pipeline.

NOVEL DRUG DEVELOPMENT PLATFORM

Antibe's drug development platform originates, develops and out-licenses patent protected new pharmaceuticals that are

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improved versions of existing drugs. These improvements originate from Nobel Prize-winning medical research 1 highlighting the crucial role of gaseous mediators: chemical substances produced in the human body to regulate a range of fundamental cellular processes. The Company's drug design methodologies involve chemically linking a base drug to a hydrogen sulfide-releasing moiety; in short, improving existing inflammation-targeted therapies with the goal of making them safer and/or more effective.

Otenaproxesul: Lead Drug Candidate

Otenaproxesul (formerly ATB-346) is a novel NSAID that releases hydrogen sulfide. It combines a gaseous mediator (H2S) with naproxen, a widely used NSAID, to create a novel therapeutic compound. Antibe is leveraging the drug's remarkable potency, GI protection, and its overall safety profile to position otenaproxesul as the NSAID-of-choice for post-operative pain. Antibe plans to rapidly expand to the full range of acute pain indications such as migraine, dysmenorrhea, traumatic injury, dental pain and gout - all large markets with few safe and effective therapies.

Recent Developments

On March 29, 2021, Antibe announced that the U.S. FDA had cleared the Company's Investigational New Drug ("IND") application for otenaproxesul. This enables Antibe to undertake human clinical trials for otenaproxesul in the United States.

During calendar Q3 2021, the Company commenced an AME study of otenaproxesul in Canada, which was expected to conclude in calendar Q4 2021. On August 3, 2021, the Company announced that it had placed the AME study on a required pause because a pre-specified safety threshold was exceeded. At that point, the study had enrolled a total of 42 subjects on either a 75 mg or 100 mg daily dose of otenaproxesul, of whom 35 had completed the 28-day drug administration period, with seven subjects having been administered the drug for 21 days. Three subjects in the 100 mg cohort, who had completed the full drug administration period, exhibited liver transaminase elevations ("LTEs") exceeding five times the upper limit of normal, triggering the required pause. Other indicators of liver function for these subjects were normal. Following the 4-week drug administration period, a further three subjects exhibited similar LTEs. All six subjects, including five in the 100 mg cohort and one in the 75 mg cohort, completed their in-clinic observation period without any additional safety findings. All LTEs were transient, self-limiting and required no clinical intervention. While it continues to investigate alternative dosing regimens as a potential path forward for chronic indications, the Company has launched an acute pain program for otenaproxesul.

Also in calendar Q3 2021, the Company completed a single-dose pharmacokinetic ("PK") and pharmacodynamic ("PD") study in 24 healthy volunteers in the U.S. in connection with its IND filing with the U.S. FDA. Subjects were administered the single dose of either 150 mg or 100 mg of otenaproxesul, tolerating the drug without incident and successfully completing on-study and follow-up assessments with no clinically meaningful adverse events or clinically significant laboratory abnormalities. The results are being used to guide future development of otenaproxesul.

Development Plan for Acute Pain Indications

By leveraging otenaproxesul's existing comprehensive clinical data package, including its demonstrated efficacy and GI safety profile, the Company launched its clinical program for post-operative pain in calendar Q1 2022. The plan involved a series of short pharmacokinetic/pharmacodynamic ("PK/PD") studies to identify optimal treatment regimens for postoperative pain before entering Phase II. Although four such studies were planned, the Company has concluded that the results from the first two studies merit moving directly into a Phase II program.

Antibe anticipates launching otenaproxesul's Phase II program in early calendar Q4 2022. The Company has updated its plan for the Phase II program to involve two sequential trials. The first is a third molar (i.e., wisdom tooth) extraction trial designed to measure otenaproxesul's PK/PD properties in surgery patients, supporting the selection of optimal treatment regimens for the second Phase II trial. Third molar extraction trials are widely used in acute pain drug development and are relatively straightforward to recruit for. The Company intends to carry out this trial at a leading U.S. site for such trials with top-line data expected within three months of initiation. With the savings realized from not conducting two previously planned pre-Phase II PK/PD studies, the early shift to the Phase II program is not expected to have a material impact on the Company's projected cashflow.

  • The 1998 Nobel Prize in Physiology or Medicine was awarded jointly to Robert F. Furchgott, Louis J. Ignarro and Ferid Murad "for their discoveries concerning nitric oxide as a signaling molecule in the cardiovascular system". Louis J. Ignarro is a member of the Company's Scientific Advisory Board.

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Antibe Therapeutics Inc. published this content on 30 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 June 2022 02:51:00 UTC.