ANTIBE THERAPEUTICS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS

Year Ended March 31, 2023

Dated: June 28, 2023

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, 2023 ("Q4 2023" and "Q4 2023 YTD" respectively) and for the comparative periods, the three and twelve month period ended March 31, 2022 ("Q4 2022" and "Q4 2022 YTD" respectively) and should be read in conjunction with the Company's most recent audited consolidated financial statements (the "2023 Audited FS") and the notes thereto for the twelve months ended March 31, 2023. The Company's accounting policies and estimates used in the preparation of the 2023 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 28, 2023.

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 used 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;

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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 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 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 is also planning to pursue regulatory approval in major markets in Europe and Asia.

RECENT EVENTS

On April 11, 2023, the Company announced that, further to the disclosure provided in last year's AIF, the dispute with Nuance Pharma ("Nuance") has not yet been settled. Accordingly, in May 2023, arbitration proceedings were held with Nuance and a decision is pending. (Please see "Legal Proceedings" in the AIF for further information.)

On November 1, 2022, the Company announced the closing of the sale of Citagenix to HANSAmed Limited. The transaction involves a guaranteed $3.5 million, divided into four equal payments over three years, with an additional $4 million subject to Citagenix achieving sales milestones in the four year period following closing. In accordance with the agreement, the Company received proceeds totaling approximately $1.4 million, comprising the first of the four guaranteed payments of $875 thousand and an adjustment of $0.3 million in excess working capital. In addition, prior to the closing Citagenix paid the Company $1.1 million to retire Preferred Shares in Citagenix.

On October 10, 2022, Antibe announced a new faster-absorbing formulation of otenaproxesul that aims to increase its therapeutic benefit and commercial potential. Accordingly, the Company filed a patent application that strengthens the drug's IP protection to 2043.

On May 25, 2022, 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 former Chair, and Dr. John L. Wallace, Chief Scientific Officer and Director since he founded the Company. As Vice Chairs, they provide ongoing counsel to the Company on key business initiatives. Dr. Wallace is also taking the opportunity to return to his vocation as a research scientist.

NOVEL DRUG DEVELOPMENT PLATFORM

Antibe's drug development platform originates, develops and out-licensespatent-protected new pharmaceuticals for pain and inflammation that originate from Nobel Prize-winning medical research1 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, creating new chemical entities ("NCEs") with the potential to deliver safer and/or more effective inflammation-targeted therapies.

  • 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". Dr. Ignarro is a member of the Company's Scientific Advisory Board.

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OTENAPROXESUL: LEAD DRUG CANDIDATE

Otenaproxesul (formerly ATB-346) is a novel NSAID that releases hydrogen sulfide. It combines naproxen, a widely used NSAID, with a hydrogen sulfide-releasing moiety to create a novel therapeutic compound. Antibe is leveraging the drug's remarkable potency, GI protection, and overall safety profile to position it as the NSAID-of-choice for acute pain, including post-operative pain, acute musculoskeletal pain, dysmenorrhea, migraine, gout and dental pain - all large markets with an ongoing medical need for safe and effective therapies. The Company intends to utilize the characteristics of the acute pain dosing regimen to identify an optimal dosing regimen for chronic pain indications.

Recent Developments

On October 10, 2022, Antibe announced a new faster-absorbing formulation of otenaproxesul that promises to increase its speed of onset, thereby improving its therapeutic benefit and commercial potential. (Please see the following subsection for further detail.)

During 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.

Also in calendar Q3 2021, the Company commenced an Absorption, Metabolism and Excretion ("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 formulations and dosing regimens as a potential path forward for chronic indications, the Company has launched an acute pain program for otenaproxesul.

On March 29, 2021, Antibe announced that the U.S. FDA had cleared the Company's IND application for otenaproxesul. This enabled Antibe to undertake human clinical trials for otenaproxesul in the United States.

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 acute pain clinical program in calendar Q1 2022. This program began with 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 concluded that the results from the first two studies warranted moving into a Phase II program.

In late 2021, the Company began intensive research to improve the immediate post-treatment bioavailability of otenaproxesul while concomitantly accelerating onset of cyclooxygenase inhibition, seeking tablet dosages much lower in strength than would be needed with the existing drug formulation. In October 2022, Antibe announced a new formulation of otenaproxesul that aims to increase the drug's therapeutic benefit and commercial potential. Its intended benefits include: (i) rapid dissolution mechanics, accelerating otenaproxesul's onset of action, a key benchmark for acute pain medications; and (ii) enhanced bioavailability, enabling a significant dose reduction compared to its current formulation. The lower dose provides an additional safety buffer as well as a potential pathway to address chronic pain indications. The new formulation was developed in collaboration with Antibe's global manufacturing partner; all related IP is owned exclusively by Antibe.

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Antibe Therapeutics Inc. published this content on 29 June 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 June 2023 17:23:32 UTC.