Management's Discussion and Analysis of

NervGen Pharma Corp.

(Expressed in Canadian Dollars)

For the three and nine months ended September 30, 2021

Effective Date: November 17, 2021

MANAGEMENT'S DISCUSSION AND ANALYSIS

The following discussion is management's assessment and analysis of the results of operations and financial conditions of NervGen Pharma Corp. (the "Company" or "NervGen") and should be read in conjunction with the accompanying consolidated financial statements and related notes thereto for the period ended September 30, 2021.

All financial information in this Management's Discussion and Analysis ("MD&A") has been prepared in accordance with International Financial Reporting Standards ("IFRS") and all dollar amounts are expressed in Canadian dollars unless otherwise indicated.

FORWARD-LOOKING STATEMENTS

This MD&A includes certain statements that are "forward-looking information" within the meaning of applicable Canadian securities legislation (collectively, the "forward-looking statements"). Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing and other information that is not historical information. These statements appear in a number of different places in this MD&A and can often be identified by words such as "anticipates", "estimates", "projects", "expects", "intends", "believes", "plans", "will", "could", "may", or their negatives or other comparable words. Such forward-looking statements are necessarily based on estimates and involve known and unknown risks, uncertainties and other factors that may cause 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-looking statements.

Forward-looking statements in this MD&A, include, but are not limited to, statements relating to:

  • requirements for, and the ability to obtain, future funding on favourable terms or at all;
  • business strategy;
  • expected future loss and accumulated deficit levels;
  • projected financial position and estimated cash burn rate;
  • expectations about the timing of achieving milestones and the cost of our development programs;
  • estimates of the size and characteristics of the potential markets for the Company's products;
  • observations and expectations regarding the effectiveness of our lead compound, NVG-291, and the potential benefits to patients;
  • the impact of the COVID-19 pandemic on our operations;
  • plans to use NVG-291 in our clinical development programs;
  • plans to use Imeka Solutions Inc.'s imaging technology as a sensitive pharmacodynamic biomarker for NVG- 291;
  • expectations about the timing with respect to commencement and completion of clinical trials;
  • expectations about the timing with respect to preclinical studies;
  • expectations about the Company's products' safety and efficacy;
  • our ability to identify and secure sources of non-dilutive funding for the development of NVG-291;
  • expectations regarding our ability to arrange for the manufacturing of our products and technologies;
  • expectations regarding the cost, progress and successful and timely completion of the various stages of the regulatory approval process;
  • ability to secure strategic partnerships with larger pharmaceutical and biotechnology companies;
  • strategy to acquire and develop new products and technologies and to enhance the safety and efficacy of existing products and technologies;
  • plans to market, sell and distribute our products and technologies;
  • expectations regarding the acceptance of our products and technologies by the market;
  • expectations regarding the use of our products and technologies in treating diseases and medical disorders;
  • ability to retain and access appropriate staff, management, and expert advisers;
  • expectations with respect to existing and future contractual obligations, corporate alliances and licensing transactions with third parties, and the receipt and timing of any payments to be made by the Company or to the Company in respect of such arrangements; and
  • our strategy and ability with respect to the protection of our intellectual property.

Such statements reflect our 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 that, while considered reasonable by us, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our 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-looking statements.

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In making the forward-looking statements included in this MD&A, we have made various material assumptions, including but not limited to:

  • our ability to obtain financing on acceptable terms;
  • additional sources of funding, including grants and funding from partners;
  • our ability to attract and retain skilled staff;
  • favourable general business and economic conditions;
  • the COVID-19 pandemic not having a material impact on our operations;
  • our future research and development plans proceeding substantially as currently envisioned;
  • our ability to obtain positive results from our research and development activities, including clinical trials;
  • future expenditures to be incurred by the Company;
  • research and development and operating costs;
  • our ability to find partners in the pharmaceutical industry;
  • the products and technology offered by our competitors;
  • the impact of competition on the Company;
  • our ability to identify a product candidate;
  • our ability to obtain regulatory and other approvals to commence clinical trials involving future product candidates;
  • our ability to successfully out-license or sell our future products, if any, and in-license and develop new products;
  • our ability to protect patents and proprietary rights; and
  • expected research and development tax credits.

In evaluating forward-looking statements, current and prospective shareholders should specifically consider the risk factors and uncertainties set forth under the heading "Risks Factors" in our Annual Information Form for the year ended December 31, 2020 (the "AIF") and our Prospectus Supplement dated November 8, 2021. Certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties related to the fact that:

  • we have no sources of product revenue and will not be able to maintain operations and research and development without significant additional funding which we may not be able to obtain on favourable terms or at all;
  • pandemics, such as the recent outbreak of the novel coronavirus COVID-19, may adversely impact multiple aspects of our business;
  • we are highly dependent upon certain key personnel and their loss could adversely affect our ability to achieve our business objectives;
  • if we breach any of the agreements under which we license rights to product candidates or technology from third parties, we can lose license rights that are important to our business;
  • preclinical and clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results and our product candidates may not have favourable results in later trials or in the commercial setting;
  • if we are unable to enroll subjects in clinical trials, we will be unable to complete these trials on a timely basis;
  • significant disruption in availability of key components for ongoing preclinical and clinical studies could considerably delay completion of potential clinical trials, product testing and regulatory approval of potential product candidates;
  • if our competitors develop and market products that are more effective than our existing product candidates or any products that we may develop, or obtain marketing approval before we do, our products may be rendered obsolete or uncompetitive;
  • we rely on and will continue to rely on third parties to plan, conduct and monitor preclinical studies and clinical trials, and their failure to perform as required could cause substantial harm to our business;
  • we rely on contract manufacturers over whom we have limited control and if we are unable to secure our drug supplies from our contract manufacturers, it may result in delays in preclinical and clinical drug development timelines;
  • our future success is dependent primarily on the regulatory approval of a single product;
  • our drug candidates are in preclinical and early phase clinical development and, as a result, we cannot predict whether we will be able to profitably commercialize our products;
  • we will be subject to extensive government regulation that may increase the cost and uncertainty associated with gaining final regulatory approval of our product candidates;
  • our products may become subject to unfavourable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, thereby having an adverse effect on our business;
  • negative results from clinical trials or studies or others and adverse safety events involving the targets of our products may have an adverse impact on future commercialization efforts;

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  • we face the risk of product liability claims, which could exceed our insurance coverage and produce recalls, each of which could deplete cash resources;
  • we may not achieve our publicly announced milestones according to schedule, or at all;
  • changes in government regulations, although beyond our control, could have an adverse effect on our business;
  • our discovery and development processes involve use of hazardous and radioactive materials which may result in potential environmental exposure;
  • if we are unable to successfully develop companion diagnostics or biomarkers for our therapeutic product candidates, or experience significant delays in doing so, we may not achieve marketing approval or realize the full commercial potential of our therapeutic product candidates;
  • significant disruption in availability of key components for ongoing preclinical and clinical studies could considerably delay completion of potential clinical trials, product testing and regulatory approval of potential product candidates;
  • our competitors could develop alternative methods for targeting the protein tyrosine phosphatase sigma ("PTPσ") receptor;
  • our products or technologies may need to be used in connection with third-party technologies or products;
  • we could be adversely impacted by unauthorized actions or the distribution of inaccurate information;
  • our success depends upon our ability to protect our intellectual property and our proprietary technology;
  • our potential involvement in intellectual property litigation could negatively affect our business;
  • our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them;
  • product liability claims are an inherent risk of our business and, moving forward, if our clinical trial and product liability insurance prove inadequate, product liability claims may harm our business;
  • we will have significant additional future capital needs and there is uncertainty as to our ability to raise additional funding;
  • the Company's shareholders may experience significant dilution from future sales of our securities;
  • the price of our common shares ("Common Shares") has experienced volatility and may be subject to fluctuation in the future based on market conditions;
  • we may pursue other business opportunities in order to develop our business and/or products;
  • generally, a litigation risk exists for any company that may compromise our ability to conduct our business;
  • our success depends on our ability to effectively manage our growth;
  • we are likely a "passive foreign investment company," which may have adverse United States ("U.S.") federal income tax consequences for U.S. shareholders;
  • it may be difficult for non-Canadian investors to obtain and enforce judgments against us because of our Canadian incorporation and presence;
  • significant disruptions of information technology systems or security breaches could adversely affect our business;
  • we have never paid dividends on our Common Shares and we do not anticipate paying any dividends in the foreseeable future;
  • future sales or issuances of equity securities or the conversion of securities to Common Shares could decrease the value of the Common Shares, dilute investors' voting power, and reduce earnings per share;
  • the exercise of stock options or Warrants and the subsequent resale of such Common Shares in the public market could adversely affect the prevailing market price and our ability to raise equity capital in the future at a time and price which we deem appropriate;
  • our warrants are not listed on any exchange and we do not intend to list our warrants on any exchange;
  • we will have broad discretion over the use of the net proceeds of an offering of our securities and we may not use these proceeds in a manner desired by our shareholders; and
  • there is no assurance of a sufficient liquid trading market for our Common Shares in the future.

If one or more of these risks or uncertainties or a risk that is not currently known to us materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from those expressed or implied by forward-looking statements. The forward-looking statements represent our views as of the date of this MD&A. While we may elect to update these forward-looking statements in the future, we have no current intention to do so except as to the extent required by applicable securities law. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements. We advise you that these cautionary remarks expressly qualify in their entirety all forward-looking statements attributable to us or persons acting on our behalf.

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COMPANY OVERVIEW

NervGen is a publicly traded company incorporated on January 19, 2017 as 1104403 B.C. Ltd. under the Business Corporations Act (British Columbia). The name was changed to NervGen Pharma Corp. on November 15, 2017. Our corporate office is Suite 1703, 595 Burrard Street, Vancouver, BC, V7X 1J1, Canada.

On June 25, 2018, the Company entered into an exclusive worldwide licensing agreement to research, develop and commercialize a patented technology with the potential to bring new treatments for nervous system damage due to trauma or underlying (e.g. neurodegenerative) disease. The technology was developed in the laboratory of Dr. Jerry Silver, a leading spinal cord injury and regenerative medicine researcher at Case Western Reserve University. Dr. Silver's research has identified PTPσ as a key neural receptor which inhibits nervous system repair in spinal cord injury and other medical conditions. Targeted treatment against PTPσ with an agent known as intracellular sigma peptide ("ISP", also known as NVG-291-R) promoted regeneration of damaged neurons and functional improvement in animal models for various medical conditions. A series of receptor antagonists that can be delivered systemically have been identified, including an analogue of ISP, NVG-291, that is structurally similar but slightly different in composition.

We have conducted initial preclinical development of NVG-291 and filed an Investigational New Drug ("IND") application with the United States Food and Drug Administration (the "FDA"). On March 2, 2021, NervGen was cleared by the FDA to proceed with the single ascending dose ("SAD") portion of the Phase 1 healthy volunteer trial in females, and the multiple ascending dose ("MAD") portion of the trial in post-menopausal females. The FDA has asked for additional preclinical safety data prior to including males in the Phase 1 program, and prior to including premenopausal females in the MAD portion of the trial. The Company has modified its proposed Phase 1 protocol and has dosed the first human subject in this program in May 2021 in Australia, while continuing to complete additional preclinical work in parallel, prior to testing NVG- 291 in broader patient populations in various indications.

Subject to successful completion of the Phase 1 study in healthy volunteers, we intend to initiate a Phase 1b/2a clinical study in Alzheimer's disease ("AD") patients and Phase 1b/2 studies in spinal cord injury patients and in multiple sclerosis ("MS") patients in 2022.

In addition, we have initiated research collaborations in preclinical models of Alzheimer's disease to further understand disease mechanisms related to PTPσ to determine the effect of NVG-291 in these models of Alzheimer's disease. These objectives replace and supersede those described in the "Description and General Development of the Business" section of our Short Form Base Shelf Prospectus dated January 2, 2020. All clinical development plans are subject to additional funding (see "Liquidity and Capital Resources" below).

These three indications represent a significant market opportunity due to the high-cost burden to the health care system and the dramatic impact on quality of life. We are also identifying additional therapeutic candidates for other medical conditions involving nervous system damage.

ACHIEVEMENTS & HIGHLIGHTS

The following are the achievements and highlights for the nine months ending September 30, 2021 through to the date hereof:

  • On January 5, 2021, we announced the engagement of Encode Ideas, L.P. to provide capital markets consulting that will complement the services provided by LifeSci Partners.
  • On January 26, 2021, we announced the establishment of an Alzheimer's Disease Scientific Advisory Board comprised of four world-class scientists and clinical researchers who will work closely with us as we plan our upcoming preclinical studies and clinical trials and analyze the results from these studies.
  • On January 27, 2021, we announced that we plan to add an Alzheimer's disease patient cohort to our Phase 1 clinical trial program for NVG-291 starting in Q1 2022. Currently, the plans are to conduct the study as a stand- alone Phase 1b study rather than as an additional cohort to the Phase 1 study starting in 2022.
  • On March 4, 2021, we provided an update regarding our NVG-291 IND submission, announcing that we have been cleared by the U.S. FDA to proceed with the single ascending dose portion of our Phase 1 clinical trial in females, and the multiple ascending dose portion of the trial in post-menopausal females in Australia under all of the conditions required by the FDA once obtain final approval from the ethics review board governing the study and provide notification to the Therapeutic Goods Administration.

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NervGen Pharma Corp. published this content on 18 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 November 2021 13:22:07 UTC.