Neuphoria Therapeutics (NEUP) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations
2. 02Raising additional capital may cause dilution to our shareholders, including holders of our ADSs, restrict our operations or require us to relinquish rights to our technologies or product candidates
3. 03Our financial statements have been prepared assuming a going concern
4. 04Our operating results have fluctuated significantly in the past and may continue to do so in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance
5. 05If we lose research and development incentives from the Australian government, then we could encounter difficulties in funding future research and development projects, which could harm our operating results
6. 06Our ability to utilize our tax losses and certain other tax attributes may be limited
7. 07Inflation could adversely affect our business and results of operations

Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates

1. 08Our preclinical and clinical programs may experience delays, unforeseen costs or may never advance, which could adversely affect our ability to obtain regulatory approvals or commercialize our product candidates on a timely basis or at all, which could have an adverse effect on our business and shareholder value
2. 09In order to obtain FDA approval to market a new small molecule product, we must demonstrate the safety and efficacy of our product candidates in humans to the satisfaction of the FDA. To meet these requirements, we will have to conduct adequate and well-controlled clinical trials
3. 10We have entered Phase 3 of our development efforts for BNC210 in SAD and are preparing to enter into Phase 3 of our development efforts for BNC210 in PTSD. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed
4. 11If we experience delays or difficulties in the initiation, enrollment and/or retention of patients in clinical trials, our regulatory submissions or receipt of necessary regulatory approvals could be delayed or prevented
5. 12Interim, topline or preliminary data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data
6. 13Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials
7. 14Our current or future product candidates may cause adverse or other undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any
8. 15The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
9. 16We plan to seek regulatory approval of our current or future product candidates outside of the United States. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction
10. 17We may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials, which may subject us to delays and expenses
11. 18The success of our business depends primarily on our ability to identify, develop and commercialize one or more product candidates
12. 19We are highly dependent on the members of our senior management and scientific staff. We may have difficulties in attracting and retaining key personnel, and if we fail to do so our business may suffer
13. 20Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug development programs and other critical business functions
14. 21Risks associated with our international operations, including seeking and obtaining approval to commercialize our product candidates in foreign jurisdictions, could harm our business
15. 22We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management
16. 23Clinical drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials are prolonged or delayed, we, or our collaborators, may be unable to commercialize our product candidates on a timely basis

Risks Related to Our Reliance on Third Parties

1. 24We may explore future collaborations with third parties for the development and commercialization of our current product candidates that are not partnered. If we are unable to form such collaborations or they are not successful, we may not be able to complete the development of these product candidates
2. 25Combination-use products, including a potential combination of EMP-01 and BNC210, may present safety or supply issues that could delay or prevent development and approval of our product candidates
3. 26The third parties upon whom we rely for the supply drug product and starting materials used in our product candidates are limited in number, and the loss of any of these suppliers, or their noncompliance with regulatory requirements or our quality standards, could significantly harm our business
4. 27We rely and will continue to rely on outsourcing arrangements for many of our activities, including clinical development and supply of BNC210
5. 28Manufacturing our product candidates is complex and we may encounter difficulties in production. If we encounter such difficulties, our ability to provide supply of our current or future product candidates for preclinical studies and future clinical trials or for commercial purposes could be delayed or stopped
6. 29A COVID-19 pandemic resurgence (or other pandemic breakout) could materially and adversely impact our business, including our clinical trials, supply chain, capital raising and business development activities
7. 30These and other disruptions in our operations, the global economy or serious impacts on our share price and ability to raise additional funds could negatively impact our business, operating results and financial condition
8. 31Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
9. 32The increasing use of social media platforms presents new risks and challenges

Risks Related to Commercialization of our Product Candidates

1. 33Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales
2. 34If we are unable to establish sales, marketing and distribution capabilities for any product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved
3. 35We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do
4. 36Third-party payor coverage and reimbursement status of newly-approved drugs is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those drugs and decrease our ability to generate revenue
5. 37Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States
6. 38We are exposed to potential product liability or similar claims, and insurance against these claims may not be available to us at a reasonable rate in the future or at all

Risks Related to Regulation of Our Industry

1. 39The regulatory approval processes of the FDA, EMA and comparable authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed
2. 40Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization
3. 41Changes in methods of product candidate manufacturing, formulation and mixed clinical trial results calling for an altered clinical approach may result in additional costs or delay
4. 42Even if we obtain and maintain approval for our product candidates from one jurisdiction, we may never obtain approval for our product candidates in other jurisdictions, which would limit our market opportunities and adversely affect our business
5. 43We may be subject to healthcare laws, regulation and enforcement and our failure to comply with these laws could harm our results of operations and financial conditions
6. 44The scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations
7. 45Our employees, independent contractors, principal investigators, CROs, consultants, vendors and collaboration partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business
8. 46Healthcare legislative reform measures may have a material adverse effect on our business and results of operations
9. 47In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted
10. 48Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition

Risks Related to Our Intellectual Property

1. 49We may not be able to protect our intellectual property rights throughout the world
2. 50Periodic maintenance fees, renewal fees, annuities fees and various other governmental fees on patents and/or patent applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent and/or patent application
3. 51Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
4. 52Changes in U.S. patent laws, or laws in other countries, could diminish the value of patents in general and may limit our ability to obtain, defend, and/or enforce our patents
5. 53Our intellectual property licensed from third parties may be subject to retained rights
6. 54If we are unable to obtain intellectual property licenses from third parties on commercially reasonable terms or at all, our business could be harmed
7. 55Any issued patents we may own covering our product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO
8. 56Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from developing or selling our products
9. 57Any litigation or claim against us, even those without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business and harm our reputation
10. 58Intellectual property litigation may lead to unfavorable publicity that harms our reputation
11. 59Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
12. 60We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products
13. 61We may be subject to claims challenging the inventorship of our patents and other intellectual property
14. 62If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
15. 63We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non-solicitation agreements with our competitors or their former employers
16. 64If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Related to Ownership of Our ADSs

1. 65The trading price of our ordinary shares has been volatile, and that of our ADSs may be volatile, and holders of our ADS may not be able to resell the ADSs at or above the price paid
2. 66Sales of ADSs issuable upon exercise of the Warrants and other derivative securities could cause the market price of our ADSs to decline
3. 67Fluctuations in currency exchange rates may have a material adverse effect on our results of operations
4. 68Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and results of operations and the price of our ADSs
5. 69If we fail to meet the continued listing requirements of Nasdaq, it could result in a de-listing of our ADSs
6. 70Sales of a substantial number of our ADSs or ordinary shares in the public market or the perception that these sales may occur could significantly reduce the market price of our ADSs and impair our ability to raise adequate capital
7. 71Investors’ right to participate in any future rights offering may be limited, which may cause dilution to holdings in our ADSs
8. 72Our executive officers, directors, principal shareholders and their affiliates will continue to exercise significant influence over our company, which will limit the ability of holders of our ADSs to influence corporate matters and could delay or prevent a change in corporate control
9. 73An active, liquid trading market for our ADSs may not be maintained
10. 74ADS holders may be subject to additional risks related to holding ADSs rather than ordinary shares, and we may incur significant costs related to our Depositary Agreement for the ADSs
11. 75ADS holders’ right to participate in any future preferential subscription rights offering or to elect to receive dividends in ordinary shares may be limited, which may cause dilution to their holdings
12. 76Investors may be subject to limitations on transfers of our ADSs and withdrawal of the underlying ordinary shares
13. 77ADS holders must act through the ADR depositary to exercise their voting rights and, as a result, may be unable to exercise voting rights on a timely basis
14. 78If a United States person is treated as owning at least 10% of Bionomic Limited’s ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences
15. 79Holders of our ADSs may not receive dividends on our ordinary shares represented by the ADSs or any value for such dividend if it is illegal or impractical to make them available to holders of ADSs
16. 80We are an “emerging growth company” (as defined in the JOBS Act) and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our ADSs may be less attractive to investors
17. 81Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares or ADSs
18. 82Our Constitution and Australian laws and regulations applicable to us may adversely affect our ability to take actions that could be beneficial to our shareholders and holders of our ADSs
19. 83We incur significant costs as a result of operating as a U.S. listed public company and our management is required to devote substantial time and expense to various compliance issues
20. 84If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our ADSs adversely, the trading price and volume of our ADSs could decline
21. 85As a U.S. public reporting company, we are required to maintain effective internal control over financial reporting suitable to prepare our publicly reported financial statements in a timely and accurate manner
22. 86We may become involved in securities class action litigation that could divert management’s attention and adversely affect our business and could subject us to significant liabilities
23. 87Significant disruptions of information technology systems or data security breaches could adversely affect our business
24. 88The loss of our status as a “foreign private issuer” could result in additional cost