Neuphoria Therapeutics (NEUP) risk factors, 2026 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. 02costs associated with any product candidates, products or technologies that we may in-license or acquire
3. 03Raising additional capital may cause dilution to our shareholders, including holders of our common stock, restrict our operations, or require us to relinquish rights to our technologies or product candidates38% rewritten
4. 04Sales of Common Stock issuable upon exercise of the Warrant and other derivative securities could cause the market price of our Common Stock to decline41% rewritten
5. 05Sales of a substantial number of our shares of common stock or securities exercisable or convertible into common stock in the public market or the perception that these sales may occur could significantly reduce the market price of our common stock and impair our ability to raise adequate capital65% rewritten
6. 06The trading price of our shares of common stock has been volatile, and holders of our common stock may not be able to resell the shares of common stock at or above the price paid
7. 07the loss of any of our key scientific or senior management personnel
8. 08Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and results of operations and the price of our common stock
9. 09If we fail to meet the continued listing requirements of Nasdaq, it could result in a de-listing of our Common Stock47% rewritten
10. 10An active, liquid trading market for our common stock may not be maintained
11. 11We are not currently paying dividends and will likely continue not paying cash dividends on our common stock for the foreseeable future
12. 12We 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 common stock may be less attractive to investors
13. 13We 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 issues21% rewritten
14. 14If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our commons stock adversely, the trading price and volume of our Common Stock could decline
15. 15As 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 manner35% rewritten
16. 16Our operating results and financial condition have been, and may continue to be, adversely affected by non-cash goodwill impairment chargesnew
17. 17We 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
18. 18Our financial statements in prior years had been prepared assuming that we will continue as a going concern89% rewritten
19. 19Our 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
20. 20future accounting pronouncements or changes in our accounting policies
21. 21If 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 results42% rewritten
22. 22Our ability to utilize our tax losses and certain other tax attributes may be limited
23. 23Inflation could adversely affect our business and results of operations33% rewritten

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

1. 24Our 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. 25In 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 must conduct adequate, well-controlled clinical trials
3. 26third parties being unwilling or unable to satisfy their contractual obligations to us
4. 27If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmednew
5. 28our ability to maintain continued acceptable safety profiles of our product candidates following approval
6. 29If 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 prevented59% rewritten
7. 30the rarity of some diseases, the eligibility criteria of our clinical studies may further limit the pool of available study participants as we will require that patients have specific characteristics that we can measure or to assure their disease is either severe enough or not too advanced to include them in a studynew
8. 31the risk that patients enrolled in clinical trials will drop out before completion22% rewritten
9. 32Interim, 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
10. 33If our clinical trials fail to replicate results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidatesnew
11. 34Our 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
12. 35our reputation may suffer91% rewritten
13. 36We have obtained a Fast Track designation for BNC210 for the treatment of PTSD and other trauma-related and stressor-related disorders. We may also seek Fast Track designation or Breakthrough Therapy designation for one or more of our other current or future product candidatesnew
14. 37If the market opportunities for our product candidates in PTSD or other indications we may pursue are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materiallynew
15. 38The 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
16. 39We 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 jurisdiction66% rewritten
17. 40manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our businessnew
18. 41We 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
19. 42The success of our business depends primarily on our ability to identify, develop and commercialize one or more product candidates20% rewritten
20. 43We have historically been highly dependent on the members of our senior management and scientific staff. We may in the future have difficulties in attracting and retaining key personnel, and if we fail to do so our business may suffer70% rewritten
21. 44Our 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
22. 45Risks associated with our international operations, including seeking and obtaining approval to commercialize our product candidates in foreign jurisdictions, could harm our business
23. 46Clinical 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
24. 47governmental or regulatory delays and changes in regulatory requirements, policy and guidelines

Risks Related to Our Reliance on Third Parties

1. 48if our collaboration partners receive approval for any of the collaboration product candidates, reductions in marketing or sales efforts or a discontinuation of marketing or sales of our product candidates by our collaboration partners would reduce any milestones and royalties we could be entitled to receive
2. 49We 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 candidates70% rewritten
3. 50form relationships with other entities, some of which may be our competitors67% rewritten
4. 51The 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
5. 52We rely and will continue to rely on outsourcing arrangements for many of our activities, including clinical development and supply of BNC210
6. 53sanctions imposed by regulatory authorities if compounds supplied or manufactured by a third-party supplier or manufacturer fail to comply with applicable regulatory standards84% rewritten
7. 54candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing shareholders, or disrupt our management and businessnew
8. 55collaborators may not pay milestones and royalties due to the company in a timely manner51% rewritten
9. 56product loss or failure that requires additional manufacturing runs or a change in manufacturer, either of which could significantly increase the cost of and significantly delay the manufacture of our current or future product candidates.new
10. 57Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
11. 58The increasing use of social media platforms presents new risks and challenges

Risks Related to Commercialization of our Product Candidates

1. 59Even 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. 60the willingness of patients to pay out-of-pocket in the absence of third-party coverage
3. 61If 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
4. 62unforeseen costs and expenses associated with creating an independent sales and marketing organization
5. 63We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do88% rewritten
6. 64Third-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
7. 65Net 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
8. 66We 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
9. 67substantial monetary awards to plaintiffsnew

Risks Related to Regulation of Our Industry

1. 68The 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. 69refusal to approve pending NDAs, BLAs, marketing authorization applications, or supplements to approved NDAs, BLAs or extensions or variations to marketing authorizations
3. 70the approval policies or regulations of the FDA, EMA or comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
4. 71Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization
5. 72Changes 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
6. 73Even 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
7. 74We 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
8. 75federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers
9. 76The 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
10. 77Our 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 business41% rewritten
11. 78to detect and prevent misconduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulationsnew
12. 79Healthcare legislative reform measures may have a material adverse effect on our business and results of operations
13. 80establishment of the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services (“CMS”) to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending61% rewritten
14. 81In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted
15. 82On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces
16. 83On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020
17. 84The OBBBA also mandates that able-bodied Medicaid recipients aged 19-64 must work, volunteer, or attend school for at least 80 hours per month, or risk losing coverage. This is expected to reduce costs, but potentially also coverage for millions of people
18. 85Actual 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. 86We may not be able to protect our intellectual property rights throughout the world
2. 87Periodic 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. 88Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
4. 89Changes 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 patents32% rewritten
5. 90able to do on reasonable terms, or at all, which may impact our ability to continue to develop and commercialize our product candidates incorporating the relevant intellectual propertynew
6. 91the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners
7. 92Our intellectual property licensed from third parties may be subject to retained rights
8. 93If we are unable to obtain intellectual property licenses from third parties on commercially reasonable terms or at all, our business could be harmed
9. 94Any 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
10. 95Litigation 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
11. 96Any 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
12. 97Intellectual property litigation may lead to unfavorable publicity that harms our reputation
13. 98Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
14. 99We 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
15. 100We may be subject to claims challenging the inventorship of our patents and other intellectual property
16. 101If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
17. 102We 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
18. 103If 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 Relating to the Consummation of the Proposed Merger and such transactions related thereto

1. 104We may not be successful in consummating a strategic transaction, any strategic transaction will require us to devote significant time and cost away from potential operational plans and a strategic transaction that we may consummate could have negative consequencesnew
2. 105Even if we successfully consummate a transaction from our strategic evaluation, we may fail to realize all of the anticipated benefits of the transaction, those benefits may take longer to realize than expected, or we may encounter integration difficultiesnew
3. 106If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risksnew
4. 107Any of the foregoing risks could have a material adverse effect on our business, financial condition and prospectsnew
5. 108Our ability to consummate a strategic transaction depends on our ability to retain key executives required to consummate such transaction, as well as resolving the continuation, amendment or termination of certain contracts involving key assets of the Companynew
6. 109Our ability to successfully complete a strategic transaction depends in large part on our ability to retain certain of our remaining key personnel; if we fail to retain them, we risk disruption to our consummation of a strategic alternative as well as business operationsnew
7. 110Failure to complete the proposed Scancell Merger and such transactions related thereto could negatively impact the Companynew
8. 111The Company may not be able to satisfy the requirements for the closing under the Merger Agreement, which may cause material adverse consequences due to the consequent failure to complete the proposed Merger and such other transactions related theretonew
9. 112The Company and Scancell will incur substantial costs related to the proposed Merger and integration of their businessesnew
10. 113The Proposed Merger transaction is subject to review, clearance and approval of both the Securities and Exchange Commission, as well as the Nasdaq Stock Marketnew
11. 114Upon the consummation of the proposed Merger, existing holders of the Company’s Common Stock will experience substantial dilution of their ownership interest in the Company, which could materially reduce or be perceived to reduce the value of their Company shareholdingsnew
12. 115The future results of the combined company following the consummation of the proposed Merger and such related transactions may suffer if it does not efficiently manage the various regulatory and accounting compliance issues of the newly combined companynew
13. 116Scancell’s directors, executive officers and principal stockholders will have substantial control over the Company after the consummation of the proposed Merger, which could limit other stockholders’ ability to influence the outcome of corporate matters and key transactions, including a change of controlnew
14. 117The market price of the Company’s Common Stock may be affected by factors different from those currently affecting the shares of the Company’s Common Stock assuming the consummation of the proposed Merger and such related transactionsnew