Neuphoria Therapeutics (NEUP) FY2025 10-K Risk Factors: 28 New, 16 Dropped

What the changes say

Neuphoria Therapeutics relies heavily on clinical success, particularly for lead product candidate BNC210, and continued external financing.
The company maintains a crucial research collaboration with Merck for central nervous system conditions and Alzheimer's disease.
Operations depend on outsourced clinical development and manufacturing, alongside navigating complex Nasdaq listing and regulatory compliance.

What changed since the prior 10-K

New

NewRisks Related to Our Financial Condition and Capital Requirements
costs associated with any product candidates, products or technologies that we may in-license or acquire
We need additional financing to conduct clinical trials and research, and if we cannot raise capital, we must delay or eliminate programs.
NewRisks Related to Our Financial Condition and Capital Requirements
the loss of any of our key scientific or senior management personnel
Stock market volatility in biotech stocks could lead to securities class action litigation, causing substantial defense costs and management distraction.
NewRisks Related to Our Financial Condition and Capital Requirements
We are not currently paying dividends and will likely continue not paying cash dividends on our common stock for the foreseeable future
We do not anticipate paying cash dividends for the foreseeable future, so investor returns depend entirely on stock price appreciation.
NewRisks Related to Our Financial Condition and Capital Requirements
future accounting pronouncements or changes in our accounting policies
Accounting policy changes or large fluctuations in operating results could cause us to miss analyst expectations and drop our stock price.
NewRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
third parties being unwilling or unable to satisfy their contractual obligations to us
Conducting clinical trials in foreign countries creates risks like patient protocol non-adherence and foreign regulatory burdens that can delay product approvals.
NewRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
our ability to maintain continued acceptable safety profiles of our product candidates following approval
Even if our product candidates are approved, we may incur heavy marketing costs and still fail to achieve commercial success or profitability.
NewRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
the risk that patients enrolled in clinical trials will drop out of the trials before completion
Difficulties in enrolling or retaining enough patients in clinical trials could cause significant development delays and increased costs.
NewRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
our reputation may suffer
We may fail to obtain FDA Fast Track or Breakthrough Therapy designations for BNC210 or other candidates, which could impair commercialization.
NewRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
difficulty attracting experienced personnel to our company and may be required to expend significant financial resources in our employee recruitment and retention efforts
We may struggle to attract and retain qualified scientific and medical personnel amidst intense competition from other biotech and pharma companies.
NewRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
governmental or regulatory delays and changes in regulatory requirements, policy and guidelines
Clinical trials can be suspended or terminated by regulatory authorities due to safety issues, protocol non-compliance, or manufacturing problems.
NewRisks Related to Our Reliance on Third Parties
terminated, the potential for us to generate future revenue from such product candidates would be significantly reduced and our business would be significantly harmed
We depend on Merck to develop and commercialize compounds under our 2014 Merck License Agreement and provide timely updates.
NewRisks Related to Our Reliance on Third Parties
if 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
Merck and other partners have rights to terminate our collaboration agreements at their convenience, which would harm our drug development efforts.
NewRisks Related to Our Reliance on Third Parties
combination, the continued pursuit and emphasis on our drug development or commercialization program could be delayed, diminished or terminated
NewRisks Related to Our Reliance on Third Parties
form relationships with other entities, some of which may be our competitors
NewRisks Related to Our Reliance on Third Parties
size of any clinical trials we conduct and this could significantly delay commercialization and require significantly greater expenditures
NewRisks Related to Our Reliance on Third Parties
sanctions imposed by regulatory authorities if compounds supplied or manufactured by a third-party supplier or manufacturer fail to comply with applicable regulatory standards
NewRisks Related to Our Reliance on Third Parties
collaborators may not pay milestones and royalties due to the company in a timely manner
NewRisks Related to Commercialization of our Product Candidates
the willingness of patients to pay out-of-pocket in the absence of third-party coverage
NewRisks Related to Commercialization of our Product Candidates
unforeseen costs and expenses associated with creating an independent sales and marketing organization
NewRisks Related to Commercialization of our Product Candidates
research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization of new drugs
NewRisks Related to Regulation of Our Industry
refusal to approve pending NDAs, BLAs, marketing authorization applications, or supplements to approved NDAs, BLAs or extensions or variations to marketing authorizations
NewRisks Related to Regulation of Our Industry
the 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
NewRisks Related to Regulation of Our Industry
federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers
NewRisks Related to Regulation of Our Industry
establishment 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 spending
NewRisks Related to Regulation of Our Industry
On 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
NewRisks Related to Regulation of Our Industry
On 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
NewRisks Related to Regulation of Our Industry
The 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
NewRisks Related to Our Intellectual Property
the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners

Dropped

DroppedRisks Related to Our Reliance on Third Parties
Combination-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
DroppedRisks Related to Our Reliance on Third Parties
A 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
DroppedRisks Related to Our Reliance on Third Parties
These 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
DroppedRisks Related to Ownership of Our ADSs
Fluctuations in currency exchange rates may have a material adverse effect on our results of operations
DroppedRisks Related to Ownership of Our ADSs
Investors’ right to participate in any future rights offering may be limited, which may cause dilution to holdings in our ADSs
DroppedRisks Related to Ownership of Our ADSs
Our 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
DroppedRisks Related to Ownership of Our ADSs
ADS 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
DroppedRisks Related to Ownership of Our ADSs
ADS 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
DroppedRisks Related to Ownership of Our ADSs
Investors may be subject to limitations on transfers of our ADSs and withdrawal of the underlying ordinary shares
DroppedRisks Related to Ownership of Our ADSs
ADS 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
DroppedRisks Related to Ownership of Our ADSs
If 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
DroppedRisks Related to Ownership of Our ADSs
Holders 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
DroppedRisks Related to Ownership of Our ADSs
Australian 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
DroppedRisks Related to Ownership of Our ADSs
Our 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
DroppedRisks Related to Ownership of Our ADSs
Significant disruptions of information technology systems or data security breaches could adversely affect our business
DroppedRisks Related to Ownership of Our ADSs
The loss of our status as a “foreign private issuer” could result in additional cost

Reworded

90% rewrittenRisks Related to Commercialization of our Product Candidates
We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do
Removed specific references to FDA-approved generic antidepressants paroxetine, sertraline, and venlafaxine for SAD.
84% rewrittenRisks Related to Our Financial Condition and Capital Requirements
If we fail to meet the continued listing requirements of Nasdaq, it could result in a de-listing of our Common Stock
Updated to reflect recent common stock listing details, a post-redomiciliation structure, and a July 18, 2025 Nasdaq deficiency notice.
Was: If we fail to meet the continued listing requirements of Nasdaq, it could result in a de-listing of our ADSs
84% rewrittenRisks Related to Regulation of Our Industry
In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted
Adjusted formatting and text regarding historical legislative healthcare changes and Medicare payment reductions.
83% rewrittenRisks Related to Our Financial Condition and Capital Requirements
Sales 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 capital
Updated details regarding the Armistice private placement warrants to reflect post-redomiciliation share counts and an exercise price of $11.88 per share.
Was: Sales 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
81% rewrittenRisks Related to Our Financial Condition and Capital Requirements
Sales of Common Stock issuable upon exercise of the Warrant and other derivative securities could cause the market price of our Common Stock to decline
Updated warrant exercise figures and pre-funded warrant share counts to reflect the post-redomiciliation common stock structure.
Was: Sales of ADSs issuable upon exercise of the Warrants and other derivative securities could cause the market price of our ADSs to decline
81% rewrittenRisks Related to Regulation of Our Industry
The 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
Retained core regulatory approval risks involving the FDA and EMA without major structural text alterations.
80% rewrittenRisks Related to Our Financial Condition and Capital Requirements
Our financial statements in prior years had been prepared assuming a going concern
Updated going concern disclosures to reference financial statements as of June 30, 2025.
Was: Our financial statements have been prepared assuming a going concern
70% rewrittenRisks Related to Our Reliance on Third Parties
We rely and will continue to rely on outsourcing arrangements for many of our activities, including clinical development and supply of BNC210
Maintained outsourcing and manufacturing reliance disclosures for BNC210 without substantial alterations.
61% rewrittenRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
We 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
61% rewrittenRisks Related to Our Financial Condition and Capital Requirements
Inflation could adversely affect our business and results of operations
60% rewrittenRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
Our 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
55% rewrittenRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
Clinical 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
46% rewrittenRisks Related to Our Financial Condition and Capital Requirements
The 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
Was: The 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
46% rewrittenRisks Related to Commercialization of our Product Candidates
If 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
42% rewrittenRisks Related to Our Financial Condition and Capital Requirements
Our 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
38% rewrittenRisks Related to Our Financial Condition and Capital Requirements
Raising 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 candidates
Was: Raising 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
35% rewrittenRisks Related to Regulation of Our Industry
Healthcare legislative reform measures may have a material adverse effect on our business and results of operations
28% rewrittenRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
Our 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
28% rewrittenRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
In 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
26% rewrittenRisks Related to Commercialization of our Product Candidates
Even 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
25% rewrittenRisks Related to Regulation of Our Industry
We 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
24% rewrittenRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
We have entered Phase 3 of our development efforts for BNC210 in SAD and are preparing to enter into Phase 2b/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
Was: We 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
24% rewrittenRisks Related to Our Financial Condition and Capital Requirements
If 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
Was: If 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
23% rewrittenRisks Related to Our Financial Condition and Capital Requirements
We 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
22% rewrittenRisks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
If 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
21% rewrittenRisks Related to Our Financial Condition and Capital Requirements
An active, liquid trading market for our common stock may not be maintained
Was: An active, liquid trading market for our ADSs may not be maintained

All 100 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Condition and Capital Requirements

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 operations23% rewritten
02costs associated with any product candidates, products or technologies that we may in-license or acquireNew
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
04Sales of Common Stock issuable upon exercise of the Warrant and other derivative securities could cause the market price of our Common Stock to decline81% rewritten
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 capital83% rewritten
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 paid46% rewritten
07the loss of any of our key scientific or senior management personnelNew
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
09If we fail to meet the continued listing requirements of Nasdaq, it could result in a de-listing of our Common Stock84% rewritten
10An active, liquid trading market for our common stock may not be maintained21% rewritten
11We are not currently paying dividends and will likely continue not paying cash dividends on our common stock for the foreseeable futureNew
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
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 issues
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 decline24% rewritten
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 manner
16We 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
17Our financial statements in prior years had been prepared assuming a going concern80% rewritten
18Our 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 guidance42% rewritten
19future accounting pronouncements or changes in our accounting policiesNew
20If 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
21Our ability to utilize our tax losses and certain other tax attributes may be limited
22Inflation could adversely affect our business and results of operations61% rewritten

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

23Our 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
24In 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 trials28% rewritten
25third parties being unwilling or unable to satisfy their contractual obligations to usNew
26We have entered Phase 3 of our development efforts for BNC210 in SAD and are preparing to enter into Phase 2b/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 harmed24% rewritten
27our ability to maintain continued acceptable safety profiles of our product candidates following approvalNew
28If 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 prevented22% rewritten
29the risk that patients enrolled in clinical trials will drop out of the trials before completionNew
30Interim, 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
31Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials
32Our 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 any60% rewritten
33our reputation may sufferNew
34The 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
35We 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
36We 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
37The success of our business depends primarily on our ability to identify, develop and commercialize one or more product candidates
38We 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 suffer61% rewritten
39difficulty attracting experienced personnel to our company and may be required to expend significant financial resources in our employee recruitment and retention effortsNew
40Our 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 functions28% rewritten
41Risks associated with our international operations, including seeking and obtaining approval to commercialize our product candidates in foreign jurisdictions, could harm our business
42We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management
43Clinical 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 basis55% rewritten
44governmental or regulatory delays and changes in regulatory requirements, policy and guidelinesNew

Risks Related to Our Reliance on Third Parties

45terminated, the potential for us to generate future revenue from such product candidates would be significantly reduced and our business would be significantly harmedNew
46if 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 receiveNew
47We 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
48combination, the continued pursuit and emphasis on our drug development or commercialization program could be delayed, diminished or terminatedNew
49form relationships with other entities, some of which may be our competitorsNew
50size of any clinical trials we conduct and this could significantly delay commercialization and require significantly greater expendituresNew
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
52We rely and will continue to rely on outsourcing arrangements for many of our activities, including clinical development and supply of BNC21070% rewritten
53sanctions imposed by regulatory authorities if compounds supplied or manufactured by a third-party supplier or manufacturer fail to comply with applicable regulatory standardsNew
54collaborators may not pay milestones and royalties due to the company in a timely mannerNew
55Manufacturing 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
56Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
57The increasing use of social media platforms presents new risks and challenges

Risks Related to Commercialization of our Product Candidates

58Even 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 sales26% rewritten
59the willingness of patients to pay out-of-pocket in the absence of third-party coverageNew
60If 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 approved46% rewritten
61unforeseen costs and expenses associated with creating an independent sales and marketing organizationNew
62We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do90% rewritten
63research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization of new drugsNew
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
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
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

Risks Related to Regulation of Our Industry

67The 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 harmed81% rewritten
68refusal to approve pending NDAs, BLAs, marketing authorization applications, or supplements to approved NDAs, BLAs or extensions or variations to marketing authorizationsNew
69the approval policies or regulations of the FDA, EMA or comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approvalNew
70Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization
71Changes 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
72Even 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
73We 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 conditions25% rewritten
74federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customersNew
75The 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
76Our 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
77Healthcare legislative reform measures may have a material adverse effect on our business and results of operations35% rewritten
78establishment 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 spendingNew
79In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted84% rewritten
80On 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 marketplacesNew
81On 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, 2020New
82The 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 peopleNew
83Actual 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

84We may not be able to protect our intellectual property rights throughout the world
85Periodic 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
86Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
87Changes 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
88the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partnersNew
89Our intellectual property licensed from third parties may be subject to retained rights
90If we are unable to obtain intellectual property licenses from third parties on commercially reasonable terms or at all, our business could be harmed
91Any 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
92Litigation 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
93Any 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
94Intellectual property litigation may lead to unfavorable publicity that harms our reputation
95Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
96We 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
97We may be subject to claims challenging the inventorship of our patents and other intellectual property
98If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
99We 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
100If 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

Other Neuphoria Therapeutics 10-Ks

FY2026 10-K risk factors
117 risks26 new9 dropped23 reworded
A $5.4 million goodwill impairment followed setbacks involving out-licensed assets and could recur if partners suspend development.
Filed Sep 18, 2026
FY2024 10-K risk factors
88 risks
Neuphoria Therapeutics faces typical clinical-stage biotechnology risks centered on cash burn, clinical trial execution, regulatory approval, and third-party manufacturing dependencies.
Filed Sep 30, 2024

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.