InMed Pharmaceuticals (INM) risk factors, FY2026 10-K

InMed Pharmaceuticals's FY2026 10-K, filed Sep 09, 2026, lists 78 risk factors in 6 groups. Against the prior year's 73: 5 new, 2 substantially reworded.

Risk factors listed
786 groups
New this year
5vs 73 last year
Dropped
0since the prior 10-K
Substantially reworded
2of those kept
Section length
30k wordsItem 1A

What the changes say

  • Merger execution, litigation, and failure to complete the transaction now dominate the risk disclosures.
  • BayMedica’s wind-down removes InMed’s only revenue-generating segment and creates substantial liquidity and going-concern uncertainty.
  • Nasdaq compliance was regained, but future delisting could restrict financing, trading, and investor interest.
  • Currency exposure remains unchanged, involving U.S.-dollar cash and Canadian-dollar operations.

What changed since the prior 10-K

New

  • NewRisks Related to the Proposed Merger

    Failure to complete, or delays in completing, the potential Merger could materially and adversely affect our results of operations, business, financial results, and/or the price of our Common Shares

    The proposed Merger may be delayed or fail because closing conditions are unmet, disrupting operations and employee retention.

  • NewRisks Related to the Proposed Merger

    If the Merger is not completed, the price of our Common Shares may decline significantly

    If the Merger fails and replacement financing or a strategic transaction is unavailable, Common Shares could lose significant value.

  • NewRisks Related to the Proposed Merger

    Lawsuits may be filed against us, Mentari, or any of the members of their respective boards of directors arising out of the Merger, which may delay or prevent the Merger

    Merger-related stockholder litigation could delay or block closing, divert management, impose costs, and potentially lead to liquidation.

  • NewRisks Related to our Business and Industry

    InMed is winding down InMed’s only revenue-generating business segment, which creates substantial uncertainty regarding InMed’s liquidity, results of operations, prospects, and ability to continue as a going concern

    BayMedica’s shutdown of InMed’s only revenue-generating segment may consume cash, cost more than expected, and impair funding of obligations.

  • NewRisks Related to our Business and Industry

    On June 3, 2026, InMed received formal notice from the Listing Qualifications Department of The Nasdaq Capital Market that it had regained compliance with Nasdaq Listing Rule 5550(a)(2), the minimum bid price requirement for continued listing

    Although Nasdaq compliance was regained, future delisting could impair equity financing, trading liquidity, institutional interest, and analyst coverage.

Reworded

  • 99% rewrittenRisks Related to our Business and Industry

    Any actual or threatened delisting of our securities by Nasdaq could have a material and adverse effect on our business, operations and financial condition, and could, among other things, limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions

    The disclosure shifts from a 2024 delisting determination and appeal to a March 2026 $1 bid-price deficiency with 180 days to cure.

  • 71% rewrittenRisks Related to our Securities

    We are exposed to risks related to currency exchange rates

    The currency-risk wording is substantively unchanged, retaining exposure from U.S.-dollar holdings and Canadian-dollar operations.

All 78 risk factors

Headings as the filing states them, in filing order.

Risks Related to the Proposed Merger

  1. 01Failure to complete, or delays in completing, the potential Merger could materially and adversely affect our results of operations, business, financial results, and/or the price of our Common SharesNew
  2. 02If the Merger is not completed, the price of our Common Shares may decline significantlyNew
  3. 03Lawsuits may be filed against us, Mentari, or any of the members of their respective boards of directors arising out of the Merger, which may delay or prevent the MergerNew

Risks Related to our Business and Industry

  1. 04Our prospects depend on the success of our Product Candidates which are at early stages of development with a statistically high probability of failure
  2. 05InMed is winding down InMed’s only revenue-generating business segment, which creates substantial uncertainty regarding InMed’s liquidity, results of operations, prospects, and ability to continue as a going concernNew
  3. 06Even if our Product Candidates advance through preclinical studies and clinical trials, we may experience difficulties in managing our growth and expanding our operations
  4. 07The threat or actual adoption of tariffs, retaliatory tariffs and duties, trade barriers and restrictions, and related international trade conflicts, including by the United States, Canada or other jurisdictions, could materially impact the macroeconomic framework in which we operate
  5. 08Any actual or threatened delisting of our securities by Nasdaq could have a material and adverse effect on our business, operations and financial condition, and could, among other things, limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions99% rewritten
  6. 09On June 3, 2026, InMed received formal notice from the Listing Qualifications Department of The Nasdaq Capital Market that it had regained compliance with Nasdaq Listing Rule 5550(a)(2), the minimum bid price requirement for continued listingNew
  7. 10If we have difficulty enrolling patients in clinical trials, the completion of the trials may be delayed or cancelled
  8. 11If we experience delays in clinical testing, we will be delayed in commercializing our Product Candidates, and our business may be substantially harmed
  9. 12Our IntegraSyn manufacturing approach may prove unsuccessful in achieving yields and/or cost levels required to be economically competitive with alternative methods of manufacturing
  10. 13Negative results from clinical trials or studies of others and adverse safety events involving the targets of our products may have an adverse impact on our future commercialization efforts
  11. 14We intend to expend our limited resources to pursue our Product Candidates for certain indications and may fail to capitalize on other Product Candidates or other indications for our Product Candidates that may be more profitable or for which there is a greater likelihood of success
  12. 15We intend to conduct clinical trials for our Product Candidates in several international jurisdictions, and acceptance by all regulatory authorities for such “international” data is not certain
  13. 16Our Product Candidates contain compounds that may be classified as “controlled substances”, the use of which may generate public controversy and restrict their development or commercialization
  14. 17If any of our Product Candidates receives marketing approval and we or others later identify undesirable side effects caused by the Product Candidate, our ability to market and derive revenue from the product candidates could be compromised
  15. 18Research restrictions, product shipment delays or prohibitions could have a material adverse effect on our business, results of operations and financial condition
  16. 19Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our Product Candidates
  17. 20Any Product Candidates we develop may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby materially and adversely impacting our business
  18. 21Increased scrutiny on drug pricing or changes in pricing regulations could restrict the amount that we are able to charge for our Product Candidates, which could adversely affect our revenue and results of operations
  19. 22Negative publicity may adversely affect us and our business
  20. 23Even if we are able to commercialize our Product Candidates, they may not receive coverage and adequate reimbursement from third-party payors, which could harm our business
  21. 24Failure to comply with the FCPA, the CFPOA, and other global anti-corruption and anti-bribery laws could subject us to penalties and other adverse consequences
  22. 25Federal legislation and actions by state and local governments may permit reimportation of drugs from/to foreign countries where the drugs are sold at lower prices than in the country of origination, which could materially adversely affect our business and financial condition
  23. 26We are dependent upon our key personnel to achieve our business objectives
  24. 27Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could subject us to significant liability and harm our reputation
  25. 28Our internal computer systems, or those of our contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs
  26. 29Our insurance may be insufficient to cover losses that may occur as a result of our operations
  27. 30Our insurance costs may increase significantly, we may be unable to obtain the same level of insurance coverage and our insurance coverage may not be adequate to cover all possible losses we may suffer
  28. 31There may be changes in laws, regulations and guidelines which are material and detrimental to our business
  29. 32If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected
  30. 33Our proprietary information, or that of our customers, suppliers and business partners, may be lost or we may suffer security breaches
  31. 34We expect to face intense competition, often from companies with greater resources and experience than we have
  32. 35Industry consolidation may lead to increased competition and costs, and may harm our operating results
  33. 36If we receive regulatory approvals, we intend to market our Product Candidates in multiple jurisdictions where we have limited or no operating experience and may be subject to increased business and economic risks that could affect our financial results
  34. 37Controlled substance legislation may differ in other jurisdictions and could restrict our ability to market our products internationally, which would result in increased business and economic risks that could affect our financial results
  35. 38Product liability lawsuits against us could cause us to incur substantial liabilities
  36. 39Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions, or data corruption could significantly disrupt our operations and adversely affect our business and operating results
  37. 40Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us and adversely impact our operating results
  38. 41Our results of operations could be materially and adversely affected if we cannot keep pace with technological changes impacting the development of our products and implementation of our business needs, including with respect to automation and the use of AI
  39. 42Climate change may have an impact on our business
  40. 43Our success depends on our ability to continue to innovate and create new products and enhancements to our existing products

Risks Related to our Securities

  1. 44The market prices for our Common Shares are volatile and will fluctuate
  2. 45Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies or Product Candidates
  3. 46Future offerings of debt or equity securities may rank senior to our Common Shares
  4. 47Future sales of Common Shares by our officers, directors and affiliates may negatively impact the market price for our Common Shares
  5. 48We do not currently pay dividends on our Common Shares and have no intention to pay dividends on our Common Shares for the foreseeable future
  6. 49We are exposed to risks related to currency exchange rates71% rewritten
  7. 50There remains increased focus from lawmakers and regulators on corporate Environmental, Social and Governance (“ESG”) practices, including climate change and related ESG disclosure requirements
  8. 51If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our Common Shares
  9. 52Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
  10. 53Deficiencies in disclosure controls and procedures and internal control over financial reporting could result in a material misstatement in our financial statements
  11. 54We have incurred, and will continue to incur, increased costs as a result of operating as a public company, and our management has been required, and will continue to be required, to devote substantial time to new compliance initiatives
  12. 55Future sales and issuances of our Common Shares or rights to purchase Common Shares pursuant to our equity incentive plan could result in additional dilution of the percentage ownership of our shareholders and may cause our share price to fall
  13. 56Provisions in our corporate charter documents and certain Canadian laws could delay or deter a change of control
  14. 57If securities or industry analysts publish inaccurate or unfavorable research about our business, our share price and trading volume may decline
  15. 58We are incorporated in Canada, with our assets and officers primarily located in Canada, with the result that it may be difficult for investors to enforce judgments obtained against us or some of our officers

Risks Related to our Financial Position and Capital Needs

  1. 59Our operating losses have raised substantial doubt regarding our ability to continue as a going concern
  2. 60We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future
  3. 61We will require additional capital to fund our operations and if we fail to obtain necessary financing, we will not be able to complete the development and commercialization of our Product Candidates
  4. 62We may have difficulties identifying, successfully completing or integrating acquisitions, or maintaining or growing our acquired businesses
  5. 63Our ability to generate revenue and become profitable depends upon our ability to obtain regulatory approval for, and successfully commercialize, our Product Candidates that we may develop, in-license or acquire in the future
  6. 64Changes in tax laws and unanticipated tax liabilities could adversely affect our effective income tax rate and ability to achieve profitability
  7. 65As of June 30, 2026, we had net operating loss (“NOL”) carryforwards of approximately $99.9 million available to offset future taxable income in Canada and the United States. These NOL carry-forwards begin to expire in 2026
  8. 66Natural disasters, public health crises, political crises, or other catastrophic events may adversely affect our business affairs, results of operations, financial condition, liquidity, availability of credit and foreign exchange exposure
  9. 67The ongoing Russo-Ukraine War and the Israel-Hamas conflict, including the actual or perceived threat of an exacerbation of such conflicts, could have a material and adverse effect on our business, operations and financial condition
  10. 68High rates of global inflation, the occurrence of a recession and higher interest rates could have a material and adverse impact on our business, results of operations and financial condition

Risks Related to our Intellectual Property

  1. 69Our success is largely dependent upon our patents, proprietary technology, and other intellectual property
  2. 70Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
  3. 71We may become subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property
  4. 72We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse effect on the success of our business
  5. 73If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished
  6. 74We may not be able to protect our intellectual property rights throughout the world
  7. 75Patent terms may be inadequate to protect our competitive position on our Product Candidates for an adequate amount of time
  8. 76Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to our Third Parties

  1. 77We rely heavily on contract manufacturers over whom we have limited control. If we are subject to quality, cost or delivery issues with the preclinical and clinical grade materials supplied by contract manufacturers, our business operations could suffer significant harm
  2. 78Our existing collaboration agreements and any that we may enter into in the future may not be successful

Other InMed Pharmaceuticals 10-Ks

  • FY2025 10-K risk factors
    73 risks2 new5 dropped8 reworded

    New U.S. tariffs and global trade conflicts create macroeconomic uncertainty for operations.

    Filed Sep 23, 2025
  • FY2024 10-K risk factors
    76 risks

    InMed Pharmaceuticals faces early-stage clinical trial risks and Nasdaq delisting threats due to minimum bid price requirements. The company relies heavily on its proprietary IntegraSyn manufacturing approach and EB disease indications. Regulatory approval processes across the FDA, HC, and EMA remain lengthy and uncertain.

    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.