Firefly Neuroscience (AIFF) risk factors, FY2025 10-K

Firefly Neuroscience's FY2025 10-K, filed Mar 31, 2026, lists 69 risk factors in 5 groups. Against the prior year's 127: 69 new, 127 dropped.

Risk factors listed
695 groups
New this year
69vs 127 last year
Dropped
127since the prior 10-K
Substantially reworded
0of those kept
Section length
27k wordsItem 1A

What the changes say

  • Firefly Neuroscience faces going concern doubts with an accumulated deficit of $111,615 and negative operating cash flows of $8,194.

What changed since the prior 10-K

New

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    We are facing significant liquidity risks that raise substantial doubt about our ability to continue as a going concern

    We face going concern risks due to recurring operating losses, an accumulated deficit of $111,615, and minimal product revenue.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    We have engaged, and may continue to engage, in strategic acquisitions or transactions, which could have a material adverse effect on our business, results of operations, financial condition and cash flows

    Strategic acquisitions could divert management attention, incur debt or equity issuance, and fail to deliver anticipated benefits.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    We may not realize the anticipated benefits of past or future acquisitions and integration of these acquisitions may disrupt our business

    Our April 2025 acquisition of Evoke Neuroscience significantly expanded our operations, but integrating future acquisitions remains unproven.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    We are subject to operating risks, including excess or constrained capacity and operational inefficiencies, which could adversely affect our results of operations

    We face operating risks including capacity constraints, system failures, and difficulties in retaining and training employees.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    Our products and information technology systems are critical to our business. Issues with product development or enhancements, IT system integration, implementation, updates and upgrades could disrupt our operations and have a material impact on our business and operating results

    Our business relies on IT systems and third-party software that are vulnerable to cyber-attacks and require ongoing capital expenditures.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    Political events, trade and other international disputes, war, and terrorism could harm or disrupt international commerce and the global economy and could have a material effect on our business as well as our potential customers, suppliers, contract manufacturers, distributors, and other business partners

    International political events, wars, and trade restrictions could increase costs, disrupt supply chains, and harm gross margins.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    We conduct certain of our operations in Israel. Conditions in Israel, including the attack by Hamas and other terrorist organizations from the Gaza Strip and Israel ’ s war against them, may affect our operations

    Our operations involving five full-time employees in Israel are directly affected by regional military conflicts and terrorism.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    The active military conflict involving Iran, Israel and the United States poses immediate and material risks to our operations, employees, financial condition and business

    The active military conflict involving Iran, Israel, and the United States threatens our employees, operations, and regional infrastructure.

  • NewRisks Related to the Company ’ s Business, Operations and Industry

    Our operations may be impacted by natural disaster and may adversely impact our business and operating results as well as those of our potential customers and suppliers

    Natural disasters and extreme weather events can cause facility shutdowns, logistics disruptions, and increased operating costs.

  • NewRisks Related to our Software Platform

    Our operations depend in part on third-party software platforms and artificial intelligence services, and disruptions to those services, including interruptions resulting from government actions or policy decisions, could adversely affect our business

    Government actions or policy decisions affecting third-party cloud and AI platforms could disrupt our research and development operations.

  • NewRisks Related to our Software Platform

    If we are not successful in enhancing awareness of our products, driving adoption across our current target markets and expanding the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affected

    Our financial results depend on successfully marketing our products and increasing clinician adoption and patient awareness in the United States.

  • NewRisks Related to our Software Platform

    If we fail to successfully initiate our broad commercialization program, market and sell our products cost-effectively, our sales, business, financial condition and results of operations will be negatively affected

    We cannot predict how quickly clinicians and patients will adopt our products into patient work streams to drive sales growth.

  • NewRisks Related to our Software Platform

    Our industry is competitive and has been evolving rapidly. Our current customer base includes neurology and psychiatric clinics in the United States

  • NewRisks Related to our Software Platform

    acquire products or technologies complementary to or necessary for our business

  • NewRisks Related to our Software Platform

    Patient and product variability may produce misleading report results

  • NewRisks Related to our Software Platform

    Use of our platform requires appropriate training and inadequate training may lead to negative clinician experiences, which could harm our business, financial condition, and results of operations

  • NewRisks Related to our Software Platform

    We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success

  • NewRisks Related to our Software Platform

    We expect to increase the size of our organization in the future, and we may experience difficulties in managing the operational elements or timing of this growth. If we are unable to manage or appropriately time the anticipated growth of our business, our future revenue and operating results may be harmed

  • NewRisks Related to our Software Platform

    improving our operational, financial and management controls, reporting systems and procedures

  • NewRisks Related to our Software Platform

    We may not be able to achieve or maintain satisfactory pricing and margins for our products, which could harm our business and results of operations

  • NewRisks Related to our Software Platform

    Future sales of our products may depend on healthcare providers ’ or patients ’ ability to obtain reimbursement from third-party payors, such as insurance carriers

  • NewRisks Related to our Software Platform

    Our results of operations may be harmed if we are unable to accurately forecast clinician demand for our products or any future products

  • NewRisks Related to our Software Platform

    Adoption of our products depends on positive clinical data as well as clinician acceptance of the data and our products, and negative clinical data or perceptions among these clinicians would harm our sales, business, financial condition, and results of operations

  • NewRisks Related to the Integration of the Evoke and Firefly Businesses

    We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Complying with regulations enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    product import and export

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    We may not receive the necessary authorizations to market any future new products, and any failure to timely do so may adversely affect our ability to grow our business

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Our Evoke System and BNA Platform are Class II medical devices, which were cleared by FDA for commercialization in the U.S. pursuant to the 510(k) notification process

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturers

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Certain modifications to our products may require new 510(k) clearance or other marketing authorizations

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Our acquisition of Evoke increases our exposure to 510(k) regulatory risks due to the expansion of our medical device portfolio

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Ongoing changes in healthcare regulation could negatively affect our revenues, business and financial condition

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    These modifications may have an effect on the way we conduct our business

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Changes in internet regulations could adversely affect our business

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Since our software platform will utilize cloud-based information systems and the exchange of protected information, we will be subject to numerous U.S. federal and state laws and regulations related to the privacy and security of personally identifiable information, including health information

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Cybersecurity incidents, including data security breaches or computer viruses, could harm our business by disrupting our delivery of services, damaging our reputation, or exposing us to liability

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Many of these laws may require consent from individuals for the use of data for various purposes, including marketing, which may reduce our ability to market our products

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Our business could be adversely affected by professional and legal challenges to our business model or by new state actions restricting our ability to provide our products and services in certain states

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Security breaches, data breaches, cyber-attacks, other cybersecurity incidents or the failure to comply with privacy, security and data protection laws could materially impact our operations, patient care could suffer, we could be liable for damages, and our business, operations and reputation could be harmed

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    The ESG regulatory landscape has shifted materially under the current U.S. administration, and we face risks from both the relaxation of certain federal requirements and the continued — and potentially intensifying — pressure from state, international, and market-driven ESG expectations

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    Additionally, the administration has revoked billions of dollars in clean energy and transportation funding, rolled back environmental regulations, and taken executive action aimed at limiting the ability of state and local governments to regulate energy and environmental matters

  • NewRisks Related to Legal, Regulatory and Compliance Matters

    New FDA Quality Management System Regulation (“QMSR”) requirements could increase our compliance costs and expose us to additional regulatory risk

  • NewRisks related to Our Intellectual Property

    Our success depends in part on our proprietary technology, and if we are unable to successfully enforce our intellectual property rights, our competitive position may be harmed

  • NewRisks related to Our Intellectual Property

    Economic and trade policy, including tariffs and customs regulations, could have a material and adverse effect on our business

  • NewRisks related to Our Intellectual Property

    If we infringe or violate the patents or proprietary rights of other parties or are subject to an intellectual property infringement or misappropriation claim, our ability to grow our business may be severely limited

  • NewRisks related to Our Intellectual Property

    Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our business

  • NewRisks related to Our Intellectual Property

    We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers

  • NewRisks related to Our Intellectual Property

    Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements

  • NewRisks related to Our Intellectual Property

    Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time

  • NewRisks related to Our Intellectual Property

    We may be subject to claims challenging the inventorship of our patents and other intellectual property

  • NewRisks related to Our Intellectual Property

    We use AI in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations

  • NewRisks related to Our Intellectual Property

    Our limited access to sufficient funding may hinder our ability to conduct planned operations and realize potential profits

  • NewRisks related to Our Intellectual Property

    We may not continue to meet the continued listing requirements of Nasdaq, which could result in a delisting of our Common Stock

  • NewRisks related to Our Intellectual Property

    The market price of our Common Stock may be subject to significant fluctuations and volatility, and the stockholders of the company may be unable to resell their shares at a profit and may incur losses

  • NewRisks related to Our Intellectual Property

    other events or factors, many of which may be out of our control

  • NewRisks related to Our Intellectual Property

    We currently take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our Common Stock being less attractive to investors

  • NewRisks related to Our Intellectual Property

    Our Charter provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders ’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees

  • NewRisks related to Our Intellectual Property

    We will issue additional equity securities in the future, which may result in dilution to existing investors

  • NewRisks related to Our Intellectual Property

    We are subject to the SEC's "baby shelf" rules, which limit the amount we may raise pursuant to our shelf registration statement, and our ability to access capital markets may be constrained as a result

  • NewRisks related to Our Intellectual Property

    Certain stockholders could attempt to influence changes, which could adversely affect our operations, financial condition and the value of our Common Stock

  • NewRisks related to Our Intellectual Property

    The sale or availability for sale of a substantial number of shares of Common Stock could adversely affect the market price of such shares

  • NewRisks related to Our Intellectual Property

    If securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our Common Stock could decline

  • NewRisks related to Our Intellectual Property

    Our management will be required to devote substantial time to comply with public company regulations

  • NewRisks related to Our Intellectual Property

    As a non-accelerated filer, we will not be required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act

  • NewRisks related to Our Intellectual Property

    A non-accelerated filer is not required to file an auditor attestation report on internal control over financial reporting that is otherwise required under Section 404(b) of the Sarbanes-Oxley Act

  • NewRisks related to Our Intellectual Property

    As a recently listed public company, we may not be able to timely and effectively implement controls and procedures required by Section 404 that are applicable to us as public company

  • NewRisks related to Our Intellectual Property

    We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition, results of operations and stock price, which could cause you to lose some or all of your investment

  • NewRisks related to Our Intellectual Property

    Anti-takeover provisions under Delaware corporate law may make it difficult for our stockholders to replace or remove our Board, and could deter or delay third parties from acquiring us, which may be beneficial to our stockholders

  • NewRisks related to Our Intellectual Property

    Our management team will have broad discretion over the use of the net proceeds from the sales of our Common Stock to Konik via the ATM, if any, and investors may not agree with how we use the proceeds and the proceeds may not be invested successfully

Dropped

  • Dropped

    Recent Sales of Unregistered Securities

    Details regarding unregistered securities sales and equity repurchases during 2024.

  • Dropped

    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

    A summary of management discussion and analysis and financial statement references.

  • Dropped

    Reverse Merger with WaveDancer

    The November 2023 reverse merger transaction between Private Firefly and WaveDancer.

  • Dropped

    The Convertible Promissory Note and Warrant Offering

    The December 2024 convertible promissory note and warrant offering with Helena.

  • Dropped

    The ELOC Purchase Agreement

    The December 2024 equity line of credit purchase agreement with Arena for up to $10,000,000.

  • Dropped

    Research and Development Expenses

    Research and development expense components and accounting policies.

  • Dropped

    other expenses incurred to advance our research and development activities

    Expectations that research and development expenses will increase to optimize the BNA Platform.

  • Dropped

    General and Administrative Expenses

    General and administrative expense components including employee, legal, and accounting fees.

  • Dropped

    Critical Accounting Estimates

    Management's critical accounting estimates and judgments used in financial statement preparation.

  • Dropped

    Selling and Marketing Expenses

    Selling and marketing expense increases of $562,000 or 88% for the year ended December 31, 2024.

  • Dropped

    General and Administration Expenses

    General and administration expense increases of $3,937,000 or 179% for the year ended December 31, 2024.

  • Dropped

    Impairment of Intangible Assets

    An impairment charge of $874,000 recorded in 2024 for a capitalized software upgrade no longer utilized.

  • Dropped

    For the next 12 months, we expect to continue to incur negative cash flows from operations as we continue to make targeted investments in sales and marketing and research and development of our next generation BNA Platform

  • Dropped

    Known Trends, Events, and Uncertainties

  • Dropped

    On October 29, 2024, the Audit Committee dismissed Turner, Stone & Company LLP (“Turner Stone”) as our independent registered public accounting firm, effective immediately

  • Dropped

    Off-Balance Sheet Arrangements

  • Dropped

    Recent Accounting Pronouncements

  • Dropped

    Evaluation of Disclosure Controls and Procedures

  • Dropped

    Management’s Annual Report on Internal Control over Financial Reporting

  • Dropped

    During our evaluations of internal controls, we concluded that material weaknesses exist in our internal controls over financial reporting as outlined below. These material weaknesses did not result in any identified misstatements and there were not changes to previously reported financial results

  • Dropped

    Remediation Plan for the Material Weaknesses

  • Dropped

    Remediation efforts include but are not limited to (a) developing, documenting and enhancing processes surrounding ITGCs, and (b) hiring / contracting additional resources to support the financial reporting process

  • Dropped

    Directors and Executive Officers

  • Dropped

    Involvement in Certain Legal Proceedings

  • Dropped

    Composition of the Board of Directors

  • Dropped

    The Class I directors consist of David DeCaprio and Greg Lipschitz, to serve until the annual meeting of stockholders to be held in 2027, or until each one’s respective successor has been duly elected and qualified

  • Dropped

    The Class III director consists of Arun Menawat, whose term will expire at the third annual meeting of stockholders to be held following the Filing Date

  • Dropped

    We are required to comply with Nasdaq’s rules in determining whether a director is independent. The Board undertook a review of the independence of the individuals named above and determined that each of the directors except Greg Lipschitz qualify as “independent” as defined under the applicable Nasdaq rules

  • Dropped

    Committees of the Board of Directors

  • Dropped

    Code of Ethics and Business Conduct

  • Dropped

    Compensation Committee Interlocks and Insider Participation

  • Dropped

    Limitation on Liability and Indemnification of Directors and Officers

  • Dropped

    Delinquent Section 16(a) Reports

  • Dropped

    Summary Compensation Table - Years Ended December 31, 2024 and 2023

  • Dropped

    $ 98,629 $ - $ - $ 56,333 (8) $ - $ 154,962

  • Dropped

    Management Employment and Consulting Agreements

  • Dropped

    Gil Issachar, Chief Technology Officer

  • Dropped

    Paul Krzywicki, Chief Financial Officer

  • Dropped

    Greg Lipschitz, Chief Executive Officer

  • Dropped

    Stephen Purcell, Former Chief Financial Officer

  • Dropped

    Other Elements of Compensation

  • Dropped

    Potential Payments Upon Termination of Employment or Change in Control

  • Dropped

    Outstanding Equity Awards at Fiscal Year-End

  • Dropped

    Stephen Purcell (former Chief Financial Officer)

  • Dropped

    Additional Narrative to Director Compensation

  • Dropped

    Consists of a grant of options to purchase 55,183 shares of Firefly Common Stock made to 2686255 Ontario Inc., an entity controlled by Mr. Lipschitz, on July 8, 2023, of which 27,694 are currently exercisable

  • Dropped

    Narrative Disclosure to Director Compensation Table

  • Dropped

    Firefly 2007 Incentive Plan

  • Dropped

    Authorized Shares. A total of 300,000 shares of Firefly Common Stock have been authorized for the grant of awards under the Firefly 2007 Incentive Plan

  • Dropped

    Firefly 2023 Incentive Plan

  • Dropped

    Authorized Shares. A total of 4,440,355 shares of Common Stock have been authorized for the grant of awards under the Firefly 2023 Incentive Plan

  • Dropped

    Firefly Neuroscience, Inc. 2024 Long-Term Incentive Plan

  • Dropped

    SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

  • Dropped

    Represents beneficial ownership of less than 1%

  • Dropped

    Consists of shares underlying options to purchase up to 5,850 shares of Common Stock that are currently exercisable or exercisable within 60 days of March 25, 2025

  • Dropped

    Securities Authorized for Issuance Under Equity Compensation Plans

  • Dropped

    Represents shares available for award grant purposes under the 2024 Plan

  • Dropped

    Transactions with Related Persons

  • Dropped

    WaveDancer Related Party Transactions

  • Dropped

    WaveDancer believes the terms obtained or consideration that WaveDancer paid or received, as applicable, in connection with the transactions described below were comparable to terms available or the amounts that would be paid or received, as applicable, in arm’s-length transactions

  • Dropped

    Firefly Related Party Transactions

  • Dropped

    Indemnification Agreements

  • Dropped

    We have granted equity awards to certain of our executive officers. For a description of equity awards granted to our named executive officers, see the section titled “Executive Compensation” included elsewhere in this filing

  • Dropped

    Related Party Transactions Policy

  • Dropped

    any other persons whom the Board determines may be considered to be related persons as defined by Item 404 of Regulation S-K promulgated under the Securities Act

  • Dropped

    Nominating and Corporate Governance Committee

  • Dropped

    Disclosure Controls and Procedures Committee

  • Dropped

    Independent Auditors’ Fees

  • Dropped

    Pre-Approval Policies and Procedures

  • Dropped

    The Company’s principal accountant did not provide, and the Audit Committee or the board of directors of the Company did not approve, any services that would have been described under “—Tax Fees”, “—Audit-Related Fees”, or “—All Other Fees” above for either of the last two fiscal years

  • Dropped

    ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES

  • Dropped

    Agreement and Plan of Merger, dated November 15, 2023, by and among WaveDancer, Inc., FFN Merger Sub, Inc., and Firefly Neuroscience, Inc. (incorporated herein by reference to Annex A-1 to the Company’s registration statement on Form S-4/A, filed with the SEC on February 2, 2024)

  • Dropped

    Stock Purchase Agreement between Registrant and Wavetop Solutions, Inc., dated November 15, 2023 (incorporated herein by reference to Annex F to the Company’s registration statement on Form S-4/A, filed with the SEC on February 2, 2024)

  • Dropped

    10.20† Employment Agreement, dated as of March 12, 2025, by and between Deel Canada Services, Inc. and Paul Krzywicki

  • Dropped

    Opinion on the Financial Statements

  • Dropped

    Explanatory Paragraph – Going Concern

  • Dropped

    Convertible Promissory Note

  • Dropped

    We examined the executed securities purchase agreement and analyzed the terms in the agreement, such as the conversion price and conversion price adjustments, events of default, and other terms of the convertible note, and evaluated management’s analysis, accounting memorandum and supporting schedules

  • Dropped

    Opinion on the Consolidated Financial Statements

  • Dropped

    Common Stock Private Placement

  • Dropped

    Share-based compensation expense

  • Dropped

    Share exchange: former shareholders’ of WaveDancer

  • Dropped

    Warrants issued for convertible promissory note

  • Dropped

    BALANCE AT DECEMBER 31, 2024

  • Dropped

    Change in related party payable

  • Dropped

    Firefly Neuroscience Ltd. was initially incorporated and commenced its operations as a development company in 2006 under the laws of the State of Israel, and in May 2014, initiated its marketing and distribution activity in the United States through Elminda 2022 Inc

  • Dropped

    The combined entity operates under the name Firefly Neuroscience, Inc., and on August 13, 2024, the Company began trading on the Nasdaq Capital Market (NASDAQ Ticker Symbol: AIFF)

  • Dropped

    Principles of consolidation

  • Dropped

    Use of estimates in the preparation of consolidated financial statements

  • Dropped

    ii) Warrants and Derivative liability

  • Dropped

    Functional currency and foreign currency translations

  • Dropped

    Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions

  • Dropped

    Cash, accounts receivable, accounts payable, related party payable and accrued liabilities are carried at amortized cost, which management believes approximates their respective fair value due to the short-term nature of these instruments

  • Dropped

    Derivative financial instruments

  • Dropped

    Shares issued for services

  • Dropped

    Revenue consists of BNA testing, equipment rental and the undertaking of projects and clinical studies

  • Dropped

    recognize revenue when (or as) the entity satisfies a performance obligation

  • Dropped

    Software development costs

  • Dropped

    Disaggregation of Income Statement Expenses

  • Dropped

    Induced Conversions of Convertible Debt Instruments

  • Dropped

    Accordingly, for accounting purposes, the Merger was treated as the equivalent of Private Firefly issuing stock for the net assets of WaveDancer, accompanied by a recapitalization. The net assets of WaveDancer were stated at carrying values, with no goodwill or other intangible assets recorded

  • Dropped

    As of December 31, 2024, 55,784 shares of common stock owned by WaveDancer’s pre-Merger shareholders were in Company’s treasury

  • Dropped

    warrants exercisable for up to 76,098 shares of common stock of the combined entity

  • Dropped

    NOTE 5: ACCOUNTS RECEIVABLE, NET

  • Dropped

    NOTE 6: PREPAID EXPENSES AND DEPOSITS

  • Dropped

    NOTE 8: INTANGIBLE ASSETS, NET

  • Dropped

    During the fourth quarter of 2024, management performed the assessment and determined that one of the capitalized upgrades was no longer expected to be utilized. Consequently, the upgrade was deemed fully impaired, resulting in the Company recording an impairment charge of $874

  • Dropped

    The Company bifurcated the Conversion Option and accounted for it as a derivative liability due to the conversion feature not being clearly and closely related to the economic characteristics of the host contract

  • Dropped

    NOTE 10: LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT

  • Dropped

    a. Royalty Commitment - Israeli Innovation Authority (“IIA”)

  • Dropped

    On February 16, 2023, the Company sold 3,383,784 shares of common stock at a price per share of $0.0041. The Company received aggregate gross proceeds from the offering of $133

  • Dropped

    On August 12, 2024, the Company issued 45,344 shares of common stock with the intention to settle accrued liabilities. As the Company did not reach a contractual agreement to settle the outstanding amount, the Company recognized a note receivable as contra-equity in return for shares of common stock issued

  • Dropped

    Warrants exercisable for little or no consideration

  • Dropped

    Employees stock option plan

  • Dropped

    Restricted share units (“RSUs”)

  • Dropped

    Upon the consummation of the Merger on August 12, 2024, RSUs vested and the Company issued 59,264 shares of common stock and recognized $410 of share-based compensation expense

  • Dropped

    NOTE 13: BASIC AND DILUTED NET LOSS PER SHARE

  • Dropped

    On July 8, 2023, the Company granted options to its employees, officers, directors and consultants to purchase an aggregate of 327,421 shares of common stock in the capital of the Company (Note 12.e), 288,794 of these options were granted to related parties

  • Dropped

    NOTE 16: SEGMENT REPORTING

  • Dropped

    Nondeductible option expenses

  • Dropped

    The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities and certain carry-forward balances

  • Dropped

    The net deferred tax assets have been offset by a valuation allowance because it is not more likely than not the Company will realize the benefit of these deferred tax assets. The Company does not have any unrecognized tax benefits as of December 31, 2024 and 2023

  • Dropped

    $ 17 $ 17,733 $ 6,081 $ 67,706

  • Dropped

    In Canada, the taxation years of 2021-2024 remain open to assessment by the Canadian tax authority, which the tax authority can reassess within four years of the date it sent the original notice of assessment for the tax year given the Company is not a Canadian-controlled private corporation

  • Dropped

    NOTE 18: SUBSEQUENT EVENTS

  • Dropped

    On February 19, 2025, Convertible Promissory Note Warrants (Note 9) to purchase up to 800,000 warrants were exercised and 800,000 shares of common stock were issued. The Company received aggregate gross proceeds of $3,200

  • Dropped

    (Principal Financial and Accounting Officer)

All 69 risk factors

Headings as the filing states them, in filing order.

Risks Related to the Company ’ s Business, Operations and Industry

  1. 01We are facing significant liquidity risks that raise substantial doubt about our ability to continue as a going concernNew
  2. 02We have engaged, and may continue to engage, in strategic acquisitions or transactions, which could have a material adverse effect on our business, results of operations, financial condition and cash flowsNew
  3. 03We may not realize the anticipated benefits of past or future acquisitions and integration of these acquisitions may disrupt our businessNew
  4. 04We are subject to operating risks, including excess or constrained capacity and operational inefficiencies, which could adversely affect our results of operationsNew
  5. 05Our products and information technology systems are critical to our business. Issues with product development or enhancements, IT system integration, implementation, updates and upgrades could disrupt our operations and have a material impact on our business and operating resultsNew
  6. 06Political events, trade and other international disputes, war, and terrorism could harm or disrupt international commerce and the global economy and could have a material effect on our business as well as our potential customers, suppliers, contract manufacturers, distributors, and other business partnersNew
  7. 07We conduct certain of our operations in Israel. Conditions in Israel, including the attack by Hamas and other terrorist organizations from the Gaza Strip and Israel ’ s war against them, may affect our operationsNew
  8. 08The active military conflict involving Iran, Israel and the United States poses immediate and material risks to our operations, employees, financial condition and businessNew
  9. 09Our operations may be impacted by natural disaster and may adversely impact our business and operating results as well as those of our potential customers and suppliersNew

Risks Related to our Software Platform

  1. 10Our operations depend in part on third-party software platforms and artificial intelligence services, and disruptions to those services, including interruptions resulting from government actions or policy decisions, could adversely affect our businessNew
  2. 11If we are not successful in enhancing awareness of our products, driving adoption across our current target markets and expanding the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affectedNew
  3. 12If we fail to successfully initiate our broad commercialization program, market and sell our products cost-effectively, our sales, business, financial condition and results of operations will be negatively affectedNew
  4. 13Our industry is competitive and has been evolving rapidly. Our current customer base includes neurology and psychiatric clinics in the United StatesNew
  5. 14acquire products or technologies complementary to or necessary for our businessNew
  6. 15Patient and product variability may produce misleading report resultsNew
  7. 16Use of our platform requires appropriate training and inadequate training may lead to negative clinician experiences, which could harm our business, financial condition, and results of operationsNew
  8. 17We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our successNew
  9. 18We expect to increase the size of our organization in the future, and we may experience difficulties in managing the operational elements or timing of this growth. If we are unable to manage or appropriately time the anticipated growth of our business, our future revenue and operating results may be harmedNew
  10. 19improving our operational, financial and management controls, reporting systems and proceduresNew
  11. 20We may not be able to achieve or maintain satisfactory pricing and margins for our products, which could harm our business and results of operationsNew
  12. 21Future sales of our products may depend on healthcare providers ’ or patients ’ ability to obtain reimbursement from third-party payors, such as insurance carriersNew
  13. 22Our results of operations may be harmed if we are unable to accurately forecast clinician demand for our products or any future productsNew
  14. 23Adoption of our products depends on positive clinical data as well as clinician acceptance of the data and our products, and negative clinical data or perceptions among these clinicians would harm our sales, business, financial condition, and results of operationsNew

Risks Related to the Integration of the Evoke and Firefly Businesses

  1. 24We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitionsNew

Risks Related to Legal, Regulatory and Compliance Matters

  1. 25Complying with regulations enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penaltiesNew
  2. 26product import and exportNew
  3. 27We may not receive the necessary authorizations to market any future new products, and any failure to timely do so may adversely affect our ability to grow our businessNew
  4. 28Our Evoke System and BNA Platform are Class II medical devices, which were cleared by FDA for commercialization in the U.S. pursuant to the 510(k) notification processNew
  5. 29the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturersNew
  6. 30Certain modifications to our products may require new 510(k) clearance or other marketing authorizationsNew
  7. 31Our acquisition of Evoke increases our exposure to 510(k) regulatory risks due to the expansion of our medical device portfolioNew
  8. 32Ongoing changes in healthcare regulation could negatively affect our revenues, business and financial conditionNew
  9. 33These modifications may have an effect on the way we conduct our businessNew
  10. 34Changes in internet regulations could adversely affect our businessNew
  11. 35Since our software platform will utilize cloud-based information systems and the exchange of protected information, we will be subject to numerous U.S. federal and state laws and regulations related to the privacy and security of personally identifiable information, including health informationNew
  12. 36Cybersecurity incidents, including data security breaches or computer viruses, could harm our business by disrupting our delivery of services, damaging our reputation, or exposing us to liabilityNew
  13. 37Many of these laws may require consent from individuals for the use of data for various purposes, including marketing, which may reduce our ability to market our productsNew
  14. 38Our business could be adversely affected by professional and legal challenges to our business model or by new state actions restricting our ability to provide our products and services in certain statesNew
  15. 39Security breaches, data breaches, cyber-attacks, other cybersecurity incidents or the failure to comply with privacy, security and data protection laws could materially impact our operations, patient care could suffer, we could be liable for damages, and our business, operations and reputation could be harmedNew
  16. 40The ESG regulatory landscape has shifted materially under the current U.S. administration, and we face risks from both the relaxation of certain federal requirements and the continued — and potentially intensifying — pressure from state, international, and market-driven ESG expectationsNew
  17. 41Additionally, the administration has revoked billions of dollars in clean energy and transportation funding, rolled back environmental regulations, and taken executive action aimed at limiting the ability of state and local governments to regulate energy and environmental mattersNew
  18. 42New FDA Quality Management System Regulation (“QMSR”) requirements could increase our compliance costs and expose us to additional regulatory riskNew

Risks related to Our Intellectual Property

  1. 43Our success depends in part on our proprietary technology, and if we are unable to successfully enforce our intellectual property rights, our competitive position may be harmedNew
  2. 44Economic and trade policy, including tariffs and customs regulations, could have a material and adverse effect on our businessNew
  3. 45If we infringe or violate the patents or proprietary rights of other parties or are subject to an intellectual property infringement or misappropriation claim, our ability to grow our business may be severely limitedNew
  4. 46Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our businessNew
  5. 47We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employersNew
  6. 48Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirementsNew
  7. 49Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of timeNew
  8. 50We may be subject to claims challenging the inventorship of our patents and other intellectual propertyNew
  9. 51We use AI in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operationsNew
  10. 52Our limited access to sufficient funding may hinder our ability to conduct planned operations and realize potential profitsNew
  11. 53We may not continue to meet the continued listing requirements of Nasdaq, which could result in a delisting of our Common StockNew
  12. 54The market price of our Common Stock may be subject to significant fluctuations and volatility, and the stockholders of the company may be unable to resell their shares at a profit and may incur lossesNew
  13. 55other events or factors, many of which may be out of our controlNew
  14. 56We currently take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our Common Stock being less attractive to investorsNew
  15. 57Our Charter provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders ’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employeesNew
  16. 58We will issue additional equity securities in the future, which may result in dilution to existing investorsNew
  17. 59We are subject to the SEC's "baby shelf" rules, which limit the amount we may raise pursuant to our shelf registration statement, and our ability to access capital markets may be constrained as a resultNew
  18. 60Certain stockholders could attempt to influence changes, which could adversely affect our operations, financial condition and the value of our Common StockNew
  19. 61The sale or availability for sale of a substantial number of shares of Common Stock could adversely affect the market price of such sharesNew
  20. 62If securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our Common Stock could declineNew
  21. 63Our management will be required to devote substantial time to comply with public company regulationsNew
  22. 64As a non-accelerated filer, we will not be required to comply with the auditor attestation requirements of the Sarbanes-Oxley ActNew
  23. 65A non-accelerated filer is not required to file an auditor attestation report on internal control over financial reporting that is otherwise required under Section 404(b) of the Sarbanes-Oxley ActNew
  24. 66As a recently listed public company, we may not be able to timely and effectively implement controls and procedures required by Section 404 that are applicable to us as public companyNew
  25. 67We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition, results of operations and stock price, which could cause you to lose some or all of your investmentNew
  26. 68Anti-takeover provisions under Delaware corporate law may make it difficult for our stockholders to replace or remove our Board, and could deter or delay third parties from acquiring us, which may be beneficial to our stockholdersNew
  27. 69Our management team will have broad discretion over the use of the net proceeds from the sales of our Common Stock to Konik via the ATM, if any, and investors may not agree with how we use the proceeds and the proceeds may not be invested successfullyNew

Other Firefly Neuroscience 10-Ks

  • FY2024 10-K risk factors
    127 risks

    Firefly Neuroscience relies on the commercialization of its BNA Platform, which is unproven and requires significant multi-year investments.

    Filed Apr 03, 2025

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.