INTELLIGENT BIO SOLUTIONS INC.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 10, 2026
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Item 1A. Risk Factors
As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risk factors disclosed in our 2026 Form 10-K, except for risks described below. Any of those risk factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.
Our common stock is listed on the Nasdaq Capital Market, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly held shares, market value of listed shares, a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”), and minimum stockholders’ equity, among others, and requirements relating to board and committee independence. If we fail to satisfy one or more of the requirements, we may be delisted from the Nasdaq Capital Market. The last sale price of our shares of common stock on November 6, 2026, was $1.97 per share.
We will need to raise additional capital to fund our operations in the future. If we are unsuccessful in attracting new capital, we may not be able to continue operations or may be forced to sell assets to do so. Alternatively, capital may not be available to us on favorable terms, or at all. If available, financing terms may lead to significant dilution of our stockholders’ equity.
We are not profitable and have had negative cash flow from operations since our inception. To fund our operations and to develop and commercialize our products (including the IFP System), we have relied primarily on equity and some debt financing and government support income. The Company believes there is material risk that its cash and cash equivalents as of September 30, 2026, of $5,929,871 will be insufficient to allow the Company to fund its current operating plan through at least the next 12 months from the issuance of its unaudited condensed consolidated financial statements for the three months ended September 30, 2026. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date these unaudited condensed consolidated financial statements are issued. Accordingly, the Company will be required to raise additional funds during the next 12 months. However, there can be no assurance that when the Company requires additional financing, such financing will be available on terms which are favorable to the Company, or at all. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations. In addition, the Company may be unable to realize its assets and discharge its liabilities in the normal course of business.
To obtain the additional capital necessary to fund our operations, we expect to finance our cash needs through public or private equity offerings, debt financing and/or other capital sources. Even if capital is available, it might be available only on unfavorable terms. Any additional equity or convertible debt financing into which we enter could be dilutive to our existing stockholders. Any future debt financing into which we enter may impose covenants upon us that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, we may need to relinquish rights to our technologies or our products or grant licenses on terms that are not favorable to us. If access to sufficient capital is not available as and when needed, our business will be materially impaired and we may be required to cease operations, curtail one or more product development or commercialization programs, scale back or eliminate the development of business opportunities, or significantly reduce expenses, sell assets, seek a merger or joint venture partner, file for protection from creditors or liquidate all of our assets. Any of these factors could harm our operating results.
The exercise of our outstanding warrants would result in substantial dilution to our existing stockholders and could cause the market price of our common stock to decline.
As of September 30, 2026, there were warrants outstanding to purchase 12,045,102 shares of our common stock (with a weighted-average exercise price of $3.64 per share and that terminate between 2026 and 2031), including the Series M Pre-Funded Warrants, Series N-1 Warrants, Series N-2 Warrants and placement agent warrants issued in connection with the September 2026 Private Placement, compared to 3,316,803 shares of common stock outstanding as of such date. The number of shares issuable upon exercise of our outstanding warrants is more than three times the number of shares of our common stock currently outstanding. The exercise of these warrants would result in substantial dilution to our existing stockholders. In addition, the shares issuable upon exercise of the warrants issued in the September 2026 Private Placement have been registered for resale, and the sale of a substantial number of these shares in the public market, or the perception that such sales could occur, could cause the market price of our common stock to decline and could impair our ability to raise additional capital through the sale of equity securities.
Our 510(k) premarket notification for the Intelligent Fingerprinting Drug Screening System may not be cleared by the FDA on a timely basis, or at all.
On September 9, 2026, we submitted a 510(k) premarket notification to the FDA seeking regulatory clearance of our Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. The FDA may issue an Additional Information request in connection with its review of our 510(k) submission, may determine that a new 510(k) submission is required, or may issue a not substantially equivalent determination. If the FDA does not clear our 510(k) submission on a timely basis, or at all, our ability to commercialize the Intelligent Fingerprinting Drug Screening System in the United States beyond Forensic Use Only settings, and to realize the potential benefits of FDA clearance, could be delayed or adversely affected, which could have a material adverse effect on our business, financial condition, results of operations and the market price of our common stock.
As a smaller reporting company, we continue to be eligible to utilize certain reduced disclosure requirements, and we cannot be certain if our use of such scaled disclosure requirements will make our common stock less attractive to investors.
On June 30, 2026 (the last day of the fiscal year following the fifth anniversary of our initial public offering), we ceased to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or JOBS Act. As a result, we will no longer be able to rely on certain exemptions from various reporting and governance requirements that were available to us, including reduced disclosure obligations regarding executive compensation (except to the extent such accommodations are also available to smaller reporting companies) and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. However, we continue to be a “non-accelerated filer” and, for so long as we remain a non-accelerated filer, we will remain exempt from the auditor attestation requirement for internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act.
In addition, under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, we were not subject to the same new or revised accounting standards as other public companies during the period we were an emerging growth company. As a result, our financial statements while we were an emerging growth company may not be comparable to companies that complied with new or revised accounting pronouncements as of public company effective dates.
We will continue to qualify as a smaller reporting company if, as determined annually, either (i) the market value of our voting and non-voting common equity held by non-affiliates is less than $250 million as of the last business day of our most recently completed second fiscal quarter, or (ii) our annual revenues are less than $100 million for our most recently completed fiscal year for which audited financial statements are available and the market value of our voting and non-voting common equity held by non-affiliates is less than $700 million as of the last business day of our most recently completed second fiscal quarter. If we determine that we no longer qualify as a smaller reporting company, we will no longer be able to use the scaled disclosure accommodations beginning with our Quarterly Report on Form 10-Q for the first fiscal quarter of the following fiscal year. Once we lose smaller reporting company status, we will not regain it unless, in a later annual determination, we meet the requalification thresholds in Rule 12b-2, which are lower than the initial thresholds for the criteria we exceeded.
As a smaller reporting company, we are eligible to take advantage of many of the same scaled disclosures available to emerging growth companies, including scaled executive compensation disclosures. In addition, as a non-accelerated filer, we are exempt from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We have elected to utilize the accommodations available to smaller reporting companies. Until we cease to be a smaller reporting company, the scaled disclosure in our SEC filings will result in less information about our company being available than for public companies that are not smaller reporting companies.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.