Intelligent Bio Solutions Inc. 8-K Filings

INTELLIGENT BIO SOLUTIONS INC. (INBS) reports that on September 9, 2026 it submitted a 510(k) premarket notification to the U.S. FDA, seeking regulatory clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine. The submission is based on a structured 2026 clinical program run with Cliantha Research and CenExel Clinical Research under FDA guidance and ICH GCP standards, including more than 18,000 hours of data collection, 18 detailed test reports, over 170 attachments and more than 15,000 lines of analyzed data.

A key Method Comparison Study showed accuracy above 98%, sensitivity above 94% and 100% specificity, with specimens verified by LC‑MS/MS. Additional usability, interference, precision, and cut-off studies, plus cybersecurity and software documentation resolving all 19 SBOM vulnerabilities and 100% of medium-risk issues, were included. The company frames this as supporting entry into the multi‑billion‑dollar U.S. drug screening market if FDA clearance is obtained, expanding its current non‑U.S. deployments.

Intelligent Bio Solutions Inc. (INBS) entered into a private placement with a single institutional investor involving 2,036,659 shares of common stock (or Series M pre-funded warrants in lieu) plus Series N-1 and Series N-2 warrants to purchase up to 2,036,659 shares each, at a combined price of $2.455 per unit, for gross proceeds of approximately $5.0 million before fees. At closing on September 2, 2026, all 2,036,659 units were issued as Pre-Funded Warrants instead of common stock.

Each Pre-Funded Warrant is exercisable for one share at $0.01 per share, and each Series N-1 and N-2 Warrant is exercisable for one share at $2.33 per share, with five-year terms starting when a resale registration statement is declared effective; N-2 warrants become exercisable only after shareholder approval. INBS agreed to file a resale registration statement for the shares and warrant shares by September 15, 2026 and to seek effectiveness by October 15, 2026, and will pay Ladenburg Thalmann a 9% total upfront fee on gross proceeds plus placement agent warrants for 101,833 shares at $3.06875 per share. The company expects to use net proceeds for working capital and general corporate purposes.

Intelligent Bio Solutions Inc. (INBS) reported new clinical performance data for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine. In a multi-site U.S. Method Comparison Study, the System achieved overall 98.2% accuracy, 94.6% sensitivity, and 100% specificity across pre-employment and workplace screening settings.

The results, measured against a validated LC-MS/MS reference method, reflect an increase from a prior study that showed approximately 94% accuracy and 82% sensitivity, while maintaining 100% specificity. The company states these data complete the clinical component of its FDA 510(k) package and expects to submit its 510(k) application for the System in September 2026 as part of its planned entry into the U.S. market following FDA clearance.

INTELLIGENT BIO SOLUTIONS INC. (INBS) furnished an investor presentation under a Regulation FD current report. The company made a presentation about its business and operations available to investors on August 28, 2026, which can be accessed through the Investors section of its website.

The presentation is furnished, not filed, so it is not automatically incorporated into other Securities Exchange Act or Securities Act filings unless specifically referenced there.

Intelligent Bio Solutions Inc. (INBS) reported strong top-line growth for the full year ended June 30, 2026, while remaining significantly loss-making. Revenue reached $4.2 million, a 38% increase year-over-year, driven by a 22% rise in reader installed base to 1,886 units and a 35% increase in consumable cartridges to 106,500 units. Active customers grew to 502.

Gross profit rose to $2.05 million, up 64%, with gross margin expanding from 40.85% to 48.63%, helped by a manufacturing transition to Syrma Johari and a higher mix of cartridge consumables. Cash and cash equivalents increased to $3.99 million from $1.02 million, and total assets were $11.94 million with shareholders’ equity of $5.29 million.

Despite operating improvements, the business generated a sizeable net loss attributable to INBS of $12.43 million, compared with $10.57 million a year earlier, reflecting high selling, general and administrative plus development and regulatory expenses. The company advanced its FDA 510(k) program through multiple clinical, interference, precision, and usability studies and targets a submission in the second half of calendar 2026 to support planned U.S. market entry.

Intelligent Bio Solutions Inc. reported completing its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, a key component of its FDA 510(k) program for U.S. clearance to detect the opiate codeine. All clinical data collection across the FDA 510(k) clinical study program is now finished. The study, conducted under ICH GCP guidelines at three independent U.S. clinical sites over three weeks with 135 participants and nine operator participants, is intended to demonstrate that typical workplace users can operate the system accurately by measuring sensitivity, specificity, and accuracy. The company is analyzing data and assembling its 510(k) submission package, targeting submission in the second half of 2026 ahead of planned entry into the U.S. market.

Intelligent Bio Solutions Inc. reported completion of a Usability Study for its Intelligent Fingerprinting Drug Screening System, supporting an FDA 510(k) submission for U.S. market clearance to detect the opiate codeine. The study, run with CenExel Clinical Research, followed FDA guidance and ICH GCP standards.

The study evaluated how easily workplace operators can be trained to use the system; 15 operators with no specialist laboratory background successfully participated, reinforcing that the system can be administered by non-specialists. This Usability Study is part of a broader 510(k) program that also includes cut-off, method comparison, interference, precision and penetration testing. The company states it remains on track to submit its 510(k) package in calendar H2 2026 as it moves toward planned entry into the multi-billion-dollar U.S. drug screening market.

Intelligent Bio Solutions Inc. reported completion of an Interference Study for its Intelligent Fingerprinting Drug Screening System, a key element supporting an FDA 510(k) submission for U.S. market clearance to detect the opiate codeine.

The study, conducted with CenExel Clinical Research, Inc. under FDA guidance and ICH GCP standards, tested whether everyday substances such as hand creams, alcohol-based products, oils, dirt, and water affect test accuracy. Data analysis is underway, with independent verification via LC-MS/MS. The Interference Study forms part of a broader program including clinical cut-off, method comparison, precision, and penetration testing, and the company states it remains on track to submit its 510(k) package in calendar H2 2026 as it works toward entry into the multi-billion-dollar U.S. drug screening market.

Intelligent Bio Solutions Inc. reported that its total outstanding common stock was 3,018,188 shares as of the close of business on July 31, 2026. This updated share count reflects sales under an At The Market Offering Agreement, exercises of previously issued warrants, and issuances of restricted shares under an investor relations and corporate development advisory agreement.

Intelligent Bio Solutions Inc. reports that it has addressed all cybersecurity and software-related review items for its planned FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System. This follows independent third-party penetration testing, with 100% of medium-risk vulnerabilities remediated and low-risk items reduced from 11 to 2, supported by risk-based justifications that remaining issues do not affect device safety, effectiveness, or performance.

The company has also fully resolved all 19 software bill of materials (SBOM) vulnerabilities, aligning documentation and system configuration with FDA guidance and obtaining independent verification that no issues remain. Management states these steps materially reduce regulatory risk and strengthen its 510(k) package, which is on track for submission in calendar H2 2026, initially targeting codeine detection in a multi-billion-dollar U.S. drug screening market. A manufacturing partnership with Syrma Johari MedTech is expected to deliver more than 40% annual production cost savings and approximately 20 percentage-point gross margin improvement to support a scalable U.S. launch following potential FDA clearance.

Intelligent Bio Solutions Inc. reported completing extensive precision testing to support its planned FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

The precision program covered more than 1,600 tests across three production runs and three independent sites, demonstrating repeatable, reproducible performance suited to workplace and other drug screening environments. These data, together with penetration testing and prior Cut-off, Method Comparison, and Interference Studies, form a comprehensive package addressing safety, accuracy, usability, specificity, security, and precision. The company describes the U.S. drug screening market as a multi‑billion‑dollar annual opportunity and highlights rapid, non‑invasive fingerprint testing with results in under ten minutes.

Intelligent Bio Solutions Inc. filed a current report describing a new Interference Study to support its FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine. The company has partnered with CenExel Clinical Research to run the study with 75 healthy adult participants under undosed and dosed conditions while handling common substances that might affect results.

The study is designed to show the system maintains specificity for codeine and avoids false positives or negatives, with samples confirmed by LC‑MS/MS analysis. It will run alongside a Method Comparison Study and follows a Cut-off Study that began in January 2026. Intelligent Bio Solutions expects to finish the Interference Study by mid‑July 2026 and include the data in its FDA 510(k) submission package.

Intelligent Bio Solutions Inc. is starting a multi-site Method Comparison Study to support an FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System for the opiate codeine. The company is working with CenExel Clinical Research to test the system’s accuracy when used by typical workplace screening staff.

The study will enroll 135 donor participants and use nine operator participants to mirror real-world employment and safety-sensitive settings. Key metrics such as sensitivity, specificity, and overall accuracy will be confirmed using LC-MS/MS, and enrollment and data collection are expected to finish by the end of July 2026, with results included in the company’s 510(k) package.

Intelligent Bio Solutions Inc. reported strong fiscal third quarter 2026 growth, with revenue of $1.06 million, up 46% year-over-year, and nine-month revenue of $3.07 million, up 39%.

Gross profit margin improved to 50.5% in Q3 and 49.3% for the nine months, about 800 basis points higher than a year earlier, driven mainly by higher-margin cartridge sales. Despite this progress, the company still posted a Q3 net loss of $2.86 million and a nine-month net loss of $8.52 million, although cash and cash equivalents increased to $6.86 million as of March 31, 2026, helped by capital raising.

Intelligent Bio Solutions Inc. filed a current report highlighting two main updates. The company furnished an investor presentation made available on April 20, 2026, describing its business and operations and accessible through the Investors section of its website.

The company also reported that its total outstanding common shares were 2,176,848 as of April 20, 2026. This outstanding share count reflects issuances tied to exercised warrants and sales of common stock under a previously disclosed at-the-market offering agreement since a prior filing on March 23, 2026.

Intelligent Bio Solutions Inc. granted new restricted stock awards and reported an update on its at-the-market (ATM) offering capacity. On March 18, 2026, the CEO and CFO each received 9,150 time-vesting shares and 21,350 performance-vesting shares under the 2019 Long Term Incentive Plan, with multi-year vesting tied to clinical, FDA submission, and commercial milestones and a ten-year deadline for meeting performance goals.

Non-employee directors received an aggregate 20,000 time-vesting shares, while non-executive employees received 10,500 time-vesting and 24,500 performance-vesting shares. The company stated that total common shares outstanding were 2,001,173 as of March 23, 2026. It also filed a 2026 ATM prospectus supplement, allowing sales of additional common stock with an aggregate gross sales price of up to $3,966,316 under its existing Form S-3 shelf and ATM agreement.

Intelligent Bio Solutions Inc. announced that it has received and deployed the first shipment of its Intelligent Fingerprinting Drug Screening Readers manufactured by new partner Syrma Johari MedTech Ltd. This confirms that the strategic manufacturing partnership, first announced in December 2025, is operating as planned.

The readers, produced to ISO 13485 and MDSAP standards, are being rolled out across construction, transportation, logistics, and manufacturing customers in the U.K. and Europe, expanding the installed base ahead of planned U.S. market entry in 2026. The partnership provides access to manufacturing capacity about four times prior levels and is expected to deliver annual production cost savings of more than 40%, supporting an anticipated improvement of roughly 20 percentage points in gross margin.

The company has also doubled in-house production capacity for its lateral flow test strips, giving it greater control over critical components, faster innovation cycles, and the ability to develop cartridges with additional test lines for expanded drug panels.

Intelligent Bio Solutions Inc. reported strong growth for its fiscal second quarter ended December 31, 2025, while remaining loss-making. Revenue rose to $896,774, a 48% year-over-year increase, driven by reader sales of $246,519 (up 104%) and cartridge sales of $516,754 (up 33%).

For the first half of fiscal 2026, revenue reached $2.01 million, up 36% year-over-year, with gross profit margins improving to 49% from 39%. Despite this, the company recorded a net loss of $2.68 million for the quarter and $5.66 million for the six months.

The company closed a $10.0 million private placement with healthcare-focused institutional investors, generating $9.40 million in net proceeds received on January 2, 2026, to support working capital, its FDA 510(k) submission, and international expansion. As of December 31, 2025, total assets were $17.65 million and shareholders’ equity was $10.89 million.

Intelligent Bio Solutions Inc. filed a current report stating that it has issued a press release announcing preliminary, unaudited revenue results for its fiscal second quarter ended December 31, 2025. The press release is included as Exhibit 99.1.

The company clarifies that this information is being furnished, not filed, so it is not subject to certain liability provisions under U.S. securities laws and will only be incorporated into other filings if specifically referenced.

Intelligent Bio Solutions Inc. announced that it has started a clinical study program to support a new FDA 510(k) submission seeking U.S. market clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine. The update was shared via a furnished press release attached as an exhibit.

Intelligent Bio Solutions Inc. reported that it has regained compliance with Nasdaq’s minimum bid price listing rule. The company previously received notice that its common stock had closed below the required $1.00 per share for 30 consecutive business days, putting its Nasdaq Capital Market listing at risk under Listing Rule 5550(a)(2).

On January 7, 2026, Nasdaq’s Listing Qualifications Staff notified the company that it is back in compliance because the closing bid price of its common stock was at or above $1.00 per share for 14 consecutive business days from December 16, 2025 to January 6, 2026. Nasdaq has indicated that the matter is now closed.

Intelligent Bio Solutions Inc. reported that Nasdaq notified the company on December 15, 2025 that its common stock failed to meet the $1.00 minimum bid price for 30 consecutive business days, putting it out of compliance with Nasdaq’s Bid Price Rule. The notice does not immediately remove the stock from the Nasdaq Capital Market, and the company has until June 15, 2026 to regain compliance by maintaining a closing bid of at least $1.00 for 10 consecutive business days.

Nasdaq may grant a further 180-day compliance period if other listing standards are satisfied, but this is not assured, and the stock could become subject to delisting, with the company able to appeal to a Nasdaq Hearings Panel. To address the issue, the company filed a Certificate of Amendment to implement a 1-for-10 reverse stock split effective late on December 15, 2025, with shares trading on a split-adjusted basis on December 16, 2025.

Intelligent Bio Solutions Inc. is implementing a 1-for-10 reverse stock split of its common stock, effective at 11:59 p.m. Eastern Time on December 15, 2025.

At the effective time, every 10 issued and outstanding shares will be combined into 1 share, with the par value remaining $0.01. As a result, common shares outstanding will decrease from approximately 9,595,335 as of December 14, 2025 to approximately 959,533 immediately after the split, while authorized common shares will stay at 100 million.

Outstanding stock options, restricted stock units, warrants and the share reserve under the 2019 Plan will be adjusted proportionately. Split-adjusted shares are expected to begin trading on The Nasdaq Capital Market on December 16, 2025 under the symbol INBS with a new CUSIP number. No fractional shares will be issued; instead, holders will receive cash based on the average closing prices over the five trading days before the split. The company also provided post-split versions of recent share and loss-per-share data.

Intelligent Bio Solutions Inc. furnished a Form 8-K announcing financial results for the fiscal quarter ended September 30, 2025. The results were communicated via a press release attached as Exhibit 99.1. The company stated that the information is furnished, not filed, and will not be incorporated by reference into other filings unless expressly stated.

Intelligent Bio Solutions Inc. furnished an update on business performance, announcing preliminary, unaudited revenue results for the fiscal first quarter ended September 30, 2025. The details are provided in a press release attached as Exhibit 99.1.

The disclosure is presented as information furnished under Item 2.02 and is not deemed “filed” for purposes of the Exchange Act, nor incorporated by reference unless expressly stated.

Intelligent Bio Solutions Inc. announced the addition of 33 new customer accounts during its fiscal first quarter for the period ended September 30, 2025. The update was furnished under Item 7.01 (Regulation FD) and accompanied by a press release filed as Exhibit 99.1.

The company listed its common stock under the symbol INBS on the Nasdaq Stock Market LLC. The disclosure was signed by Spiro Sakiris, Chief Financial Officer.

Intelligent Bio Solutions (INBS) reported results from its October 16 annual meeting. Stockholders approved an amendment to the 2019 Long Term Incentive Plan, increasing the share pool by 495,000 to 1,795,000 shares. They also approved, for Nasdaq Listing Rule 5635(d) purposes, the potential issuance of up to 4,147,616 shares upon warrant exercise.

Directors were elected and the appointment of UHY LLP as auditor for the fiscal year ending June 30, 2026 was ratified. Stockholders authorized a reverse stock split within a 1‑for‑2 to 1‑for‑10 range, at the Board’s discretion within 12 months, solely to help regain compliance with the Nasdaq Capital Market minimum bid price requirement. At the meeting, 4,482,941 shares voted, representing approximately 49.65% of the 9,028,712 shares outstanding as of September 11, 2025.

Intelligent Bio Solutions Inc. furnished a current report describing a press release about its regulatory plans. On September 26, 2025, the company announced an update to the timeline for its anticipated FDA 510(k) clearance for using its Intelligent Fingerprinting Drug Screening System to test for the opiate codeine. The press release with further details is attached as an exhibit to the report and is treated as furnished, not filed, under securities law.

INTELLIGENT BIO SOLUTIONS, INC. (INBS) filed an Form 8-K reporting a material event that attaches the Form of Amended Series H-1 Warrant as an exhibit. The filing lists Exhibit 4.1 as the amended warrant form and includes an Inline XBRL cover page data file. The document is signed by Spiro Sakiris, Chief Financial Officer.

The filing notifies stakeholders that the company has documented changes to the Series H-1 warrant in a formal amended warrant agreement, but it does not disclose the economic terms, number of warrants affected, exercise price, expiration, or any related cash or equity effects.

Intelligent Bio Solutions Inc. reported that the FDA has requested additional information on its Intelligent Fingerprinting Drug Screening System, requiring the company to submit a new 510(k) notification. The FDA’s requests were communicated in a letter dated September 12, 2025. The company plans to provide an investor update within the next ten days to outline a revised timeline for potential FDA 510(k) clearance of the drug screening system.

Intelligent Bio Solutions Inc. filed a current report to disclose that it issued a press release on August 15, 2025 announcing its financial results for the three months and full fiscal year ended June 30, 2025. The press release is attached as Exhibit 99.1.

The company states that the information in this report and the exhibit is being furnished, not filed, so it is not subject to certain liability provisions under U.S. securities laws and will not be incorporated into other filings unless specifically referenced.