# EDGAR Filing Document

**Accession Number:** 0001873875
**File Stem:** 0001213900-26-026644
**Filing Date:** 2026-3
**Character Count:** 22385
**Document Hash:** 9a0bdeb7f93dfe31a399b6c1f73ddb38
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-26-026644.hdr.sgml**: 20260312

**ACCESSION NUMBER**: 0001213900-26-026644

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 51

**CONFORMED PERIOD OF REPORT**: 20260311

**ITEM INFORMATION**: Termination of a Material Definitive Agreement

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260312

**DATE AS OF CHANGE**: 20260312

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Incannex Healthcare Inc.
- **CENTRAL INDEX KEY:** 0001873875
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41106
- **FILM NUMBER:** 26745698

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 8 CENTURY CIRCUIT
- **STREET 2:** STE. 105
- **CITY:** NORWEST NSW
- **NON US STATE TERRITORY:** NSW
- **PROVINCE COUNTRY:** C3
- **BUSINESS PHONE:** 61 409 840 786

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 8 CENTURY CIRCUIT
- **STREET 2:** STE. 105
- **CITY:** NORWEST NSW
- **NON US STATE TERRITORY:** NSW
- **PROVINCE COUNTRY:** C3

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Incannex Healthcare Ltd
- **DATE OF NAME CHANGE:** 20210720

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d)**

**of the Securities Exchange Act of 1934**

Date of Report (Date of earliest event reported): **March 11, 2026**

**Incannex Healthcare Inc.**

**(Exact name of registrant as specified in its charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-41106** | **93-2403210** |
| (State or other Jurisdiction <br> of Incorporation) | (Commission File Number) | **(**IRS Employer <br> Identification No.) |

---

---

| | |
|:---|:---|
| **Rialto South Tower<br> Level 23, 525 Collins Street<br> Melbourne VIC 3008<br> Australia** | **Not applicable** |
| (Address of Principal Executive Offices) | (Zip Code) |

---

Registrant's Telephone Number, including Area Code**: +61 409 840 786**

**(**Former Name or Former Address, if Changed Since Last Report): **Not Applicable**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol** | **Name of exchange on which registered** |
| Common Stock, $0.0001 par value per share | IXHL | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter)

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 1.02. Termination of a Material Definitive Agreement**

As previously disclosed, on May 27, 2025, Incannex Healthcare Inc. (the "Company") entered into an Amended and Restated Sales Agreement (the "Amended and Restated Sales Agreement") by and among the Company, Curvature Securities, LLC ("Curvature") and A.G.P./Alliance Global Partners ("A.G.P." and together with Curvature, the "Sales Agents"), which amended that certain Sales Agreement, dated April 7, 2025, by and between the Company and A.G.P. (the "Original Sales Agreement" and collectively, with the Amended and Restated Sales Agreement, the "Sales Agreement"), pursuant to which the Company could offer and sell shares of its common stock from time to time through the Sales Agents, acting as the sales agents.

On March 11, 2026, the Company and the Sales Agents mutually agreed to terminate the Sales Agreement, effective immediately. During the term of the Sales Agreement, the Company sold shares of its common stock for aggregate gross proceeds to the Company of approximately $108.4 million. The Sales Agreement was terminable at will by the Company with no penalty.

**Item 7.01 Regulation FD Disclosure.**

From time to time, the Company presents and/or distributes slides and presentations to the investment community to provide updates and summaries of its business. On March 12, 2026, the Company updated its corporate presentation, which is available on the Investor Relations section of the Company's website at http://ir.incannex.com. This presentation is also furnished as Exhibit 99.1 to this Current Report on Form 8-K. Information contained on the Company's website is not incorporated by reference into and should not be considered to be part of this Current Report on Form 8-K**.** 

The information in Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

**Item 8.01. Other Events**

On March 12, 2026, the Company issued a press release announcing its enhanced Phase 2 dose-optimisation study. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated by reference herein.

**Item 9.01. Financial Statements and Exhibits**

**(d) Exhibits**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Corporate Presentation, dated March 12, 2026.](ea027841501ex99-1.htm) |
| 99.2 | [Press Release of Incannex Healthcare Inc., dated March 12, 2026.](ea027841501ex99-2.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | | |
|:---|:---|:---|:---|
|  | **Incannex Healthcare Inc.** | **Incannex Healthcare Inc.** | **Incannex Healthcare Inc.** |
| Date: March 12, 2026 | By: | /s/ Joel Latham | /s/ Joel Latham |
|  |  | Name: | Joel Latham |
|  |  | Title: | Chief Executive Officer and President |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ea027841501_ex99-1img1.jpg)

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• RA flares are episodes of disease exacerbation with increased joint pain, swelling, and stiffness often debilitating o Intensity, duration, and frequency vary; can be unpredictable • Biologics and JAK inhibitors are costly and can be difficult to access o Patients must meet specific criteria to obtain (varies per insurer and country) and coverage • FDA boxed warnings for JAK inhibitors o Increased risk of serious heart - related events, cancer, blood clots, and death 31 Targeting RA Inflammation and Pain Chronic inflammatory disorder affecting joints, but also other tissue types Immune system mistakenly attacking its own tissues Flare - ups and remission periods occur, making the condition challenging to treat NASDAQ:IXHL

![](ea027841501_ex99-1img32.jpg)

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• 38+ years in global regulatory affairs • VP, U.S. Regulatory Affairs, Novo Nordisk (since 2012) • Former VP, Worldwide Regulatory Strategy, Pfizer (1992 – 2021) • Director at Incannex since 2023; previously served on Incannex Australia board 34 Board of Directors Robert Clark Board Member • Co - founder of APIRx Pharmaceuticals • Pioneer in cannabinoid - based therapies • Co - developed world's first cannabinoid - containing chewing gum • Former CEO/Co - founder of AXIM Biotechnologies (ophthalmologic R&D) George Anastassov , M.D. Board Member • Former Regional CEO, Heinz (Australasia & Greater China); CEO of Heinz Australia • Current Chairman, Sunny Queen Australia; NED at Youi Insurance • Senior roles at Starkist Foods • Fellow Chartered Accountant Peter Widdows Board Member • Incannex Chairman of the Board since 2023 • 27+ years in finance, advisory, and board leadership • Former Associate Director at Patersons Securities (now Canaccord Genuity) • Co - founder and Director of Alignment Capital, a boutique advisory firm Joel Latham President & CEO • CEO, President, and Director since 2023 • 20+ years in senior management across public and private sectors • Advanced multiple clinical - stage therapeutic programs • Senior leadership roles at Mars Foods, Tabcorp, and Philip Morris International Troy Valentine Chairman

![](ea027841501_ex99-1img35.jpg)

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## Exhibit 99.2

**Exhibit 99.2**

![](ea027841501_ex99-2img1.jpg)

**Incannex Strengthens Clinical Development Pathway for IHL-42X Following Positive Phase 2 Outcomes**

**Enhanced Phase 2 dose-optimization study designed to accelerate development and support a streamlined Phase 3 program**

Melbourne and New York – March 12, 2026 – Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, today announced an enhanced clinical development strategy for IHL-42X, its lead oral drug candidate for the treatment of obstructive sleep apnea (OSA), following statistically significant outcomes across key endpoints in its completed Phase 2 program.

Importantly, IHL-42X has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), enabling more frequent interaction with the FDA as the program advances.

The updated development strategy includes a Phase 2 crossover dose-optimization study (DReAMzz), followed by a streamlined Phase 3 clinical program. This strategy is designed to optimize efficacy, strengthen the clinical data package, and potentially accelerate the pathway toward registration while maintaining strong capital efficiency.

"Following the strong, statistically significant outcomes from our Phase 2 RePOSA trial, we believe IHL-42X is emerging as one of the most promising oral therapies in development for obstructive sleep apnea," said Joel Latham, President and Chief Executive Officer of Incannex Healthcare. "The optimization study we are initiating is designed to further refine the drug's efficacy while strengthening the clinical package ahead of Phase 3. We believe the optimized study design provides a pathway that could accelerate development timelines, potentially shorten time to registration if successful, and allow us to progress efficiently through the end of Phase 3 development."

**Phase 2 Results Demonstrate Broad Clinical Benefit**

Data from the completed RePOSA Phase 2 trial demonstrated that IHL-42X achieved statistically significant and clinically meaningful improvements across both objective physiological measures and patient-reported outcomes, reinforcing the therapeutic potential of the drug in OSA.

RePOSA demonstrated:

● 33.3% of patients in low-dose group and 41.2% in high-dose group achieved greater than 30% reduction in apnea-hypopnea index (AHI), while 13.9% (low-dose) and 14.7% (high-dose) experienced reductions exceeding 50%

● Maximum of 83% and 79% reduction in AHI for high and low dose IHL-42X respectively

● Preservation of REM sleep, differentiating from existing sleep medications

● 58% of participants reported their OSA condition improved. Among those, ~90% described the benefit as meaningful to daily life (better rest, reduced fatigue, improved function)

● No serious adverse events (SAEs)

The study demonstrated efficacy across both dose strengths, with differentiated performance observed between objective and subjective endpoints. This outcome highlights the robustness of the underlying drug combination and presents a clear opportunity to further optimize dosing to maximize benefit across all clinically relevant measures.

**Data-Driven Optimization Strategy**

Following a comprehensive review of the RePOSA data and discussions with the FDA, Incannex elected to conduct a Phase 2 crossover study evaluating alternative ratios of the two active pharmaceutical ingredients in IHL-42X, dronabinol and acetazolamide. FDA feedback emphasized the importance of demonstrating benefits across both physiological endpoints and patient-reported outcomes, particularly in chronic diseases such as OSA. Given the statistically significant improvements already observed in both domains in RePOSA, Incannex believes the program is well positioned to advance into this next optimization phase with a strong clinical foundation.

**DReAMzz Phase 2 Study Designed to Maximize Phase 3 Success**

The DReAMzz Phase 2 crossover study will evaluate multiple ratios of dronabinol and acetazolamide to identify the optimal formulation that delivers consistent improvements across objective sleep and respiratory endpoints while maintaining meaningful patient-reported benefits and the favorable safety profile observed to date.

The study design has been developed with input from Incannex's Obstructive Sleep Apnea Clinical Advisory Board, comprising world-leading experts in sleep medicine and respiratory disease, and has been reviewed by the FDA with agency feedback incorporated into the final protocol.

Importantly, Incannex has already appointed a leading contract research organization (CRO), and expects to begin dosing patients in the coming months.

**Streamlined Phase 3 Program Supports Efficiency and Value Creation**

Results from the DReAMzz study are expected to enable Incannex to advance into a highly efficient Phase 3 development program, potentially conducted under a single master protocol comprising parallel studies.

This optimized development design has several potential advantages, including accelerating the clinical development timeline, potentially shortening time to registration if successful, reducing overall development costs, and maximizing the probability of regulatory success.

By refining the optimal dose prior to Phase 3, Incannex believes this approach provides a capital-efficient pathway to completing late-stage development while maximizing the probability of clinical and regulatory success.

**Unlocking the Full Potential of IHL-42X**

Incannex believes the enhanced development strategy builds directly on the clinical outcomes already generated in RePOSA and represents the most effective pathway to advancing IHL-42X toward potential registration and commercialization.

With Fast Track designation, statistically significant Phase 2 results and a clearly defined regulatory pathway, Incannex believes IHL-42X is well positioned to continue advancing as a potential first-in-class oral therapy for obstructive sleep apnea.

**About Incannex Healthcare Inc.** Incannex is leading the way in developing combination medicines that target the underlying biological pathways associated with chronic conditions, including obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. The Company is advancing three clinical-stage drug candidates based on evidence-based innovation, and supported by streamlined operations. Incannex's lead clinical program, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of obstructive sleep apnea. In a Phase 2 development program, IHL-675A is an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate designed to act synergistically to alleviate inflammatory conditions, such as rheumatoid arthritis. Approved for Phase 2 clinical development, PSX-001 is an oral synthetic psilocybin treatment for the treatment of generalized anxiety disorder. Incannex's programs target disorders that have limited, inadequate, or no approved pharmaceutical treatment options. For additional information on Incannex, please visit our website at www.incannex.com.

**Forward Looking Statements**

This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements other than historical facts and relate to future events, future circumstances and Incannex's future performance. These statements are based on management's current assumptions, expectations, and beliefs. Examples of forward-looking statements in this press release include statements about, among other things: the objectives considered in the design of Incannex's clinical trials; evaluations and judgments regarding Incannex's research and development efforts and potential future commercialization, including any implications that the results (including qualitative patient-reported outcomes) of earlier clinical trials or interim or topline results will be representative or consistent with later clinical trials or their respective interim or final results; the potential benefits (including qualitative patient-reported outcomes) and safety of Incannex's drug candidates and the market opportunity for these candidates; Incannex's ability to execute on its strategies objectives, prospects, commercial discussions or plans; any statements regarding Incannex's beliefs with respect to or objectives in seeking or potential to obtain regulatory approvals or regulatory success, including any implication that communications with regulators affect the likelihood of obtaining any regulatory approvals in a timely and cost efficient manner or at all. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: that Incannex may fail to maintain the listing of the Company's common stock on Nasdaq and to comply with applicable listing requirements; the closing price of the common stock may fall below $0.10 for ten consecutive trading days and be subject to Nasdaq's low bid price rules and subject to delisting or denial of compliance periods; the continued availability of financing; Incannex's ability to raise capital to fund continuing operations; the impact of any infringement actions or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability to progress its drug candidates through clinical trials on the timelines expected and to obtain necessary regulatory approvals for commercialization of its drug candidates; the effects of competition from other providers and products as currently existing or that may be developed in the future; that the market for its drug candidates may not grow at the rates anticipated or at all or that estimates for these markets may ultimately be incorrect; that Incannex may be unable to successfully execute upon any commercial discussions; Incannex's ability to comply with the various evolving and complex laws and regulations applicable to its business and its industry; Incannex's ability to protect its proprietary technology and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations. The forward-looking statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation to update publicly any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law. Incannex's reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended June 30, 2025, filed with the SEC on September 29, 2025, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Incannex's website upon their filing with the SEC. These reports contain more information about Incannex, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release. For additional information on Incannex, please visit our website at www.incannex.com.

**Investor & Media Contacts**

**CORE IR**

(212) 655-0924

investors@incannex.com

media@incannex.com.au