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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
of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

Rialto South Tower
Level 23, 525 Collins Street
Melbourne VIC 3008
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.
     
99.2   Press Release of Incannex Healthcare Inc., dated March 12, 2026.
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

1

 

 

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.
     
Date: March 12, 2026 By: /s/ Joel Latham
    Name: Joel Latham
    Title: Chief Executive Officer and President

 

2

Exhibit 99.1

 

Innovating New Pathways to Relief NASDAQ:IXHL INVESTOR PRESENTATION February 2026

 

 

2 Corporate Presentation Legal Disclaimers This presentation of Incannex Healthcare Inc . (" Incannex ") 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 presentation include statements about, among other things : Incannex's ability to execute on its objectives, prospects or plans ; evaluations and judgments regarding Incannex's research and development efforts, clinical trial results, its ability to expedite to accelerate future development, future interactions with the FDA and potential future commercialization, including any implications that the results 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 and safety of Incannex's drug candidates and the market opportunity for these candidates ; and potential shareholder value . 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 presentation 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 : Incannex’s ability to comply with applicable listing standards ; Incannex's ability to raise capital to fund continuing operations ; 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 ; 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 business, its operations and results of operations . The forward - looking statements made in this presentation speak only as of the date of this presentation, 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 (the "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 . This presentation includes information and statistics regarding market participants in the sectors in which Incannex competes and other industry data (including data regarding market size and projected market size) which was obtained from third - party sources, including reports by market research firms and company filings . None of the information provided by third - party sources has been independently verified . 2 NASDAQ:IXHL SAFE HARBOR STATEMENT

 

 

Incannex is a leading science - led combination medicines company focused on rapidly developing innovative oral fixed - dose treatments and therapeutic regimens for people living with challenging chronic conditions • Obstructive Sleep Apnea (OSA) • Generalized Anxiety Disorder (GAD) A • Rheumatoid Arthritis (RA) 3 Clinical Programs in Phase 2/3 & Phase 2 Development COMPANY OVERVIEW 3 NASDAQ:IXHL Well - Funded, Phase 3 - Ready with Seasoned Leadership Late - Stage Pipeline with Positive Data in Large Markets Positive Data Reported AUG 25 Positive Data Reported AUG 25 • Approx. 70 Million cash on hand as of December 2025 • Late - stage clinical trial ready with strategic advisory support (e.g., ResMed affiliation)

 

 

4 Incannex Product Opportunity Disease Prevalence Addressable Segment Total Sales (USD) Markets IHL - 42X: First once - daily oral addressing underlying disease 936 million (Global) ~30 million (U.S.) 3 70% of non - obese and 30% of obese OSA patients 2 $4.5 billion (Global) $1.5 billion (U.S.) 1 Obstructive Sleep Apnea PSX - 001: First oral therapeutic in category 280 million (Global) 11 6.8 million (U.S.) 12 ~50% of patients fail first - line treatment (SSRI/SNRI) 10 $2.14 billion (Global) 8 $1 billion (U.S.) 9 Generalized Anxiety Disorder IHL - 675A: First once - daily oral addressing underlying disease ~19 million (Global) 6 1.5 million (U.S.) 7 ~40% of patients fail bDMARDs 5 $25 billion (Global) $11 billion (U.S.) 4 Rheumatoid Arthritis 1. Sleep Apnea Device Market, 2023. https://www.grandviewresearch.com/industry - analysis/sleep - apnea - devices - market, 2. OSA and Obesity Epidemiology, 2024. https://www.sciencedirect.com/science/article/pii/S108707922400100X, 3. Global and U.S. Prevalence of OSA , 2019. https://doi.org/10.1016/s2213 - 2600(19)30198 - 5, 4. RA Therapeutic Market, 2023. https://www.grandviewresearch.com/industry - analysis/rheumatoid - arthritis - therapeutics - market, 5. Failure Rates for RA Patients on bDMARDs , 2017. https://www.sciencedirect.com/science/article/pii/S1568997217302525?via%3Dihub, 6. Global Prevalence of RA, 2020. https://doi.org/10.1016/S2665 - 9913(23)00211 - 4, 7. U.S. Prevalence of RA, 2021. https://www.arthritis.org/diseases/rheumatoid - arthritis, 8. GAD Global Treatment Market, 2023. https://www.futuremarketinsights.com/reports/generalized - anxiety - disorder - treatment - market, 9. GAD U.S. Treatment Market, 2023. https://www.delveinsight.com/report - store/generalized - anxiety - disorder - gad - market, 10. GAD First Line Treatment Failure, 2020. https://doi.org/10.9740/mhc.2020.11.326 , 11. Global 12 - month Prevalence of GAD, 2017. https://doi.org/10.1001/jamapsychiatry.2017.0056, 12. U.S. 12 - month Prevalence of GAD, 2023. https://adaa.org/understanding - anxiety/generalized - anxiety - disorder - gad Addressing Unmet Needs in Major Therapeutic Areas NASDAQ:IXHL

 

 

Obstructive Sleep Apnea IHL - 42X • 120 - patient, Phase 2 randomized, double - blind safety and efficacy study • Phase 2 patient dosing completed, Positive Data Reported Aug 25’ RePOSA Phase 2 • 125 subjects, pharmacokinetics (PK) study (AUS) • P ositive topline results reported in January 2025 PK Study Completed • Four - arm Phase 2 crossover POC study (AUS) • Positive safety and efficacy results reported Phase 2 POC Study Completed Generalized Anxiety Disorder PSX - 001 PsiGAD2 Phase 2 Study PsiGAD1 Phase 2 Trial Completed Rheumatoid Arthritis IHL - 675A Phase 2 Clinical Program Phase 1 Clinical Study Completed 5 Driving a Diversified Pipeline to Generate Value NASDAQ:IXHL • 94 - patient, Phase 2 double - blind, safety and efficacy study in U.S. and UK IND open • 73 patients, double - blind, safety and efficacy study completed P ositive D ata R eported Aug 25’ • Positive topline findings reported • Phase 2 double - blind, safety and efficacy study, initial small patient group completed, and trial paused (AUS) • Phase 2 IND study in planning • 36 patients, Phase 1 safety and PK study completed • Positive safety and PK results reported

 

 

IHL - 42X Obstructive Sleep Apnea Program Overview NASDAQ:IXHL 6

 

 

Increase in prevalence driven by: • More frequent diagnoses and individual risk assessments o Rise in public recognition and awareness o Impact of wearables and AI • Lifestyle factors like obesity and aging population 7 Addressing Patient Need in the Dynamic and Growing OSA Market ~1 billion adults globally have OSA ~30 million in the U.S. Only 20% of Adults in the U.S. Currently Diagnosed 2 1. CPAP Therapy Adherence in Patients with OSA, 2023. https://doi.org/10.1016/j.chest.2023.01.025, 2. American Academy of Sleep Med. OSA Report, 2016. https://aasm.org/resources/pdf/sleep - apnea - economic - crisis.pdf, 3. SHHS Study on OSA Epidemiology, 2002. https://doi.org/10.1001/archinte.162.8.893 OSA Epidemiology (2022) 3 Obesity BMI≥ 30 Non-obesity BMI<30 37% obese 63% non - obese ~50% of Patients on PAP “Gold Standard” Treatment Non - Compliant After 12 Months 1 NASDAQ:IXHL

 

 

8 IHL - 42X: Blockbuster Potential in the Treatment of Moderate - to - Severe OSA First oral therapeutic to target key underlying disease pathways Well - known profile and activity of component drugs 50% discontinue first - line treatment (PAP) within the first - year Potential for improved OSA patient compliance and long - term adherence Low - dose combination therapeutic advancing quickly through large Phase 2/3 clinical study Positive topline Phase 2 data reported August 2025 Demonstrated tolerability in Phase 1 and Phase 2 clinical development Market Unique MOA Safety Clinical Safety Clinical Market Unique MOAs NASDAQ:IXHL

 

 

Acetazolamide Dronabinol Prevents breakdown of carbonic acid by inhibiting carbonic anhydrase; higher levels of carbonic acid prompt the body to take a breath at lower CO 2 levels Activates muscles in upper airway. Dampens afferent vagal feedback; stabilizes respiratory patterns and dilates upper airway 9 IHL - 42X Targets Two Different Physiological Processes Underlying OSA IHL - 42X Dronabinol Cannabinoid Receptor Muscle Cells Carbonic Anhydrase Take a Breath T Dronabinol Acetazolamide NASDAQ:IXHL Oral Fixed - dose Combination of Acetazolamide and Dronabinol Rapidly Advancing Through a Large Phase 2/3 Clinical Study

 

 

Phase 2 RePOSA Study NASDAQ:IXHL 10 Topline data | Reported August 2025

 

 

11 NASDAQ:IXHL RePOSA Study Sites and Population 121 Subjects Recruited at 16 Sites, All Based in the US • Subject demo were representative of the OSA population in the US Key Inclusion Criteria • Patients had to be non - compliant, intolerant or naïve to positive airway pressure (PAP) • AHI ≥15 • Agree to abstain from use of cannabinoid products, other than study drug Key Exclusion Criteria • BMI >45 kg/m 2 • Current use of oral appliances, such as mandibular advancement splints • Upper airway or bariatric surgery within 6 months • Craniofacial malformation syndromes • Use of benzodiazepines, sedative hypnotics or stimulants to treat sleep disorders • Conditions the investigator considers may be clinically significant with regards to patient safety or that may impact study findings . IHL - 42X Phase 2 RePOSA | Topline Results

 

 

12 NASDAQ:IXHL PSG & PRO Study Endpoints Apnea Hypopnea Index (AHI) • Greater percent reductions relative to baseline AHI observed for low and high dose IHL - 42X than placebo (p<0.05) • 33.3% of patients in low - dose group and 41.2% in high - dose group achieved greater than 30% reduction in 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 Oxygen desaturation index (ODI) • Both low and high dose IHL - 42X groups had a greater reduction in ODI than placebo (p<0.05) IHL - 42X Phase 2 RePOSA | Topline Results Patient global impression of change for both fatigue and sleep related impairment were improved for IHL - 42X low dose compared to placebo * These differences were statistically significant (p<0.05). Positive trends were observed for IHL - 42X treatment for other patient reported measures including ESS, FOSQ - 10, PROMIS SRI and PROMIS fatigue. * The magnitude of the changes in these measures was clinically meaningful. PSG STUDY PRO STUDY *Trends observed for IHL - 42X improving other sleep parameters captured during PSG including WASO and arousal index

 

 

IHL - 42X Phase 2 Data Summary 13 NASDAQ:IXHL • IHL - 42X demonstrates first - in - class potential as a disease - modifying therapy in OSA, addressing both clinical endpoints and patient - reported outcomes • Supports advancement into late - stage clinical development with a clear path toward a large, underserved global market Robust Efficacy • Up to 83% reduction in Apnea – Hypopnea Index (AHI) in treated patients • Significant improvements in Oxygen Desaturation Index (ODI) , fatigue, daytime alertness, and sleep quality • Preservation of REM sleep , differentiating from existing sleep medications Meaningful Patient Impact Strong Safety & Tolerability Key Takeaways • 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) • Treatment - emergent adverse events infrequent, mostly mild to moderate

 

 

DReAMzz Clinical Trial Protocol Overview

 

 

15 Trial Overview Phase II Obstructive Sleep Apnea (OSA) USA only 14 sites 3.5 – 5 months recruitment

 

 

Primary: • To assess the change in efficacy at the end of each dosing period compared with baseline Secondary: • To assess the change in efficacy and functional status over time • To evaluate the safety and tolerability of IHL - 42X Methodology / Study Design • Consists of three separate four - way dose confirmation crossovers comparing three dose strengths of IHL - 42X to placebo 16 Multi - center Double blind Randomized Placebo controlled

 

 

Trial Schematic 17

 

 

Crossover A – low dose acetazolamide (125mg) • IHL - 42X: 2.5 mg dronabinol + 125 mg acetazolamide • IHL - 42X: 5 mg dronabinol + 125 mg acetazolamide • IHL - 42X: 7.5 mg dronabinol + 125 mg acetazolamide • Placebo: Negative control 18 IMP administered

 

 

Crossover B – medium dose acetazolamide (250mg) • IHL - 42X: 2.5 mg dronabinol + 250 mg acetazolamide • IHL - 42X: 5 mg dronabinol + 250 mg acetazolamide • IHL - 42X: 7.5 mg dronabinol + 250 mg acetazolamide • Placebo: Negative control 19 IMP administered

 

 

Crossover C – high dose acetazolamide (375mg) • IHL - 42X: 2.5 mg dronabinol + 375 mg acetazolamide • IHL - 42X: 5 mg dronabinol + 375 mg acetazolamide • IHL - 42X: 7.5 mg dronabinol + 375 mg acetazolamide • Placebo: Negative control 20 IMP administered

 

 

Primary endpoint: • Change in AHI at the end of each treatment period compared to baseline (each treatment period is 28 days) Key Secondary endpoints: • Percent change in AHI at the end of each treatment period compared to baseline (each treatment period is 28 days) • Change in FOSQ - 10 at the end of each treatment period compared to baseline (each treatment period is 28 days) • Change in Patient - reported outcome measurement information system (PROMIS) - Fatigue 7a at the end of each treatment period compared to baseline (each treatment period is 28 days) • Change in Patient - reported outcome measurement information system – Sleep Related Impairment (PROMIS - SRI) 8a at the end of each treatment period compared to baseline (each treatment period is 28 days) • Change in Patient Global Impression of Severity (PGI - S) the end of each treatment period compared to baseline (each treatment period is 28 days) • Patient Global Impression of Change (PGI - C) score at the end of each treatment period compared to baseline (each treatment period is 28 days) • Change in Patient - reported Longitudinal Assessment Tool for OSA - 11 item (PLATO) at the end of each treatment period compared to baseline (each treatment period is 28 days) 21 Endpoints

 

 

Observations and Changes Implemented 1. Intra - patient variability – PSGs 2. Failure to capture baseline demographic data 3. PRO fatigue 4. Form 222s 5. Failure to confirm if IMP was taken prior to PSGs 6. State specific controlled drug regulations 22 Observation/issue identified 1. Now require 2 x PSGs at baseline and exclude subjects with large variability 2. Capturing more data points (PAP status, date of OSA diagnosis, GLP - 1 status etc) 3. Reduced the number of PRO questionnaires and repetitive questions 4. Inflexible process – instructions will be provided 5. Witnessing IMP dosing at PSG visits 6. Be aware of nuances and potential delays Resolution/risk minimisation

 

 

PSX - 001 Generalized Anxiety Disorder Program Overview 23

 

 

24 280 million adults globally experience GAD annually 6.8 million affected in the U.S. • Prevalence driven by: o Increased isolation and aging population o Better diagnosis and societal awareness o Lifestyle: excessive screen time, lack of sleep, sedentary behavior o Patients continue to experience low rates of remission and inadequate comprehensive treatment options $1.8B Global Market in 2023 ; $4.26B by 2033 • ~50% of patients unresponsive to first - line SSRI treatment 1 • Chronic, unlikely to remit without treatment • Higher risk of co - morbid conditions and physical health problems • One of the most common mental health conditions worldwide . • Characterized by: • Excessive and difficult to control worry about various aspects of life • Restlessness, fatigue, lack of focus, irritability, muscle tension, and altered sleep An Underserved and Growing Generalized Anxiety Disorder (GAD) Patient Population 1. Management of Treatment Resistant GAD, 2020. https://doi.org/10.9740/mhc.2020.11.326 NASDAQ:IXHL

 

 

25 NASDAQ:IXHL PSX - 001 Study Sites and Population 73 Subjects Recruited at Monash University’s Alfred Psychiatry Research Centre (Australia) • Subject demo: Adults with moderate to severe Generalized Anxiety Disorder (GAD) Key Inclusion Criteria • Diagnosis of Generalized Anxiety Disorder (DSM - 5 criteria) • HAM - A score ≥ 20 at screening (moderate to severe anxiety) • Willingness to undergo two supervised psilocybin dosing sessions with psychotherapy • Commitment to follow - up assessments for 11 weeks Key Exclusion Criteria • Current or prior psychotic disorder, bipolar disorder, or active suicidal ideation • Unstable medical conditions judged clinically significant by the investigator • Recent substance use disorder (excluding nicotine and caffeine) • Use of investigational drugs or psychedelic compounds within a defined washout period • Pregnancy, breastfeeding, or contraindications to psilocybin treatment PSX - 001 Phase 2 Topline Results

 

 

26 PSX - 001: A New Oral Therapeutic for Generalized Anxiety Disorder ( GAD) First oral synthetic psilocybin therapeutic for adults with GAD • 44% of patients showed a clinically meaningful improvement, or at least a 50% reduction in anxiety scores from baseline, compared to placebo • PSX - 001 was well - tolerated with no SAEs reported U.S. Phase 2 IND approved for a 94 - patient, double - blind, safety and efficacy study -20 -16 -12 -8 -4 0 PSX-001 Placebo Change in HAM - A from Baseline NASDAQ:IXHL

 

 

PSX - 001 Phase 2 Data Summary 27 NASDAQ:IXHL • Statistically significant, durable anxiety relief with meaningful remission rates • Broad patient benefits and strong safety profile support advancement to late - stage trials Robust Efficacy • – 12.8 HAM - A reduction vs – 3.6 placebo (p<0.0001) • 44.1% achieved ≥50% anxiety reduction (4 × placebo) • 27% remission rate (HAM - A ≤7, 5 × placebo) • Effects sustained through 11 weeks Meaningful Patient Impact Strong Safety & Tolerability Key Takeaways • Broad benefits beyond anxiety: GAD - 7: – 7.4 vs – 3.5 // SDS (Function): – 6.0 vs – 1.3. // PHQ - 9 (Depression): – 3.9 vs – 0.3 // PWI (Quality of Life): +10.6 vs +2.7 • Demonstrates real - world improvement in daily functioning and well - being • Well tolerated at both dosing sessions • Adverse events mostly mild to moderate and transient • Only 1 discontinuation, no suicidality, psychosis, or prolonged distress observed

 

 

28 NASDAQ:IXHL PSX - 001 Strategic Next Steps • Preparing multi - jurisdiction Phase 2/3 trial under FDA IND • Formulation optimization and IP strategy underway • Pursuing partnerships to accelerate development and commercialization • Addressing a large unmet need: GAD affects ~6% of the population globally • Positioned to capture a multibillion - dollar market opportunity PSX - 001 Phase 2 Topline Results Advancing toward larger trials and global market opportunity. Clear path to late - stage development with strong IP and commercial potential.

 

 

IHL - 675A Rheumatoid Arthritis Program Overview NASDAQ:IXHL

 

 

Increase in prevalence driven by: • Aging population • Improved diagnosis and patient awareness • Obesity and sedentary lifestyle 30 The Ongoing Need for a Safer and Effective Treatment Option for RA Patients ~19 million adults globally have RA 1.5 million in U.S. affected RA is one of the most common systemic autoimmune diseases globally • Inadequate control of joint inflammation associated with RA may result in irreversible joint erosions 40% of patients discontinue first - line bDMARD treatment due to intolerance and/or insufficient response (<20%) NASDAQ:IXHL

 

 

• 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

 

 

Hydroxychloroquine Cannabidiol Well - established Disease - Modifying Anti - Rheumatic Drug (DMARD). Evidence suggests it regulates immune system hyperactivity by interfering with antigen presentation by immune cells and decreasing TLR signaling . Downregulates pro - inflammatory cytokines, inhibiting production of key inflammatory mediators. Modulates non - cannabinoid receptor pathways, exerting analgesic effect and immune - driven inflammation. 32 IHL - 675A: A Proprietary Oral Anti - Inflammatory Therapeutic Designed to Treat Inflammation and Pain Associated with Rheumatoid Arthritis Oral fixed - dose combination of synthetic cannabidiol and hydroxychloroquine sulfate in Phase 2 for RA • IHL - 675A demonstrated to be well - tolerated and bioavailable in Phase 1 study IHL - 675A TRPV1 GPR55 NMDAR µ/ δ opioid receptor α 1 - adrenoceptor T - type Ca 2+ channel COX2 5 - HT 1A Inflammation 5 - HT 2A Inflammation Cannabidol Hydroxychloroquine NASDAQ:IXHL

 

 

Late - stage pipeline of oral fixed - dose treatments and therapeutic regimens for large market chronic conditions NASDAQ:IXHL 33 INVESTMENT SUMMARY ~$70M capital position (as of December, 2025) • Obstructive Sleep Apnea (OSA) Positive Phase 2 Data Reported August 2025 • Generalized Anxiety Disorder (GAD) Positive Phase 2 Data Reported August 2025 • Rheumatoid Arthritis (RA) 3 Clinical Programs in Phase 2/3 & Phase 2 Development

 

 

• 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

 

 

35 Executive Management • Leads technology strategy and innovation at Incannex • Co - founder of APIRx Pharmaceuticals and AXIM Biotechnologies • Former CTO of Incannex Australia and AXIM • 10+ years developing cannabinoid - based APIs and ophthalmologic therapeutics Lekhram Changoer Chief Technology Officer • 20+ years in R&D across industry and academia • Leads candidate design, CMC, IP, and early clinical strategy • Former senior scientist at Hexima ; honorary fellow at La Trobe University • Ph.D. in Genetics; 45+ peer - reviewed publications Mark Bleackley , Ph.D Chief Scientific Officer • 25+ years in global drug development • Led programs at Jazz, AbbVie, Novartis, and Biogen • Contributed to approvals of Marplan ®, Luvox CR, Marinol®, Gilenya • Clinical faculty at Emory; 65+ publications 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 Lou Barbato , M.D. Chief Medical Officer

 

 

NASDAQ :IXHL INVESTORS MEDIA [email protected] [email protected] CONTACTS

 

Exhibit 99.2

 

 

 

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.

 

 

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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

[email protected]  

[email protected] 

 

 

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