Incannex Healthcare Inc. · NASDAQ:IXHL
Incannex Healthcare — Investor Presentation (August 2022)
36 slides from Incannex Healthcare's investor presentation, Aug 9, 2022
Slide 1: Company Overview
Company Overview | ASX Ticker: IHL NASDAQ Ticker: IXHL
Slide 2: Disclosure and Disclaimer
Disclaimer Disclosure and Disclaimer This presentation has been prepared by Incannex Healthcare Limited (“Incannex” or the “Company) for informational purposes only and not for any other purpose . Such offering of securities will only be made by means of a registration statement (including a prospec
Slide 3: Company Overview
Incannex is a global biotech company developing cannabinoid and psychedelic compound medicines. Our mission is to deliver novel drugs and therapies that transform the lives of patients currently experiencing unmet medical needs. We aim to develop targeted medicines at the cutting edge of biomedical
Slide 4: Our mission in action
Our mission in action Incannex Healthcare (NASDAQ: IXHL, ASX: IHL) is a world leader in the development of novel cannabinoid pharmaceuticals and psychedelic therapies. Diversified portfolio of candidates: clinical and pre - clinical studies have established proof of concept over 28 drug candidates f
Slide 5: Corporate Information
Corporate Information Shares on issue 1,523,593,695 Top 40 Shareholders 720,170,447 shares 47.27% Market Capitalization (A0.28 per share / USD $4.89 per ADS) $426M AUD / $294M USD Cash position as of 30 th June 2022 A $ 3 7 . 5 M ASX share code: IHL NASDAQ code: IXHL 75.5 ¢ All time high 03/03/2022
Slide 6: Management team
Madhukar Bhalla Company Secretary Madhukar “Madhu” is an experienced company secretary who has previously worked with multiple ASX - listed companies and is proficient in corporate governance, company administration, financial management and corporate law. Lekhram Changoer, MSc Chief Technical Offic
Slide 7: Clinical Project Addressable Market Opportunity
Clinical Project Addressable Market Opportunity (in US$) Stage of Development Regulatory Stage of Development Next Steps Relevant Patents IHL - 42X Obstructive Sleep Apnoea $10.4B (U.S.) Phase 2A completed FDA Pre - IND completed IND opening study 1x Pending Deemed novel & inventive IHL - 675A Infla
Slide 8: Clinical Project Addressable Market Opportunity
Clinical Project Addressable Market Opportunity (in US$) Stage of Development Regulatory Stage of Development Next Steps Relevant Patents CanChew Plus Gastro: IBS $40B (U.S.) in '21 (d) Phase 2A Completed Pre - IND, ethical approval Phase 2B Granted CanChew RX Gastro: IBD $2.78B (U.S.) by '28 (r) Pr
Slide 9: Our growth and where we are heading
Recruitment of key medical partners Clinical trial design Recruitment of Key Staff Seed Capital Raise Ideation Lab testing & idea filtration Operational capital raise Filing of provisional patents Recruitment of clinical partners Drug design Idea refinement Recruitment of key delivery staff FDA Mark
Slide 10: The six categories of opportunity
The six categories of opportunity Incannex intellectual property 15 Lead Drug Candidates 3 Near Term Revenue Opportunities 3 Novel Drug Delivery Systems 3 Commercial, Agricultural & Industrial Technology 2 Psychedelic Treatment Therapies 13 Secondary Drug/treatment Candidates Addressable Market Esti
Slide 11: Partnerships
Partnerships Investor Presentation 11
Slide 12: Competitive MOAT Strategy
Competitive MOAT Strategy First to combine cannabinoids with established medicines for enhanced research outcomes and receive approval to investigate psilocybin in combination with psychotherapy for Generalized Anxiety Disorder. We are pursuing FDA registration and marketing approval for each produc
Slide 13: APIRx Intellectual Property Families
APIRx Intellectual Property Families Extraction 3 Granted 2 Pending Investor Presentation 13 API modification 4 Pending Formulation 17 Granted 15 Pending Methods of use 3 Granted 5 Pending 19 granted and 23 pending patents to secure commercial exclusivity and our R&D investment. Some patents meet mo
Slide 14: IHL-42X Obstructive Sleep Apnea
IHL - 42X Obstructive Sleep Apnea Problem People suffering from OSA (Obstructive Sleep Apnea) have interrupted breathing while asleep. It’s a highly prevalent condition and current treatments have poor patient compliance. There are no approved pharmacotherapies for OSA. Solution IHL - 42X has two ac
Slide 15: IHL-42X: dronabinol and acetazolamide
– Carbonic anhydrase inhibitor. – Used to treat glaucoma, altitude sickness, epilepsy and other indications. – Increases the difference between prevailing PCO 2 and apnoeic PCO 2 . – Demonstrated as an effective treatment for OSA in 14 clinical studies. Strategic composition of dronabinol and acetaz
Slide 16: IHL-42X reduced AHI at a group level
IHL - 42X reduced AHI at a group level. Results – Low dose IHL - 42X (2.5mg dronabinol, 250mg acetazolamide) was the most effective dose strength with an average reduction in AHI of 50.7% compared to the baseline. – When comparing the means of the treatment groups, the difference observed for both l
Slide 17: IHL-42X was well tolerated
IHL - 42X was well tolerated. Results – No serious treatment emergent adverse events (TEAE) were reported during the study. – Low dose IHL - 42X had the lowest proportion of participants reporting TEAEs and the fewest number of total TEAEs compared to other treatment groups including placebo. – One
Slide 18: IHL-42X THC clearance
– THC levels in blood samples collected the morning after dose 7 were below the limit of detection (0.1 ng/mL) in 37.5% of low dose IHL - 42X samples. 1. https:// www.justice.gc.ca/eng/cj - jp/sidl - rlcfa/qa2 - qr2.html 2. Vindenes, V., et al., (2012) Impairment based legislative limits for driving
Slide 19: IHL-42X Conclusions
Results IHL - 42X Conclusions 01. Data from phase 2 proof of concept clinical trial supports the potential of IHL - 42X as an effective and well tolerated treatment for OSA, meeting the unmet needs of millions of people. 02. IHL - 42X reduced AHI, improved sleep quality with respect to both patient
Slide 20: IHL-675A Novel multi-use drug candidate
IHL - 675A Novel multi - use drug candidate 45.0 40.0 35.0 30.0 25.0 20.0 15.0 10.0 5.0 0.0 Relative Inhibition (%) IL - 6 Pulmonary inflammation model Mice were treated with IHL - 675A, CBD or Hydroxychloroquine (“HCQ”) prior to induction of pulmonary inflammation. Lung fluid was collected and anal
Slide 21: IHL-675A Inflammatory Lung Disease
Asset Preclinical FDA Pre - IND Phas e 1 CT FD A IND FDA Phase 2 FDA Phase 3 Anticipated Milestones IHL - 675A Inflammatory Lung Disease # Complete Phase 1 CT Open FDA IND Phase 2 CT 2023 Addressable Market IHL - 675A Lung Inflammation Problem Inflammation is a major contributing factor to a range o
Slide 22: IHL-675A Rheumatoid Arthritis
Addressable Market IHL - 675A Rheumatoid Arthritis Problem Inflammation is a major contributing factor to rheumatoid arthritis. Many patients do not respond to current drug treatments. Solution IHL - 675A targets two components of the inflammatory pathway by combining two anti - inflamamtory drugs,
Slide 23: IHL-675A Inflammatory Bowel Disease
Addressable Market IHL - 675A Inflammatory Bowel Disease Problem Inflammation is a major contributing factor to inflammatory bowel disease. Many patients do not respond to current drug treatments. Solution IHL - 675A targets two components of the inflammatory pathway by combining two anti - inflamam
Slide 24: IHL-216A TBI/Concussion
Asset Preclinical FDA Pre - IND Phas e 1 CT FD A IND FDA Phase 2 FDA Phase 3 Anticipated Milestones IHL - 216A TBI/Concussion FDA pre - IND Q3 2022 Commencement of Phase 1 CT Addressable Market IHL - 216A Concussion Problem Concussion and minor TBI (Traumatic Brain Injury) have major long term effec
Slide 25: IHL-216A TBI animal model study results
IHL - 216A TBI animal model study results IHL - 216A restored the spatial learning and memory deficit that occurs with TBI as assessed using the Morris water maze. The effect of IHL - 216A was greater than either CBD or isoflurane monotherapy. IHL - 216 reduced neuroinflammation, assessed by determi
Slide 26: Why cannabinoid oral delivery via medicated chewing gum
Why cannabinoid oral delivery via medicated chewing gum and chewable tablets Medicated chewing gum and chewable tablets (‘MCGT’) is a drug delivery system growing in favour amongst the medical community due to widespread potential applications as an extended - release dosage form that provides a con
Slide 27: Improved bioavailability of CheWell
Improved bioavailability means that even small doses of CBD within MCGTs could be highly effective even without a prescription from a doctor. That is, they would meet the TGA requirements for an OTC product. Increased bioavailability also reduces cost of goods, which increases margins. First marketi
Slide 28: Cannabinoid chewing gums for treatment of addiction
Opioid use disorder addressable market US$ 64B * Nicotine chewing gum market sales of US$ 5.2B ** in 2020 MCGs for nicotine addiction already accepted in the real world. Cannabinoid Chewing Gums and chewable tablets for Treatment of Addiction – Cannabis dependence is predicted to to be the fastest g
Slide 29: MedChew Rx for MS spasticity and pain
Problem Up to 84% of people suffering from MS also experience spasticity, which causes involuntary muscle stiffness and spasms. Pain is also a common symptom in MS, with up to two - thirds of people with MS reporting pain in worldwide studies. Solution MedChew ΠRx is absorbed through the oral mucos
Slide 30: MedChew Dronabinol Nausea and Vomiting in Chemotherapy
MedChew TM Dronabinol Nausea and Vomiting in Chemotherapy Problem According to the WHO, cancer is one of the leading causes for death. Chemotherapy is utilized by 10 million cancer patients each year. This number will grow by 53% by 2040. Nausea and vomiting are two of the most dreaded cancer treatm
Slide 31: Psi-GAD Generalized Anxiety Disorder
Asset Preclinical FDA Pre - IND Phas e 2a CT FD A IND FDA Phase 2 FDA Phase 3 Anticipated Milestones Psilocybin (“Psi - GAD”) Generalized Anxiety Disorder + Phase 2a mid trial results “readout” Q4 2022 Open FDA IND Addressable Market Psi - GAD Generalized Anxiety Disorder Problem GAD is diffuse, exc
Slide 32: Psilocybin-assisted psychotherapy
Psi - GAD: Psilocybin - assisted psychotherapy A new mental health treatment paradigm Psilocybin is a naturally - occurring psychedelic molecule produced by more than 100 species of mushrooms. It is a well - tolerated serotonergic psychedelic that produces therapeutically useful altered states of co
Slide 33: Psi-GAD Phase 2a trial design
Psi - GAD Phase 2a trial design The Study A phase 2 randomised triple - blind active - placebo - controlled clinical trial Safety and Efficacy The safety, efficacy and tolerability of psilocybin - assisted psychotherapy Participants 72 participants that will experience two psilocybin or active - pla
Slide 34: Investment Highlights
Investment Highlights Multiple clinical programs addressing unmet medical needs – 28 clinical programs guided by a world class advisory board and group of partners – Targeting conditions for patients with unmet needs – Multiple INDs open with accelerated FDA registration strategy Large Market Opport
Slide 35: Short term priorities and value drivers
Short term priorities and value drivers Program Value driver Next steps CheWell for treatment of IBS РOTC product for Australia with potential to extend to global markets РMeeting with TGA to discuss clinical data requirements for CheWell Πto become an OTC CBD product in Australia CanQuit (addict
Slide 36: Media, Investor and Partnership Enquiries
Media Enquiries For media related enquiries please contact: Joel Latham joel@incannex.com.au Investor Enquiries For investor related enquiries please contact: Brad Dilkes investors@incannex.com.au Partnership Enquiries For partnership related enquiries please contact: admin@incannex.com.au incannex.
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