Incannex Healthcare Inc 6-K, filed May 18, 2023
Incannex Healthcare Inc. (IXHL)
About this 6-K
Incannex Healthcare Inc filed this 6-K on May 18, 2023.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of May, 2023
Commission File Number: 001-41106
Incannex Healthcare Limited
(Exact name of Registrant as specified in its charter)
not applicable
(Translation of Registrant’s name into English)
Australia
(Jurisdiction of incorporation or organization)
Joel Latham
Chief Executive Officer and Managing Director
Level 39, Rialto South Tower
525 Collins Street
Melbourne 3000
Australia
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Yes ☐ No ☒
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Yes ☐ No ☒
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On May 16, 2023, Incannex Healthcare Limited filed with the Australian Securities Exchange an announcement captioned “Psychennex Pty Ltd – Company Update”, a copy of which announcement is attached to this Form 6-K as Exhibit 99.1.
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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, thereunto duly authorized.
| Incannex Healthcare Limited | ||
| Date: May 18, 2023 | By: | /s/ Joel Latham |
| Name: | Joel Latham | |
| Title: | Chief Executive Officer and Managing Director | |
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INDEX TO EXHIBITS
| Exhibit No. | ||
| 99.1 | ASX Announcement, dated May 16, 2023 – Psychennex Pty Ltd – Company Update |
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Exhibit 99.1
P s y c h en n e x P t y L td C o m p a n y U p d a t e Market Update May 2023 Psychennex Pty Ltd A Division of Incannex Healthcare Ltd (IHL - ASX) (IXHL - NASDAQ)
Disclaimer Not an offer of Securities : This document has been independently prepared by Incannex Healthcare Limited (Incannex) and is provided for informational purposes only . This document does not constitute or contain an offer, invitation, solicitation, or recommendation with respect to the purchase or sale of any security in Incannex . This document does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in any jurisdiction (in particular, the United States), or a securities recommendation . This document is not a prospectus, product disclosure statement or other offering document under Australian law or any other law and will not be lodged with the ASIC . Summary Information : This document contains a summary of information about Incannex and its activities that is current as at the date of this document . The information in this document is general in nature and does not purport to be complete or to contain all the information which a prospective investor may require in evaluating a possible investment in Incannex or that would be required in a prospectus or a product disclosure statement prepared in accordance with the Corporations Act 2001 (Cth) (Corporations Act) . No Liability : The information contained in this document has been prepared in good faith by Incannex, however no guarantee representation or warranty expressed or implied is or will be made by any person (including Incannex and its affiliates and their directors, officers, employees, associates, advisers and agents) as to the accuracy, reliability, correctness, completeness or adequacy of any statements, estimates, options, conclusions or other information contained in this document . To the maximum extent permitted by law, Incannex and its affiliates and their directors, officers employees, associates, advisers and agents each expressly disclaims any and all liability, including, without limitation, any liability arising out of fault or negligence, for any loss arising from the use of or reliance on information contained in this document including representations or warranties or in relation to the accuracy or completeness of the information, statements, opinions, forecasts, reports or other matters, express or implied, contained in, arising out of or derived from, or for omissions from, this document including, without limitation, any financial information, any estimates or projections and any other financial information derived therefrom . Statements in this document are made only as of the date of this document unless otherwise stated and the information in this document remains subject to change without notice . No responsibility or liability is assumed by Incannex or any of its affiliates for updating . Not Financial Product Advice : This document does not it constitute financial product advice or consider your investment objectives, taxation situation, financial situation or needs . This document consists purely of factual information and does not involve or imply a recommendation of a statement of opinion in respect of whether to buy, sell or hold a financial product . An investment in Incannex is considered to be speculative in nature . Before making any investment decision in connection with any acquisition of securities, investors should consult their own legal, tax and/or financial advisers in relation to the information in, and action taken on the basis of, this document . Information in this Document is Confidential : This document and the information contained within it are strictly confidential and are intended for the exclusive benefit of the persons to whom it is given . It may not be reproduced, disseminated, quoted or referred to, in whole or in part, without the express consent of Incannex . By receiving this document, you agree to keep the information confidential, not to disclose any of the information contained in this document to any other person and not to copy, use, publish, record or reproduce the information in this document without the prior written consent of Incannex, which may be withheld in its absolute discretion . Acceptance By attending an investor presentation or briefing, or accepting, accessing, or reviewing this document you acknowledge and agree to the “Disclaimer” as set any information in this document or to inform any recipient of any new or more accurate information or any errors or mis - descriptions of which Incannex and any of its affiliates or advisers may become aware . Forward Looking Statements : Certain information in this document refers to the intentions of Incannex, but these are not intended to be forecasts, forward looking statements, or statements about the future matters for the purposes of the Corporations Act or any other applicable law . The occurrence of the events in the future are subject to risk, uncertainties and other actions that may cause Incannex’s actual results, performance, or achievements to differ from those referred to in this document . Accordingly, Incannex and its affiliates and their directors, officers, employees and agents do not give any assurance or guarantee that the occurrence of these events referred to in the document will actually occur as contemplated . Statements contained in this document, including but not limited to those regarding the possible or assumed future costs, performance, dividends, returns, revenue, exchange rates, potential growth of Incannex, industry growth or other projections and any estimated company earnings are or may be forward looking statements . Forward - looking statements can generally be identified by the use of words such as ‘project’, ‘foresee’, ‘plan’, ‘expect’, ‘aim’, ‘intend’, ‘anticipate’, ‘believe’, ‘estimate’, ‘may’, ‘should’, ‘will’ or similar expressions . These statements relate to future events and expectations and as such involve known and unknown risks and significant uncertainties, many of which are outside the control of Incannex . Actual results, performance, actions and developments of Incannex may differ materially from those expressed or implied by the forward - looking statements in this document . Such forward - looking statements speak only as of the date of this document . There can be no assurance that actual outcomes will not differ materially from these statements . To the maximum extent permitted by law, Incannex and any of its affiliates and their directors, officers, employees, agents, associates and advisers : • disclaim any obligations or undertaking to release any updates or revisions to the information to reflect any change in expectations or assumptions ; • do not make any representation or warranty, express or implied, as to the accuracy, reliability or completeness of the information in this document, or likelihood of fulfilment of any forward - looking statement or any event or results expressed or implied in any forward - looking statement ; and • disclaim all responsibility and liability for these forward - looking statements (including, without limitation, liability for negligence) . PSYCHENNEX PTY LTD 2
M e n t a l u n w e ll n e s s i s t h e d e f i n i n g h e a l t h c r i s i s o f o u r t i m e . I t a f f e c t s m i l l i o n s o f p e o p l e i n many ways. Traditional treatments successfully enable a number of those affected to manage their symptoms but many are left behind, their ill n e s s u n r e s p o n s i v e t o t h o s e t r e a t m e n t s . Psychennex Pty Ltd Psychedelic - assisted psychotherapy offers the hope of sustained improvement to the significant proportion of people for whom traditional treatment has not worked. Psychennex is pioneering the Australian psychedelics sector via its clinical research programs and its move into service delivery through its Clarion Clinics Group. P S Y C H E NN E X PSYCHENNEX PTY LTD 3
P S Y C H E D E L I C A S S E T S All of IHL’s psychedelic assets in one place. I m p r o v i n g t h e q u al i t y o f li f e f o r p e o p l e w h o s u f f e r d e b i l i t a t i n g a n d i n t r a c t ab l e m e n t a l he a l t h c o n d i t i o n s . Psychennex Pty Ltd is the holding company for: • INTELLECTUAL PROPERTY FROM: PsiGAD Clinical Trials MOVER License All future psychedelic clinical trails • PSYCHEDELIC PRODUCT DEVELOPMENT • DISTRIBUTION CONTRACTS FOR PSYCHEDELIC DRUGS • PSYCHEDELIC CLINIC SUBSIDIARIES P s y c h e n n ex Pty Ltd PSYCHENNEX PTY LTD 4
GROUP STRUCTURE The Psychennex Group Structure has been designed to hold all IHLʼs psychedelic assets to facilitate coordinated management and potential future exit. Psychennex Group Structure Clarion Clinics Licensing & Franchising Pty Ltd Clarion Model Clinic Pty Ltd IHL Ltd P s y c h e n n ex Pty Ltd Clarion Clinics Group Pty Ltd PSYCHENNEX PTY LTD 5
Peter Widdows Peter, a long time IHL director, is leading the Psychennex businesses. “ B e i n g e n Ě r u s Ě e d Ě o d e l i v e r s o m e Ě hi n g w hi c h has Ěhe poĚenĚial Ěo maĚerially improve Ěhe healĚh of so many people is a privilege I Ěake s Ě o c k o f e v e r y d a y . I Ě r e i n f o r c e s m y d r i v e Ě o make Ěhis venĚure successful.” LEADERSHIP 30 Years of Senior Business Leadership • HJ Heinz – CEO covering: • AusĚralasia & large parĚ of Asia, 18,500 employees & Mu l Ě i - b i l l i o n d o l l a r r e v e n u e s • Director: Youi insurance • Chairman: Sunny Ǫueen Australia • Extensive international business leadership experience • Chartered Accountant Experienced B us i n e s s L e a d e r s h i p PSYCHENNEX PTY LTD 6
ASSETS P s y c he d e l i C - A s sis t e d P s y c h o t h e r a p y C l i ni C s C G M P P s y l o C y b i n I n t e ll e c t u al P r op e r t y f r om C l i n i C a l T r i a l s Three Distinct Asset Groups Strong revenue drivers Psychennex has a strong platform o f c l i n i c a l I P , i n h o u s e d r u g a s s e t s and service delivery capability to drive strong near term revenue. 01 02 03 PSYCHENNEX PTY LTD 7
Multiple Revenue Streams Strong revenue streams Within each of its asset platforms are multiple near term revenue stream plans. R EV E N U E S T R E A M S • Operation and ownership of clinics • Training of psychotherapists • Franchising & licensing • Sale to IHL Clinics • Sale to IHL Franchisees & Licensees • External sale to other clinics • Global licensing fees Clarion Clinics Group cGMP P s i l o c y b i n Intellectual Property from Clinical Trials ST R E A M O N E S T R E A M T W O ST R E A M T H R E E PSYCHENNEX PTY LTD 8
Clinical Trials & I P A s s e t s 01 P s i G A D 02 V i r t u a l R e a l i t y A u g me n t e d Psychedelic - Assisted Psychotherapy 03 C l i n i c s a s T r i a l S i t e s T R I A L S & A S S E T S PSYCHENNEX PTY LTD 9 Potential Market for IP Assets A $1.5B
T R I A L S & A S S E T S PsiGAD - Phase 2 Clinical Trial Psychedelic - Assisted Psychotherapy for Generalised Anxiety Disorder. Psychennex is completing a phase 2 clinical trial at the Monash University BrainPark, under the supervision of Prof. Suresh Sundram, Dr. Paul Liknaitzky and Prof. Murat Yucel. Clinical Trials & I P A s s e t s 01 P s i G A D 55 of 72 Patients completed trial so far – No patients have dropped out Power analysis of interim results shows strong probability (85% + with 95% CI) of statistically significant benefit at end of trial Mid point DSMB reported no safety or trail design concerns Trial completion due Q4 2023 PSYCHENNEX PTY LTD 10
T R I A L S & A S S E T S Virtual Reality (VR) Psychedelic - Assisted Psychotherapy Augmented by Virtual Reality. Psychennex has an exclusive, perpetual, global license over ground - breaking virtual reality technology developed at the BrainPark in Monash University. Clinical Trials & I P A s s e t s Exclusive global license over immersive virtual reality technology developed at BrainPark Monash university To be used in conjunction with psychedelic - assisted psychotherapy by providing triggering stimuli in a controlled manner Potential to treat multiple anxiety disorders 02 V i r t u a l R e a l i t y A u g me n t e d Psychedelic - Assisted Psychotherapy PSYCHENNEX PTY LTD 11
T R I A L S & A S S E T S Clinical T r i a l S i te s We will conduct clinical trials as a commercial provider and continue to gather clinical data . Psychennex clinics will provide clinical trail services where capacity allows on a commercial basis to 3rd parties. It will also continue to collect clinical data from treatments to support efforts in regulatory approval and Medicare approval. Clinical Trials & I P A s s e t s Commercial Provider of Clinical Trials Continued Data Collection from Patients Health Economics and Clinical Results to Support Regulatory Approval Ongoing Data Driven Protocol Development 03 C l i n i c s a s T r i a l S i t e s PSYCHENNEX PTY LTD 12
MA N U F A C T U R I N G cGMP Psilocybin Psychennex Licensed and Franchised External Clinics Clinical Trials S U PP L Y T O Psychennex has entered a manufacturing agreement with Catalent, which will deliver its own cGMP psilocybin product. M a n u fa c t u ri ng Agreement While sales in early years will be modest, they are expected to grow as the treatment becomes more mainstream . SCALING PSYCHENNEX PTY LTD 13
I N T R O D UC I NG The Clarion Clinics Group CLARION CLINICS 14 The worldʼs leading Psychedelic - Assisted Psychotherapy Clinics
CLARION CLINICS GROUP The companyʼs move into clinical service delivery is the natural next step in its efforts to reduce the mental health burden society faces. Giving us the capability to treat many more patients than we could in a trial setting. O w n a n d o p e r a t e Established to own and operate a chain of psychedelic - assisted psychotherapy clinics, nationally and internationally . W o r l d c l a s s Partly owned and clinically directed by 3 world class mental health professionals with incomparable experience in Australia. Rapid expansion Designed for rapid expansion capability through ownership and license/franchise options . Effective treatment Goal to deliver ethical and effective treatment to over 1 m i ll i o n p e o p l e . CLARION CLINICS 15
Clinical Experts Experience with psychedelic drugs in conjunction with psychotherapy is rare in Australia. Psychennex has partnered with Australiaʼs most experienced and able clinical experts in this field, creating a strong competitive advantage. LEADERSHIP W o r l d C l a s s Clinical Leadership Dr Paul Liknaitzky C o - F o u n d e r , D i r e c t o r , C h i e f S t r a t e g y a n d S C i e n t i f i C O f f i C e r Professor Suresh Sundram Co - Founder, Director and Head Of Psychiatry Sean O’Carroll Co - Founder, Director and Head Of Psychotherapy CLARION CLINICS 16
Co - Founder, Director, Chief Strategy and Scientific Officer Dr Paul Liknaitzky CLINICAL EXPERT Paul Liknaitzky is Head of the Clinical Psychedelic Lab at Monash University, and Chief Principal Investigator on a program of psychedelic trials. He is a Senior Research Fellow within both the Dept of Psychiatry and the Turner Institute at Monash University, and earned an Honours in Neuroscience and a PhD in Psychology from the University of Melbourne. In Australia, Liknaitzky has played a central role in establishing the field of psychedelic research, is an Investigator on several of the country’s initial psychedelic trials across multiple institutions, has coordinated a number of psychedelic therapist training and supervision programs, and leads the first clinical psychedelic lab. He has been invited to deliver numerous academic, professional, and public talks on psychedelic science, and has been interviewed on the topic for television, documentaries, print media, radio, and podcasts. Liknaitzky supervises a team of over 40 researchers, clinicians and students, co - convenes the Australasian Research Group for Psychedelic Science, and is a member of a number of Scientific Advisory Boards. He has Adjunct or Honorary appointments at St Vincent’s Hospital, the University of Melbourne, Swinburne University, and Deakin University. His work is focused on a rigorous program of research in clinical psychedelics that seeks to innovate on treatment design, evaluate therapeutic effects, mitigate known risks, explore potential drawbacks, and understand therapeutic mechanisms. “The safe, useful, and eĚhical ĚranslaĚion of clinical psychedelic research inĚo pracĚice has been aĚ Ěhe forefronĚ of my mind for s o m e y e a r s , a s w e c o n d u c Ě Ě r i a l s a n d l e a r n r s Ě - h a n d a b o u Ě Ě h e poĚenĚial and Ěhe complexiĚy of providing psychedelic Ěherapies. I feel moĚivaĚed now Ěo conĚribuĚe Ěo a communiĚy - based service where we can draw on our subsĚanĚial experience in coordinaĚing and delivering Ěhis ĚreaĚmenĚ, alongside a wealĚh of ĚreaĚmenĚ and Ěraining resources, and an exĚensive neĚwork of menĚors a n d c o l l a b or a Ě o r s f r o m a r o u n d Ě h e w o r l d . ” CLARION CLINICS 17
Co - Founder, Director and Head Of Psychiatry Professor Suresh Sundram CLINICAL EXPERT Professor Sundram (MBBS, MMed, FRANZCP, PhD) is a psychiatrist and neuroscientist committed to understanding the biological foundations of schizophrenia and related disorders in order to improve the lives of affected patients and families through the development of relevant biomarkers and ultimately disease modifying treatments. He is Chair and Head, Department of Psychiatry, School of Clinical Sciences, Monash University; Director of Research, Mental Health Program, Monash Health; and Clinical Director, Cabrini Outreach. He is co - Chair of the Monash Partners Neuroscience and Mental Health Theme. At Monash University and Monash Health, he established and leads the Translational Molecular Psychiatry program with over 25 staff and students which uses a recursive bedside to bench and back philosophy to discover new molecules and genes of relevance to the major psychiatric disorders. Prior to these roles he established and led a molecular laboratory at the Mental Health Research Institute in conjunction with a clinical research laboratory at the Northern Hospital which transferred to the Florey Institute of Neuroscience and Mental Health where he also was appointed as Head of the Statewide Psychotropic Drug Advisory Service. Professor Sundram has conducted in excess of 40 phase II, IIIA, IIIB and IV industry sponsored and investigator initiated clinical trials with multiple pharmaceutical companies. Currently, he co - supervises the Clinical Psychedelic Laboratory at Monash University conducting cutting edge clinical research using psychedelic agents in mental disorders. He has held a number of international roles including: current President - elect, Asian College of Neuropsychopharmacology; expert consultant, United Nations High Commissioner for Refugees; Member, Joint Advisory Committee to the Governments of Australia and Nauru on Nauruan Regional Processing; Co - Chair, Asian Schizophrenia Network; Executive Committee Member and Member, Section on Developing Countries, World Psychiatric Association. “The down - scheduling of cerĚain psychedelic ĚreaĚmenĚs for cerĚain condiĚions is an imporĚanĚ ĚransiĚion poinĚ Ěo esĚablish Ěhe u Ě i l i Ě y a n d r o l e o f p s y c h e d e l i c - a s s i s Ě e d p s y c h o Ě h e r a p y i n m e n Ě a l illness. Providing a cusĚom - Ěailored environmenĚ in order Ěo deliver Ěhe besĚ possible ĚherapeuĚic experience is criĚical. To enable Ěhis, a n d Ě o e v a l u a Ě e a n d d e l i v e r o u Ě c o m e s , i s a r a r e op p o r Ě u n i Ě y . ” CLARION CLINICS 18
Co - Founder, Director and Head Of Psychotherapy Sean O’Carroll CLINICAL EXPERT Sean is the Lead Psychotherapist and Trainer with the Clinical Psychedelics Lab at Monash University. He has conducted training for numerous other psychedelic research teams and individuals, including teams from Swinburne University and Curtin University. He works as a psychedelic - assisted psychotherapy consultant within the industry - both academic and commercial - with an emphasis on psychotherapy training and protocol development. Sean has a background in academic philosophy, earning his Honours in Philosophy from the University of Western Australia in 2004, before going on to study psychotherapy and experiential therapy. He opened his private psychotherapy practice in Melbourne in 2011, and works as an integrative psychotherapist, trainer, and academic. He is a qualified Dancing Freedom instructor (ecstatic dance), and has a longstanding interest in the use of “non - ordinary states” in healing and ceremony. He completed his Masters by Research in Experiential Therapy in 2017. He completed the MDMA Training Program with MAPS (Multidisciplinary Association for Psychedelic Studies) in 2021. Sean is the director of the Wild Mind Institute, which he founded in 2014. Through the institute, he has trained hundreds of mental health practitioners in psychedelic - assisted psychotherapy, “bad trip” integration, and eco - psychotherapy. Since 2019, Sean’s primary focus has been on supporting the emergence of psychedelic - assisted psychotherapy in Australia as a safe, efficacious, and affordable treatment. “ T h e r e a r e ve r y f e w e x p e r i e n c e d p s yc h e d e l i c - a s s i s Ě e d p s y c h o Ě h e r a p i s Ě s i n A u s Ě r a l i a , a n d Ě h e Ě e a m w e a r e a s s e m b l i n g includes many of Ěhe mosĚ experienced pracĚiĚioners in Ěhe counĚry. We Ěake Ěhis responsibiliĚy seriously and are uniquely placed Ěo s u p p o r Ě Ě h e e m e r g e n c e o f p s y c h e d e l i c - a s s i s Ě e d p s y c h o Ě h e r a p y a s a safe and efficacious new ĚreaĚmenĚ modaliĚy.” CLARION CLINICS 19
W h o l y o w n s a n d o p e r a t e s a l company owned clinics, except ‘model’ clinic O w n s 1 0 0 % o f C l a r i o n C l i n i c s Licensing and Franchising Pty Ltd 1 5 . 5 % o w n e d b y i t s c l i n i c a l l e a d e r s and 84.5% by Psychennex Pty Ltd. Clarion Clinics Group Pty Ltd is the home of Psychennexʼs clinics business. Clarion Clinics Group Pty Ltd CLARION CLINICS GROUP CLARION CLINICS 20
The transfer of psychedelic - assisted psychotherapy from a clinical trail setting to a treatment setting will create commercially scalable treatment protocols and valuable intellectual capital. M D M A A s s i s t e d Psychotherapy for PTSD Psilocybin Assisted Psychotherapy for TRD Psilocybin Assisted Psychotherapy for Generalised Anxiety Disorder (Post Approval) 0 1 . 0 3 . 0 2 . Leading Edge Treatments T R E A T M E N T S CLARION CLINICS 21
It is natural to feel afraid during and after a traumatic situation. Fear triggers many split - second changes in the body to help defend against danger or to avoid it. This “fight - or - flight” response is a typical reaction meant to protect a person from harm. Nearly everyone will experience a range of reactions after trauma, yet most people recover from initial symptoms naturally. Those who continue to experience problems may be diagnosed with PTSD. People who have PTSD may feel stressed or frightened, even when they are not in danger. According to the 2007 National Survey of Mental Health and Wellbeing, an estimated 12% of Australians experience PTSD in their life (lifetime prevalence), with women being at almost twice the risk of men (15.7% and 8.6% respectively) (ABS 2008). According to the 2017 - 18 National Health S u r v e y , a n e s t i m a t e d 1 . 7 % o f w o m e n a n d 1 . 3 % o f m e n r e p o r t e d t h a t t h e y h a d b e e n told by a doctor, nurse, or health professional that they have PTSD (point prevalence estimate) (ABS 2019). Post - traumatic Stress Disorder P T S D Post - traumatic stress disorder (PTSD) is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. 12% 1.5% of Australians suffer from PTSD at any given time of Australians experience PTSD in their lifetime CLARION CLINICS 22
Treatment Resistant Depression (TRD) T R D Depression is considered treatment resistant when the patient has failed to respond to two types of intervention. The Australian Department of Health and Aged Care estimates that, of the 4.1% of the population who suffer from depression, 26.5% experience treatment resistant depression. Other supporting data studies show similar results: “Our results suggest that between 29% and 46% of depressed patients fail to respond fully with antidepressant treatment of adequate dose and duration. In particular, although partial response a p p e a r s t o o c c u r i n 1 2 % t o 1 5 % o f t h e depressed patients studied, nonresponse is observed in 19% to 34% of this population.” * “From an epidemiologic point of view, because the prevalence of depression has been estimated to vary from 2.6% to 5.5% i n m e n a n d f r o m 6 . 0 1 % t o 1 1 . 8 % i n w o m e n , one must conclude that treatment - resistant depression is a very common clinical problem that is likely to affect more than one third of depressed patients.” * * Fava M, Davidson KG. De niĚion and epidemiology of ĚreaĚmenĚ - resisĚanĚ depression 4 . 1 % of them e x p e r i en c e TRD of Australians suffer from depression 26.5% CLARION CLINICS 23
Addressable Market MA R K E T TRD and PTSD are highly prevalent in society, with PTSD affecting 1.5% of the population at any given time and TRD a f f e c t i n g 1 . 1 % o f t h e p o p u l a t i o n . * Source: AusĚralian InsĚiĚuĚe of HealĚh & Welfare (Aus Gov) ** The number of people suffering PTSD aĚ any given Ěime. Source AusĚralian InsĚiĚuĚe of healĚh and Welfare (Aus Gov) *** Source: AusĚralian GovĚ DeparĚmenĚ of HealĚh and Aged Care. **** EsĚimaĚe is based on a number of facĚors: affordabiliĚy of ĚreaĚmenĚ, willingness Ěo be ĚreaĚed, eĚc. This percenĚage will grow signi canĚly as ĚreaĚmenĚ becomes more widely accepĚed and governmenĚ funding is available. Australia A d v ance d N a tions Population 26,100,000 1,200,000,000 PTSD Li f e tim e p r ev a l enc e o f P T S D ( 12% ) ** 3,132,000 144,000,000 P oi n t P r ev a l enc e ( 1.5%) ** 391,500 18,000,000 TRD P r ev a l enc e o f Dep r ession *** 1,070,100 49,200,000 Prevalence of TRD (26.5% of above) *** 283,577 13,038,000 A dd r essab l e M ar k e t ( P eop l e ) 675,077 31,038,000 T o ta l A dd r essab l e M ar k e t ($ ) 13,501,530,000 620,760,000,000 Psychedelic - Assisted Psychotherapy Penetration PTSD **** TRD **** 20% 15% 20% 15% Annua l P a tie n t Deman d E stim a t e - P T SD 78,300 3,600,000 Annua l P a tie n t Deman d E stim a t e - TRD 42,536 1,955,700 T o ta l Annua l T a r g e t M ar k e t ( P eop l e ) 120,836 5,555,700 T o ta l Annua l T a r g e t M ar k e t ($ ) 2,416,729,500 111,114,000,000 CLARION CLINICS 24
Domestic Expansion Plans MA R K E T E X P A N S I O N Clarion has plans to expand rapidly and help as many patients as possible . However, the market is expected the be under - supplied into the foreseeable future . M ode l Clinic S y dn e y Clinic 1,500 3 , 4 28 3 , 4 28 3 , 4 28 3 , 4 28 M elbourn e Clinic 1 , 000 3 , 4 28 3 , 4 28 3 , 4 28 3 , 4 28 Bris b an e Clinic 1,500 3 , 4 28 3 , 4 28 3 , 4 28 S y dn e y 2 Clinic 1,500 3 , 4 28 3 , 4 28 P e r t h Clinic 1 , 000 2 , 000 2 , 000 A de l aid e Clinic 1 , 000 2 , 000 2 , 000 Gol d C o as t Clinic 750 1,500 1,500 Canber r a Clinic 750 1,500 1,500 O t he r R egiona l Clinics 2 , 000 4 , 000 P l anne d Ca p a city 400 3 , 100 9 , 156 16 , 184 23 , 692 25 , 692 M ar k e t S i z e 12 0 , 8 36 123,253 128 , 1 8 3 1 4 1 , 001 155 , 101 1 7 0 , 611 % of Market Treated by Clarion Group * 0.33% *This is noĚ markeĚ share as we believe Ěhe available capaciĚy will noĚ meĚ Ěhe markeĚ for some Ěime, so people who wanĚ ĚreaĚmenĚ will go unĚreaĚed. 2.52% 7 . 14 % 11 . 48 % 15.28% 15 . 06 % 2 0 23 400 2024 600 2 0 25 800 PATIENT CAPACITY 2 0 2 6 900 2 0 27 980 2028 980 CLARION CLINICS 25
Helping Provide More Accessible Treatment A C C E S S I B I L I T Y Clarion Group is committed to making psychedelic - assisted psychotherapy accessible to everybody who will benefit from it. The group is actively working on numerous patient funding opportunities. Funding options Medicare Mental Heath Plan and Private Insurance Subsidy. Work With Medicare and Department of Health for Full Patient Funding. Veterans and First Responder Associations Funding. Charitable Contributions. Psychennex Pro - Bono Treatments. CLARION CLINICS 26
Ǫ3 2023 Location O p e n i ng Abbotsford Riverfront, Melbourne Capacity Patient Capacity – 600 in normal working hours – 1,000 in extended operating hours P R OTO T Y P E T h e f i r s t C l a r i o n C l i n i c w i l l o p e n i n Melbourneʼs inner - north later this year. The Model clinic will serve as a prototype for the Companyʼs planned rapid roll - out of further clinics. While being a prototype, the clinic will be run at a commercial scale and is a significant business in its own right. S t ag e O n e Model Clinic CLARION CLINICS 27
At each step, the company will decide whether owning or licensing/franchising the clinics is the better option, based on speed to market, financial returns and management capability. Franchised and Licensed Clinics Commencing Target 80+ Clinics L i c e n s e / F r a n c h i s e R ev e n ue 2024 E x i s t i n g & N e w O p e r a t o r s Based on a percentage of clinic revenue S t ag e T w o E X P A N S I O N CLARION CLINICS 28
International expansion will be dictated by the regulatory and competitive environment of target geographies. I n t e r na t i o n a l Expansion E X P A N S I O N S t ag e T h r ee S ee k L i c e n s i n g a n d F r a n c h i s i n g P a r t n e r s Al geographies where l e g i s l a t i o n a l o ws O p e n O w n e d C li n i cs Major populations centres w h e r e l e g i s l a t i o n a l o w s Targets T o b e d e t e r mi n e d a s opportunity arises CLARION CLINICS 29
A number of providers, motivated by the down - scheduling of MDMA and psilocybin, have said they will enter the market for psychedelic - assisted psychotherapy. We believe that ethical and competent competition will be good for the industry. It will offer the patients a choice of providers and also help to meet what is expected to be a surplus of demand over capacity for the foreseeable future. C o m p e t it i o n I N D U S T R Y At Clarion Group we believe that we have strong advantages over most other providers in that: 0 1 . 0 2 . 0 3 . We are clinically led by a world class team of psychedelic - assisted psychotherapy experts, with extensive experience in the application. CLARION CLINICS 30 We have a team of dedicated therapists who understand and have hands on experience in psychedelic - assisted psychotherapy. Our services will be solely dedicated to the provision of psychedelic assisted psychotherapy and our knowledge in this specific treatment.
Exit Options E X IT IHL will continually evaluate its options regarding the exit of Psychennex Pty Ltd based on what is most beneficial to IHL shareholders . I P O Trade Sale Continued Ownership CLARION CLINICS 31
I n v e s t o r & M e d i a E n q u i r i e s For investor related enquiries please contact: Peter Widdows peterwiddows@clarionclinics.com Market Update May 2023 Psychennex Pty Ltd A Division of Incannex Healthcare Ltd (IHL - ASX) (IXHL - NASDAQ)