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 3, 2023, Incannex Healthcare Limited filed with the Australian Securities Exchange an announcement captioned “IHL-675A Phase 1 Results Presentation”, 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 3, 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 3, 2023 – IHL-675A Phase 1 Results Presentation |
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Exhibit 99.1
IHL - 675A P h a s e 1 c li n i c a l t r i a l t o a s s e s s s a f e t y an d p h a r m a c o k i n e t i c s a s a p o t e n t i al a n t i - i n f i a m m a t o r y d r u g c and i d a t e A S X T i c k e r : I H L | N A S DA Q T i c k e r : I X H L
D i s c l o su r e a n d D i s c la i m e r 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 take into account 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) . IHL - 675A Results Presentation 2
R e su l t s S u m m a r y T h e 3 6 p a t i e n t c li n i c a l t r i al d e m o n s t r a t e s I H L - 6 7 5 A t o b e w e l l t o l e r a t e d , w i t h n o s e r i o u s a d v e r s e e v e n t s o f c o n c e r n . I H L - 6 7 5 A P h a s e 1 c l i n i c a l t r i al IHL - 675A Results Presentation 3
IHL - 675A Abo u t I n c a n n e x h a s d e m o n s t r a t e d t h a t I H L - 6 7 5 A c o m p o n e n t s , H C Q a n d C B D a c t s y n e r g i s t i c a ll y t o i n h i b i t p r o d u c t i on of i n fi a m m a t o r y c y to k i n e s a n d r e d uc e d i s e a s e s e v e r i t y i n a n i m a l m o d e l s o f : Rhe u m a t o i d a r t h r i t i s I n fi a m m a t o r y l u n g c o n d i t i ons I n f i a m m a t o r y b o w e l d i se a ses I H L - 6 7 5 A i s a c a n n a b i n o i d c o m b i n a t i o n d r u g comprising hydroxychloroquine sulphate (‘HCQ’) a n d c a n n a b i d i o l ( ‘ C B D ’ ) . HCQ is a disease - modifying anti - rheumatic d r u g ( D M A R D ) t h a t w o r k s b y c a l m i n g a p e r s o n ’ s i m m u n e s y s t e m. CBD is a non - psychoactive phytocannabinoid d e r i v e d f r o m t h e c a n n a b i s pla n t , a s s o c i a t ed with anti - infiammatory and analgesic activity. IHL - 675A Results Presentation 4
IHL - 675A R e d u c i n g d i s e a s e s e v e r i t y i n a n i m a l m o d e l s IHL - 675A outperformed HCQ and CBD administered alone at reducing infiammatory disease scores — a strong efficacy s i gn a l d e m an d i n g c li n i c a l a s s e s s m e n t. P e r f o r m a n c e R e su l t s IHL - 675A Results Presentation 5
– A n i m a l d i s e a s e m o d e l r e s u l t s w e r e a m a j o r commercial signal: targeting the disruption of i n cu m b e n t m u l t i - b ill i o n d olla r m a r k e t s f o r d i se a se s of i n f i a m m a t i o n . – T h e a d d r e s s a b l e t a r g e t m a r k e t s e x c ee d $ 1 2 5 B p er a nn u m g l oba ll y a n d i n c l u d e r h e u m a t o i d a r t h r i t i s , COPD, asthma, bronchitis, colitis and Crohn’s disease. – IHL - 675A Phase 2 clinical trial launched for patients w ith r h e u m a t o i d a r t h r i t i s . – Phase 2 trials for infiammatory lung conditions and i n fi a m m a t o r y b o w e l d i s e a s e a r e c u r r e n t l y i n p l a n n i n g. I H L - 6 7 5 A C li n i c a l d e v e l o p m e n t A d d r e s s ab l e M a r k e t A $ 1 2 5 B p e r a nn u m g l oba lly I n c l u d i n g ; R h e u m a t o i d a r t h r i t i s , COPD, Asthma, Bronchitis, Colitis a n d C r o h n ’ s d i s e a s e IHL - 675A Results Presentation 6
Aim T o a s s e s s t h e s a f e t y , t oler a b il i t y a n d p h a rm a c o k i n e t i c s of I H L - 6 7 5 A c o m p a r e d t o r e f e r e n c e listed drugs for CBD and HCQ, marketed as Epidiolex a n d P la q u en i l r e sp e c t i v e l y , i n h ea l t h y v o l u n t eer s . IHL - 675A F ir s t a s s e s s m e n t i n h u m a ns P h a s e 1 c li n i c a l t r i al M o n i t o r i n g , i n c l u d i n g P K b l oo d s a m p l e c ol l e c t i o n a n d E C G o v e r 4 w ee k s 01 I H L - 6 7 5 A E p i d i ol e x T h r e e - a r m e d s tud y w i t h t w e l v e p a t i e n t s p e r a r m 02 03 Plaquenil IHL - 675A Results Presentation 7
IHL - 675A S a f e t y / t ole r a b il i t y r e s u l t s R e s u l t s – N o a d v e r s e e v e n t s o f c o n c e r n . – Adverse events were consistent with public reports for Epidiolex an d P l a q uen i l . – Treatment - related treatment emergent adverse events (TEAEs) included abdominal pain, dizziness, fatigue, frequent bowel m o v e m e n t s , h e a d a c h e an d s o m n o l en c e . – The number of TEAEs for IHL - 675A was the same as Epidiolex. – A l l T E A E s w e r e m i l d i n s e v e r i t y w i t h t h e e x c e p t i o n o f o n e i n c i d e n t o f a b d o m i n a l c r a m p s o f m o d e r a t e s e v e r i t y i n t h e I H L - 6 7 5 A g r o u p , w h i c h r e so l v e d s oo n a f t e r o n s e t. – N o c a r d i a c r e l a t e d T E A E s w e r e r e p o r t e d . IHL - 675A Results Presentation 8
P h a r m a c o k i n e t i c s: CBD R e s u l t s – C o m p a r e d t o E p i d i o l e x , C B D d o s e d i n I H L - 6 7 5 A : – Reached a greater maximum concentration (C max ), 1.57 times higher – Was taken up more rapidly (T max ), 26 % faster – W a s c l ea r e d m o r e q u i c k l y ( T 1 / 2 ) , 1 3 % f a s t er – Had a similar level of total exposure (AUC inf ) – These differences are only trends at this point (p>0.05). – Similar patterns were observed for major CBD metabolites 7 - C O O H - C B D a n d 7 - O H - C B D . IHL - 675A Results Presentation 9
R e s u l t s – Compared to Plaquenil, HCQ from IHL - 675A was: – Taken up more slowly (T max ), 46% slower – Reached a similar maximum concentration (C max ) – Had a similar rate of clearance (T 1/2 ) – Had a similar total exposure (AUC inf ) – These differences are only trends at this point (p>0.05). – O n l y l o w ( a v e r a ge < 2 n g / mL ) c o n c e n t r a t i o n s o f HCQ metabolites desethylhydroxychloroquine, b i s d e s e t h yl h y d r o x y ch lo r o q ui n e a n d d e s e t h ylc h lo r o q ui n e w e r e d e t e c t e d a t a l l p o i n t s i n t h e s t u d y . P h a r m a c o k i n e t i c s: HCQ IHL - 675A Results Presentation 10
R e s u l t s Conclusions 01. IHL - 675A is well tolerated in healthy volunteers. 02. Adverse events for IHL - 675A were consistent w i t h w h a t w a s o b s e r v e d , a n d h a s b e e n p u b l i c l y r e po r t e d fo r E p i d i o l e x a n d P la q u e n il . 03. B o t h ac t i v e p h a r m a c e u t i c a l i ng r ed i e n t s , C B D a n d H C Q , a r e a b s o r b e d f r o m I H L - 6 7 5 A . 04. Trends in PK profiles indicate that the uptake of CBD may be more rapid for IHL - 675A than E p i d i o l e x a n d t h e u p t a k e o f H C Q m a y b e s l o w e r fo r I H L - 6 7 5 A t h a n P la q u e n il . 05. T h i s c o uld b e ad v a n t a g e o u s for I H L - 6 7 5 A . C B D p r o v i d e s i mm e d i a t e relief for infiammation and pain whereas H C Q i s a s l o w e r ac t i n g m o l e c ul e a nd p r o v i d e s e x t en d e d r e l i e f . IHL - 675A Results Presentation 11
Incannex has commenced a phase 2, blinded, placebo controlled clinical trial to determine the safety and effect on pain and function of IHL - 675A in patients with rheumatoid arthritis. The trial is engaging up to 10 trial sites and recruiting 120 patients in total. Planning of Phase 2 studies in patients with inflammatory bowel disease and lung inflammation is underway. The treatment of these three indications has a combined global addressable annual market size exceeding US$125B per annum. Commencement Engagement Planning Treatment 02 03 04 01 P h a s e 2 C l i n i c a l T r i a ls N e x t S t e p s IHL - 675A Results Presentation 12
Clinical and Regulatory Progression P r e - c li n i c al studies F D A p r e - I N D meeting P h a s e 1 c l i n i c a l t r i al P h a s e 2 – I n fi a m m a t o r y B o w e l Diseases P h a s e 2 – Infiammatory L un g C o n d i t i ons P h a s e 2 – R h e u m a t oi d Arthritis P h a s e 3 P h a s e 3 P h a s e 3 F D A / E M A a n d o t he r regulatory body marketing approval s u b m i s s i ons IHL - 675A Results Presentation 13
IHL - 675A Epidiolex C max T max AUC inf T 1/2 C max T max AUC inf T 1/2 (ng/mL) (hr) (hr*ng/mL) (hr) (ng/mL) (hr) (hr*ng/mL) (hr) CBD Mean 207.04 2.13 841.08 220.17 131.89 2.88 725.9 231.22 SD 117.44 0.91 358.63 53.85 61.92 1.21 223.98 56.45 Min 72.6 1.02 391 113.84 45.6 1.5 355 144.41 Max 472 4 1699 301.17 241 6 1121 305.88 7 - OH - CBD Mean 55.24 2.17 389.18 40.54 21.06 3 262.27 21.15 SD 34.58 0.94 214.49 52.79 9.15 1.22 103.95 10.05 Min 14.9 1.02 220 10.78 7.7 1.5 149 10.54 Max 116 4 950 202.58 38.4 6 448 49.36 7 - COOH - CBD Mean 479.75 2.83 18753.9 167.87 362.17 4.97 16268 153.68 SD 218.74 1.2 8979.02 95.47 299.63 1.3 11069.2 92.41 Min 209 1.5 11445 46.03 116 2.5 4475 18.47 Max 921 6 43714 332.65 1180 6.05 42018 317.68 C B D a n d m e t ab ol i t e P K r e s u l t s IHL - 675A Results Presentation 14
H C Q a n d m e t ab ol i t e P K r e s u l t s IHL - 675A Epidiolex C max T max AUC inf T 1/2 C max T max AUC inf T 1/2 (ng/mL) (hr) (hr*ng/mL) (hr) (ng/mL) (hr) (hr*ng/mL) (hr) HCQ Mean 54.71 5.59 2986 182.62 55.52 3.46 3430.8 251.6 SD 23.85 2.51 1244.46 93.7 24.81 1.94 1104.38 73.65 Min 22 2 800 35.68 26.1 1 2073 163.92 Max 105 12.03 4217 311.57 124 6 5888 421.51 DESETHYL - HYDROXY - C H L O R O Q U I NE Mean 1.38 81.08 NA NA 1.29 17.46 NA NA SD 1.24 183.01 NA NA 1.04 35.04 NA NA Min 0 0 0 0 0 0 0 0 Max 4.4 673.83 0 0 3.3 123.93 0 0 THYL - C H L O R O Q U I NE Mean 0.8 7.77 NA NA 0.42 5.59 NA NA SD 0.72 13.03 NA NA 0.84 13.58 NA NA Min 0 0 0 0 0 0 0 0 Max 2 49.05 0 0 2.9 49.07 0 0 BISDESETHYL - HYDROXY - C H L O R O Q U I NE Mean 0 0 NA NA 0 0 NA NA SD 0 0 NA NA 0 0 NA NA Min 0 0 0 0 0 0 0 0 Max 0 0 0 0 0 0 0 0 NA - metabolite not detected at levels sufficient to calculate PK parameter IHL - 675A Results Presentation 15
M e d i a E n q ui r i e s F o r m e d i a r e l a t e d e n q ui r i e s p le a s e c o n t a c t : J o e l L a t h a m joel@incannex.com.au I n v e s t o r E n q ui r i e s F o r i n v e s t o r r e l a t e d e n q ui r i e s p le a s e c o n t a c t : B r a d D i l k e s investors@incannex.com.au P a r t n e r s h i p E n q uir i e s F o r pa r t n e r s h i p r e l a t e d e n q ui r i e s p le a s e c o n t a c t : admin@incannex.com.au incannex.com.au IHL - 675A Results Presentation 16