Hey BB!
Busy Quarters Ahead -
IHL-42X - Sleep Apnoea - (Pipeline #1)Expect updates on;
> Most interesting will be locations/partnerships with IHL-42x phase 2/3 trials.
> No toxicology studies required and accelerated process via 505(b) (2) pathway.
> Next steps for the development of IHL-42X includes the finalisation of clinical trial designs
> Arrangement of operational imperatives necessary to open an investigational new drug application (‘IND’) with FDA.
IHL-675A - Wonder Drug - Inflammation (Pipelines # 2,3,4)
Expect updates on;
> Incannex received approval from the Human Research Ethics Committee (HREC) to commence a phase 1 clinical trial investigating IHL-675A in humans for the first time.
> C-Max S.A enrollments called for to commence trial Phase 1 around the end of August
> We may see some trial results by end of the year. "Expect trial to completed by the back-end of the year" Joel Podcast 9/5/22
> @Oldpa1 and I consider this is our IHL-675A request for enrolments on the C-Max website
https://www.cmax.com.au/cmax-current-trials/
IHL-216A - Traumatic Brain Injury - (Pipeline #5)
Expect updates on;
> Pre-ind with FDA for TBI - Q3 - 2022 to discuss the Company’s intention to conduct an expedited clinical trial program required for a new drug application and marketing approval.
> IHL-216A drug formulation development required for in-human studies is also nearing a conclusion following an extensive research and development process commenced in June 2021. (Vectura - Inhaler update?)
PSI-GAD - Monash Uni Partnership (Pipeline #6)
Expect updates on;
> Phase 2a results for the psi-gad program from Monash Uni partnership,
> 22 participants are enrolled in the trial and the remaining 8 participants are anticipated to be enrolled during the current quarter.
> Current Trial "Data read-out by the end of the year" Joel Podcast 9/5/22
> New Updates expected on the research agreement/s for other Anxiety Indications with Monash using VR Incannex and Monash are in advanced stages of discussion in relation to a research agreement for the clinical trials required to develop the new treatment form. The initial clinical trial will assess the efficacy, safety, tolerability, and optimal dose of the treatment method.-----------------------------------------------------------
Remaining Possible News/Updates - Development Pipelines APIRx ( Subject to Legal Transfers into Incannex's APIRX Subsidiary.)
$10M has been allocated for the following APIRx Acquired - Pipelines
Expect updates on any of the following pipelines once transfer is completed;
CheWell for treatment of IBS - (Pipeline #7)> OTC product for Australia with potential to extend to global markets
> Awaiting Meeting with TGA to discuss clinical data requirements for CheWell™ to become an OTC CBD product in Australia
CanQuit (addiction products) - chewing gum for treatment of addiction (Pipeline #8)> Awaiting Pre-IND meeting with FDA and clinical trial preparations
MedChew™ Rx - (Pipeline #9)> Fast path to market by bridging to Sativex regulatory data
> Awaiting Regulatory approval application following bridging clinical trial. (Awaiting news trial commencement)
MedChew™ Dronabinol (Pipeline #10)> Fast path to market by bridging to Dronabinol regulatory data
> Awaiting Regulatory approval application following bridging clinical trial. (Awaiting news trial commencement)
CanChew Rx/SuppoCan for treatment of IBD (Pipeline #11)> Unique route of delivery for treatment of gastrointestinal disorders
> Phase 1 clinical trial to understand bioavailability of CBD suppository. (Awaiting news trial commencement)
Oraximax for treatment of periodontal disease and gingivitis (Pipeline #12)> Fast path to market due to regulation of mouthwash products as a “medical device”
> Awaiting Phase 2 clinical trial to support efficacy and potentially product registration. (Awaiting news trial commencement)
Topical CBD formulation (Pipeline #13)> Patented formulation with proof of concept clinical trial data
> No approved cannabinoid products with a similar delivery route
> Awaiting – Pre-IND meeting with FDA
Opthalmic formulation (Pipeline #14)> Patented formulation
> No approved cannabinoid products with a similar delivery route
> Phase 1 and proof of concept clinical trials (Awaiting news trial commencement)
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Corporate Action NewsIncannex adequately funded with cash of $37.5M
A$1.83M was recorded as cash outflows associated with research and development activities. Notably, Incannex is eligible to receive ( $796K ) an annual cash rebate equivalent to approximately 43.5% of all monies spent on research and development in Australia.
Expect updates on;
News is pending concerning new staff appointments as highlighted by
@rhino78"
The thing about Joel and the IHL board is that they don’t take backward steps or down grade, so I would be expecting they appoint a new board member at some point with the skills and contacts to help us take the next big step fwd. In my mind, if IHL can get a board member with contacts in big pharma and or experience in bringing blockbuster drugs to market, we are well and truly on the way to where we all want to go."--------------------------------------------------------
StrategyExpect updates on;
Partnerships - News, could be forthcoming for any development pipeline in the coming weeks/months
3 mentions of "Partnership" word from BOD in the past few weeks.
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New York NewsExpect updates on;
> Incannex will have a dedicated office managed by Dr George Anastassov, following the successful completion of the APIRx acquisition, to facilitate additional stakeholder engagement with the investment community, as well as clinical research facilitators and regulatory authorities. (ASX 28th April)
> Also keen to learn of any further Conference/Presentations booked by Rx Communications NY
https://www.rxir.com/our-clients---------------------------------------------------------
We can also expect an update on the Legal Transfer of APIRX Assets.(Looks like shareholders are in good hands with Lisa)
https://www.tglaw.com.au/corporate/staff/lisa-marcus/----------------------------------------------------------------
Finally a big welcome to all of our new shareholders, a nice base has been building at the current SP levels.
This bubble chart is for you!
CLICK THE IMAGE TO ENLARGE YOUR VIEW
And as always with this BOD, expect the unexpected update!
Sorry bit bigger post than I expected!!
Good luck
@Bigbanana
