ENTROPY NEURODYNAMICS LIMITED — Capital/Financing Update 2024

Aug 25, 2024

ASX Release

26 August 2024

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Successful completion of subject dosing in TRP-8803 (IV-infused psilocin) Healthy Human Volunteer Study

• Phase 1b study completed with 11 participants administered TRP-8803 – Participants across three cohorts were given an IV-infusion of psilocin in increasing doses over 150 minutes

• All participants were administered TRP-8803, TYP's innovative IV-infused psilocin formulation and discharged after dosage follow up was completed

• Study designed to refine and optimise dosing and infusion rates for TRP-8803 (IV-infused psilocin) in volunteers to achieve precise blood levels of psilocin with an acceptable pharmacokinetic profile to determine TRP-8803’s ideal safety profile for therapeutic use in patients

• Completion of Phase 1b trial marks an important milestone for TYP and will provide specific insights into upper and lower blood concentration limits of psilocin required to gain and maintain the ideal patient therapeutic zone of circulating psilocin to achieve optimal patient response

• Safety Review Council of all data is now underway which will determine safety criteria have been met

• Results will be utilised for patent applications, anticipated to be lodged in the near term

• Completion and positive results will underpin future trials utilising TRP-8803 in key indications including Binge Eating Disorder (BED) and Fibromyalgia Syndrome (FMS)

• Upcoming TRP-8803 clinical trials have been significantly de-risked through successful completion of Phase 2a trials utilising TRP-8802 (oral psilocybin):

  • Phase 2a trial with the University of Florida highlighted an average reduction in binge eating episodes of over 80% in patients with BED and commensurate reductions in both anxiety and depression

  • Phase 2a trial with the University of Michigan in fibromyalgia delivered a clinically meaningful reduction in pain, pain interference, pain anxiety, brain-fog and fatigue in patients

• Additional updates to follow in coming weeks upon receipt of full results

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Melbourne, Australia – Tryptamine Therapeutics Limited (‘ Tryp ’ or the ‘ Company ’) ( ASX: TYP ), a clinical-stage biotechnology company is pleased to advise it has successfully completed all participant dosing in its Healthy Human Volunteer Study (‘Phase 1b’) which was undertaken at CMAX Clinical Research in Adelaide, South Australia (refer ASX announcement: 1 July 2024).

As part of the Phase 1b study, TRP-8803 was successfully administered for a period of up to 150 minutes to a total of 11 participants, each of whom were safely discharged following treatment and dosing follow-up.

The trial was an open-label design, undertaken with therapist support. It aims to refine and optimise dose and infusion rate of TRP-8803 to achieve precise blood levels of psilocin with an acceptable pharmacokinetic profile in participants and to determine its safety prior to additional clinical studies that will focus on identified clinical needs.

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Completion of the Phase 1b trial marks an important milestone for Tryp. Results from the initiative will provide specific insight into refining TRP-8803 dosing to achieve a precise psilocin blood level in patients, reduce inter-patient variability as well as form the basis for a number of new patent applications which will be lodged in the near term.

Safety Review Council review of all data is now underway, which will determine if results meet the proposed safety criteria of the trial. The Company will provide further updates on results as they materialise in the coming weeks.

Positive results will provide a strong foundation for future trials using TRP-8803, which will be focused on specific clinical indications including Binge Eating Disorder and Fibromyalgia.

Completion of the Company’s Phase 1b TRP-8803 study follows exceptional results obtained from both a Phase 2a study alongside the University of Florida focused on Binge Eating Disorder utilising TRP-8802 (oral psilocybin) which delivered an average reduction in binge eating episodes by over 80%, and a Phase 2a trial with the University of Michigan in Fibromyalgia that delivered a clinically meaningful reduction in pain, pain interference, pain anxiety, brain-fog and fatigue in patients (refer ASX announcement: 12 August 2024).

Management commentary:

Chief Executive Officer, Mr. Jason Carroll said: “To have completed this Phase 1b clinical study in just two months and have had all 11 participants discharge following their IV-infusion is a major achievement for Tryp. This study was pivotal for the Company, as it allowed us to learn and refine the ideal infusion dose level for TRP-8803 to ensure that circulating blood concentrations of psilocin remain consistent and within the proposed therapeutic zone in participants over a two and a half hour period. Further, the results will continue to build on our thesis that Tryp’s innovative and proprietary IV-infusion may overcome the significant problems associated with oral dosing of a psychedelic pharmaceutical compound.”

“Defining therapeutic, reproducible blood level results in patients is one of the key pillars to the Company’s strategy and we look forward to reviewing results and providing these to shareholders in the coming weeks. These results will then allow us to advance additional clinical trials using TRP-8803, in close collaboration with our partners and the Therapeutic Goods Administration (TGA) focusing squarely on specific clinical indications of high unmet patient need. We have considerably de-risked our program through our Phase 2a trial program into Binge Eating Disorder and Fibromyalgia with two of the finest teaching hospitals in the US and are very excited to replicate or improve on these results with our proprietary IV-infusion technology.”

This announcement has been authorised for release by the Board of Tryptamine Therapeutics Limited.

-ENDS-

About Tryptamine Therapeutics Limited

Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp’s lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) with potential to alleviate numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has completed a Phase 2a clinical trial for the treatment of binge eating disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%.

The Company also has also just completed a Phase 2a clinical trial for the treatment of fibromyalgia in collaboration with the University of Michigan and has initiated a Phase 2a clinical trial in collaboration with Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from irritable bowel

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syndrome. Each of the studies is utilising TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response is demonstrated, subsequent studies are expected to utilise TRP-8803 (IV-infused psilocin), that has the potential to further improve efficacy, safety, and patient experience. TRP-8803 is currently being evaluated in a Phase 1 Healthy Volunteer Study in Adelaide, Australia.

For more information, please visit www.tryptherapeutcs.com.

Investor & Media Contact

Jason Carroll Chief Executive Officer Tryptamine Therapeutics Limited jcarroll@tryptherapeutcs.com

Henry Jordan Six Degrees Investor Relations +61 (0) 431 271 538 henry.jordan@sdir.com.au

Forward-Looking Information

Certain information in this news release, constitutes forward looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", "is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward looking information, including but not limited to the factors described in greater detail in the "Risk Factors" section of Tryp’s Replacement Prospectus available at www.asx.com.au These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.