ENTROPY NEURODYNAMICS LIMITED — Capital/Financing Update 2024

Nov 21, 2024

ASX Release

22 November 2024

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First patient safely dosed in TRP-8803 (IV-infused psilocin) Phase 1b study in obese subjects

• First participant from an obese population was successfully administered TRP-8803 over 140 minutes and safely discharged

• Cost-effective Phase 1b study is being undertaken at CMAX clinical research in Adelaide to refine TRP-8803 safety and dosing rates in three obese participants

• TRP-8803 is an innovative and scalable psilocin-based IV-infusion with potential neuroplastic benefits. Pharmaceuticals that achieve a change in neuroplasticity are known to cause adaptive structural and functional changes within the brain that are thought to be responsible for clinical improvements

• TRP-8803 has multiple advantages over oral psilocybin dosing including faster onset (under 20 minutes) with precise control of the depth and duration to the psychedelic state in a commercially feasible timeframe

• Dosing of two additional participants to be undertaken over the coming weeks with interim results anticipated this year

• Safe dosing of TRP-8803 in obese patients will provide valuable, cost-effective data to support dose selection for future Phase 2 trials into specific weight-related indications including Binge Eating Disorder

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Melbourne, Australia – Tryptamine Therapeutics Limited (‘ Tryp ’ or the ‘ Company ’) ( ASX: TYP ), a clinical-stage biopharmaceutical company focused on the development of TRP-8803 (a proprietary psilocin-based, IV-infused formulation with neuroplastic benefits), is pleased to advise that it has successfully and safely completed first subject dosing in its Phase 1b study into an obese subject population.

The open-label study at CMAX Clinical Research in Adelaide using TRP-8803 to determine if there are any differences in pharmacokinetic parameters compared to previous studied non-obese patients. The study will add three obese participants to the Company’s existing Phase 1b study protocol (ASX announcement: 19 November 2024).

Tryp advises that the first participant was provided TRP-8803 on Thursday, 21 November for approximately 140 minutes and safely progressed through the treatment. The participant was discharged shortly after dosing follow-up was completed.

Two additional study applicants will receive dosing over the coming weeks. Results are anticipated to support TRP8803’s dosing within obese study participants and to provide valuable and cost-effective data to optimise dose selection for the Company’s Phase 2 clinical program using TRP-8803 in specific indications. Interim results from the obese subject population are anticipated this year.

Management commentary:

Chief Executive Officer, Mr. Jason Carroll said: “We are very excited to have commenced this trial focused on an obese subject population. The initiative is very capital efficient and will provide the Company with valuable data to further refine TRP-8803 dosing rates across a broader cross section of the population, while also building on our comprehensive dataset.

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“The first patient dosing follows exceptional and positive results from an initial three patient cohorts, which have determined TRP-8803’s safety, optimal dose and infusion rates and highlighted TRP-8803’s ability to achieve improved health outcomes at scale.

“This dataset will be used to inform the Company’s phase 2 trial planning, which will explore the application of TRP8803 across specific indications. The Board and management are assessing a number of opportunities in relation to Phase 2 trials for TRP-8803 and look forward to providing further updates as developments materialise.”

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

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About Tryptamine Therapeutics Limited

Tryp Therapeutics is a clinical-stage biopharmaceutical 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 asset, TRP8803, is a proprietary, scalable and innovative formulation of IV-infused psilocin (the active metabolite of psilocybin) with neuroplastic benefits. It has the potential to alleviate numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the neuroplastic state, controlling the depth and duration of the neuroplastic 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 successful 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 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.

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

Investor & media enquiries:

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

Risks associated with psilocin

All medicines carry risks and specialist prescribers, such as registered psychiatrists are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding. Adverse effects of psilocybin and similar compounds, such as psilocin, can include temporary increase in blood pressure and a raised heart rate. There may be some risk of psychosis in predisposed individuals. These effects of psilocybin and its derivatives are unlikely at low doses and in the treatment regimens used in psychedelic-assisted psychotherapy and appropriately managed in a controlled environment with direct medical supervision.

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.