Emyria : Appendix 4C - Quarterly

ASX Announcement

28 July 2022

Emyria completes Phase 1 trial for EMD-RX5, readies for Phase 3; extends UWA partnership and expands MDMA analogue library

Emyria Limited (ASX: EMD) (Emyria or the Company), a clinical stage biotech
developing multiple treatments for unmet needs powered by Real-World Data,	is
only
pleased to report on the Company's activities for the quarter ending June 30, 2022.
HIGHLIGHTS
use	● Completed EMD-RX5 Phase 1 clinical trial comparing Emyria's Ultra-Pure
		cannabidiol (CBD) capsule to Epidyolex oil - the sole registered CBD medicine
			in the US and Australia; Positive results include:
personal	1.	EMD-RX5 demonstrated excellent safety and tolerability
2.	Equivalent bioavailability to Epidyolex with less dose variability, and
			higher CBD exposures between 3 and 8 hours post-dosing
	3.	Twice the bioavailability compared to other, plant-derived CBD
				products with published pharmacokinetics (PK) data
	● Executed agreement with Clinitrials to coordinate the pivotal Phase 3 trial
			required to support registration of EMD-RX5 as an over-the-counter medicine
			with the Therapeutic Goods Administration (TGA);
			Trial to commence following ethics approval
	● Extended MDMA analogue development partnership with University of
			Western Australia (UWA); expanded proprietary library of MDMA-like analogues
			and completed additional extensive screening
For
● Cash available ~$4.68m to advance multiple drug development programs

Emyria's Managing Director, Dr. Michael Winlo, said: "Emyria has substantially advanced its drug development programs this quarter.

We achieved outstanding Phase 1 results for EMD-RX5, Emyria's proprietary, Ultra-Pure CBD capsule and engaged partner Clinitrials to lead the pivotal, multi-site Phase 3 trial required for TGA registration.

We are also delighted to extend our partnership with UWA, enabling us to generate additional proprietary MDMA-like analogues with the potential to become registered treatments for a range of major psychiatric, neurological and non-neurological disorders."

Emyria ASX Announcement | 28 July 2022

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ULTRA-PURE CANNABINOID DEVELOPMENT

Completed Phase 1 clinical trial for EMD-RX5

onlyEMD-RX5 is Emyria's first, wholly-owned proprietary formulation of Ultra-Pure cannabidiol (CBD). The Phase 1 clinical trial assessed the safety, tolerability and bioavailability

(a measure of the amount of the drug reaching the bloodstream) of EMD-RX5 capsules compared to Epidyolex oil in 12 healthy human volunteers.

Epidyolex is sold by Jazz Pharmaceuticals (NASDAQ: JAZZ) and is the sole CBD medicine registered with the TGA and Food and Drug Administration (FDA).

EMD-RX5 demonstrated a number of features that are desirable for solid, oral delivery of CBD, such as:

use

● Excellent safety and tolerability with no gastrointestinal upset or adverse events

of concern at test dose of 150mg

● Equivalent bioavailability to Epidyolex with less dose variability

● Higher CBD exposures 3 to 8 hours after dosing, indicating EMD-RX5provides

more predictable drug exposure over time; suited for non-acute indications and

supporting a preferred once to twice daily dosing regime

personalFor

● Twice the bioavailability compared to other plant-derived CBD products with

published pharmacokinetics data (see Figure 1).

Pivotal Phase 3 for

across 5-6 sites in Australia to commence following

EMD-RX5

receipt of ethics approval and to be coordinated by leading Contract Research

Organisation (CRO) and Site Management Organisation (SMO), Clinitrials

(See ASX release 13 APR 2022).

Cannabinoid product development advanced for

EMD-RX7

, Emyria's higher dose

form of Ultra-Pure CBD intended for registration of prescription-only medicines.

Bioavailability comparison of EMD-RX5 with Epidyolex at 150 mg dose

Fig 1.

Emyria ASX Announcement | 28 July 2022

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Presentation

"Drug Development Webinar" 1 June 2022

https://wcsecure.weblink.com.au/pdf/EMD/02527659.pdf

Emyria ASX Announcement | 28 July 2022

CORPORATE

Emyriahas $4.7M cash available on hand as of 30 June 2022. This comprises $3.88M cash and an $800k drawdown facility provided by Radium Capital against an expected R&D refund of at least $1.8M for the financial year ending 30 June 2022.

The board of directors were paid $330,000 for the quarter ended 30 June 2022 (as disclosed in section 6 of the 4C quarterly report) and this comprised wages, fees and superannuation.

PROMOTIONS DURING QUARTER

MDMA ANALOGUE DEVELOPMENT PROGRESS

Expanded MDMA analogue library and UWA agreement

onlyEmyria's extended the partnership agreement with the University of Western Australia, which supports the further expansion of a one-of-a-kind pipeline of new MDMA analogues (now over 100 compounds) exclusively optioned to Emyria.

As part of the drug development program, each new compound is extensively screened to reveal both desired and unwanted cell target interactions. These results help direct further compound generation and identify which compounds have the greatest potential to become next-generation psychotherapy adjuncts or treatments for other neurological and

usenon-neurologicaldisorders. (See ASX announcement 05 Aug 2021)

Positive initial screening:

• 82 of 85 compounds showed no off-target effects
  (See ASX announcements 08 Dec 2021 and 20 May 2021)
• Selective receptor activity results suggest potential applications as:
• • Novel MDMA analogues to assist with psychotherapy (i.e. "next-generationpsychedelic-assisted therapeutics") for major mental health disorders and;
  • New treatments for a range of neurological and non-neurological conditions

personalEmyria's additional investment is expected to accelerate compound synthesis and screening via team expansion, specialist materials, equipment and software, ongoing commercialisation activities and multiple patent family filings.

For

3

This announcement has been approved and authorised

for release by the Board of Emyria Limited.

OUTLOOK

The Company's top priority is to advance the registration and commercialisation of

onlyEmyria's drug development assets .

EMD-RX5 is initially seeking registration as an over-the-counter medicine with the TGA as a treatment for the symptoms of psychological distress. However, the unique formulation of EMD-RX5 has the potential to become a registered treatment in other major global markets for a variety of indications. Therefore, we believe EMD-RX5 has the potential to address large unmet health needs globally and represents a significant commercial opportunity for Emyria.

useA pivotal Phase 3 clinical trial for EMD-RX5 is expected to commence imminently upon receipt of ethics approval. Emyria's wholly-owned clinical service subsidiary, already operating across Australia, is expected to further accelerate recruitment by helping identify suitable patients who will be referred for formal screening at independent sites managed by Clinitrials.

Emyria continues to evaluate FDA pathways for its other proprietary cannabinoid

personalprograms, including EMD-RX5 and EMD-RX7, leveraging the Company's proprietary Real World Data for insights.

In parallel, the Company is using early screening results to guide the expansion of its novel MDMA analogue library with partner the University of Western Australia, creating a proprietary preclinical pipeline of compounds with the potential to become next-generationpsychedelic-assisted therapies as well as treatments for major mental health illnesses and neurological disorders.

For
For further information:
Dr. Michael Winlo		Lexi O'Halloran	Andrew Williams
Managing Director		Investor Relations	Media Relations
1300 436 363		+ 61 (0) 404 577 076		[phone]
[e-mail]	[e-mail]	[e-mail]

Emyria ASX Announcement | 28 July 2022

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only

UPCOMING

DRUG DEVELOPMENT MILESTONES

CLINICAL PROGRAMS

PRE-CLINICAL

Repurposing "Ultra-Pure" cannabinoids

PROGRAM

use

EMD-RX5

EMD-RX7

MDMA-like

"direct-to-consumer"

"prescription medicine"

medicine

program

program

Formulation

Formulation

Screening results for first

optimisation

optimisation

85 compounds

Phase 1

Phase 1

First patent family filed

personal

Commercial

Pre-IND(FDA)

Human cell line assays

Ethics submitted

Batch 3 sent

for Phase 3

Phase 3

Pivotal trials

Batch 3 screening results

commencement

Regulatory

Create and screen

ubmission

additional batches

Commercial

Metabolic studies

strategy Australia

Commercial

Preclinical assays

strategy Europe

(multiple animal models)

strategy USA

For

Lead selection

Phase 1 trials

Emyria ASX Announcement | 28 July 2022

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