June 2023 Quarterly Activities Report and Appendix 4C
Released
Released
Announcement PDF
ASX Announcement
31 July 2023 ASX Announcement
07 Mar 2023
Quarterly Activities Report (June 2023)
Acquisition of Leading Psychological Trauma Centre - The Pax Centre
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Leading in mental health: Emyria initiated the acquisition of the Pax Centre, renowned for its
comprehensive care of complex psychological trauma, amplifying the Company’s reach in
the mental health landscape.
Building a Centre of Excellence: The Company will bring its expertise treating patients with
recently rescheduled medicines and collecting robust Real-World Data to the Pax Centre to
deliver and develop emerging treatments like psychedelic-assisted therapy.
Revenue boosting synergies: By integrating the operations of The Pax Centre with Emerald
Clinics, Emyria expects to enhance patient outcomes and service revenues while expanding
its Real-World Data collection capabilities and payer engagement opportunities.
(See ASX release 29 June 2023)
Expanding Care Options with MDMA and Psilocybin-Assisted Therapy
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MDMA-assisted therapy for PTSD: Emyria received Human Research Ethics Committee
approval to commence EMDMA-001, a novel MDMA-assisted therapy trial for PTSD. This
milestone marks our strategic expansion into advanced mental health care therapies.
Developing new care models: Emyria has commenced development of a psilocybin-assisted
therapy care model to complement our existing MDMA-assisted therapy program which
already has a supply of patient-ready MDMA secured.
Fostering expertise: Renowned psychedelic-assisted therapy researcher, Dr. Ben Sessa
completed training for an initial team of 20 Emyria-affiliated therapists and clinicians.
(See ASX releases 08 June 2023 and 18 April 2023)
Completion of $2.5m Placement for Advanced Therapies and Drug Discovery
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Investment support: Emyria successfully completed a $2.5 million placement with support
from existing institutional and strategic investors.
Funding emerging therapy delivery and development: Capital to support delivery of MDMA
and psilocybin-assisted therapies from July 1st, pivotal clinical trials and Emyria’s pioneering
MDMA-inspired drug discovery program with the University of Western Australia.
(See ASX release 01 May 2023)
Securing Commercial Partner for Cannabinoid Program
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Strategic partnership: Emyria signed an exclusive licensing and commercialisation term
sheet with Aspen Pharmacare Australia, securing a major partner to support the registration
and commercialisation of the prospective EMD-RX5 treatment for mild anxiety and stress
Monetising milestones: Emyria stands to gain up to a 10% royalty from annual net sales, plus
milestone payments totaling $400,000.
(See ASX release 04 April 2023)
Emyria ASX Announcement | 31 Jul 2023
1
Emyria’s Managing Director, Dr. Michael Winlo, said: “Emyria’s acquisition of The Pax Centre this
quarter is a substantial extension of our capabilities and expertise in mental health.
By integrating the Pax Centre with Emerald Clinics we aim to create a thriving, multidisciplinary
clinical service that generates growing revenues while capturing robust clinical data to support
our ongoing cannabinoid and MDMA-inspired medicine development programs.
We believe the unique “wraparound” care model we are building offers advantages over
alternative models for delivering promising emerging interventions like MDMA and
psilocybin-assisted therapy and that the data we are gathering can help advance the
development and registration of treatments with potential to help large patient populations.
CORPORATE
Net cash used in operating activities has reduced from $5.66m for FY22 down to $4.1m reflecting
the steps taken by management to reduce costs and improve efficiencies. We anticipate further
reductions in our expenditures as certain clinical trials near completion.
Raised $2.5m and utilised Radium facility to drawdown against FY23 R&D tax incentive claim.
Director and related party payments were $252k comprising wages, fees and superannuation. This
figure includes $47k allocated to investing activities (as disclosed in section 6 of the 4C report).
OUTLOOK
Advancing the development and commercialisation of Emyria’s proprietary drug products remains
a core priority. Emyria's portfolio of innovative MDMA analogues continues to expand and now
exceeds 180 compounds. A meticulous preclinical screening program and robust patent strategy is
proceeding. Concurrently, we are scoping select animal behavioural models to help identify the
most promising candidates for future development of our two leading development series in
Parkinson’s disease and faster-acting MDMA. During the quarter, Emyria was shortlisted for a major
grant to advance the analogue program with results of the application expected in the September
2023 quarter.
Progress for EMD-RX5 continues, with over 160 participants recruited. There have been no safety or
tolerability concerns reported to date. The Company expects the study to proceed at a slower pace
while we navigate temporary delays of EMD-RX5 with our CDMO. Preclinical work with EMD-RX7
and EMD-RX9 continues. EMD-RX7 is currently under evaluation at the NIH in the USA as part of a
fully-funded “Preclinical Screen Program for Pain” initiative. Emyria will seek commercial partners
for these prospective cannabinoid assets.
The Company eagerly anticipates treating our first patients with MDMA-assisted therapy within our
comprehensive, multidisciplinary care model. With Australia's global advantage — offering these
therapies a full year ahead of others—Emyria is well positioned to lead the world in the delivery of
these promising psychiatric treatments while gathering valuable Real World Data on their safety,
efficacy and cost effectiveness. This data will be used to inform care, develop proprietary
treatments and protocols, and help evaluate efficacy and cost-effectiveness.
The Company is proactively exploring further growth avenues, including strategic acquisitions and
partnerships, to bolster our service offerings, revenues and footprint. We are looking to expand our
suite of mental health services by incorporating promising emerging treatments into the Pax
Centre such as psilocybin-assisted therapy. In parallel, we are committed to engaging payers with
our robust clinical data to help with cost-effectiveness evaluations. This concerted effort reflects
Emyria's dedication to advancing mental health care on a global scale.
Emyria ASX Announcement | 31 Jul 2023
2
RECENT TRACTION & UPCOMING MILESTONES
CLINICAL DELIVERY
Advanced mental health care
THERAPY DEVELOPMENT
MDMA-inspired Medicines
Ultra-Pure Cannabinoids
First patent family filed
Preclinical Screening
Program for Pain (RX7)
US-focused
preclinical program
Formulation optimisation
(RX7 > RX9)
Develop psilocybin
therapy model
Metabolic studies
AUS Commercial partner
(RX5)
Expansion of treatment
offerings
Preclinical animal models
US Commercial partners
Expansion of clinical
footprint
Lead selection
Phase 3 conclusion (RX5)
Engagement with
payers
Phase 1 trials
Phase 1 (RX7 & RX9)
Leverage data platform
Global commercial strategy
FDA Pre-IND (RX7 & RX9)
Acquisition of leading
psychological trauma service
Commencement of
MDMA-assisted therapy
PROMOTIONS DURING QUARTER
Australian Financial Review
https://www.afr.com/companies/healthcare-and-fitness/would-you-pay-30-000-to-treat-your-depre
ssion-20230606-p5def2
Washington Post
https://www.washingtonpost.com/world/2023/06/29/mdma-drug-therapy-ptsd-ecstasy-australia/
This release has been approved by the Managing Director of Emyria.
FOR FURTHER INFORMATION
Dr. Michael Winlo
Managing Director
+61 (0) 8 6559 2800
mwinlo@emyria.com
Emyria ASX Announcement | 31 Jul 2023
Sara Polanski
Communication Manager
+61 (0) 404 110 099
media@emyria.com
Sufian Ahmad
Corporate Advisor
+61 (0) 412 316 162
info@62capital.com.au
3
ABOUT EMYRIA | emyria.com
Emyria Limited is a clinical services and drug development company with a focus on
revolutionising patient outcomes in neuroscience and mental health via:
○
Clinical Service Delivery: Emyria delivers evidence-based & emerging therapies for
mental health via a multidisciplinary team comprising psychiatrists, GPs, mental health
generates
nurses, psychologists, social, physical and occupational therapists.
○
Proprietary Real-World Data (RWD): Emyria collects robust and ethically-sourced
Real-World Data to improve care provision and distinct therapy and drug development.
Emyria’s core data platform powered by Palantir Foundry.
informs
○
Innovative Therapy Development: Guided by its RWD, Emyria is developing several
proprietary Ultra-Pure cannabinoid dose forms and one of the world's largest libraries
of MDMA-like compounds in partnership with the University of Western Australia.
●
EMYRIA’S INTERACTIVE INVESTOR HUB
Investorhub.emyria.com Interact with Emyria’s announcements and updates by asking
questions and comments, which our team can respond to where possible.
ABOUT The Pax Centre | paxcentre.com.au
The Pax Centre specialises in treating individuals grappling with the psychological impacts of
traumatic experiences. Our treatment approach is highly personalised, addressing a wide range of
mental health issues, from PTSD and depression to anxiety disorders and substance abuse, often
stemming from various life traumas.
Complex trauma, characterised by repeated, relational traumatic events often occurring during
developmental stages, requires specialised attention due to its pervasive and lasting impact. In these
cases, The Pax Centre prioritises early diagnosis and evidence-based treatments.
We also focus on proactive strategies for health expansion and personal growth, empowering our
clients with skills and tools to improve wellbeing and performance. At the Pax Centre, we believe in
transforming lives through focused, evidence-based mental health care
ABOUT Emerald Clinics | emeraldclinics.com.au
Emerald Clinics is an Australian-based, patient-centric clinical services specialising in providing
treatments for patients with complex and chronic conditions, where traditional therapies might not
have yielded satisfactory results.
Leveraging our deep expertise with unregistered medicines, such as cannabinoids, we strive to
pioneer and personalise care for our patients. Our robust, ethically-sourced data collection methods
underpin our commitment to improving patient outcomes and advancing healthcare innovation.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS Any statements in this press release about future
expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other
statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements. Actual results may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the Company’s ability to successfully develop its
product candidates and timely complete its planned clinical programs and the Company’s ability to obtain
marketing approvals for its product candidates. In addition, the forward-looking statements included in this
press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent
events and developments will cause the Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the future, the Company specifically disclaims any
obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s
views as of any date subsequent to the date hereof.
Emyria ASX Announcement | 31 Jul 2023
4
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
EMYRIA LIMITED
ABN
Quarter ended (“current quarter”)
96 625 085 734
30 June 2023
Consolidated statement of cash flows
Current quarter
$A’000
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
Year to date
(12 months)
$A’000
424
1,816
(a) research and development
(287)
(1,645)
(b) product manufacturing and operating
costs
(417)
(1,848)
(c) advertising and marketing
(29)
(198)
(d) leased assets
(53)
(333)
(e) staff costs
(421)
(1,934)
(f)
(476)
(1,914)
administration and corporate costs
1.3
Dividends received (see note 3)
-
-
1.4
Interest received
8
24
1.5
Interest and other costs of finance paid
(12)
(84)
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
2,103
1.8
Other (provide details if material)
-
-
1.9
Net cash from / (used in) operating
activities
(1,263)
(4,013)
2.
Cash flows from investing activities
2.1
Payments to acquire or for:
(a) entities
-
-
(b) businesses
-
-
(c) property, plant and equipment
-
(16)
(d) investments
-
-
(1,261)
(3,217)
-
-
(e) intellectual property
(f)
other non-current assets
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 1
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
2.2
Current quarter
$A’000
Year to date
(12 months)
$A’000
Proceeds from disposal of:
(a) entities
-
-
(b) businesses
-
-
(c) property, plant and equipment
-
-
(d) investments
-
-
(e) intellectual property
-
-
(f)
-
-
other non-current assets
2.3
Cash flows from loans to other entities
-
-
2.4
Dividends received (see note 3)
-
-
2.5
Other (provide details if material)
-
-
2.6
Net cash from / (used in) investing
activities
(1,261)
(3,233)
3.
Cash flows from financing activities
3.1
Proceeds from issues of equity securities
(excluding convertible debt securities)
2,500
5,500
3.2
Proceeds from issue of convertible debt
securities
-
-
3.3
Proceeds from exercise of options
-
-
3.4
Transaction costs related to issues of
equity securities or convertible debt
securities
(150)
(320)
3.5
Proceeds from borrowings
920
1,720
3.6
Repayment of borrowings
-
(800)
3.7
Transaction costs related to loans and
borrowings
-
-
3.8
Dividends paid
-
-
3.9
Other – net payments from cash backed
guarantees
-
-
3.10
Net cash from / (used in) financing
activities
3,270
6,100
4.
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
1,987
3,879
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
(1,263)
(4,013)
4.3
Net cash from / (used in) investing activities
(item 2.6 above)
(1,261)
(3,233)
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 2
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
4.4
Net cash from / (used in) financing activities
(item 3.10 above)
4.5
Effect of movement in exchange rates on
cash held
4.6
5.
Current quarter
$A’000
Year to date
(12 months)
$A’000
3,270
6,100
-
-
Cash and cash equivalents at end of
period
2,733
2,733
Reconciliation of cash and cash
equivalents
Current quarter
$A’000
Previous quarter
$A’000
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
5.1
Bank balances
2,733
2,733
5.2
Call deposits
-
-
5.3
Bank overdrafts
-
-
5.4
Other (provide details)
-
-
5.5
Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
2,733
2,733
6.
Payments to related parties of the entity and their
associates
6.1
Aggregate amount of payments to related parties and their
associates included in item 1
205
6.2
Aggregate amount of payments to related parties and their
associates included in item 2
47
Current quarter
$A'000
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 3
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
7.
Financing facilities
Note: the term “facility’ includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
sources of finance available to the entity.
Total facility
amount at quarter
end
$A’000
Amount drawn at
quarter end
$A’000
920
920
7.1
Loan facilities
7.2
Credit standby arrangements
-
-
7.3
Other (please specify)
-
-
7.4
Total financing facilities
920
920
7.5
Unused financing facilities available at quarter end
7.6
Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing
facilities have been entered into or are proposed to be entered into after quarter end,
include a note providing details of those facilities as well.
-
In April 2023, Emyria secured a loan facility with Radium Capital for $920,000 with an
interest rate of 15% pa, maturity date of 31 December 2023 and secured against the R&D
tax rebate.
8.
Estimated cash available for future operating activities
$A’000
8.1
Net cash from / (used in) operating activities (item 1.9)
(1,263)
8.2
Cash and cash equivalents at quarter end (item 4.6)
2,733
8.3
Unused finance facilities available at quarter end (item 7.5)
8.4
Total available funding (item 8.2 + item 8.3)
2,733
8.5
Estimated quarters of funding available (item 8.4 divided by
item 8.1)
2.16
-
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a
figure for the estimated quarters of funding available must be included in item 8.5.
8.6
If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1
Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
Answer:
8.6.2
Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
Answer:
8.6.3
Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
Answer:
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 4
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance statement
1
This statement has been prepared in accordance with accounting standards and policies
which comply with Listing Rule 19.11A.
2
This statement gives a true and fair view of the matters disclosed.
Date:
31 July 2023
Authorised by: By the Board
Notes
1.
This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the
entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An
entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is
encouraged to do so.
2.
If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions
in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been
prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the
corresponding equivalent standard applies to this report.
3.
Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
4.
If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”.
If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the
[name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a
disclosure committee, you can insert here: “By the Disclosure Committee”.
5.
If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial
records of the entity have been properly maintained, that this report complies with the appropriate accounting standards
and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a
sound system of risk management and internal control which is operating effectively.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 5
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