Pax Centre Acquisition to Advance Psychedelic Therapies
Released
Released
Announcement PDF
ASX Announcement
03 Jul 2023 ASX Announcement
07 Mar 2023
Emyria to acquire Pax Centre and Develop
Leading Mental Health Service
HIGHLIGHTS
Emyria announces the strategic acquisition of the Pax Centre, a top-tier, multidisciplinary
clinical service specialising in comprehensive psychological trauma care
Emyria to establish a global Centre of Excellence for the development and delivery of
innovative and sustainable therapies including psychedelic-assisted therapy
Integrated Emyria/Pax/Emerald Clinics model unlocks significant operational synergies &
opportunities to generate Real World Data and robust clinical service revenues, fortifying
Emyria’s leadership position in mental health care delivery and improving patient outcomes
Emyria to advance patient recruitment and foster payer engagement for ethics approved
pivotal trial for MDMA-assisted Post-Traumatic Stress Disorder therapy (EMDMA-001). 1 With
over 100 expressions of interest already received, this positive momentum to expedite the
development of our psilocybin-assisted therapy protocols for treatment-resistant depression
An investor webinar explaining the acquisition and expected synergies will be held Thursday
July 6th - to be notified, please sign up to Emyria’s Investor Hub here:
https://investorhub.emyria.com/welcome
Emyria Limited (ASX: EMD) (Emyria, or the Company) is proud to announce it has reached
final and binding terms for the the strategic acquisition of the Pax Centre, enhancing its
patient-centric clinical service portfolio.
The Pax Centre, Australia’s leading multidisciplinary psychological trauma care service,
serves for over 4,000 clients utilising a comprehensive offering of conventional and
emerging therapies. In the six years since founding, the Pax Centre has grown rapidly. Pax
Centre currently supports 20 clinicians across psychiatry, mental health nursing, clinical
psychology, counseling, social work, occupational therapy and chiropractic care. The Pax
Centre currently generates over $2.6M of annual billings(A) and has established strong
relationships with referrers and major health payers.
The acquisition is valued at $1.7m payable in a combination of shares (76%) and cash (24%)
(the Acquisition) and signifies a landmark moment for Emyria's mission to expand and
improve mental health care. The acquisition remains subject to the completion of conditions
precedent.
Emyria ASX Announcement | 03 Jul 2023
(A) The clinical billings figures for the Pax Centre are based on unaudited management accounts.
Investors are cautioned that past performance is not indicative of future performance.
1
THE OPPORTUNITY:
Psychedelic-assisted therapy is an innovative new treatment approach showing great promise
for the most challenging mental health conditions like Post-Traumatic Stress Disorder (PTSD) 2
and treatment-resistant Depression (tr-D).3 The recent rescheduling of MDMA and psilocybin
as controlled medicines by the Therapeutic Goods Administration (TGA) from July 1st 2023 4
offers exciting opportunities for broadening the clinical application of these new treatments.
The important and rigorous regulatory compliance and implementation required to administer
these new treatments will restrict their availability to highly specialised and appropriately
trained clinical services and a cost-effective delivery model needs to be established.
THE EMYRIA + PAX SOLUTION UTILISING PALANTIR FOUNDRY:
Emyria has long demonstrated excellence in developing complex care protocols, managing
clinical studies, and working with newly rescheduled medicines. This is best exemplified by its
existing clinical service, Emerald Clinics 5. This service has successfully treated thousands of
patients with pharmaceutical-grade cannabinoids and simultaneously gathered robust clinical
data using the advanced data capture, analysis and machine learning platform, Palantir
Foundry 6, 7. Emyria’s data assets have also guided personalised care plans as well as help launch
and commercialise 8 several innovative drug development programs.
By acquiring The Pax Centre, Emyria significantly expands its care team in mental health by
adding world-class, fit-for-purposes mental healthcare facilities and a multidisciplinary team of
20 mental health professionals covering psychiatry, mental health nursing, clinical psychology,
counselling, social work, occupational therapy and chiropractic care.
The Company plans to integrate key operations of Emyria's GP-led service, Emerald Clinics,
within the established framework of the Pax Centre. The goal is to generate stronger and
broader clinical service revenue synergies while also establishing a global centre of excellence in
the delivery and development of new and innovative therapies for complex mental health and
neuropsychiatric conditions such as psychedelic-assisted therapy.
Uniquely, the Emyria + Pax model will provide a suite of integrated clinical services thereby
circumventing the limitations of standalone single treatment clinics. This ensures those with
severe complex mental health needs have wrap-around care to focus not only on the disease
but on recovery, rehabilitation, care and well-being of patients, carers and family.
READINESS FOR PSYCHEDELIC-ASSISTED THERAPY
Emyria
and
the
Pax
Centre
are
already
psychedelic-assisted therapy having:
●
●
●
●
well
advanced
to
deliver
Secure supply of patient-ready MDMA 9
Trained team of therapists and clinicians 10
Ethics-approved care protocol for MDMA-assisted therapy 1
Established an advanced patient data registry 6
Emyria and the Pax Centre are now developing care models for psilocybin-assisted therapy
for treatment-resistant depression (tr-D) as well as the additional clinical trial protocols to
broaden and expand the knowledge of how these new interventions work for additional
indications.
Emyria ASX Announcement | 03 Jul 2023
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ACQUISITION TO SUPPORT EMYRIA’S NOVEL MDMA ANALOGUE PROGRAM
Emyria’s collaborative MDMA-inspired medicine discovery program with the University of
Western Australia stands to gain significantly from this development. The partnership has
yielded several promising IP protected novel candidates, including a rapidly-acting MDMA-like
compound to enhance treatment efficiency and a novel therapeutic for Parkinson’s disease
symptoms. 11
The recent rescheduling of psychedelics by the Therapeutic Goods Administration (TGA)
provides further support, forging a clear pathway for the registration and reimbursement of
novel compounds inspired by MDMA for a wide range of neuropsychiatric disorders. The
Acquisition underscores Emyria's commitment to bring innovative, safe, and effective therapies
to patients globally.
Emyria’s Managing Director, Dr Michael Winlo said: “This acquisition is a transformation for
Emyria. By integrating Pax's multidisciplinary team into our existing clinical operations, we're
strengthening our clinical service foundations and building a unique model for the delivery of
emerging mental health treatments, such as psychedelic-assisted therapies.
The Acquisition also improves our ability to collect crucial clinical data that can help engage
payers as well as drive further care model improvements and novel drug development.”
Medical Director C/Prof Alistair Vickery added: "This multi-therapy approach with Pax is
exciting and essential. The introduction of novel and emerging therapies necessitates
wrap-around sophisticated care. One-size fits all services do not take into account the
complexity, and coexisting illnesses, of severe long-term mental disease.
Emerald clinics has demonstrated, after nearly 10,000 patients, that careful regular monitoring,
rigorous data collection, and a safety net, is vital for the safe effective use of new and
unregistered products and can lead to new insights and drug development opportunities.”
Pax Centre Director, Psychiatrist Dr Jon Laugharne said: "The prospects of integrating
Emyria's data-driven research approach with our existing care models is incredibly
exciting. We believe that with Emyria’s support we have an opportunity to become a
centre of excellence that only offers innovative and cost-effective treatments to patients
but also helps train and support the next generation of specialists and therapists."
Pax
Centre
Director,
Mental
Health
Nurse
Claire
Kullack
said:
"The Pax Centre and Emyria share a commitment to excellence and innovation and a
vision to improve mental health outcomes on a global scale. We are so excited to leverage
our combined expertise and resources and deliver great conventional care as well as
advanced treatments that prioritise safety, effectiveness, and long-term recovery.”
Emyria ASX Announcement | 03 Jul 2023
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SYNERGIES OF THE ACQUISITION:
1.
Data Mastery: Emyria's unique data capabilities, backed by cutting-edge tools, enable us
to capture robust clinical data and generate valuable insights. Emyria’s data guides our
clinical care and therapy development. By making a commitment to “learn from the
experience of every patient” we lay a strong foundation for future advancements.
2.
Therapy Innovation: Emyria stands at the forefront of mental health innovation. By
combining the Pax Centre's deep clinical expertise with our team at Emerald Clinics,
we're uniquely positioned to pioneer a number of research and development programs.
3.
A Suite of Clinical Services: Our acquisition of the Pax Centre expands our clinical
capabilities, creating a comprehensive care ecosystem. With an expanded team of
mental health professionals, we're not just offering broader services but also improving
health outcomes, all while generating sustainable revenues.
The combination of our diverse strengths enables us to deliver an unmatched level of patient
care and therapy innovation.
Emyria ASX Announcement | 03 Jul 2023
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The Advantages Of Emyria’s Integrated Service
For The Delivery Of Psychedelic Therapies:
1.
Safety and Professional Expertise: Given the potent and often unpredictable nature of
psychedelic substances, it's essential to administer them in a controlled, professional
environment. Patients can experience intense psychological shifts during these therapies,
requiring expert oversight and immediate response capabilities to manage any adverse
reactions. An integrated clinical service ensures that this safety and expertise is
consistently maintained.
2.
Continuity of Care: Psychedelic-assisted therapy isn't a one-off treatment; it's a journey
that requires pre-session preparation, the session itself, and post-session integration
work. Delivering this therapy within a multidisciplinary service facilitates a seamless
continuity of care, ensuring that all stages of the treatment are harmoniously
interconnected.
3.
Comprehensive Understanding: In an integrated clinical service, all aspects of a patient's
health - physical, psychological, and social - are considered. This comprehensive view is
crucial for the success of psychedelic-assisted therapy, as it allows for a deeper
understanding of the patient's condition and tailoring the therapeutic process
accordingly.
4.
Psychotherapeutic Support: Psychedelic experiences often unveil deeply embedded
psychological content that can be difficult for patients to process. An integrated service
with mental health professionals such as psychiatrists, psychotherapists, and social
workers can provide essential support during and after these intense experiences,
enhancing the therapy's efficacy.
Emyria ASX Announcement | 03 Jul 2023
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APPENDIX: Key Terms of Business and Asset Sale Agreement
ITEM
PARTIES
DESCRIPTION
Emyria Limited (Emyria);
Glenroy WA Pty Ltd & Vivo (WA) Pty Ltd (together, the Sellers); and
Mind Body Consulting Pty Ltd trading as the 'Pax Centre’ (Company).
The Sellers are the shareholders of the Company and are not related parties of
Emyria.
ACQUISITION
Emyria will acquire 100% of the fully paid ordinary shares in the Company
(Acquisition) from the Sellers.
CONSIDERATION
The consideration for the Acquisition comprises (subject to a market standard
completion adjustment):
a cash payment of $400,000, to be paid on a deferred basis on 1 October 2023;
And; the issue of 10,236,220 fully paid ordinary shares in Emyria, (Consideration
Shares). The Consideration Shares will be issued from Emyria’s Listing Rule 7.1
placement capacity and will be subject to voluntary escrow, with 50% restricted for
12 months and the balance to be restricted for a period of 24 months from issue.
CONDITIONS
PRECEDENT
Completion of the Acquisition is subject to the following conditions precedent:
(Due diligence) Emyria completing legal and other relevant due diligence on the
Company to its satisfaction.
(Voluntary restriction agreements) Each Seller executing a voluntary restriction
agreement for their respective portion of the Consideration Shares.
(Services and consulting agreements) Each Seller entering into a services
agreement and consulting agreement with Emyria to supersede and replace any
prior agreements between each Seller and the Company.
(Third party approvals) The parties having obtained all other approvals, consents,
or waivers of a third party required to implement the Acquisition.
TIMING
The timing and completion of the Acquisition will depend on the satisfaction of
the conditions precedent, which in some cases are not within the control of the
Company. If a condition is not satisfied or waived within 90 days of the execution
date (unless extended), Emyria may terminate the agreement by notice in writing
to the Sellers.
WARRANTIES
As is customary with these types of agreements:
The Sellers have given certain representations, warranties and indemnities in
relation to the Company, its business and assets; and Emyria has given customary
buyer representations, warranties and indemnities for a transaction of this nature.
TERMINATION
Either party may terminate the agreement if:
there is a breach of the other parties’ obligations under the agreement prior to
completion; and the breach continues for 10 business days after the receipt of
notice in writing to remedy the default.
Emyria ASX Announcement | 03 Jul 2023
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RECENT TRACTION & UPCOMING MILESTONES
CLINICAL PROGRAMS
“Direct-To-Consumer”
Formulation
optimisation (RX5)
Phase 1 study done
Phase 3
commencement
Regulatory submission
Commercial strategy
Australia
PRE-CLINICAL + THERAPY PROGRAMS
“Prescription Medicine”
New Drug Discovery
Psychedelic-Assisted Therapy
Formulation optimisation
(RX7 > RX9)
Continuous creation
& screening
Protocols developed
(MDMA)
Preclinical Screening
Program for Pain
First patent family filed
Clinical partnerships
US-focused
preclinical program
Real-World Data system
Metabolic studies
MDMA supply secured
Lead selection
Therapist training
Phase 1 trials
Ethics approval (MDMA)
Global commercial strategy
Protocol developed (psilocybin)
Phase 1
Pre-IND (FDA)
Pivotal trials
Commercial strategy Europe
Commercial strategy USA
Psilocybin supply secured
Authorised Prescriber (MDMA)
Authorised Prescriber (psilocybin)
This release has been approved by the Board of Emyria.
FOR FURTHER INFORMATION
Dr.
Michael
Winlo
Managing Director
+61 (0) 8 6559 2800
mwinlo@emyria.com
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
REFERENCES:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
See ASX release 08 Jun 2023
Mitchell, J.M., Bogenschutz, M., Lilienstein, A. et al. MDMA-assisted therapy for severe PTSD: a randomized,
double-blind, placebo-controlled phase 3 study. Nat Med 27, 1025–1033 (2021)
von Rotz, Robin et al. Single-dose psilocybin-assisted therapy in major depressive disorder: a
placebo-controlled, double-blind, randomised clinical trial. eClinicalMedicine, Volume 56, 101809
https://www.tga.gov.au/sites/default/files/2023-02/notice-of-final-decision-to-amend-or-not-amend-the-cur
rent-poisons-standard-june-2022-acms-38-psilocybine-and-mdma.pdf accessed 05 Feb 2023
www.emeraldclinics.com.au
See ASX release 07 Oct 2021
www.palantir.com/platforms/aip
See ASX 04 Apr 2023
See ASX 13 Feb 2023
See ASX 07 Mar 2023
See ASX 01 Sep 2021
Emyria ASX Announcement | 03 Jul 2023
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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: With Emerald Clinics, and the recent acquisition of the Pax
Centre, a leading psychological trauma center, Emyria delivers emerging health
treatments for mental health and other unmet needs.
○
Proprietary Real-World Data (RWD): Through its advanced data platform powered by
Palantir, Emyria collects robust and ethically-sourced Real-World Data to improve its
care models and support its drug development initiatives.
○
Drug Discovery & Development: Guided by its RWD, Emyria is developing several
proprietary Ultra-Pure cannabinoid dose forms and advancing them towards
registration. In parallel, we are establishing 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 | 03 Jul 2023
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