Proactiveinvestors Australia Zelda Therapeutics Ltd https://www.proactiveinvestors.com.au Proactiveinvestors Australia Zelda Therapeutics Ltd RSS feed en Thu, 20 Dec 2018 02:48:39 +1100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Zelda Therapeutics investing in medicinal cannabis oral spray ]]> https://www.proactiveinvestors.com.au/companies/news/210616/zelda-therapeutics-investing-in-medicinal-cannabis-oral-spray-210616.html Zelda Therapeutics Ltd (ASX:ZLD) has entered an agreement with SUDA Pharmaceuticals Ltd (ASX:SUD) to develop a medicinal cannabis oral spray.

Under the feasibility and option agreement, SUDA will optimise its OroMist® oro-mucosal spray technology to deliver Zelda’s pharmaceutical-grade cannabis formulations across a 12-month work plan.

If successful, a 24-month option gives Zelda the right to negotiate an exclusive license over SUDA’s OroMist® technology for defined indications.

READ: Zelda Therapeutics partners with St Vincent’s Hospital for opioid reduction study

Zelda’s managing director Dr Richard Hopkins said: “Our aim is to improve upon existing market-approved oral-mucosal formulations that have proven very effective for delivering cannabis medicines in patients.

“This agreement provides Zelda with an option to license a proprietary technology for oral-mucosal delivery of medicinal cannabis. Having access to proprietary technologies strengthens our competitive position and helps accelerate our path to commercialisation.”

SUDA ’s managing director Stephen Carter added: “We are delighted to be working with Zelda on this project. We believe our technology can offer unique advantages compared to other routes of administration for delivering medicinal cannabis.”

Zelda will pay $300,000 up front to SUDA

Zelda will pay SUDA an option fee of $200,000 consisting of an upfront payment of $100,000 and a further $100,000 in downstream milestone payments.

The company will also fund SUDA's pre-agreed project expenditure.

Clinical trials are still at the centre of Zelda's operations

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Thu, 06 Dec 2018 09:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210616/zelda-therapeutics-investing-in-medicinal-cannabis-oral-spray-210616.html
<![CDATA[Media files - Zelda Therapeutics poised to 'value add all the way from clinical trials to the market' ]]> https://www.proactiveinvestors.com.au/companies/stocktube/11389/zelda-therapeutics-poised-to-value-add-all-the-way-from-clinical-trials-to-the-market--11389.html Mon, 03 Dec 2018 09:30:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/11389/zelda-therapeutics-poised-to-value-add-all-the-way-from-clinical-trials-to-the-market--11389.html <![CDATA[News - Zelda Therapeutics partners with St Vincent’s Hospital for opioid reduction study ]]> https://www.proactiveinvestors.com.au/companies/news/209866/zelda-therapeutics-partners-with-st-vincents-hospital-for-opioid-reduction-study-209866.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCMKTS:ZLDAF) has expanded a human clinical trial program to use cannabinoid medications in patients on chronic, high dose opioid pain management therapy.

This will see Zelda partner with St Vincent’s Hospital in Melbourne in a clinical trial partnership to examine the potential to use certain cannabinoid medications.

The joint clinical trial program is aimed at assisting patients who have become dependent on opioids for chronic pain management.

READ: Zelda Therapeutics to focus on US and Australia clinical trials

Managing director Dr Richard Hopkins said, “Zelda is delighted to work with the team at St Vincent’s, which continues our partnership activities with world-class institutes across the globe.”

Prescription opioids are used to treat chronic pain and these drugs can have serious side effects including physical dependence.

Research shows growing numbers of Australians receiving treatment for dependence on painkillers with the rate of accidental deaths due to opioids doubling for those aged 35 to 44 since 2007.

More than two-thirds of these deaths have been due to pharmaceutical opioids.

Dr Hopkins said: “While similar studies have been conducted in other countries with promising results, we believe that local medical community participation in these studies will accelerate acceptance of the potential of cannabinoid-based medicines.”

The clinical team will be led by Associate Professor Yvonne Bonomo, and includes Dr Jane Trinca, Professor David Castle and Dr Nigel Strauss.

READ: Zelda Therapeutics begins observational trial for medicinal cannabis treatment of autism

An initial pharmacokinetic study will inform a small-scale 20 patient double-blinded, randomised, placebo-controlled study, with the potential to expand into a larger trial depending on results.

Protocols being finalised

Clinical trial protocols are being finalised and are expected to be lodged soon with the human ethics committee for review.

Subject to approvals, the trial would be expected to start in early 2019.

Trial medication will be sourced from Zelda’s strategic partner HAPA Medical for manufacture and supply of pharmaceutical-grade medicinal cannabis.

Should the trial results show benefits, Zelda expects to be able to supply the medicines to Australian patients via specialists registered under the Authorised Prescriber Scheme.

READ: Zelda Therapeutics doses first patient in insomnia clinical trial

Zelda is focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

Range of human clinical trials

The company is undertaking human clinical trials focused on insomnia, autism and opioid reduction with activities in Australia and the USA.

It is also undertaking pre-clinical research examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

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Mon, 26 Nov 2018 09:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/209866/zelda-therapeutics-partners-with-st-vincents-hospital-for-opioid-reduction-study-209866.html
<![CDATA[News - Zelda Therapeutics founders commit to not selling their shares ]]> https://www.proactiveinvestors.com.au/companies/news/208679/zelda-therapeutics-founders-commit-to-not-selling-their-shares-208679.html Zelda Therapeutics Ltd (ASX:ZLD) has received a vote of confidence from a group of directors who have committed to not sell their shares and options coming out of escrow for a further 12 months.

The relevant directors - Messrs Karelis, Washer, Peterson and Ms Mara Gordon, collectively known as the Founders, are demonstrating their belief in the company’s future.

The relevant shares and options are being released from their 24-month escrow on 22 November 2018.

The Founders’ voluntary lock-up commitments represent 220.26 million shares and 20 million unlisted options.

READ: Zelda Therapeutics to focus on US and Australia clinical trials

Zelda’s chairman Harry Karelis said: “Since founding the company in 2015, the Founders have worked hard to position Zelda at the forefront of the burgeoning global medicinal cannabis industry.

“We have established a number of collaborations with globally recognised institutions and commenced our clinical trial activities.

“We are excited by the potential for company transformational milestones being achieved over the next year.

“Voluntarily extending our escrow term clearly demonstrates our long-term commitment to the company.”

Founders interests aligned with shareholders

Zelda’s managing director Dr Richard Hopkins added: “By agreeing to a voluntary escrow, the Founding Directors have demonstrated their interests are aligned with all shareholders.

“The Founders are to be commended for their decision, which sends a strong positive signal regarding the longer-term future of the company.”

Dr Hopkins formally commenced as managing director with the Zelda on 16 July 2018.

Preliminary autism trial results are expected in the first half of 2019

In the recent September quarterly report Dr Hopkins said: “We are delighted to have commenced the insomnia and autism trials, which represents a significant landmark for the company.

"This was complemented by the strategic partnership with HAPA, which provides Zelda with access to one of the world’s most significant markets for medicinal cannabis.

"The fact that HAPA are one of the few suppliers in the world who can manufacture to EU-GMP standards provides Zelda with a huge competitive advantage.

"With the results of the clinical trials expected during the first half of 2019, we are now well positioned to continue leveraging our strong strategic position into global markets.”

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Wed, 07 Nov 2018 09:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/208679/zelda-therapeutics-founders-commit-to-not-selling-their-shares-208679.html
<![CDATA[News - Zelda Therapeutics to focus on US and Australia clinical trials ]]> https://www.proactiveinvestors.com.au/companies/news/206837/zelda-therapeutics-to-focus-on-us-and-australia-clinical-trials-206837.html Zelda Therapeutics Ltd (ASX:ZLD) has made a decision following a strategic review to prioritise its clinical trial activities in the US and Australia and cease clinical operations in Chile.

This will ensure Zelda’s resources are focussed on generating clinical data that will best facilitate access to the largest global markets for medicinal cannabis.

Zelda is currently undertaking clinical trials in autism and insomnia in the US and Australia.

READ: Zelda Therapeutics begins observational trial for medicinal cannabis treatment of autism

The Chilean clinical trial collaboration with Fundación Daya has agreed to be ended and also the company’s eczema program will be de-prioritised for now.

Zelda’s managing director Dr Richard Hopkins said: “Following the recent strategic review, the board decided to cease clinical operations in Chile to concentrate on our clinical trial activities in the US and Australia.

“Successful outcomes to clinical studies undertaken in these countries will strengthen our commercialisation position in all major global markets, including Chile.

“Companies evaluating license deals usually put greater weight on US and Australian-based clinical trials so it makes sense to focus on these markets.”

READ: Zelda Therapeutics doses first patient in insomnia clinical trial

Recently, Zelda dosed the first patient in its pioneering medical cannabis insomnia clinical trial.

The company also recently commenced recruitment for its observational trial for autism in the US.

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Thu, 11 Oct 2018 11:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/206837/zelda-therapeutics-to-focus-on-us-and-australia-clinical-trials-206837.html
<![CDATA[News - Zelda Therapeutics begins observational trial for medicinal cannabis treatment of autism ]]> https://www.proactiveinvestors.com.au/companies/news/206728/zelda-therapeutics-begins-observational-trial-for-medicinal-cannabis-treatment-of-autism-206728.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCMKTS:ZLDAF) (FRA:G1G) has started recruitment for an autism observational trial in the USA centred on medicinal cannabis treatment.

Fifteen patients have been formally enrolled and first results are expected in the first half of 2019.

The trial, which is seeking to better understand the efficacy of medicinal cannabis treatment in existing patients, is being carried out at Children’s Hospital of Philadelphia (CHOP) in the USA.

“Diagnosis rates on the rise”

Zelda and CHOP will work closely with patient advocacy groups during the trial.

The company’s managing director Dr Richard Hopkins said, “We are excited to have this study underway and to be working alongside CHOP to conduct one of the first formal, robust studies of its type in the world.

“With studies showing that around one in 100 people have autism and with diagnosis rates on the rise, we’re focused on addressing a major unmet need for potential new therapies to help treat this condition.”

The study will utilise CHOP’s extensive research infrastructure and is designed to capture a number of key efficacy and safety measures, including clinical pharmacological data using a novel micro-sampling technique developed by CHOP.

Pediatric patients already being treated with medicinal cannabis formulations will be monitored.

Possible future clinical trial

It will lay the groundwork for a possible future clinical trial to generate high-quality, robust and acceptable data to validate the existing anecdotal data amongst patient populations.

The ultimate goal is to identify cannabinoid-based compounds that may demonstrate efficacy in the treatment of pediatric autism.

Developing cannabinoid-based formulations

Zelda is an Australian-based bio-pharmaceutical company focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company has a two-armed strategy comprising:

- A human clinical trial program focused on insomnia and autism with activities in Australia, Chile and the USA.

- A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

READ: Zelda Therapeutics doses first patient in insomnia clinical trial

The company recently dosed the first patient in its medical cannabis insomnia clinical trial with results expected in the first half of 2019.

A randomised, placebo-controlled, crossover study design will be used to treat 24 patients with Zelda’s medicinal cannabis formulation.

The study will collect and analyse data to determine the effect of the formulation on the time it takes to fall asleep, time spent awake and asleep during the night and quality of sleep.

READ: Zelda Therapeutics enters German medical cannabis market with partnership

Another recent development has been a distribution and manufacturing strategic partnership with German medicinal cannabis group HAPA Medical.

Under this arrangement, HAPA has first rights to distribute and/or manufacture Zelda’s clinically validated formulations into the rapidly growing German market.

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Wed, 10 Oct 2018 09:33:00 +1100 https://www.proactiveinvestors.com.au/companies/news/206728/zelda-therapeutics-begins-observational-trial-for-medicinal-cannabis-treatment-of-autism-206728.html
<![CDATA[News - Zelda Therapeutics doses first patient in insomnia clinical trial ]]> https://www.proactiveinvestors.com.au/companies/news/205692/zelda-therapeutics-doses-first-patient-in-insomnia-clinical-trial-205692.html Zelda Therapeutics Ltd (ASX:ZLD) has dosed the first patient in its pioneering medical cannabis insomnia clinical trial.

A randomised, placebo-controlled, crossover study design will be used to treat 24 patients with Zelda’s medicinal cannabis formulation.

The study will collect and analyse data to determine the effect of the Zelda formulation on the time it takes to fall asleep, time spent awake and asleep during the night and quality of sleep.

Results from the trial are expected in the first half of 2019.

READ: Zelda Therapeutics enters German medical cannabis market with partnership

Dr Richard Hopkins, Managing Director of Zelda said, “This is a major milestone for Zelda as it represents the first of a number of clinicaltrials we’re planning to commence over the coming months.

“Positive data will enable Zelda to accelerate its commercialisation plans, which have been facilitated by our recent agreement with HAPA Medical to manufacture and distribute Zelda products in Germany and Europe.”


Bloomberg recently reported that US investors are piling into an exchange-traded fund (ETF) known as ETFMG Alternative Harvest ETF which tracks the Canadian cannabis industry.

This comes as the country moves toward legalisation and liquor producers show growing interest in selling cannabis.

The US-listed US$662 million cannabis ETF is up 20% over the past month.

Alcohol giants teaming up with cannabis companies

Recently, alcohol giant Constellation Brands Inc (NYSE:STZ) invested $3.8 billion in Canadian marijuana maker Canopy Growth Corp (NYSE:CGC).

This is the biggest deal to date in what is now a fast emerging industry and has played a key role in turning investors’ attention to the industry.

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Wed, 26 Sep 2018 09:25:00 +1000 https://www.proactiveinvestors.com.au/companies/news/205692/zelda-therapeutics-doses-first-patient-in-insomnia-clinical-trial-205692.html
<![CDATA[Media files - Zelda enters rapidly-growing German market with product commercialisation strategy ]]> https://www.proactiveinvestors.com.au/companies/stocktube/10409/zelda-enters-rapidly-growing-german-market-with-product-commercialisation-strategy-10409.html Sun, 09 Sep 2018 20:46:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/10409/zelda-enters-rapidly-growing-german-market-with-product-commercialisation-strategy-10409.html <![CDATA[News - Zelda Therapeutics enters German medical cannabis market with partnership ]]> https://www.proactiveinvestors.com.au/companies/news/204079/zelda-therapeutics-enters-german-medical-cannabis-market-with-partnership-204079.html Zelda Therapeutics Ltd (ASX:ZLD) has entered a distribution and manufacturing strategic partnership with German medicinal cannabis group HAPA Medical.

As per the deal, HAPA will have first rights to distribute and/or manufacture Zelda’s clinically validated formulations into the rapidly growing German market. 

READ: Zelda Therapeutics strengthens Scientific and Medical Advisory Board with two appointments

Zelda’s managing director Dr Richard Hopkins said: “This partnership re-enforces the global breadth of Zelda’s relationships and shows our focus on commercialising our clinically validated formulations.

“This is also important because Germany is expected to become the world’s single largest market for medicinal cannabis.”

With a population of 83 million people, Germany is estimated to have the potential to become the world’s largest single medical cannabis market.

HAPA attracted to Zelda’s science-driven approach

HAPA’s managing director Ricardo Pendón said: “We are delighted to be entering this partnership with Zelda which is positioned as one of the world’s leading science-driven medicinal cannabis companies.

“Growth in doctor and patient use is enabled by clinically validated data and having access to Zelda’s pipeline of products is an important success factor for us.”

Zelda remains focused on rapid commercialisation of its products subject to success in clinical trials.

READ: Zelda Therapeutics attracts new managing director, Dr Richard Hopkins

Germany is a very attractive market for Zelda with legislation passed in March 2017 allowing doctors to prescribe cannabis in certain circumstances.

Furthermore, recreational use and self-cultivation are prohibited in Germany.

Cannabis-related medicines potentially reimbursable

Under the German regulatory framework, the cost of cannabis-related medicines is potentially reimbursable for patients that register with their insurer.

The subsidised nature of the medicinal cannabis industry in Germany has catalysed growth in the number of registered patients that has far exceeded initial forecasts.

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Tue, 04 Sep 2018 09:13:00 +1000 https://www.proactiveinvestors.com.au/companies/news/204079/zelda-therapeutics-enters-german-medical-cannabis-market-with-partnership-204079.html
<![CDATA[News - Zelda Therapeutics strengthens Scientific and Medical Advisory Board with two appointments ]]> https://www.proactiveinvestors.com.au/companies/news/203344/zelda-therapeutics-strengthens-scientific-and-medical-advisory-board-with-two-appointments-203344.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCBB:ZLDAF) has added clinical expertise and depth to its Scientific and Medical Advisory Board through the appointment of two medicinal cannabis experts.

Professor David Casarett and Dr Dustin Sulak are internationally recognised as key opinion leaders in the clinical use of medicinal cannabis and are both based in the United States.

READ: Zelda Therapeutics attracts new managing director, Dr Richard Hopkins

The appointments support the development of Zelda’s novel medicinal cannabis therapies for autism, insomnia and cancer.

Zelda’s managing director Dr Richard Hopkins said, “We are delighted Dr Casarett and Dr Sulak have agreed to join our Scientific and Medical Advisory Board.

“They bring extensive expertise in the use of medicinal cannabis that will inform our clinical programs for indications including autism, insomnia and cancer.

“Their ability to access US-based patient groups will also support our strategy to bring Zelda-branded products to market.”

 

Professor Casarett is a leading palliative care physician and researcher at Duke University in North Carolina with a core interest in medicinal cannabis.

Dr Sulak is a high-profile medicinal cannabis practitioner who has treated more than 18,000 patients in the US.

World-class advisory board

Other members of the board are Professor Manuel Guzmán, Dr Cristina Sánchez and Dr Noah Federman.

Professor Guzmán is Full Professor of Biochemistry and Molecular Biology at Madrid’s Complutense University and Dr Sánchez is an Assistant Professor at Complutense University, Madrid, Spain.

Dr Federman is director of the Pediatric Bone and Soft Tissue Sarcoma Program at University of California (Los Angeles), part of the UCLA Sarcoma Program and UCLA’s Jonsson Comprehensive Cancer Centre.

READ: Zelda Therapeutics progresses medicinal cannabis brain cancer research

Zelda is an Australian-based bio-pharmaceutical company focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company has a two-pronged strategy comprising:

- A human clinical trial program focused on insomnia, autism and eczema with activities in Australia, Chile and the USA.

- A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

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Wed, 22 Aug 2018 08:49:00 +1000 https://www.proactiveinvestors.com.au/companies/news/203344/zelda-therapeutics-strengthens-scientific-and-medical-advisory-board-with-two-appointments-203344.html
<![CDATA[News - Zelda Therapeutics attracts new managing director, Dr Richard Hopkins ]]> https://www.proactiveinvestors.com.au/companies/news/200799/zelda-therapeutics-attracts-new-managing-director-dr-richard-hopkins-200799.html Zelda Therapeutics Ltd (ASX:ZLD) has appointed experienced drug developer Dr Richard Hopkins as its managing director, effective today.

Dr Hopkins brings extensive knowledge and experience with his established track record in drug development of novel cancer therapies.

He also has strong experience with corporate strategy, business development and intellectual property matters.

Strategic focus on clinical validation of medicinal cannabis

Zelda’s new managing director Dr Richard Hopkins said: “I am excited to be joining Zelda Therapeutics at such a key point in the company’s development.

“I look forward to adding value to Zelda’s strategic direction and in particular leveraging revenue opportunities from the current clinical programs in the fast-growing medicinal cannabis sector.”

READ: Zelda Therapeutics progresses medicinal cannabis brain cancer research

Zelda is an Australian-based bio-pharmaceutical company that is focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company has a two-pronged strategy comprising:

• A human clinical trial programme focused on insomnia, autism and eczema with activities in Australia, Chile and the US; and
• A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

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Mon, 16 Jul 2018 09:12:00 +1000 https://www.proactiveinvestors.com.au/companies/news/200799/zelda-therapeutics-attracts-new-managing-director-dr-richard-hopkins-200799.html
<![CDATA[Media files - Zelda Therapeutics ready to test 'entourage effect' hypothesis in cancer research ]]> https://www.proactiveinvestors.com.au/companies/stocktube/9606/zelda-therapeutics-ready-to-test-entourage-effect-hypothesis-in-cancer-research-9606.html Mon, 18 Jun 2018 17:23:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/9606/zelda-therapeutics-ready-to-test-entourage-effect-hypothesis-in-cancer-research-9606.html <![CDATA[News - Zelda Therapeutics progresses medicinal cannabis brain cancer research ]]> https://www.proactiveinvestors.com.au/companies/news/198313/zelda-therapeutics-progresses-medicinal-cannabis-brain-cancer-research-198313.html Zelda Therapeutics Ltd (ASX:ZLD) continues to progress its paediatric (children) brain cancer research project with the Telethon Kids Institute in Perth, Western Australia.

The research project is focused on the pre-clinical testing of Zelda’s compounds, formulations and protocols on pediatric medulloblastoma cell lines.

Medulloblastoma is a common brain tumour in children and accounts for about 15% of brain cancers in children.

Cannabinoids are having an anticancer effect

Initial results have shown that increasing doses of pure ∆9 tetrahydrocannabinol (THC) or pure cannabidiol (CBD) reduces cancer cell viability in cell-based assays.

That means the cannabinoids are having an anticancer effect by reducing the proliferation of cancer cells.

Furthermore, high doses of THC and CBD in combination with cyclophosphamide (a type of chemotherapy agent) shows an increase in antiproliferative effect.

Additional studies are planned to further understand the nature of this effect.

READ: Zelda Therapeutics attracts experienced biopharmaceutical managing director

Zelda’s chairman Harry Karelis said: “We are very pleased to show that pure cannabinoids have demonstrated anti-cancer effect in these assays which gives us confidence that our systems are working well.

“We look forward to the results from the next phase of our research which will test the effectiveness of our formulations on these same assays providing rigorous comparative data as well as in in vivo models.”

Next phase testing full plant extracts

The next phase of the research project will be testing Zelda’s full plant extracts in these same assays and hoping to achieve better results than the individual pure cannabinoids.

At the same time, these full plant extracts will be tested in animal models hosting human tumours to determine the extent of any anti-cancer effect in these in vivo models.

These in vivo studies will generate invaluable data on the potential for cannabinoids to play a role in future cancer therapy regimes.

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Wed, 06 Jun 2018 08:33:00 +1000 https://www.proactiveinvestors.com.au/companies/news/198313/zelda-therapeutics-progresses-medicinal-cannabis-brain-cancer-research-198313.html
<![CDATA[News - Zelda Therapeutics attracts experienced biopharmaceutical managing director ]]> https://www.proactiveinvestors.com.au/companies/news/197405/zelda-therapeutics-attracts-experienced-biopharmaceutical-managing-director-197405.html Zelda Therapeutics Ltd (ASX:ZLD) has appointed Dr Richard Hopkins as its managing director commencing 1 July 2018.

Hopkins is an experienced biopharmaceutical executive with over 11 years in corporate leadership roles with public biotechnology companies.

Dr Stewart Washer will step back from his executive position but positively will revert to a non-executive director and remain with the company.

READ: Zelda Therapeutics advancing Australia-first insomnia trial

Zelda’s executive chairman Harry Karelis said: “We have achieved much since our inception in 2015 and have developed deep relationships across the globe and created significant value for our shareholders.

“As the company prepares for its next phase of growth we are very pleased to have been able to attract someone of the calibre of Richard to join the team in a leadership position.

“We are in very capable hands and we will be working closely together to build on our success to date.

“Furthermore, the options incentive package recognises the importance of aligning the interests of management with those of shareholders.”

During Dr Hopkins’ career he has managed and overseen several strategic alliance and licensing deals with multiple global pharmaceutical partners.

He holds a PhD in molecular biology, is an author on over 25 peer-reviewed publications and is an inventor on 17 patents and patent applications.

Most recently, he was the CEO of biotech PharmAust Ltd (ASX:PAA) and he currently serves as chair of the Western Australian Ausbiotech Committee.

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Tue, 22 May 2018 09:16:00 +1000 https://www.proactiveinvestors.com.au/companies/news/197405/zelda-therapeutics-attracts-experienced-biopharmaceutical-managing-director-197405.html
<![CDATA[Media files - Zelda Therapeutics "ahead of the pack" in gaining first-mover advantages ]]> https://www.proactiveinvestors.com.au/companies/stocktube/9208/zelda-therapeutics-ahead-of-the-pack-in-gaining-first-mover-advantages-9208.html Fri, 04 May 2018 18:11:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/9208/zelda-therapeutics-ahead-of-the-pack-in-gaining-first-mover-advantages-9208.html <![CDATA[News - Zelda Therapeutics advancing Australia-first insomnia trial ]]> https://www.proactiveinvestors.com.au/companies/news/195509/zelda-therapeutics-advancing-australia-first-insomnia-trial-195509.html Zelda Therapeutics Ltd (ASX:ZLD) has completed patient recruitment for Australia’s first clinical study of medical cannabis to treat insomnia.

The next phase of the study will commence shortly with patients undergoing baseline sleep measurements before commencing pharmaceutical dosing.

Positive results will mean Zelda will rapidly focus on commercialisation

Zelda’s executive chairman Harry Karelis said: “This is a significant achievement for Zelda and has the potential to introduce a safe, effective and affordable treatment for patients.

“It is no small feat to be progressing a pioneering study of this nature using medicinal cannabis and is a testament to the quality of people involved that we have reached this point in such a rapid time-frame.

“Positive results will mean Zelda will rapidly focus on commercialisation activities in markets where we have existing knowledge, relationships and access to patients.”

READ: Zelda Therapeutics expands research program to include diabetes related cognitive decline

Zelda’s clinical trial will target a sample population of people with characteristic symptoms of chronic insomnia, which include difficulty falling and staying asleep on a long-term basis.

A randomised, placebo-controlled, cross over study design will be used, where patients are selected at random to be treated with Zelda’s medicinal cannabis formulation or a placebo formulation.

The study will be undertaken by the prestigious University of Western Australia (UWA) Centre for Sleep Science (CSS).

Results expected in late 2018

The study will collect and analyse data to determine the effect of the Zelda formulation on the time of onset of sleep, sleep cycle duration and quality of sleep.

In addition, subjective feedback from patients via standard questionnaires will be collected and analysed alongside the analytical data collected.

It is anticipated that preliminary results from this clinical trial will be available in late 2018.

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Mon, 23 Apr 2018 09:20:00 +1000 https://www.proactiveinvestors.com.au/companies/news/195509/zelda-therapeutics-advancing-australia-first-insomnia-trial-195509.html
<![CDATA[News - Zelda Therapeutics expands research program to include diabetes related cognitive decline ]]> https://www.proactiveinvestors.com.au/companies/news/195200/zelda-therapeutics-expands-research-program-to-include-diabetes-related-cognitive-decline-195200.html Zelda Therapeutics Ltd (ASX:ZLD) has expanded its pre-clinical research program with Curtin Health Innovation Research Institute, which is part of Curtin University.

The company’s research will now include diabetes-related cognitive decline.

There will be a focus on studying the effect of a cannabinoid-based therapeutic moderating the effects of cerebral capillary damage associated with diabetes.

Executive chairman Harry Karelis said: “This study has potential to demonstrate that daily dosing of certain cannabinoids can provide some type of long-term benefit to diabetes sufferers and moderate the effect of capillary damage – at least in validated animal models.”

Links with other conditions such as dementia

Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces.

This can lead to a number of complications including damage to blood vessels in the brain, associated with cognitive decline that can lead to dementia and other conditions.

Globally in 2017, 50 million people suffered from dementia alone, and the risk of developing dementia for people with diabetes is 2.77-fold greater than the healthy population.

Research study could lead to commercialisation

Zelda’s research study will occur in validated animal models of diabetic cognitive decline developed by Curtin University and led by Associate Professor Ryu Takechi.

The study will occur over the next 12-18 months and positive results would allow Zelda to consider commercialisation opportunities of cannabinoid-based medicines.

Karelis said: “The market for cannabis-based therapeutics and wellness products is growing very rapidly.

“Positive results in this study will open up a significant market opportunity for Zelda.”

From a marketing perspective, Zelda will focus on jurisdictions where there is a clear pathway to market and access to distribution partners.

Dementia market valued at US$1 trillion

Diabetes-associated cognitive decline is a rapidly growing market, with the number of dementia sufferers expected to almost double every 20 years, reaching 75 million in 2030.

In 2018, the global cost of dementia is expected to rise above US$1 trillion.

As such, any treatment option shown to provide some form of protective benefit is likely to be a significant relief for potential suffers and a global economic benefit.

READ: Zelda Therapeutics receives approval for US autism study

This development comes less than a week after the company received approval from the Institutional Review Board for its autism project to be conducted at the Children’s Hospital of Philadelphia (CHOP) in the US.

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Wed, 18 Apr 2018 09:06:00 +1000 https://www.proactiveinvestors.com.au/companies/news/195200/zelda-therapeutics-expands-research-program-to-include-diabetes-related-cognitive-decline-195200.html
<![CDATA[News - Zelda Therapeutics receives approval for US autism study ]]> https://www.proactiveinvestors.com.au/companies/news/194897/zelda-therapeutics-receives-approval-for-us-autism-study-194897.html Zelda Therapeutics Ltd (ASX:ZLD) has received Institutional Review Board (IRB) approval for its autism project, to be conducted at the Children’s Hospital of Philadelphia (CHOP) in the US.

The study will monitor child patients already being treated with medicinal cannabis formulations.

This initial study will lay the groundwork for a possible future clinical trial.

READ: Zelda Therapeutics and Children's Hospital of Philadelphia to study the pharmacology of cannabinoids

Zelda’s executive chairman Harry Karelis said “We are very excited to be formally commencing this study in the US working alongside CHOP.

“The high calibre of CHOP researchers and clinicians coupled with access to extensive infrastructure positions this study to be one of the first formal, robust studies of its type conducted to date.

“Positive results will allow Zelda to potentially expand into a formal clinical trial to study the efficacy of standardised, high-quality medicines.

“This study is being conducted in parallel with our pending clinical trial in Chile leveraging the observational data generated in 2017.”

Results expected within six months

This study will utilise CHOP’s extensive research infrastructure.

It will also capture a number of key efficacy and safety measures including bioanalytical studies.

The ultimate goal is to identify cannabinoid-based compounds that may demonstrate efficacy in the treatment of paediatric autism.

Preliminary results expected within six months.

READ: Zelda Therapeutics expands pancreatic cancer research with Curtin University

In early March, Zelda outlined that it would expand its research program with Curtin University testing cannabinoid extracts to potentially treat pancreatic cancer.

New research activities were to investigate the effect of a range of Zelda’s formulations with a focus on animals.

Results from these studies are expected to generate highly relevant data for potential future human clinical trials.

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Fri, 13 Apr 2018 10:32:00 +1000 https://www.proactiveinvestors.com.au/companies/news/194897/zelda-therapeutics-receives-approval-for-us-autism-study-194897.html
<![CDATA[News - Zelda Therapeutics expands pancreatic cancer research with Curtin University ]]> https://www.proactiveinvestors.com.au/companies/news/192631/zelda-therapeutics-expands-pancreatic-cancer-research-with-curtin-university-192631.html Zelda Therapeutics Ltd (ASX:ZLD) will expand its research program with Curtin University testing cannabinoid extracts to potentially treat pancreatic cancer.

New research activities will investigate the effect of a range of Zelda’s formulations with a focus on animals.

Results from these studies are expected to generate highly relevant data for potential future human clinical trials.

Evidence growing that cannabinoid extract can fight cancer

There is a growing body of evidence that whole plant cannabinoid extracts can impede cancer growth.

READ: Zelda Therapeutics well-funded to advance cannabinoid treatments for medical conditions

Harry Karelis, executive chairman, said: “We are very excited to be able to expand the existing collaboration with Professor Marco Falasca’s team at Curtin University.

“The data to be generated by this new program has the potential to open new avenues of treatment for a cancer with very low survival rates.

“We look forward to results being generated over coming months and progressing the body of knowledge in this important field.”

Pancreatic cancer has a very low survival rate

Pancreatic cancer is the twelfth most common cancer globally, with over 330,000 diagnoses in 2012.

Should Zelda yield successful results from this research program, there is a valuable global market Zelda can tap into.

With a very low five-year survival rate, the pancreatic cancer market will greatly benefit from further research and development using novel approaches.

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Tue, 06 Mar 2018 08:50:00 +1100 https://www.proactiveinvestors.com.au/companies/news/192631/zelda-therapeutics-expands-pancreatic-cancer-research-with-curtin-university-192631.html
<![CDATA[News - Zelda Therapeutics well-funded to advance cannabinoid treatments for medical conditions ]]> https://www.proactiveinvestors.com.au/companies/news/192312/zelda-therapeutics-well-funded-to-advance-cannabinoid-treatments-for-medical-conditions-192312.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCQB:ZLDAF) is well funded to make strong progress in 2018 with the development of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company’s cash at bank was $6.61 million at 31 December 2017 and it is fully funded for its near-term initiatives.

Zelda’s performance in the second half of 2017 has supported strengthening share prices with the company reaching a 5-year high of $0.16 in mid-February.

It is trading in the range of $0.14 and is up more than four times its 12-month low of a year ago.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions

Harry Karelis, executive chairman, said: “We continue to push ahead with our clinical trial activities which in some cases have never been done before at the level of rigour we are applying.

“This investment in planning will result in very strong and reliable data that can be used to push forward into the next stage of commercialisation activities.

“Our intellectual property portfolio continues to grow from our pre-clinical cancer research activities and we look forward to reporting results in coming months.

“It is a very exciting time for the company as we move into our clinical trial phase.

“Much has been achieved since our inception and 2018 is poised to be a pivotal year in the company’s development.”

Net loss during half year is 90% down

During the half-year ending 31 December 2017, the company reported a net loss after tax of $496,648, down 90% on the corresponding period of 2016.

Zelda is expecting a strong flow of news during 2018 to follow the strong half year performance.

Pre-clinical research targets breast cancer

The company’s pre-clinical cancer research in Spain targeting breast cancer is progressing and generating additional data.

Zelda continues to progress its active intellectual property strategy built around this data.

In Australia, a pre-clinical research program in the area of brain cancer at the Telethon Kids Institute and pancreatic cancer at Curtin University is underway.

This has been made possible by the approval of cannabinoid material for import into Australia.

READ: Zelda Therapeutics approved for Australia’s first medicinal cannabis trial targeting insomnia

Zelda has received full regulatory approval for an insomnia clinical trial, which is expected to start during the first quarter of 2018.

It is the first of its kind in Australia to gain approval from the Human Research Ethics Committee and the Therapeutic Goods Administration, to investigate the effects of medicinal cannabis on chronic insomnia patients.

Preliminary results are anticipated by the third quarter of 2018 and if positive will progress to commercialisation activities for the formulation in various jurisdictions.

Population-based data show that about one-third of adults have regular difficulty getting to sleep or staying asleep.

READ: Zelda Therapeutics and Children's Hospital of Philadelphia to study the pharmacology of cannabinoids

Zelda has also entered into a research agreement with the Children’s Hospital of Philadelphia in the U.S. to study the pharmacology of cannabinoids in the treatment of pediatric patients.

This is an important study and potentially a key milestone in ongoing medicinal cannabis research in a clinical environment.

Trial protocols are being progressed in the company’s Chile autism clinical trial with a view to lodging these with the approving bodies in the coming quarter.

The trials are expected to start later this year.

READ: Zelda Therapeutics' US listing provides access to broader research and capital networks

Zelda recently gained approval for its shares to trade on the OTCQB Venture Market in the United States under the symbol ZLDAF.

This listing provides a new source of demand for the cannabinoid-based formulations developer’s shares from the U.S., the world’s largest market.

The OTCQB is a trading platform operated by OTC Markets Group in New York, and is home to early-stage and developing U.S. and international companies.

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Wed, 28 Feb 2018 13:14:00 +1100 https://www.proactiveinvestors.com.au/companies/news/192312/zelda-therapeutics-well-funded-to-advance-cannabinoid-treatments-for-medical-conditions-192312.html
<![CDATA[News - Zelda Therapeutics' US listing provides access to broader research and capital networks ]]> https://www.proactiveinvestors.com.au/companies/news/190332/zelda-therapeutics-us-listing-provides-access-to-broader-research-and-capital-networks-190332.html Zelda Therapeutics Ltd’s (ASX:ZLD) (OTCQB:ZLDAF) shares have been approved for trading on the OTCQB Venture Market (OTCQB) in the United States under the symbol ZLDAF.

The dual listing structure is non-dilutive for existing Zelda shareholders in that no capital is being raised and no new shares are being issued.

This listing provides a new source of demand for the cannabinoid-based formulations developer’s shares from the US, the world’s largest market.

Opportunity to be recognised as early stage international company

The OTCQB is a US-based trading platform operated by OTC Markets Group in New York, and home to early-stage and developing US and international companies.

To be eligible companies must be current in their financial reporting, pass a minimum $0.01 bid price test and undergo an annual company verification and management certification process.

The OTCQB quality standards provide a strong baseline of transparency, improving the information and trading experience for US-based investors.

Improved access to research and broader capital networks

Through trading on OTCQB, companies can engage a far greater network of US investor, data distributors and media partners.

Harry Kareliss, chairman, said: “We are pleased to announce our new trading relationship with OTCQB.

“As part of our ongoing strategy to introduce Zelda Therapeutics to a broader international audience, this milestone will provide greater visibility, better access to the US investment community, and improved convenience of trading in Zelda’s ordinary shares.”

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Mon, 22 Jan 2018 09:11:00 +1100 https://www.proactiveinvestors.com.au/companies/news/190332/zelda-therapeutics-us-listing-provides-access-to-broader-research-and-capital-networks-190332.html
<![CDATA[News - Zelda Therapeutics and Children's Hospital of Philadelphia to study the pharmacology of cannabinoids ]]> https://www.proactiveinvestors.com.au/companies/news/188549/zelda-therapeutics-and-children-s-hospital-of-philadelphia-to-study-the-pharmacology-of-cannabinoids-188549.html Zelda Therapeutics Ltd (ASX:ZLD) has entered into a research agreement with Children’s Hospital of Philadelphia (CHOP) relating to the pharmacology of cannabinoids.

The ultimate goal is to describe cannabinoid disposition in pediatric patients, and identify compounds that may demonstrate efficacy in the treatment of pediatric autism.

This news was well received with the company’s shares trading as high as $0.10 in mid-morning trading, up nearly 10% from Friday’s close of $0.091.

This builds on recent share price strength which was partly driven by the company being approved for Australia’s first medical cannabis trial for insomnia.

Read: Zelda Therapeutics approved for Australia’s first medicinal cannabis trial targeting insomnia

The collaborative research with CHOP will focus on autism with an observational trial to better understand the efficacy of treatment in existing patients.

The collaborative group will also be working closely with patient advocacy bodies and licensed growers.

This study will leverage CHOP’s extensive research infrastructure and is designed to capture a number of key efficacy and safety measures including bioanalytical studies.

Study to provide a platform for possible future clinical trials

Participating in this study could lay the foundations for a possible future clinical trial to generate high quality, robust and acceptable data.

The information should then be used to assist in validating the extensive positive anecdotal data amongst patient populations.

Preliminary results expected within six months

This collaboration effectively lifts Zelda’s profile as it will be an important U.S.-based study, focusing on the use of cannabinoids in controlled clinical settings.

The observational study is expected to commence in early 2018, with preliminary results anticipated within six months. 

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Mon, 11 Dec 2017 12:39:00 +1100 https://www.proactiveinvestors.com.au/companies/news/188549/zelda-therapeutics-and-children-s-hospital-of-philadelphia-to-study-the-pharmacology-of-cannabinoids-188549.html
<![CDATA[News - Zelda Therapeutics enters medical cannabis research partnership ]]> https://www.proactiveinvestors.com.au/companies/news/188478/zelda-therapeutics-enters-medical-cannabis-research-partnership-188478.html Zelda Therapeutics Ltd (ASX:ZLD) continues to advance its medical cannabis strategy, and the company entered a trading halt this morning pending details of a partnership with a US-based research institution.

READ: Zelda approved for Australia’s first medicinal cannabis trial targeting insomnia

The halt will remain in place until the opening of trade on Tuesday 12th December 2017, or earlier if an announcement is made to the market.

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Fri, 08 Dec 2017 09:23:00 +1100 https://www.proactiveinvestors.com.au/companies/news/188478/zelda-therapeutics-enters-medical-cannabis-research-partnership-188478.html
<![CDATA[News - Zelda Therapeutics approved for Australia’s first medicinal cannabis trial targeting insomnia ]]> https://www.proactiveinvestors.com.au/companies/news/187935/zelda-therapeutics-approved-for-australias-first-medicinal-cannabis-trial-targeting-insomnia-187935.html Zelda Therapeutics Ltd's (ASX:ZLD) shares have bounded 13% higher to $0.13 in early trade following the company being approved for Australia’s first medicinal cannabis trial for insomnia.

The clinical trial approval was granted from the Therapeutics Goods Administration and the Human Research Ethics Committee.

The trial will be undertaken by the prestigious University of Western Australia (UWA) Centre for Sleep Science (CSS), which has state of the art research facilities and is directed by Professor Peter Eastwood, National Health and Medical Research Council Senior Research Fellow.

Zelda’s clinical trial will target a sample population of people with characteristic symptoms of chronic insomnia, which include difficulty falling and staying asleep on a long-term basis.

A randomised, placebo controlled, cross over study design will be used, where patients are selected at random to be treated with Zelda’s medicinal cannabis formulation or a placebo formulation.

Harry Karelis, executive chairman for Zelda, commented: "This is a very exciting milestone for Zelda.

"We have been meticulously working our way through the regulatory framework to ensure we achieve all necessary approvals.

"This has been a very rigorous process and has taken some time but we are now very well positioned and are the first to undertake a clinical trial of this nature in Australia.

"We are very pleased to have partnered with the leading researchers in this field at the prestigious UWA Centre for Sleep Science, and are confident this clinical trial will deliver the high-quality data we need to further develop and commercialise our medicinal cannabis formulation."

WATCH: Zelda's Stewart Washer discussed medical cannabis trials with investors at Proactive's CEO Sessions

The company has been focused on targeting its medicinal cannabis formulations to treat a number of disease conditions, and progress its research to clinical trials, the first being chronic insomnia.

Professor Peter Eastwood, director, centre for sleep science, added:

"Australia has been a leader in sleep medicine for many years and our Western Australia based Centre comes equipped with state-of-the-art sleep recording and analysis equipment.

"For this trial we have assembled a team of experts including sleep physiologists, sleep physicians and clinical psychologists."

Patient data

Zelda has access to patient data in the U.S. and Chile, which shows anecdotal evidence of benefit from medicinal cannabis when used to treat insomnia.

Based on this data and other studies on the safety of medicinal cannabis, the company has worked with the research team at UWA to develop a rigorous research trial protocol to study the clinical efficacy of its insomnia formulations.

Analysis

It is anticipated that the clinical trial will formally commence in the first quarter of 2018, with patient recruitment expected to commence shortly.

Clinical trials are a key research tool for advancing medical knowledge and patient care.

Population-based data show that about one third of adults have regular difficulty getting to sleep or staying asleep.

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Wed, 29 Nov 2017 10:17:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187935/zelda-therapeutics-approved-for-australias-first-medicinal-cannabis-trial-targeting-insomnia-187935.html
<![CDATA[News - Zelda Therapeutics' soaring shares attract ASX speeding ticket ]]> https://www.proactiveinvestors.com.au/companies/news/187550/zelda-therapeutics-soaring-shares-attract-asx-speeding-ticket-187550.html Zelda Therapeutics Ltd's (ASX:ZLD) shares are currently in pre-open following the ASX granting the company a trading halt.

Zelda requested the halt pending a response to an ASX price query.

The stock had jumped 24% intra-day to $0.11 before the halt was called.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions

The halt will remain in place until the opening of trade on Thursday 23rd November 2017, or earlier if an announcement is made to the market.

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Tue, 21 Nov 2017 15:33:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187550/zelda-therapeutics-soaring-shares-attract-asx-speeding-ticket-187550.html
<![CDATA[News - Zelda's Stewart Washer discussed medical cannabis trials with investors at Proactive's CEO Sessions ]]> https://www.proactiveinvestors.com.au/companies/news/187188/zelda-s-stewart-washer-discussed-medical-cannabis-trials-with-investors-at-proactive-s-ceo-sessions-187188.html Zelda Therapeutics Ltd's (ASX:ZLD) executive director, Stewart Washer, joined Proactive's CEO Sessions in Melbourne and Sydney this week.

Zelda is developing a range of cannabinoid-based formulations to treat medical conditions.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions ACCESS THE FULL PRESENTATION HERE ]]>
Fri, 17 Nov 2017 11:23:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187188/zelda-s-stewart-washer-discussed-medical-cannabis-trials-with-investors-at-proactive-s-ceo-sessions-187188.html
<![CDATA[News - Zelda Therapeutics' shares released from escrow ]]> https://www.proactiveinvestors.com.au/companies/news/187405/zelda-therapeutics-shares-released-from-escrow-187405.html Zelda Therapeutics Ltd (ASX:ZLD) now has an additional 111.6 million shares available for trade on the ASX, following the end of an escrow period.

Zelda now has 530 million shares on issue.

The company is developing a range of cannabinoid-based formulations to treat medical conditions, and Dr. Stewart Washer, executive director, recently presented the next steps to investors.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions ]]>
Fri, 17 Nov 2017 10:41:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187405/zelda-therapeutics-shares-released-from-escrow-187405.html
<![CDATA[Media files - Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions ]]> https://www.proactiveinvestors.com.au/companies/stocktube/8368/zelda-therapeutics-dr-stewart-washer-presents-at-proactive-s-ceo-sessions-8368.html Wed, 15 Nov 2017 08:30:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/8368/zelda-therapeutics-dr-stewart-washer-presents-at-proactive-s-ceo-sessions-8368.html <![CDATA[Media files - Zelda Therapeutics closing in on development of autism clinical trial ]]> https://www.proactiveinvestors.com.au/companies/stocktube/8303/zelda-therapeutics-closing-in-on-development-of-autism-clinical-trial-8303.html Mon, 30 Oct 2017 09:41:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/8303/zelda-therapeutics-closing-in-on-development-of-autism-clinical-trial-8303.html <![CDATA[News - Zelda Therapeutics brings medical cannabis trials to Proactive's CEO Sessions ]]> https://www.proactiveinvestors.com.au/companies/news/186138/zelda-therapeutics-brings-medical-cannabis-trials-to-proactive-s-ceo-sessions-186138.html Zelda Therapeutics Ltd (ASX:ZLD) is developing a range of cannabinoid-based formulations to treat medical conditions, and recently sponsored an observation autism trial in Chile.

The trial demonstrated successful results for treating the core symptoms of autism with medicinal cannabis extracts that Zelda is planning on taking into clinical trials.

Results showed that in a cohort of 21 patients, cannabis extracts were significantly more effective than conventional medicines used, including atypical antipsychotics, and these extracts were well tolerated by the patients overall.

Find out more from Dr. Stewart Washer at Proactive's CEO Sessions.

Click below to register by email

- Melbourne: Tuesday 14th November.
- Sydney: Wednesday 15th November.
- Email Pauline here.
- Call office on (02) 9280 0700.

Presenter list

- Zelda Therapeutics (ASX:ZLD): Dr. Stewart Washer
- Thred Ltd (ASX:THD): Geoff Marshall
- De Grey Mining (ASX:DEG): Simon Lill
- Peninsula Energy (ASX:PEN): David Coyle
- Aspire Mining (ASX:AKM): David Paull

 

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Fri, 27 Oct 2017 08:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/186138/zelda-therapeutics-brings-medical-cannabis-trials-to-proactive-s-ceo-sessions-186138.html
<![CDATA[News - Zelda Therapeutics demonstrates successful results treating autism with medicinal cannabis ]]> https://www.proactiveinvestors.com.au/companies/news/184098/zelda-therapeutics-demonstrates-successful-results-treating-autism-with-medicinal-cannabis-184098.html Zelda Therapeutics Ltd (ASX:ZLD) has sponsored an observation autism trial in Chile, demonstrating successful results for treating the core symptoms of autism with medicinal cannabis extracts that Zelda is planning on taking into clinical trials.

The results demonstrated that in a cohort of 21 patients (median age of 9 years 10 months), cannabis extracts were significantly more effective than conventional medicines used, including atypical antipsychotics, and these extracts were well tolerated by the patients overall.

Harry Karelis, executive chairman for Zelda, commented:

"The results from this observational study are very exciting and supports the anecdotal evidence we have, showing the positive effect medicinal cannabis has on treating autism symptoms.

"Zelda will use this baseline data to design its clinical trials and generate rigorous scientific data that validates the clinical benefit of medicinal cannabis.

"We hope that in the near future Zelda Therapeutics can provide an alternative treatment for sufferers of this condition which is of major global significance."

Details of the study

Patients in the study were treated over at least a 12-week period and were examined by electroencephalogram (EEG), neuropsychological analysis as well as metabolism and genetic tests.

The patients in the study had not responded well to conventional treatments.

Patients treated with cannabis extracts demonstrated significant improvements in at least one core symptom including social interaction, language or repetitive behaviours in 71.4% of cases and 66.7% of treated patients showing significant general overall improvement. 

The trial was managed by leading clinician Dr Gisela Kuester who is a highly regarded neurologist specialising in the diagnosis and treatment of autism.

She also holds the position of Clinical Research Director at Fundación Daya.

Strategic alliance

Zelda has previously outlined its strategic alliance with Chilean non-profit patient advocate group Fundación Daya, to leverage their patient data on using cannabinoid-based therapy to treat autism patients.

The results from this observation trial will assist Zelda in the development of its autism clinical trial.

A submission for ethics approval is being finalized and is expected to be submitted in coming weeks.

Zelda expects the trial will commence within three months of regulatory approvals being obtained and will be conducted over a six to nine-month period.

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Mon, 18 Sep 2017 09:48:00 +1000 https://www.proactiveinvestors.com.au/companies/news/184098/zelda-therapeutics-demonstrates-successful-results-treating-autism-with-medicinal-cannabis-184098.html
<![CDATA[News - Zelda Therapeutics making strides in medical cannabis research ]]> https://www.proactiveinvestors.com.au/companies/news/183867/zelda-therapeutics-making-strides-in-medical-cannabis-research-183867.html Zelda Therapeutics Ltd (ASX:ZLD) is making significant progress with its medical cannabis research program in Chile.

The company has already established a focus on autism, eczema and insomnia.

Zelda has now engaged the services of an experienced team of clinicians and scientists to help manage its clinical trials.

Harry Karelis, executive chairman, commented:

"We welcome Dr Kuester, Dr Sasso and Ms Vergara to our research team and are delighted to have such a high calibre local team coordinating our activities in Chile.

"Zelda is steadily progressing towards commencement of its clinical trial program in Chile and I look forward to providing shareholders positive updates in due course."

Why Chile

Zelda has strategically focused on conducting its research activities in Chile due to the efficiency of its legal and regulatory framework, cost effectiveness and its market access into the large South American pharmaceutical market.

The Chilean government granted permission for the first cannabis crop to be planted for medicinal purposes in 2015, and has subsequently allowed the sale of medicinal cannabis in pharmacies.

This has given rise to researchers and organisations specialising in medicinal cannabis treatments.

Zelda has capitalised on this, forming strategic alliances with world-class researchers and physicians, and has access to valuable patient data which will assist in the development of robust clinical trials.

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Wed, 13 Sep 2017 08:58:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183867/zelda-therapeutics-making-strides-in-medical-cannabis-research-183867.html
<![CDATA[News - Zelda shareholders granted priority on float of CannPal Animal Therapeutics ]]> https://www.proactiveinvestors.com.au/companies/news/183056/zelda-shareholders-granted-priority-on-float-of-cannpal-animal-therapeutics-183056.html Zelda Therapeutics Ltd (ASX:ZLD) has a strategic collaborative partnership with CannPal Animal Therapeutics, which is in the process of listing on the ASX.

The companies are looking to exploit opportunities of mutual interest in both the human and animal pharmaceutical markets through the sharing of research data compiled by each of the parties.

CannPal is looking to strengthen the ties between the companies by inviting Zelda shareholders to participate as a priority applicant in the prospectus capital raising lodged with ASIC.

The prospectus is to raise $6 million.

Prospectus and offer details

Under the prospectus, 5 million shares at $0.20 have been allocated and made available to Zelda shareholders registered on the 1st September 2017 holding a minimum of 25,000 shares.

The minimum subscription in CannPal is 10,000 shares worth $2,000.

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Tue, 29 Aug 2017 11:23:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183056/zelda-shareholders-granted-priority-on-float-of-cannpal-animal-therapeutics-183056.html
<![CDATA[News - Zelda Therapeutics' Dr. Stewart Washer discusses medical cannabis achievements ]]> https://www.proactiveinvestors.com.au/companies/news/183050/zelda-therapeutics-dr-stewart-washer-discusses-medical-cannabis-achievements-183050.html Zelda Therapeutics Ltd (ASX: ZLD) has secured exclusive, global access to an extensive set of human data related to medicinal cannabis based formulations and treatment protocols.

This human data has been generated over several years by a California-based group (Aunt Zelda’s) that has a high profile within the U.S. which is also growing internationally.

The company has a deep knowledge of the scientific rationale for certain cannabis-based formulations and protocols to treat a variety of medical conditions.

Zelda has embarked on a program of human clinical trials.

WATCH NOW: Zelda half-year review by Stewart Washer, executive director

Zelda is scheduled to release its financial statements to the ASX on Wednesday 30 August 2017.

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Tue, 29 Aug 2017 09:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183050/zelda-therapeutics-dr-stewart-washer-discusses-medical-cannabis-achievements-183050.html
<![CDATA[News - Zelda Therapeutics expands breast cancer research ]]> https://www.proactiveinvestors.com.au/companies/news/181672/zelda-therapeutics-expands-breast-cancer-research-181672.html Zelda Therapeutics (ASX:ZLD) has expanded its research collaboration with Complutense University, based on positive initial research results from its breast cancer research program.

The program builds on positive results from its initial proof of concept study from 2016 and follow-on studies in 2017 on its pre-clinical research on cannabinoids as anti-cancer agents.

Results showed a number of key findings, but most importantly that there were anti-cancer effects observed across a range of different breast cancer cell lines using Zelda’s formulations.

Harry Karelis, chairman, commented: “We are delighted to be in a position to expand our research collaboration with Complutense University, who have already generated exciting results using Zelda formulations on breast cancers.

“Expanding our research to gain a deeper understanding of the impact of cannabinoids on tumour re-occurrence is a critical area of research to be able to develop effective anti-cancer therapies in future.”

Expansion of research program

The expansion and extension of Zelda’s current research program with Complutense University will investigate the effect of cannabinoids on cancer stem cell-like cells.

These cells are cancer cells found within tumours that are self-renewing, causing tumour re-growths.

Tumour reoccurrence is a common concern for women following treatment of breast cancer.

The majority of current anticancer therapies are primarily focused on trying to inhibit cancer cell growth, causing cancer cells to die, or a combination of both.

However, even if initial treatments appear successful, some tumours can reoccur at a later date.

The role that cannabinoids can play

Understanding how tumours re-occur and what controls the ability of cancer cells to spread throughout the body, is a crucial aspect of cancer research.

Furthermore, investigating the impacts that cannabinoids could have on cancer stem-cell like cells could provide much needed data in this area of research, and most importantly lead to new treatment regimes for highly resistant tumours.

How this fits into the bigger picture

With positive data already at hand and expansion into further research areas, Zelda continues to make progress on its preclinical activities, in-line with its strategic plan.

Zelda is focused on developing high-quality data packs and an intellectual property portfolio expected to be of great interest to the biopharmaceutical industry and potential future partnering deals.

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Mon, 31 Jul 2017 14:09:00 +1000 https://www.proactiveinvestors.com.au/companies/news/181672/zelda-therapeutics-expands-breast-cancer-research-181672.html
<![CDATA[News - Zelda Therapeutics enters manufacturing and distribution agreement ]]> https://www.proactiveinvestors.com.au/companies/news/179273/zelda-therapeutics-enters-manufacturing-and-distribution-agreement-179273.html Zelda Therapeutics (ASX:ZLD) has entered into a strategic manufacturing and distribution agreement with leading Chilean pharmaceutical manufacturing group, Knop Laboratorios SA.

The agreement locks in a high-quality supply of Zelda’s formulated medicinal-cannabis medicines initially, for its planned clinical trials, and subsequently a secure, scalable and GMP-grade source of commercial quantities following product registration.

Furthermore, Knop operates a chain of pharmacies throughout Chile and the agreement contemplates Knop becoming a key distribution channel in the future for Zelda.

Harry Karelis, chairman, commented: “We are delighted to be entering into this partnership with Knop who have an impressive history in Chile and extensive relationships with key regulators.

“They operate a world-class facility with a newly commissioned ethanol-extraction facility dedicated to producing high-quality cannabis-derived extracts.“


Knop Laboratories

Knop Laboratories are recognised as a signature trusted brand in Chile, dating back to the 1920s.

Knop’s related companies include a pharmacy chain which spans across Chile.

This organisational structure makes Knop an ideal partner for the manufacture of Zelda’s products, providing access to a large distribution network to fast track market penetration in South America.

Zelda has chosen to expand its research programme into Chile because the country’s legal framework recognises the importance of medical cannabis, allowing its production under strict regulatory controls for the treatment of medical conditions.

The country also provides a cost-effective location for Zelda to conduct clinical trials.


Background

Zelda is bio-pharmaceutical company focused on a series of clinical and pre-clinical programs utilising cannabinoid-based medicines.

Zelda has secured exclusive, global access to an extensive set of human data related to medicinal cannabis based formulations and treatment protocols.

This human data has been generated over several years by a California-based group that has a high profile within the U.S. and a growing international profile.

Zelda has embarked on a program of human clinical trials initially in sleep disorder (insomnia), autism and eczema indications.

In addition, Zelda is building a pre-clinical research portfolio targeting cancer.

 

Analysis

The partnership provides a solid platform to expand the company’s activities including its focus on rapid commercialisation.

It will allow Zelda to expedite the clinical trial process, with the certainty of product supply.

Furthermore, it will potentially allow the mass production of Zelda’s medicines for the treatment of eczema, insomnia and autism, providing a natural alternative to many patients who suffer from these conditions.

Knop sees the rapidly growing medicinal cannabis market as a key opportunity and the partnership as a pathway to global opportunities.

Knop believes that Australia and Chile are both well placed to secure leading positions in the global medicinal cannabis market and help fast-track high quality, affordable medicines to patients in need.

Zelda shares have more than doubled in 2017, currently priced at $0.083.

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Thu, 15 Jun 2017 10:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/179273/zelda-therapeutics-enters-manufacturing-and-distribution-agreement-179273.html
<![CDATA[News - Zelda Therapeutics builds upon breast cancer research ]]> https://www.proactiveinvestors.com.au/companies/news/178675/zelda-therapeutics-builds-upon-breast-cancer-research-178675.html Zelda Therapeutics (ASX:ZLD) has received positive results from its ongoing pre-clinical research into the effects of cannabinoids against various types of human breast cancers.

These latest results from a series of in-vitro studies confirms statistically significant anti-cancer effects across a range of different breast cancer cell lines using medicinal cannabis oils.

Studies are ongoing with further data expected in coming months from additional in-vitro and in-vivo studies that are currently underway.

Harry Karelis, chairman, commented: “We are very excited by the continued positive data being generated by our studies.

“We continue to develop our knowledge in this important clinical area and believe there is growing evidence to consider cannabinoids as part of the future treatment regimes for breast cancer particularly for Triple Negative tumours that currently have limited treatment options.”


Pre-clinical research details

These latest experiments follow on from initial results announced in November 2016 which showed:

- Specific formulations of THC-rich oil was significantly more potent at reducing HER2+ breast tumour growth than pure THC; and
- Was equally as potent as breast cancer drug Lapatanib in reducing tumour growth in mice hosting HER2+ human tumours.

The new results demonstrate the potential for cannabinoid-based therapies to be therapeutically beneficial in a broad spectrum of breast cancer types including hormone receptor positive, HER2+ and Triple Negative cancer types.

Significantly, the Zelda THC-rich formulation showed significantly greater anti-cancer effect than pure synthetic THC suggesting that full extracts have greater efficacy than pure compounds.

This effect was consistent across all cancer sub-types suggesting a novel mechanism of action that could form the basis for the development for future therapies.

These results were generated by world leading cannabis cancer researchers at Complutense University of Madrid, led by Professor Cristina Sánchez and Professor Manuel Guzmán.


Analysis

Triple Negative breast cancers, constitute circa 15% of breast cancers and are the most aggressive type.

With chemotherapy, radiation and surgery being the only options, there is significant market demand for new treatments to increase survival rates.

While there is a long way to go before this approach reaches formal human clinical trials, this data importantly supports the anecdotal experiences already seen in patients in California.

Furthermore, the results provide additional evidence that strongly points in favour of using whole-plant extracts over single cannabinoid molecules.

Zelda shares are trading up over 40% year to date, currently priced at $0.056.

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Fri, 02 Jun 2017 12:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/178675/zelda-therapeutics-builds-upon-breast-cancer-research-178675.html
<![CDATA[Media files - Zelda Therapeutics expands medical cannabis clinical trials ]]> https://www.proactiveinvestors.com.au/companies/stocktube/7411/zelda-therapeutics-expands-medical-cannabis-clinical-trials-7411.html Tue, 09 May 2017 08:00:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/7411/zelda-therapeutics-expands-medical-cannabis-clinical-trials-7411.html <![CDATA[News - Zelda Therapeutics expands medical cannabis clinical trial ]]> https://www.proactiveinvestors.com.au/companies/news/176563/zelda-therapeutics-expands-medical-cannabis-clinical-trial-176563.html Zelda Therapeutics (ASX:ZLD) has expanded its medical cannabis clinical trial program in Chile to include autism, which is expected to commence in the second half of 2017.

Autism is a lifelong development disability characterized by impairments in social communication and interactions.

The global market for autism diagnosis and treatments is expected to grow to US$412.7 million by 2019.

Zelda will work together with Chilean non-profit patient advocate group Fundación Daya, leveraging their clinical experiences with autism patients.

Harry Karelis, executive chairman, commented: “Our investment into conducting a rigorous and controlled clinical trial paves the way for product registrations next year significantly improving patient access to a novel form of treatment.

“Our intention would be to replicate this trial in other key jurisdictions to rapidly improve patient access in other jurisdictions.”


Chile’s advantage

The legal framework in Chile recognises the importance of medical cannabis, allowing its production under strict regulatory controls for the treatment of medical conditions.

The country also provides a cost-effective location for Zelda to conduct clinical trials.

Furthermore, Zelda through its relationship with AusCann Group Holdings (ASX:AC8) will leverage Auscann’s Chilean joint-venture DayaCann to supply high quality medical cannabis for the autism trial.

Fundación Daya has extensive experience over a number of years in using medical cannabis to treat patients diagnosed with autism.

This clinical experience demonstrates solid anecdotal evidence of positive quality of life outcomes using cannabinoid-based therapy.


Trial details

Subject to regulatory approvals being obtained, Zelda expects the trial will commence in the second half of 2017, with trial protocols already being developed.

Zelda expects the trial to be conducted over a period of 3-6 months.


Well-funded pathway to revenue

Zelda’s recent $6.0 million capital raising provides it with increased flexibility to pursue new opportunities and diversify such as this.

Successful results will allow Zelda to immediately commence the product registration process to sell clinically approved products in the Chilean market.

This provides a clear pathway to potential revenue generation from Chile and other South American markets as early as 2018.

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Wed, 19 Apr 2017 13:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/176563/zelda-therapeutics-expands-medical-cannabis-clinical-trial-176563.html
<![CDATA[News - Zelda Therapeutics completes successful share placement ]]> https://www.proactiveinvestors.com.au/companies/news/175640/zelda-therapeutics-completes-successful-share-placement-175640.html Zelda Therapeutics (ASX:ZLD) has successfully raised $6 million through the placement of 85.7 million shares to sophisticated and professional investors priced at $0.07.

The capital raising was significantly oversubscribed with strong support from new Australasian institutional investors.

Funds will be used to accelerate and expand research and clinical programs.

The placement will increase the company’s cash position to circa $8.3 million before costs.

This provides sufficient financial capacity for Zelda to execute its current research programs and pursue new opportunities to grow its clinical pipeline for the development of new medicinal cannabis therapies in Australia and Chile.

In-line with the company’s business strategy, Zelda is focused on delivering world-class research to clinically prove the benefits of medical cannabis for specific disease targets, with a clear commercialisation pathway to drive maximum shareholder value.

Zelda shares are trading up 145% year to date, currently priced at $0.096.

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Thu, 30 Mar 2017 11:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/175640/zelda-therapeutics-completes-successful-share-placement-175640.html
<![CDATA[News - Zelda Therapeutics to increase cash position ]]> https://www.proactiveinvestors.com.au/companies/news/175482/zelda-therapeutics-to-increase-cash-position-175482.html Zelda Therapeutics (ASX:ZLD) has been granted a trading halt by the ASX, pending details of a capital raising.

The halt will remain in place until the opening of trade on Thursday 30th March 2017, or earlier if an announcement is made to the market.

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Tue, 28 Mar 2017 10:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/175482/zelda-therapeutics-to-increase-cash-position-175482.html
<![CDATA[News - Zelda Therapeutics embraces opportunities in the animal health market ]]> https://www.proactiveinvestors.com.au/companies/news/175406/zelda-therapeutics-embraces-opportunities-in-the-animal-health-market-175406.html Zelda Therapeutics (ASX:ZLD) has been an ASX-outperformer in recent months, as the company continues to receive a positive re-rating on the back of milestones.

Zelda has today executed a binding term sheet with CannPal Pty Ltd to assist in the development of opportunities in the animal health market utilising cannabinoid-based treatments.

CannPal is an Australian company focused on developing cannabis based prescription and non-prescription medicines.

The company also is also targeting animal feed nutrition for the emerging global pet pharmaceutical market.


Importance of the deal

The term sheet allows Zelda to be granted the first rights for human applications over any data generated in CannPal’s veterinary trials.

This directly increases Zelda’s treatment pipeline.

Zelda will also be granted options over 10% of CannPal. CannPal is aiming to list on the ASX in the latter part of 2017.

Harry Karelis, executive chairman for Zelda, commented that the CannPal partnership outsources Zelda’s animal studies, while retaining the company's focus on human studies for a zero cost.

"It also provides Zelda with exposure to pet pharmaceuticals, a whole new market segment which is growing at rapid pace."


Analysis

Zelda's strategic purpose is moving towards the production of cannabis based therapies for humans.

This new agreement provides further opportunity to potentially expand the company's current research focus areas while opening doors to capitalise on the pet pharmaceutical market.

Investors have embraced Zelda's strategy and ability to continually deliver on milestones.

Zelda is trading 13.3% higher in morning trade at $0.094 per share.

In late 2016 when the company completed re-compliance and listed back on the ASX, shares in the raising could have been snapped up for just $0.025 per share.

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Mon, 27 Mar 2017 11:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/175406/zelda-therapeutics-embraces-opportunities-in-the-animal-health-market-175406.html
<![CDATA[News - Zelda Therapeutics plans medical cannabis trials in Chile this year ]]> https://www.proactiveinvestors.com.au/companies/news/175253/zelda-therapeutics-plans-medical-cannabis-trials-in-chile-this-year-175253.html Zelda Therapeutics (ASX:ZLD) has expanded its clinical trial program to include two new trials to begin in the second half of CY2017 in Chile.

The trials will target insomnia and eczema, two significantly sized markets with combined global value of circa $8 billion in 2016.

Zelda intends to register products for sale in Chile should trials be successful providing a pathway to maiden revenues.

Harry Karelis, chairman, commented: “The sleep and dermatitis markets represent significant opportunities for Zelda Therapeutics.

“The proposed clinical trials in Chile will complement our other trial and pre-clinical research activities.”


Advantages of Chile

Chile provides a cost-effective location for Zelda to conduct clinical trials.

Chile has made significant progress in its legal framework to recognize the importance of medical cannabis research, allowing the production of medical cannabis under strict regulatory controls for the treatment of medical conditions, since 2014.

Zelda has identified key clinicians and sites within Chile where the trials will take place, with clinical trial protocols being finalised for submission to the relevant human ethics committees for approval.


Relationship with AusCann Group Holdings (ASX:AC8)

To streamline the Chilean clinical trials and facilitate the research program, Zelda will leverage its relationship with AusCann through its Chilean joint-venture DayaCann and will also work together with Chilean non-profit patient advocate group Fundacion Daya.

DayaCann is the only licensed producer of medicinal cannabis in Chile and is expected to harvest its first crop in the second quarter of CY2017.


Analysis

These trials provide a valuable opportunity and potential pathway to revenue for Zelda.

The company expects to conclude the trials by the end of CY2017 with data available shortly thereafter.

The product registration process will then commence allowing Zelda to sell clinically approved products as soon as positive trial data is in hand.

This provides a pathway to potential revenue generation as early as 2018.

Zelda shares have continued their strong run in 2017 trading up over 100% year to date to $0.082.

This also means that the medical cannabis company’s share price has more than tripled since listing via reverse takeover on the Australian Stock Exchange in November, 2016 at $0.025.

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Thu, 23 Mar 2017 11:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/175253/zelda-therapeutics-plans-medical-cannabis-trials-in-chile-this-year-175253.html
<![CDATA[News - Zelda Therapeutics expands pipeline of opportunities ]]> https://www.proactiveinvestors.com.au/companies/news/175112/zelda-therapeutics-expands-pipeline-of-opportunities-175112.html Zelda Therapeutics (ASX:ZLD) continues to leverage world-class knowledge and expertise in the medical cannabis sector.

A new license agreement with Caziwell Inc increases flexibility to expand the clinical trial program.

The agreement provides significant immediate and long-term financial benefits for Zelda and replaces the existing agreement.

Harry Karelis, executive chairman for Zelda, commented:

“The restructuring of the Caziwell Licence Agreement provides a meaningful positive impact to Zelda shareholders by reducing future financial obligations it would have incurred through executing its clinical trials strategy.

"With these amendments in place, Zelda moves closer to industry standards for agreements of this nature.

"We have a full pipeline of opportunities ahead of us and reducing future expenses helps extend our financial capacity to progress these projects.

"We have a very exciting year ahead."


New license agreement benefits

- Zelda maintains exclusive access to patient data, formulations and protocols for use in its current research activities;
- Positive impact on cashflow, with an immediate $200,000 saving;
- Permanent reduction in future royalty and sub-licence fees; and
- Significantly increases flexibility to expand clinical trial program.


Trials

Zelda has embarked on a program of human clinical trials initially in sleep disorder (insomnia) and eczema indications.

In addition, Zelda is building a pre-clinical research portfolio targeting cancer.


World-leading Scientific Advisory Board

Prof. Manuel Guzman: Full Professor of Biochemistry and Molecular Biology at Madrid’s Complutense University and expert on the molecular mechanisms of action and role of cannabinoids in controlling cell generation and death.

Dr Cristina Sanchez: Assistant Professor at Complutense University, Madrid Spain. Specialist in the area of lipid signaling, including cannabinoids in an oncology setting.

Dr Joe Goldstrich: Distinguished clinical career in preventive cardiology and nutrition spanning over 40 years. He has evaluated over 3,500 patients in the US using cannabis as a fundamental medicine in the management of a variety of medical conditions.

Dr Noah Federman: Highly respected paediatric clinical and research oncologist. Currently, Director of the Paediatric Bone and Soft Tissue Sarcoma Program at University of California, part of the prestigious UCLA Sarcoma Program and UCLA's Jonsson Comprehensive Cancer Centre.


Analysis

Zelda continues to expand its relationships and agreements in the sector.

The company has a strong background in medical cannabis, and was formed to fund clinical efficacy trials developed by its U.S. partner, Aunt Zelda, and used to treat a range of diseases showing strong efficacy data.

Investors are recognising the potential since the listing (via RTO) in November 2016, where shares could be purchased at $0.025 in the $4 million raising.

Since then Zelda has more than tripled in value, last trading at $0.085 per share.

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Tue, 21 Mar 2017 14:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/175112/zelda-therapeutics-expands-pipeline-of-opportunities-175112.html
<![CDATA[News - Zelda Therapeutics trade higher on medical cannabis focus ]]> https://www.proactiveinvestors.com.au/companies/news/175021/zelda-therapeutics-trade-higher-on-medical-cannabis-focus-175021.html Zelda Therapeutics (ASX:ZLD) shares have continued their strong run in 2017 trading up over 85% year to date to $0.074.

This also means that the medical cannabis company’s share price has nearly tripled since listing on the Australian Stock Exchange in November, 2016 at $0.025.

Zelda is an Australian-based bio-pharmaceutical company that has secured exclusive, global access to an extensive set of human data related to medicinal cannabis.

This human data has been generated over several years by a California-based group that has a high profile within the U.S. and a growing international profile.

Zelda has embarked on a program of human clinical trials initially in sleep disorder (insomnia) and eczema indications.

In addition, Zelda is building a pre-clinical research portfolio targeting cancer.

The company expects to be commencing these trials during 2017 and have identified a relatively rapid path to commercialisation.

If successful, this could see Zelda obtaining product registrations in selected markets in 2018 with revenues flowing from there.

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Mon, 20 Mar 2017 11:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/175021/zelda-therapeutics-trade-higher-on-medical-cannabis-focus-175021.html
<![CDATA[News - Zelda Therapeutics to offer share sale facility ]]> https://www.proactiveinvestors.com.au/companies/news/171912/zelda-therapeutics-to-offer-share-sale-facility-171912.html The facility is open to any holder with 15,151 shares of less, at a fixed price of $0.033 per share.

This represents 1,936,134 shares held by 891 shareholders.


Medicinal cannabis

Zelda has a focus on medicinal cannabis biotechnology, and all of the company's research and clinical programs are fully funded and benefit from the Australian Government R&D tax rebate program.

This provides non-dilutive funding for the company.


Analysis

Zelda has identified several indications (medical disease areas) where it can fast-track formulations into human clinical trials – notably sleep disorders such as insomnia and dermatology indications such as eczema.

The company expects to be commencing these trials during 2017 and have identified a relatively rapid path to commercialisation.

If successful, this could see Zelda obtaining product registrations in selected markets in 2018 with revenues flowing from there.

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Fri, 20 Jan 2017 09:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/171912/zelda-therapeutics-to-offer-share-sale-facility-171912.html
<![CDATA[News - Zelda Therapeutics shares gain 60% since listing on medicinal cannabis focus ]]> https://www.proactiveinvestors.com.au/companies/news/171287/zelda-therapeutics-shares-gain-60-since-listing-on-medicinal-cannabis-focus-171287.html The company has a solid pipeline of news and achievements pending for 2017.

Zelda is implementing a two-pronged strategy to develop Zelda into a leading medicinal cannabis biotechnology company.

This approach provides a pathway to revenues in the short term through fast-tracked clinical trials, whilst generating potential value in the background through its cancer research activities.


Research and clinical programs

Importantly, all of the company's research and clinical programs are fully funded and benefit from the Australian Government R&D tax rebate program providing non-dilutive funding for the company.


Analysis

Zelda has identified several indications (medical disease areas) where it can fast-track formulations into human clinical trials – notably sleep disorders such as insomnia and dermatology indications such as eczema.

The company expects to be commencing these trials during 2017 and have identified a relatively rapid path to commercialisation.

If successful, this could see Zelda obtaining product registrations in selected markets in 2018 with revenues flowing from there.

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Mon, 09 Jan 2017 09:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/171287/zelda-therapeutics-shares-gain-60-since-listing-on-medicinal-cannabis-focus-171287.html
<![CDATA[News - Zelda Therapeutics teams with Curtin University ]]> https://www.proactiveinvestors.com.au/companies/news/170710/zelda-therapeutics-teams-with-curtin-university-170710.html Research is expected to commence in early 2017.

The collaboration will test a range of Zelda’s formulations and protocols against Curtin’s suite of in vitro pancreatic cancer models.

This is where the cannabis formulations will be tested against human pancreatic cell cancer lines grown in the laboratory.

Harry Karelis, executive chairman for Zelda, commented: "The pancreatic cancer market is an important market for many reasons.

"Not only is it one of the most common cancers but the survival rates are astoundingly low and we at Zelda are hopeful of demonstrating anti-cancer activity in this area.

"This collaboration builds on the existing partnership with Professor Manuel Guzmán and Professor Cristina Sánchez at Complutense University, who are both considered the leaders in the field of anti-cancer effects of cannabinoids.

"Positive results from this work will lay the foundation for progression into further anti-cancer studies and is expected to generate new intellectual property for the company."

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Tue, 20 Dec 2016 11:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/170710/zelda-therapeutics-teams-with-curtin-university-170710.html
<![CDATA[News - Zelda Therapeutics outlines strategy as shares continue to climb ]]> https://www.proactiveinvestors.com.au/companies/news/170299/zelda-therapeutics-outlines-strategy-as-shares-continue-to-climb-170299.html Zelda Therapeutics (ASX:ZLD) continues to garner strong investor support, following its recent transition into the medical cannabis, following a reverse takeover.

As part of the re-listing, Zelda raised $4 million at $0.025.

Zelda has been re-rated in recent weeks as the company continues to deliver on milestones.

Today the stock is trading 5.3% higher at $0.04 after outlining its strategy to target the significant sleep disorder market.

The company has identified trial sites in multiple target locations, including the U.S. and Australia.

Zelda is also progressing discussions with potential partner Clinical Research Organisations (CROs) in local markets and submissions for the necessary approvals from the relevant ethics committees in each location are now in progress.

The company anticipates receiving approvals early next year with the trials able to commence shortly thereafter in 2017.


Market opportunity

Harry Karelis, executive chairman, commented: "The sleep disorder market represents a significant opportunity for medical cannabis treatments.

"We believe that consumers are looking for safe, effective, affordable alternatives to current prescription medication.

"Our exclusive access to Aunt Zelda’s patient data has provided us with the ability to trial a formula that already has existing evidence and data to demonstrate its
efficacy in this particular disorder.

"The purpose of these trials is to establish robust, clinical evidence and to create a comprehensive data pack that can be used to progress later stage trials and/or seek product registrations in certain markets and generate product sales in the
medium term."


Market size

Insomnia is estimated to impact approximately 35% of the global population and is considered to be a prime factor for chronic disability in the workforce.

The global sleep aids market was valued at US$58.1 billion in 2014 and is expected to expand to reach US$80.8 billion by 2020, according to the research firm Persistence Market Research.

Sleep aids are drugs and medical devices that help a person to fall asleep.


The making of Zelda

Zelda was spun out of a successful US-based medicinal cannabis group - Aunt Zelda’s - that has treated hundreds of patients in California.

The company has exclusive, global access to an extensive set of human data related to medicinal cannabis-based formulations and treatment protocols.

This human data has been generated over several years by the Aunt Zelda’s group.

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Mon, 12 Dec 2016 14:10:00 +1100 https://www.proactiveinvestors.com.au/companies/news/170299/zelda-therapeutics-outlines-strategy-as-shares-continue-to-climb-170299.html
<![CDATA[News - Zelda Therapeutics to work with a leading medical research institute ]]> https://www.proactiveinvestors.com.au/companies/news/169926/zelda-therapeutics-to-work-with-a-leading-medical-research-institute-169926.html Zelda Therapeutics (ASX:ZLD) has entered into a collaboration agreement with the highly regarded, Perth-based Telethon Kids Institute.

This collaboration will initially focus on pre-clinical testing of Zelda’s compounds, formulations and protocols in the area of children’s brain cancer.

Zelda was spun out of a successful U.S. based medicinal cannabis group - Aunt Zelda’s - that has treated hundreds of patients in California.

The company has exclusive, global access to an extensive set of human data related to medicinal cannabis-based formulations and treatment protocols.

This human data has been generated over several years by the Aunt Zelda’s group.


Collaboration

The collaboration with the Telethon Kids Institute will be confined to pre-clinical research accessing the Institute’s validated cell and animal models for the studies.

Through the research, the Institute will examine the potential for Zelda’s compounds to act as anti-cancer agents, either alone or in combination with existing treatments.

The initial studies are due to commence in early 2017 with results expected later in the year.

Harry Karelis, chairman, commented:

"Zelda was established to conduct a series of pre-clinical and clinical activities to determine whether positive anecdotal experiences observed in patients in California can be reproduced in a controlled laboratory and clinical setting.

"We are excited to be partnering with the Telethon Kids Institute in the important area of childhood cancer.

"Positive results from these studies have the potential to lay the foundations for improved treatment outcomes and quality of life for cancer patients."

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Mon, 05 Dec 2016 10:40:00 +1100 https://www.proactiveinvestors.com.au/companies/news/169926/zelda-therapeutics-to-work-with-a-leading-medical-research-institute-169926.html