Proactiveinvestors USA & Canada Zelda Therapeutics Ltd https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Zelda Therapeutics Ltd RSS feed en Tue, 23 Apr 2019 15:05:55 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - Ilera Healthcare deal is 'one piece of the puzzle' for Zelda Therapeutics in 'globalising product' ]]> https://www.proactiveinvestors.com/companies/stocktube/12562/ilera-healthcare-deal-is--one-piece-of-the-puzzle--for-zelda-therapeutics-in--globalising-product--12562.html Tue, 12 Mar 2019 15:03:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12562/ilera-healthcare-deal-is--one-piece-of-the-puzzle--for-zelda-therapeutics-in--globalising-product--12562.html <![CDATA[News - Zelda Therapeutics in deal with Ilera to access US market ]]> https://www.proactiveinvestors.com/companies/news/216230/zelda-therapeutics-in-deal-with-ilera-to-access-us-market-216230.html Zelda Therapeutics Ltd (ASX:ZLD) has entered into a binding heads of agreement (HoA) with US-based medicinal cannabis company Ilera Healthcare, LLC to explore collaborative opportunities.

The broad range of commercialisation opportunities includes licensing of Zelda products, co-dev elopement and data sharing.

No upfront payments will be received initially however the terms provide for both parties to negotiate separate additional commercial agreements.

READ: Zelda Therapeutics secures patent to detect breast cancer

Zelda’s managing director Dr Richard Hopkins said: “We’re delighted to formalise our partnership with Ilera, which is designed to leverage the strong synergies between our companies.

“As a vertically integrated company, Ilera’s strengths in cultivation, extraction/formulation and distribution are complemented by Zelda’s expertise in clinical validation, product differentiation and downstream value-adding.

“Given the current barriers to undertaking clinical trials using medicinal cannabis at the Federal level in the US, Zelda can help fast-track clinical validation of Ilera products while Zelda potentially gains access to a significant North American market for its products.”

Partnerships now provide access to 110,000 patients globally

This partnership reinforces the global breadth of Zelda’s relationships and shows our focus on commercialising our clinically validated formulations.

“When considered alongside our recent manufacturing and distribution agreement with HAPA in Germany, our partnerships provide access to over 110,000 registered medicinal cannabis patients globally which is approximately 30 times larger than the current Australian market.”

Deal unlocks value for both parties

Ilera noted that entering the partnership with Zelda was part of its strategy to extend the reach of its research and product development around the world.

Ilera’s installed capacity to formulate specific medicines, its commercialisation expertise combined with its executive teams’ global experience creates a unique opportunity for this partnership to deliver condition-specific cannabinoid-based medicines to the global stage.

READ: Zelda Therapeutics reflects on busy December half

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Tue, 12 Mar 2019 09:38:00 -0400 https://www.proactiveinvestors.com/companies/news/216230/zelda-therapeutics-in-deal-with-ilera-to-access-us-market-216230.html
<![CDATA[News - Zelda Therapeutics secures patent to detect breast cancer ]]> https://www.proactiveinvestors.com/companies/news/215875/zelda-therapeutics-secures-patent-to-detect-breast-cancer-215875.html Zelda Therapeutics Ltd (ASX:ZLD) has been granted a new patent in Australia covering a novel method to predict patient disease-free survival.

The patent details a method for detecting levels of expression of a novel receptor complex containing HER2 and CB2 (types of protein).

HER2 is a well-recognised marker of aggressive breast cancer while CB2 is a key receptor in the endocannabinoid system.

Together they form a novel receptor complex that represents a prognostic marker for HER2 positive breast cancer.

READ: Zelda Therapeutics leveraged to study results that progress cannabis-based cancer therapies

Zelda’s managing director Dr Richard Hopkins said: “We’re delighted with the allowance of this patent, which supports Zelda’s strategy of building a world-class intellectual property portfolio and the development of cannabis-based products.

“Further news is expected as this patent family progresses through the international examination phase.

“I’d also like to acknowledge the work of Professor Cristina Sanchez and her team who generated the data that supported this patent.

“This work was recently published in the prestigious peer-reviewed Proceedings of the National Academy of Sciences.

“This outcome highlights the benefit of Zelda’s approach of partnering with world-leading cannabis researchers.

“Importantly, Professor Sanchez’s discovery of a novel prognostic biomarker, will complement our ongoing efforts develop to cannabis-based medicines to treat breast cancer.”

A vertically integrated medical cannabis strategy

The company’s focus remains on the development of novel cannabinoid-based therapies for a range of diseases.

Zelda is undertaking a human clinical trial program focused on insomnia, autism and opioid reduction with activities in Australia and the US.

Pre-clinical research activities include programs 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, 06 Mar 2019 12:20:00 -0500 https://www.proactiveinvestors.com/companies/news/215875/zelda-therapeutics-secures-patent-to-detect-breast-cancer-215875.html
<![CDATA[News - Zelda Therapeutics links up with International Cannabis and Cannabinoids Institute ]]> https://www.proactiveinvestors.com/companies/news/214396/zelda-therapeutics-links-up-with-international-cannabis-and-cannabinoids-institute-214396.html Zelda Therapeutics Ltd (ASX:ZLD) has engaged the International Cannabis and Cannabinoids Institute (ICCI) to support its clinical trial programs in autism, opioid reduction and insomnia. 

This provides Zelda with an opportunity to collaborate with a panel of leading international medicinal cannabis experts.

The ICCI is an international centre of excellence for the advancement of cannabis and cannabinoid treatments.

The ICCI provides access to a global network of specialist services including expert advice on clinical study design and execution, requirements for regulatory approval, a full range of contract research services and direct liaison with study investigators.

READ: Zelda Therapeutics on track to report on multiple clinical trials

Zelda’s managing director Dr Richard Hopkins said: “We’re honoured to be working with the ICCI and Dr Ethan Russo, who are recognised globally as leading authorities on medicinal cannabis. Their insights will help inform and accelerate our clinical trial programs.

“Dr Russo and the ICCI will complement our existing medical advisory team and maintains Zelda’s strategy of engaging the world’s best medicinal cannabis researchers and clinicians.”

Dr Ethan Russo was recently appointed the Director of Research and Development at the ICCI.

He is a US-trained board-certified paediatric and adult neurologist, psychopharmacology researcher, former Senior Medical Advisor to GW Pharmaceuticals, and Medical Director of PHYTECS.

Dr Russo said: “I’m delighted to be collaborating with Zelda who is at the forefront of efforts to develop plant-derived cannabis medicines that have the potential to improve quality of life for patients.”

Progressing clinical and pre-clinical activities in 2019

Zelda remains on-track to report on the outcome from its clinical trials for insomnia, autism and opioid reduction by mid-2019.

The company is also continuing to assess opportunities to expand its clinical programs where they align with its strategic objectives.

Finally, Zelda is progressing discussions with third parties aiming at securing agreements to distribute clinically-validated Zelda products globally.

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Tue, 12 Feb 2019 10:55:00 -0500 https://www.proactiveinvestors.com/companies/news/214396/zelda-therapeutics-links-up-with-international-cannabis-and-cannabinoids-institute-214396.html
<![CDATA[News - Zelda Therapeutics on track to report on multiple clinical trials ]]> https://www.proactiveinvestors.com/companies/news/213657/zelda-therapeutics-on-track-to-report-on-multiple-clinical-trials-213657.html Zelda Therapeutics Ltd (ASX:ZLD) continues to progress its core clinical and pre-clinical activities focused on medicinal cannabis.

Importantly, it has also established the foundations to commercialise its medicinal cannabis products in the event the clinical programs are successful.

Zelda remains on-track to report on the outcome from its clinical trials for insomnia, autism and opioid reduction by mid-2019.

The company is also continuing to assess opportunities to expand its clinical programs where they align with its strategic objectives.

Finally, Zelda is progressing discussions with third parties aiming at securing agreements to distribute clinically-validated Zelda products globally.

READ: Zelda Therapeutics investing in medicinal cannabis oral spray

Zelda closed the December quarter with a cash position of $4.41 million and is forecasting expenditure of $1.4 million (including $980,000 on R&D) in the current March quarter.

The increase in R&D expenditure reflects an expansion to the company’s clinical trial activities and additional costs associated with management of its growing intellectual property portfolio.

Harry Karelis steps back from executive role, remains chairman

Zelda’s chairman Harry Karelis said: “This move marks a key step in Zelda’s strategic plan to position the company for success as it enters into the clinical trial and commercialisation phases of its development.

“With the recent appointment of Dr Richard Hopkins as managing director, along with key additions to our Medical Advisory Board and operational team, the time is right for me to step-back from the executive role, as we intended.

“In my ongoing role as chair, I will continue to work with my colleagues on the Zelda Board and the executive team to ensure we deliver on our key milestones.

“With a number of clinical trials underway and our path to commercialisation well advanced, this promises to be a transformational year for the company.”

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Thu, 31 Jan 2019 10:55:00 -0500 https://www.proactiveinvestors.com/companies/news/213657/zelda-therapeutics-on-track-to-report-on-multiple-clinical-trials-213657.html
<![CDATA[News - Zelda Therapeutics investing in medicinal cannabis oral spray ]]> https://www.proactiveinvestors.com/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 -0500 https://www.proactiveinvestors.com/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/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 -0500 https://www.proactiveinvestors.com/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/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 -0500 https://www.proactiveinvestors.com/companies/news/209866/zelda-therapeutics-partners-with-st-vincents-hospital-for-opioid-reduction-study-209866.html
<![CDATA[News - Zelda Therapeutics to focus on US and Australia clinical trials ]]> https://www.proactiveinvestors.com/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 -0400 https://www.proactiveinvestors.com/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/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 -0400 https://www.proactiveinvestors.com/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/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 -0400 https://www.proactiveinvestors.com/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/companies/stocktube/10409/zelda-enters-rapidly-growing-german-market-with-product-commercialisation-strategy-10409.html Sun, 09 Sep 2018 20:46:00 -0400 https://www.proactiveinvestors.com/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/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 -0400 https://www.proactiveinvestors.com/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/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 -0400 https://www.proactiveinvestors.com/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/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 -0400 https://www.proactiveinvestors.com/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/companies/stocktube/9606/zelda-therapeutics-ready-to-test-entourage-effect-hypothesis-in-cancer-research-9606.html Mon, 18 Jun 2018 17:23:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/9606/zelda-therapeutics-ready-to-test-entourage-effect-hypothesis-in-cancer-research-9606.html <![CDATA[Media files - Zelda Therapeutics "ahead of the pack" in gaining first-mover advantages ]]> https://www.proactiveinvestors.com/companies/stocktube/9208/zelda-therapeutics-ahead-of-the-pack-in-gaining-first-mover-advantages-9208.html Fri, 04 May 2018 18:11:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/9208/zelda-therapeutics-ahead-of-the-pack-in-gaining-first-mover-advantages-9208.html <![CDATA[News - Gleneagle / Zelda Therapeutics Ltd outlines medical cannabis strategy with investors ]]> https://www.proactiveinvestors.com/companies/news/165195/gleneagle-zelda-therapeutics-ltd-outlines-medical-cannabis-strategy-with-investors-70266.html Gleneagle Gold Ltd (ASX:GLN) shareholders recently approved the acquisition of Zelda Therapeutics Pty Ltd, a biotechnology company focused on medical cannabis therapies.

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

This week Dr. Stewart Washer, executive director, joined the Proactive Spotlight CEO Investor Session in Sydney, outlining the company strategy to investors.

ACCESS THE FULL PRESENTATION HERE

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Fri, 05 Aug 2016 15:00:00 -0400 https://www.proactiveinvestors.com/companies/news/165195/gleneagle-zelda-therapeutics-ltd-outlines-medical-cannabis-strategy-with-investors-70266.html
<![CDATA[News - Gleneagle Gold Ltd brings medical cannabis to Proactive's CEO Spotlight Session ]]> https://www.proactiveinvestors.com/companies/news/136472/gleneagle-gold-ltd-brings-medical-cannabis-to-proactives-ceo-spotlight-session-69865.html Gleneagle Gold Ltd (ASX:GLN) is in the final stages of its transition into the medical cannabis sector through the reverse takeover of Zelda Therapeutics.

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

Zelda 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.

Aunt Zelda’s has a very high profile within the USA and a growing international profile based upon its deep knowledge of the scientific rationale for certain cannabis-based formulations and protocols to treat a variety of medical conditions.

Zelda has been granted a worldwide, exclusive and perpetual licence to this data, related systems, formulations and treatment protocols by the Aunt Zelda’s group.

Zelda will use this information to design a series of Phase 2-ready human clinical trials which the company is confident will be successful given the existing patient experiences and treatment outcomes.

 

Find out more from Dr. Stewart Washer, executive director, at Proactive's Spotlight CEO Sessions in Sydney in August 2016.

REGISTER HERE, CLICK ON LINK: Sydney Investor Sessions, Wednesday, 3rd August

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 19 Jul 2016 09:00:00 -0400 https://www.proactiveinvestors.com/companies/news/136472/gleneagle-gold-ltd-brings-medical-cannabis-to-proactives-ceo-spotlight-session-69865.html
<![CDATA[News - Gleneagle Gold Ltd receives notice of initial substantial holder ]]> https://www.proactiveinvestors.com/companies/news/136471/gleneagle-gold-ltd-receives-notice-of-initial-substantial-holder-69713.html Gleneagle Gold Ltd (ASX:GLN) continues to advance towards re-listing on the ASX as a medical cannabis company.

The company has now received a notice of initial substantial holder from Gemelli Nominees Pty Ltd, which holds 33.3 million shares, or around 5.5%.

Gleneagle is in the final steps of the reverse takeover of Zelda Therapeutics, a California-based biotechnology company.

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

The company will host its general meeting on the 25th July 2016 in Perth, where shareholders will vote on the significant change to the nature and scale of its activities.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 11 Jul 2016 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/136471/gleneagle-gold-ltd-receives-notice-of-initial-substantial-holder-69713.html
<![CDATA[News - Gleneagle Gold Ltd to consolidate shares ahead of medical cannabis transition ]]> https://www.proactiveinvestors.com/companies/news/136470/gleneagle-gold-ltd-to-consolidate-shares-ahead-of-medical-cannabis-transition-69502.html Gleneagle Gold Ltd (ASX:GLN) continues to advance towards re-listing on the ASX as a medical cannabis company.

The company is now undertaking a consolidation of 5 shares into 1, which will reduce the total number of shares on issue to 120.6 million.

The company will host its general meeting on the 25th July 2016 in Perth, where shareholders will vote on the significant change to the nature and scale of its activities.

Gleneagle is in the final steps of the reverse takeover of Zelda Therapeutics, a California-based biotechnology company.

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

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

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 29 Jun 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/136470/gleneagle-gold-ltd-to-consolidate-shares-ahead-of-medical-cannabis-transition-69502.html
<![CDATA[News - Gleneagle Gold Ltd outlines final timeline to medicinal cannabis transition ]]> https://www.proactiveinvestors.com/companies/news/136469/gleneagle-gold-ltd-outlines-final-timeline-to-medicinal-cannabis-transition-69353.html Gleneagle Gold Ltd (ASX:GLN) is well-advanced in its transition into the medical cannabis sector, as it progresses the  reverse takeover of Zelda Therapeutics, a California-based biotechnology company.

The company will host its general meeting on the 25th July 2016 in Perth, where shareholders will vote on the significant change to the nature and scale of its activities.

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

Zelda 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.

Aunt Zelda’s has a very high profile within the U.S. and a growing international profile based upon its deep knowledge of the scientific rationale for certain cannabis-based formulations and protocols to treat a variety of medical conditions.

Zelda has been granted a worldwide, exclusive and perpetual licence to this data, related systems, formulations and treatment protocols by the Aunt Zelda’s group.

Zelda will use this information to design a series of Phase 2-ready human clinical trials that have a high probability of success given the existing patient experiences and treatment outcomes


Next steps post acquisition

- Expand the management team;
- Continue pre-clinical research and development activities in Spain and eventually Australia; and
- Plan and fund the commencement of human clinical trials in Canada and eventually Australia.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 22 Jun 2016 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/136469/gleneagle-gold-ltd-outlines-final-timeline-to-medicinal-cannabis-transition-69353.html
<![CDATA[News - Gleneagle Gold Ltd completes Pre-IPO Capital Raise ]]> https://www.proactiveinvestors.com/companies/news/136468/gleneagle-gold-ltd-completes-pre-ipo-capital-raise-68919.html Gleneagle Gold Ltd (ASX:GLN) is well-advanced in its transition into the medical cannabis sector, as it progresses the  reverse takeover of Zelda Therapeutics, a California-based biotechnology company.

Zelda has secured exclusive, global access to an extensive set of human data related to medicinal cannabis.

Zelda has now raised AU$1.05 million via the issue of convertible notes, ahead of its proposed acquisition by Gleneagle and listing on the Australian Securities Exchange.

These funds were raised from certain professional and sophisticated investors, including cornerstone investor, the Merchant Opportunities Fund.

Harry Karelis, chairman for Zelda, commented:

“We are delighted that Zelda has received such strong support from key investor, Merchant Group highlighting the significant opportunity to be a leader in this fast moving and emerging sector.

"Our focus is clearly on designing and conducting world-class trials to generate the clinical data demanded by regulators.

"Our activities should help to breakdown the barriers to providing increasing access to patients in need.”


Note details

Under the terms of the issue, the convertible notes automatically convert into ordinary shares at a 20% discount to the prospectus capital raising price as part of the recompliance listing process.

The notes form part of a broader equity raising that will fund the company’s planned clinical trial program and research initiatives, including key clinical trials in sleep disorders (insomnia) and certain dermatology indications (acne).

Funding will also be for pre-clinical research in certain cancer indications with leading global groups including Complutense University Madrid.


Growth strategy

Zelda's growth strategy will be focused on developing existing products.

This means completing phase 2 clinical trials in dermatology indications and insomnia. It also means completing Spanish pre‐clinical research in cancer.

Zelda will then out‐license products with successful phase 2 results.

The secondary growth strategy will be expanding trials into new diseases and territories, which may come through partnerships.

A broad range of medical indications have been shown to be alleviated by medical cannabis

Zelda will also be looking at opportunities to merge and/or acquire as well as in-license new extracts for clinical testing and validation.


Strategic partnerships

Zelda has secured a number of partnerships with leaders in cannabis medicine.

It has an exclusive patient data access agreement in place with Aunt Zelda’s, a pioneering, data‐driven developer of cannabis‐based medicines.

A manufacturing agreement is in place with AusCann, an Australian company working with one of the largest medical cannabis groups in the world to supply clinical trial material.

Zelda has a partnership with New Frontier, the leading cannabis data company based in the U.S. for data sharing.

Zelda also has exclusive access to CDRMed for clinical trial use, which is software which creates optimal formulations of medicinal cannabis based on the Aunt Zelda’s database.

Finally, a partnership is also in place with the prestigious Complutense University Madrid for pre‐clinical research in cancer.


Analysis

The application of medical cannabis in modern medicine is still growing and represents a diverse global opportunity.

Partnerships with New Frontier, CDRMed and Aunt Zelda could provide for the acceleration to phase 2 efficacy clinical trials.

Today's news shows strong investment support into the sector.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 30 May 2016 13:30:00 -0400 https://www.proactiveinvestors.com/companies/news/136468/gleneagle-gold-ltd-completes-pre-ipo-capital-raise-68919.html
<![CDATA[News - Gleneagle Gold Ltd is well-advanced in transition to medical cannabis ]]> https://www.proactiveinvestors.com/companies/news/136467/gleneagle-gold-ltd-is-well-advanced-in-transition-to-medical-cannabis-68468.html Gleneagle Gold Ltd (ASX:GLN) is well-advanced in its transition into the medical cannabis sector, as it progresses the  reverse takeover of Zelda Therapeutics, a California-based biotechnology company.

Gleneagle has issued 1.6 billion shares to acquire Zelda.

Gleneagle now plans to issue a prospectus and change its name to Zelda Therapeutics Limited.

Zelda 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, Caziwell Inc., which operates the Aunt Zelda’s group.

Zelda will use this information to design a series of phase 2-ready human clinical trials.

Zelda sees a strong probability of success given the existing patient data and experiences it has access to.

Road to commercialisation

Zelda has a clear commercialisation strategy, which begins with pre-clinical and clinical studies in-house.

The end goal is to out-license or partner with leading pharmaceutical and biotechnology companies for phase 3 trials and marketing.

The out-licensing revenue model consists of up-front and milestone payments and also royalties from marketed products.


Growth strategy

Zelda's growth strategy will be focused on developing existing products.

This means completing phase 2 clinical trials in dermatology indications and insomnia. It also means completing Spanish pre‐clinical research in cancer.

Zelda will then out‐license products with successful phase 2 results.

The secondary growth strategy will be expanding trials into new diseases and territories, which may come through partnerships.

A broad range of medical indications have been shown to be alleviated by medical cannabis

Zelda will also be looking at opportunities to merge and/or acquire as well as in-license new extracts for clinical testing and validation.


Strategic partnerships

Zelda has secured a number of partnerships with leaders in cannabis medicine.

It has an exclusive patient data access agreement in place with Aunt Zelda’s, a pioneering, data‐driven developer of cannabis‐based medicines.

A manufacturing agreement is in place with AusCann, an Australian company working with one of the largest medical cannabis groups in the world to supply clinical trial material.

Zelda has a partnership with New Frontier, the leading cannabis data company based in the U.S. for data sharing.

Zelda also has exclusive access to CDRMed for clinical trial use, which is software which creates optimal formulations of medicinal cannabis based on the Aunt Zelda’s database.

Finally, a partnership is also in place with the prestigious Complutense University Madrid for pre‐clinical research in cancer.


News flow pipeline

Pending a successful reverse takeover, the company has the following news flow pipeline:

- Commencement of pre‐clinical research in human breast cancer via Complutense University Madrid;
- Commencement of clinical trials in wound care and sleep disorders;
- Pre‐clinical trial results in cancer;
- Clinical trial results from acne, insomnia and wound trials;
- Commencement of observational trials in cancer; and
- Signing of partner for clinical trials in sleep and dermatology applications.

Highly active investment into the sector

Five companies in the US biotechnology sector completed 17 capital raises for a total of $217.4 million in 2015.

GW Pharmaceuticals (NasdaqGM:GWPH) secondary offering of American Depository Shares raised $206.1 million, with the company having a current market cap of circa US$1.6 billion.

NEMUS Bioscience (OTCQB:NMUS) raised a total of $7.2 million, including $5.0 million in its largest raise.

Axim Biotechnologies (OTCQB:AXIM) acquired Can Chew License for CanChew® gum, a unique patented controlled-release cannabinoid-infused chewing gum in 2015.


Analysis

The application of medical cannabis in modern medicine is still growing and represents a diverse global opportunity.

Partnerships with New Frontier, CDRMed and Aunt Zelda could provide for the acceleration to phase 2 efficacy clinical trials.

Zelda has an active news flow pipeline with multiple near term share price catalysts.

With the Zelda valuation <$10 million, this provides material upside potential for incoming investors given median market capitalisation of Phase 2 ready biotechs listed on ASX is circa $50 million.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 06 May 2016 08:00:00 -0400 https://www.proactiveinvestors.com/companies/news/136467/gleneagle-gold-ltd-is-well-advanced-in-transition-to-medical-cannabis-68468.html
<![CDATA[News - Gleneagle: Dr Noah Federman joins Zelda’s scientific advisory board ]]> https://www.proactiveinvestors.com/companies/news/136466/gleneagle-dr-noah-federman-joins-zeldas-scientific-advisory-board-67288.html Gleneagle Gold (ASX:GLN) has positioned itself at the forefront of the medical cannabis sector, after recently entering into an agreement in relation to acquiring 100% of the issued capital of Zelda Therapeutics Pty Ltd.

Zelda has now appointed oncologist and physician scientist, Dr Noah Federman, to its Scientific Advisory Board.

Dr Federman holds extensive clinical oncology experience specialising in treating children with aggressive cancers.

His knowledge and experience in the oncology field will be highly valuable for developing rigorous medical cannabis clinical trials in cancer.

The appointment signals the strong level of medical and scientific support for Zelda’s strategy to validate the efficacy of medical cannabis in key indications.

Harry Karelis, chairman for Zelda, commented:

“Zelda is now clearly positioned as a key thought-leader globally in the medical cannabis space and with numerous governments legislating to allow medical cannabis, most recently in Australia, we are uniquely placed through our relationships to accelerate the scientific understanding and clinical benefits of medical cannabis.”

Dr Federman added:

"I have been aware of Mara Gordon (Zelda co-founder) and her activities for some time and have witnessed first-hand the improvement in the quality of life for my patients from her deep knowledge of the biological effects of medical cannabis.

"Focusing on robust clinical trials to show statistically significant outcomes is crucial to validating the potential of medical cannabis to provide patients in need with new treatment options.”


Zelda's Scientific Advisory Board also includes:

- Dr Joe Goldstrich: An experienced specialist and physician with extensive knowledge in the use of medical cannabis to treat a variety of conditions.

- Professor 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 and specialist in the area of lipid signalling, including cannabinoids in an oncology setting Dr Donald Abrams - a cancer and integrative medicine specialist at the UCSF Osher Center for Integrative Medicine at Mount Zion and Chief of Haematology and Oncology at San Francisco General Hospital.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Wed, 02 Mar 2016 10:00:00 -0500 https://www.proactiveinvestors.com/companies/news/136466/gleneagle-dr-noah-federman-joins-zeldas-scientific-advisory-board-67288.html
<![CDATA[News - Gleneagle Gold: Zelda Therapeutics Pty Ltd appoints Dr Joe Goldstrich ]]> https://www.proactiveinvestors.com/companies/news/136465/gleneagle-gold-zelda-therapeutics-pty-ltd-appoints-dr-joe-goldstrich-66926.html Gleneagle Gold (ASX:GLN) has positioned itself at the forefront of the medical cannabis sector, after entering into an agreement to acquire 100% of the issued capital of Zelda Therapeutics Pty Ltd.

Zelda has now appointed medical clinician, Dr Joe Goldstrich, to the company’s Scientific Advisory Board, with immediate effect.

Dr Goldstrich holds over 40 years of clinical medicine experience, including caring for and evaluating thousands of patients receiving medicinal cannabis.

His knowledge and experience in the US medical cannabis industry will be instrumental in shaping Zelda’s rigorous scientific research and clinical trials.

Harry Karelis, Zelda chairman, commented:

"We are honoured to have a clinician of Dr Goldstrich's calibre and experience joining the Zelda team.

"With a medical career spanning over 40 years and his evidence-based evaluations of the benefits that thousands of patients receive from medical cannabis treatments, his guidance will be instrumental in helping to place Zelda at the forefront of cannabis-based medicines."

Dr Joe Goldstrich, added:

“Whilst the medical cannabis industry is well established in the US and Europe, the medicine is still wildly under-researched.

"It is for this reason I am delighted to join the Scientific Advisory Board of Zelda Therapeutics as they look to validate the use of medical cannabis in treating a variety of ailments and serious illnesses through extensive scientific research and clinical trials.”


Other members of the Scientific Advisory Board include

Professor 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 and specialist in the area of lipid signaling, including cannabinoids in an oncology setting.

Dr Donald Abrams: A cancer and integrative medicine specialist at the UCSF Osher Center for Integrative Medicine at Mount Zion and Chief of Haematology and Oncology at San Francisco General Hospital.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Tue, 09 Feb 2016 13:30:00 -0500 https://www.proactiveinvestors.com/companies/news/136465/gleneagle-gold-zelda-therapeutics-pty-ltd-appoints-dr-joe-goldstrich-66926.html
<![CDATA[News - Gleneagle talks medical cannabis ambitions in Proactive Q&A Sessions™ ]]> https://www.proactiveinvestors.com/companies/news/136464/gleneagle-talks-medical-cannabis-ambitions-in-proactive-qa-sessions-66622.html Gleneagle (ASX:GLN) has positioned itself at the forefront of the medical cannabis sector, after recently entering into an agreement in relation to acquiring 100% of the issued capital of Zelda Therapeutics Pty Ltd.

Zelda is leveraging its close relationship with established California based medical cannabis company Aunt Zelda’s.

Aunt Zelda’s has a significant database of patient records indicating solid anecdotal evidence for treating a variety of ailments using protocols and formulations developed by Aunt Zelda’s over several years.

Zelda seeks to fund clinical trials aimed at validating this anecdotal evidence in controlled conditions initially aiming for topical treatment for wound healing, eczema, post-burn itch, acne and certain cancers.

We are joined by Harry Karelis, chairman, Zelda Therapeutics, in the Proactive Q&A Sessions™.


PROACTIVE INVESTORS: Welcome Harry.


First of all, can you outline the intellectual property Zelda either directly holds or has access to, and how is this unique to other companies in the medical cannabis sector?

Harry Karelis: The founders of Zelda have taken a very considered approach to the global medical cannabis sector and spent several months learning about the sector, speaking with many different players in the ecosystem and identifying opportunities that make sense for investors.

We are taking a long term approach to one of the fastest growing sectors in the world and seeking early-mover advantages.

This culminated in identifying a gap in the market in terms of hard, clinical data where there are not more than a handful of companies globally that have approved, cannabinoid-based medicines.

These companies appear to be highly valued by investors and given our backgrounds in the life sciences sector, our knowledge and experience has guided Zelda towards obtaining an exclusive global licence to a set of actual human data via Aunt Zelda’s in California.

This potentially gives us a 10 year head-start over a typical biotech start-up company.

Our sole focus is on converting this anecdotal data into clinically validated data via conducting a series of clinical trials in a variety of indications over time.

We have built a global network of relationships both formal and informal that we will use to accelerate Zelda’s progress which we think is a fairly unique proposition for investors.


A key milestone for Zelda is to fund clinical trials aimed at validating anecdotal evidence. What is an estimate on costs, potential timeline to results and where could this be conducted?

Harry Karelis: The beauty of our business plan is that we already have tremendous insights into what formulations, and importantly what protocols (what to give, how much to give and when to give it) seem to have therapeutic benefit in humans.

This means we can basically skip the lengthy and costly discovery and pre-clinical phases of your typical biotech company.

We have deliberately focused on topically-based trials to start with – that is, applying cannabinoid-based creams to the skin and focused on skin-based conditions.

These are significantly less costly and less complicated than systemic trials of new drugs.

We expect that these trials will be relatively short duration in nature – we are talking a few months and as such relatively inexpensive to conduct with all activities to be out-sourced to professional contract research organisations.

We are hopeful to have a series of trials underway generating regular results over the course of the next 12-24 months.

Positive results combined with creating new intellectual property will open doors to partnerships with third parties and help generate license and milestone fees and ongoing royalties where we choose to work with larger groups.

Working with acknowledged leaders in their respective fields also helps raise our profile amongst the bio-pharmaceutical industry.


Looking forward, how will Zelda protect its intellectual property, and is there a patent structure you will follow?

Harry Karelis: Intellectual property (IP) is the heart of what a biotech company is about especially if you want to maximise your value creation.

We are working with one of Australia’s leading intellectual property firms to ensure that everything we do conforms with international expectations of the regulators and the bio-pharmaceutical sector.

It is not just about lodging a patent over a discovery it is about having a long term IP strategy that incorporates global “landscape” reviews helping to identify areas of interest and opportunities for Zelda to focus on those areas, licensing agreements, royalty arrangements, ensuring all confidentiality and employment agreements are water-tight to minimise “IP leakage”.

Everything we do will work within this over-riding IP strategy and philosophy.


What has been the current interest and investor appetite to provide funding for these trials?

Harry Karelis: At this stage, Zelda is a private company that has been supported by a small group of sophisticated investors based in several parts of the world that have had a greater exposure and understanding of the sector.

These investors recognise the potential of Zelda.

This has allowed Zelda to build its strong global network, secure the core licence and prepare the company for its next round of funding which is now being addressed through the proposed transaction with Gleneagle Gold.


Where could an investor source more knowledge on how to potentially invest in Zelda?

Harry Karelis: I would encourage investors to visit www.zeldatherapeutics.com and register their interest so that a prospectus can be sent to them when complete in early 2016.

Alternatively, if an investor qualifies as a “sophisticated investor” they are able to invest directly into Zelda now as part of a pre-deal convertible note issue.


Finally, can you outline steps that would need to be achieved to move from the current agreement to a new entity listed on the ASX?

Harry Karelis: This transaction will result in a significant change to the nature and scale of Gleneagle’s activities and as such will require shareholders’ approval and will also require the company to re-comply with Chapters 1 and 2 of the ASX Listing Rules.

This means we will be lodging a full form prospectus to raise at least $3 million after Gleneagle Shareholders vote on the transaction in early 2016.

A Notice of Meeting will be despatched in coming weeks with the Gleneagle shareholder meeting to be held roughly four weeks later.

Following a successful capital raising Gleneagle will change its name to Zelda Therapeutics Ltd – at this stage likely to be in March 2016.


PROACTIVE INVESTORS: Thank-you Harry.


Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Tue, 19 Jan 2016 11:00:00 -0500 https://www.proactiveinvestors.com/companies/news/136464/gleneagle-talks-medical-cannabis-ambitions-in-proactive-qa-sessions-66622.html
<![CDATA[News - Gleneagle talks medicinal cannabis transition in Proactive Q&A Sessions™ ]]> https://www.proactiveinvestors.com/companies/news/136463/gleneagle-talks-medicinal-cannabis-transition-in-proactive-qa-sessions-66063.html Gleneagle Gold (ASX:GLN) has positioned itself to transition into the medical cannabis sector after entering into an agreement in relation to acquiring 100% of the issued capital of Zelda Therapeutics Pty Ltd.

Zelda has been established to focus on funding clinical trials incorporating medicinal cannabis formulations and protocols developed over the past few years by California-based group Aunt Zelda’s in treating >500 patients.

A pipeline of Phase 2 ready clinical trials helps de-risk the opportunity.

To discuss the transition, we are joined exclusively by Harry Karelis, chairman, Zelda Therapeutics, in Proactive Q&A Sessions™.


PROACTIVE INVESTORS: Welcome Harry.


What would the acquisition of Zelda mean for existing Gleneagle shareholders, and what potential could new shareholders expect?

Harry Karelis: The medical cannabis sector is one of the fastest growing sectors globally and Zelda provides a relatively unique, high quality exposure to the sector.

This acquisition gives an opportunity for existing Gleneagle shareholders, and is also likely to attract new investors, which will fund the development of the company.

The proposed backdoor listing will fast-track its development and have it on track to be commencing trials in 2016 initially for skin-based conditions such as eczema, acne and a condition known as post-burn itch.

We will be conducting some pre-clinical research with the world’s best cancer cannabis researchers, with other relationships with key opinion leaders are pending.


Who is Zelda, and what does it control?

Harry Karelis: The founders of Zelda identified the opportunity of medical cannabis, by conducting clinical trials around an extensive set of human data based formulations and treatment protocols developed by a California-based group over several years.

Whilst Zelda is based in Perth, it is globally connected with some of the world’s most respected medical cannabis researchers and clinicians.

There is tremendous anecdotal evidence that cannabis has a role to play in the treatment of a range of illnesses the missing link is formal clinical trial data and related intellectual property in a form acceptable by regulators such as the FDA & TGA and the bio-pharmaceutical industry.

The team behind Zelda’s are all seasoned executives with multi-decade experiences in the life-sciences, capital markets and research sectors.

This experience has helped guide us in formulating Zelda’s focus and objectives and identify priority areas of interest and manage our risk by constructing a pipeline of Phase 2 ready projects that address a large commercial market, are relatively inexpensive to run and are relatively short duration.

Overlaid with the existing human data we have access to that already demonstrated the efficacy in humans, we have initially focused our clinical trial program on skin based conditions such as eczema, acne and wound healing using formulations and protocols that have already demonstrated success.

In addition, we will also conduct some pre-clinical research in the area of cancer with one of the world’s leading academic groups in Madrid.  


Can you outline consideration for the deal, and where would you and current directors of Zelda be positioned in the new entity?

Harry Karelis: Gleneagle will be acquiring 100% of the issued capital of Zelda in an all-scrip deal.

No money is being taken off the table by the Zelda vendors.

The Zelda directors are all founders and as such retain a sizable shareholding aligning interests with all Gleneagle/Zelda shareholders.

These shareholdings will be escrowed for two years and everybody is focused on successfully implementing its business objectives.


Moving on the clinical data of Zelda, how could the existing human data be validated?

Harry Karelis: The main aspect that differentiates Zelda from other groups in the medical cannabis space is our exclusive, global access to an extensive set of patient data.

This data has been generated over several years by the Aunt Zelda’s group in California - founded by Ms Mara Gordon who is a founding director of Zelda.

This group has adopted a very rigorous approach to patient intake, formulation, dosing and the often overlooked and critical treatment protocols.

That is, what to take and when to take it.

Zelda will take that data, prioritise the areas of interest and then work with professional Clinical Research Organisations (CRO’s) who will design and run appropriate trials using industry standard methodology and generate results in a form acceptable to the regulators.

We will engage across multiple-sites in jurisdictions such as Spain, Australia, the U.S. and Canada.

At the same time, we are working with one of Australia’s leading intellectual property firms, Griffith Hack, to ensure that any novel intellectual property is identified and secured.


What intellectual property data does Zelda hold, and can you take us through steps which would ultimately lead to monetisation?

Harry Karelis: The initial intellectual property revolves around our licence to the Aunt Zelda’s data coupled with our human resources and our global linkages.

Combined, these form the core proposition that is Zelda Therapeutics.

The key executives and directors have extensive experience in monetising intellectual property and have existing linkages and relationships within the global bio-pharmaceutical sector.

There is a fairly well established process to generate returns from solid clinical data and industry standard deal terms around up-front, milestone and royalty payments.

Think of Zelda as a bio-pharmaceutical company that has a 10 year head start given its products have already been shown to work in humans.


Finally, can you outline steps that would need to be achieved to move from the current agreement to a new entity listed on the ASX?

Harry Karelis: This transaction will result in a significant change to the nature and scale of Gleneagle’s activities and as such will require shareholders’ approval and will also require the company to re-comply with Chapters 1 and 2 of the ASX Listing Rules.

Steps we would need to take would be shareholders voting in favour of the transaction, then lodging a full form prospectus to raise at least $3 million.

A Notice of Meeting will be despatched in coming weeks with the Gleneagle shareholder meeting to be held roughly four weeks later.

The final step post a successful capital raising, is that Gleneagle will change its name to Zelda Therapeutics Ltd, with timing likely to be in March 2016.


PROACTIVE INVESTORS: Thank-you Harry.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 09 Dec 2015 11:00:00 -0500 https://www.proactiveinvestors.com/companies/news/136463/gleneagle-talks-medicinal-cannabis-transition-in-proactive-qa-sessions-66063.html
<![CDATA[News - Gleneagle Gold has acquisition to reveal ]]> https://www.proactiveinvestors.com/companies/news/136462/gleneagle-gold-has-acquisition-to-reveal-66015.html Gleneagle Gold (ASX:GLN) has been granted a trading halt by the ASX, pending details of an acquisition.

Gleneagle added that the proposed acquisition is outside of its existing principal activity.

The halt will remain in place until the opening of trade on Wednesday 9th December 2015, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 07 Dec 2015 12:00:00 -0500 https://www.proactiveinvestors.com/companies/news/136462/gleneagle-gold-has-acquisition-to-reveal-66015.html
<![CDATA[News - Gleneagle Gold, International Gold top ASX gainers by midday ]]> https://www.proactiveinvestors.com/companies/news/136461/gleneagle-gold-international-gold-top-asx-gainers-by-midday-63152.html Friday’s leading ASX % Gainers at midday.

NameCodeLastChangeVolume Gleneagle Gold ASX:GLN $0.003 50% 2,915,472 International Goldfields ASX:IGS $0.003 50% 750,000 Venture Minerals ASX:VMS $0.034 47.8% 890,372 GB Energy ASX:GBX $0.007 40% 2,200,000 East Africa Resources ASX:EAF $0.004 33.3% 1,879,607 Pacifico Minerals ASX:PMY $0.016 33.3% 1,319,737 ADX Energy ASX:ADX $0.004 33.3% 129,797 Bass Strait Oil Company ASX:BAS $0.004 33.3% 1,280,000 Antipa Minerals ASX:AZY $0.014 27.3% 18,102,392 Vector Resources ASX:VEC $0.014 27.3% 282,000

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 26 Jun 2015 13:00:00 -0400 https://www.proactiveinvestors.com/companies/news/136461/gleneagle-gold-international-gold-top-asx-gainers-by-midday-63152.html
<![CDATA[News - These are the biggest ASX% Gainers at mid-day ]]> https://www.proactiveinvestors.com/companies/news/136460/these-are-the-biggest-asx-gainers-at-mid-day-61267.html Monday’s leading ASX % Gainers at mid-day.

NameCodeLastChangeVolume Gleneagle Gold ASX:GLN $0.003 50% 4,426,000 Latin Resources ASX:LRS $0.015 36.4% 1,022,049 Hannans Reward ASX:HNR $0.004 33.3% 2,167,666 Bass Metals ASX:BSM $0.004 33.3% 132,250 Viento Group ASX:VIE $0.04 33.3% 110,826 Kazakhstan Corporation ASX:KPC $0.09 28.6% 46,000 OncoSil Medical ASX:OSL $0.115 27.8% 14,348,103 Ark Mines ASX:AHK $0.05 25% 95,000 Holista Colltech ASX:HCT $0.082 24.2% 8,323 HGL LIMITED ASX:HNG $0.39 21.9% 3,800

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 16 Mar 2015 14:00:00 -0400 https://www.proactiveinvestors.com/companies/news/136460/these-are-the-biggest-asx-gainers-at-mid-day-61267.html
<![CDATA[News - Gleneagle Gold could be about to reveal acquisition ]]> https://www.proactiveinvestors.com/companies/news/136459/gleneagle-gold-could-be-about-to-reveal-acquisition-61211.html Gleneagle Gold (ASX:GLN) has been granted a trading halt by the ASX pending details regarding a proposed acquisition outside of its existing principal activity.

The company had $447,000 in cash at the end of December 2014.

The halt will remain in place until the opening of trade on Monday 16th March 2015, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 12 Mar 2015 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/136459/gleneagle-gold-could-be-about-to-reveal-acquisition-61211.html
<![CDATA[News - Gleneagle Gold, PhytoTech Medical among ASX % Gainers at midday ]]> https://www.proactiveinvestors.com/companies/news/136458/gleneagle-gold-phytotech-medical-among-asx-gainers-at-midday-60280.html Friday’s leading ASX % Gainers at midday.

NameCodeLastChangeVolume Gleneagle Gold ASX:GLN $0.002 100% 447,901 Cardia Bioplastics ASX:CNN $0.002 100% 1,000,000 PhytoTech Medical ASX:PYL $0.77 83.3% 22,455,273 Scotgold Resources ASX:SGZ $0.022 57.1% 4,209,703 Broken Hill Prospect ASX:BPL $0.057 35.7% 236,618 Modun Resources ASX:MOU $0.004 33.3% 480,750 Walkabout Resources ASX:WKT $0.004 33.3% 250,000 Segue Resources ASX:SEG $0.009 28.6% 6,158,784 PepinNini Minerals ASX:PNN $0.014 27.3% 10,000 Middle Island Resources ASX:MDI $0.014 27.3% 162,500

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 23 Jan 2015 13:30:00 -0500 https://www.proactiveinvestors.com/companies/news/136458/gleneagle-gold-phytotech-medical-among-asx-gainers-at-midday-60280.html
<![CDATA[News - Gleneagle Gold, Mining Projects Group among Tuesday’s Volume leaders ]]> https://www.proactiveinvestors.com/companies/news/136457/gleneagle-gold-mining-projects-group-among-tuesdays-volume-leaders-57465.html Tuesday’s leading volume stocks on the ASX.

NameCodeLastChangeVolume FAR Limited ASX:FAR $0.065 18.182% 94,250,347 Gleneagle Gold ASX:GLN $0.003 50% 62,509,539 Mining Projects Group ASX:MPJ $0.012 9.091% 42,067,128 Heron Resources ASX:HRR $0.175 -5.405% 34,301,098 Titan Energy ASX:TTE $0.020 11.111% 24,098,895 Billabong ASX:BBG $0.685 3.008% 23,213,300 CFS Retail Property Trust Group ASX:CFX $2.170 3.828% 23,207,080 Metals Australia ASX:MLS $0.011 37.5% 23,130,491 Tychean Resources ASX:TYK $0.003 50% 23,004,653 Integrated Resources ASX:IRG $0.002 0% 22,927,699

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 10 Sep 2014 08:00:00 -0400 https://www.proactiveinvestors.com/companies/news/136457/gleneagle-gold-mining-projects-group-among-tuesdays-volume-leaders-57465.html
<![CDATA[News - Gleneagle Gold, Indus Coal, Gulf Minerals among ASX % Gainers ]]> https://www.proactiveinvestors.com/companies/news/136456/gleneagle-gold-indus-coal-gulf-minerals-among-asx-gainers-57221.html Thursday's leading % Gainers on the ASX intra-day.

CompanyCodeLastChangeVolume Gleneagle Gold GLN $0.002 100% 254,384 Indus Coal ICZ $0.052 67.74% 35,000 Gulf Minerals GMC $0.003 50% 400,000 King Solomon Mines KSO $0.003 50% 250,000 BioProspect BPO $0.004 33.33% 1,296,400 Lakes Oil LKO $0.004 33.33% 425,000 Oklo Resources OKU $0.004 33.33% 800,300 Atlantic Gold AGB $0.470 30.56% 110,000 Transerv Energy TSV $0.005 25% 10,890,736 Montech Holdings MOQ $0.028 21.74% 498,667 Resonance Health RHT $0.054 20% 2,015,850

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 28 Aug 2014 14:00:00 -0400 https://www.proactiveinvestors.com/companies/news/136456/gleneagle-gold-indus-coal-gulf-minerals-among-asx-gainers-57221.html
<![CDATA[News - Gleneagle Gold to raise A$1.1m to progress gold exploration in Western Australia ]]> https://www.proactiveinvestors.com/companies/news/136455/gleneagle-gold-to-raise-a11m-to-progress-gold-exploration-in-western-australia-25145.html Gleneagle Gold (ASX: GLN) was active with a geochemical sampling and assaying program at the company's Peak Hill exploration licenses in 2011, and has now initiated a capital raising to progress exploration.

The funding is in two parts, with a placement of 100 million shares at $0.05 to raise $500,00, plus an underwritten rights issue covering 122 million shares

The Peak Hill goldfield is located along the southern margin of the Proterozoic belt and the northern edge of the Yilgarn Craton and lies within the western part of the Palaeoproterozoic Bryah Basin.

The company’s tenements are prospective for mesothermal gold-only style deposits, with one tenement positioned 2 kilometres due west of the abandoned Fiveways Pit at Peak Hill.

The second project is 2.5 kilometres north-east of the abandoned Horseshoe Pit gold-copper-silver deposit, and immediately north of the Saturn gold prospect.

 

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Fri, 10 Feb 2012 10:00:00 -0500 https://www.proactiveinvestors.com/companies/news/136455/gleneagle-gold-to-raise-a11m-to-progress-gold-exploration-in-western-australia-25145.html
<![CDATA[News - Gleneagle Gold shares surge on Mauritania iron ore acquisition plan ]]> https://www.proactiveinvestors.com/companies/news/136454/gleneagle-gold-shares-surge-on-mauritania-iron-ore-acquisition-plan-6335.html Gleneagle Gold (ASX: GLN) has signed a letter of intent to conditionally acquire up to a 75% interest in two iron ore exploration projects, via a proposed acquisition and farm in joint venture agreement with Sonko Lowenthal Mauritanie sarl (Sonko), a company incorporated in Mauritania.

The Projects are located in the Inchiri district of western Mauritania, Western  Africa. Exploration licences for iron ore Cetal (791B1) and Kaoua El Khadhra (792B1) will be granted immediately upon payment of final government fees and performance bonds.

Both projects are considered prospective for magnetite-quartzite deposits within banded iron formations (BIF).

Cetal, the northern project of some 498sq km, is located less than 70km south of heavy gauge rail and road infrastructure and a further 180km east, by rail, of the port of Nouâdhibou.

It lies immediately north and along strike of the eastern most of the two exploration licences of the Lebtheinia iron ore project owned by Sphere Minerals (ASX: SPH).

Sphere has reported a combined JORC mineral resource of 2.74Bt (2.18Bt indicated and .56Bt inferred) (ASX: 22 Oct 2009) from its central deposit located 30km west of the company’s northern project.

Kaoua El Khadhra, the southern project of some 960sq km, is 250km northeast of the capital, Nouakchott, by paved road. It is located a short distance from the copper-gold mining operations at Guelb Moghrein and the district capital of Akjoujt.

The project areas have been subject to previous reconnaissance exploration through geological surveys conducted by the British Geological Survey and the French agency, BRGM.

The rail and port infrastructure supports iron ore exports from a number of mines owned
and operated by Societe Nationale Industrielle et Miniere (SNIM).

SNIM, 78% owned by the Mauritanian government, is the world’s 7th largest exporter of iron ore with production expected to double following an expansion of its rail capacity and the construction of a second dedicated port berth facility.

The Mauritanian government fully supports the development of the country’s iron ore assets. A decision by Gleneagle to proceed is conditional on, amongst other things, the completion of due diligence and the obtaining of all necessary shareholder and regulatory approvals.

Gleneagle Gold shares rose 15% to 2.2 cents in trading today.

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Fri, 09 Apr 2010 10:56:00 -0400 https://www.proactiveinvestors.com/companies/news/136454/gleneagle-gold-shares-surge-on-mauritania-iron-ore-acquisition-plan-6335.html
<![CDATA[News - Gleneagle Gold requests trading halt ]]> https://www.proactiveinvestors.com/companies/news/136453/gleneagle-gold-requests-trading-halt-6174.html Gleneagle Gold (ASX: GLN) has requested that the company's shares be placed in a trading halt until commencement of trading on Wednesnesday 7 April 2010, unless advised earlier by the company, pending an announcement in relation to a joint venture agreement.

The company said it is not aware of any reason why the trading halt should not be granted.

Gleneagle is an exploration company with a focus on Southern African mineral and coal opportunities which have defined programmes of work in place to develop into operating mines supporting major energy generating services.

Gleneagle recently signed agreements to conditionally acquire up to a 70% interest in two Prospecting Rights for coal, over the farms Verloren Valey, Kleinberg, Duikerpan and Houwhoek, located in the Waterberg region of South Africa.

The acquisition is conditional on, amongst other things, the completion of due diligence and the obtaining of shareholder approval and all necessary regulatory approvals.

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Thu, 01 Apr 2010 08:55:00 -0400 https://www.proactiveinvestors.com/companies/news/136453/gleneagle-gold-requests-trading-halt-6174.html