6 May 2016
Here’s the press release as reported by Proactive Investors.com.au
Gleneagle Gold Ltd is well-advanced in transition to medical cannabis
Harry Karelis, chairman, Zelda Therapeutics Pty Ltd
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.
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.
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.
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.