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Perth-based biopharmaceutical company Zelira Therapeutics (ASX: ZLD) has secured US$33 million (A$49 million) in funding after its HOPE 1 special purpose vehicle (SPV) signed a deal with ThirdGate Capital’s TGC Biotechnology Fund.
Launched in October 2020 in Australia, HOPE 1 is a medicinal cannabis oil blended with purified olive oil and contains equal amounts of THC and CBD, with five milligrams of each per millilitre.
Classified by the Therapeutic Goods Administration (TGA) as a Category 3 “balanced” product, it is designed to deliver therapeutic effects without being heavily intoxicating.
HOPE 1 is being developed for the treatment of autism and Phelan-McDermid Syndrome, which is a rare genetic condition that causes symptoms such as developmental delay, intellectual disability and low muscle tone.
A 2022 white paper titled ‘HOPE 1 demonstrates improvements in Clinical Global Impression (CGI) in patients with Autism Spectrum Disorder’ reported on the use of HOPE 1 in patients with ASD, with a mean age of 14.
According to clinician assessments, 67 per cent of patients were rated as “minimally improved” after one month, with reported improvements increasing over subsequent months, reaching 100 per cent by five months.
The raise values Zelira HOPE 1 SPV at a post-money valuation of $96 million, with Zelira’s post-money interest valued at $38 million.
“This transformative Fundraising directly into the HOPE 1 SPV represents a compelling endorsement of our vision, our science, and the significant potential of HOPE 1,” Zelira CEO Oludare Odumosu said.
“We welcome ThirdGate Capital as our partner and its recognition of what we have always believed: that HOPE 1 stands to revolutionise the treatment landscape for individuals living with autism, including rare and underserved forms, starting with Phelan-McDermid Syndrome.
“We are energised by the path forward and remain committed to delivering real solutions for autism patients, families and physicians/healthcare professionals who treat autism, while ensuring value for our shareholders.”
In Q2 2024, Zelira met with the US Food and Drug Administration (FDA) to clarify the development pathway for HOPE 1.
The agency also endorsed Zelira’s plans to submit an Investigational New Drug (IND) application - the formal approval needed to begin testing a new treatment in humans - clearing the way for the company’s first FDA-regulated clinical trial.
The latest capital injection comes from US-based private investment firm ThirdGate Capital, which is headquartered in New York and has affiliate offices in Kenya, London, Mauritius, Singapore and Switzerland.
Following the capital raise, ThirdGate Capital’s TGC Biotechnology Fund will hold a 50 per cent fully diluted stake in HOPE 1 SPV, with Zelira retaining a 39.7 per cent stake following its contribution of intellectual property and real-world clinical data.
Existing investors will also retain 5.42 per cent, with 4.88 per cent allocated to a management incentive pool.
Zelira chairman Osagie Imasogie has been appointed executive chairman of the SPV.
“I am thrilled to build on our relationship with the ThirdGate Capital Team to get HOPE 1 through the FDA process in the most efficient and expeditious manner,” Imasogie said.
“We are grateful for ThirdGate Capital’s funding and investment and that of The 2011 Forman Investment Trust and Mr. Malik Majeed, who were our first institutional/Family Office investors into the SPV.
“Their initial funding was crucial in getting the SPV to the inflection point at which we were able to attract ThirdGate Capital’s interest and transformative funding investment.”
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