Transformative journey driving Argent BioPharma’s growth and US listing plans

• Argent BioPharma’s journey of transformation is aimed at delivering long-term growth and shareholder value
• Company has undertaken key acquisitions, cost saving measures and is now focused on dual US listing
• Argent actively generating clinical data to support safety and efficacy of its cannabinoid-based products

Argent BioPharma has undergone a transformative journey, rebranding and accelerating growth through strategic acquisitions, global expansion and a focused R&D strategy — with its sights now set on securing a dual US listing on a major exchange.

CEO and managing director Roby Zomer told Stockhead Argent Biopharma (ASX:RGT) was carefully following a clear strategic path aimed at delivering growth and value for shareholders.

Known as MGC Pharma before a rebrand in April 2024, Argent’s cornerstone move came with the recent purchase of key assets from former ASX-listed AusCann Group in a strategic deal worth ~$15 million.

This deal secures Argent’s research and manufacturing infrastructure, strengthening its balance sheet, IP, audited assets and position in the biopharma space as well as a planned listing on the Nasdaq or NYSE.

After delisting from the London Stock Exchange in December 2024, citing high costs and lack of liquidity, the company has been building its US investor base through its angel-based private investors.

“We realised the UK stock exchange was not where we want to be and restructured as a company to focus on the R&D and bring better value to shareholders,” Zomer said.

“The acquisition is the last piece of the puzzle and enables us to have ticks in all the boxes to be listed on the Nasdaq or New York Stock Exchange.

“It means we have positive equity and financials are above the requirement.”

Key manufacturing changes reduce costs

In another key move Argent signed a deal with David Trading to grant exclusive rights to its Malta manufacturing facility for 49 years, aiming to save up to US$1 million a year in operating costs.

Argent’s fully automated, EU-GMP-certified manufacturing plant in Malta, commissioned in May 2023, specialises in liquid-dose medicines.

The facility was dedicated to producing CimetrA, the company’s anti-inflammatory and immunomodulatory formulation, with capacity for thousands of units a day and strong support through multi-million-dollar Maltese government grants.

“CimetrA will still be manufactured there, but David Trading will take full managerial and financial responsibility reducing our liability to zero,” Zomer said.

And in what could be a further boost to Argent’s bottom line David Trading has also been granted an exclusive, irrevocable option to acquire 100% ownership of the manufacturing facility.

Argent has also signed a contract with ECCPharm, an EU-GMP-certified pharmaceutical manufacturer, to outsource manufacturing of two of its cannabinoid therapies at its North Macedonia site.

These include its flagship product for refractory epilepsy CannEpil along with CogniCann, an investigational therapy targeting neurodegenerative diseases including dementia, Alzheimer’s disease and potentially Parkinson’s.

Under the deal Argent will retain ownership of all R&D and IP of CannEpil and CogniCann.

ECCPharm will take on full manufacturing and batch release responsibilities ensuring the treatments are available across key European markets, including Ireland, the UK and Germany under early patient access programs.

“With these deals we’re able to reduce our costs of manufacturing, cost of product and increase our profitability,” Zomer said.

“About two years ago with the same treatments we were providing, we needed 4000 to 5000 patients to be cash flow neutral.

“Today I can say if we reach 1500 to 2000 patients, we would be cash flow neutral, so it’s improved our trajectory.”

CannEpil gets boost with German approval and positive case report

Zomer said recent approval of CannEpil in Germany under the country’s special access scheme (SAS) represented a significant milestone in Argent’s European expansion.

He said it underscored the company’s commitment to delivering innovative treatments for central nervous system (CNS) disorders with ~816,000 people in Germany diagnosed with epilepsy and a significant portion experiencing drug-resistant forms.

“Commercially German approval is very good for us and we’re looking to gain approval in other European countries,” Zomer said.

“We’re working to structure our distribution network in Europe, where millions of patients don’t have effective treatment.”

Case study builds on clinical evidence

Argent BioPharma is focused on actively generating clinical data to support the safety and efficacy of its cannabinoid-based products.

The rigorous approach sets it apart from many listed cannabis companies that rely primarily on commercial or anecdotal use.

A peer-reviewed case report published recently in the International Journal of Clinical Medicine & Case Reports, describes the successful use of CannEpil to treat a paediatric patient with Lennox-Gastaut Syndrome (LGS).

LGS is a severe, complex childhood epilepsy marked by multiple seizure types, developmental delays and resistance to conventional treatments.

“We’re looking to help patients who have not been able to be treated and with support of this publication believe we have a strong candidate,”  Zomer said.

“We took an eight-year-old child in a wheelchair who could not communicate with parents, not hold a pencil and after a one-and-a-half-year treatment was back to school.

“She was running, and it was a tremendous change.”

Supported by clinical case data and head-to-head comparative research, Zomer said CannEpil was emerging as a potential next-generation cannabinoid treatment for refractory epilepsy.

Argent is also advancing its second key product, CimetrA — marketed as ArtemiC in the USA — with distribution underway in select markets such as the US while clinical development and regulatory approvals progress.

The company recently reported positive results from in vivo study of ArtemiC showing up to 85% survival in a severe viral acute respiratory distress syndrome (ARDS) model versus 0% in controls.

Conducted independently by AMC Pharma USA and the University of South Florida, treatment also reduced viral load, suppressed inflammatory damage and extended life expectancy by 20–40%.

CimetrA has also successfully completed multiple studies including a phase 2a trial for ARDS in Israel and India with ongoing open-label studies and most recently completed its phase 2b studies in Israel, covering hundreds of patients in various clinical studies.

“CimetrA already has generated more than $2 million in sales until now and sold more than 200,000 units,” Zomer said.

“The restructure gave us clarity as a business and our trajectory now is about scaling innovation, deepening US and international engagement, and delivering long-term value to shareholders.”

At Stockhead, we tell it like it is. While Argent BioPharma is a Stockhead advertiser, the company did not sponsor this article.