For the likes of Moderna and Immunocore, raising SFr40m ($40.4m) in a single investment round would be the equivalent of finding loose change down the back of the couch, but for Swiss biotech Addex its two most recent cash injections this year, totalling $45m, have been enough to bring it back from the brink.
Today the group reported full-year results that showed just how dire things had become, with losses of SFr3.3m and cash of SFr2.6m in 2017. Speaking to EP Vantage Tim Dyer, Addex’s chief executive, expressed his relief at the company’s reversal of fortune: “It’s been hard work, but we have removed the financial overhang that was holding us back.”
Addex’s first get-out-of-jail-free card came in January in the form of a licensing deal with Indivior. The addiction specialists paid $5m upfront for Addex’s ADX71441, a GABAB positive allosteric modulator (GABAB PAM) for the treatment of treat alcohol and cocaine addiction.
The collaboration also included a research alliance to develop further compounds, allowing potential milestones to reach $330m.
In return for its investment, Indivior gets first pick of any programme that comes out of the partnership. Addex is in turn free to develop any remaining projects. “As long as we produce more than two clinical programmes we will get a molecule,” Mr Dyer says.
While interest from an outside party is always a welcome validation of an asset, the event that has transformed Addex is last month’s share placing. The offering raised SFr40m and attracted investors that included New Enterprise Associates and Credit Suisse Asset Management.
With the financial brakes off Mr Dyer is very clear about what he wants to do with Addex’s newfound cash. “Dosing of our first PD-LID patient with dipraglurant in our registration studies is our primary objective.”
Dipraglurant is Addex’s lead product and is currently in phase II for Parkinson’s disease levodopa-induced dyskinesia (PD-LID), the jerky, uncontrollable movements that come with long-term use of the Parkinson’s disease treatment levodopa.
Getting to the point of pivotal trials will involve more staff.
Since 2013, Addex has been run almost like a virtual company. The lead up to its 2013 financial crisis, however, happened almost four years previously in 2009, when its stock tumbled following liver toxicity issues with lead product ADX10059, a treatment for GERD and migraine.
What followed was a gradual decline in the share price as investors worried that the issue might be an mGluR class effect, effectively nullifying most of the pipeline.
In 2013 Addex was forced to mothball the majority of its projects and substantially scale down, cutting headcount to single figures. During the years in limbo that followed the company managed to keep going through a mixture of collaborations with academic institutions, governmental organisations and patient advocacy groups.
Putting the LID on the opportunity
With fresh cash on hand, Mr Dyer is looking for staff not only to help with the pivotal trial, but also to build the group’s presence in the US, where most of the industry’s investors and money reside.
Mr Dyer says the hope is “to have 20 to 30 people by the end of the year”, when dipraglurant’s phase III trial is also expected to start.
Addex estimates that the US PD-LID market is worth $4.2bn and that dipraglurant could capture a third of this, giving it potential peak sales of $1.4bn.
This could, however, be viewed as a very optimistic prediction from a company keen to attract new investors/partners. And it should also be remembered that there is a long way to go from phase II to approval in one of the most notoriously tricky therapy areas, where the promise of mGluR has been tempered by multiple failures.
For now, there are still pavements to be pounded and doors knocked on if Mr Dyer wants to get Addex back in the forefront of investors’ minds, not to mention securing new analyst coverage and landing either the next funding round or partnership the group will inevitably need. “I still need to do a lot of work to get the message out there,” Mr Dyer says simply.