Tell us a bit about your clinical programs and how they are different from the existing therapies.
Addex is a clinical-stage biopharmaceutical company, founded around the technology that is called allosteric modulators. We’re focused on targeting the G protein-coupled receptors. We’ve now got our lead molecule, mGlu5 negative allosteric modulator. We’re in a pivotal study for dyskinesia associated with Parkinson’s disease.
As Parkinson’s disease progresses, patients suffer from a number of other facets of the disease, like dyskinesias, psychosis, etc. There are a number of players who have launched drugs, which have been extremely successful in treating hallucinations and psychosis. The drug that has been launched in the United States for dyskinesia is a modified release formulation of amantadine, which is an old generic antiviral drug. Amantadine is active on the same molecule pathway as mGlu5. The big difference with Addex is we are absolutely selective on the mGlu5 and we have a very short PK profile of mirrors l-dopa.
And we believe that brings a number of advantages because we’re absolutely selective on the target. And looking at the data we’ve seen so far, it’s much safer than amantadine. The data is due at the end of the year.
With regards to dyskinesia, what’s the market opportunity that you see?
There are about 200,000 patients in the United States who have dyskinesia, where we have been granted an orphan drug designation. There’s a more than $4 billion market opportunity and we’re certainly expecting to get about 25-30% of that based on our estimates today.
What can you tell us about your IP portfolio?
Because we’re a technology company, we discover our entire portfolio through high-throughput screening. The company has been here around for 20 years now. So we have NCE patents, polymorph salt patterns. We’ve got a number of other patents on each one of the programs and each program has backup and compounds behind it. On the portfolio we have dipraglurant, which is being pushed forward for dyskinesia, but also, we are currently running a blepharospasm study. Blepharospasm is a type of dystonia of the eyelid muscles.
We are in a feasibility Phase 2 study. We’re looking at multiple doses and a lot of measurements. It’s a data-rich study. That we will report in Q1. Then we’ve got a partnership with Janssen Pharmaceuticals, who are responsible for financing the clinical development and that’s in a Phase 2 study for epilepsy. That’s looking to read out in Q3 of 2022. So yeah, quite a lot going on.
How do you see your balance sheet and tell us a bit about your funding activities?
We reported having 15.5 million Swiss francs, about $16.6 million on the balance sheet last year. At the end of September, we raised another $10 million.
We have got the cash now to read out all these studies. And we are certainly hoping that positive data would have a positive impact on our stock price. Unfortunately, stock prices have been languishing for some time now. I think one of the reasons is that people were waiting for us to start our studies. And there was also a perceived financing overhang, which I think we’ve now got rid of. And so we are hopeful that if we deliver good data, the stock price will take care of itself.
One of our programs is funded by Indivior, so that takes some strain off the balance sheet. We are certainly looking to do other deals as well in addition to the capital.
Should investors expect the R&D expenses to trend upwards next year?
In the preclinical stage, we’ve got four programs now sent to deliver compounds that will start IND enabling studies. And to that, the costs will start to ramp up as those molecules get prepared to move into the advanced phase.
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