LONDON Addex Therapeutics SA raised $10.3 million in a private placement, bolstering the balance sheet as it begins serious negotiations on partnering lead asset dipraglurant and awaits data from a Phase IIa trial of ADX71149 in treating schizophrenia.
The company sold 918,000 new shares at CHF10.50 (US$11.32) per share, a discount of CHF1.30 to the closing price Oct. 12, but a premium over the CHF7.50 at which the shares were trading around the middle of September.
Tim Dyer, the firm's chief financial officer, said the share price "bobbed up" last month following a favorable analyst's report, prompting the move to raise cash at the end of last week. "We took the decision when the share price went up. In the market we got some push-back on pricing, so the discount was significant, but on the other hand, it was a significant premium over what the shares had been trading at," he told BioWorld International.
In June, Addex said it would run out of cash in the second quarter of next year. Following the placement, there now is sufficient cash to last at least until the end of 2013. Between now and then, some "potentially lucrative datapoints" are coming up that will influence the exact length of the Geneva-based company's cash runway.
Chief among those will be a deal for dipraglurant, a treatment for levodopa-induced dyskinesia (LID) in Parkinson's disease. The data room was opened following publication of the final Phase IIa trial results in June and of new preclinical data in July. The Phase IIa study showed that dipraglurant, a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator, met the primary endpoint of a good safety and tolerability profile and demonstrated statistically significant reduction in LID severity at both 50-mg and 100-mg doses.
Addex said dipraglurant has the potential to be used in combination with levodopa or dopamine agonists, or as a standalone treatment for LID, Parkinson's disease-related motor symptoms, nonmotor symptoms of Parkinson's disease and for treating other movement disorders. The company is discussing specific terms with potential partners, to take the program into Phase IIb. "We feel we are still on track [to close a deal] by the end of the year," Dyer said.
Also expected before the end of the year are Phase IIa data on ADX71149, a positive allosteric modulator of mGluR2, in treating schizophrenia. The product also is in a Phase IIa trial in patients with major depressive disorder who are also suffering from anxiety. Both trials are being run by partner Janssen Pharmaceuticals Inc.
Under the terms of the agreement with Janssen, Addex is eligible for up to €112 million (US$145.3 million) in development and regulatory milestone payments and will receive low double-digit royalties on sales of any mGluR2 modulator that makes it to market.
The new money also will allow Addex to go ahead with an additional program in multiple sclerosis. In September, the firm announced preclinical proof of concept in rodent models for its mGluR4 compound series and will select a candidate for Phase I development before the end of the year. The preclinical data indicated that mGluR4 positive allosteric modulation promotes regulatory T-cell formation and reverses pro-inflammatory T-cell release, an effect that could potentially stop the destruction of myelin.
Addex said an orally available mGluR4 modulator would represent a major advance in the treatment of multiple sclerosis, having the ability to slow disease progression and provide a neuroprotective effect.
Dyer noted that mGluR4 modulation "is a hot mechanism at the moment." In September, Vanderbilt University and Bristol-Myers Squibb Co. signed a collaboration for the discovery, development and commercialization of compounds acting on the mGluR4 glutamate receptor, in that case for the treatment of Parkinson's disease.
Before that, in July, Merck Serono SA announced the spin out of Prexton Therapeutics from its soon-to-be shuttered Geneva R&D facility, to develop compounds targeting mGluR3 and mGluR4.
"We've got the most advanced program in the field," Dyer claimed of Addex's pipeline.
The upturn in fortune comes after significant retrenchment by Addex in April, when in a second round of job cuts in a year, the company axed 35 percent of its 80-strong work force.
Dyer said investors are buying into the potential of a dipraglurant deal and positive Phase IIa data from the two Janssen trials. "Investors like the [drug discovery] platform. Now it's shots on goal that are attracting them."