Geneva, Switzerland, 27 July 2011 – Addex Pharmaceuticals (SIX: ADXN), a leader in allosteric modulation-based drug discovery and development, announced today financial results for the first half of 2011 and reviewed the status of its pipeline.
Highlights
- Cash and cash equivalents of CHF50.2 million at 30 June 2011
- Operating loss of CHF14.6 million
- Cash used of CHF13.6 million in line with full year guidance (CHF28-32 million)
- 111.8 FTEs at June 30 with 82 FTEs projected by September 30, 2011
- Dipraglurant-IR Phase IIa PD-LID clinical study progressing as planned
- ADX71149 Phase IIa schizophrenia clinical study by partner Janssen Pharmaceuticals progressing as planned
- mGluR4-targeted PAM for Parkinson’s disease collaboration with Merck & Co., Inc., ongoing
- Addex regains from Merck & Co., Inc. rights to mGluR5-targeted PAM for schizophrenia
- Preclinical pipeline for neurological, metabolic and inflammatory diseases growing and progressing well
“We are happy with the progress we have made in the first half of 2011. Our most advanced pipeline products are advancing through Phase IIa testing, we have a strong cash position and we are operating with a more efficient organization,” said André Mueller, Executive Chairman of Addex Pharmaceuticals. “The search for a new CEO has been fruitful and we hope to announce the appointment of our new CEO in the coming weeks.”
Tim Dyer, CFO of Addex Pharmaceuticals, said: “We are pleased to report cash utilization in line with estimates and maintain our full year cash utilization guidance at CHF28–30 million. The ongoing re-organization is on track to deliver significant improvements in operational efficiency and cash utilization and we now expect our cash reserves to reach to the end of 2013, without taking into account any new partnership revenues.”
First Half 2011 Financial Summary
Income was CHF3.2 million for the first half of 2011 (H1 2010: CHF2.7 million) including a CHF2.6 million milestone payment received from Janssen Pharmaceuticals, Inc. (JPI), formerly Ortho-McNeil-Janssen Pharmaceuticals, Inc. under the mGluR2 PAM license agreement, CHF0.1 million of technology access fees from Merck & Co. under the mGluR4 PAM license agreement, CHF0.2 million of French research tax credits for 2011 and a CHF0.2 million grant received from The Michael J. Fox Foundation for Parkinson’s Research.
Research & Development expenses decreased by 13% to CHF14.6 million in the first half of 2011 compared to CHF16.7 million in the first half of 2010, mainly due to our reduced headcount.
General and Administration expenses remained stable at CHF3.3 million.
Net Loss decreased to CHF14.8 million for the first half of 2011, compared to CHF17.3 million for the first half of 2010, mainly due to the significant decrease in our operating expenses.
Cash and cash equivalents amounted to CHF50.2 million at 30 June 2011, compared to CHF63.8 million at the end of 2010. Cash used for the first half of 2011 of CHF13.6 million is mainly due to the cash used in operations.
Outlook: Based on current expectations, full year cash spend guidance is CHF28-32 million.
Reorganization: While steps have been taken to ensure that the reorganization retained key talent and core competencies it is expected to yield significant savings. The consultation period required under Swiss law has been completed and the affected staff members have been notified. Staff will be reduced from 111.8 full time equivalents (FTEs) at June 30 to 82 FTEs by September 30. Pipeline prioritization and strategy review efforts are underway and will be finalized after the new CEO has been appointed.
Pipeline Status Review
The lead partnered product candidate, ADX71149, an mGluR2-targeted positive allosteric modulator (PAM), or activator, in clinical development for the treatment of schizophrenia, started Phase IIa clinical testing in patients with schizophrenia earlier this year. ADX71149 was discovered in collaboration with JPI as part of a drug discovery and development partnership initiated in 2005. JPI is responsible for development and commercialization of ADX71149. Addex is eligible for a further €109 in development and regulatory milestones and low double-digit royalties.
The lead wholly-owned clinical product candidate, dipraglurant is an mGluR5-targeted negative allosteric modulator (NAM), or inhibitor. An immediate release formulation, dipraglurant-IR, which mimics the pharmacokinetic profile of levodopa, is currently undergoing Phase IIa clinical testing in Parkinson’s disease levodopa-induced dyskinesia (PD-LID) patients. The Michael J Fox Foundation for Parkinson’s Research awarded Addex a $900,000 grant to support this PD-LID study.
Inhibition of mGluR5 has been validated in several indications. Addex has chosen to focus on PD-LID because PD-LID represents a significant and growing unmet medical need. In addition, the lead compound, dipraglurant, demonstrated exceptional efficacy in preclinical testing. Dipraglurant-IR effectively inhibited, in a dose dependent manner, chorea and dystonia, the two key movement disorders associated with levodopa-induced dyskinesia. Dipraglurant-IR is the only drug candidate under development that has been reported to have efficacy effects on both chorea and dystonia in representative preclinical models. In addition, the highest tested dose of dipraglurant-IR completely abolished both chorea and dystonia in many of the non-human primates in preclinical testing, which has not been reported with other compounds.
An extended-release formulation, dipraglurant-ER, is also being developed by Addex. Dipraglurant-ER is expected to be optimal for several other indications where mGluR5 inhibition has been clinically validated, e.g. dystonia, anxiety, depression, pain, GERD as well as addictive or compulsive behaviors. While the majority of these conditions can frequently be co-morbid with Parkinson’s disease, dipraglurant-ER may also be tested as a treatment for these indications in non-PD patients.
Addex has a partnership with Merck & Co., Inc. for the development of mGluR4 PAM drug candidates for treatment of Parkinson’s disease. The mGluR4-targeted PAM partnership signed in late 2007 has achieved two preclinical milestones and the collaborative discovery phase of the agreement has been successfully completed. Merck is responsible for future development of mGluR4 PAM. Addex is eligible for up to a total of USD167 million in milestones plus royalties.
Under a separate agreement, Addex will regain from Merck & Co., Inc. its intellectual property surrounding ADX63365 and other mGluR5-targeted PAM candidates and backup candidates, a novel approach for treating schizophrenia. The decision ends a 2008 license agreement under which Merck had received exclusive rights to mGluR5-targeted PAM.