Plan-les-Ouates, Geneva, Switzerland, April 30, 2014 (GLOBE NEWSWIRE) --
2013 Financial Highlights
- Significant reduction in 2013 cash utilization of CHF12.3 million, significantly below guidance of CHF15 million, CHF1.6 million used in second half of 2013
- Cash and cash equivalents of CHF2.9 million at 31 December 2013
- Capital increase of CHF3.2 million completed in August 2013
- CHF0.1 million of grant income recognized in 2013
2013 Operating Highlights
- Received regulatory approval to initiate Phase 1, first-in-man, clinical study for ADX71441
- Entered collaboration with NIDA to evaluate ADX71441 (GABA-BR PAM) and ADX88178 (mGlu4 PAM) compounds in preclinical models of drug abuse and addiction
- ADX71149 Phase 2 anxious depression trial completed enrolment of 120 patients
- Completed characterization of dipraglurant in preclinical models of dystonia and receptor occupancy studies in non-human primates
- Completed characterization of ADX71441 in preclinical models of Charcot-Marie-Tooth 1A disease and alcohol addiction
- Secured USD1M grant from the Michael J. Fox Foundation for Parkinson's Research to further characterize dipraglurant for Parkinson's disease levodopa-induced dyskinesia
- Competed restructuring, reducing headcount to 5 full time equivalents and significantly reducing facilities
Geneva, Switzerland, 30 April 2014 - Addex Therapeutics (SIX: ADXN) announced today 2013 financial results.
Key 2013 Financial Data
|R&D expenses||(10 940)||(20 650)||(47%)||(1 625)||(9 088)||(82%)|
|G&A expenses||(5 781)||(6 481)||(11%)||(1 021)||(3 173)||(68%)|
|Impact of IAS19 revised||2 121||-||100%||2 121||-||100%|
|Total operating loss||(14 458)||(27 010)||(46%)||(525)||(12 261)||(96%)|
|Finance result, net||(3)||(8)||(62%)||1||1||0%|
|Net loss for the period||(14 461)||(27 018)||(46%)||(524)||(12 260)||(96%)|
|Basic and diluted net loss per share||(1.60)||(3.41)||(53%)||(0.06)||(1.50)||(96%)|
|Net cash used (cash burn)||(12 344)||(20 808)||(41%)||(1 566)||(4 980)||(69%)|
|Cash and cash equivalents||2 913||15 257||(81%)||2 913||15 257||(81%)|
|Shareholders' equity||3 026||16 291||(81%)||3 026||16 291||(81%)|
2013 Financial Summary
Income was CHF0.1 million in 2013 compared to CHF0.1 million in 2012, and corresponds to the first installment recognized under a grant received from The Michael J. Fox Foundation for Parkinson's Research to support characterization of dipraglurant for Parkinson's disease levodopa-induced dyskinesia.
Research & Development expenses decreased by 47% to CHF10.9 million in 2013 compared to CHF20.6 million in 2012, primarily due to our significant reduction in headcount and pipeline prioritization.
General & Administration expenses decreased by 11% to CHF5.8 million in 2013 compared to CHF6.5 million in 2012 mainly due to our reduced headcount off-set by the costs of restructuring.
Net Loss decreased by 46% to CHF14.5 million for 2013 compared to CHF27.0 million for 2012, mainly due to the decrease in our operating expenses.
Cash and Cash Equivalents amounted to CHF2.9 million at 31 December 2013, compared to CHF15.3 million at the end of 2012. 2013 cash burn of CHF12.3 million is mainly due to the cash used in operations of CHF16.0 million, off-set by the proceeds from the capital increase, net of costs, of CHF3.1 million and proceeds from the sale of property plant and equipment of CHF0.5 million.
Outlook: Based on current expectations, full year 2014 cash utilization guidance is CHF2.5 million.
Organization and Strategy
The Company has completed its reorganization and reduced its headcount to 5 full time equivalents and significantly reduced its facilities accordingly. The Company is focused on preserving the value of its assets, including the intellectual property surrounding its portfolio of allosteric modulator drug candidates and its proprietary allosteric modulator technology platform, while pursuing a strategy to secure the resources necessary to advance the pipeline and maximize value for shareholders. In parallel the Company continues to enter collaborations with academic institutions, government organizations and patient groups to advance its portfolio of drug candidates for the benefit of patients.
2013 Annual Report
The 2013 Annual report will be available at latest by 31 May 2014. The Company has been granted an extension, by the SIX Exchange Regulation, of the deadline to publish its 2013 annual report of 30 April 2014 until 31 May 2014 due to resource prioritization following its restructuring.
About Addex Therapeutics
Addex Therapeutics (www.addextherapeutics.com) is a discovery and development stage company focused on advancing innovative oral small molecules utilizing its pioneering allosteric modulation-based drug discovery platform. The Company's two lead products are being investigated in Phase 2 clinical testing: dipraglurant (an mGlu5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson's disease levodopa-induced dyskinesia (PD-LID) and rare forms of dystonia; and ADX71149 (mGlu2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals, Inc. Addex also has several preclinical programs including: GABAB receptor positive allosteric modulator (PAM) for addiction, Charcot-Marie-Tooth (type 1a) disease, spasticity in patients with multiple sclerosis (MS), pain, overactive bladder, autism and other disorders; mGlu4 PAM for MS, Parkinson's disease, anxiety and other diseases; mGlu2 NAM for treatment resistant depression and cognitive deficits; and mGlu7 NAM for psychosomatic disorders. Allosteric modulators are an emerging class of small molecule drugs which have the potential to be more specific and confer significant therapeutic advantages over conventional "orthosteric" small molecule or biological drugs. The Company uses its proprietary discovery platform to target receptors and other proteins that are recognized as essential for the therapeutic modulation of important diseases with unmet medical needs.
Chief Executive Officer
+41 22 884 15 61
Disclaimer: The foregoing release may contain forward-looking statements that can be identified by terminology such as "not approvable", "continue", "believes", "believe", "will", "remained open to exploring", "would", "could", or similar expressions, or by express or implied discussions regarding Addex Therapeutics, formerly known as, Addex Pharmaceuticals, its business, the potential approval of its products by regulatory authorities, or regarding potential future revenues from such products. Such forward-looking statements reflect the current views of Addex Therapeutics regarding future events, future economic performance or prospects, and, by their very nature, involve inherent risks and uncertainties, both general and specific, whether known or unknown, and/or any other factor that may materially differ from the plans, objectives, expectations, estimates and intentions expressed or implied in such forward-looking statements. Such may in particular cause actual results with allosteric modulators of mGlu2, mGlu4, mGlu5, mGlu7, GABA-BR or other therapeutic targets to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that allosteric modulators of mGlu2, mGlu4, mGlu5, mGlu7, GABA-BR or other therapeutics targets will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGlu2, mGlu4, mGlu5, mGlu7, GABA-BR or other therapeutic targets will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGlu2, mGlu4, mGlu5, mGlu7, GABA-BR or other therapeutic targets could be affected by, among other things, unexpected actions by our partners, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Addex Therapeutics is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except as may be required by applicable laws.
SIX exemption: Addex Therapeutics Ltd was granted an extension of the deadline to publish its 2013 annual report and to file such report with the SIX Exchange Regulation until 31 May 2014. The extension was granted (i) with the following reservation: trading in the shares of Addex Therapeutics will be suspended in case the 2013 annual report is not published until 31 May 2014, at the latest, in accordance with the provisions regarding ad hoc publicity (art. 53 of the Listing Rules [LR] in conjunction with the Directive on Ad hoc publicity [DAH]). In such case, trading in the shares of Addex Therapeutics Ltd will not be resumed until the 2013 annual report is published according to the provisions regarding ad hoc publicity; and (ii) under the following conditions: Addex Therapeutics is required to publish an ad hoc notice (in accordance with art. 53 LR in conjunction with DAH) until Wednesday, 30 April 2014, 7:30 am CET, at the latest. The ad hoc notice must reproduce the wording of cif. I. of this decision. Further, the ad hoc notice must contain the following information: unaudited financial results for the business year 2013, including the financial and operating highlights, key financial data, the financial summary including an outlook as well as an update on organizational changes and strategy, equivalent to the information provided with the press release of 28 February 2013; and the reason for which Addex Therapeutics Ltd was not able to publish its 2013 annual report until 30 April 2014.