QUARTERLY NEWSLETTER Q4 2013 Issue No 4 PARTNERING NEWS Dear Reader, On 18th October, Ablynx signed an exclusive license agreement with Eddingpharm for the development and commercialisation of the anti-RANKL Nanobody, ALX0141, in Greater China, for the treatment of bone related disorders, including osteoporosis and bone metastases. We are pleased to send you Ablynx’s quarterly newsletter designed to provide an update for the investment community. Ablynx received an upfront payment of €2 million and is eligible to receive commercial milestones plus tiered, double-digit royalties of up to 20%. Ablynx will have access to the clinical data generated by Eddingpharm and retains full ownership over the programme in other regions ex Greater China. This newsletter highlights the key progress Ablynx has made during the fourth quarter of 2013 and also gives an overview of the investor events Ablynx has participated in, as well as the upcoming events where you have an opportunity to meet with management. This is Ablynx’s first step in exploring business opportunities in emerging markets. PIPELINE UPDATE On 29th October, Ablynx announced that its partner Boehringer Ingelheim dosed the first healthy volunteers in a Phase I clinical trial as part of the evaluation of a Nanobody for the treatment of Alzheimer’s disease. The start of the Phase I study triggered a milestone payment of €5 million to Ablynx. The study is expected to recruit 80 subjects and results are anticipated during H2 2014. At the time of its business update for the first nine months of 2013, Ablynx announced that it had adapted the protocol of the global Phase II trial with caplacizumab in order to help facilitate recruitment. Ablynx is monitoring the situation closely and during early 2014 the Company will assess whether recruitment has improved sufficiently to complete the trial before the end of the year. Potential proof-of-concept results on 110 patients would then be available towards the end of 2014. If, however, recruitment has not improved sufficiently, Ablynx will stop the trial early, analyse and present the data during H1 2014. If these data are encouraging and demonstrate proof-of-concept, a simplified Phase III clinical trial is expected to be designed and executed. CORPORATE DEVELOPMENT Ablynx has seen an important evolution of its shareholder base towards long-term financial institutions, which has allowed the exit of a large proportion of the remaining venture capital shareholders. During the full year 2013, 17 million shares from venture capital investors have successfully been placed with new institutional investors in Europe and the United States. As a result, the free float of the Company has increased from 53% at the end of 2012 to 85% today. As part of this maturing of Ablynx, the Company established a fully independent Board of Directors with significant industry experience which further strengthens Ablynx’s position as a leading European biopharmaceutical company. The roles of Chairman and CEO have been separated with Dr Edwin Moses remaining as Chief Executive Officer and Dr Peter Fellner appointed as his successor as Chairman. Dr Bo Jesper Hansen and Dr William Jenkins have been appointed as independent Directors to replace Dr Stephen Bunting and Mr Denis Lucquin who have resigned from the Ablynx Board. For further information please email us: [email protected] or phone +32 9 262 00 00 1 SCIENTIFIC CONFERENCES FINANCIAL AND CORPORATE NEWS Ablynx presented pre-clinical proof-of-concept data from ALX-0761 at the Annual Meeting of the American College of Rheumatology (ACR). The poster presentation included data from in vivo experiments that assessed the efficacy of ALX0761 in a cynomolgus monkey model that mimics human rheumatoid arthritis. In addition, total target levels of both IL-17A and IL-17F, pharmacodynamic biomarkers, immunogenicity and drug exposure were presented. Business update for the first nine months of 2013 ALX-0761 is a bi-specific half-life extended Nanobody that neutralises both IL-17A and IL-17F. The Nanobody is currently in Phase I clinical development by Ablynx’s partner Merck Serono. Following the successful private placement completed on 28th February 2013, the Company had a positive net cash inflow of €0.2 million (2012: cash burn of €18.8 million), and ended the period with a strong financial position of €63.0 million in cash, cash equivalents, restricted cash and short-term investments. The poster is available on the Ablynx website. SHAREHOLDERS’ CLUBS AT ABLYNX On 14th November, Ablynx announced its results for the first nine months ending 30th September 2013. Revenues were €16.7 million (2012: €22.2 million) and included FTE and contract income from on-going collaborations and a milestone payment from Merck Serono. Operating expenses decreased to €36.2 million (2012: €45.4 million) due to lower R&D costs primarily in external development costs. The net loss for the period was €18.9 million (2012: €22.3 million). SHAREHOLDER STRUCTURE Ablynx organises on a regular basis shareholders’ clubs at its headquarters in Ghent where individual retail investors have the opportunity to meet with the CFO and visit the laboratories. The next event (Dutch only) is scheduled to take place on 13th March 2014 at 17.45h CET. If you would like to attend, please make your registration via [email protected]. The calendar for all upcoming shareholders clubs is available on the Ablynx website. Ablynx is evaluating the option to extend the shareholders’ club to be held in English or French. Please email [email protected] if you would like to attend the event in English or French. FINANCIAL CALENDAR 2014 IR EVENTS IN Q1 2014 INSTITUTIONAL INVESTORS 13th -16th January 2014 Annual JP Morgan Healthcare Conference – San Francisco – presentation on 16th Jan at 2pm PST 27 February 14 May 28 August 13 November – – – – Full year results 2013 Q1 2014 results Half year results 2014 Q3 2014 results 27th March 2014 BioCapital 2014 - Amsterdam RECENT IR EVENTS IR EVENTS IN Q1 2014 INDIVIDUAL INVESTORS During the fourth quarter, Ablynx met with about 90 institutional investors during 1-1 meetings at the annual KBC Biotech & Healthcare Conference in New York and the Global Jefferies Healthcare Conference in London, as well as road shows in Europe and New York. 22nd March 2014 KBC Private Banking Investors Forum – Ghent The Company also met with individual investors during four retail investors’ events organised at Ablynx and a retail investors’ event organised in Ghent by the Flemish Federation of Investors (VFB). 24th March 2014 VFB Trefpunt – Brussels MARIEKE VERMEERSCH Associate Director Investor Relations Ablynx nv Technologiepark 21 9052 Zwijnaarde Belguim Tel +32 (0)9 262 00 82 Fax +32 (0)9 262 00 01 Mobile +32 (0) 479 490 603 [email protected] www.ablynx.com 2
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