Very important clinical pipeline developments and a successful financing.
GHENT, Belgium, 25 August 2016 – Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its financial results for the six-month period ending 30 June 2016, which have been prepared in accordance with the IAS 34 “Interim Financial Reporting” as adopted by the European Union, a business update for the year-to-date and the outlook for the next period.
R&D highlights year-to-date
Delivered compelling efficacy and safety results from both Phase IIb RA monotherapy and combination therapy studies of vobarilizumab
Reported encouraging data from the Phase I/IIa study of inhaled ALX-0171 in infants hospitalised with an RSV infection
Good progress in the recruitment of patients in the Phase III HERCULES study with caplacizumab in acquired TTP
Three partnered Nanobody® programmes began Phase I clinical development
Initiated >15 new wholly-owned and partnered pre-clinical programmes bringing the total active programmes in the R&D pipeline to >45
Financial highlights first six months of 2016
Total revenues were €53.5 million, a 39% increase compared with 2015
Operating loss reduced to €2.0 million, compared with €7.4 million in 2015
Net profit of €22.8 million, mainly driven by the accounting treatment of the convertible bond
Cash position of €288.7 million, strengthened by the successful private placement of new shares (raising €71.4 million in net proceeds)
Outlook for the remainder of the year confirmed
“It has been a hugely productive year so far for us,” said Dr Edwin Moses, CEO of Ablynx. “We successfully completed three clinical trials in RSV and RA and the results provide an excellent platform for the continued development of both ALX-0171 and vobarilizumab. With ALX-0171, we are now preparing for a worldwide Phase II efficacy study in hospitalised infants with an RSV infection which is expected to start before the end of the year. The Phase IIb data for vobarilizumab give us great confidence that the molecule should move into Phase III development as soon as possible. We are now preparing the complete data package from the Phase IIb vobarilizumab studies for AbbVie and we expect them to decide before the end of the year if they wish to opt-in and license the product for RA. In parallel, we are starting preparations for a Phase III programme with vobarilizumab in RA and we plan to move forward with this in the event AbbVie do not opt-in, while then at the same exploring new relationships which will allow us to maximize the potential of this exciting drug candidate.”
“We continued to make good progress in our most advanced clinical programme, where we are developing caplacizumab for the treatment of acquired TTP, and are on track to file the dossier for conditional approval in Europe early next year. Recruitment for the HERCULES Phase III trial with caplacizumab in acquired TTP patients is proceeding well and we now intend to increase the power of the key secondary efficacy endpoint by recruiting about 40% more patients than originally planned while still aiming to meet our original goal to report the study results before the end of 2017.”
“Our R&D pipeline is developing very encouragingly and now includes more than 45 proprietary and partnered programmes. Three new programmes entered clinical development with our partners and >15 new wholly-owned and partnered discovery programmes have been initiated since the beginning of the year, demonstrating our commitment to continue to fuel our product pipeline.”
“In June, we further strengthened our cash position through a €74.2 million (gross) oversubscribed private placement of new shares with existing and new investors, and we remain focused on delivering sustainable value to all our stakeholders.”
Financial review – 1 January 2016 to 30 June 2016
Key figures
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Outlook for the remainder of 2016 confirmed
In Q3 2016, Ablynx expects to start the three year follow-up study with patients that completed the Phase III HERCULES study of its wholly-owned anti-vWF Nanobody, caplacizumab. In parallel, the Company will continue the preparations to file the dossier for conditional approval of caplacizumab in Europe in early 2017.
In Q4 2016, Ablynx plans to initiate a Phase II dose-ranging efficacy study of ALX-0171 in infants aged 1-24 months who have been hospitalised as a result of an RSV infection.
Following the successful completion of the two Phase IIb studies of vobarilizumab, partnered with AbbVie, in a total of 596 RA patients, the Company is on track to transfer the complete RA data package to AbbVie and to start the preparations to initiate a Phase III programme with vobarilizumab. AbbVie’s decision on whether they will opt-in and license the programme in RA is expected before the end of the year, and if they do, Ablynx would be eligible to receive a US$75 million opt-in fee as well as regulatory and sales milestones plus tiered double-digit royalties. In the event AbbVie do not decide to opt-in, Ablynx is committed to initiating a Phase III programme itself while in parallel exploring new relationships which will allow the Company to develop this asset in RA.
Additionally, various pre-clinical milestones may be received by Ablynx in other partnered programmes.
The Company reiterates its net cash burn guidance for the full year 2016 which is expected to be in the range of €65-75 million, not including the potential licensing payment of US$75 million by AbbVie for opting-in and licensing vobarilizumab in RA.
tijd 09.12
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