Important progress in key programmes and a strategic collaboration with Sanofi
Conference call and webcast today at 4pm CET/10am ET
GHENT, Belgium, 24 August 2017 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its financial results for the six-month period ending 30 June 2017, which have been prepared in accordance with IAS 34 “Interim Financial Reporting” as adopted by the European Union, a business update for the year-to-date and the outlook for the remainder of the year.
Business highlights for the year-to-date
? Caplacizumab – wholly-owned first-in-class anti-vWF Nanobody® for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP)
o submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA)
o completed recruitment of 145 patients in the Phase III HERCULES study, with topline results expected in late Q3 2017
o received Fast Track designation for aTTP from the U.S. Food and Drug Administration (FDA)
? ALX-0171 – wholly-owned inhaled anti-RSV Nanobody
o completed the sequential dose escalation part of the Phase IIb RESPIRE study in 36 infants hospitalised as a result of a respiratory syncytial virus (RSV) infection and subsequently initiated the parallel dose part, with topline results expected in H2 2018
? Vobarilizumab – anti-IL-6R Nanobody
o held “end-of-Phase II” meetings with regulators in Europe and the USA to discuss the Phase IIb data in rheumatoid arthritis (RA) and the design of a potential Phase III programme
o advanced the Phase II study in patients with systemic lupus erythematosus (SLE), with enrollment completed and topline results expected in H1 2018
o after discussions with AbbVie and other potential pharmaceutical partners, decided to await the results of the SLE study, and the outcome of AbbVie’s opt-in decision, before deciding on the future strategy for vobarilizumab
? Partnerships
o entered into a strategic research collaboration with Sanofi on up to eight new programmes, focused initially on immune-mediated inflammatory diseases, with €23 million in upfront payments and up to €2.4 billion in potential milestones plus tiered royalties
o reported encouraging results with the bi-specific anti-IL17-A/F Nanobody in a Phase Ib study in plaque psoriasis run by our partner Merck KGaA
o received a €15 million milestone payment from Merck KGaA for the completion of a pre-clinical package for a novel Nanobody (ALX-1141) targeting ADAMTS-5 in osteoarthritis, with Merck KGaA planning to initiate a Phase I study in H2 2017
REGULATED INFORMATION
o received a €2.5 million milestone payment from Merck & Co., Inc. as a result of their initiation of a toxicology study with a bi-specific Nanobody as part of the immuno-oncology collaboration
Financial highlights for the first six months of 2017
? Revenues of €34.7 million (2016: €53.1 million)
? R&D expenditure of €50.5 million (2016: €49.0 million)
? Operating loss of €24.8 million (2016: €2.0 million)
? Net cash burn1 of €30.9 million (2016: €19.0 million)
? Cash position of €204.5 million (2016: €288.7 million)
Dr Edwin Moses, CEO of Ablynx, commented:
“Completing recruitment on time of 145 patients with aTTP in the Phase III HERCULES study was a key achievement and will allow us to communicate topline results in late Q3 2017. In addition, the filing of our first MAA with the EMA for caplacizumab in aTTP was a very important step for Ablynx as was the Fast Track designation received from the FDA. In parallel, we have been further developing our commercial infrastructure in preparation for a potential first launch of caplacizumab in 2018.”
“We have also made good progress with our wholly-owned, inhaled anti-RSV Nanobody (ALX-0171) as we continue the Phase IIb RESPIRE study. The three initial safety cohorts, encompassing 36 RSV-infected infants, have been satisfactorily completed and after a positive recommendation from the Data Monitoring Committee (DMC), we are now proceeding with the parallel dose exploration part of the RESPIRE study with the aim to recruit an additional 144 infants.”
“During the period, we held meetings with regulators in Europe and the USA to discuss the Phase IIb data generated with vobarilizumab, our IL-6R Nanobody, in RA patients and the path to a Phase III programme. We also continued to have discussions with AbbVie and other potential pharmaceutical partners and have now decided to await the outcome of the SLE study with vobarilizumab in H1 2018, and AbbVie’s subsequent decision on whether to opt-in. If AbbVie does opt-in based on the SLE results, they will pay a US$25 million milestone payment and they will have an obligation to use commercial reasonable efforts to advance the programme in RA. If AbbVie does not opt-in at that point, then all rights to vobarilizumab will revert unencumbered to us and we will decide what next steps we will take with the molecule.”
“As well as achieving important milestones in our collaborations with Merck & Co., Inc. and Merck KGaA, we were also delighted to sign a new strategic collaboration with Sanofi where we will work together on up to eight Nanobody product candidates, initially in the area of immune-mediated inflammatory diseases. In total now we have received payments from our pharmaceutical partners of >€450 million with the potential still to earn >€10 billion in milestone payments plus royalties from the various partnered programmes.”
“Additionally during the period, we were joined by a new Chief Business Officer, Dr Markus Ewert, who will help further strengthen our senior management team.”
“This has been a good period for Ablynx and we look forward to further developments over the next months.”
1 Net cash burn is the difference between the liquidity position of the current and the previous year minus the proceeds (net of issue costs), if any, from the issuance of ordinary shares.
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