OREANDA-NEWS. Ablynx today announced its non-audited financial position for the first three months of 2016, a business update for the year so far and the outlook for the next period.

Business highlights year-to-date

  • Met primary endpoint of safety and tolerability for the inhaled anti-RSV Nanobody (ALX-0171) in a Phase I/IIa study in infants, aged 1-24 months, hospitalised with an RSV infection. In addition, inhaled ALX-0171 had an immediate impact on viral replication and also reduced viral load, as compared to placebo. There was also an encouraging initial indication of therapeutic effect. These results support the advancement of the programme into a Phase II efficacy study in infants in Q4 2016.
  • Ablynx's partner, Boehringer Ingelheim started two Phase I trials with Nanobodies triggering milestone payments to Ablynx totalling €16 million. The first trial is with a bi-specific anti-VEGF/Ang2 Nanobody, BI 836880, in patients with solid tumours. The second trial is with an anti-CX3CR1 Nanobody, BI 655088, in healthy volunteers - the initial target indication for this Nanobody will be chronic kidney disease.
  • Ablynx's partner, Novartis received clearance by the FDA to start a Phase I study with a Nanobody that binds to a GPCR target, which triggered an undisclosed payment to Ablynx.
  • Publication in The New England Journal of Medicine of the TITAN Phase II study of the wholly-owned anti-vWF Nanobody, caplacizumab, in patients with acquired TTP. Continued progress in recruitment for the Phase III HERCULES study with caplacizumab and preparations are underway to file for conditional approval in Europe in H1 2017.
  • On-track to communicate top line results in Q3 2016 from the Phase IIb RA monotherapy and combination therapy studies of the anti-IL-6R Nanobody, ALX-0061, partnered with AbbVie. Patients from both studies have continued to roll-over into the open-label extension study. Recruitment for the Phase II STEADY study of ALX-0061 in patients with moderate to severe active SLE continues to proceed well, with the goal to communicate initial results in 2018.
  • Initiated 10 pre-clinical proprietary and partnered programmes with now more than 40 programmes in the pipeline, of which 8 are in clinical development.

Financial highlights - first quarter 2016

  • Revenues up 94% to €27.4 million (2015: €14.1 million)
  • Investment in R&D up 49% to €24.9 million (2015: €16.7 million)
  • Operating result of -€0.7 million (2015: -€5.0 million)
  • Net cash outflow of €2.5 million (2015: €12.9 million)
  • €233.7 million in cash, cash equivalents, restricted cash and short-term investments (2015: €193.3 million)

Commenting on today's update, Dr Edwin Moses, CEO of Ablynx, said:
"We are very pleased to report excellent progress since the beginning of the year. Our clinical product pipeline is rapidly expanding with eight programmes now in clinical development, of which two are bi-specific Nanobodies, two are Nanobodies against GPCRs and one is an inhaled product, demonstrating the broad potential of our platform to generate innovative therapeutics. With the positive outcome of the Phase I/IIa study of our wholly-owned inhaled anti-RSV Nanobody, ALX-0171, we have made an important step forward in the development of a possible breakthrough for the treatment of RSV infections in infants. This trial also illustrates the potential to use inhalation as the route of administration in the development of Nanobodies for the treatment of other important lung-based diseases."

Revenues increased 94% to €27.4 million (2015: €14.1 million) mainly driven by higher milestones and recognition of upfront payments from on-going collaborations. As a result of the pipeline maturing with later-stage clinical assets, the operating expenses increased to €28.1 million (2015: €19.1 million) primarily due to higher external R&D costs. The net financial result increased to €17.5 million (2015: €1.1 million) mainly relating to the effect of the fair value calculation of the Convertible Bond. As a result of the above, the Company ended the period with a net profit of €16.8 million (2015: net loss of €4.0 million).

As of 31st March 2016, the Company had €233.7 million in cash, cash equivalents, restricted cash and short-term investments.

Financial guidance and 2016 outlook confirmed

In the third quarter of 2016, Ablynx expects to communicate top line results from the monotherapy and combination therapy studies with the anti-IL-6R Nanobody, ALX-0061, in patients with RA. Following a review of the complete RA data package, AbbVie is expected to decide, before the end of 2016, whether it intends to exercise its option to exclusively license ALX-0061 in RA, in which case Ablynx will receive a US$75 million milestone payment. AbbVie would then be responsible for providing all the resources to further develop and commercialise ALX-0061 in this indication and Ablynx would be eligible to receive regulatory and sales milestones plus double-digit royalties.

In the third quarter of 2016, the Company expects that the first patients from the Phase III HERCULES study of its wholly-owned anti-vWF Nanobody, caplacizumab, will have rolled-over into a three-year follow-up study to evaluate the long-term safety and clinical effects of the product.
In the fourth quarter 2016, Ablynx expects to start a Phase II efficacy study with the wholly-owned inhaled anti-RSV Nanobody, ALX-0171, in infants who are hospitalised as a result of an RSV infection.

The Company reiterates its net cash burn guidance for the full year 2016 of €65-75 million.