DUBLIN – Ablynx NV took in €74.2 million (US$82.8 million) in an upsized share placing that adds about an extra year's cash to its balance sheet and extends its strategic options across multiple facets of the business.

The Ghent, Belgium-based company had originally planned to raise €60 million via an accelerated bookbuilding procedure, which it priced at €13.40 per share, a 6.3 percent discount to its closing share price Tuesday. There was enough demand, however, to enable it to place about 5.5 million new shares with domestic and international investors, representing 10 percent of the company's equity base prior to the transaction. The share sale offered a large-scale buying opportunity to institutional investors, including those from the U.S., who would not be able to build up a large holding by trading on the open market.

"People who want to enter the stock want to enter with a significant ticket," CEO Edwin Moses told BioWorld Today.

The equity raise follows a five-year €100 million convertible bond issue, which it completed last year. The company reported €230 million on its balance sheet on March 31 and is guiding €65 million to €75 million in cash burn this year.

Ablynx has plenty of cash, but it also has plenty of ways to spend it. As its clinical pipeline of llama-derived nanobody drugs starts to mature, it is considering how to build further value by exploring additional indications for existing drug candidates, by triggering co-development options on preclinical programs that reach the clinic and by leveraging know-how gained on existing programs – such as its inhaled biologic ALX-0171 for treating pediatric respiratory syncytial virus (RSV) infection – into new therapeutic areas.

It may also in-license additional products to complement its lead asset, caplacizumab, which it plans to commercialize in-house.

Caplacizumab, which targets the blood-clotting protein von Willebrand factor (vWF), is in development for acute episodes of acquired thrombotic thrombocytopenic purpura, an autoimmune disorder characterized by the presence of extensive microscopic clots in the microvasculature. The condition, which is caused by the presence of autoantibodies directed against ADAMTS13, an enzyme that cleaves the vWF precursor, leads to excessive platelet aggregation and low blood platelet counts. Plasma exchange and immunosuppression are the standard of care. Caplacizumab, which prevents vWF from binding the platelet glycoprotein Ib-IX-V receptor, is being positioned as an add-on therapy, as it speeds up time to normalization of platelet counts. (See BioWorld Today, June 18, 2014.)

Ablynx is on track to file for conditional approval in Europe in the first half of 2017, on the back of phase II data, which appeared in the Feb. 11, 2016, issue of The New England Journal of Medicine. It aims to complete a confirmatory phase III trial by the end of 2017, which would form the basis of a U.S. biologics license application filing in early 2018.

The company is also considering development of the drug for prophylactic therapy, based on identifying biomarkers in patients that could anticipate an acute episode before its onset. It is currently working to that end with key opinion leaders around the world, who have built up patient registries, Moses said. It is also considering development of caplacizumab in other disorders in which vWF is implicated.

Plans to commercialize the drug are also under way. "We're building a limited but focused commercial infrastructure," Moses said.

It will require an organization of about 100 people to commercialize the drug in the U.S. and Europe. Initially about two-thirds of those will be working for a contract sales force. "We can backward integrate these people as the drug becomes a success," he said.

To leverage that investment, Ablynx also wants to add in additional commercial products. "What we'd like is something that's important to the same physicians and ideally to the same patient groups," Moses said.

"We'd like it to be a complementary technology as well," he added. A biologic product aimed at hematologists would fit the profile of what the company is looking for. The firm is open to franchises with peak sales estimates in the €100 million to €200 million range, below big pharma's threshold of interest.

Caplacizumab has a peak sales estimate of €300 million attached to it.

ABBVIE OPTION THIS YEAR

The new funding will enable the company to take ALX-0171 through clinical proof of concept in infants before seeking a deal, while also exploring its potential in other populations, such as elderly adults.

But the ability to deliver biologic drugs to the lung opens up additional avenues to explore. "It's a simple step to deliver nanobodies into the lung in other indications, not just RSV," said Moses. The company does not get credit from the market for capabilities such as this, he said. "We don't get the read-through."

The company is facing a big payday later this year, as a phase IIb trial in rheumatoid arthritis of ALX-0061, an anti-interleukin 6 receptor (IL-6R) nanobody, is due to read out in the third quarter. It would pocket a $75 million milestone if partner Abbvie Inc., of North Chicago, triggered an option to take it into phase III development.

Basel, Switzerland-based Roche Holding AG is already on the market with its blockbuster anti-IL-6R antibody, Actemra (tocilizumab).

ALX-0061 has a different binding profile, which may differentiate its safety and efficacy profiles. It selectively binds the soluble form of the IL-6R, Moses said, whereas Actemra nonselectively binds both the soluble and membrane-bound forms of the receptor.

"We're hoping we have a molecule that has a lot of the benefits of something like Actemra, but which also has some advantages, he said.

Shares in Ablynx (BRUSSELS:ABLX) closed Thursday at €13.40, down 6.3 percent.

No Comments