Ionis’ Akcea closes in on $125M IPO to fund phase 3 trials

Akcea will use $80 million of the IPO haul to bring volanesorsen to market (Getty Images)

Akcea Therapeutics is closing in on an IPO expected to gross in the region of $125 million. The Ionis Pharmaceuticals’ lipid disorder subsidiary plans to spend most of the money on the generation of phase 3 data to support the approval of volanesorsen in two indications.

Cambridge, MA-based Akcea is aiming to offload close to 10 million shares for between $12 and $14 each. If Akcea hits the midpoint of the range, the IPO will gross $125 million. But if Akcea can sell the shares for $14 a pop and shift its overallotment, the total will swell past $150 million.

Akcea is also in line to get up to $50 million from Novartis through a separate private placement. That investment is one part of the deal Novartis struck with Ionis and Akcea in January, the value of which could ultimately hit $1 billion.

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The infusion of capital will equip Akcea to advance on multiple fronts. Management has set aside $80 million to wrap up development of volanesorsen in familial chylomicronemia syndrome (FCS) and familial partial lipodystrophy (FPL) and bring it to market in both indications. Akcea plans to file for approval in FCS in the third quarter on the strength of data that linked it to a sharp drop in triglyceride levels but failed to quash safety concerns. Phase 3 FPL data are due in 2019.

Akcea has earmarked a further $70 million for phase 2 trials of three other drugs, two of which are covered by the collaboration with Novartis. Data from the phase 2b trials of AKCEA-APO(a)-LRx in patients with hyperlipoproteinemia and AKCEA-APOCIII-LRx in patients with hypertriglyceridemia will dictate whether Novartis exercises its $150 million options on the assets.

The opt-in decisions contribute to a busy, stock-moving schedule for Akcea and investors who back the IPO.

Whether those stock moves are positive or negative will depend on how the risks and benefits of Akcea’s antisense drugs are perceived. Efficacy data on volanesorsen show it lowers triglycerides. But reports of sharp drops in platelets in patients taking volanesorsen and other antisense drugs have raised concerns of a class-wide problem that would harm Akcea’s prospects.

Akcea has downplayed such concerns while arguing the benefits of volanesorsen outweigh the risks. The biotech plans to help healthcare providers manage those risks if volanesorsen comes to market by providing routine platelet monitoring.