Roivant CEO hints at more deals shaping up as key Immunovant data loom

Roivant Sciences has more potential asset deals in the works — after setting up two Vants around Pfizer assets in the past two years — and hopes to be talking about them in 2024, CEO Matt Gline told analysts on a quarterly earnings call on Monday morning.

Before that, key data from its family of Vants, including clinical trial readouts from two anti-FcRn assets at the publicly-traded Immunovant, are on tap. The data could dictate the direction Roivant takes.

“We are in a privileged moment in terms of the amount of clinical data we have generated and will generate soon,” Gline told analysts. “That data is both deeply informative to our own strategic future and also exciting to potential partners, acquirers and so on.”

The Wall Street Journal, citing unnamed sources, reported last month that Roche is in talks to buy Roivant’s Pfizer-derived asset RVT-3101, part of the hot immunology and inflammation space that has shot up to the top of many business development hunts. On the call, Gline said it’s “flattering to be the focus of attention.”

“We’ve got things on our racket right now that are just as exciting to me, bluntly, as anything in our late-stage portfolio, and I hope we can convert some of those, and that next year we’ll be talking about them as well,” Gline said, noting it’s been a “phenomenal asset-sourcing environment” for Roivant.

The company had $1.4 billion in consolidated cash, cash equivalents and restricted cash at the end of June, per the quarterly update.

As Immunovant said in its own update last week, Roivant reiterated Monday that the company expects key Phase I single-ascending dose data on IMVT-1402 in September and multiple-ascending dose data in October or November of this year. Immunovant also anticipates data by year’s end for its lead candidate batoclimab in a Phase II trial for Graves’ disease. The drug is also being tested in myasthenia gravis, thyroid eye disease and other indications.

“On the monetization side, we’re value-oriented, and we’re going to have to make these decisions carefully knowing that a number of our late-stage programs are really rare opportunities with huge potential, so we don’t take any decision on the meter direction lightly, with the dollar sums at hand being very large and the opportunity for patients being very large,” Gline said. “I certainly wouldn’t expect us to make any decisions of substance on this point until we’ve started to get some of the Immunovant data in, just because that’s a pretty important strategic catalyst for us as we think through what the future of Roivant could look like across the breadth of our portfolio.”

Mayukh Sukhatme

Roivant also disclosed new data on what it called the sixth positive Phase II study of its oral autoimmune candidate brepocitinib, which comes from Pfizer as part of their Priovant collaboration. The biotech said the drug cleared a 12-week induction period with statistical significance on the primary endpoint, which tracked the endoscopic response rate. With a 21.4% difference from placebo, Priovant reported a one-sided p-value of 0.0012. On the secondary endpoint, measuring the clinical remission rate, Priovant reported a 33.5% difference from placebo for patients on the oral candidate.

En route to what Roivant president Mayukh Sukhatme predicts to be blockbuster potential in each indication it goes after, the company said it plans to report topline results from a potentially registrational Phase IIb study in systemic lupus erythematosus by year’s end.

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