CAR-T specialist Allogene is planning to raise around $287 million from a public listing that signals a swift return to Wall Street for Arie Belldegrun and David Chang.
The ex-Kite Pharma executive sold the company to Gilead for $12 billion last year only to launch Allogene just a few months later, switching track to focus on allogeneic or ‘off-the-shelf’ CAR-T that doesn’t require cells to be harvested from patients.
Allogene debuted with $300 million in first-round capital and a suite of CAR-T assets licensed from Cellectis by way of Pfizer, and Belldegrun and Chang topped up the pot with another $120 million from a private placement last month.
The proposed IPO would take the fundraising tally to around $700 million, and is for considerably more than the $100 million initially proposed in mid-September, reflecting an ambitious development timeframe for Allogene’s CAR-T programs. The plan is to sell 16 million shares at between $16 and $18 per share and, according to Renaissance Capital, that would give the biotech an enterprise value of $1.4 billion.
The latest raise will go towards funding four trials of Servier-partnered lead candidate UCART19 in CD19-expressing blood cancers malignancies, as well as the first studies of follow-up candidates ALLO-501 and ALLO-715, early-stage R&D, and expansion of Allogene’s facilities.
Some of the cash may also go towards licensing in new assets, said Allogene in its latest IPO prospectus, which is seeking a Nasdaq listing under the ALLO symbol. If all goes to plan, the biotech reckons it will have the resources it needs to fund the next three years of operations.
That timeframe takes it through the CALM and PALL clinical trial programs, which are testing UCART19 in relapsed or refractory B-cell precursor acute lymphoblastic leukemia, although Allogene said it may need to raise more funds to complete the CALM II and PALL II registration studies which are due to get underway in the second half of 2019.
ALLO-501 the same molecular design as UCART19 and also targets CD19, but uses a different manufacturing method that Allogene said is more efficient and easier to scale up. It’s also partnered with Servier and the companies intend to file for FDA approval to start trials in non-Hodgkin's lymphoma in the first half of next year.
Following after is ALLO-715, targeting B-cell maturation antigen with a lead indication in multiple myeloma and is scheduled to start clinical trials in 2019.
It’s worth noting that Allogene’s CALM and PALL trials use Sanofi’s CD52-targeting drug Lemtrada (alemtuzumab) to deplete patients’ immune systems ahead of the CAR-T procedure, and the biotech has decided to develop its own CD52 agent to ensure a secure supply.
Its planning to pursue a truncated regulatory pathway via the FDA’s Drug Master File system for approval to use the antibody—called ALLO-647—in clinical trials.
Goldman Sachs, J.P. Morgan, Cowen and Jefferies are the joint bookrunners on the IPO, said Renaissance Capital. It is expected to price during the week of Oct. 8.