SpringWorks seeks $115M to push Pfizer drugs across finish line while Satsuma sells migraine play in $86M IPO
Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.
To be sure, the company is still flush with cash. In an SEC filing, SpringWorks says it’s been going through the $102 million Series A for the operations, with $185.3 in cash and cash equivalents remaining at last count. The new infusion from a public debut should extend the runway to 2022.
Pfizer’s Lara Sullivan got the support in August 2017 to split off four promising assets that nevertheless didn’t make the internal R&D cut into a new shop. As soon as the deal was sealed execs got to work repurposing the drugs for rare tumors, racking up orphan drug and fast track designations along the way. Nirogacestat, a gamma secretase inhibitor, is in a Phase III trial for the treatment of desmoid tumors (rare soft tissue tumors); mirdametinib, a MEK inhibitor, is being tested in Phase IIb for neurofibromatosis type 1-associated plexiform neurofibromas.
Both of these targets are well defined, with multiple trials for related drugs over the past decade or more. The gamma secretase inhibitor was born in the Alzheimer’s field, where Eli Lilly experienced a colossal disaster years ago. That MEK inhibitor, SpringWorks execs say, also has potential to make good as a backbone combination drug in oncology, following other approved therapies. In fact, Pfizer had recently bagged one such drug — Mektovi — in its $11.4 billion buyout of Array Biopharma.
With potentially registrational trials on the way, Pfizer stands to receive $462 million in milestones — or more if SpringWorks in-licenses some of the compounds that the pharma giant has agreed to make available once a year until next October.
Meanwhile, Saqib Islam, who was promoted to CEO after serving as the first CFO and CBO, has also championed a couple of collaborations with BeiGene and GlaxoSmithKline.
The former features a Phase Ib combo trial of mirdametinib and lifirafenib for a one-two punch of MEK and RAF in solid tumors. The latter pairs nirogacestat with belantamab mafodotin, an anti-BCMA ADC that GSK R&D chief Hal Barron has touted for tough cases of multiple myeloma.
Then there’s BGB-3245, a preclinical BRAF inhibitor from BeiGene that covers both V600 and non-V600 BRAF mutations. Owned by a joint venture with the China-based partner dubbed MapKure, the drug can eventually form the backbone of a regimen (again, together with mirdametinib) that competes directly with Pfizer.
For all his efforts Islam was rewarded with a compensation package worth more than $1.7 million, the majority of which was in stock. Sullivan, the former president, received close to $1.3 million in 2018.
John Kollins and his team at Satsuma Pharmaceuticals have been much more laser-focused, but still busy. The San Francisco biotech closed a $62 million Series B in April, bringing in a slate of new investors, and jumped right into a Phase III efficacy trial for its migraine drug/device last month. Now it’s looking to pile up its cash reserves as it pencils in a $86 million IPO.
The company was spun out of Japan’s Shin Nippon Biomedical Laboratories two years ago with a singular mission: To develop a dry-powder nasal formulation of the generic drug dihydroergotamine, delivered by a tech from the parent company.
DHE works by tightening blood vessels in the brain and inhibiting the release of pro-inflammatory substances. Unlike the much-watched CGRP class, it is designed for acute treatment instead of prevention. Although nasal sprays are currently available, they are generally considered less effective than the injectable versions — something Satsuma is out to change.
A Phase I trial among 42 healthy volunteers showed that STS101 induced the target DHE plasma concentration within 10 minutes, and hit all measures of drug exposure.
Satsuma intends to recruit 1,140 patients for the Phase III study it’s just kickstarted, release topline data and commence a 12-month safety trial in Q2 2020, then file an NDA by the end of 2021.
CEO Kollins — an alum of Athena Neurosciences and Amgen-acquired Immunex — and his head of operations, Mic Iwashima, have spent $23.9 million executing the quick leap to late-stage development. There’s still $47.6 million in the bank, including a $5 million loan from Silicon Valley Bank. The current headcount of full-time employees sits at 11.
To realize all of its plans, though, Satsuma will likely need to expand drastically. From the S-1:
If approved, we plan to commercialize STS101 in the United States by building a specialized sales organization focusing on headache specialists, as well as general neurologists and primary care physicians who are high prescribers of migraine therapeutics.
Its plans to seek ex-US partners for the drug also calls for a larger business development team.
For now, though, much of the IPO proceeds should go toward the Phase III trials.