Tempest Therapeutics jumps onto Nasdaq in merger with struggling Millendo Therapeutics; Biohaven hits $100M milestone as it gears up for a late-stage study in migraine patients
Less than a month after landing a Big Pharma partner on one of its lead oncology programs, Tempest Therapeutics is backflipping onto Nasdaq through a reverse merger with Millendo Therapeutics.
Back in January, Millendo shut down the sole remaining early-stage study for its NK3R antagonist MLE-301 — just nine months after pulling the plug on a pivotal study for its lead drug livoletide. The biotech planned some deep cuts for the remaining staff, while looking for a sale or merger.
In support of the merger, Tempest secured commitments from a slate of investors for a $30 million PIPE financing, including Versant Ventures, Rock Springs Capital, F-Prime Capital, Monashee Investment Management, Quan Capital, Lyfe Capital, Maven Investment Partners US, Lilly Asia Ventures and Eight Roads Ventures, the company said on Monday. Overall, the deal should extend the company’s cash runway through early 2023, according to a statement.
Earlier this month, the company inked a deal with Roche to study its TPST-1120 in combination with Tecentriq and Avastin in previously untreated patients with advanced hepatocellular carcinoma (HCC). The company also has TPST-1495, which is in a Phase Ia/Ib dose and schedule optimization study in patients with advanced solid tumors, specifically known prostaglandin-driven tumors like colorectal cancer, lung adenocarcinoma and urothelial cancer.
“The transition of Tempest to a public company enhances our ability to fund these potentially important product candidates, as well as consider additional programs with exciting new targets,” CEO Tom Dubensky said in a statement.
The merger is expected to close in the first half of this year, with Millendo stockholders expected to own approximately 18.5% of the combined company and pre-merger Tempest stockholders to hold 81.5%.
Biohaven hits $100M milestone as it gears up for a late-stage study in migraine patients
Biohaven has officially launched a Phase II/III trial for its oral migraine drug, triggering a $100 million payoff from Royalty Pharma.
Back in August, Biohaven added nearly $1 billion to its balance sheet through a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of its new migraine drug, Nurtec. As part of an agreement with Royalty, Biohaven was promised up to $250 million to advance its zavegepant in migraine and other CGRP-mediated diseases. Biohaven had already pocketed $150 million, and will now receive the last $100 million as it enrolls the first patient in the Phase II/III study. In total, Biohaven is looking for 2,900 migraine patients to test the efficacy and safety of 100 mg and 200 mg doses of oral zavegepant.
“Our successful, multi-year partnership with Biohaven to support both the regulatory approval and commercialization of Nurtec as well as pipeline development is an excellent example of how Royalty Pharma can be a collaborative partner to innovative biopharma companies,” Royalty CSO and co-head of research and investments Jim Reddoch said in a statement.
An intranasal formulation of zavegepant, formerly known as vazegepant, achieved superior efficacy to placebo in a Phase II/III study, the company said.
Simcere promises nearly $300M for the rights to a former Genentech candidate
There’s a new glioblastoma candidate in Greater China.
Simcere Pharmaceutical Group is putting down $11 million upfront and up to $281 in milestones for the development and commercialization rights to Kazia Therapeutics’ paxalisib — a PI3K inhibitor licensed from Genentech back in 2016. The candidate entered a pivotal study earlier this year, and is in seven additional studies for other brain cancers.
“The need for new therapies in brain cancer is significant in China, and we share Kazia’s commitment to bringing forward new treatment options for patients,” Simcere senior VP Renhong Tang said in a statement.
Paxalisib is distinguished by its ability to cross the blood-brain barrier, which prevents many drugs from fully affecting brain tissue, the company said.
Simcere’s upfront payment includes $7 million in cash and a $4 million equity investment. In addition to the $281 million in milestones for glioblastoma, Kazia can snag more for other indications, according to the deal. And Simcere will dole out commercial royalties in the “mid-teens.” Simcere can develop and market the drug in Mainland China, Hong Kong, Macau, and Taiwan, while Kazia retains the rights everywhere else.