X4 slashes pipeline, lays off staff just three weeks after netting a $55M PIPE

21 Jul 2022
endpts.com
Not even a PIPE financing could save X4 Pharmaceuticals from enacting layoffs and trimming its pipeline. The Boston biotech revealed Wednesday afternoon that it would downsize its research to focus on its lead program, mavorixafor, and lay off about 20% of its staff. The move comes less than three weeks after X4 pulled together a $55 million PIPE and amended a loan facility with Hercules Capital to reduce cash burn. “We believe that commercializing mavorixafor and providing a new therapeutic option to individuals with life-threatening CN disorders has the potential to revolutionize the treatment landscape,” CEO Paula Ragan said in a statement. X4 is developing mavorixafor in a handful of different indications, with the top priority being WHIM syndrome (warts, hypogammaglobulinemia, infections, and myelokathexis). Data from a Phase III study are expected in the fourth quarter this year, X4 said Wednesday, and an FDA submission is expected in the second half of 2023. That would also mark a delay from the company’s previous guidance of 2023’s first quarter. X4 said as recently as its Q3 2021 report the NDA would come during that quarter, though its language shifted in a Q4 filing to a “possible” NDA in 2023’s latter half. Researchers are also developing the program for chronic neutropenic disorders, where Phase Ib data are expected to inform next regulatory steps this quarter. But with the reorganization, X4 now plans to partner out some of mavorixafor’s development costs. The biotech is currently researching how the program can impact patients with a rare form of non-Hodgkin lymphoma known as Waldenström’s macroglobulinemia, but despite new Phase Ib data expected next month, execs say new trials won’t go forward without a partner. X4’s other two announced programs, two small-molecule CXCR4 antagonists called X4P-003 and X4P-002, were placed essentially in limbo. X4P-003’s next steps will depend on an approval for mavorixafor, the biotech said, while X4P-002 — which hasn’t reached an IND filing — will only advance if X4 finds a partner. Mavorixafor came to X4 in a 2015 deal with Sanofi, as the company launched with cash from Genzyme founder Henri Termeer and the program it picked up off the Big Pharma’s scrapheap. The company added another $27 million in a 2017 Series B before reverse-merging onto Nasdaq in late 2018, using a subsidiary of the now-defunct Arsanis.
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