If at first you don’t succeed… maybe it wasn’t such a good idea.
Alzheon has learned that the hard way as it withdraws its IPO for a second time, despite drastically downsizing the offering and adjusting its goal from a Phase III pivotal study to a Phase IIb for its lead drug.
That wasn’t enough to woo investors into backing its ultra-risky project of turning a once-failed drug for Alzheimer’s, at a time the humiliating flop at Axovant — which essentially pursued the same strategy — still haunts its stock.
It doesn’t help Alzheon’s odds that its pursuing the amyloid beta hypothesis, which has defeated every drug thrown at it so far in a pivotal study. Having licensed the drug, now dubbed ALZ-801, from Montreal-based Bellus Health (formerly Neurochem) back in 2013, Alzheon made some tweaks to the once-daily pill that the company hopes will get the drug to its target more quickly while reducing side effects in the gut.
Back in 2016, Alzheon’s CEO Martin Tolar told Endpoints News the company would need more like $100 million to pay for two Phase III studies for the lead drug — substantially less than what other late-stage Alzheimer’s programs would cost, he argued, because it’s targeting “patients known to have risk factors for amyloid pathology.” Under that plan, formulated based on a post doc analysis, Alzheon would only need to recruit 500 patients each for its two Phase III trials, focusing on a genetically-defined AD population of APOE4/4 homozygotes.
It first filed for an $80 million IPO in March 2018, only to step back from it a month later. The second attempt was launched in last August, eyeing $30 million in proceeds. At that point, according to the S-1, it was running on a little more than $3 million in cash and cash equivalents.
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