Acumen Pharmaceuticals has set the terms for its IPO, teeing it up to raise around $125 million to take an antibody against amyloid-beta oligomers to the end of phase 2 in Alzheimer’s disease.
Virginia-based Acumen filed the paperwork for its proposed Nasdaq IPO days after the FDA granted accelerated approval to Biogen’s Aduhelm. Acumen made the move, which was initially penciled in to raise $100 million, to support the development of an Alzheimer’s candidate that emerged out of a collaboration with Merck that ran from 2003 to 2011.
The project began to regain momentum in 2018, when Acumen raised $15 million and hired some Eli Lilly veterans, and finally reached the clinic this year. The start of the study was held up by a clinical hold the FDA imposed over concerns about potential off-target binding. Now, with that regulatory barrier cleared and the Aduhelm approval revealing an accelerated path to market, Acumen is seeking money for further development of ACU193.
Acumen has priced its IPO at $14 to $16 a share. If Acumen sells the targeted 8.3 million shares at the midpoint of that range, it will reel in $125 million. Acumen has earmarked $75 million for clinical trials of ACU193.
The money will support the phase 1 trial, which is designed to deliver data on safety, tolerability and clinical proof of mechanism by the end of next year. Acumen anticipates having enough money left over to complete the phase 2 portion of a phase 2/3 clinical trial. The company expects the study to start in 2023.
It may be possible for Acumen to seek accelerated approval on the strength of the phase 2 data. Lilly is set to put that prospect to the test by filing for accelerated approval of its Alzheimer’s candidate donanemab on the basis of a 257-subject phase 2 clinical trial later this year.
If the FDA is willing to grant accelerated approval to Alzheimer’s drugs on the strength of midphase data against surrogate endpoints, Lilly and other companies may have joined Biogen on the market by the time Acumen has the evidence to support a submission to the FDA. The challenge then will be to differentiate ACU193 from other products on the market.
Acumen sets out the potential advantages of its candidate in the IPO filing. Unlike molecules such as Aduhelm and donanemab, ACU193 barely binds with amyloid plaque, but rather is designed to zero in on amyloid-beta oligomers. Acumen argues the approach means its drug hits the primary toxin behind the initiation and propagation of Alzheimer’s and is less likely to cause amyloid-related imaging abnormalities.
Some big-name investors are betting Acumen can make money from ACU193. Key investors include BlackRock, PBM Capital and RA Capital Management. This month, Acumen closed the second tranche of its series B round, pulling in $30 million.