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Athira, armed with data on 11 patients, plans $100M IPO to fund pivotal Alzheimer’s trial

Athira Pharma has filed to raise $100 million on public markets to take a treatment for Alzheimer’s and Parkinson’s diseases through phase 2 clinical trials. The IPO will fund development of an HGF/MET activator Athira thinks can treat neurological diseases by promoting a natural regenerative system.

The biotech, formerly known as M3 Biotechnology, is moving lead candidate ATH-1017 into a pivotal phase 2/3 Alzheimer’s trial on the strength of an early-phase program that enrolled 11 patients with mild to moderate disease and 77 healthy volunteers. After eight days of treatment, P300 latency in the Alzheimer’s patients had “returned to levels close to those observed in healthy elderly subjects.”

Athira attributes the change in P300 latency, which it expects to correlate to improved cognition, to the “long-term regeneration of neuronal connections and the improvement in brain function.” While Athira is yet to link ATH-1017 to improved cognition, it has persuaded investors to bankroll its plans.

In June, Perceptive Advisors led an $85 million series B round, securing itself a 12% stake in Athira. Now, Athira is turning to public investors for more money to support its clinical development plans.

Using the IPO haul, Athira plans to start the phase 2/3 Alzheimer’s trial by the end of the year, setting it up to deliver data on the effect of ATH-1017 on the Global Statistical Test in 2022. In parallel, Athira will run another phase 2 Alzheimer’s trial “to better understand the overall effects of ATH-1017 on working memory processing speed and cognitive measures.” That trial is also due to start this year and post data in 2022. The two trials could set Athira up to file for approval of ATH-1017.

Athira also plans to start a phase 2 trial in Parkinson’s disease dementia by the end of next year. The trial will assess the effect of ATH-1017 on P300 latency and the Parkinson’s Disease-Cognitive Rating Scale. Athira expects to have enough money left over to fund IND-enabling studies of two follow-up candidates: neuropsychiatric prospect ATH-1019 and neuropathy treatment ATH-1018.

The development timeline gives Athira, which had just 14 full-time employees as of the end of June, a shot at ending the long wait for a new Alzheimer’s drug in the next few years. However, by its own admission, Athira only has data “from a relatively small number of subjects” and, as has happened throughout the history of Alzheimer’s R&D, could fail to translate early promise into pivotal data that support FDA approval. Athira’s use of electroencephalogram (EEG) methods is another possible issue.

“In our phase 1a and 1b clinical trials, data from certain subjects were not obtained due to problems encountered with the placement of the EEG electrodes and other technical issues, such as subject movement. While we believe the lack of data from these subjects did not impact the reliability or interpretation of the remaining data from these trials, we may in the future face similar issues with EEG methods, which could compromise future clinical trial results,” Athira wrote in its IPO filing.

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