Athira Pharma is advancing its clinical trials in the wake of allegations of image manipulation in papers authored by its CEO, the company reported today in its second quarter financial and business update.
Former CEO Leen Kawas was placed on leave in June after allegations of altered images in scientific papers she authored. The company’s COO, Mark Litton, has since assumed day-to-day leadership responsibilities.
Litton said in today’s news release that the company “made significant advancements across our corporate and clinical initiatives” during the past quarter. It is in clinical-stage development of a compound for Alzheimer’s and Parkinson’s disease dementia.
Athira made further leadership changes following the the recent death of board chair Tadataka Yamada. The Bothell, Wash.-based company on Aug. 5 appointed Kelly Romano as board chair to replace Yamada. Romano has a background in commercial buildings and aerospace and is founder and CEO of BlueRipple Capital, LLC, a consultancy firm for global technology companies.
Other recent appointments include Rachel Lenington, formerly at Seagen and the Bill & Melinda Gates Foundation, as CTO and head of product development strategy. Mark Worthington has been appointed general counsel.
On June 17 the news site STAT published a story examining the claims of image manipulation in Kawas’ papers, which first emerged on PubPeer, a service where scientists can comment on the integrity of data in scientific papers.
A comment first appeared in 2016 on one paper, and more recently on three other studies. They concern papers Kawas researched while a graduate student at Washington State University, where she received a doctorate degree in 2011.
The company in June said it would complete a review “stemming from doctoral research Dr. Kawas conducted while at Washington State University.”
Those papers set the stage for the company’s current clinical trials for ATH-1017, an agent designed to regenerate brain tissue.
In an Athira press release before he died, Yamada said, “ATH-1017 was discovered, developed, and patented by Athira on the basis of novel data generated within the Company. The Company is confident in the therapeutic potential of ATH-1017 for treating dementia.”
Though the company does not appear to have published preclinical data on ATH-1017, it recently presented early findings at the Alzheimer’s Association International Conference from a phase 1 study that included patients with Alzheimer’s disease.
In addition, Athira is proceeding with an extension of its phase 2/3 trial for people with mild-to-moderate Alzheimer’s. After completion of a 26-week treatment period, people in either the placebo or active groups may elect to continue for up to an additional 26 weeks at the high dose. The company expects data to emerge from this trial by the first half of 2022 and plans to initiate a phase 2 trial testing the agent in people with Parkinson’s disease by the end of 2021.
The company’s net loss for the quarter was $14 million, compared to $2 million for the same quarter in 2020, with $12 million going to research and development expenses. It has about $350 million of cash, cash equivalents and investments on hand. Net loss per share came in at $0.38, which was just above analyst expectations.
Athira, which raised $204 million as part of its IPO last year, is also facing lawsuits for potentially misleading investors. The value of its stock decreased by about half in mid-summer after the image manipulation allegations came to light, and was down another 6% on Monday.
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