The former head of clinical development and research at Athira Pharma criticized the company’s handling of an investigation that led to the resignation of longtime CEO Leen Kawas in October.
Xue Ha published a blog post Tuesday describing her departure from the Seattle-area biotech company. Ha first joined Athira in 2015 from the University of Southern California, where she was an assistant professor of neurology.
“I left Athira in February 2022, as I strongly disagree with the Board’s decision to dismiss Leen Kawas as the CEO, the rationale Athira provided to the public to purportedly justify her dismissal, and the lack of transition that resulted in growing leadership gaps,” she wrote.
Kawas resigned and departed the board after an independent special committee concluded that she had altered data-containing images in scientific papers as a graduate student. Those papers were central to the founding of the Bothell, Wash.-based neurosciences company, then called M3 Biotechnology, in 2011.
“In my opinion, the handling of Athira’s investigation regarding Leen Kawas and her subsequent dismissal fell below what scientific ethics called for and raises many unanswered questions,” Ha said in the post.
Reached via email, Kawas declined to comment on Ha’s post. GeekWire reached out to Athira for comment and we’ll update when we hear back.
The post is the latest addition to ongoing drama at Athira, which this week was hit with another lawsuit filed by a shareholder accusing the company of withholding information about the image alteration before Athira’s IPO in 2020. Athira is facing similar lawsuits from other shareholders.
Ha said the image manipulation was disclosed to the board in 2015, and that a recent company presentation on its clinical candidate for neurological disease did not properly attribute Kawas. Ha has retained documents from the company related to invention and authorship, she said.
Athira is performing four clinical trials on a compound called fosgonimeton (also called ATH-1017) for neurological conditions, including Alzheimer’s disease. But the company has not yet published its preclinical findings on that compound in a peer-reviewed journal. The company’s data, said Ha, show that underlying conclusions of Kawas’ graduate work on a similar compound are valid.
The company released its preclinical data on fosgonimeton in a presentation at a conference in March.
Ha also criticizes the board for distancing the company from Kawas’ original papers. For instance, she noted that company’s recent annual report with the SEC stated, “the conduct that was the subject of the allegations is not related to any of our current product candidates or ongoing clinical research.”
Ha disagrees with that characterization. She notes that Kawas’ original papers assessed a compound very similar to fosgonimenton, called dihexa. Fosgonimeton is a “prodrug” of dihexa, meaning that it breaks down in the body into dihexa. Dihexa “is not only related to fosgonimeton it is the core active drug that delivers the therapeutic potential.”
By stating that Kawas’ research is not related to the company’s current candidate, the company also is not providing proper attribution, said Ha.
Instead of pushing Kawas out of the company, Athira should have shown the scientific validity of dihexa and “integrity of the prior research,” Ha said.
“Doing so would not only have been the right thing to do, but it also would have avoided the costly and disruptive ousting of the CEO,” said Ha in her post.
Ha said “none of the inventors of dihexa” were listed as co-authors on the recent conference presentation. Kawas’ name was not listed, nor was that of her advisor at Washington State University, fellow co-founder Joseph Harding.
In her post, Ha said that she has an “ongoing dispute” with Athira because she retained documents from the company. “I saw how Leen’s authorship was handled and the inventorship was managed, I retained documents to support the contributions,” she added in an email.
Ha is one of several of Kawas’ associates to weigh in with support. In April, Harding wrote a letter on LinkedIn praising her work as a graduate student and CEO. He wrote that he raised the issue of data “embellishment” by Kawas with then-board chair John Fluke and other individuals within the company, when he first learned about it in 2015.
Ha added in her post: “Leen Kawas made a mistake over ten years ago as a young and inexperienced graduate student. She acknowledged and fixed her mistake with the support of her advisor and colleagues to the best extent possible, with proper disclosure to the university, Athira board, and other key stakeholders more than five years ago.”
Kawas has since co-founded an investment firm with another supporter, Athira investor Richard Kayne. Kayne has criticized the board for replacing Kawas and has launched an effort to replace the current CEO, Mark Litton, with the former chief medical officer of GlaxoSmithKline, Ronald Krall.
Athira is expected to report early data on a phase 2 clinical trial for fosgonimeton this quarter.