Internal memo: Ex-Athira CEO says ‘I should have known better’ after data manipulation investigation

Former Athira Pharma CEO Leen Kawas. (Athira Pharma Photo)

The former CEO of Athira Pharma wrote a letter of contrition addressed to employees on Thursday, after resigning in the wake of a company investigation concluding she had altered images in scientific papers stemming from her graduate studies.

Data in her studies assessed a compound that was central to the founding of the neurosciences company. Athira announced the findings from the investigation and Leen’s resignation on Thursday as president and CEO. She also stepped off the board.

Kawas earned her Ph.D. from WSU in 2011, co-founded the company the same year and led it through its $204 million IPO last September.

“I regret that mistakes I made as a graduate student many years ago caused any distraction to Athira today,” said Kawas in the letter obtained by GeekWire. “At the time, I was navigating an unfamiliar environment and did not fully comprehend the significance of my decision to enhance the images I used in my research. I want to make clear that the enhancement to images was not a change to or manipulation of the underlying data.”

The company investigators concluded that Kawas had “altered” — not enhanced — the data-containing images.

Kawas went on to say: “Even more importantly, it did not involve ATH-1017, Athira’s lead development candidate. Regardless, I should have known better.”

A spokesperson for Kawas said she would not comment beyond the letter, which you can read in full below.

The company’s investigation similarly concluded that a June patent issued for ATH-1017 did not cite the papers containing the altered images, nor did the underlying patent application. ATH-1017 is currently being tested by the company in patients with Alzheimer’s disease in late stage clinical trials.

However, in a 2014 grant application to fund the company, Kawas stated that flagged scientific papers were “most relevant to the current application,” according to a report by the Puget Sound Business Journal.

Studies by Kawas and her colleagues claimed to show that a compound called dihexa had therapeutic effects on rats. Those studies supported the formation of the company, which was spun out of WSU to develop and commercialize dihexa. In addition, altered images from papers co-authored by Kawas were incorporated into WSU’s patent for dihexa, according to an SEC filing outlining Athira’s investigation.

The company performed research on dihexa for several years but later pivoted to developing ATH-1017. ATH-1017 is a related compound: once in the body, ATH-1017 breaks down into dihexa, according to the filing.

There have been no studies published on ATH-1017 in peer-reviewed journals.

However, the company has submitted its preclinical studies for publication and presented data from its phase 1 clinical study at a meeting. The company noted in its filing that key studies on ATH-1017 were carried out by third parties.

Some of the images apparently altered involve data called western blots. Such data can quantify the amount of protein in a sample, and were used to assess the molecular target for dihexa. The images were first flagged on PubPeer, a site where scientists can comment on data integrity, and were reported in June by Stat News.

Comments on PubPeer suggest that portions of the western blot images may have been pasted in from other datasets.

Comment in PubPeer on a paper by Kawas and her colleagues. The comment suggests that portions of the image may have been pasted from another data set. The images show western blots, which can quantify proteins. (Image from PubPeer)

One of the WSU papers including her research was published as late as 2014, while Kawas was the CEO of the company, formerly called M3 Biotechnology. She was vice president of research until that year.

Kawas co-founded the company with her graduate advisor Jay Write and WSU researcher Joseph Harding. Harding resigned from the company’s board of directors in August of 2020 and Wright also does not appear on the website or IPO filings of the Bothell, Wash.-based company.

WSU is conducting its own investigation “into claims of potential misconduct” related to Kawas’ research. Athira said its investigation committee “understands that this review is ongoing, and Athira cannot predict when WSU’s investigation will be completed or what conclusions WSU will reach.”

Meanwhile, Athira faces lawsuits from shareholders claiming that Kawas’ graduate research laid the groundwork for the company’s efforts to develop new treatments.

“I am confident that the relationships I have built, my dedication to patients and their families, and the potentially life-changing treatments we have developed, will be what defines me in the future,” said Kawas in the letter.

Kawas was the first woman to guide a company to an initial public offering in Washington state in more than two decades. She was inspired to pursue medicine after her grandmother died of cancer and forced into leadership roles after the death of her mother. Kawas is an immigrant entrepreneur who moved to the U.S. from Jordan in 2007.

Read the letter below:

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