throbber
Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 1 of 22
`
`
`
`
`
`FAN WANG and HANG GAO, Individually
`and on Behalf of All Others Similarly
`Situated,
`
`
`
`
`
`
`
`
`
`
`Plaintiff,
`
`v.
`
`
`
`
`
`
`
`
`
`
`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF WASHINGTON
`AT SEATTLE
`
`Case No.:
`
`CLASS ACTION COMPLAINT FOR
`VIOLATIONS OF THE FEDERAL
`SECURITIES LAWS
`
`Jury Trial Demanded
`
`
`ATHIRA PHARMA, INC., a Delaware
`Corporation, and LEEN KAWAS,
`
`
`
`
`
`
`
`
`Defendants.
`
`
`
`
`
`Plaintiffs Fan Wang and Hang Gao (“Plaintiffs”), individually and on behalf of all others
`
`similarly situated, by and through their attorneys, allege upon personal knowledge as to their own
`
`acts, and upon information and belief as to all other matters, based upon the investigation
`
`conducted by and through their attorneys, which included, among other things, a review of
`
`documents filed by Defendants (as defined below) with the United States Securities and Exchange
`
`Commission (the “SEC”), news reports, press releases issued by Defendants, and other publicly
`
`available documents as follows:
`
`CLASS ACTION COMPLAINT - 1
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 2 of 22
`
`
`
`
`NATURE AND SUMMARY OF THE ACTION
`
`1.
`
`This is a federal securities class action on behalf of all investors who purchased or
`
`otherwise acquired Athira Pharma, Inc. (“Athira” or the “Company”) securities between
`
`September 18, 2020 and June 17, 2021, inclusive (the “Class Period”). This action is brought on
`
`behalf of the Class for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of
`
`1934 (the “Exchange Act”), 15 U.S.C. §§ 78j(b) and 78t(a) and Rule 10b-5 promulgated
`
`thereunder by the SEC, 17 C.F.R. § 240.10b-5.
`
`2.
`
`Athira is a clinical-stage biopharmaceutical company focused on developing small
`
`molecules to restore neuronal health and stop neurodegeneration for those suffering from
`
`devastating neurological diseases, including Alzheimer’s disease. The Company’s product
`
`candidates aim to provide rapid cognitive improvement and alter the course of neurological
`
`diseases with their novel mechanism of action.
`
`3.
`
`On June 17, 2021, after the market closed, Athira issued a press release announcing
`
`that the Company’s Board of Directors had placed Leen Kawas, Athira’s President and Chief
`
`Executive Officer, on temporary leave pending a review of actions stemming from doctoral
`
`research Kawas conducted while at Washington State University.
`
`4.
`
`An article published in STAT News later that day revealed that the investigation of
`
`Kawas relates to allegations that she altered images in four separate papers relating to her research
`
`on hepatocyte growth factor (HGF), a protein with the potential to treat Alzheimer’s disease and
`
`other neurological disorders. The article noted that although Athira “has since moved on to a
`
`different molecule than the one Kawas was working on, it still aims to target HGF. And so Kawas’
`
`doctoral work laid the biological groundwork that Athira continues to use in their approach to
`
`treating Alzheimer’s.”
`
`CLASS ACTION COMPLAINT - 2
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 3 of 22
`
`
`
`
`5.
`
`Paul Matteis, a securities analyst at Stifel, highlighted the significance of the
`
`allegations, writing in a note that “The scientific hypothesis behind Athira came out of the work
`
`[that] Dr. Kawas did in graduate school so there is risk here that whatever comes out of this
`
`investigation could have clear negative implications for how we/investors view the asset, and/or
`
`management credibility.”
`
`6.
`
`On this news, Athira’s stock price fell $7.09 per share, or nearly 39%, to close at
`
`$11.15 per share on June 18, 2021, on unusually heavy trading volume.
`
`7.
`
`Throughout the Class Period, Defendants made materially false and misleading
`
`statements and omitted to material adverse facts regarding the Company’s business. Specifically,
`
`Defendants failed to disclose to investors: (1) that the research conducted by Kawas, which formed
`
`the foundation for Athira’s product candidates and intellectual property, was tainted by Kawas’
`
`scientific misconduct, including the manipulation of key data; and (2) that, as a result of the
`
`foregoing, Defendants’ positive statements about the Company’s business, operations, and
`
`prospects were materially misleading and omitted material facts necessary in order to make the
`
`statements made not misleading.
`
`JURISDICTION AND VENUE
`
`8.
`
`The federal law claims asserted herein arise under §§10(b) and 20(a) of the
`
`Exchange Act, 15 U.S.C. §§ 78j(b) and 78t(a), and Rule 10b-5 promulgated thereunder by the
`
`SEC, 17 C.F.R. §240.10b-5, as well as under the common law.
`
`9.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§ 1331, and § 27 of the Exchange Act, 15 U.S.C. § 78aa.
`
`10.
`
`This Court has jurisdiction over each Defendant named herein because each
`
`Defendant is an individual or corporation who has sufficient minimum contacts with this District
`
`CLASS ACTION COMPLAINT - 3
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 4 of 22
`
`
`
`so as to render the exercise of jurisdiction by the District Court permissible under traditional
`
`notions of fair play and substantial justice.
`
`11.
`
`Venue is proper in this District pursuant to § 27 of the Exchange Act, 15 U.S.C.
`
`§ 78aa and 28 U.S.C. § 1391(b), because Defendants maintain their principal office in this District,
`
`and many of the acts and omissions complained of herein occurred in substantial part in this
`
`District.
`
`12.
`
`In connection with the acts, omissions, conduct and other wrongs alleged in this
`
`Complaint, Defendants, directly or indirectly, used the means and instrumentalities of interstate
`
`commerce, including but not limited to, the United States mail, interstate telephone
`
`communications and the facilities of a national securities exchange.
`
`PARTIES
`
`13.
`
`Plaintiffs Fan Wang and Hang Gao, as set forth in the attached Certifications,
`
`acquired and held shares of Athira at artificially inflated prices during the Class Period, and have
`
`been damaged by the revelation of the Company’s material misrepresentations and material
`
`omissions.
`
`14.
`
`Defendant Athira is a Delaware corporation with principal executive offices located
`
`at 18706 North Creek Parkway, Suite 104, Bothell, Washington 98011. Athira’s common stock
`
`trades on the NASDAQ Stock Market (“NASDAQ”) under the ticker symbol “ATHA.”
`
`15.
`
`Defendant Leen Kawas, Ph.D. (“Kawas”) has served as Athira’s President, Chief
`
`Executive Officer and a member of the Company’s Board of Directors at all relevant times. On
`
`June 17, 2021, the Company announced that Kawas had been placed on temporary leave pending
`
`an investigation by the Board of Directors, but would remain a Director of the Company.
`
`CLASS ACTION COMPLAINT - 4
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 5 of 22
`
`
`
`
`16.
`
`Kawas, because of her positions at the Company, possessed the power and authority
`
`to control the content and form of the Company’s annual reports, quarterly reports, press releases,
`
`investor presentations, and other materials provided to the SEC, securities analysts, money and
`
`portfolio managers and investors, i.e., the market. Kawas authorized the publication of the
`
`documents, presentations, and materials alleged herein to be misleading prior to its issuance and
`
`had the ability and opportunity to prevent the issuance of these false statements or to cause them
`
`to be corrected. Because of her position with the Company and access to material non-public
`
`information available to her but not to the public, Kawas knew that the adverse facts specified
`
`herein had not been disclosed to and were being concealed from the public and that the positive
`
`representations being made were false and misleading. Kawas is liable for the false statements
`
`pleaded herein.
`
`SUBSTANTIVE ALLEGATIONS
`
`17.
`
`Athira describes itself as a late clinical-stage biopharmaceutical company focused
`
`on developing small molecules to restore neuronal health and stop neurodegeneration for those
`
`suffering from devastating neurological diseases, including Alzheimer’s disease. The Company’s
`
`product candidates aim to provide rapid cognitive improvement and alter the course of
`
`neurological diseases with their novel mechanism of action.
`
`
`
`
`
`CLASS ACTION COMPLAINT - 5
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 6 of 22
`
`
`
`
`MATERIALLY FALSE AND MISLEADING STATEMENTS
`
`18.
`
`On September 18, 2020, Athira filed its Prospectus Supplement on Form 424B4
`
`with the SEC. The Company emphasized the central role of HGF—the focus of Kawas’ doctoral
`
`research—in Athira’s product candidates:
`
`We are a late clinical-stage biopharmaceutical company focused on
`developing small molecules to restore neuronal health and stop
`neurodegeneration. With our product candidates, we aim to provide
`rapid cognitive improvement and alter the course of neurological
`diseases, with our novel mechanism of action. Our approach is
`designed to augment neuronal growth factor signaling through
`the HGF/MET, a naturally occurring regenerative system. We
`believe enhancing HGF/MET signaling has the potential to
`protect existing neurons from damage, reduce inflammation,
`promote regeneration, and positively modulate brain activity. We
`anticipate that all of these characteristics may improve neuronal
`health and translate into clinical benefits. Our pipeline is built from
`our proprietary drug discovery platform, or ATH platform, and
`consists of a series of small molecules that are designed to target
`either (1) the central nervous system, or CNS, by crossing the blood
`brain barrier, or BBB, or (2) the peripheral nervous system. Our lead
`candidate, ATH-1017, is a subcutaneous administered, BBB-
`penetrating, small molecule HGF/MET activator. . . .
`
`*
`
`*
`
`*
`
`We are pioneering the use of small molecules that are designed to
`promote the hepatocyte growth factor/MET, or HGF/MET, a
`naturally occurring regenerative system, in neurological disorders.
`While discovered in the liver, HGF is a critical growth factor across
`multiple organs, including in the brain. HGF/MET has long been
`known as a promising therapeutic target for CNS disorders,
`however, delivery of large proteins or gene therapy to the CNS to
`augment HGF/MET is challenging due to the invasive methods
`needed for them to bypass the BBB and the risk of potential adverse
`immune response. Our novel BBB-penetrating small molecules are
`designed to overcome many of these hurdles, allowing us to
`efficiently tap into the regenerative potential of HGF/MET. For
`therapeutic applications in CNS disorders, particularly AD,
`treatments that target neuronal growth factors can potentially
`accomplish several therapeutic goals, including rapid cognitive
`improvement and sustained neuroprotective effects.
`
`CLASS ACTION COMPLAINT - 6
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 7 of 22
`
`
`
`(Emphasis added).
`
`19.
`
`Athira also touted Kawas’ key role in the Company’s development strategy: “Dr.
`
`Leen Kawas, our founder and chief executive officer, has been essential in creating our
`
`innovative translational development strategy.”
`
`20.
`
`Under the section titled “Intellectual Property,” Athira told investors::
`
`We own or have in-licensed numerous patents and patent
`applications and possess substantial know-how and trade secrets
`relating to the development and commercialization of our product
`candidates,
`including
`related manufacturing processes and
`technologies.
`
`As of June 20, 2020, our patent portfolio consisted of nine owned or
`in-licensed U.S. issued patents, . . . . Our solely-owned and in-
`licensed patents and patent applications include, among others,
`claims directed to:
`
`• ATH-1017 and related compounds;
`
`• methods of using ATH-1017; and
`
`• methods of using related compounds
`
`We intend to pursue, when possible, further composition, method of
`use, dosing, formulation, and device patent protection directed to the
`neurogenerative products and processes we develop. We may also
`pursue patent protection with respect to manufacturing and drug
`development processes and technology.
`
`(Emphasis added).
`
`21.
`
`On November 12, 2020, Athira issued a press release announcing the Company’s
`
`third quarter 2020 financial results. The press release provided in part:
`
`“At Athira, we are continuing to execute on our mission to restore
`neuronal health for those suffering from neurological diseases,
`including Alzheimer’s, and we have successfully begun enrollment
`in our Phase 2/3 clinical study, LIFT-AD, evaluating our lead
`product candidate ATH-1017 in individuals with mild-to-moderate
`Alzheimer’s disease,” said Leen Kawas, Ph.D., President and Chief
`Executive Officer at Athira. “Supported by a strong cash investment
`
`CLASS ACTION COMPLAINT - 7
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 8 of 22
`
`
`
`
`from our Series B financing in June and our initial public offering
`in September, we remain focuses on advancing the development of
`ATH-1017 and our other pipeline programs.”
`
`22.
`
`Also on November 12, 2020, Athira filed its third quarter 2020 financial results on
`
`Form 10-Q with SEC. Under the section entitled “Management’s Discussion and Analysis of
`
`Financial Condition and Results of Operations,” Defendants stated:
`
`We are a late clinical-stage biopharmaceutical company focused on
`developing small molecules to restore neuronal health and stop
`neurodegeneration. With our product candidates, we aim to
`potentially provide cognitive improvement and alter the course of
`neurological diseases with our novel mechanism of action. Our
`approach is designed to augment neuronal growth factor
`signaling
`through
`the hepatocyte growth factor/MET, or
`HGF/MET, a naturally occurring regenerative system. We believe
`enhancing HGF/MET signaling has the potential to protect
`existing neurons from damage, reduce inflammation, promote
`regeneration, and positively modulate brain activity. We anticipate
`that all of these characteristics may improve neuronal health and
`translate into clinical benefits. Our pipeline is built from our
`proprietary drug discovery platform, or ATH platform, and consists
`of a series of small molecules that are designed to target either (1)
`the central nervous system, or CNS, by crossing the blood brain
`barrier, or BBB, or (2) the peripheral nervous system.
`
`*
`
`*
`
`*
`
`We were incorporated in in March 2011 and since our inception,
`we have devoted substantially all of our resources to our research
`and development efforts such as small molecule compound
`discovery, nonclinical studies and clinical trials, as well as
`manufacturing activities, establishing and maintaining our
`intellectual property portfolio, hiring personnel, raising capital, and
`providing general and administrative support for these operations.
`We do not have any products approved for commercial sale, and we
`have not generated any revenues related to our products since
`inception. Our ability to generate product revenue sufficient to
`achieve profitability, if ever, will depend on the successful
`development of one or more of our product candidates which we
`expect will take several years.
`
`(Emphasis added).
`
`CLASS ACTION COMPLAINT - 8
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 9 of 22
`
`
`
`
`23.
`
`On March 25, 2021, Athira issued a press release announcing its fourth quarter and
`
`fiscal 2020 financial results. The press release contained the following quote from Defendant
`
`Kawas:
`
`“2020 was a momentous year for the Athira team, particularly as we
`initiated two trials evaluating ATH-1017. The goal of the ACT-AD
`and LIFT-AD studies is to demonstrate the clinical utility of this
`promising agent to treat Alzheimer’s disease and preserve cognitive
`health. Alzheimer’s disease is an area of immense medical need and
`we are actively enrolling patients with the aim of reporting data in
`2022,” said Leen Kawas, Ph.D., President and Chief Executive
`Officer at Athira. “Our novel treatment approach is agnostic to the
`underlying disease pathology and focuses on network recovery
`and information transmission in the brain, which has the potential
`to improve clinical outcomes for patients. Our compounds have
`potential in a broad range of clinical applications, and we look
`forward to submitting INDs for our Parkinson’s disease dementia
`program as well as our neuropsychiatric program this year. With our
`recently completed follow-on public offering, our balance sheet
`places us in a strong position to execute on our goals.”
`
`(Emphasis added).
`
`24.
`
`That same day, Athira filed its fourth quarter and fiscal 2020 financial results on
`
`Form 10-K with the SEC. Under the section entitled “Management’s Discussion and Analysis of
`
`Financial Condition and Results of Operations,” Defendants stated:
`
`We are a late clinical-stage biopharmaceutical company focused on
`developing small molecules to restore neuronal health and stop
`neurodegeneration. With our product candidates, we aim to
`potentially provide cognitive improvement and alter the course of
`neurological diseases with our novel mechanism of action. Our
`approach is designed to augment neuronal growth factor
`signaling
`through
`the hepatocyte growth factor/MET, or
`HGF/MET, a naturally occurring regenerative system. We believe
`enhancing HGF/MET signaling has the potential to protect
`existing neurons from damage, reduce inflammation, promote
`regeneration, and positively modulate brain activity. We anticipate
`that all of these characteristics may improve neuronal health and
`translate into clinical benefits. Our pipeline is built from our
`proprietary drug discovery platform, or ATH platform, and consists
`of a series of small molecules that are designed to target either (1)
`
`CLASS ACTION COMPLAINT - 9
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`
`
`
`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 10 of 22
`
`the central nervous system, or CNS, by crossing the blood brain
`barrier, or BBB, or (2) the peripheral nervous system.
`
`*
`
`*
`
`*
`
`We were incorporated in in March 2011 and since our inception,
`we have devoted substantially all of our resources to our research
`and development efforts such as small molecule compound
`discovery, nonclinical studies and clinical trials, as well as
`manufacturing activities, establishing and maintaining our
`intellectual property portfolio, hiring personnel, raising capital, and
`providing general and administrative support for these operations.
`We do not have any products approved for commercial sale, and we
`have not generated any revenues related to our products since
`inception. Our ability to generate product revenue sufficient to
`achieve profitability, if ever, will depend on the successful
`development of one or more of our product candidates which we
`expect will take a number of years.
`
`(Emphasis added).
`
`25.
`
`Under the section titled “Intellectual Property,” Athira told investors:
`
`We own or have in-licensed numerous patents and patent
`applications and possess substantial know-how and trade secrets
`relating to the development and commercialization of our product
`candidates,
`including
`related manufacturing processes and
`technologies.
`
`As of December 31, 2020, our patent portfolio consisted of eight
`owned or in-licensed U.S. issued patents, . . . . Our solely-owned
`and in-licensed patents and patent applications include, among
`others, claims directed to:
`
`• ATH-1017 and related compounds, including but not
`limited to ATH-1019 and ATH-1020;
`
`• methods of using ATH-1017; and
`
`• methods of using related compounds, including but not
`limited to ATH-1019 and ATH-1020.
`
`We intend to pursue, when possible, further composition, method of
`use, dosing, formulation, and device patent protection directed to the
`neurogenerative products and processes we develop. We may also
`pursue patent protection with respect to manufacturing and drug
`development processes and technology.
`
`CLASS ACTION COMPLAINT - 10
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 11 of 22
`
`
`
`
`26.
`
`On May 13, 2021, Athira issued a press release announcing its first quarter 2021
`
`financial results. The press release contained the following quote from Defendant Kawas:
`
`“We continue to execute on our corporate and clinical goals
`during this very important time in Athira’s history,” said Leen
`Kawas, Ph.D., President and Chief Executive Officer at Athira. “Our
`clinical trials, ACT-AD and LIFT-AD, are actively enrolling and
`will evaluate the clinical utility of ATH-1017 to treat Alzheimer’s
`disease and improve cognitive health. In addition to developing
`ATH-1017 in Alzheimer’s disease, we plan to evaluate it in
`Parkinson’s disease dementia. We also remain committed to
`advancing our expanding pipeline of novel, small molecule
`compounds. We have a well-defined strategic plan ahead of us and
`are well-funded
`to reach multiple clinical and regulatory
`milestones.”
`
`(Emphasis added).
`
`27.
`
`That same day, Athira filed its first quarter 2021 financial results on Form 10-Q
`
`with the SEC. Under the section entitled “Management’s Discussion and Analysis of Financial
`
`Condition and Results of Operations,” Defendants stated:
`
`We are a late clinical-stage biopharmaceutical company focused on
`developing small molecules to restore neuronal health and stop
`neurodegeneration. With our product candidates, we aim to
`potentially provide cognitive improvement and alter the course of
`neurological diseases with our novel mechanism of action. Our
`approach is designed to augment neuronal growth factor
`signaling
`through
`the hepatocyte growth factor/MET, or
`HGF/MET, a naturally occurring regenerative system. We believe
`enhancing HGF/MET signaling has the potential to protect
`existing neurons from damage, reduce inflammation, promote
`regeneration, and positively modulate brain activity. We anticipate
`that all of these characteristics may improve neuronal health and
`translate into clinical benefits. Our pipeline is built from our
`proprietary drug discovery platform, or ATH platform, and consists
`of a series of small molecules that are designed to target either (1)
`the central nervous system, or CNS, by crossing the blood brain
`barrier, or BBB, or (2) the peripheral nervous system.
`
`*
`
`*
`
`*
`
`CLASS ACTION COMPLAINT - 11
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`
`
`
`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 12 of 22
`
`We were incorporated in in March 2011 and since our inception,
`we have devoted substantially all of our resources to our research
`and development efforts such as small molecule compound
`discovery, nonclinical studies and clinical trials, as well as
`manufacturing activities, establishing and maintaining our
`intellectual property portfolio, hiring personnel, raising capital, and
`providing general and administrative support for these operations.
`We do not have any products approved for commercial sale, and we
`have not generated any revenues related to our products since
`inception. Our ability to generate product revenue sufficient to
`achieve profitability, if ever, will depend on the successful
`development of one or more of our product candidates which we
`expect will take a number of years.
`
`(Emphasis added).
`
`28.
`
`The statements identified in paragraphs 18–27 above were materially false and
`
`misleading and failed to disclose material facts about the Company’s business, operations, and
`
`prospects. As alleged herein, Defendants misled investors by misrepresenting and/or failing to
`
`disclose: (1) that the research conducted by Defendant Kawas, which formed the foundation for
`
`Athira’s product candidates and intellectual property, was tainted by Kawas’ scientific misconduct,
`
`including the manipulation of key data through the altering of Western blot images; and (2) that,
`
`as a result of the foregoing, Defendants’ positive statements about the Company’s business,
`
`operations, and prospects were materially misleading and omitted material facts necessary in order
`
`to make the statements made not misleading.
`
`THE TRUTH EMERGES
`
`29.
`
`On June 17, 2021, after the market closed, Athira issued a press release entitled,
`
`“Athira Pharma Chief Operating Officer, Mark Litton, Assumes Day-to-Day Leadership
`
`Responsibilities of Company[:] Leen Kawas Place on Temporary Leave Pending Board Review of
`
`Actions Stemming from Doctoral Research While at Washington State University.” Therein, the
`
`Company stated in relevant part:
`
`CLASS ACTION COMPLAINT - 12
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`
`
`
`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 13 of 22
`
`Athira Pharma, Inc. (NASDAQ: ATHA) (“Athira”), a late clinical-
`stage biopharmaceutical company focused on developing small
`molecules to restore neuronal health and stop neurodegeneration,
`today announced that Mark Litton, PhD, MBA, in his capacity as
`Chief Operating Officer, has assumed day-to-day leadership
`responsibilities for the Company, effective immediately.
`
`This follows the Board’s determination to place Leen Kawas, PhD,
`President and Chief Executive Officer of Athira, on temporary leave
`pending a review of actions stemming from doctoral research Dr.
`Kawas conducted while at Washington State University. Dr. Kawas
`will remain on the Board. The Board has formed an independent
`special committee to undertake this review. The Company does not
`intend to comment further on this matter until the review is
`concluded.
`
`30.
`
`Although Athira’s press release provided the vaguest of explanations for placing
`
`Kawas on leave, investigative journalist Olivia Goldhill published an article titled “Athira Pharma
`
`CEO placed on leave amid allegations of altered images in her research papers.” The article,
`
`published in STAT News on June 17, 2021, revealed the underlying allegations and the serious
`
`implications for Athira. The article stated:
`
`The chief executive officer of Athira Pharma, a biotech developing
`treatments for Alzheimer’s and other neurodegenerative diseases,
`has been placed on temporary leave as her university investigates
`claims she published several papers containing altered images while
`she was a graduate student.
`
`The Seattle-based company did not disclose the reasons for the
`investigation of Leen Kawas, but STAT has learned that it involves
`allegations of altered images in four separate papers on which
`Kawas is the lead author. Images of Western blots, used to determine
`the presence of specific proteins in biological samples, look as
`though they’ve been altered from their original state, according to
`two image experts who spoke with STAT.
`
`Washington State University is investigating the claims after several
`of the images were flagged on PubPeer, a forum dedicated to
`discussing scientific research after publication, in recent weeks.
`
`CLASS ACTION COMPLAINT - 13
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`

`

`Case 2:21-cv-00861 Document 1 Filed 06/25/21 Page 14 of 22
`
`
`
`
`31.
`
`The STAT News article explained the significance of the allegations and the
`
`potential impact for Athira despite the fact that the alleged misconduct occurred years ago:
`
`Although the papers are up to a decade old, dating back to when
`Kawas was a doctoral student, the papers are foundational to
`Athira’s efforts to treat Alzheimer’s and are cited in a patent
`licensed by Athira. Kawas, who co-founded Athira, is described as
`a co-inventor in the patent.
`
`Athira is working to regrow neurons and strengthen synapses in the
`brain, based on a theory that doing so will alleviate the symptoms of
`the disease. The drugs under investigation by the company aim to
`achieve this by targeting hepatocyte growth factor (HGF), a protein
`present in the brain that stimulates the growth of cells, along with its
`receptor MET. Kawas’ papers established that a particular molecule
`affects the activity of HGF.
`
`Although the company . . . has since moved on to a different
`molecule than the one Kawas was working on, it still aims to target
`HGF. And so Kawas’ doctoral work laid the biological
`groundwork that Athira continues to use in their approach to
`treating Alzheimer’s, neuroscientist George Perry of
`the
`University of Texas at San Antonio, told STAT: “They are the
`foundational basic science.”
`
`32.
`
`The STAT News article further expounded on the specifics of the allegations, and
`
`spoke with multiple experts who dismissed the possibility that the altered images might have been
`
`the result of error or careless work:
`
`In all four papers led by Kawas, Western blots are surrounded by
`faint lines. “These lines suggest that some parts of the photo might
`have been derived from elsewhere, and that this was not the blot as
`it was originally obtained,” said Elisabeth Bik, a microbiologist and
`science consultant who focuses on image authenticity.
`
`In eight different images in four different papers, the same
`Western blot bands seemingly appear repeatedly. “That’s
`highly unlikely that came about accidentally,” said Paul Brookes,
`professor at the University of Rochester Medical Center, who has
`also worked on exposing scientific errors. . . .
`
`In two instances, the same image seems to be used to show the
`results of two different experiments published in different papers.
`
`CLASS ACTION COMPLAINT - 14
`
`TOUSLEY BRAIN STEPHENS PLLC
`1700 Seventh Avenue, Suite 2200
`Seattle, Washington 98101
`TEL. 206.682.5600 • FAX 206.682.2992
`
`1
`2
`3
`4
`5
`6
`7
`8
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket