Allegations of research improprieties at Spherical Nucleic Acids company Exicure

Update 2 (14/12/2021): a class action has been filed by Bragar Eagel & Squire, P.C on behalf of stockholders

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that there had been certain improprieties in Exicure’s preclinical program for the treatment of Friedreich’s ataxia; (2) that, as a result, there was a material risk that data from the preclinical program would not support continued clinical development; and (3) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Update 1 (14/12/2021): Exicure has filed a 8-K form (whatever that is). We learn that the Board of Directors of the Company (the “Board”) appointed Brian C. Bock, the Company’s Chief Financial Officer, as the Company’s Chief Executive Officer, replacing David Giljohann, effective December 10, 2021. He will serve as Chief Technology Officer of the Company through January 30, 2022, at which time he will separate from the Company and resigned as a member of the Board, effective December 10, 2021. So the scientist who developed the technology in Chad Mirkin’s group and who was one of the founders is exiting the company. Parts of the research program are winding down: On December 10, 2021, the Company announced its commitment to a plan to wind down the Company’s immuno-oncology program for cavrotolimod (AST-008) and the Company’s XCUR-FXN preclinical program for the treatment of Friedreich’s ataxia. […] This plan will implement a reduction in force where the Company will eliminate approximately 50% of the Company’s existing workforce on a staggered basis through January 2022 as well as other cost-cutting measures. […] Additionally, the Company is evaluating its facilities and contractual relationships utilized in the cavrotolimod and XCUR-FXN programs and the associated contractual obligations to determine the appropriate course of action and any associated charges to wind down the ongoing clinical trials. We also learn more about the results of the audit: the Audit Committee and the Company investigated statements made by Dr. Grant Corbett, the Company’s former Group Leader of Neuroscience. Dr. Corbett voluntarily resigned from the Company on November 8, 2021. As part of his resignation, he claimed that when he was employed by the Company, he intentionally misreported certain raw data related to the research and development of XCUR FXN. […] The investigation revealed that: (1) beginning in the autumn of 2020, Dr. Corbett misreported raw data from certain research and development experiments related to XCUR-FXN; (2) Dr. Corbett misreported the results of at least three different experiments that were conducted through at least February 2021; (3) the misreported data related solely to efficacy rather than safety of XCUR-FXN; (4) the misreported data was included in various public presentations and SEC filings from as early as January 7, 2021 through as late as August 12, 2021; (5) Dr. Corbett acted alone in misreporting the data, without the assistance or knowledge of anyone else at the Company, including Company management and other research and development employees and did not inform anyone at the Company of his actions until his resignation in November 2021; (6) Company management reasonably relied on Dr. Corbett’s analysis when making public statements that included Dr. Corbett’s misreported data; and (7) no other Company program was impacted by Dr. Corbett’s misreporting of the XCUR-FXN data. […] The Board and the Audit Committee also intend to enhance the Company’s policies and procedures regarding data management and integrity.

Original post 22/11/2021

Last Tuesday, Twitter user @NanoSkeptic drew my attention to a report by the company Exicure that develops biomedical applications of Spherical Nucleic Acids. Exicure was founded in 2011 by David Giljohann, Chad Mirkin and Shad Thaxton.

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The report mentions allegation of research improprieties:

on November 9, 2021, the Audit Committee of our Board of Directors was notified of a claim made by a former Company senior researcher regarding alleged improprieties that researcher claims to have committed with respect to our XCUR-FXN preclinical program for the treatment of Friedreich’s ataxia. The Audit Committee has retained external counsel to conduct an internal investigation of the claim. We are currently unable to predict the timing or outcome of the investigation. We are unable to determine the potential impact of the asserted claim on our research and development activities or the timing of completion of our current research and development of our XCUR-FXN preclinical program for the treatment of FA, as the investigation of the asserted claim remains ongoing. In connection with the ongoing investigation, securities class actions and other lawsuits may be filed against us, certain current and former directors, and certain current and former officers. Any future investigations or lawsuits may also adversely affect our business, financial condition, results of operations and cash flow.”

Since Exicure’s Friedreich’s ataxia research is not published in scientific journals, there isn’t a lot more to say at this point. I have raised concerns about Exicure for some years…

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It is interesting to note that when allegations of research improprieties are made about the research programme of a listed company, those have to be made public immediately (even if the research results have not been shared publicly), whereas when something similar happens say in a University lab everything can stay secret for years until investigations are completed (even if the erroneous/fraudulent results have been published).

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