Exicure Files Form 12b-25

Rhea-AI Summary

Exicure, Inc. (NASDAQ: XCUR) has filed a Form 12b-25 with the SEC, delaying its Q3 2021 10-Q Report due to an ongoing internal investigation prompted by claims of impropriety from a former senior researcher regarding the XCUR-FXN program for Friedreich’s ataxia. The Audit Committee has engaged external counsel for the investigation, and the company is unable to predict its duration or outcome. Exicure aims to submit the 10-Q within five days after the original due date. The firm develops therapies using its proprietary SNA technology for various medical conditions, including neurological disorders.

Positive

• Proprietary SNA technology may provide competitive advantages in therapeutics.
• XCUR-FXN is in preclinical development stage for Friedreich’s ataxia, indicating ongoing innovation.

Negative

• Delay in filing the Q3 2021 10-Q raises concerns about financial transparency.
• Internal investigation could divert management focus and resources from core operations.

CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Exicure, Inc.® (NASDAQ: XCUR) today announced that it has filed a Form 12b-25 with the U.S. Securities and Exchange Commission (the “SEC”) in connection with its Quarterly Report on Form 10-Q for the period ended September 30, 2021 (the “Form 10-Q”).

Exicure, Inc. (the “Company”) is unable to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 (the “Q3 2021 10-Q”) with the SEC within the prescribed time period without unreasonable effort or expense. On November 9, 2021, the Audit Committee of the Board of Directors of the Company was notified of a claim made by a former Company senior researcher regarding alleged improprieties that researcher claims to have committed with respect to the Company’s 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. The Company is currently unable to predict the timing or outcome of the investigation. Despite working diligently in an effort to timely file its Q3 2021 10-Q, the Company requires additional time to complete certain disclosures and procedures, including disclosures relating to the internal investigation.

The Company expects to file its Q3 2021 10-Q with the SEC as soon as practicable, and no later than the fifth calendar day following the prescribed due date, in accordance with Rule 12b-25.

About Exicure, Inc.

Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for neurology, immuno-oncology, inflammatory diseases and other genetic disorders based on its proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure is in preclinical development of XCUR-FXN, a lipid-nanoparticle SNA–based therapeutic candidate, for the intrathecal treatment of Friedreich’s ataxia (FA). Exicure’s therapeutic candidate cavrotolimod (AST-008) is in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Exicure is based in Chicago, IL and in Cambridge, MA. For more information, visit Exicure’s website at www.exicuretx.com.

Exicure Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical fact could be deemed forward looking including, but not limited to, statements regarding the Company’s preliminary results for the third quarter of 2021 and the Company’s anticipated timing for filing its Q3 2021 10-Q, statements regarding the internal investigation being conducted by the Audit Committee including, but not limited to, the timing and scope of the investigation; and the Company’s business plans and objectives. Words such as “plans,” “expects,” “will,” “anticipates,” “continue,” “expand,” “advance,” “believes,” “guidance,” “target,” “may,” “remain,” “project,” “outlook,” “intend,” “project,” “estimate,” “could,” “should,” and other words and terms of similar meaning and expression are intended to identify forward-looking statements, although not all forward-looking statements contain such terms. The forward-looking statements in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update these forward-looking statements. Forward-looking statements are based on management’s current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the time necessary for the Audit Committee to complete its investigation and review; the diversion of management attention to the internal investigation; the final conclusions and outcome of the Audit Committee and board of directors following the completion of its investigation and review, including any related investigations or proceedings. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information or to publicly announce the results of any revisions to any of such statements to reflect future events or developments, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211115006324/en/

Karen Sharma

MacDougall

781-235-3060

ksharma@macbiocom.com

Source: Exicure, Inc.

FAQ

What is the reason for Exicure's delay in filing its Q3 2021 10-Q?

Exicure's delay is due to an internal investigation concerning claims made by a former senior researcher related to the XCUR-FXN program.

What is Exicure (XCUR) developing for Friedreich’s ataxia?

Exicure is developing XCUR-FXN, a lipid-nanoparticle SNA-based therapeutic candidate for the treatment of Friedreich’s ataxia.

When is Exicure expected to file its Q3 2021 10-Q?

Exicure plans to file its Q3 2021 10-Q no later than five calendar days following the original due date.

What are the implications of Exicure's internal investigation?

The internal investigation could affect management's focus and potentially impact Exicure's business operations and financial disclosures.

How does Exicure's SNA technology differ from other nucleic acid therapeutics?

Exicure believes its SNA technology has distinct chemical and biological properties that may provide advantages in targeting diseases not addressed by other nucleic acid therapeutics.