EXICURE, INC. Item 7.01 Regulation FD Disclosure.
On
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, are being "furnished" and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"). The information in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
Item 8.01 Other Events.
On
To date, the trial has enrolled 20 patients consisting of: ten (10) melanoma patients, five (5) MCC patients, two (2) CSCC patients, two (2) head and neck squamous cell carcinoma patients, and one (1) leiomyosarcoma patient. The objectives of the Phase 1b dose-escalation stage of the study clinical trial were to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cavrotolimod alone and in combination with pembrolizumab, and to identify a recommended Phase 2 dose.
The preliminary data shows cavrotolimod (AST-008) had been well-tolerated at all doses studied, with 98% of all treatment-emergent adverse events (AEs) assessed as Grade 1 or 2 in severity. No treatment-related serious adverse events were reported to date. The most common adverse events were flu-like symptoms and injection site reactions, which are commonly expected effects from a TLR9 mechanism of action. These results are preliminary in nature and may change as additional patients are enrolled and progress in the trial.
Forward-Looking Statements
Any statements in this Current Report on Form 8-K about future expectations,
plans and prospects for the Company and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking statements
within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors, including:
uncertainties inherent in the initiation of future clinical studies and in the
availability and timing of data from ongoing clinical studies; whether interim
results from a clinical trial such as the interim data referenced in this
Current Report on Form 8-K will be predictive of the final results of the trial;
whether results from preclinical studies or earlier clinical studies will be
predictive of the results of future trials; whether results from clinical
studies will warrant meetings with regulatory authorities or submissions for
regulatory approval; whether the Company will be able to satisfy the pathway to
regulatory approval that it has identified; whether the Company will obtain
regulatory approvals to conduct trials or to market products on a timely basis
or at all; whether the Company's cash resources will be sufficient to fund the
Company's foreseeable and unforeseeable operating expenses and capital
expenditure requirements; other matters that could affect the availability or
commercial potential of the Company's therapeutic candidates; and other factors
discussed in the "Risk Factors" section of the Company's most recent Form 10-K
filed with the
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press r elease dat e d September 16, 2020. 99.2 KOL presentation dated September 16, 2020.
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