Exicure, Inc. (XCUR) 10-K Annual Report March 2019

- Exicure, Inc., a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) constructs, today reported full year financial results for the year ended December 31, 2018 and provided an update on corporate progress.

“We’re very proud of our achievements on each of our strategic priorities for 2018,” said Dr. David Giljohann, Chief Executive Officer of Exicure. “We drove two programs through Phase 1 clinical trials while laying the foundation for expanding our pipeline in neurology, rare dermatology, ophthalmology and gastroenterology. We also strengthened the management of our company and our access to capital. In the coming year, we expect to execute and advance our ongoing clinical programs, while expanding into new therapeutic areas,” Giljohann concluded.

Corporate Progress

Key achievements for Exicure during 2018 include:


•	Completed the Phase 1 clinical trial of AST-008, a TLR9 agonist for immuno-oncology applications showing activation of the immune system and robust cellular response.


•	Completed a successful Phase 1 clinical trial of XCUR17 showing clinical effect in patients with psoriasis


•	Demonstrated, in preclinical animal models, superior bio-distribution and prolonged survival when administering nusinersen in SNA format versus nusinersen in linear format


•	Strengthened management team with addition of Dr. Matthias Schroff as Chief Operating Officer


•	Commenced public trading on the OTCQB market


•	Completed $22.0 million financing in August of 2018 at $4.50/share

Pipeline Updates

AST-008: AST-008 is an SNA consisting of toll-like receptor 9, or TLR9, agonists designed for immuno-oncology applications. The company began subject dosing of AST-008 in a Phase 1 clinical trial during the fourth quarter 2017 and the trial completed in September of 2018. AST-008 was shown to be safe and tolerable in all subjects, with no serious adverse events and no dose limiting toxicity. During the fourth quarter of 2018 the FDA opened the IND for AST-008 and informed the Company that our proposed Phase 1b/2 trial may proceed. During early 2019 we opened four clinical sites and began dosing and recruiting patients in that trial.

XCUR17: XCUR17 is an antisense SNA that targets the mRNA encoding IL-17RA, a protein that is considered essential in the initiation and maintenance of psoriasis. In the fourth quarter of 2018 we reported results from the Phase 1 trial of XCUR17. Of the twenty-one treated patients, eleven treated with the highest strength XCUR17 gel were observed to have a reduction in redness and improvement in healing as determined by blinded physician assessments. Further, the highest strength XCUR17 gel showed a statistically significant improvement in psoriasis symptoms versus the vehicle gel. By comparison, seventeen of the twenty-one patients treated with the positive comparator showed a clinical response, while four patients treated with the placebo vehicle had a clinical response.

The following information was filed by Exicure, Inc. (XCUR) on Friday, March 8, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Exicure, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.18.2: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: XCUR
CIK: 1698530
Form Type: 10-K Annual Report
Accession Number: 0001698530-19-000015
Submitted to the SEC: Fri Mar 08 2019 5:21:12 PM EST
Accepted by the SEC: Fri Mar 08 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations