On March 8, 2019 Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported full year financial results for the year ended December 31, 2018 and provided an update on corporate progress (Press release, Exicure, MAR 8, 2019, View Source;p=RssLanding&cat=news&id=2390748 [SID1234534125]).
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"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.
2018 Financial Results and Financial Guidance
Cash Position: As of December 31, 2018, Exicure had cash and cash equivalents of $26.3 million compared to $25.8 million as of December 31, 2017. In 2018, Exicure raised approximately $22.0 million in gross proceeds from the private placement of common stock.
Research and Development Expense: Research and development expense was $14.1 million for the year ended December 31, 2018 compared to $13.1 million for the year ended December 31, 2017. The increase in research and development expense of $1.0 million was primarily due to higher employee-related expense of $1.2 million and higher platform and discovery-related expense of $0.6 million, partially offset by a net decrease of $0.9 million in costs related to our clinical development programs.
General and Administrative Expense: General and administrative expense was $7.8 million for the year ended December 31, 2018 and $7.0 million for the year ended December 31, 2017, an increase of $0.8 million. This increase was due to higher costs of $0.9 million associated with being a public company, including higher expense for investor and public relations and director and officer insurance, as well as higher compensation and related expense of $0.5 million associated with salary increases and the addition of an executive during 2018, partially offset by lower legal and accounting costs of $0.7 million resulting from a change in mix of transaction support in 2018 as compared to 2017.
Net Loss: Net loss was $22.4 million for the year ended December 31, 2018, compared to net loss of $11.0 million for the year ended December 31, 2017. Net loss reflects the changes in expenses discussed above and also reflects that revenue for the year ended December 31, 2018 decreased $9.6 million compared to revenue for the year ended 2017. Revenue in 2017 was primarily related to the Purdue Collaboration and reflects the amortization of the upfront payment on the Collaboration which did not reoccur in 2018.
Cash Runway Guidance: Exicure believes that, based on its current operating plans and as of the date of this press release, its existing cash and cash equivalents as of December 31, 2018 is sufficient to meet its anticipated cash requirements into early 2020.