On May 15, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported financial results for the first quarter ended March 31, 2018, and provided an update on corporate progress (Press release, Exicure, MAY 15, 2018, View Source;p=RssLanding&cat=news&id=2349297 [SID1234526643]).
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"Exicure continues to drive forward our SNA technology through ongoing clinical development. In the fourth quarter of 2017, we launched a Phase 1 clinical trial of AST-008, our TLR9 agonist developed for immuno-oncology applications. We expect to report results from this trial in the third quarter of 2018," said Dr. David Giljohann, Chief Executive Officer of Exicure. "We are also expanding our efforts in neurology, where pre-clinical results have suggested our spherical nucleic acid platform has advantages over existing technology. We look forward to presenting animal data later this summer."
Corporate Progress
Launched Phase 1 clinical trial of AST-008, a TLR9 agonist for immuno-oncology applications. Received authorization from Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to conduct a Phase 1 clinical trial of AST-008 in the United Kingdom and began dosing healthy subjects during the fourth quarter of 2017. Our current plan anticipates preparing and commencing a Phase 1b/2 clinical trial for AST-008 late this year.
Began dosing patients in the Phase 1 clinical trial of XCUR17 in early April 2018. This trial is designed to test safety and efficacy of the drug. Twenty-five patients will be enrolled and dosed over a period of 26 days. We expect trial data during the third quarter of this year.
Generated pre-clinical data utilizing an SNA designed to stimulate the production of SMN2 mRNA for application in spinal muscular atrophy (SMA). These data suggest that the SNA design may potentially have superior pharmacodynamics properties compared to other nucleic acid therapeutic designs. We are currently collecting in vivo data in SMA mouse models.
Informed by our sponsoring market maker that FINRA has cleared our Form 211. This important step in our path toward trading on the OTCQB has been completed. We are now addressing final administrative items and expect to announce beginning of trading in the near future.
Strengthened management team with the appointment of Matthias Schroff as Chief Operating Officer. Dr. Schroff brings to Exicure a proven track record in clinical development and deep experience in the immuno-oncology, RNAi and gene expression, and TLR9 biology.
Pipeline Updates
AST-008: AST-008 is an SNA consisting of toll-like receptor 9, or TLR9 agonists designed for immuno-oncology applications. The Phase 1 clinical trial of AST-008 evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of AST-008 by subcutaneous administration in healthy volunteers. Our current plan anticipates preparing and commencing a Phase 1b/2 clinical trial for AST-008 late this year. The Company ultimately plans to clinically advance AST-008 in combination with checkpoint inhibitors.
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. Our Phase 1 trial of XCUR17 is a microplaque study in patients with mild to moderate psoriasis.
AST-005: AST-005 is an SNA containing TNF antisense oligonucleotides and is intended to be applied in a gel to psoriatic lesions. AST-005 is the subject of our collaboration with Purdue Pharma L.P. Purdue Pharma has notified Exicure it has declined to exercise its option to develop AST-005 at this time, but that it also intends to retain rights relating to the TNF target, and Purdue reserves its right to continue joint development, with Exicure, of new anti-TNF drug candidates and to retain its exclusivity and other rights to AST-005.
First Quarter 2018 Financial Results and Financial Guidance
Cash Position: As of March 31, 2018, Exicure had cash and cash equivalents of $21.1 million compared to $25.8 million as of December 31, 2017.
Research and Development (R&D) Expenses: Research and development expenses were $3.3 million for the quarter ended March 31, 2018, compared to $3.5 million for the quarter ended March 31, 2017. The decrease in research and development expense of $0.2 million was primarily due to a net decrease in costs related to our clinical development programs of $0.6 million, partially offset by higher employee-related expenses of $0.2 million and higher platform and discovery-related expense of $0.2 million.
General and Administrative (G&A) Expenses: General and administrative expenses were $2.0 million for the quarter ended March 31, 2018, compared to $1.4 million for the quarter ended March 31, 2017. The increase in general and administrative expenses of $0.6 million was primarily due to higher legal costs associated with preparation and filing of form S-1 to register the shares of common stock sold last year in connection with our merger and private placement. Also contributing to the increase versus the prior quarter were expenses associated with being a public company and salary increases and new hires.
Net Loss: Net loss was $5.5 million for the quarter ended March 31, 2018, compared to net loss of $2.7 million for the quarter ended March 31, 2017. The $2.9 million increase in net loss is due principally to a $2.4 million decrease in non-cash collaboration revenue in addition to the net increase in operating expenses of $0.4 million discussed above. The quarter ended March 31, 2017 included $2.4 million of collaboration revenue which represented the amortization of deferred revenue associated with the upfront cash payment of $10.0 million received in December of 2016 connected with the Purdue collaboration. On January 1, 2018, we adopted ASC 606 and recorded any remaining unamortized deferred revenue under the Purdue collaboration to the beginning balance of accumulated deficit at January 1, 2018.
Cash Runway Guidance: Exicure believes that, based on its current operating plans and estimates of expenses, as of the date of this press release, its existing cash and cash equivalents as of March 31, 2018, will be sufficient to meet its anticipated cash requirements through March 31, 2019.