On August 6, 2018 Exicure, Inc. (OTCQB:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported financial results for the second quarter ended June 30, 2018, and provided an update on corporate progress (Press release, Exicure, AUG 6, 2018, View Source [SID1234528463]).
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"With the addition of a new COO and the topical dosing of XCUR17 in patients with mild to moderate psoriasis, Exicure continues to make progress on our mission," said Dr. David Giljohann, Chief Executive Officer of Exicure. "In June of 2018, we released data at the Cure SMA Annual Conference demonstrating the use of Exicure’s SNA technology in Spinal Muscular Atrophy mouse models. Based on the results of this preclinical study, we intend to further pursue our early stage research activities in neurological applications," added Dr. Giljohann.
Corporate Progress
Began trading on OTCQB market under the ticker symbol XCUR.
Announced the addition of Matthias Schroff as Chief Operating Officer. Dr. Schroff previously served as CEO of Vaximm and Mologen.
Commenced topical dosing in our Phase 1 clinical trial for XCUR17 in patients with mild to moderate psoriasis.
Presented pre-clinical data demonstrating the performance of Exicure’s SNA compound designed for use in spinal muscular atrophy at the Cure SMA Annual Conference with collaborators at The Ohio State University Wexner Medical Center.
Completed third cohort of volunteers in our AST-008 trial and announced the planned enrollment of a Phase 1b/2 trial expected to commence in late 2018 in combination with checkpoint inhibitors.
Pre-Clinical Updates
In June, Exicure and The Ohio State University Wexner Medical Center presented a poster at the Cure SMA Annual Conference titled: "Nusinersen in spherical nucleic acid (SNA) format improves efficacy both in vitro in SMA patient fibroblasts and in Δ7 SMA mice and reduces toxicity in mice." It was observed in the preclinical study that nusinersen in SNA format prolonged survival by four-fold (maximal survival of 115 days compared to 28 days for nusinersen-treated mice) as well as doubled the levels of healthy full-length SMN2 mRNA and protein in SMA patient fibroblasts when compared to nusinersen.
Pipeline Updates
AST-008: AST-008 is an SNA consisting of toll-like receptor 9 (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. This trial is expected to be completed in the third quarter of 2018. We currently anticipate preparing and commencing a Phase 1b/2 clinical trial for AST-008 in combination with checkpoint inhibitors in late 2018.
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. We have dosed 19 of the prospective 25 patients. Full enrollment and trial completion is expected during the fourth quarter.
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 notified Exicure that 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. 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.
Second Quarter 2018 Financial Results and Financial Guidance
Cash Position: As of June 30, 2018, Exicure had cash and cash equivalents of $16.4 million compared to $25.8 million as of December 31, 2017.
Research and Development (R&D) Expenses: Research and development expenses were $3.8 million for the three months ended June 30, 2018, compared to $3.3 million for the three months ended June 30, 2017. The increase in research and development expense of $0.5 million was primarily due to higher employee related expenses resulting from the hire of our Chief Operating Officer and higher platform discovery expenses attributable to costs necessary to maintain our intellectual property portfolio. Clinical development expenses were nearly flat quarter over quarter.
General and Administrative (G&A) Expenses: General and administrative expenses were $2.0 million for the quarter ended June 30, 2018, compared to $2.1 million for the quarter ended June 30, 2018. The decrease in general and administrative expenses of $0.1 million reflects the net change attributable to a decrease in legal and accounting expenses due to the absence of certain financing expenses incurred during 2017 offset by an increase in costs attributable to being a public company.
Net Loss: Net loss was $6.8 million for the quarter ended June 30, 2018, compared to net loss of $3.0 million for the quarter ended June 30, 2017. The $3.8 million increase in net loss is due principally to a decrease in revenue of $2.7 million that mostly reflects the absence of revenue recognized in the prior period related to the amortization of the upfront payment, and certain reimbursable research and development activities, under the Purdue Collaboration. In addition, we had an increase in Other Loss of $0.8 million principally due to the fair value adjustment of our common stock warrant liability.
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 June 30, 2018, will be sufficient to meet its anticipated cash requirements through March 31, 2019.