On May 8, 2019 Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported financial results for the first quarter ended March 31, 2019 and provided an update on corporate progress (Press release, Exicure, MAY 8, 2019, View Source [SID1234535918]).
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"Exicure continues to drive our SNA technology into the clinic and expand our therapeutic areas of interest. In the first quarter of 2019, we opened four clinical sites and began enrolling patients in the Phase 1b/2 trial of AST-008 for patients with advanced or metastatic solid tumors including, Merkel cell carcinoma, melanoma, squamous carcinoma and squamous cell carcinoma of the head and neck," said Dr. David Giljohann, Chief Executive Officer of Exicure. "We are also pursuing significant unmet medical need in rare dermatological indications through our partnership with Dermelix and are expanding our platform in neurology."
Corporate Progress
Launched Phase 1b/2 clinical trial of AST-008—AST-008 is an SNA consisting of toll-like receptor 9, or TLR9, agonists designed for immuno-oncology applications.
Received authorization from the FDA for a Phase 1b/2 clinical trial of AST-008
Opened four clinical sites and began dosing patients
Expects to release results of the Phase 1b stage of this trial late in 2019
Entered into partnership with Dermelix for rare dermatological conditions—Dermelix will initially develop a targeted therapy for the treatment of Netherton Syndrome (NS) and Exicure is currently screening sequences against the target genes.
Presented a scientific poster at ARVO 2019—This poster showed that in a rat eye model, our SNAs distributed to both the back and the front of the eye, persisted in the eye longer than did conventional oligonucleotides, and did not cause inflammation. These data support the therapeutic potential of SNAs for treating retinal and corneal eye diseases.
Presented a scientific poster at AAN 2019—This poster demonstrated that SNAs containing the same sequence as the approved SMA drug nusinersen, delivered by intrathecal injection to rats, widely distributed throughout the CNS and persisted to a greater extent than did nusinersen. These data support the therapeutic potential of SNAs for treating CNS disorders.
First Quarter 2019 Financial Results and Financial Guidance
Cash Position: As of March 31, 2019, Exicure had cash and cash equivalents of $22.2 million compared to $26.3 million as of December 31, 2018.
Research and Development (R&D) Expenses: Research and development expenses were $3.4 million for the quarter ended March 31, 2019, compared to $3.3 million for the quarter ended March 31, 2018.
The increase in research and development expense of $0.1 million was primarily due to higher platform and discovery-related expense of $0.2 million and higher employee related expenses of $0.2 million, mostly offset by lower clinical development programs expense of $0.3 million.
General and Administrative (G&A) Expenses: General and administrative expenses were $2.2 million for the quarter ended March 31, 2019, compared to $2.0 million for the quarter ended March 31, 2018. The increase in general and administrative expenses of $0.2 million was primarily due higher compensation and travel expenses, partially offset by lower legal fees.
Net Loss: Net loss was $5.3 million for the quarter ended March 31, 2019, compared to net loss of $5.5 million for the quarter ended March 31, 2018. The $0.2 million reduction in net loss is due to the $0.5 million in other income attributable to the (non-cash) fair value adjustment of our common stock warrant liability, partially offset by the increase in operating expenses of $0.3 million as described above.
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, 2019, will be sufficient to meet its anticipated cash requirements into early 2020.