On November 12, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported financial results for the quarter and nine months ended September 30, 2020 and provided an update on corporate progress (Press release, Exicure, NOV 12, 2020, View Source [SID1234570733]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Exicure has seen growth and clinical and pre-clinical advancement during the third quarter of this year," said Dr. David Giljohann, Exicure’s Chief Executive Officer. "During the third quarter of 2020, Exicure hosted a virtual KOL event where we presented promising interim results from our ongoing Phase 1b/2 clinical trial of cavrotolimod (AST-008) and we announced that our poster on the safety and preliminary efficacy of intertumoral cavrotolimod (AST-008) in combination with pembrolizumab in the Phase 1b stage was accepted for presentation at the 2020 SITC (Free SITC Whitepaper) Annual Meeting. We also entered into a $25.0 million senior secured term loan during the third quarter of 2020 which extends our cash runway into 2022," concluded Dr. Giljohann.
Exicure’s candidate, XCUR-FXN
•Despite the ongoing COVID-19 pandemic, the Company’s laboratories have continued operations with limited impact on our research and development activities.
•The Company remains on track to initiate IND-enabling studies for Friedreich’s ataxia in the fourth quarter of this year.
Exicure announced promising interim results from ongoing Phase 1b/2 clinical trial of cavrotolimod (AST-008) in September 2020
•Confirmed overall response rate (ORR) of 21% in the dose-escalation stage across all doses, confirmed ORR 33% at the highest dose cohort and recommended Phase 2 dose.
•Target tumor shrinkage was observed in 37% of patients.
•Preliminary data show activity in patients with melanoma, Merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (CSCC).
•Phase 2 arms in both MCC and CSCC are currently recruiting.
Cavrotolimod (AST-008) Phase 1b/2 clinical trial is open and actively enrolling patients
•In the second quarter of 2020, the Company began enrolling patients in the Phase 2 dose expansion phase of its Phase 1/2 clinical trial of intra-tumoral cavrotolimod (AST-008) in combination with approved checkpoint inhibitors pembrolizumab or cemiplimab, for the treatment of patients with advanced or metastatic MCC or CSCC.
•Currently, 14 clinical trial sites are open for enrollment and 7 additional sites are pending activation; the Company expects to open up to 25 sites for the Phase 2 stage of the clinical trial.
•We continue to monitor the impact that COVID-19 may be having on patient enrollment and safety, site initiation, and study integrity. We have put in place and continue to maintain a variety of measures to mitigate the effects of COVID-19 and our top priority is to maintain patient safety and clinical trial continuity. During the third quarter of 2020, we have observed delays in our enrollment plans for the Phase 2 dose expansion phase of this clinical trial. The effects of the COVID-19 pandemic or its impact may have contributed to such delays. As a result, we have taken additional measures to increase the enrollment of patients, including frequent interaction with our clinical trial sites currently open as well as increasing the number of clinical trial sites that potentially are activated for this clinical trial so that we may continue to enroll patients as planned. However, these delays have caused us to lengthen our clinical development timeline fo
cavrotolimod (AST-008) and we now expect to report ORR results in the first half of 2022 rather than by year end 2021 as previously guided.
Third Quarter Financial Results, Financial Guidance and Recent Developments
Cash Position: Cash, cash equivalents, and short-term investments were $94.1 million as of September 30, 2020 compared to $85.8 million as of June 30, 2020, and the increase is attributed to the borrowing of the first tranche ($17.5 million) of the $25.0 million senior secured term loan with MidCap Financial Trust (MidCap), as agent, and Silicon Valley Bank (SVB).
Research and Development (R&D) Expenses: Research and development expenses were $9.1 million for the quarter ended September 30, 2020, as compared to $4.2 million for the quarter ended September 30, 2019. The Company continues to increase staffing in the R&D function, increasing headcount from 26 at September 30, 2019 to 48 at September 30, 2020 and the associated increase in hiring, in addition to growth in cavrotolimod (AST-008) clinical trial activities, has driven the Company’s increase in R&D costs. The associated increases in platform and discovery-related costs reflected increased preclinical R&D activities associated with the Company’s collaboration with AbbVie Inc. (AbbVie), increased costs related to XCUR-FXN, as well as other preclinical discovery work in neurology and ophthalmology.
General and Administrative (G&A) Expenses: General and administrative expenses were $2.4 million for the quarter ended September 30, 2020, as compared with $2.2 million for the quarter ended September 30, 2019.
Net Loss: The Company had a net loss of $8.8 million for the quarter ended September 30, 2020 compared to a net loss of $5.8 million for the quarter ended September 30, 2019 reflecting a higher net loss of $3.0 million. This increase in net loss was driven principally by the increases in R&D expenses and G&A expenses discussed above, partially offset by the recognition of $2.4 million of revenue associated with our collaboration with AbbVie.
Cash Runway Guidance: The Company believes that, based on its current operating plans and estimates of future expenses, as of the date of this press release, its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.
Response to COVID-19: With the global spread of the ongoing COVID-19 pandemic in 2020, we have been closely monitoring developments and have taken active measures to protect the health of our employees and their families, our communities, as well as our clinical trial investigators, patients and caregivers. We continue to carefully manage laboratory staffing and take other appropriate managerial actions to maintain progress on our preclinical and collaboration programs. We also continue to work closely with our third-party manufacturers and other partners to manage our supply chain activities and will take such action as we believe appropriate with our clinical operations to maintain patient safety and clinical trial continuity.
Resignation of Director: On November 10, 2020, Helen S. Kim resigned as a Class II director of our Board of Directors, or the Board, as well as from the Nominating and Corporate Governance Committee of the Board, effective immediately. Ms. Kim’s decision to resign was not the result of any disagreement between Ms. Kim and our Company, management, the Board or any committee thereof, on any matter relating to our operations, policies or practices. We thank Ms. Kim for her six years of service on the Board.