Following completion of the Phase 1 clinical trial and achievement of a maximum tolerated dose, we intend to commence a Phase 2 clinical trial of GFH009 in combination with venetoclax and azacitidine in AML patients. The current standard of care for the vast majority of AML patients, including older patients, is venetoclax in combination with a hypomethylating agent such as azacitidine. GFH009 has shown in preclinical models a strong synergy with venetoclax.
Nelipepimut-S or NPS
Impact of COVID-19
Components of Results of Operations
Cost of license revenue consists of sublicensing fees incurred under our license from MSK in connection with the 3DMed License Agreement.
Research and Development Expense
Research and development expense consists of expenses incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred. These expenses include:
•expenses incurred under agreements with CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;
•quality control and quality assurance services;
•outsourced professional scientific development services;
•employee-related expenses, which include salaries, benefits and stock-based compensation;
•payments made under our license agreements, under which we acquired certain intellectual property;
•expenses relating to certain regulatory activities, including filing fees paid to regulatory agencies;
•laboratory materials and supplies used to support our research activities; and
•allocated expenses, utilities and other facility-related costs.
•the number of clinical sites and participating countries included in the trials;
•the length of time required to enroll suitable patients;
•the number of patients that ultimately participate in the trials;
•the number of doses patients receive;
•the duration of patient follow-up;
•the results of clinical trials;
•the expenses associated with manufacturing;
•the receipt of marketing approvals;
•the commercialization of current and future product candidates; and
•the impact of the COVID-19 pandemic.
Acquired in-process research and development consists of costs to acquire or license product candidates from third-parties for development with no alternative future use.
General and Administrative Expense
Non-Operating (Expense) Income, Net
Critical Accounting Policies and Estimates
Results of Operations for the Three and Nine Months Ended
The following table summarizes our results of operations for the three months ended
Further analysis of the changes and trends in our operating results are discussed below.
Cost of License Revenue
During the three months ended
General and Administrative
Non-Operating Income (Expense), Net
Non-operating income (expense), net for the three months ended
Change in fair value of warrant liability
Total non-operating income (expense), net
Net non-operating expense was nominal for the three months ended
The change in fair value of warrant liability and change in fair value of contingent consideration are non-cash in nature.
Income Tax Expense
There was no income tax expense for the three months ended
Liquidity and Capital Resources
We had no investing activities during the three months ended
Net Cash Provided by Financing Activities
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet financing arrangements as of
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