ACET
Overview
Recent Developments
Public Offerings and Private Placement
At-the-Market (ATM) Offering
Loan Agreement
Change Order for 1000 Bridge Parkway Construction
Impact of COVID-19 Pandemic
--------------------------------------------------------------------------------
Operating Expenses
Research and Development
Research and development expenses, which consist primarily of costs incurred in connection with the development of our product candidates, are expensed as incurred. Research and development expenses consist primarily of:
•
employee related costs, including salaries, benefits and stock-based compensation expenses for research and development employees;
•
costs incurred under agreements with consultants, contract manufacturing organizations (CMOs) and contract research organizations (CROs);
•
lab materials, supplies, and maintenance of equipment used for research and development activities; and
•
•
the scope, rate of progress and expense of clinical trials and other research and development activities;
•
uncertainties in clinical trial enrollment rate or design;
•
significant and changing government regulation;
•
the timing and receipt of any regulatory approvals;
•
the FDA's or other regulatory authority's influence on clinical trial design;
•
establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
•
commercializing product candidates, if and when approved, whether alone or in collaboration with others;
•
obtaining and maintaining patent and trade secret protection and regulatory exclusivity for product candidates;
•
continued applicable safety profiles of the products following approval; and
•
retention of key research and development personnel.
General and Administrative
Interest Income
Interest income consists primarily of interest income earned on our cash and cash equivalents and marketable debt securities.
Interest Expense
Interest expense consists primarily of the non-cash amortization of costs incurred in connection with the Loan Agreement entered into with PacWest in April 2020, and subsequently amended in October 2021.
Other Expense, Net
Other income (expense), net primarily consists of state franchise and capital taxes not related to income.
Comparison of the Three Months Ended March 31, 2022 and 2021
The following table summarizes our results of operations for the periods indicated (in thousands, except percentages):
--------------------------------------------------------------------------------
months ended March 31, 2021, there was a change in estimate related to the estimated costs to complete the Company's performance obligations related to the Regeneron Agreement, which resulted in negative revenue during the period.
3,018
1,055
1,726
$ 11,743
(1) Employee related costs, including salaries, benefits, bonuses, and stock-based compensation expenses for research and development employees.
(2) Allocated facility-related costs, such as rent, utilities, insurance, repairs and maintenance, depreciation and amortization, information technology costs and general support services.
Interest income
Interest Expense
--------------------------------------------------------------------------------
Income tax expense
Liquidity and Capital Resources
Sources of Liquidity
Loan Agreement
As of the date of this Quarterly Report on Form 10-Q, we were in compliance with such covenants and had no indebtedness outstanding under the Loan Agreement.
Future Funding Requirements
We recorded net income of $4.6 million for the three months ended March 31, 2022. Prior to this period, we have recorded net losses since inception. As of March 31, 2022, we had an accumulated deficit of $163.7 million.
•
•
the number and scope of clinical programs we decide to pursue;
•
the cost, timing and outcome of preparing for and undergoing regulatory review of our product candidates;
•
the scope and costs of development and commercial manufacturing activities;
•
the cost and timing associated with commercializing our product candidates, if they receive marketing approval;
•
the extent to which we acquire or in-license other product candidates and technologies;
•
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•
our ability to establish and maintain collaborations on favorable terms, if at all;
•
•
our implementation of operational, financial and management systems;
•
the impact of the COVID-19 pandemic on United States and global economic conditions that may impact our ability to access capital on terms anticipated, or at all; and
•
the post-merger costs associated with being a public company.
See the section of this Quarterly Report on Form 10-Q titled "Risk Factors" for additional risks associated with our substantial capital requirements.
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses