Forward-Looking Statements
Overview
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Table of Contents
Recent Developments in Our Clinical Programs
Contingent on discussions with the hematology division of the FDA expected in the second half of calendar year 2022, we intend to initiate a randomized, placebo-controlled study of batoclimab as a treatment for WAIHA.
License Agreement with HanAll (“HanAll Agreement”)
Product Service Agreement and Master Services Agreement
The minimum purchase commitment related to this agreement is estimated to be approximately
Related Party Transactions
For a description of our transactions under agreements with related parties, refer to “Note 5 – Related Party Transactions” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report.
Unallocated costs include:
•costs related to contract manufacturing operations not allocated to a specific program;
•personnel-related expenses for research and development personnel, which includes employee-related expenses such as salaries, benefits and other staff-related costs;
•stock-based compensation expenses for research and development personnel;
•payments upon the achievement of certain development and regulatory milestones under the HanAll Agreement;
•costs allocated to us under our services agreements with RSI and RSG (the “Services Agreements”); and
•other expenses, which include the cost of consultants who assist with our research and development, but are not allocated to a specific program.
•the number of trials required for approval;
•the per patient trial costs;
•the number of patients that participate in the trials;
•the number of sites included in the trials;
•the countries in which the trial is conducted;
•the length of time required to enroll eligible patients;
•the number of doses that patients receive;
•the drop-out or discontinuation rates of patients;
•the potential additional safety monitoring or other studies requested by regulatory agencies;
•the duration of patient follow-up;
•the timing and receipt of regulatory approvals;
•the potential impact of the ongoing COVID-19 pandemic;
•the efficacy and safety profile of the product candidate; and
•the cost of manufacturing.
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Table of Contents
General and Administrative Expenses
Results of Operations for the Three Months Ended
The following table sets forth our results of operations for the three months ended
Research and Development Expenses for the Three Months Ended
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*Certain prior year amounts have been reclassified to conform to current year presentation.
General and Administrative Expenses for the Three Months Ended
Liquidity and Capital Resources
Sources of Liquidity
The following table sets forth a summary of our cash flows for the three months ended
30,
2021
(21,214)
(18)
Investing Activities
For the three months ended
Financing Activities
Product Service Agreement and Master Services Agreement
HanAll Agreement
Lease Agreements
In
Our future minimum lease payments as of
We anticipate that our short-term and long-term future capital requirements will increase substantially as we:
•fund our clinical development programs;
•launch any potential Phase 2 proof-of-concept studies of batoclimab in additional indications;
•increase manufacturing of batoclimab substance to support clinical trials;
•seek to identify, acquire, develop and commercialize additional product candidates;
•integrate acquired technologies into a comprehensive regulatory and product development strategy;
•maintain, expand and protect our intellectual property portfolio;
•hire scientific, clinical, quality control and administrative personnel;
•add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•ultimately establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and
•incur insurance, legal and other regulatory compliance expenses to operate as a public company.
Outlook
Critical Accounting Estimates
Recent Accounting Pronouncements
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