Overview
An overview of our current therapeutic product candidates and their planned next development steps is illustrated below:
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AXA1125 for the Treatment of Long COVID
In May 2022, we completed patient enrollment in our Phase 2a Clinical Trial and on August 2, 2022, and we reported topline results.
AXA1665 for the Reduction in Risk of Overt Hepatic Encephalopathy (OHE) Recurrence
Effects of COVID-19 Pandemic
Components of our Condensed Consolidated Results of Operations
Revenue
Research and Development Expenses
•employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research and development functions;
•the cost of developing and scaling our manufacturing process and manufacturing products for use in our preclinical studies, Clinical Studies and Clinical Trials, including under agreements with third parties, such as consultants, contractors and CMOs;
•patent-related costs incurred in connection with filing and prosecuting patent applications; and
•facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance.
General and Administrative Expenses
Other Income (Expense), Net
Income Taxes
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Results of Operations
Comparison of the Three Months Ended September 30, 2022 and 2021
The following table summarizes our results of operations for the three months ended September 30, 2022 and 2021 (in thousands):
(38)
Total other income (expense), net (748) (710) (38) Net loss
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended September 30, 2022 and 2021 (in thousands):
Clinical research and outside services 8,037 5,578 2,459 Facility-related and other
97
Total research and development expenses $ 13,317 $ 10,130 $ 3,187
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General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2022 and 2021 (in thousands):
Change
(76)
(20)
Total general and administrative expenses $ 3,776 $ 4,773
$ (997)
Salary and benefits-related costs decreased by $0.9 million due to lower stock based compensation and employee-related costs.
Other Income (Expense), Net
Comparison of the Nine Months Ended September 30, 2022 and 2021
The following table summarizes our results of operations for the nine months ended September 30, 2022 and 2021 (in thousands):
September 30,
The following table summarizes our research and development expenses incurred during the nine months ended September 30, 2022 and 2021 (in thousands):
September 30,
$ 30,668 $ 13,059
General and Administrative Expenses
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2022 and 2021 (in thousands):
September 30,
$ 13,975 $ (1,660)
Salary and benefits-related costs decreased by $1.7 million due to lower stock based compensation and employee-related costs. Other contract services and outside costs increased by $0.2 million due to higher consulting and professional fees.
Other Income (Expense), Net
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Liquidity and Capital Resources
Sources of Liquidity
•On September 20, 2022, we issued convertible notes in aggregate principal amount of $6.0 million to existing investor Flagship Pioneering.
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Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):
(40,584)
(5,183)
268
Net increase (decrease) in cash and cash equivalents $ 1,851 $ (45,499)
Investing Activities
During the nine months ended September 30, 2021, net cash used in investing activities consisted of purchases of marketable securities and capital equipment, which were partially offset by proceeds from maturities of marketable securities.
During the nine months ended September 30, 2022, net cash provided by financing activities consisted of net proceeds from the issuance of common stock and convertible notes, which were partially offset by payments of the principal portion of a finance lease and principal portion of debt.
Funding Requirements
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Critical Accounting Policies and Use of Estimates
Recently Issued Accounting Pronouncements
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Emerging Growth Company Status
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Diabeets
02/11/2022