Components of Our Results of Operations
employee-related expenses, including salaries, related benefits and stock-based
? compensation expense for employees engaged in research and development
? fees paid to consultants for services directly related to our product
expenses incurred under agreements with contract research organizations, or
? CROs, as well as contract manufacturing organizations, or CMOs, and consultants
that conduct and provide supplies for our preclinical studies and clinical
? costs associated with preclinical activities and development activities;
? costs associated with our technology and our intellectual property portfolio;
? costs related to compliance with regulatory requirements.
The following table summarizes our research and development expenses for the three and six months ended June 30, 2022 and 2021:
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, and commercial functions. General and administrative expenses also include professional fees for legal, accounting, auditing, tax and consulting services; travel expenses; and facility-related expenses, which include allocated expenses for rent and maintenance of facilities and other operating costs.
Three Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021:
The following table summarizes our research and development expenses for the three months ended June 30, 2022 and 2021:
Total research and development expenses $ 15,396 $ 14,802 $
a decrease in drug manufacturing and formulation costs of $2.2 million
? primarily related to the completion and release of AT-007 drug product batches
an increase in clinical and pre-clinical expense of $2.2 million, primarily
? related to the progression of the SORD pivotal trial, progression of the AT-007
ACTION-Galactosemia long-term extension adult study, and progression of the
AT-007 ACTION-Galactosemia Kids pediatric registrational study;
? an increase in personnel expenses of $0.3 million due to the increase in
headcount in support of our clinical program pipeline;
? a decrease in regulatory and other expenses of $19,000; and
? an increase in stock-based compensation of $0.3 mllion due to new stock option
The following table summarizes our general and administrative expenses for the three months ended June 30, 2022 and 2021:
Total general and administrative expenses $ 6,125 $ 11,073 $
? a decrease in legal and professional fees of $0.5 million due to lower external
? a decrease in commercial expenses of $2.5 million related to a decrease in
? a decrease in personnel expenses of $0.4 million related to a decrease in
? a decrease in stock-based compensation of $0.7 million relating to options
being forfeited during the current period as well as decrease in headcount;
? a decrease in insurance expenses of $0.1 million related to decreased insurance
? a decrease in other expenses of $0.7 million relating to decreased costs of
Change in Fair Value of Warrant Liabilities
Six Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021:
The following table summarizes our research and development expenses for the six months ended June 30, 2022 and 2021:
Total research and development expenses $ 30,426 $ 29,250 $
a decrease in drug manufacturing and formulation costs of $7.8 million
? primarily related to the completion and release of AT-001 and AT-007 drug
product batches in the six months ended June 30, 2021;
an increase in clinical and pre-clinical expense of $7.3 million, primarily
? related to the progression of the SORD pivotal trial, progression of the AT-007
ACTION-Galactosemia long-term extension adult study, and progression of the
AT-007 ACTION-Galactosemia Kids pediatric registrational study;
? an increase in personnel expenses of $1.2 million due to the increase in
headcount in support of our clinical program pipeline;
? an increase in regulatory and other expenses of $0.2 million; and
? an increase in stock-based compensation of $0.3 million due to new stock option
The following table summarizes our general and administrative expenses for the six months ended June 30, 2022 and 2021:
? a decrease in legal and professional fees of $0.6 million due to lower external
? a decrease in commercial expenses of $3.1 million related to a decrease in
spend relating to commercial operations;
? a decrease in stock-based compensation of $1.7 million relating to options
being forfeited during the current period;
? a decrease in personnel expenses of $0.2 million related to an decrease in
? a decrease in insurance expenses of $23,000 related to decreased insurance
? a decrease in other expenses of $1.0 million relating to decreased costs of
Change in Fair Value of Warrant Liabilities
During the six months ended June 30, 2021, there was a net realized loss of $0.2 million related to the sale and or maturities of marketable securities.
Net cash provided by/(used in) investing activities 15,054 (7,892) Net cash provided by financing activities
Net increase (decrease) in cash and cash equivalents $ 1,840 $ 20,968
In June 2020, we entered into the Goldman Equity Distribution Agreement to sell shares of our common stock, from time to time, having an aggregate offering price of up to $100 million. The Goldman Equity Distribution Agreement was terminated as of January 24, 2022.
? initiate, conduct and complete any ongoing, anticipated or future preclinical
studies and clinical trials for our current and future product candidates;
? seek marketing approvals for any product candidates that successfully complete
establish a sales, marketing, manufacturing and distribution infrastructure to
? commercialize any current or future product candidate for which we may obtain
? seek to discover and develop additional product candidates;
? continue to build a portfolio of product candidates through the acquisition or
in-license of drugs, product candidates or technologies;
? maintain, protect and expand our intellectual property portfolio;
? hire additional clinical, regulatory and scientific personnel; and
add operational, financial and management information systems and personnel,
? including personnel to support our product development and planned future
? the initiation, scope, progress, timing, costs and results of our ongoing and
planned clinical trials for our product candidates;
? the outcome, timing and cost of meeting regulatory requirements established by
the FDA and other comparable foreign regulatory authorities;
? the cost of filing, prosecuting, defending and enforcing our patent claims and
? the cost of defending potential intellectual property disputes, including
the achievement of milestones or occurrence of other developments that trigger
? payments under the Columbia Agreements, the 2020 Miami License Agreement, the
2020 Miami Research Agreement, the 2020 Miami Option Agreement, or other
agreements we may enter into;
? the extent to which we are obligated to reimburse, or entitled to reimbursement
of, clinical trial costs under future collaboration agreements, if any;
? the effect of competing technological and market developments;
? the cost and timing of completion of clinical or commercial-scale manufacturing
? the costs of operating as a public company;
? the extent to which we in-license or acquire other products and technologies;
? our ability to establish and maintain collaborations on favorable terms, if at
the cost of establishing sales, marketing and distribution capabilities for our
? product candidates in regions where we choose to commercialize our product
? the initiation, progress, timing and results of the commercialization our
product candidates, if approved, for commercial sale.
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.
(1) Represents future minimum lease payments under our operating leases for
Critical Accounting Policies and Significant Judgments and Estimates
We have not entered into any off-balance sheet arrangements and do not have any holdings in variable interest entities.
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