The Company has experienced net losses and negative cash flows from operations
each period since its inception. Through June 30, 2021, the Company had an
accumulated deficit of approximately $118.1 million. The Company's net loss was
approximately $9.7 million and $10.7million for the six-month periods ended June
30, 2021 and 2020, respectively.
The Company has been engaged in developing LYPDISO (formerly MAT9001) as well as
its lipid nanocrystal ("LNC") platform delivery technology and a pipeline of
associated product candidates, including MAT2203 and MAT2501, since 2011. To
date, the Company has not obtained regulatory approval for any of its product
candidates nor generated any revenue from product sales, and the Company expects
to incur significant expenses to complete development of its product candidates.
The Company may never be able to obtain regulatory approval for the marketing of
any of its product candidates in any indication in the United States or
internationally and there can be no assurance that the Company will generate
revenues or ever achieve profitability.
Assuming the Company obtains Food and Drug Administration ("FDA") approval for
one or more of its product candidates, the Company expects that its expenses
will continue to increase once the Company reaches commercial launch. The
Company also expects that its research and development expenses will continue to
increase as it moves forward with additional clinical studies for its current
product candidates and development of additional product candidates. As a
result, the Company expects to continue to incur substantial losses for the
foreseeable future, and that these losses will be increasing.
To continue to fund operations, during January 2021, the Company sold 3,023,147
shares of common stock under its At-The-Market Sales Agreement with BTIG, LLC,
generating net proceeds of approximately $5.6 million (See Note 11 -
Stockholders' Equity).
As of June 30, 2021, the Company had cash and cash equivalents of approximately
$30.4 million, marketable securities of approximately $29.5million and
restricted cash of approximately $0.3 million. The Company believes the cash and
cash equivalents and marketable securities on hand are sufficient to fund
planned operations into 2024.
Note 3 - Summary of Significant Accounting Policies
Basis of presentation and principles of consolidation
The accompanying unaudited condensed consolidated financial statements include
the consolidated accounts of Holdings and its wholly owned subsidiaries,
BioPharma, and Nanotechnologies. The Company has prepared its condensed
consolidated financial statements following the requirements of the SEC for
interim reporting. The accompanying unaudited condensed consolidated financial
statements have been prepared in accordance with accounting principles generally
accepted in the United States of America ("U.S. GAAP") and reflect the
operations of the Company and its wholly owned subsidiaries. All intercompany
transactions have been eliminated in consolidation.
The Company's significant accounting policies are described in Note 3 within the
Company's Notes to Consolidated Financial Statements included in the Company's
2020 Form 10-K.
5
COVID-19
In March 2020, the World Health Organization declared COVID-19 a global
pandemic. This contagious disease outbreak, which has continued to spread, and
any related adverse public health developments, has adversely affected
workforces, economies, and financial markets globally, and has and may continue
to cause economic downturns.
The Company has been actively monitoring the impact of COVID-19. The financial
results for the three and six months ended June 30, 2021 were not significantly
impacted by COVID-19. However, the Company cannot predict the impact of the
progression of COVID-19 on future results or the Company's ability to raise
capital due to a variety of factors, including but not limited to the continued
good health of Company employees, the ability of suppliers to continue to
operate and deliver, the ability of the Company to maintain operations, any
further government and/or public actions taken in response to the pandemic and
ultimately the length of the pandemic.
Note 4 - Cash, Cash Equivalents, Restricted Cash and Marketable Securities
The Company considers all highly liquid financial instruments with original
maturities of three months or less when purchased to be cash and cash
equivalents and all investments with maturities of greater than three months
from date of purchase are classified as marketable securities. Cash and cash
equivalents consisted of cash in bank checking and savings accounts, money
market funds and short-term U.S. treasury bonds that mature within three months
of settlement date.
Cash, Cash Equivalents and Restricted Cash
The Company presents restricted cash with cash and cash equivalents in the
Consolidated Statements of Cash Flows. Restricted cash represents funds the
Company is required to set aside to cover building operating leases and other
purposes.
The following table provides a reconciliation of cash, cash equivalents and
restricted cash reported in the Condensed Consolidated Balance Sheets to the
total of the amounts in the Condensed Consolidated Statements of Cash Flows as
of June 30, 2021, December 31, 2020, June 30, 2020 and December 31, 2019:
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