What changed in this filing

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Item 1A. Risk Factors

2021-05-13 compared with 2020-11-12 · 9 added, 41 removed, 7 unchanged (88% of the section changed)

operate in a dynamic and rapidly changing environment that involves numerous risks and uncertainties.

Certain factors may have

a material adverse effect on our business, financial condition, and results of operations, and you should carefully consider them.

Other events that we do not currently anticipate or that we currently deem immaterial may also affect our results of operations

and financial condition.

Certain factors may have a material

adverse effect on our business, financial condition, and results of operations, and you should carefully consider them.

that we do not currently anticipate or that we currently deem immaterial may also affect our results of operations and financial condition.

should carefully consider the factors discussed in Part I, Item 1A.

“Risk Factors”

in our 2019 10-K and Part II, Item

1A of our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31 and June 30, 2020 which could materially affect

our business, financial condition, cash flows or future results.

The risk factors described in our 2019 10-K and 10-Q for the

quarterly periods ended March 31 and June 30, 2020 are not the only risks facing our company.

Additional risks and uncertainties

not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial

condition, or future results.

risk factor below constitutes an update to the risk factors included in our Annual Report on Form 10-K for the year ended December

31, 2019 filed with the SEC on March 5, 2020 and the risk factor included in our Quarterly Reports on Form 10-Q for the quarterly

periods ended March 31, 2020 filed with the SEC on May 14, 2020 and June 30, 2020 filed with the SEC on August 12, 2020.

business is adversely affected by the ongoing coronavirus pandemic and the impact could be material.

global COVID-19 pandemic has resulted in widespread requirements for individuals to stay in their homes and strained medical facilities

worldwide, including certain aspects of our business.

For example, we began commercializing our Biorphen product in December 2019,

however we have encountered difficulty in creating significant market pull-through demand for Biorphen in 2020 as our in-person

sales calls to key personnel at hospitals and surgical centers and introductory product presentation seminars were cancelled as

a result of the COVID-19 pandemic.

We are working on other promotional efforts to drive further adoption in the market, but we

expect that our Biorphen sales and marketing efforts will continue to be adversely affected by the pandemic in 2020.

may also affect our ability to complete recruitment and data analysis for our clinical trials and our ability to conduct research

and development of our complement programs in our planned timeframe.

The extent to which COVID-19 impacts our operations will

depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and

severity of the outbreak, and the actions that may be required to contain COVID-19 or treat its impact.

In particular, as a result

of the COVID-19 pandemic, we may experience disruptions that could severely impact our business, preclinical studies, drug manufacturing

and clinical trials including:

or difficulties in enrolling patients in our human factor study for Lamotrigine Oral Suspension (ET-105);

of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical

trial sites and hospital staff supporting the conduct of our clinical trials;

of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended

by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures,

which may impact the integrity of subject data and clinical study endpoints;

or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

of, or delays in promoting our products in-person, at conferences and at hospitals due to limitations on travel and in-person

gatherings imposed or recommended by federal or state governments

in our 2020 10-K, which could materially

affect our business, financial condition, cash flows or future results.

The risk factors described in our 2020 10-K, which was filed

with the SEC on March 16, 2021, are not the only risks facing our company.

Additional risks and uncertainties not currently known to

us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, or future results.

Unregistered Sales of Equity Securities and Use of Proceeds

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors