What changed in this filing

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Item 1A. Risk Factors

2020-11-12 compared with 2020-08-12 · 35 added, 55 removed, 13 unchanged (87% of the section changed)

7 unchanged sentences

in our 2019 10-K and Part II, Item

1A of our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 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 period

ended March 31, 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.

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 Report on Form 10-Q for the quarterly

period ended March 31, 2020 filed with the SEC on May 14, 2020.

face uncertainty and risks related to the outbreak of the novel coronavirus disease, COVID-19, which could significantly disrupt

our operations and may materially and adversely impact our business and financial conditions.

COVID-19 Pandemic continues to evolve rapidly and the related risks and uncertainty could materially and adversely affect our

business and financial conditions.

The United States and many other countries have declared a national emergency with respect

to the COVID-19 outbreak.

The outbreak and government measures taken in response to the Pandemic have severely impacted global

economic activity.

Many countries and almost all states in the United States have reacted to the outbreak by implementing stay-at-home

or quarantine orders, mandating certain business and school closures, enacting social distancing requirements, and restricting

large gatherings and travel.

response to the Pandemic, we have taken steps to protect the health and safety of our employees and comply with governmental mandates

and restrictions while working to ensure the sustainability of our business operations.

sales force has been subject to limitations on their ability to visit physicians and we are utilizing virtual meeting platforms

and other forms of social media to connect with our existing and potential customers and healthcare professionals.

Our sales force

has resumed in-person office visits in some areas and continues to work virtually in other territories based on the varying stay-at-home

orders, restrictions and phased openings during the ongoing Pandemic.

These restrictions and closures have also limited patient

access to physicians, and we have experienced, and may continue to experience, a decrease in new orders for our products.

effects of these restrictions may negatively impact productivity and demand for our products, disrupt our business and delay development

programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other

limitations on our ability to conduct our business in the ordinary course.

These restrictions and others in the future, as well

as the continued uncertainty on the duration, scope and severity of the outbreak, could negatively impact our business, operating

results and financial condition.

ongoing spread of COVID-19 in the United States and the mitigation measures imposed may limit healthcare professional interaction,

curtail patient visits to physicians and reduce the demand for our products in the future which could have a material adverse

impact on our business.

Moreover, to the extent that we or our partners are conducting clinical trials, the Pandemic could cause

delays or disruptions in these or future development programs.

The Pandemic could potentially impact the FDA or other regulatory

authorities which could cause delays in meetings or review of pending applications or submissions and impact our business.

the full economic impact and duration of the Pandemic and the mitigation measures may be difficult to assess or predict at this

time, global economic conditions have already been adversely affected by the COVID-19 crisis and these conditions could have an

adverse effect on our business including demand for our product, future revenue and operating results.

global Pandemic continues to evolve rapidly and the ultimate impact is highly uncertain and subject to change.

The full extent

to which the Pandemic may impact our business or the economy as a whole is unknown and will depend on future developments, which

are highly uncertain and cannot be predicted, such as the ultimate spread and rate of infection, the duration of the pandemic,

travel restrictions and social distancing requirements, business closures or business disruptions and the effectiveness of actions

taken in the United States and other countries to contain and treat the disease and to address its impact, including on financial

markets or otherwise.

These effects could have a material and adverse impact on our business and operations.

the extent the Pandemic adversely affects our business and financial results, it may also have the effect of heightening many

of the other risks described in the “Risk Factor”

section in our other filings with the SEC.

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

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