What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2020-08-14 compared with 2020-05-12 · 30 added, 29 removed, 113 unchanged (34% of the section changed)

3 unchanged sentences

The occurrence of any single risk or any combination of risks could materially and adversely affect our business, financial condition, results of operations, cash flows and the trading price of our common stock.

We will require substantial additional funding to finance our operations, complete the development and commercialization of COR388 and evaluate future drug candidates.

We will require substantial additional funding to finance our operations, complete the development and commercialization of atuzaginstat (COR388) and evaluate future drug candidates.

If we are unable to raise this funding when needed, we may be forced to delay, reduce or eliminate our drug development programs or other operations.

Since our inception, we have used substantial amounts of cash to fund our operations, and we expect our expenses to increase substantially in the foreseeable future in connection with our ongoing activities, particularly as we continue the research and development of, initiate clinical trials of, and seek marketing approval for, COR388.

Developing COR388 and conducting clinical trials for the treatment of Alzheimer’s disease and any other indications that we may pursue in the future will require substantial amounts of capital.

In addition, if we obtain marketing approval for COR388 or any future drug candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution.

Developing atuzaginstat and conducting clinical trials for the treatment of Alzheimer’s disease and any other indications that we may pursue in the future will require substantial amounts of capital.

In addition, if we obtain marketing approval for atuzaginstat or any future drug candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution.

Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations.

As of March 31, 2020, we had $223.6 million in cash, cash equivalents and investments.

Our balance sheet includes publicly-traded corporate debt securities.

We may be required to recognize impairments in the value of these investments if the relevant companies are materially adversely effected as a result of the negative effects arising from the COVID-19 pandemic or for other reasons, become unable to repay debt securities when due, or experience credit rating downgrades, or if the public trading price of these securities decreases.

We believe that our existing capital resources will be sufficient to fund our projected operations through at least 2022.

2 unchanged sentences

The amount and timing of our future funding requirements will depend on many factors, some of which are outside of our control, including but not limited to:

the progress, costs, trial design, results of and timing of our Phase 2/3 GAIN trial and other clinical trials of COR388, including for potential additional indications that we may pursue beyond Alzheimer’s disease;

the progress, costs, trial design, results of and timing of our Phase 2/3 GAIN trial and other clinical trials of atuzaginstat, including for potential additional indications that we may pursue beyond Alzheimer’s disease;

the willingness of the U.S.

Food and Drug Administration, or FDA, and European Medicines Agency, or EMA, to accept our GAIN trial, as well as data from our completed and planned clinical and preclinical studies and other work, as the basis for review and approval of COR388 for Alzheimer’s disease;

the outcome, costs and timing of seeking and obtaining FDA, EMA and any other regulatory approvals;

6 unchanged sentences

our need and ability to retain management and hire scientific and clinical personnel;

the effect of competing drugs and drug candidates and other market developments;

the effect of competing drugs and drug candidates and oth er market developments;

our need to implement additional internal systems and infrastructure, including financial and reporting systems;

5 unchanged sentences

Additionally, while the potential global economic impact and the duration of the COVID-19 pandemic may be difficult to assess or predict, a widespread pandemic could result in significant long-term disruption of global financial markets, which could in the future reduce our ability to access capital and negatively affect our liquidity.

In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our operations and the value of our common stock.

In addition, the trading prices for our common stock and other biopharmaceutical companies, as well as the broader equity and debt markets, have been highly volatile as a result of the COVID-19 pandemic and the resulting impact on economic activity.

Furthermore, a recession or market correction resulting from the spread of COVID-19 could materially affect our operations, overall yields from our investment portfolio and the value of our common stock.

We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates.

12 unchanged sentences

the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate;

our drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulatory authorities or institutional review boards to suspend or terminate the trials;

our drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our investi gators, regulatory authorities or institutional review boards to suspend or terminate the trials;

occurrence of serious adverse events in trials of the same class of agents conducted by other companies;

11 unchanged sentences

the potential for so-called “parallel importing,” which is what occurs when a local seller, faced with relatively high local prices, opts to import goods from another jurisdiction with relatively low prices, rather than buying them locally;

the potential for so-called “parallel exporting,” which is what occurs when a local seller buys goods meant for the locals and sells the goods for a higher price in another country, potentially causing or aggravating supply problems;

unexpected changes in tariffs, trade barriers and regulatory requirements;

1 unchanged sentence

economies and markets, including several countries in Europe;

compliance with tax, employment, immigration and labor laws for employees traveling abroad;

compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

taxes in other countries;

3 unchanged sentences

business interruptions resulting from geo-political actions, including war and terrorism, public health crises, such as pandemics and epidemics, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes and fires.

Natural disasters, public health crises, political crises, and other catastrophic events or other events outside of our control may be detrimental to our capabilities or the capabilities of third parties on which we depend.

Natural disasters, public health crises, political crises, and other catastrophic events o r other events outside of our control may be detrimental to our capabilities or the capabilities of third parties on which we depend.

Our headquarters are located in California near major geologic faults that have experienced earthquakes in the past.

2 unchanged sentences

In addition, if any of our suppliers or third-party service providers, such as our manufacturing partners or CROs, are affected by natural disasters, such as earthquakes, tsunamis, power shortages or outages, floods or monsoons, public health crises, such as pandemics and epidemics, political crises, such as terrorism, war, political instability or other conflict, cyberattacks, or other events outside of our control, our business and operating results could suffer.

Disasters, public health crises and political crises occurring at third-party facilities also could negatively impact our clinical development and regulatory approval timelines, our reputation and the perception of our company.

For example, as a result of the COVID-19 pandemic, we and our third-

party service providers have limited our operations or implemented limitations, including work-from-home policies.

Our a nd our third-party service providers increased reliance on personnel working from home may negatively impact productivity, or disrupt, delay, or otherwise adversely impact our business.

The increase in working remotely could increase cybersecurity risk, cr eate data accessibility concerns, and make us and our third-party service providers more susceptible to communication disruptions, any of which could adversely impact our or their business operations or delay necessary interactions with local and federal r egulators, manufacturing sites, clinical trial sites, and other third parties.

In addition, as a result of shelter-in-place orders or other mandated travel restrictions, our on-site staff conducting research and development activities may not be able to ac cess our laboratories, and these core activities may be significantly limited or curtailed, possibly for an extended period of time.

Further, we may experience limitations on the ability to recruit and hire key personnel due to the inability to meet with c andidates because of travel restrictions and “shelter in place” orders.

We also may experience operational challenges caused by sickness of our employees or their families, the desire of employees to avoid contact with large groups of people, and an increa sed reliance on working from home or mass transit disruptions.

Furthermore, new quarantines for COVID-19 or other viruses could impact personnel at contract manufacturing facilities in China , Europe or elsewhere to deliver key materials or the availability or cost of starting materials.

Any disruption of our ability to manufacture COR388 or the ability of our contract manufacturing vendors in China , Europe or elsewhere to deliver key materials on a timely basis could have a material adverse effect on the in itiation of new trials, the duration of open label extension studies and overall product development .

Disasters, public health crises and

political crises occurring at third-party facilities also could negatively impact our clinical development and regulatory approval timelines, our reputation and the perception of our company.

For example, as a resu lt of the COVID-19 pandemic, we and our third-party service providers have limited our operations or implemented limitations, including work-from-home policies.

Our and our third-party service providers increased reliance on personnel working from home may negatively impact productivity, or disrupt, delay, or otherwise adversely impact our business.

The increase in working remotely could increase cybersecurity risk, create data accessibility concerns, and make us and our third-party service providers more s usceptible to communication disruptions, any of which could adversely impact our or their business operations or delay necessary interactions with local and federal regulators, manufacturing sites, clinical trial sites, and other third parties.

In addition , as a result of shelter-in-place orders or other mandated travel restrictions, our on-site staff conducting research and development activities may not be able to access our laboratories, and these core activities may be significantly limited or curtailed , possibly for an extended period of time.

Further, due to travel restrictions and “shelter in place” orders, we may experience limitations on the ability to recruit and hire key personnel due to the inability to meet with candidates and reduced ability to engage with the medical and investor communities due to the cancelation of conferences scheduled throughout the year.

We also may experience operational challenges caused by sickness of our employees or their families, the desire of employees to avoid con tact with large groups of people, and an increased reliance on working from home or mass transit disruptions.

Furthermore, new quarantines for COVID-19 or other viruses could impact personnel at contract manufacturing facilities in China, Europe or elsewhe re to deliver key materials or the availability or cost of starting materials.

Any disruption of our ability to manufacture atuzaginstat or the ability of our contract manufacturing vendors in China, Europe or elsewhere to deliver key materials on a timely basis could have a material adverse effect on the initiation of new trials, the duration of open label extension studies and overall product development.

In addition, we may experience delays or disruptions in non-clinical experiments and supplies for suc h experiments, including animals required for such experiments.

These and other factors arising from the COVID-19 pandemic could worsen in countries that are already afflicted with COVID-19, could continue to spread to additional countries, or could return to countries where the pandemic has been partially contained, each of which could further adversely impact our ability to conduct clinical trials and our business generally, and could have a material adverse impact on our operations and financial conditio n and results.

Changes in funding for the FDA and other government agencies or other disruptions at these agencies could prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.

9 unchanged sentences

It is unknown how long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our clinical trials or delay in regulatory review resulting from such disruptions could affect the development and study of COR388.

Any elongation or de-prioritization of our clinical trials or delay in regulatory review resulting from such disruptions could affect the development and study of atuzaginstat.

The market price of our common stock is likely to be volatile and could fluctuate or decline, resulting in a substantial loss of your investment.

35 unchanged sentences

Our amended and restated certificate of incorporation also provides that the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action against us or any of our directors, officers, employees or agents and arising under the Securities Act.

We believe these provisions may benefit us by providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable, particularly experienced in resolving corporate disputes, efficient administration of case s on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation.

However, these provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes wit h us or our directors, officers, or other employees.

While the Delaware Supreme Court recently determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring such a claim arising under the Securities Act ag ainst us, our directors, officers, or other employees in a venue other than in the federal district courts of the United States of America.

In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provis ions of our amended and restated certificate of incorporation, and this may require significant additional costs associated with resolving such action in other jurisdictions.

We believe these provisions may benefit us by providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable, particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation.

However, these provisions may limit a stockholder’s ability to bring a claim in a jud icial forum that it finds favorable for disputes with us or our directors, officers, or other employees.

While the Delaware Supreme Court recently determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to br ing such a claim arising under the Securities Act against us, our directors, officers, or other employees in a venue other than in the federal district courts of the United States of America.

In such instance, we would expect to vigorously assert the valid ity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation, and this may require significant additional costs associated with resolving such action in other jurisdictions.

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