What changed in this filing

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Item 1A. Risk Factors

2020-11-10 compared with 2020-08-12 · 37 added, 35 removed, 117 unchanged (38% of the section changed)

55 unchanged sentences

supply of our product candidates, other resources and the conduct of our preclinical and clinical activities.

If the measures to contain the coronavirus

outbreak continue or are extended, it may adversely affect our operations and those of third parties on which we rely, including

causing disruptions in the supplies we order, outsourced development services for our product candidates and the conduct of current

and planned preclinical and clinical studies.

We have not yet experienced any significant impacts or interruptions to our supply

chain or third-party vendors as a result of the coronavirus pandemic, but are starting to see some of the third-parties on which

we rely becoming impacted.

If the measures to contain the outbreak are continued or extended, it may affect our operations and

those of our service providers.

Without a sustained improvement of the current situation, we may experience significant impacts

to certain of our development activities outsourced to third-party service providers beginning in the second half of 2020.

far, we have been able to engage with third-party service providers in areas with limited or no impact (e.g.

countries with limited

or no restrictions), but with the global spread of the virus and associated restrictions, this is no longer possible.

If the measures to contain the coronavirus outbreak continue or are extended,

it may adversely affect our operations and those of third parties on which we rely, including causing disruptions in the supplies

we order, outsourced development services for our product candidates and the conduct of current and planned preclinical and clinical

Presumably as a result of the pandemic, we have begun to see some of our third-party suppliers and service providers

on which we rely becoming impacted.

If the impact on their operations continue or extend, it may affect our operations.

We previously

had been able to engage with third-party service providers in areas with limited or no impact (e.g.

countries with limited or

no restrictions), but with the global spread of the virus and associated restrictions, this has been no longer possible.

providers, for example those performing required preclinical research studies, are now facing impacts to their operations, including

restrictions on the availability of critical materials that are needed for this type of research.

If the measures to contain the

outbreak are extended or further expanded, it could reduce or delay the availability of supplies and services that we purchase

and outsource or result in closures of businesses that we work with.

This may in turn slow or delay our research and development

activities, and/or result in higher costs.

The ultimate impact of the coronavirus pandemic is highly uncertain and subject to change.

The Company does not yet know the full extent of potential delays or impacts on its business and preclinical and clinical trial

Without a significant and sustained

improvement of the current situation, we may experience significant impacts to certain of our development activities outsourced

to third-party service providers, however, the ultimate impact on our third-party service providers is highly uncertain and subject

If the measures to contain the outbreak are extended or further expanded, it could reduce or delay the availability

of supplies and services that we purchase and outsource or result in closures of businesses that we work with.

This may in turn

slow or delay our preclinical and clinical research and development activities, and/or result in higher costs.

The ultimate impact

of the coronavirus pandemic is highly uncertain and subject to change.

The Company does not yet know the full extent of potential

delays or impacts on its business and preclinical and clinical trial activities.

Anticipated declines in the commencement

1 unchanged sentence

product candidates and may adversely affect our business.

The first stage of the Federal Drug Administration

FDA ”) approval process for a new biologic or drug involves the submission of an investigational new drug

application, which includes the clinical protocol along with the approval of the IRB at the institutions participating in the trials

prior to commencement of human clinical trials.

We anticipate a decline in the commencement of clinical trials, at least in the

short-term, as regulatory authorities and IRBs are currently focused primarily on reviewing and approving clinical trial protocols

related to COVID-19.

Additionally, due to the implementation of restrictive measures such as stay-at-home orders by government

authorities in the United States and global economies to try and contain the spread of coronavirus, we anticipate a significant

decline, at least in the short-term, in the enrollment of patients in clinical trials outside of those related to COVID-19.

impact on clinical trial operations may be temporarily delayed or regulatory clearances and approvals paused.

Therefore, our planned

preclinical and clinical activities, including the commencement of clinical trials for our drug candidates, may be temporarily

delayed or paused as a result, which may, in turn, impact our expected development milestones.

The first stage of the Federal

Drug Administration (the “

FDA ”) approval process for a new biologic or drug involves the submission of an investigational

new drug application, which includes the clinical protocol along with the approval of the IRB at the institutions participating

in the trials prior to commencement of human clinical trials.

We anticipate a continued decline in the commencement of new clinical

trials, at least in the short-term, as regulatory authorities and IRBs are currently focused primarily on reviewing and approving

clinical trial protocols related to COVID-19.

Additionally, due to the implementation of restrictive measures such as stay-at-home

orders by government authorities in the United States and global economies to try and contain the spread of coronavirus, we anticipate

a continued negative impacts, at least in the short-term, in the enrollment and participation of patients in clinical trials outside

of those related to COVID-19.

The impact on clinical trial operations may be temporarily delayed or regulatory clearances and

approvals paused.

Therefore, our planned preclinical and clinical activities, including the commencement of clinical trials for

our drug candidates, may be temporarily delayed or paused as a result, which may, in turn, impact our expected development milestones.

The required studies and steps needed to

55 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