What changed in this filing

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Item 1A. Risk Factors

2020-11-05 compared with 2020-08-06 · 2 added, 67 removed, 5 unchanged (93% of the section changed)

Risk Factors.

Our business is subject to substantial risks and uncertainties, including risks, uncertainties and developments related to the COVID-19

You should carefully consider the risk factors set forth below as well as the other information contained in this Quarterly Report on Form 10-Q

and in our other public filings in evaluating our business, including risk factors in our 2019 Annual Report on Form 10-K

for the year ended December 31, 2019, which was filed with the SEC on February 26, 2020 (collectively, our “Risk Factors”).

Any of our Risk Factors either alone or taken together, may be heightened due to the COVID-19

pandemic or other factors and could materially and adversely affect our business, financial condition, results of operations or prospects and the value of our common stock.

In addition, these risks and uncertainties could cause actual results to differ materially from those expressed or implied by forward-looking statements contained in this Form 10-Q

or any of our public disclosures.

See “Special Note Regarding Forward-Looking Statements” in this Form 10-Q.

There have been no material changes to the Risk Factors as previously disclosed in the Company’s 2019 Annual Report on Form 10-K,

except as follows:

The continuation or worsening of the COVID-19

pandemic, which had worldwide effect in the first quarter of 2020, could affect our ability to complete our ongoing clinical trials, disrupt regulatory activities and delay or disrupt commercialization of resmetirom, and may have other adverse effects on our stock price and business operations.

pandemic is causing many governments to implement measures to slow the spread of the outbreak through quarantines, travel restrictions, heightened border security, shelter-in

place guidelines, social distancing restrictions and other measures.

This outbreak and the resulting governmental measures have had a significant impact, both direct and indirect, on businesses and commerce in the life sciences industry generally, as supply chains have been disrupted;

facilities and production have been suspended;

unemployment has increased;

and demand for certain third-party goods and services, such as medical services and supplies, has spiked.

The future progression of the pandemic and its effects on our business and operations are extremely uncertain and subject to the risks described below.

We and our contract research organizations (“CROs”) and contract manufacturing organizations (“CMO”) may face disruptions that may affect our ability to conduct and timely complete ongoing clinical trials including disruptions in procuring items that are essential for our development activities, such as materials and intermediates used in the manufacturing of resmetirom.

We and our CROs and CMOs, as well as clinical trial sites, may face disruptions related to our ongoing clinical trials arising from staffing disruptions and limitations on our activities and the activities of our CROs and CMOs, and delays in the ability to obtain necessary institutional review board or other necessary site approvals or delays in site initiations or site monitoring visits, as well as other delays at clinical trial sites.

We may also face limitations on enrollment and patients withdrawing from our clinical trials or not complying with the protocol procedures, which could delay completion of our clinical trials or adversely affect the data generated by our clinical trials.

For instance, patient screening and enrollment has been impacted and study patients may not be able to comply with clinical trial protocols (including biopsy testing), in each case where quarantines or shelter-in-place

restrictions impede patient movement or interrupt patient demand for, or a medical facility’s delivery of, protocol-required services and procedures.

Additionally, our ability to recruit and retain patients and principal investigators and site staff who may have heightened risks if exposed to COVID-19

may adversely impact the Company’s clinical trial operations.

The response to the COVID-19

pandemic also could redirect resources with respect to regulatory and intellectual property matters in a way that could adversely impact our ability to progress regulatory approvals and protect our intellectual property.

In addition, we may face impediments to regulatory meetings and approvals due to measures that are intended to limit in-person

interactions.

The pandemic has significantly impacted economies worldwide, which could result in adverse effects on our business and operations.

Moreover, the pandemic has also caused significant disruptions in the financial markets, and may continue to cause such disruptions, which has led to increased trading volatility and significant stock price declines, particularly in the first quarter of 2020, and the pandemic or related consequences may adversely impact the future volatility and value of our stock and future trading in our stock.

In accordance with governmental pronouncements, we have instituted policies to facilitate working remotely.

The continuation of personnel working from home (not only at Madrigal, but also at CROs, CMOs, clinical sites and governmental and supervisory bodies) may negatively impact our productivity, or disrupt, delay, or otherwise adversely impact our business.

This could adversely impact our business operations or delay necessary interactions with regulators, ethics committees, manufacturing sites, research or clinical trial sites and other important agencies and contractors, including our CROs and CMOs.

We cannot be certain what the overall impact of the COVID-19

pandemic will be on our business.

However, it has the potential to adversely affect our business, financial condition, results of operations, and prospects.

If we continue to experience delays or difficulties in the enrollment of patients in our MAESTRO-NASH trial, our receipt of necessary regulatory approvals, and the commercialization of resmetirom, could be delayed or prevented.

We may not be able to complete our MAESTRO-NASH clinical trial for resmetirom as previously planned if we are unable to locate and enroll on a timely basis a sufficient number of eligible patients to participate in this trial, as required by the FDA or similar regulatory authorities outside of the United States.

The global coronavirus pandemic has presented significant challenges in the conduct of MAESTRO-NASH enrollment in 2020.

Screening for MAESTRO-NASH was negatively impacted due to the outbreak of the COVID-19

pandemic, and the resulting governmental quarantine restrictions and shelter-in-place

guidelines that influenced the closing or suspension of many European and U.S.

trial sites and a decline in U.S.

patients seeking screening biopsies.

In addition, because MAESTRO-NASH is focused on specific patient populations with protocol-specified biopsy requirements, our ability to enroll eligible patients may be limited and enrollment may be slower than we anticipated before the pandemic.

In the face of these challenges, we have taken steps to mitigate the delay in MAESTRO-NASH enrollment by arranging biopsy and MRI services at non-hospital

facilities near many of our site locations, increasing the number of clinical sites and enrolling patients with existing biopsies, including patients from NASH trials which were discontinued and/or in which the drug was inactive in NASH.

We believe these mitigation efforts have positioned us to accelerate enrollment growth going forward, but the pace of new enrollment ultimately will be dependent on our target study patients becoming comfortable initiating the protocol-prescribed biopsies during the COVID-19

External factors that would help accelerate MAESTRO-NASH enrollment include new or emerging developments such as:

declines in the number of new reported COVID-19

actual (or perceived) reduced risks associated with potential surges in cases or “second-wave” COVID-19

developments in the U.S.

the easing of COVID-19

governmental restrictions;

the emergence of widely-recognized effective therapeutics, therapeutic combinations or vaccines to combat COVID-19;

and a sustained return to pre-COVID-19

daily routines, including routine on-site

work and school schedules and medical procedure scheduling in the U.S.

If the COVID-19

pandemic continues or worsens, patient recruitment and enrollment in our MAESTRO-NASH trial may be adversely affected, delayed or interrupted.

In addition, patients may choose to withdraw from our studies or we may choose to or be required to pause enrollment and or patient dosing in our trial in order to preserve health resources and protect trial participants.

It is unknown whether or how long pauses, delays or disruptions could occur or continue.

Our ability to successfully complete MAESTRO-NASH enrollment and study objectives in the midst of the COVID-19

pandemic is subject to circumstances beyond our control and is subject to the enhanced risks and uncertainties that are described in our Risk Factors.

There have been no material changes to the risk factors included in detail in the “Risk Factors” sections appearing in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 26, 2020, and in Part II, Item 1A in our Quarterly Report on Form 10-Q

for the period ended June 30, 2020 filed with the SEC on August 6, 2020.

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