What changed in this filing

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Item 1. Financial Statements

2022-08-04 compared with 2022-05-09 · 147 added, 92 removed, 307 unchanged (44% of the section changed)

16 unchanged sentences

Long term liabilities:

Loan payable, net of discount

Lease liability

3 unchanged sentences

Preferred stock, par value $ 0.0001 per share authorized:

5,000,000 shares at March 31, 2022 and December 31, 2021;

1,969,797 shares issued and outstanding at March 31, 2022 and December 31, 2021

5,000,000 shares at June 30, 2022 and December 31, 2021;

1,969,797 shares issued and outstanding at June 30, 2022 and December 31, 2021

Common stock, par value $ 0.0001 per share authorized:

200,000,000 at March 31, 2022 and December 31, 2021;

17,103,395 and 17,103,395 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

200,000,000 at June 30, 2022 and December 31, 2021;

17,103,395 shares issued and outstanding at June 30, 2022 and December 31, 2021

Additional paid-in-capital

Accumulated other comprehensive gain (loss)

Accumulated other comprehensive loss

Accumulated deficit

5 unchanged sentences

in thousands, except share and per share amounts)

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Total revenues

5 unchanged sentences

Interest income

Interest expense

Net loss per common share:

5 unchanged sentences

in thousands)

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Other comprehensive income (loss):

5 unchanged sentences

in thousands, except share and per share amounts)

Preferred stock

comprehensive

1 unchanged sentence

stockholders’

Preferred stock

Balance at December 31, 2021

Compensation expense related to stock options for services

Unrealized gain on marketable securities

Unrealized loss on marketable securities

Balance at March 31, 2022

Compensation expense related to stock options for services

Unrealized loss on marketable securities

Issuance of warrants

Balance at June 30, 2022

Balance at December 31, 2020

4 unchanged sentences

Balance at March 31, 2021

Issuance of common shares in equity offering, excluding to related parties, net of transaction costs

Compensation expense related to stock options for services

Unrealized gain on marketable securities

Balance at June 30, 2021

See accompanying notes to condensed consolidated financial statements.

2 unchanged sentences

in thousands)

Three Months Ended March 31,

Six Months Ended

Cash flows from operating activities:

2 unchanged sentences

Depreciation and amortization expense

Amortization of debt issuance costs and discount

Changes in operating assets and liabilities:

11 unchanged sentences

Proceeds from issuances of stock, excluding related parties, net of transaction costs

Proceeds from the sale of related party stock and exercise of common stock options, net of transaction costs

Proceeds from the exercise of common stock options

Proceeds from issuance of loan payable

Payment of debt issuance costs

Net cash provided by financing activities

2 unchanged sentences

Cash and cash equivalents at end of period

Supplemental disclosure of cash flow information:

Obtaining a right-of-use

asset in exchange for a lease liability

See accompanying notes to condensed consolidated financial statements.

4 unchanged sentences

Madrigal Pharmaceuticals, Inc.

(the “Company” or “Madrigal”) is a clinical-stage pharmaceutical company developing novel, high-quality, small-molecule drugs addressing major unmet needs in cardiovascular, metabolic, and liver diseases.

The Company’s lead compound, resmetirom, is being advanced for non-alcoholic

steatohepatitis (“NASH”), a liver disease that commonly affects people with metabolic diseases such as obesity and diabetes, and non-alcoholic

fatty liver disease (“NAFLD”).

The Company initiated two Phase 3 studies of resmetirom in NASH in 2019 that are ongoing.

(the “Company” or “Madrigal”) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need.

Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-ß selective agonist designed to target key underlying causes of NASH in the liver.

Resmetirom is currently being evaluated in two Phase 3 clinical studies (MAESTRO-NASH and MAESTRO-NAFLD-1)

designed to demonstrate multiple benefits in patients with NASH.

The Company announced results from the Phase 3 MAESTRO-NAFLD-1

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To determine whether an other-than- temporary impairment exists, the Company considers whether it intends to sell the debt security and, if the Company does not intend to sell the debt security, it considers available evidence to assess whether it is more likely than not that it will be required to sell the security before the recovery of its amortized cost basis.

During the three months ended March 31, 2022 and 2021, the Company determined it did not have any securities that were other-than- temporarily impaired.

During the six months ended June 30, 2022 and 2021, the Company determined it did not have any securities that were other-than- temporarily impaired.

Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity.

1 unchanged sentence

Realized gains and losses are determined on the specific identification method.

During the three months ended March 31, 2022 and 2021, the Company did not have any realized gains or losses on marketable securities.

During the six months ended June 30, 2022 and 2021, the Company did not have any realized gains or losses on marketable securities.

Fair Value of Financial Instruments

10 unchanged sentences

These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs.

As of March 31, 2022, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs.

During the three months ended March 31, 2022 and 2021, the Company did not have any transfers of financial assets between Levels 1 and 2.

As of March 31, 2022 and December 31, 2021, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet.

As of June 30, 2022, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs.

During the six months ended June 30, 2022 and 2021, the Company did not have any transfers of financial assets between Levels 1 and 2.

As of June 30, 2022 and December 31, 2021, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet.

Research and Development Costs

1 unchanged sentence

Research and development costs are comprised of costs incurred in performing research and development activities, including internal costs (including stock-based compensation), costs for consultants, milestone payments under licensing agreements, and other costs associated with the Company’s preclinical and clinical programs.

In particular, the Company has conducted safety studies in animals, optimized and implemented the manufacturing of our drug, and

conducted Phase 1-3

In particular, the Company has conducted safety studies in animals, optimized and implemented the manufacturing of our drug, and conducted Phase 1-3

clinical trials, all of which are considered research and development expenditures.

30 unchanged sentences

Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method.

However, for the three months ended March 21, 2022 and 2021, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of unvested restricted common stock, common stock issuable upon the exercise of stock options, and common stock issuable upon the conversion of preferred stock would be anti-dilutive.

However, for the six months ended June 30, 2022 and 2021, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of unvested restricted common stock, common stock issuable upon the exercise of stock options, and common stock issuable upon the conversion of preferred stock would be anti-dilutive.

The following table summarizes outstanding securities not included in the computation of diluted net loss per common share, as their inclusion would be anti-dilutive:

Three Months Ended March 31,

Six Months Ended June 30,

Common stock options

3 unchanged sentences

The Company is subject to risks common to development stage companies in the biopharmaceutical industry including, but not limited to, uncertainty of product development and commercialization, dependence on key personnel, uncertainty of market acceptance of products and product reimbursement, product liability, uncertain protection of proprietary technology, potential inability to raise additional financing necessary for development and commercialization, and compliance with the U.S.

Food and Drug Administration and other government regulations.

The Company has incurred losses since inception, including approximately $ 57.5 million for the three months ended March 31, 2022, resulting in an accumulated deficit of approximately $ 724.8 million as of March 31, 2022.

Food and Drug Administration (FDA) and other government regulations.

The Company has incurred losses since inception, including approximately $ 128.2 million for the six months ended June 30, 2022, resulting in an accumulated deficit of approximately $ 795.6 million as of June 30, 2022.

Management expects to incur losses for the foreseeable future.

To date, the Company has funded its operations primarily through proceeds from sales of the Company’s capital stock.

The Company believes that its cash, cash equivalents and marketable securities at March 31, 2022 will be sufficient to fund operations past one year from the issuance of these financial statements.

In addition, the Company entered into a Loan and Security Agreement (the “Loan

with Hercules Capital, Inc.

and the several banks and other financial institutions or entities party thereto

in May 2022 which provides

for an aggregate of up to $ 250.0 million in term loans, which will be available in four tranches, subject to the Company’s achievement of certain milestones.

first $ 50.0 million tranche was drawn at closing (see Note 6 – Long Term Debt).

The Company believes that its cash, cash equivalents and marketable securities at June 30, 2022 will be sufficient to fund operations past one year from the issuance of these financial statements.

To meet its future capital needs, the Company intends to raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions.

4 unchanged sentences

A summary of cash, cash equivalents and available-for-sale

marketable securities held by the Company as of March 31, 2022 and December 31, 2021 is as follows (in thousands):

March 31, 2022

marketable securities held by the Company as of June 30, 2022 and December 31, 2021 is as follows (in thousands):

June 30, 2022

Cash and cash equivalents:

1 unchanged sentence

Money market funds (Level 1)

Corporate debt securities due within 3 months of date of purchase (Level 2)

Total cash and cash equivalents

2 unchanged sentences

government and government sponsored entities due within 1 year of date of purchase (Level 2)

Corporate debt securities due within 1 to 2 years of date of purchase (Level 2)

Total cash, cash equivalents and marketable securities

9 unchanged sentences

Accrued Liabilities

Accrued liabilities as of March 31, 2022 and December 31, 2021 consisted of the following (in thousands):

Accrued liabilities as of June 30, 2022 and December 31, 2021 consisted of the following (in thousands):

Contract research organization costs

3 unchanged sentences

Total accrued liabilities

Long Term Debt

In May 2022 the Company and its wholly-owned subsidiary, Canticle Pharmaceuticals, Inc., entered into the

$ 250.0 million Loan Facility with the several banks and other financial institutions or entities party thereto (each, a “Lender” and collectively referred to as the “Lenders”), and Hercules Capital, Inc.

(“Hercules”), in its capacity as administrative agent and collateral agent for itself and the Lenders.

Under the terms of the Loan Facility, the first

$ 50.0 million tranche was drawn at closing.

The Company may also draw up to an additional

$ 125.0 million in two separate tranches upon achievement of certain resmetirom clinical and regulatory milestones.

A fourth tranche of

$ 75.0 million may be drawn by the Company, subject to the approval of Hercules.

The Loan Facility has a minimum interest rate of 7.45 % and adjusts with changes in the prime rate.

The Company will pay interest-only monthly payments of accrued interest under the Loan Facility for a period of 30 months, which period may be extended to 36, 48, and 60 months upon the successive achievement of certain clinical and regulatory milestones

and if the Company maintains compliance with applicable covenants.

The Loan Facility matures in May 2026 and may be extended an additional year upon the achievement of certain clinical and regulatory milestones.

The Loan Facility is secured by a security interest in substantially all of the Company’s assets, other than intellectual property.

It includes an end of term charge

of 5.35 % of the aggregate principal amount, which is accounted for in the loan discount.

In connection with the first tranche drawn at closing, the Company issued Hercules a warrant to purchase 14,899 shares, which had a Black-Scholes value of $ 0.6 million.

Additional details of the Loan Facility were filed with the Securities and Exchange Commission (“SEC”) on a Current Report on Form 8-K

on May 9, 2022 and the Loan and Security Agreement associated with the Loan Facility is included as an exhibit to this Quarterly Report on Form 10-Q.

The Loan Facility includes affirmative and restrictive financial covenants commencing on January 1, 2023, including maintenance of a minimum cash, cash equivalents and liquid funds covenant of $ 35.0 million, which may decrease in certain circumstances if the Company achieves certain clinical milestones and a revenue milestone, and a revenue-based covenant that could apply commencing at or after the time that financial reporting is due for the quarter ending September 30, 2024 .

The Loan Facility also includes customary covenants associated with a secured loan facility, including covenants concerning financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts.

As of June 30, 2022, the outstanding principal under the Loan Facility was $ 50.0 million.

The interest rate as of June 30, 2022 was 8.70 %.

As of June 30, 2022, the Company was in compliance with all loan covenants and provisions.

Future minimum payments, including interest and principal, under the loans payable outstanding as of June 30, 2022 are as follows (in thousands):

Period Ending June 30, 2022:

2022 (remaining six months)

Less amount representing interest

Less unamortized discount

Loans payable, net of discount

Stockholders’ Equity

3 unchanged sentences

Preferred Stock

The Company’s Series A Convertible Preferred Stock (“Series A Preferred Stock”) has a par value of $0.0001 per share and is convertible into shares of the Common Stock at a

The Company’s Series A Convertible Preferred Stock (“Series A Preferred Stock”) has a par value of $0.0001 per share and is convertible into shares of the Common Stock at a one -to-one

ratio, subject to adjustment as provided in the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock, that the Company filed with the Secretary of State of the State of Delaware on June 21, 2017 (the “Series A Certificate”).

16 unchanged sentences

Of those shares sold, 1,087,126 were sold in 2021.

In June 2021, the Company filed with the U.S.

Securities and Exchange Commission (the “SEC”) and had declared

effective a new shelf registration statement on Form S-3

In June 2021, the Company filed with the SEC and had declared effective a new shelf registration statement on Form S-3

and, in connection therewith, entered into a new at-the-market

1 unchanged sentence

The terms of the 2021 Sales Agreement are substantially the same as the 2020 Sales Agreement.

The 2021 Sales Agreement authorizes an aggregate offering of up to $ 200 million in shares of our common stock, from time to time, at the Company’s option, through Cowen as its sales agent.

The 2021 Sales Agreement authorizes an aggregate offering of up to

$ 200 million in shares of our common stock, from time to time, at the Company’s option, through Cowen as its sales agent.

The 2021 Sales Agreement supersedes the 2020 Sales Agreement.

Subject to the terms and conditions of the 2021 Sales Agreement, Cowen will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).

As of March 31, 2022, 497,043 shares had been sold under the 2021 Sales Agreement for an aggregate of approximately $ 40.8 million in gross proceeds, with net proceeds to the Company of approximately $ 39.8 million after deducting commissions and other transaction costs.

of June 30, 2022,

497,043 shares had been sold under the 2021 Sales Agreement for an aggregate of approximately $

40.8 million in gross proceeds, with net proceeds to the Company of approximately $

39.8 million after deducting commissions and other transaction costs.

All of those shares were sold in 2021.

As of March 31, 2022, $ 159.2 million remained reserved and available for sale under the 2021 Sales Agreement and the Company’s related prospectus supplement.

As of June 30, 2022, $

159.2 million remained reserved and available for sale under the 2021 Sales Agreement and the Company’s related prospectus supplement.

Stock-based Compensation

The Company’s 2015 Stock Plan, as amended, is our primary equity incentive compensation plan through which equity based grants are awarded.

The 2015 Stock Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock and other stock-based compensation awards to employees, officers, directors, and consultants of the Company.

The 2015 Stock Plan provides for the grant of incentive stock options, non-statutory

stock options, restricted stock and other stock-based compensation awards to employees, officers, directors, and consultants of the Company.

The administration of the 2015 Stock Plan is under the general supervision of the Compensation Committee of the Board of Directors.

The terms of stock options awarded under the 2015 Stock Plan, in general, are determined by the Compensation Committee, provided the exercise price per share generally shall not be set at less than the fair market value of a share of the common stock on the date of grant and the term shall not be greater than

ten years from the date the option is granted.

As of March 31, 2022, the Company had options outstanding to purchase 2,878,399 shares of its common stock, which includes options outstanding under its prior incentive compensation plan, the 2006 Stock Plan.

As of March 31, 2022,

1,084,468 shares were available for future issuance under the 2015 Stock Plan.

The following table summarizes stock option activity during the three months ended March 31, 2022:

As of June 30, 2022, the Company had options outstanding to purchase 2,976,545 shares of its common stock, which includes options outstanding under its prior incentive compensation plan, the 2006 Stock Plan.

As of June 30, 2022, 986,322 shares were available for future issuance under the 2015 Stock Plan.

The following table summarizes stock option activity during the six months ended June 30, 2022:

average exercise

2 unchanged sentences

Options cancelled

Outstanding at March 31, 2022

Exercisable at March 31, 2022

The total cash received by the Company as a result of stock option exercises was $ 0 million and $ 0.5 million, respectively, for the three months ended March 31, 2022 and 2021.

The total intrinsic value of options exercised was $ 0 million and $ 0.1 million, respectively,

for the three months ended March 31, 2022 and 2021.

The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the three months ended March 31, 2022 and 2021 were $ 59.63 and $ 85.17 , respectively.

Outstanding at June 30, 2022

Exercisable at June 30, 2022

The total cash received by the Company as a result of stock option exercises was $ 0 million and $ 0.5 million, respectively, for the six months ended June 30, 2022 and 2021.

The total intrinsic value of options exercised was $ 0 million and $ 0.1 million, respectively, for the six months ended June 30, 2022 and 2021.

The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the six months ended June 30, 2022 and 2021 were $ 55.84 and $ 78.34 , respectively.

Stock-Based Compensation Expense

Stock-based compensation expense during the three months ended March 31, 2022 and 2021 was as follows (in thousands):

Ended March 31,

Stock-based compensation expense during the six months ended June 30, 2022 and 2021 was as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Stock-based compensation expense by type of award:

Stock options

Restricted stock

Total stock-based compensation expense

3 unchanged sentences

Total stock-based compensation expense included in net loss

Unrecognized stock-based compensation expense on stock options as of March 31, 2022 was $ 74.2 million with a weighted average remaining period of 3.16 years.

stock-based compensation expense on stock options as of June 30, 2022 was $ 70.0 million with a weighted average remaining period of 2.95 years.

Commitments and Contingencies

4 unchanged sentences

Furthermore, a tiered single-digit royalty is payable on net sales of resmetirom or a product developed from resmetirom, subject to certain reductions.

The Company has not achieved any additional product development or regulatory milestones and had no Licensed Product sales for the three months ended March 31, 2022 and 2021.

The Company has not achieved any additional product development or regulatory milestones and had no Licensed Product sales for the six months ended June 30, 2022 and 2021.

The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of the Phase 3 clinical trials.

Subsequent Event

In May 2022 the Company entered into a $ 250 million term loan facility with Hercules Capital, Inc.

(“Hercules”).

Under the terms of the loan agreement, $ 50 million was drawn at closing.

The Company may also draw an additional $ 125 million in two separate tranches upon achievement of resmetirom clinical and regulatory milestones.

An additional $ 75 million may be drawn by the Company, subject to the approval of Hercules.

The loan facility has a floor interest rate of 7.45 % and adjusts with future changes in the prime rate, subject to the floor rate.

The loan bears initial

interest at a rate of 7.95 %.

The Company will pay interest-only for a period of 30 months, which may be extended to 60 months upon the achievement of certain milestones .

The loan matures in May 2026 and may be extended an additional year upon the achievement of certain milestones.

Additional details of the loan agreement will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form

includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on our beliefs and assumptions and on information currently available to us, but are subject to factors beyond our control Forward-looking statements:

This Quarterly Report on Form 10-Q

Forward-looking statements:

reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events;

include all statements that are not historical facts;

and can be identified by terms such as “achieve,” “allow,” “anticipates,” “appear,” “be,” “believes,” “can,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expects,” “expectation,” “forecasts,” “future,” “goal,” “help,” “hopeful,” “inform,” “goal,” “intends,” “may,” “might,” “on track,” “planned,” “planning,” “plans,” “positions,” “potential,” “powers,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “will be,” “will achieve,” “would” or similar expressions and the negatives of those terms.

and can be identified by terms such as “accelerate,” “achieve,” “allow,” “anticipates,” “appear,” “be,” “believes,” “can,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expects,” “expectation,” “forecasts,” “future,” “goal,” “help,” “hopeful,” “inform,” “intends,” “may,” “might,” “on track,” “planned,” “planning,” “plans,” “positions,” “potential,” “powers,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “will be,” “will achieve,” “would” or similar expressions and the negatives of those terms.

In particular, forward-looking statements contained in or incorporated by reference to this Quarterly Report relate to, among other things:

Anticipated or estimated future results, including the risks and uncertainties associated with our future operating performance and financial position;

Our possible or assumed future results of operations and expenses, business strategies and plans (including

launch/partnering plans), capital needs and financing plans, including incurrence of indebtedness and compliance with debt covenants under the Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc., as agent and lender (“Hercules”), market trends, competitive position, industry environment and potential growth opportunities,

Our possible or assumed future results of operations and expenses, business strategies and plans (including ex-U.S.

launch/partnering plans), capital needs and financing plans, including incurrence of indebtedness and compliance with debt covenants under the Loan and Security Agreement with Hercules Capital, Inc., as agent and lender, market trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things;

Our ability to delay certain research activities and related clinical expenses as necessary;

Our clinical trials, including the anticipated timing of disclosure, presentations of data from, or outcomes from our trials,

Research and development activities, and the timing and results associated with the future development of our lead product candidate, resmetirom (formerly known as

including projected market size and sector leadership,

The timing and completion of projected 2022 clinical milestone events, including enrollment, additional studies,

Research and development activities, and the timing and results associated with the future development of our lead product candidate, resmetirom (formerly known as MGL-3196),

including projected market size, sector leadership, and patient treatment estimates for non-alcoholic

steatohepatitis (“NASH”) and non-alcoholic

fatty liver disease (“NAFLD”) patients;

The timing and completion of projected future clinical milestone events, including enrollment, additional studies, top-line

data and open label projections;

Plans, objectives and timing for making a Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) submission to FDA;

Our primary and secondary study endpoints for resmetirom, and the potential for achieving such endpoints and projections, including

non-alcoholic

steatohepatitis (“NASH”) resolution, safety, fibrosis treatment, cardiovascular effects and lipid treatment with resmetirom,

Optimal dosing levels for resmetirom and projections regarding potential NASH or nonalcoholic fatty liver disease (“NAFLD”) and potential patient benefits with resmetirom, including future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment and/or biomarker effects with resmetirom,

The potential efficacy and safety of resmetirom for

non-cirrhotic

Projections or objectives for obtaining accelerated or full approval for resmetirom for non-cirrhotic

NASH patients and NASH patients with compensated cirrhosis;

Our primary and key secondary study endpoints for resmetirom, and the potential for achieving such endpoints and projections, including NASH resolution, safety, fibrosis treatment, cardiovascular effects, and lipid treatment with resmetirom;

Optimal dosing levels for resmetirom and projections regarding potential NASH or NAFLD and potential patient benefits with resmetirom, including future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment, and/or biomarker effects with resmetirom;

The potential efficacy and safety of resmetirom for non-cirrhotic

NASH patients and cirrhotic NASH patients;

Increases in cash operating expenses, including as we expand our resmetirom clinical development program and our commercial development program;

The potential for resmetirom to become the best-in-class

and/or first-to-market

treatment option for patients with NASH and liver fibrosis;

Anticipated or estimated future results of operations and expenses as we expand our resmetirom clinical development program and our commercial development program;

launch/partnering plans;

The predictive power of resmetirom liver fat reduction, as measured by

The ability to develop clinical evidence demonstrating the utility of non-invasive

tools and techniques to screen and diagnose NASH and/or NAFLD patients;

The predictive power of liver fat reduction with resmetirom, as measured by non-invasive

tests, on NASH resolution and/or fibrosis reduction or improvement, and potential NASH or NAFLD patient risk profile benefits with resmetirom;

The predictive power of liver fat, volume or fibrosis reduction with resmetirom using

The predictive power of

The predictive power of liver fat, liver volume changes, or MAST scores for NASH and/or NAFLD patients;

The predictive power of NASH resolution and/or liver fibrosis reduction or improvement with resmetirom using non-invasive

tests, including the use of ELF, FibroScan, MRE and/or MRI-PDFF;

The predictive power of non-invasive

tests generally, including for purposes of diagnosing NASH, monitoring patient response to resmetirom, or recruiting and conducting a NASH clinical trial;

3 unchanged sentences

Risks associated with meeting the objectives of our clinical studies, including, but not limited to our ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for our studies, any delays or failures in enrollment, the occurrence of adverse safety events, and the risks of successfully conducting trials that are substantially larger, and have patients with different disease states, than our past trials;

Risks related to the effects of resmetirom’s mechanism of action and our ability to accomplish our business and business development objectives and realize the anticipated benefit of any such transactions, and

Assumptions underlying any of the foregoing.

4 unchanged sentences

enrollment and trial conclusion uncertainties, generally and in relation to COVID-19

shelter-in-place

and social distancing measures and individual precautionary measures that may be implemented or continued for an uncertain period of time;

related measures and individual precautionary measures that may be implemented or continued for an uncertain period of time;

our potential inability to raise sufficient capital to fund our ongoing operations as currently planned or to obtain financings on terms similar to those we have arranged in the past;

3 unchanged sentences

the risks of achieving potential benefits in studies that includes substantially more patients, and patients with different disease states, than our prior studies;

limitations associated with early stage or non-placebo

controlled study data;

the timing and outcomes of clinical studies of resmetirom;

5 unchanged sentences

We specifically discuss these risks and uncertainties in greater detail in the section appearing in Part I, Item 1A of our Annual Report on Form 10-K

for the year ended December 31, 2021, filed with the SEC on February 25, 2022, as updated by the risk factors discussed in Part II, Item 1A of this Quarterly Report on Form 10-Q,

for the year ended December 31, 2021, filed with the SEC on February 25, 2022 (the “2021 Form 10-K”),

as updated by the risk factors discussed in Part II, Item 1A of our Quarterly Report on Form 10-Q

for the quarter ended March 31, 2022 filed with the SEC on May 9, 2022 (the “1Q 2022 Form 10-Q”),

as well as in our other filings with the SEC.

You should read the 2021 Annual Report on Form 10-K,

You should read the 2021 Form 10-K,

the 1Q 2022 Form 10-Q,

this Quarterly Report, and the other documents that we file or have filed with the SEC, with the understanding that our actual future results may be materially different from the results expressed or implied by these forward-looking statements.

4 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 1. Financial Statements