21 unchanged sentences
Preferred stock, par value $ 0.0001 per share authorized:
−Removed: 5,000,000 shares at March 31, 2023 and December 31, 2022;
−Removed: 2,369,797 and 2,369,797 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively
+Added: 5,000,000 shares at June 30, 2023 and December 31,
+Added: 2,369,797 and 2,369,797 shares issued and outstanding at June 30, 2023 and December 31, 2022,
Common stock, par value $ 0.0001 per share authorized:
−Removed: 200,000,000 at March 31, 2023 and December 31, 2022;
−Removed: 18,283,074 and 18,102,523 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively
+Added: 200,000,000 at June 30, 2023 and December 31, 2022;
+Added: 18,459,033 and 18,102,523 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively
Additional paid-in-capital
7 unchanged sentences
in thousands, except share and per share amounts)
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Total revenues
13 unchanged sentences
in thousands)
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Other comprehensive income (loss):
15 unchanged sentences
Balance at March 31, 2023
+Added: Issuance of common shares in equity offering, excluding to related parties, net of transaction costs
+Added: Sale of common shares to related parties and exercise of common stock options, net of transaction costs
+Added: Compensation expense related to stock options for services
+Added: Unrealized loss on marketable securities
+Added: Hercules warrant
+Added: Balance at June 30, 2023
Balance at December 31, 2021
2 unchanged sentences
Balance at March 31, 2022
+Added: Compensation expense related to stock options for services
+Added: Unrealized loss on marketable securities
+Added: Hercules warrant
+Added: Balance at June 30, 2022
See accompanying notes to condensed consolidated financial statements.
2 unchanged sentences
in thousands)
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
Cash flows from operating activities:
15 unchanged sentences
Cash flows from financing activities:
+Added: 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
5 unchanged sentences
Cash and cash equivalents at end of period
+Added: Supplemental disclosure of cash flow information:
+Added: Obtaining a right-of-use
+Added: asset in exchange for a lease liability
See accompanying notes to condensed consolidated financial statements.
43 unchanged sentences
To determine whether an 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.
−Removed: During the three months ended March 31, 2023 and 2022, the Company determined it did not have any securities that were other-than-temporarily impaired.
+Added: During the six months ended June 30, 2023 and 2022, 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.
−Removed: During the three months ended March 31, 2023 and 2022, the Company did not have any realized gains or losses on marketable securities.
+Added: During the six months ended June 30, 2023 and 2022, the Company did not have any realized gains or losses on marketable securitie
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.
−Removed: As of March 31, 2023, 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.
−Removed: During the three months ended March 31, 2023 and 2022, the Company did not have any transfers of financial assets between Levels 1 and 2.
−Removed: As of March 31, 2023 and December 31, 2022, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet.
+Added: As of June 30, 2023, 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.
+Added: During the six months ended June 30, 2023 and 2022, the Company did not have any transfers of financial assets between Levels 1 and 2.
+Added: As of June 30, 2023 and December 31, 2022, 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
28 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.
−Removed: However, for the three months ended March 31, 2023 and 2022, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of common stock issuable upon the exercise of stock options and warrants or vesting of restricted stock units, and common stock issuable upon the conversion of preferred stock would be anti-dilutive.
+Added: However, for the six months ended June 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of common stock issuable upon the exercise of stock options and warrants or vesting of restricted stock units, 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:
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
Common stock options
5 unchanged sentences
Food and Drug Administration (FDA) and other government regulations.
−Removed: The Company has incurred losses since inception, including approximately $ 76.9 million for the three months ended March 31, 2023, resulting in an accumulated deficit of approximately $ 1,040 million as of March 31, 2023.
+Added: The Company has incurred losses since inception, including approximately $ 162.7 million for the six months ended June 30, 2023, resulting in an accumulated deficit of approximately $ 1,125 million as of June 30, 2023.
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 and debt financings.
−Removed: The Company believes that its cash, cash equivalents and marketable securities at March 31, 2023 will be sufficient to fund operations past one year from the issuance of these financial statements.
+Added: The Company believes that its cash, cash equivalents and marketable securities at June 30, 2023 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
−Removed: marketable securities held by the Company as of March 31, 2023 and December 31, 2022 is as follows (in thousands):
−Removed: March 31, 2023
+Added: marketable securities held by the Company as of June 30, 2023 and December 31, 2022 is as follows (in thousands):
+Added: June 30, 2023
Cash and cash equivalents:
+Added: Cash (Level 1)
Money market funds (Level 1)
−Removed: Corporate debt securities due within 3 months of date of purchase (Level 2)
Total cash and cash equivalents
Marketable securities:
−Removed: Corporate debt securities due within 1 year of date of purchase (Level 2)
+Added: Corporate debt securities due within 1
+Added: year of date of purchase (Level 2)
government and government sponsored entities due within 1 year of date of purchase (Level 2)
2 unchanged sentences
Cash and cash equivalents:
+Added: Cash (Level 1)
Money market funds (Level 1)
4 unchanged sentences
Accrued Liabilities
−Removed: Accrued liabilities as of March 31, 2023 and December 31, 2022 consisted of the following (in thousands):
+Added: Accrued liabilities as of June 30, 2023 and December 31, 2022 consisted of the following (in thousands):
Contract research organization costs
18 unchanged sentences
Under the Amended Loan Facility, an additional $ 35.0 million was drawn under a second, expanded, $ 65.0 million tranche (“Tranche 2”) in February of 2023 following the Company’s achievement of the Phase 3 clinical development milestone.
−Removed: The Company has the ability to draw an additional $ 15.0 million under Tranche 2 by June 19, 2023 and an additional $ 15.0 million under Tranche 2 by September 30, 2023 (for a total of $ 30.0 million in additional committed Tranche 2 capacity).
+Added: An additional $ 15.0 million was drawn under Tranche 2 in June of 2023.
+Added: The Company has the ability to draw the remaining $ 15.0 million available under Tranche 2 by September 30, 2023
+Added: in accordance with the Amended Loan Facility.
The third tranche (“Tranche 3”) of $ 75.0 million remains unchanged by the Amendment, and such borrowings are available subject to the Company obtaining a certain FDA approval for resmetirom.
Coincident with the expansion of Tranche 2 borrowing capacity by $ 15 million, the Amendment reduced the fourth tranche under the Loan Facility (“Tranche 4”) by $ 15.0 million to $ 60.0 million , which amount is available subject to Hercules’ sole discretion.
−Removed: In connection with the $ 35.0 million drawn under the second tranche at the closing of the Amendment, the Company issued to Hercules and affiliates Tranche 2 Warrants to purchase 2,453 shares of common stock, which had a Black-Scholes value of $ 0.5 million.
+Added: In connection with the $ 35.0 million drawn under Tranche 2
+Added: at the closing of the Amendment and $ 15.0 million drawn in June of 2023, the Company issued to Hercules and affiliates Tranche 2 Warrants to purchase 3,504 shares of common stock, which had a Black-Scholes value of $ 0.7 million.
The Amendment reduced the interest rate under the Amended Loan Facility to the greater of (i) the prime rate as reported in The Wall Street Journal plus 2.45 % and (ii) 8.25 %.
8 unchanged sentences
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.
−Removed: As of March 31, 2023, the outstanding principal under the Loan Facility was $ 85.0 million.
−Removed: The interest rate as of March 31, 2023 was 10.45 %.
−Removed: As of March 31, 2023, the Company was in compliance with all loan covenants and provisions.
−Removed: Future minimum payments, including interest and principal, under the loans payable outstanding as of March 31, 2023 are as follows (in thousands):
−Removed: Period Ending March 31, 2023:
+Added: As of June 30, 2023, the outstanding principal under the Loan Facility was $ 100.0 million.
+Added: The interest rate as of June 30, 2023 was 10.70 %.
+Added: As of June 30, 2023, the Company was in compliance with all loan covenants and provisions.
+Added: Future minimum payments, including interest and principal, under the loans payable outstanding as of June 30, 2023 are as follows (in thousands):
+Added: Period Ending June 30, 2023:
+Added: 2023 (remaining six months)
Less amount representing interest
26 unchanged sentences
sales agreement (the “2021 Sales Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company could, from time to time, issue and sell shares of its common stock.
−Removed: The 2021 Sales Agreement authorized an aggregate offering of up to $ 200 million in shares of our common stock, at the Company’s option, through Cowen as its sales agent.
+Added: The 2021 Sales Agreement initially
+Added: authorized an aggregate offering of up to $ 200 million in shares of our common stock, at the Company’s option, through Cowen as its sales agent.
Sales of common stock through Cowen could be made by any method that is deemed an “at-the-market”
1 unchanged sentence
Subject to the terms and conditions of the 2021 Sales Agreement, Cowen would 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 imposed).
−Removed: In December 2022, the Company sold 738,900 shares under the 2021 Sales Agreement for an aggregate of $ 159.1 million in gross proceeds, with net proceeds to the Company of $ 155.9 million after deducting commissions and other transaction costs.
−Removed: In total, under the 2021 Sales Agreement the Company sold 1,235,943 shares for an aggregate of $ 199.9 million in gross proceeds, with net proceeds to the Company of approximately $ 195.8 million after deducting commissions and other transaction costs.
+Added: In December 2022, the Company sold 738,900 shares of common stock
+Added: under the 2021 Sales Agreement for an aggregate of $ 159.1 million in gross proceeds, with net proceeds to the Company of $ 155.9 million after deducting commissions and other transaction costs.
+Added: In total, under the 2021 Sales Agreement the Company sold 1,235,943 shares for an aggregate of $ 199.9 million in gross proceeds, with net proceeds to the Company of approximately $ 195.8 million after deducting commissions and other transaction costs through December 31, 2022.
Of those shares sold, 738,900 were sold in 2022, and 497,043 were sold in 2021.
−Removed: All shares were sold pursuant to the Company’s effective shelf registration statement and the prospectus supplement relating thereto.
−Removed: As of March 31, 2023, no amounts remained reserved and available for sale under the 2021 Sales Agreement and the related prospectus supplement.
+Added: All shares were sold pursuant to the Company’s effective shelf registration statement on Form S-3 (the “Registration Statement”) and
+Added: the prospectus supplement relating thereto.
+Added: As of June 30, 2023, no amounts remained reserved and available for sale under the 2021 Sales Agreement and the related prospectus supplement.
+Added: In May 2023, the Company amended the 2021 Agreement (the “Sales Agreement Amendment
+Added: ”), with Cowen, pursuant to which the Company may, from time to time, issue and sell in additional $ 200 million in
+Added: shares of its common stock.
+Added: The Company is not obligated to make any sales of its common stock under this arrangement.
+Added: Any shares sold will be sold pursuant to the Company’s effective Registration Statement
+Added: (the “Registration Statement”) and prospectus supplement filed pursuant to the Registration Statement.
+Added: The Sales Agreement Amendment authorizes sales of
+Added: shares of our common stock, from time to time, at the Company’s option, through Cowen as its sales agent.
+Added: Sales of common stock through Cowen may be made by any method that is deemed an “at-the-market”
+Added: offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, and as described in the prospectus supplement.
+Added: In total, under the Sales Agreement Amendment,
+Added: the Company sold 85,901 shares for an aggregate of $ 22.4 million in gross proceeds, with net proceeds to the Company of approximately $ 21.8 million after deducting commissions and other transaction costs.
+Added: All shares were sold pursuant to the Company’s effective Registration Statement
+Added: and the prospectus supplement relating thereto.
+Added: As of June 30, 2023, $ 177.6 million remained reserved and available for sale under the 2023 Sales Agreement
+Added: and the Company’s related prospectus supplement.
Stock-based Compensation
4 unchanged sentences
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.
−Removed: As of March 31, 2023, the Company had restricted stock units and options outstanding to purchase 2,875,723 shares of its common stock, which includes options outstanding under its prior incentive compensation plan, the 2006 Stock Plan.
−Removed: As of March 31, 2023, 690,809 shares were available for future issuance under the 2015 Stock Plan.
+Added: As of June 30, 2023, the Company had restricted stock units and options outstanding to purchase an aggregate of
+Added: 2,805,840 shares of its common stock, which includes options outstanding under its prior incentive compensation plan, the 2006 Stock Plan.
+Added: As of June 30, 2023, 670,634 shares were available for future issuance under the 2015 Stock Plan.
Stock Options
−Removed: The following table summarizes stock option activity during the three months ended March 31, 2023:
+Added: The following table summarizes stock option activity during the six months ended June 30, 2023:
average exercise
3 unchanged sentences
Options cancelled
−Removed: Outstanding at March 31, 2023
−Removed: Exercisable at March 31, 2023
−Removed: The total cash received by the Company as a result of stock option exercises was $ 17.9 million and $ 0 million, respectively, for the three months ended March 31, 2023 and 2022.
−Removed: The total intrinsic value of options exercised was $ 32.5 million and $ 0 million, respectively, for the three months ended March 31, 2023 and 2022.
−Removed: The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the three months ended March 31, 2023 and 2022 were $ 219.02 and $ 59.63 , respectively.
+Added: Outstanding at June 30, 2023
+Added: Exercisable at June 30, 2023
+Added: The total cash received by the Company as a result of stock option exercises was $ 21.8 million and $ 0 million, respectively, for the six months ended June 30, 2023 and 2022.
+Added: The total intrinsic value of options exercised was $ 48.9 million and $ 0 million, respectively, for the six months ended June 30, 2023 and 2022.
+Added: The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the six months ended June 30, 2023 and 2022 were $ 219.02 and $ 55.84 , respectively.
Restricted Stock Units
1 unchanged sentence
Restricted stock units vest over the service period, and are subject to forfeiture if employment or service terminates before vesting.
−Removed: As of March 31, 2023, the Company had 199,125 restricted stock units outstanding, with a weighted average grant date fair value of $ 297.18 per unit.,
+Added: As of June 30, 2023, the Company had 222,300 restricted stock units outstanding, with a weighted average grant date fair value of $ 294.19 per unit.
Stock-Based Compensation Expense
−Removed: Stock-based compensation expense during the three months ended March 31, 2023 and 2022 was as follows (in thousands):
−Removed: Three Months Ended March 31,
+Added: Stock-based compensation expense during the six months ended June 30, 2023 and 2022 was as follows (in thousands):
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Stock-based compensation expense by type of award:
6 unchanged sentences
Total stock-based compensation expense included in net loss
−Removed: Unrecognized stock-based compensation expense on stock options as of March 31, 2023 was $ 52.3 million with a weighted average remaining period of 2.42 years.
+Added: Unrecognized stock-based compensation expense as of June 30, 2023 was $ 98.2 million with a weighted average remaining period of 2.90 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.
−Removed: 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, 2023 and 2022.
+Added: 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, 2023 and 2022.
The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of the clinical trials.
−Removed: Subsequent Event
−Removed: In May 2023, the Company amended the 2021 Agreement (the “2023 Sales Agreement Amendment”), with Cowen, pursuant to which the Company may, from time to time, issue and sell shares of its common stock.
−Removed: The Company is not obligated to make any sales of its common stock under this arrangement.
−Removed: Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 (the “Registration Statement”) and a prospectus supplement filed pursuant to the Registration Statement.
−Removed: The Sales Agreement Amendment authorizes an additional aggregate offering of up to $
−Removed: 200 million in shares of our common stock, from time to time, at the Company’s option, through Cowen as its sales agent.
−Removed: Sales of common stock through Cowen may be made by any method that is deemed an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, and as described in the prospectus supplement.
********** END OF FINANCIAL STATEMENTS **********
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
−Removed: This Quarterly Report on Form 10-Q
−Removed: 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:
+Added: This Quarterly Report on Form 10-Q 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:
reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events;
8 unchanged sentences
Our clinical trials, including the anticipated timing of disclosure, presentations of data from, or outcomes from our trials,
−Removed: 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),
−Removed: including projected market size, sector leadership, and patient treatment estimates for non-alcoholic
−Removed: steatohepatitis (“NASH”) and nonalcoholic fatty liver disease (“NAFLD”) patients,
−Removed: The timing and completion of projected future clinical milestone events, including enrollment, additional studies, top-line
−Removed: data and open label projections,
+Added: 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 nonalcoholic fatty liver disease (“NAFLD”) patients,
+Added: The timing and completion of projected future clinical milestone events, including enrollment, additional studies, top-line data and open label projections,
Resmetirom’s potential to be a cost-effective specialty therapy for NASH patients with significant liver fibrosis,
Plans, objectives and timing for making a Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) submission to the FDA,
−Removed: Projections or objectives for obtaining accelerated or full approval for resmetirom for NASH patients with significant fibrosis (or non-cirrhotic
−Removed: NASH patients) and NASH patients with compensated cirrhosis,
+Added: Projections or objectives for obtaining accelerated or full approval for resmetirom for NASH patients with significant fibrosis (or 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,
1 unchanged sentence
Our ability to address the unmet needs of patients suffering from NASH with significant fibrosis,
−Removed: The potential efficacy and safety of resmetirom for non-cirrhotic
−Removed: NASH patients and cirrhotic NASH patients,
−Removed: The potential for resmetirom to become the best-in-class
−Removed: and/or first-to-market
−Removed: treatment option for patients with NASH and liver fibrosis;
+Added: The potential efficacy and safety of resmetirom for non-cirrhotic NASH patients and cirrhotic NASH patients,
+Added: 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,
−Removed: The ability to develop clinical evidence demonstrating the utility of non-invasive
−Removed: tools and techniques to screen and diagnose NASH and/or NAFLD patients,
−Removed: The predictive power of liver fat reduction with resmetirom, as measured by non-invasive
−Removed: tests, on NASH resolution and/or fibrosis reduction or improvement, and potential NASH or NAFLD patient risk profile benefits with resmetirom,
+Added: The ability to develop clinical evidence demonstrating the utility of non-invasive tools and techniques to screen and diagnose NASH and/or NAFLD patients,
+Added: 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, liver volume changes or MAST scores for NASH and/or NAFLD patients,
−Removed: The predictive power of NASH resolution and/or liver fibrosis reduction with resmetirom or improvement using non-invasive
−Removed: tests, including the use of ELF, FibroScan, MRE and/or MRI-PDFF,
−Removed: The predictive power of non-invasive
−Removed: tests generally, including for purposes of diagnosing NASH, monitoring patient response to resmetirom, or recruiting and conducting a NASH clinical trial,
+Added: The predictive power of NASH resolution and/or liver fibrosis reduction with resmetirom or improvement using non-invasive tests, including the use of ELF, FibroScan, MRE and/or MRI-PDFF,
+Added: 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,
Market demand for and acceptance of our products,
10 unchanged sentences
our clinical and commercial development of resmetirom;
−Removed: enrollment and trial outlook uncertainties, generally, based on blinded, locked or limited trial data and in relation to COVID-19-related
−Removed: measures and individual precautionary measures that may be implemented or continued for an uncertain period of time;
+Added: enrollment and trial outlook uncertainties, generally, based on blinded, locked or limited trial data and in relation to COVID-19-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;
−Removed: limitations associated with early stage or non-placebo
−Removed: controlled study data;
+Added: limitations associated with early stage or non-placebo controlled study data;
the timing and outcomes of clinical studies of resmetirom;
4 unchanged sentences
Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.
−Removed: 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
−Removed: for the year ended December 31, 2022, filed with the SEC on February 23, 2023 (the “2022 Form 10-K”),
−Removed: as well as in our other filings with the SEC.
−Removed: You should read the 2022 Form 10-K,
−Removed: 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.
+Added: 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, 2022, filed with the SEC on February 23, 2023 (the “2022 Form 10-K”), as well as in our other filings with the SEC.
+Added: You should read the 2022 Form 10-K, 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.
Moreover, we operate in an evolving environment.
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.