2 unchanged sentences
Risks Related to Our Business and Industry
+Added: • We depend heavily on our ability to obtain regulatory approval in the United States for sotagliflozin in heart failure.
+Added: If we fail to obtain such regulatory approval, our business will suffer and our stock price will likely decline.
+Added: • If approved, we will depend heavily on the commercial success of sotagliflozin in heart failure.
+Added: If we do not achieve commercial success with sotagliflozin, our business will suffer and our stock price will likely decline.
+Added: • We depend heavily on our ability to obtain positive results from our ongoing Phase 2 clinical trials of LX9211 in diabetic neuropathic pain and post-herpetic neuralgia.
+Added: If we fail to successfully complete and obtain positive results from such clinical trials, our business will suffer and our stock price will likely decline.
• Clinical testing of our drug candidates in humans is an inherently risky and time-consuming process that may fail to demonstrate safety and efficacy, which could result in the delay, limitation or prevention of regulatory approval.
• Our drug candidates are subject to a lengthy and uncertain regulatory process that may not result in the necessary regulatory approvals, which could adversely affect our and our collaborators’ ability to commercialize products.
−Removed: • We depend on our ability to gain alignment with certain regulatory authorities on our regulatory strategy for sotagliflozin in heart failure and obtain regulatory approval to market sotagliflozin for heart failure in the United States.
−Removed: If we fail to effectively gain such alignment or obtain such regulatory approval, our business will suffer and our stock price will likely decline.
−Removed: • The commercial success of any products that we or our collaborators may develop will depend upon the degree of market acceptance among physicians, patients, health care payers and the medical community.
+Added: • The commercial success of any products that we or our collaborators may develop will depend upon the degree of market acceptance among physicians, patients, health care payers and the medical communit y.
• If we are unable to reestablish an effective sales force, marketing infrastructure and distribution capabilities, we will not be able to successfully commercialize any products that we or our collaborators may develop.
8 unchanged sentences
Risks Related to Our Capital Requirements and Financial Results
−Removed: • We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our research and development programs and our planned commercial launch, if approved, of sotagliflozin for heart failure in the United States.
+Added: • We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our research and development programs.
If additional capital is not available on reasonable terms, we will be forced to obtain funds, if at all, by entering into financing agreements on unattractive terms.
1 unchanged sentence
• Our operating results have fluctuated and likely will continue to fluctuate, and we believe that period-to-period comparisons of our operating results are not a good indication of our future performance.
−Removed: • We have indebtedness that may limit cash flow available to invest in the ongoing needs of our business.
+Added: • We have substantial indebtedness that may limit cash flow available to invest in the ongoing needs of our business.
+Added: • If we do not effectively manage our affirmative and restrictive covenants under the Oxford Term Loans, our financial condition and results of operations could be adversely affected.
Risks Related to Our Relationships with Third Parties
3 unchanged sentences
• We rely on third parties to carry out our nonclinical studies and clinical trials, which may harm or delay our research and development efforts.
−Removed: • We lack the capability to manufacture materials for nonclinical studies, clinical trials and rely on third parties to manufacture our drug candidates, which may harm or delay our research and development efforts.
+Added: • We lack the capability to manufacture materials for nonclinical studies and clinical trials and commercial supplies for any products which gain regulatory approval.
+Added: Our reliance on third parties to manufacture our drug candidates may harm or delay our research, development and commercialization efforts.
Risks Related to Our Intellectual Property
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and its affiliates own a controlling interest in our outstanding common stock and may have interests which conflict with those of our other stockholders.
−Removed: • Invus has additional rights under its stockholders’ agreement relating to the membership of our board of directors, which provides Invus with substantial influence over significant corporate matters.
+Added: • Invus has additional rights under its stockholders’ agreement relating to the membership of our board of directors and under our certificate of incorporation relating to preemptive and consent rights, which provide Invus with substantial influence over significant corporate matters.
• Our stock price may be extremely volatile.
−Removed: • We are subject to securities litigation, which is expensive and could divert management attention.
• Future issuances or sales of our common stock, or the perception that such issuances or sales may occur, may depress our stock price.
2 unchanged sentences
Risk Factors” included in our annual report on Form 10-K for the year ended December 31, 2021 as filed with the Securities and Exchange Commission.
−Removed: — Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
−Removed: — Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
−Removed: — Certification of Principal Executive and Principal Financial Officers Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
−Removed: — XBRL Instance Document
−Removed: — XBRL Taxonomy Extension Schema Document
−Removed: — XBRL Taxonomy Extension Calculation Linkbase Document
−Removed: — XBRL Taxonomy Extension Definition Linkbase Document
−Removed: — XBRL Taxonomy Extension Label Linkbase Document
−Removed: — XBRL Taxonomy Extension Presentation Linkbase Document
−Removed: 104 — Cover Page Interactive Data File (embedded within the Inline XBRL document)
−Removed: _____________________
−Removed: * Filed herewith.
−Removed: Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
−Removed: Lexicon Pharmaceuticals, Inc.
−Removed: November 9, 2021 By:
−Removed: /s/ Lonnel Coats
−Removed: Chief Executive Officer
−Removed: November 9, 2021 By:
−Removed: /s/ Jeffrey L.
−Removed: President and Chief Financial Officer
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.