6 unchanged sentences
If we do not achieve commercial success with sotagliflozin, our business will suffer and our stock price will likely decline.
−Removed: • We depend on our ability to obtain positive results from our ongoing Phase 2 clinical trial of LX9211 in post-herpetic neuralgia.
−Removed: If we fail to successfully complete and obtain positive results from such clinical trial, 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.
1 unchanged sentence
• 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.
−Removed: • 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.
+Added: • If we are unable to establish 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.
• If we are unable to maintain adequate coverage and reimbursement from third-party payers for any products that we or our collaborators may develop, our revenues and prospects for profitability will suffer.
5 unchanged sentences
• Our competitors may develop products that impair the value of any products that we or our collaborators may develop.
−Removed: • We face business disruption and related risks resulting from the outbreak of the novel coronavirus, or COVID-19, including delays in the enrollment of ongoing clinical trials and other operational impacts, each of which could have a material adverse effect on our business.
+Added: • The outbreak of the novel coronavirus, or COVID-19, has had an adverse impact on our business operations and clinical trials and it could continue to adversely affect our business in the future.
Risks Related to Our Capital Requirements and Financial Results
1 unchanged sentence
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.
+Added: • We do not have sufficient capital to support a full Phase 3 development program for LX9211 in neuropathic pain.
+Added: If we are unable to establish a strategic collaboration or other arrangement for that purpose, our capital needs will be substantially higher and we may be unable to obtain financing sufficient to fund Phase 3 development of LX9211 in neuropathic pain on acceptable terms, or at all, and may be required to reduce the scope of any such Phase 3 development program.
• We have a history of net losses, and we expect to continue to incur net losses and may not achieve or maintain profitability.
3 unchanged sentences
Risks Related to Our Relationships with Third Parties
−Removed: • We depend on our ability to establish collaborations with pharmaceutical and biotechnology companies for the development and commercialization of our drug candidates, particularly for the development and commercialization of LX9211 for neuropathic pain.
−Removed: If we are unable to establish such collaborations, or if pharmaceutical products are not successfully and timely developed and commercialized under such collaborations, our opportunities to generate revenues from our drug candidates will be greatly reduced.
+Added: • We depend on our ability to establish collaborations with pharmaceutical and biotechnology companies for the development and commercialization of our drug candidates.
+Added: If we are unable to establish such collaborations, or if pharmaceutical products are not successfully and timely developed and commercialized under such collaborations, our opportunities to generate revenues from our other drug candidates will be greatly reduced.
• Conflicts with our collaborators could jeopardize the success of our collaborative agreements and harm our product development efforts .
25 unchanged sentences
Risk Factors” included in our annual report on Form 10-K for the year ended December 31, 2022 as filed with the Securities and Exchange Commission.
−Removed: 10.1 — First Amendment to Loan and Security Agreement, dated August 29, 2022, with Oxford Finance, LLC ( filed as Exhibit 10.1 to Company’s Current Report on Form 8-K dated August 29, 2022 and incorporated by reference herein )
−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, 2022 By:
−Removed: /s/ Lonnel Coats
−Removed: Chief Executive Officer
−Removed: November 9, 2022 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.