5 unchanged sentences
Our results of operations and financial condition are subject to numerous risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
−Removed: There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K.
+Added: In addition to the risk factors described in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K, please note the updated Risk Factors included below.
+Added: The risk factor entitled “Our business is highly dependent on the success of our clinical stage programs, including botensilimab and related combination therapy programs, which still require significant additional clinical development” set forth in our 2023 Form 10-K is hereby updated to state the following.
+Added: Our business and future success depends in large part on our ability to obtain regulatory approval of, and then successfully launch and commercialize, our product candidates.
+Added: Our timelines are aggressive and subject to various factors outside of our control, including regulatory review and approval.
+Added: Although we have engaged with the FDA on our regulatory programs and protocols, there is no guarantee that our BLA submissions, if any, will be approved, or that we will be able to successfully commercialize these assets.
+Added: If the botensilimab programs (including combination therapies with botensilimab) encounter safety, efficacy, supply or manufacturing problems, developmental delays, regulatory or commercialization issues or other problems, our development plans and business may be significantly harmed.
+Added: Even though we have observed positive results to date, they may not necessarily be predictive of the final results of the trials or future clinical trials or otherwise be sufficient to support an approval.
+Added: Many companies in the pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results, and we cannot be certain that we will not face similar setbacks.
+Added: The FDA may disagree that our data and development program are sufficient to support BLA filing or approval.
+Added: For example, the FDA discouraged submission of our Phase 2 results in support of an Accelerated Approval based on the observed magnitude of effect, remaining questions about contributions of the components of the combination product, and their view that objective response rates may not translate to survival benefit, and they recommended the inclusion of a BOT monotherapy arm in the planned Phase 3 study.
+Added: Furthermore, because botensilimab and balstilimab are both novel agents, and are being used in combination, any BLA submission for the combination will require significant information on each agent as well as the combination.
+Added: All of our other product candidates are in earlier stages of development and will require additional nonclinical and/or clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing and commercial efforts before we can generate any revenue from product sales.
+Added: The risk factor entitled “We are dependent upon our collaborations with BMS, Gilead, Incyte and Betta to further develop and commercialize certain of our antibody programs.
+Added: If we or BMS, Gilead, Incyte or Betta Pharmaceuticals fail to perform as expected, the potential for us to generate future revenues under such collaborations could be significantly reduced, the development and/or commercialization of these antibodies may be terminated or substantially delayed, and our business could be adversely affected” set forth in our 2023 Form 10-K is hereby updated to reflect that BMS notified us in July 2024 that it will terminate the BMS license agreement effective January 26, 2025 and that in August 2024 Gilead elected to terminate the option to license AGEN2373.
+Added: As a result, the clinical development, manufacturing, regulatory approval, and commercialization efforts related to AGEN1777 and AGEN2373 could be delayed or terminated and we will not be entitled to any future milestone payments or royalties from BMS or Gilead.
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