ADDED
Form 10-K Summary 82 Signatures 83 NOTES In this annual report on Form 10-K, and unless the context otherwise requires, the Company, we, us and our refer to Citius Pharmaceuticals, Inc.
These risks include, but are not limited to, the following: Our independent registered public accounting firm s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern.
We require substantial additional funding, which may not be available on acceptable terms, or at all.
Failure to obtain this necessary capital when needed on acceptable terms, or at all, or execute on alternative strategic paths, could force us to delay, limit, reduce or terminate our commercialization efforts and business operations.
We have a history of net losses and expect to incur losses for the foreseeable future.
Our exploration of alternative strategic paths may not result in completing a transaction and the process or conclusion thereof could adversely affect our stock price.
If we do not successfully complete a strategic transaction, our Board of Directors (the Board ) may decide to pursue a dissolution and liquidation of our Company.
We, through Citius Oncology, have one approved product, LYMPHIR, that we launched in December 2025, and have an unproven business strategy, and a limited operating history upon which to evaluate it, and may never achieve successful commercialization of LYMPHIR or any future product candidates or achieve or maintain profitability.
We are the guarantor of milestone payments to the licensor and former licensee of the LYMPHIR intellectual property, which could adversely affect our profitability.
A material breach under our license agreements, including timely payment, gives the licensor party the right to terminate the license agreement, which would materially harm our business.
REMOVED
Form 10-K Summary 65 Signatures 66 i NOTES In this annual report on Form 10-K, and unless the context otherwise requires, the Company, we, us and our refer to Citius Pharmaceuticals, Inc.
These risks include, but are not limited to, the following: We have a history of net losses and expect to incur losses for the foreseeable future.
Our independent registered public accounting firm s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern.
We need to secure additional financing in the near future to complete the development of our other current product candidates and support our operations.
We are primarily a late-stage development company with an unproven business strategy and may never achieve commercialization of our therapeutic product candidates or profitability.
We have a limited operating history upon which to evaluate our ability to successfully commercialize our product candidates.
We face significant risks in our product candidate development efforts.
We may be required to make milestone payments to the licensor and former licensee of the LYMPHIR intellectual property in connection with its development and commercialization of LYMPHIR, which could adversely affect the profitability of LYMPHIR, if approved.
Any FDA programs related to the development and approval of treatments for COVID-19 and its symptoms may not be available to us or actually lead to a faster development or regulatory review or approval process for NoveCite, our proposed treatment for ARDS, nor will it assure FDA approval of such a treatment.
Because our NoveCite product candidate is based on novel mesenchymal stem cell technologies, it is difficult to predict the regulatory approval process and the time, the cost and our ability to successfully initiate, conduct and complete clinical development, and obtain the necessary regulatory and reimbursement approvals, required for commercialization of our NoveCite product candidate.