Novan Anticipates Current Cash Position Provides Sufficient Capital to Conduct Additional SB206 Phase 3 Pivotal Trial
The Company is targeting enrolling the first patient for B-SIMPLE4 in
“We are delighted to be in a position to proceed with the B-SIMPLE4 study,” commented
Currently there are no
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing for the B-SIMPLE4 Phase 3 trial and anticipated top-line results, and the sufficiency of our cash position. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, the risk that we may not be able to begin enrollment as planned or that enrollment in or the conduct of the B-SIMPLE4 Phase 3 trial may be delayed or otherwise impacted as a result of the COVID-19 pandemic or other factors; the risk that results from the B-SIMPLE4 Phase 3 trial will not be received timely or will not achieve significance sufficient to support a new drug application; the risk that the cost of the B-SIMPLE4 Phase 3 trial or other operational costs will exceed our expectations; our ability to obtain any additional funding that may become necessary to continue our business and the further development of our product candidates, including SB206 for molluscum; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; the risk that disruptions at the FDA or other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process our regulatory submissions, all of which could have a material adverse effect on our business; risks related to the manufacture of clinical trial materials; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 Phase 3 trial; and other risks and uncertainties described in our annual report filed with the
(Investors & Media)
Director, Investor Relations, Communications & Business Development
Source: Novan, Inc.