Novan is developing:
- SB204 for the treatment of acne vulgaris, or acne. The Company announced Sept. 28, 2016, that the two identically designed Phase 3 pivotal clinical trials for SB204 were fully enrolled ahead of schedule. Novan expects to announce top-line results from these parallel pivotal trials in the first quarter of 2017. Assuming successful completion of these Phase 3 pivotal trials and the long-term safety study, the Company is targeting submission of a new drug application for SB204 to the U.S. Food and Drug Administration by the end of 2017.
- SB206 for the treatment of viral skin infections, such as warts caused by human papillomavirus, or HPV. The Company has completed enrollment in this Phase 2 proof-of-concept trial and expects to announce top-line results this quarter.
- SB208 for the treatment of infections of the skin and nails, including tinea pedis and onychomycosis. Both of these diseases are caused by the same dermatophyte, Trichophyton rubrum, or T. rubrum. The Company commenced a Phase 2 proof-of-concept trial in patients with tinea pedis in July 2016 and expects to report top-line results in the first half of 2017.
For more information, visit the Company's website at www.Novan.com.Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and future prospects. 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, our ability to succeed in redeploying our resources if our nitric oxide-releasing platform in dermatology fails to meet our expectations; the length and expense of the clinical development process with uncertain outcomes, where results of earlier trials may not be predictive of results of later trials; our product candidates may pose safety issues, cause adverse effects, have side effects or have other properties that could delay or prevent regulatory approval, limit commercial potential or result in other significant negative consequences following marketing approval, if any; even if we obtain marketing approval for any product candidates, the products may become subject to unfavorable third-party coverage or reimbursement policies; our product candidates, if approved, will face significant competition; our reliance on third parties to conduct some of our preclinical and clinical trials and to manufacture our clinical drug supplies and any approved product candidates, which may affect our ability to obtain regulatory approval or negatively impact our commercialization efforts; our ability to obtain and maintain patent protection with sufficiently broad scope for our product candidates; our ability to obtain additional funding when needed; and adverse impacts to our business as a result of our independent auditor having expressed substantial doubt about our ability to continue as a going concern due to the existence of a material uncertainty. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
|Condensed Consolidated Statements of Operations|
|(unaudited; in thousands, except for share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||14,988||$||3,177||$||37,361||$||9,875|
|General and administrative||2,493||2,449||9,327||5,858|
|Total operating expenses||17,481||5,626||46,688||15,733|
|Other income, net||7||30||50||30|
|Loss from continuing operations||(17,474||)||(5,596||)||(46,638||)||(15,703||)|
|Loss from discontinued operations||—||(480||)||—||(1,191||)|
|Net loss and comprehensive loss||$||(17,474||)||$||(6,076||)||$||(46,638||)||$||(16,894||)|
|Loss per share, basic and diluted: 1|
|Net loss per share, basic and diluted||$||(5.76||)||$||(2.66||)||$||(17.64||)||$||(7.49||)|
|Weighted-average common shares outstanding, basic and diluted 2||3,033,967||2,281,001||2,644,116||2,256,536|
|Selected Consolidated Balance Sheet Data|
|September 30, 2016 (unaudited)||December 31, 2015|
|Cash and cash equivalents||$||55,664||$||45,688|
|Total current liabilities||19,233||5,095|
|Total convertible preferred stock||—||104,798|
|Total stockholders' equity (deficit)||43,414||(60,081||)|
|Total liabilities, convertible preferred stock and stockholders' equity (deficit)||70,433||49,816|
CONTACT:(Investors)Sean Andrews, Senior Director of Investor RelationsNovan, Inc.email@example.com(Media)Deb HollidayPascale Communications, LLC412firstname.lastname@example.org