SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 18, 2018
OPIANT PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
(Commission File Number
(IRS Employer Identification No.)
201 Santa Monica Boulevard, Suite 500
Santa Monica, CA
(Address of Principal Executive Offices)
Registrant’s telephone number, including area code
(Former name or former address if changed since last report,)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01 Other Events.
On April 18, 2018, Opiant Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has been awarded a grant of approximately $7.4 million from the National Institutes of Health’s National Institute on Drug Abuse. The grant provides the Company with additional resources for the ongoing development of OPNT003 (intranasal nalmefene), a long-lasting opioid antagonist for the treatment of opioid overdose. The grant includes approximately $2.6 million to be funded for the period ending March 31, 2019, with the balance to be funded over the subsequent two years. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. Description
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 hereunto duly authorized.
Opiant Pharmaceuticals, Inc.
Date: April 18, 2018
/s/ David D. O’Toole
Name: David D. O’Toole
Title: Chief Financial Officer
Opiant Pharmaceuticals Awarded Grant of Approximately $7.4 Million from the National Institutes of Health for Development of OPNT003, Intranasal Nalmefene, for
Treatment of Opioid Overdose
Grant Expected to Fund Development of OPNT003 to NDA Ready Stage
SANTA MONICA, Calif., April 18, 2018 -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ: OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced that it has been awarded a grant of approximately $7.4 million from the National Institutes of Health’s National Institute on Drug Abuse (NIDA) for the development of OPNT003 (intranasal nalmefene), a long-lasting opioid antagonist for the treatment of opioid overdose. The grant includes approximately $2.6 million to be funded for the period ending March 31, 2019, with the balance to be funded over the subsequent two years.
“We view this NIDA grant as further validation of the potential for OPNT003 to be an important treatment for opioid overdose, a growing U.S. health epidemic,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “Fentanyl was responsible for more overdose deaths (in excess of 20,000) than either heroin
or prescription opioids in 2016. Recognizing the evolution of the opioid crisis, the National Institutes of Health has called for the development of stronger, longer-acting overdose reversal products in order to address this next wave of potent synthetic opioids, like fentanyl. We look forward to using this grant to continue the development of OPNT003.”
“The receipt of this grant is reflective of our aim to maximize non-dilutive financing to support our research and development programs,” said David O’Toole, Chief Financial Officer of Opiant. “Over the last five months, we have also announced the return of our royalty stream from Adapt Pharmaceuticals and the receipt of funds from the exercise of warrants, which have further strengthened our balance sheet.”
The grant follows encouraging data from a Phase I clinical study of OPNT003 and a subsequent recent meeting with the U.S. Food & Drug Administration (FDA). Based on FDA feedback, Opiant intends to pursue a 505(b)(2) development path and anticipates the potential to submit a New Drug Application (NDA) for the drug and intranasal delivery device combination in 2020. The 505(b)(2) development path allows certain information required for NDA approval to be derived from studies not conducted by Opiant. Nalmefene for injection was previously approved by the FDA for treating suspected or confirmed opioid overdose.
Opiant was awarded this grant, to be funded over the next three years, following an in-depth evaluation by NIDA of the Company’s proposed research for scientific and technical merit. Opiant retains full commercial rights to OPNT003.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing pharmacological treatments for addictions. The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Opiant's first product, NARCAN® Nasal Spray, is approved for marketing in the U.S.
and Canada by its partner, Adapt Pharmaceuticals. For more information please visit: www.opiant.com.
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "projects," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
LifeSci Advisors, LLC