Document




UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 8-K
 
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  February 18, 2019
 
OPIANT PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
 
 
 
 
 
Delaware
 
001-38193
 
46-4744124
(State or other jurisdiction of 
incorporation) 
 
(Commission File Number

 
(IRS Employer Identification No.) 



 


201 Santa Monica Boulevard, Suite 500
Santa Monica, CA
 

90401
(Address of Principal Executive Offices) 

 
(Zip Code)

 
(310) 598 5410
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 February 21, 2019, Opiant Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the results from its Phase 2 clinical trial of OPNT001, a naloxone nasal spray for the treatment of bulimia nervosa. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. Description

99.1



1


    



SIGNATURES
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.
Dated: February 21, 2019        By:    /s/ David D. O'Toole
Name: David D. O’Toole
Title:  Chief Financial Officer

2

Exhibit
Exhibit 99.1

Opiant Pharmaceuticals Announces Top-line Results from Phase 2 Clinical Trial of OPNT001 for Treatment of Bulimia Nervosa
-Study did not meet primary endpoint-
-Company discontinuing development of OPNT001 for treatment of Bulimia Nervosa-
-Focus remains on advancing lead product candidate, OPNT003, for treatment of opioid overdose, and other promising addiction and drug overdose-related product candidates-
SANTA MONICA, Calif., February 21, 2019 – Opiant Pharmaceuticals, Inc. (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, today announced that its Phase 2 clinical trial evaluating OPNT001, a naloxone nasal spray for the treatment of bulimia nervosa (BN), did not meet the primary endpoint of reducing the number of binging days from baseline to week 8. Key secondary efficacy endpoints were also not met.
“Based on these results, Opiant will not allocate further resources to the development of OPNT001 for the treatment of BN, allowing us to invest more in our pipeline. The company’s focus for 2019 remains on conducting the pivotal trial for OPNT003, nasal nalmefene for opioid overdose, preparing to enroll patients into a Phase 2 study for OPNT002, nasal naltrexone, for the treatment of Alcohol Use Disorder and progressing the development of OPNT004, drinabant, for Acute Cannabinoid Overdose,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “We wish to express our gratitude to the investigators, as well as the patients and their families, for their support and participation in the BN study.”
In the Phase 2 trial, OPNT001 was generally safe and well-tolerated with minimal adverse events alongside good patient compliance.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing pharmacological treatments for addictions and drug overdose. National Institute on Drug Abuse, a division of the National Institutes of Health, describes addictive 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 drug overdose product, NARCAN
® Nasal Spray, is approved for marketing in the U.S. and Canada by its commercialization partner, Adapt Pharmaceuticals, now owned by Emergent BioSolutions, Inc.  For more information visit: www.opiant.com.

Forward-Looking Statements
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.


Exhibit 99.1

For Media Inquiries:
Julie Normart, W2O Group
(415) 946-1087

jnormart@w2ogroup.com
For Investor Inquiries:
Dan Ferry, LifeSci Advisors, LLC
(617) 535-7746

Daniel@lifesciadvisors.com