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): December 11, 2020
OPIANT PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
(Commission File Number
(IRS Employer Identification No.)
|233 Wilshire Blvd. Suite 280|
Santa Monica, CA
(Address of Principal Executive Offices)
|(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. ¨
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading symbol||Name of each exchange on which registered|
|Common stock, par value $0.001 per share||OPNT||Nasdaq Stock Market LLC|
Item 1.01 Entry into a Material Definitive Agreement.
On September 19, 2018, Opiant Pharmaceuticals, Inc. (the “Company”) entered into a contract (“Contract”) with the Biomedical Advanced Research and Development Authority (“BARDA”), which is part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to accelerate the Company’s development of OPTN003, its lead product candidate. OPTN003, nasal nalmefene, is a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose.
On December 14, 2020, the Company announced a modification to the Contract (the “Modification”), which provides an additional commitment from BARDA of up to $3.5 million to advance the clinical development of OPNT003. The Modification increases the total potential value of the Contract to $8.1 million.
A copy of the Modification is attached to this Current Report on Form 8-K as Exhibit 10.1 and is incorporated herein by reference. The description of the Modification provided herein is qualified in its entirety by reference to the terms of the Contract as set forth in Exhibit 10.1.
Item 8.01 Other Events
On December 14, 2020, the Company issued a press release announcing the Modification. A copy of the press release is filed herewith as Exhibit 99.1.
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.
Dated: December 14, 2020 By: /s/ David D. O’Toole
Name: David D. O’Toole
Title: Chief Financial Officer
December 11, 2020 Exhibit 10.1
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT NAME OF OFFEROR OR CONTRACTOR 2 8 CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF OPIANT PHARMACEUTICALS, INC 1530943 (A) (B) (C) (D) (E) (F) HHSO100201800029C/P00005 $6,471,230.00. The contract overall value is increased by $3,500,000.00 from $4,590,280.00 to $8,090,280.00. The period of performance end date for the Base period is December 20, 2021. UNCHANGED December 20, 2021. UNCHANGED 5 3,500,000.00 The period of performance end date for Option One (1) is Appr. Yr.: 2021 CAN: 1992021 Object Class: 25106 Period of Performance: 09/19/2018 to 12/20/2021 Add Item 5 as follows: ASPR-21-00287 -- Supplemental funding for Option 1 to Opiant Pharmaceuticals for the development of Intranasal Nalmafene under contract HHSO100201800029C Obligated Amount: $3,500,000.00 All other terms and conditions remain UNCHANGED. Additional Pages "Intentionally Omitted". NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 Exhibit 10.1
Opiant Pharmaceuticals Announces Additional $3.5 million Funding Under BARDA Contract for OPNT003 Nasal Nalmefene Development Program
SANTA MONICA, Calif., December 14, 2020 -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced an additional commitment of up to $3.5 million from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance the clinical development of OPNT003, nasal nalmefene, for opioid overdose. The contract modification increases the total potential value of the BARDA contract to $8.1 million.
“We thank BARDA for their ongoing support of OPNT003, nasal nalmefene,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “We believe OPNT003, nasal nalmefene, has the potential to be a best-in-class rescue agent for preventing opioid overdose deaths, particularly from synthetic opioids like fentanyl. We remain on track to file a New Drug Application with the U.S. Food and Drug Administration by the end of 2021.”
An earlier award from BARDA for up to $4.6 million, combined with a $7.4 million grant Opiant received from the National Institute on Drug Abuse (“NIDA”), also supports the clinical development and U.S. regulatory submission of OPNT003. The additional BARDA support will fund both a planned pharmacodynamic study in healthy volunteers and development work associated with the use of Aptar Pharma’s Unit Dose System.
Opioid overdose is a significant public health crisis that has been exacerbated by the increased availability and abuse of synthetic opioids, such as fentanyl. Fentanyl is 50-fold more potent than heroin, far easier and less expensive to produce, and has a significantly longer half-life. Fentanyl and related synthetic opioids were linked to more than 75% of the nearly 51,000 opioid overdose deaths in 2019 in the U.S. The contract with BARDA allows for development of OPNT003 as a medical countermeasure in a chemical attack using synthetic opioids.
This project has been supported in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800029C.
OPNT003, nasal nalmefene, is in development as a potent, rapid-onset, long-acting opioid antagonist for the treatment of opioid overdose. OPNT003 is designed as a rescue medication that could be especially useful in treating overdose by high-potency synthetic opioids, such as fentanyl. OPNT003 is also being considered as an antidote in a civilian mass casualty event. The development of OPNT003 is supported by grants from the NIH and BARDA. Opiant intends to pursue a 505(b)(2) regulatory pathway for OPNT003.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.
For more information 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, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on March 4, 2020, including under the caption titled "Risk 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.
For Media and Investor Inquiries:
Ben Atkins, Opiant