OPNT Opiant Pharmaceuticals Inc

 

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): December 15, 2015

 

LIGHTLAKE THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

Nevada		000-55330		N/A
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

 

445 Park Avenue, 9th Floor, New York, NY 10022

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (212) 829-5546

 

N/A

(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 (see General Instruction A.2. below):

 

¨	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))

 

 

Item 8.01

Other Events.

 

On December 15, 2015, Lightlake Therapeutics Inc. (“Lightlake”) issued a press release announcing that it has received a Two Million Dollar ($2,000,000) milestone payment from Adapt Pharma Limited (“Adapt”). This milestone payment was triggered by the U.S. Food and Drug Administration (“FDA”) approval of NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose, to be marketed by Adapt, Lightlake’s commercial partner. The FDA approved NARCAN® Nasal Spray on November 18, 2015.

 

Lightlake also expects to receive a Two Million Five Hundred Thousand Dollar ($2,500,000) milestone payment from Adapt after the prospective first commercial sale of NARCAN® nasal spray in the United States.

 

In December 2014, Lightlake announced a licensing deal with Adapt. As per the terms of the deal, in exchange for licensing its opioid overdose reversal treatment, Lightlake could receive potential development and sales milestone payments of more than $55 million, plus up to double-digit percentage royalties on net sales.

 

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K. 

 

Item 9.01

Financial Statements and Exhibits

 

(d)  Exhibits

 

Exhibit No.		Description
99.1		Lightlake Therapeutics Inc. Receives Milestone Payment for U.S. Food and Drug Administration approval of NARCAN® (Naloxone Hydrochloride) Nasal Spray

 

 

 

  

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.

 

Dated: December 15, 2015

 

	LIGHTLAKE THERAPEUTICS INC.
	By:	/s/ Dr. Roger Crystal
		Dr. Roger Crystal
		Chief Executive Officer and President

 

 

 

 

 

 

 

Exhibit 99.1

 

 

News Release

Corporate Contact:

Lightlake Therapeutics Inc.

445 Park Avenue, 9^th Floor

New York, NY 10022

Dr. Roger Crystal, CEO

(212) 829-5546

investor.relations@lightlaketherapeutics.com

 

LIGHTLAKE THERAPEUTICS INC. RECEIVES MILESTONE PAYMENT FOR U.S.

FOOD AND DRUG ADMINISTRATION APPROVAL OF NARCAN® (NALOXONE

HYDROCHLORIDE) NASAL SPRAY

 

NEW YORK – (December 15, 2015) – Lightlake Therapeutics Inc. (“Lightlake”) (OTCQB: LLTP), a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive, and eating disorders, announced today that it has received a $2 million milestone payment from Adapt Pharma Limited (“Adapt”). This milestone payment was triggered by the U.S. Food and Drug Administration (“FDA”) approval of NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose, to be marketed by Adapt, Lightlake’s commercial partner. The FDA approved NARCAN® Nasal Spray on November 18, 2015. Lightlake also expects to receive a $2.5 million milestone payment from Adapt after the prospective first commercial sale of NARCAN® Nasal Spray in the United States.

 

“We are extremely pleased with our relationship with our partner Adapt and impressed by their investment and commercial efforts with respect to NARCAN® Nasal Spray,” commented Kevin Pollack, CFO of Lightlake. “We plan to use this FDA approval milestone payment to progress Lightlake’s operational and research and development activities.”

 

In December 2014, Lightlake announced a licensing deal with Adapt. As per the terms of the deal, in exchange for licensing its opioid overdose reversal treatment, Lightlake could receive potential development and sales milestone payments of more than $55 million, plus up to double-digit percentage royalties on net sales.

 

Lightlake plans now to focus on developing products for substance abuse, addictions, and eating disorders. Over the next year, Lightlake plans to bring its next generation of products into clinical trials.

 

 

Relevant Links

 

Adapt Pharma Limited: http://www.adaptpharma.com/press-releases/

 

Indications and Important Safety Information: http://www.NarcanNasalSpray.com

 

About Lightlake Therapeutics Inc.

 

Lightlake Therapeutics Inc. is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive, and eating disorders. Lightlake has entered into a licensing deal with a subsidiary of Adapt Pharma Limited with respect to a treatment to reverse opioid overdoses, which have reached epidemic proportions in the United States. This treatment, NARCAN® Nasal Spray, was approved by the U.S. Food and Drug Administration in November 2015. Lightlake also has collaborated on clinical trials with the National Institute on Drug Abuse, part of the National Institutes of Health, with respect to this treatment. In addition, Lightlake has completed a Phase II clinical trial to treat Binge Eating Disorder. For more information please visit: www.lightlaketherapeutics.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.

 

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