ACUR Acura Pharmaceuticals Inc (CE)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 13D/A

Under the Securities Exchange Act of 1934

(Amendment No. 1)*

 

 

If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box ☐.

Note : Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See §240.13d-7 for other parties to whom copies are to be sent.

^* The remainder of this cover page shall be filled out for a reporting person's initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.

The information required on the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

 

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1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Abuse Deterrent Pharma, LLC
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☒
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	PF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			47,500,000
		8	SHARED VOTING POWER
			0
		9	SOLE DISPOSITIVE POWER
			47,500,000
		10	SHARED DISPOSITIVE POWER
			0
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	47,500,000
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	69.3%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	OO

Item 2.  Identity and Background.

Item 3.  Source or Amount of Funds or Other Consideration.

Item 4.  Purpose of Transaction.

Mr. Schutte is owner of Main Pointe Pharmaceuticals, LLC, which acquired two products from the Issuer in March 2017 and has options on several other products.  The purpose of the transaction was to provide funding to the Company so that it could continue to develop its LimitX™ technology and enhance its Impede® technology of which Main Pointe Pharmaceuticals, LLC is a licensee. On June 28, 2019, the Company granted authority to Main Pointe Pharmaceuticals, LLC (“Main Pointe”) to assign to AD Pharma the option and the right to add, as an Option Product to the Nexafed® Agreement, a Nexafed® 12-hour dosage.

Mr. Schutte owns 61.1% of AD Pharma.  On June 28, 2019, the Company entered into an agreement with AD Pharma pursuant to which AD Pharma will provide financing for the Company’s operations and completion of development of LTX-03 immediate-release tablets utilizing Acura’s patented LIMITx™ technology. The agreement grants AD Pharma exclusive commercialization rights in the United States to LTX-03. The agreement provides for monthly license payments by AD Pharma to the  Company of $350,000 up to the earlier of 18 months or FDA’s acceptance of a New Drug Application (“NDA”) for LTX-03 and reimbursement by AP Pharma of the Company’s LTX-03 outside development expenses. Upon commercialization, as defined, of LTX-03, the Company will receive stepped-up royalties on sales and is eligible for additional payments based upon the achievement of certain milestones.  AD Pharma may terminate the agreement at any time. Additionally, if the NDA for LTX-03 is not accepted by the FDA within 18 months, AD Pharma may terminate the agreement and take ownership of the intellectual property rights of the Company to LTX-03.

 In March 2017, Mr. Schutte also entered into a voting agreement pursuant to which he is entitled to designate a director to the Board of Directors and to committees thereof and pursuant to which he is required to vote for the designees of two other entities and the Chief Executive Officer as directors.

Item 5.  Interest in Securities of the Issuer.

Item 6.  Contracts, Arrangements, Understandings or Relationships with Respect to Securities of the Issuer.

Mr. Schutte purchased common stock and warrants in July 2017 as described in Item 5 pursuant to a subscription agreement incorporated herein as exhibit 99.2. The form of warrant is incorporated herein as Exhibit 99.1.

 

Mr. Schutte also entered into a Second Amended and Restated Voting Agreement dated as of July 24, 2017 with the Issuer, Galen Partners III, LP (“Galen”) and Essex Woodlands Health Ventures Fund V, LP (“Essex”), incorporated herein as Exhibit 99.3. The Second Amended and Restated Voting Agreement provides that the Issuer’s Board of Directors shall be comprised of no more than seven members (subject to certain exceptions), (i) one of whom is the Company’s Chief Executive Officer, (ii) three of whom are independent under Nasdaq standards, and (iii) one of whom shall be designated by each of Essex, Galen and John Schutte. The right of each of Essex, Galen and John Schutte   to designate one director to the Issuer’s Board will continue as long as he or it and their affiliates collectively hold at least 600,000 shares of Issuer’s Common Stock (including warrants exercisable for such shares.  In addition, each of Galen, Investor   and Essex also has the right to designate their directors to any committee established by the Issuer’s Board of Directors, so long as they meet the relevant independence standards, in the case of the Issuer’s Audit Committee and Compensation Committee.

On June 28, 2019, the Company (i) entered into a $6.0 million promissory note with Mr. Schutte that granted to Mr. Schutte conversion rights of the $6.0 million loan into the Company’s common stock at $0.16 per share, convertible immediately, and (ii) issued to him a Common Stock Purchase Warrant to purchase 10.0 million shares of the Company’s common stock at a price of $0.01 per share, exercisable immediately. With the Company’s consent, Mr. Schutte assigned and transferred to AD Pharma all of his right, title and interest in this note, security agreement and warrant effective June 28, 2019.  The form of promissory note is incorporated herein as Exhibit 99.4.  The form of Common Stock Purchase Warrant is incorporated herein as Exhibit 99.5.  The form of assignment is incorporated herein as Exhibit 99.6.

On July 29, 2019, Mr. Schutte and AD Pharma entered into an Agreement among Reporting Persons attached hereto and incorporated herein as Exhibit 99.7.

Item 7.  Material to Be Filed as Exhibits.

 

SIGNATURE

After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.

Dated:

 

 

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Exhibit Index

Exhibit Number	Exhibit Description
99.1	Form of Warrant (incorporated by reference to Exhibit 4.1 of the Form 8-K filed by the Issuer on July 28, 2017).
99.2	Subscription Agreement dated July 24, 2017 between Acura Pharmaceuticals, Inc. and John Schutte (incorporated by reference to Exhibit 10.1 of the Form 8-K filed by the Issuer on July 28, 2017).
99.3	Second Amended and Restated Voting Agreement dated as of July 24, 2017 between Acura Pharmaceuticals, Inc., Galen Partners III, LP, Essex Woodlands Health Ventures Fund V, LP and John Schutte (incorporated by reference to Exhibit 10.1 of the Form 8-K filed by the Issuer on August 1, 2017).
99.4	Form of Amended, Consolidated and Restated Convertible Secured Promissory Note by Acura Pharmaceuticals, Inc. in favor of John Schutte dated June 28, 2019.
99.5	Form of Common Stock Purchase Warrant dated June 28, 2019.
99.6	Form of Assignment of Promissory Note, Warrant and Security Agreement by John Schutte in favor of Abuse Deterrent Pharma, LLC dated June 28, 2019.
99.7	Agreement among Reporting Persons dated July 29, 2019 for the filing of a single Schedule 13D pursuant to Rule 13d-1(K).