UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Schedule 13D

(Rule 13d-101)

INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT

TO RULE 13d-1(a) AND AMENDMENTS THERETO FILED PURSUANT TO

RULE 13d-2(a)

Under the Securities Exchange Act of 1934

 

 

ELOXX PHARMACEUTICALS, INC.

(Name of Issuer)

Common Stock, $0.01 par value

(Title of Class of Securities)

29014R103

(CUSIP Number)

Kate Inman, Esq.

General Counsel and Secretary

OPKO Health, Inc.

4400 Biscayne Blvd.

Miami, Florida 33137

(305) 575-4100

Phillip Frost, M.D.

Frost Gamma Investments Trust

4400 Biscayne Blvd, Suite 1500

Miami, Florida 33137

(305) 575-6015

(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications)

May 9, 2019

(Date of Event which Requires Filing of this Statement)

 

 

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 Rule 13d-1(e), 13d-1(f) or 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 Rule 13d-7 for other parties to whom copies are to be sent.

 

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).

(Continued on following pages)

 

*

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).

 

 

 

 

Page 1 of 10 Pages

CUSIP No. 29014R103		SCHEDULE 13D		Page 2 of 10 Pages

 

1		NAME OF REPORTING PERSON     OPKO Health, Inc.
2		CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP   (a)  ☒        (b)  ☒
3		SEC USE ONLY
4		SOURCE OF FUNDS     WC
5		CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(D) OR 2(E)     ☒
6		CITIZENSHIP OR PLACE OF ORGANIZATION     Delaware

NUMBER OF SHARES   BENEFICIALLY   OWNED BY EACH REPORTING PERSON WITH				7		SOLE VOTING POWER     1,290,155 (1)
				8		SHARED VOTING POWER     0
				9		SOLE DISPOSITIVE POWER     1,290,155 (1)
				10		SHARED DISPOSITIVE POWER     0

11		AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON     1,290,155 (1)
12		CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES     ☐
13		PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)     3.6% (2)
14		TYPE OF REPORTING PERSON     CO

 

(1)	Includes (i) 1,289,818 shares of common stock, par value $0.01 (the “Common Stock”), of Eloxx Pharmaceuticals, Inc. (the “Issuer”) and (ii) 337 shares of Common Stock issuable upon the exercise of Series FE Warrants, which have an exercise price of $2.00 and an expiration date of May 16, 2019.

(2)

Calculated based on (i) 36,025,422 shares of Common Stock outstanding as of May 3, 2019, as reported in the Issuer’s quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 9, 2019 (the “Quarterly Report”) and (ii) 337 shares of Common Stock issuable upon the exercise of Series FE Warrants.

CUSIP No. 29014R103		SCHEDULE 13D		Page 3 of 10 Pages

 

1		NAME OF REPORTING PERSON     Phillip Frost, M.D.
2		CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP   (a)  ☒        (b)  ☒
3		SEC USE ONLY
4		SOURCE OF FUNDS     OO
5		CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(D) OR 2(E)     ☒
6		CITIZENSHIP OR PLACE OF ORGANIZATION     United States of America

NUMBER OF SHARES   BENEFICIALLY   OWNED BY EACH REPORTING PERSON WITH				7		SOLE VOTING POWER     15,888 (1)
				8		SHARED VOTING POWER     578,054 (2) (3)
				9		SOLE DISPOSITIVE POWER     15,888 (1)
				10		SHARED DISPOSITIVE POWER     578,054 (2)(3)

11		AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON     593,942 (1)(2)(3)
12		CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES     ☐
13		PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)     1.7% (4)
14		TYPE OF REPORTING PERSON     IN

 

(1)	Consists of options to purchase 15,888 shares of Common Stock held by Dr. Frost that are exercisable within 60 days of the date of this filing.

(2)	Includes (i) 79,907 shares of Common Stock, (ii) 497,563 shares issued in connection with the Transaction described below, and (iii) warrants to purchase 584 shares of Common Stock held by Frost Gamma Investments Trust, which are deemed to be indirectly owned and controlled by Dr. Frost.

(3)

Held by Frost Gamma Investments Trust of which Dr. Frost is the trustee. Frost Gamma Limited Partnership is the sole and exclusive beneficiary of Frost Gamma Investments Trust. Dr. Frost is one of two limited partners of Frost Gamma Limited Partnership. The general partner of Frost Gamma Limited Partnership is Frost Gamma, Inc. and the sole shareholder of Frost Gamma, Inc. is Frost-Nevada Corporation. Dr. Frost is also the sole shareholder of Frost-Nevada Corporation.

(4)	Calculated based on 36,025,422 shares of the Common Stock outstanding as of May 3, 2019, as reported in the Quarterly Report.

CUSIP No. 29014R103		SCHEDULE 13D		Page 4 of 10 Pages

 

1		NAME OF REPORTING PERSON     Frost Gamma Investments Trust
2		CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP   (a)  ☒        (b)  ☒
3		SEC USE ONLY
4		SOURCE OF FUNDS     WC, OO
5		CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(D) OR 2(E)     ☒
6		CITIZENSHIP OR PLACE OF ORGANIZATION     Florida

NUMBER OF SHARES   BENEFICIALLY   OWNED BY EACH REPORTING PERSON WITH				7		SOLE VOTING POWER     0
				8		SHARED VOTING POWER     578,054 (1)
				9		SOLE DISPOSITIVE POWER     0
				10		SHARED DISPOSITIVE POWER     578,054 (1)

11		AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON     578,054 (1)
12		CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES     ☐
13		PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)     1.6% (1)
14		TYPE OF REPORTING PERSON     OO

 

(1)	Includes (i) 79,907 shares of Common Stock, (ii) 497,563 shares issued in connection with the Transaction described below, and (iii) warrants to purchase 584 shares of Common Stock held by Frost Gamma Investments Trust, which are deemed to be indirectly owned and controlled by Dr. Phillip Frost.

(2)	Calculated based on 36,025,422 shares of the Common Stock outstanding as of May 3, 2019, as reported in the Quarterly Report.

CUSIP No. 29014R103		SCHEDULE 13D		Page 5 of 10 Pages

 

EXPLANATORY NOTE

This Schedule 13D (the “Statement”) is filed to amend and restate (i) the Schedule 13D filed May 29, 2014, as amended by Amendment No. 1 filed on June 20, 2014, Amendment No. 2 filed on December 29, 2014, Amendment No. 3 filed on October 16, 2015, Amendment No. 4 filed on February 9, 2017 and Amendment No. 5 filed on December 27, 2017 by Phillip Frost, M. D. and Frost Gamma Investments Trust (“FGIT”) and (ii) the Schedule 13D filed by OPKO Health, Inc. (“OPKO”) with the Securities and Exchange Commission (the “SEC”) on August 4, 2017, as amended by Amendment No. 1 filed on August 14, 2017, Amendment No. 2 filed on November 14, 2017 and Amendment No. 3 filed on December 27, 2017.

On September 7, 2018, the SEC filed a civil complaint in the Southern District of New York (the “Complaint”), against a number of individuals and entities, including OPKO and its CEO and Chairman, Dr. Frost.

In December 2018, OPKO, Dr. Frost and FGIT entered into settlements with the SEC, which, upon approval by the court in January 2019, resolved the claims against OPKO, Dr. Frost and FGIT. Pursuant to the settlement between OPKO and the SEC, and without admitting or denying any of the allegations of the Complaint, OPKO agreed to be enjoined from future violations of Section 13(d) of the Securities Exchange Act of 1934 (the “Exchange Act”), a claim that requires no showing of scienter, and to pay a civil monetary penalty, which has been paid. OPKO also agreed, within certain stipulated time periods, to: (i) establish a Management Investment Committee (“MIC”) that will make recommendations to an Independent Investment Committee (“IIC”) of OPKO’s board of directors in connection with existing and future strategic minority investments; and (ii) retain an Independent Compliance Consultant (“ICC”) on a time-limited basis to, among other things, advise OPKO on whether filings pursuant to Section 13(d) of the Exchange Act for previous strategic minority investments made at the suggestion of or in tandem with Dr. Frost and his related persons or entities should be made or amended to reflect group membership with Dr. Frost.

Under the terms of the settlement between the SEC, Dr. Frost and FGIT, and without admitting or denying any of the allegations in the Complaint, Dr. Frost agreed to injunctions from violations of Sections 5(a) and (c) and 17(a)(2) of the Securities Act of 1933, claims which may be satisfied by strict liability and negligence, respectively, and Section 13(d) of the Exchange Act, also a strict liability claim; to pay a civil monetary penalty, disgorgement and pre-judgment interest, which have been paid; and to be prohibited, with certain exceptions, from trading in penny stocks.

The ICC has concluded his work, determined that certain prior investments in the Issuer by OPKO and Dr. Frost should have been grouped under Section 13(d) of the Exchange Act, and recommended the filing of this form.

OPKO has now established the MIC and IIC, and following the establishment of these committees, any group between OPKO, Dr. Frost and affiliated entities with respect to investments in the Issuer has ceased to exist.

CUSIP No. 29014R103		SCHEDULE 13D		Page 6 of 10 Pages

 

ITEM 1.

SECURITY AND ISSUER

This statement on Schedule 13D relates to the common stock, par value $0.01 per share (the “Common Stock”), of Eloxx Pharmaceuticals, Inc., a Delaware corporation (the “Issuer”). The principal executive offices of the Issuer are located at: 950 Winter Street, Waltham, Massachusetts 02451.

 

ITEM 2.

IDENTITY AND BACKGROUND

Set forth in Schedule 1 to this Schedule 13D are the name, business address and present principal occupation or employment and citizenship of each executive officer and director of OPKO.

(a), (f) This statement is being filed by:

 

(i)

OPKO, a corporation incorporated under the laws of the State of Delaware;

 

(ii)

Phillip Frost, M. D.; and

 

(iii)

FGIT, a trust organized under the laws of the State of Florida.

The Reporting Persons have entered into a joint filing agreement, dated as of May 9, 2019, a copy of which is attached hereto as Exhibit 1.

(b) The address of the principal business and principal office of OPKO is 4400 Biscayne Blvd., Miami, Florida 33137. The address of the principal business and principal office of Dr. Frost and FGIT is 4400 Biscayne Blvd., Suite 1500, Miami, Florida 33137.

(c) OPKO is a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets. Dr. Frost’s principal occupation is serving as Chairman and Chief Executive Officer of OPKO. The principal business of FGIT is to invest in securities. Dr. Frost is the sole trustee of FGIT. Frost Gamma Limited Partnership is the sole and exclusive beneficiary of FGIT.

(d), (e) The information set forth under the heading “Explanatory Note” above is incorporated herein by reference in its entirety to this Item 2(d) and Item 2(e). Except as disclosed above under the heading “Explanatory Note,” during the last five years, none of the Reporting Persons or any of the persons listed on Schedule I hereto (i) has been convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors) or (ii) was a party to a civil proceeding of a judicial or administrative body of competent jurisdiction and as a result of such proceeding was or is subject to a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violations with respect to such laws.

CUSIP No. 29014R103		SCHEDULE 13D		Page 7 of 10 Pages

 

ITEM 3.

SOURCE AND AMOUNT OF FUNDS OR OTHER CONSIDERATION

The information set forth or incorporated under the heading “Explanatory Note” and in Items 4 and 5 is incorporated by reference in its entirety into this Item 3.

The source of funds used by OPKO for each of its acquisitions of securities of the Issuer and companies subsequently acquired by the Issuer was working capital or the exchange, exercise or conversion of securities previously acquired by OPKO of the Issuer or a company acquired by the Issuer. For information with respect to Dr. Frost and FGIT, please refer to the Schedule 13D filed on May 29, 2014, as amended by Amendment No. 1 filed June 20, 2014, Amendment No. 2 filed on December 29, 2014, Amendment No. 3 filed on October 16, 2015, Amendment No. 4 filed on February 9, 2017 and Amendment No. 5 filed on December 27, 2017, each of which is incorporated by reference herein.

On May 31, 2017, the Issuer, Sevion Sub Ltd., an Israeli company and a wholly-owned subsidiary of the Issuer (“Acquisition Sub”), and Eloxx Pharmaceuticals Ltd., an Israeli company (“Eloxx”), entered into an Agreement, as amended on August 1, 2017 and November 23, 2017 (the “Agreement”), pursuant to which, Acquisition Sub merged with and into Eloxx, with Eloxx as the surviving corporation and a wholly-owned subsidiary of the Issuer (the “Transaction”). The Transaction closed on December 19, 2017, at which time all of the issued and outstanding ordinary and preferred shares of Eloxx stock were converted, on a pro rata basis, into the right to receive 20,316,656 shares of the Issuer’s common stock, after giving effect to the Reverse Stock Split (as defined below). In connection with the Transaction, the Issuer effected a 1-for-20 reverse stock split, effective as of 4:00 pm on December 19, 2017 (the “Reverse Stock Split”), and changed its corporate name to “Eloxx Pharmaceuticals, Inc.” All share amounts contained herein reflect the Reverse Stock Split. Upon closing of the Transaction, pursuant to a subscription agreement by and between the Issuer and the Frost Gamma Investment Trust (“FGIT”), dated as of May 31, 2017 (the “Subscription Agreement”), FGIT received approximately 497,563 shares of the Issuer. The Agreement was filed as an exhibit to the Issuer’s Current Report on Form 8-K on June 6, 2017, and a form of the Subscription Agreement was filed as an exhibit to the Issuer’s Current Report on Form 8-K on August 3, 2017.

 

ITEM 4.

PURPOSE OF TRANSACTION

The information set forth or incorporated under the heading “Explanatory Note” and in Items 2, 3 and 5 is incorporated by reference in its entirety into this Item 4.

Steven D. Rubin, who serves as Executive Vice President – Administration and a director of OPKO, is a director of the Issuer.

Each of the Reporting Persons may, at any time or from time to time, formulate plans or proposals regarding the Issuer or its securities to the extent deemed advisable by the Reporting Persons in light of each of their general investment policies, market conditions, subsequent developments affecting the Issuer, the general business and future prospects of the Issuer, or other factors. The Reporting Persons intend to review their investments in the Issuer on a continuing basis. Depending on various factors, including, without limitation, the Issuer’s financial position and strategic direction, actions taken by the board of directors, price levels of shares of the Common Stock, other investment opportunities available to the Reporting Persons, concentration of positions in the portfolios managed by the Reporting Persons, market conditions and general economic and industry conditions, the Reporting Persons may in the future take such actions with respect to their investments in the Issuer as they deem appropriate, including, without limitation, purchasing additional shares of the Common Stock or other financial instruments related to the Issuer or selling some or all of their beneficial or economic holdings, engaging in hedging or similar transactions with respect to the securities relating to the Issuer and/or otherwise changing their intention with respect to any and all matters referred to in Item 4 of Schedule 13D.

CUSIP No. 29014R103		SCHEDULE 13D		Page 8 of 10 Pages

 

Except as disclosed herein, none of the Reporting Persons has any plans or proposals which relate to or which would result in any of the actions specified in this paragraph of Item 4 of Schedule 13D.

 

ITEM 5.

INTEREST IN SECURITIES OF THE ISSUER

(a), (b) The information contained in rows 7, 8, 9, 10, 11 and 13 on each of the cover pages of this Schedule 13D and the information set forth or incorporated in Items 2, 3, 4 and 6 is incorporated by reference in its entirety into this Item 5.

The following persons named in Item 2, other than the Reporting Persons, beneficially own securities of the Issuer:

 

Name		Number of Shares of Common Stock Beneficially Owned		Sole or Shared Voting Power		Sole or Shared Dispositive Power		Percentage of Class
Richard A. Lerner, M.D.		9,433		Shared (1)		Shared (1)		<0.1% (2)
Steven D. Rubin		59,120 (3)		Sole		Sole		0.2% (4)

 

(1)	Held through Lerner Family Trust, Richard A. & Nicola G. Lerner Trustees

(2)	Calculated based on 36,025,422 shares of Common Stock outstanding as of May 3, 2019, as reported in the Issuer’s quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2019 (the “Quarterly Report”), filed with the Securities and Exchange Commission on May 9, 2019.

(3)

Comprised of (i) 59,120 shares of Common Stock issuable upon the exercise of currently exercisable stock options. Excludes 20,000 shares of Common Stock issuable upon the exercise of stock options scheduled to vest on June 15, 2019. The stock options were received as a result of Mr. Rubin’s service as a director of the Issuer.

(4)	Calculated based on (i) 36,025,422 shares of Common Stock outstanding as of May 3, 2019, as reported in the Quarterly Report and (ii) 59,120 shares of Common Stock issuable upon the exercise of the currently exercisable stock options described above.

OPKO’s reported ownership does not include securities beneficially owned by FGIT, Dr. Frost, Dr. Lerner or Mr. Rubin. OPKO disclaims beneficial ownership of the securities of the Issuer owned by FGIT, Dr. Frost, Dr. Lerner and Mr. Rubin.

Dr. Frost and FGIT’s reported ownership does not include securities owned by OPKO. In addition to serving as Chairman and Chief Executive Officer of OPKO, Dr. Frost and entities controlled by Dr. Frost (including FGIT) beneficially own approximately 35% of the outstanding common stock of OPKO. Dr. Frost and FGIT each disclaim beneficial ownership of the securities of the Issuer owned by OPKO.

(c) There have been no transactions in shares of the Common Stock effected by any Reporting Person or any of the other persons named in Item 2 in the last 60 days.

CUSIP No. 29014R103		SCHEDULE 13D		Page 9 of 10 Pages

 

(d) No other person is known to the Reporting Persons to have the right to receive or the power to direct the receipt of dividends from, or the proceeds from the sale of, the shares of the Common Stock covered by this Schedule 13D.

(e) OPKO ceased to be a member of a group with Dr. Frost no later than the establishment of the IIC and MIC on February 1, 2019. None of the Reporting Persons beneficially own more than 5% of the outstanding Common Stock.

 

ITEM 6.

CONTRACTS, ARRANGEMENTS, UNDERSTANDINGS OR RELATIONSHIPS WITH RESPECT TO SECURITIES OF THE ISSUER

The information set forth or incorporated under the heading “Explanatory Note” and in Items 2, 3, 4 and 5 is incorporated by reference in its entirety into this Item 6.

Except for the matters described herein, the Reporting Persons do not have any contract, arrangement, understanding or relationship (legal or otherwise) with any person with respect to the securities of the Issuer.

 

ITEM 7.

MATERIAL TO BE FILED AS EXHIBITS

Exhibit 1		Joint Filing Agreement
Exhibit 2		Power of Attorney

CUSIP No. 29014R103		SCHEDULE 13D		Page 10 of 10 Pages

 

SIGNATURES

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

Date: May 9, 2019

 

EXHIBIT INDEX

 

Exhibit		Description
1		Joint Filing Agreement.
2		Power of Attorney

SCHEDULE 1

 

Directors of OPKO
Name		Business Address		Principal Occupation or Employment		Citizenship
Phillip Frost, M.D		4400 Biscayne Blvd., Suite 1500, Miami, Florida 33137		Chairman & Chief Executive Officer OPKO Health, Inc.		United States
Jane H. Hsiao, Ph.D., MBA		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Vice Chairman & Chief Technical Officer OPKO Health, Inc.		United States
Steven D. Rubin		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Executive Vice President –Administration OPKO Health, Inc.		United States
Robert S. Fishel, M.D.		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Chief Executive Officer & President Florida Electrophysiology Associates		United States
Richard M. Krasno, Ph.D.		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Lead Independent Director of Ladenburg Thalmann Financial Services, Inc.		United States
Richard A. Lerner, M.D.		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Institute Professor The Scripps Research Institute		United States
John A. Paganelli		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Chairman of the Board Pharos Systems International		United States
Richard C. Pfenniger, Jr.		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Former Chairman, Chief Executive Officer and President Continucare Corporation		United States
Alice Lin-Tsing Yu, M.D., Ph.D.		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Professor in Pediatrics at University of California in San Diego		United States

Executive Officers of OPKO
Name		Business Address		Principal Occupation or Employment		Citizenship
Phillip Frost, M.D		4400 Biscayne Blvd., Suite 1500, Miami, Florida 33137		Chief Executive Officer & Chairman of the Board.		United States
Jane H. Hsiao, Ph.D., MBA		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Vice Chairman & Chief Technical Officer.		United States
Steven D. Rubin		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Executive Vice President – Administration.		United States
Adam Logal		c/o OPKO Health, Inc. 4400 Biscayne Blvd. Miami, Florida 33137		Senior Vice President, Chief Financial Officer, Chief Accounting Officer and Treasurer.		United States