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.
¨
* 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).
CUSIP No. 69012T 206
|
13D
|
Page
2
of
10
Pages
|
1.
|
Names of Reporting Persons
BioLexis Pte. Ltd.
|
|
2.
|
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a)
¨
(b)
x
|
|
3.
|
SEC USE ONLY
|
|
4.
|
SOURCE OF FUNDS
WC
|
|
5.
|
CHECK B IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)
¨
|
|
6.
|
CITIZENSHIP OR PLACE OF ORGANIZATION
Singapore
|
|
NUMBER OF
SHARES
BENEFICIALLY
OWNED BY
EACH
REPORTING
PERSON WITH:
|
7.
|
SOLE VOTING POWER
0
|
|
8.
|
SHARED VOTING POWER
24,983,551 (1)
|
|
9.
|
SOLE DISPOSITIVE POWER
0
|
|
10.
|
SHARED DISPOSITIVE POWER
24,983,551 (1)
|
|
11.
|
AGGREGATE AMOUNT BENEFICIALLY OWNED BY
EACH REPORTING PERSON
24,983,551 (1)
|
|
12.
|
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW
(11) EXCLUDES CERTAIN SHARES
¨
|
|
13.
|
PERCENT OF CLASS REPRESENTED BY AMOUNT
IN ROW (11)
70.9% (2)
|
|
14.
|
TYPE OF REPORTING PERSON
IV
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Reflects the 1-for-8 reverse
stock split that was effected on March 15, 2019 (the “
Reverse Stock Split
”) of the common stock, par value
$0.01 per share (the “
Shares
”) of Outlook Therapeutics, Inc., a Delaware corporation (the “
Issuer
”)
and includes (1) an aggregate of 63,250 shares of Series A-1 Convertible Preferred Stock (“
Preferred Stock
”),
which converts into an aggregate of 1,195,295 Shares and (2) warrants to purchase an aggregate of 11,930,580 Shares.
|
|
(2)
|
This percentage is calculated
based upon 22,099,022 Shares outstanding as set forth in the Issuer’s Final Prospectus, as filed with the Securities and
Exchange Commission on April 10, 2019, plus (1) warrants to purchase an aggregate of 11,930,580 Shares, and (2) 1,195,295
Shares
underlying the
Preferred Stock.
|
CUSIP No. 69012T 206
|
13D
|
Page
3
of
10
Pages
|
1.
|
Names of Reporting Persons
Ghiath M. Sukhtian
|
2.
|
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a)
¨
(b)
x
|
3.
|
SEC USE ONLY
|
4.
|
SOURCE OF FUNDS
N/A
|
5.
|
CHECK B IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)
¨
|
6.
|
CITIZENSHIP OR PLACE OF ORGANIZATION
Jordan
|
NUMBER OF
SHARES
BENEFICIALLY
OWNED BY
EACH
REPORTING
PERSON WITH:
|
7.
|
SOLE VOTING POWER
0
|
8.
|
SHARED VOTING POWER
24,983,551 (1)
|
9.
|
SOLE DISPOSITIVE POWER
0
|
10.
|
SHARED DISPOSITIVE POWER
24,983,551 (1)
|
11.
|
AGGREGATE AMOUNT BENEFICIALLY OWNED BY
EACH REPORTING PERSON
24,983,551 (1)
|
12.
|
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW
(11) EXCLUDES CERTAIN SHARES
¨
|
13.
|
PERCENT OF CLASS REPRESENTED BY AMOUNT
IN ROW (11)
70.9% (2)
|
14.
|
TYPE OF REPORTING PERSON
IN
|
|
|
|
|
|
|
|
|
|
(1)
|
Reflects the 1-for-8 reverse
stock split that was effected on March 15, 2019 (the “
Reverse Stock Split
”) of the common stock, par value
$0.01 per share (the “
Shares
”) of Outlook Therapeutics, Inc., a Delaware corporation (the “
Issuer
”)
and includes (1) an aggregate of 63,250 shares of Series A-1 Convertible Preferred Stock (“
Preferred Stock
”),
which converts into an aggregate of 1,195,295 Shares and (2) warrants to purchase an aggregate of 11,930,580 Shares.
|
|
(2)
|
This percentage is calculated
based upon 22,099,022 Shares outstanding as set forth in the Issuer’s Final Prospectus, as filed with the Securities and
Exchange Commission pursuant to Rule 424(b)(4) on April 10, 2019, plus (1) warrants to purchase an aggregate of 11,930,580 Shares,
and (2) 1,195,295
Shares underlying the
Preferred Stock.
|
CUSIP No. 69012T 206
|
13D
|
Page
4
of
10
Pages
|
1.
|
Names of Reporting Persons
Arun Kumar Pillai
|
2.
|
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a)
¨
(b)
x
|
3.
|
SEC USE ONLY
|
4.
|
SOURCE OF FUNDS
N/A
|
5.
|
CHECK B IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)
¨
|
6.
|
CITIZENSHIP OR PLACE OF ORGANIZATION
India
|
NUMBER OF
SHARES
BENEFICIALLY
OWNED BY
EACH
REPORTING
PERSON WITH:
|
7.
|
SOLE VOTING POWER
0
|
8.
|
SHARED VOTING POWER
24,983,551 (1)
|
9.
|
SOLE DISPOSITIVE POWER
0
|
10.
|
SHARED DISPOSITIVE POWER
24,983,551 (1)
|
11.
|
AGGREGATE AMOUNT BENEFICIALLY OWNED BY
EACH REPORTING PERSON
24,983,551 (1)
|
12.
|
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW
(11) EXCLUDES CERTAIN SHARES
¨
|
13.
|
PERCENT OF CLASS REPRESENTED BY AMOUNT
IN ROW (11)
70.9% (2)
|
14.
|
TYPE OF REPORTING PERSON
IN
|
|
|
|
|
|
|
|
|
|
(1)
|
Reflects the 1-for-8 reverse
stock split that was effected on March 15, 2019 (the “
Reverse Stock Split
”) of the common stock, par value
$0.01 per share (the “
Shares
”) of Outlook Therapeutics, Inc., a Delaware corporation (the “
Issuer
”)
and includes (1) an aggregate of 63,250 shares of Series A-1 Convertible Preferred Stock (“
Preferred Stock
”),
which converts into an aggregate of 1,195,295 Shares and (2) warrants to purchase an aggregate of 11,930,580 Shares.
|
|
(2)
|
This percentage is calculated
based upon 22,099,022 Shares outstanding as set forth in the Issuer’s Final Prospectus, as filed with the Securities and
Exchange Commission on April 10, 2019, plus (1) warrants to purchase an aggregate of 11,930,580 Shares, and (2) 1,195,295
Shares
underlying the
Preferred Stock.
|
CUSIP No. 69012T 206
|
|
Page
5
of
10
Pages
|
This
Amendment No. 7 (“
Amendment No. 7
”) to Schedule 13D supplements and amends the statement on Schedule 13D of
BioLexis Pte. Ltd. (formerly known as GMS Tenshi Holdings Pte. Limited), a Singapore private limited company (“
BioLexis
”),
Ghiath M. Sukhtian (“
Sukhtian
”), and Arun Kumar Pillai (“
Kumar
”) originally filed with the
Securities and Exchange Commission (the “
SEC
”) on September 18, 2017 (the “
Original Schedule 13D
”),
and amended by Amendment Nos. 1, 2, 3, 4, 5 and 6 thereto, filed with the SEC on each of November 1, 2017, June 25, 2018, July
20, 2018, November 9, 2018, January 3, 2019 and February 5, 2019, respectively (together the “
Schedule 13D
”).
Except as otherwise specified in this Amendment No. 7, all items in the Schedule 13D remain unchanged. All capitalized terms used
herein and not otherwise defined have the meanings ascribed to such terms in the Original Schedule 13D.
The
Reporting Persons are filing this Amendment No. 7 to report BioLexis’s purchase in an underwritten public offering that closed
on April 12, 2019 (the “
Public Offering
”) at the combined public offering price of $2.75 per share and accompanying
warrants of (i) 3,636,364 Shares together with (ii) 3,636,364 15-month Warrants to purchase an aggregate of 3,636.364 Shares at
an exercise price of $2.90 per Share and (iii) 3,636,364 5-year Warrants to purchase an aggregate of 3,636.364 Shares at an exercise
price of $2.90 per Share.
|
Item 1.
|
Security and Issuer.
|
The
Schedule 13D relates to the common stock, par value $0.01 per share (the “
Shares
”), of Outlook Therapeutics,
Inc., a Delaware corporation (the “
Issuer
”), with its principal executive offices located at 7 Clarke Drive,
Cranbury, New Jersey 08512. The Shares are listed on the Nasdaq Capital Market under the ticker symbol “OTLK”.
Information given in response to each item shall be deemed incorporated by reference in all other items, as applicable.
|
Item 2.
|
Identity and Background.
|
|
(a)
|
This Amendment No. 7 is being filed by BioLexis, Sukhtian, and Kumar (collectively, the “
Reporting Persons
”).
|
|
(b)–(c)
|
Tenshi Life Sciences Private Limited (“
Tenshi
”), a private investment vehicle of Kumar, and GMS Pharma (Singapore) Pte. Limited (“
GMS Pharma
”), a private investment company and wholly-owned subsidiary of GMS Holdings, a private investment company (“
GMS Holdings
”), are the 50:50 beneficial owners of BioLexis in which each of Tenshi and GMS Pharma owns 50% of the outstanding voting shares. Kumar, a natural person, is the holder of a controlling interest in Tenshi. Sukhtian, a natural person, is the holder of a controlling interest in GMS Holdings, which is the holder of a controlling interest in GMS Pharma.
|
The
principal office address of BioLexis is 36 Robinson Road, #13-01, City House, Singapore 068877. The principal office address of
Kumar is #30, “Galaxy”, 1st Main, J.P. Nagar, 3rd Phase, Bangalore, India 560078. The principal office address of Sukhtian
is Zahran Street, 7th Circle Zahran Plaza Building, 4th Floor P.O. Box 142904, Amman, Jordan 11844.
CUSIP No. 69012T 206
|
|
Page
6
of
10
Pages
|
The
directors and executive officers of BioLexis are set forth on Schedule I attached hereto. Schedule I sets forth the following information
with respect to each such person:
|
(iii)
|
present principal occupation or employment and the name, principal business and address of any corporation or other organization in which such employment is conducted; and
|
|
(d)–(e)
|
None of the Reporting Persons has, during the last five years, been convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors). None of the Reporting Persons has, during the last five years, been 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 violation with respect to such laws.
|
|
(f)
|
(i)
|
Kumar is a citizen of India.
|
|
(ii)
|
Sukhtian is a citizen of Jordan.
|
|
Item 3.
|
Source and Amount of Funds or Other Consideration.
|
On April 12, 2019,
BioLexis purchased
purchase in the Public Offering at the combined public offering price
of $2.75 per share and accompanying warrants (i) 3,636,364 Shares together with (ii) 3,636,364 15-month Warrants to purchase an
aggregate of 3,636.364 Shares at an exercise price of $2.90 per Share and (iii) 3,636,364 5-year Warrants to purchase an aggregate
of 3,636.364 Shares at an exercise price of $2.90 per Share.. The source of funds for the purchase was the working capital of BioLexis
and capital contributions made to BioLexis.
|
Item 4.
|
Purpose of Transaction
|
The Issuer intends
to use the net proceeds from the Public Offering primarily to (i) fund the Phase 3 clinical trials for its lead product candidate,
ONS-5010, and (ii) for working capital and general corporate purposes, including the scheduled repayments on the senior secured
notes.
This Schedule 13D relates to the acquisition
of the Shares and other securities of the Issuer by the Reporting Persons. The securities acquired by the Reporting Persons were
acquired for the purpose of making an investment in the Issuer.
CUSIP No. 69012T 206
|
|
Page
7
of
10
Pages
|
Except as set forth in this Schedule 13D,
the Reporting Persons have not formulated any plans or proposals which relate to or would result in: (a) the acquisition by any
person of additional securities of the Issuer or the disposition of securities of the Issuer; (b) an extraordinary corporate transaction,
such as a merger, reorganization or liquidation, involving the Issuer or any of its subsidiaries; (c) a sale or transfer of a material
amount of the assets of the Issuer or any of its subsidiaries; (d) any change in the present Board or management of the Issuer,
including any plans or proposals to change the number or term of directors or to fill any existing vacancies on the board; (e)
any material change in the Issuer’s capitalization or dividend policy of the Issuer; (f) any other material change in the
Issuer’s business or corporate structure; (g) any change in the Issuer’s charter or bylaws or other instrument corresponding
thereto or other action which may impede the acquisition of control of the Issuer by any person; (h) causing a class of the Issuer’s
securities to be deregistered or delisted from a national securities exchange or to cease to be authorized to be quoted in an inter-dealer
quotation system of a registered national securities association; (i) a class of equity securities of the Issuer becoming eligible
for termination of registration pursuant to Section 12(g)(4) of the Act; or (j) any action similar to any of those enumerated above.
|
Item 5.
|
Interest in Securities of the Issuer
|
|
(a)–(b)
|
As of the date of this filing, the Reporting Persons may be deemed, for purposes of Rule 13d-3 of the Securities Exchange Act of 1934, as amended (the “
Exchange Act
”), directly or indirectly, including by reason of their mutual affiliation, to be the beneficial owners of the Shares described in Item 6 below. Based upon information contained in the Issuer’s Final Prospectus filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission on April 10, 2019, together with such Shares deemed to be indirectly beneficially owned by the Reporting Persons constitutes approximately 70.9% of the issued and outstanding Shares. Sukhtian, as the holder of a controlling interest in GMS Holdings, the holder of a controlling interest in GMS Pharma, which owns 50% of the outstanding voting shares of BioLexis, may be deemed to indirectly beneficially own the Shares held by BioLexis. Kumar, as the holder of a controlling interest in Tenshi, which owns 50% of the outstanding voting shares of BioLexis, may also be deemed to indirectly beneficially own the Shares held by BioLexis. As a result, Kumar and Sukhtian share the power to direct the vote and to direct the disposition of the Shares described in Item 6 below.
|
|
(c)
|
On March 31, 2019, BioLexis received a regular quarterly dividend of 1,542 shares of Preferred Stock pursuant to the terms of such Preferred Stock.
|
|
|
|
|
(d)
|
Not applicable.
|
|
Item 6.
|
Contracts, Arrangements, Understandings or Relationships with respect to Securities of the Issuer
|
Tenshi, a private investment vehicle of
Kumar, and GMS Pharma, a private investment company and wholly-owned subsidiary of GMS Holdings, are the 50:50 beneficial owners
of BioLexis, in which each of Tenshi and GMS Pharma owns 50% of the outstanding voting shares. Kumar, a natural person, is the
holder of a controlling interest in Tenshi. Sukhtian, a natural person, is the holder of a controlling interest in GMS Holdings,
which is the holder of a controlling interest in GMS Pharma. By virtue of such relationships, Kumar and Sukhtian may be deemed
to have voting and investment power with respect to the securities held by BioLexis noted above and as a result may be deemed to
beneficially own such securities for purposes of Rule 13d-3 under the Exchange Act. As of the date of this Schedule 13D, the number
of Shares attributable to BioLexis (assuming conversion of the Preferred Stock and warrants to purchase Shares (“
Warrants
”)
acquired by BioLexis) is 24,983,551. Kumar and Sukhtian may also each be considered to hold indirectly the same 24,983,551 Shares.
CUSIP No. 69012T 206
|
|
Page
8
of
10
Pages
|
Pursuant to the Investor Rights Agreement
(as defined below), BioLexis was granted the right to appoint four representatives to the Issuer’s Board of Directors (the
“
Board
”), and accordingly, the Reporting Persons may have the ability to affect and influence control of the
Issuer. BioLexis has designated four representatives to serve on the Board.
Investor Rights Agreement
On September 11, 2017, the Issuer entered
into an investor rights agreement with BioLexis (the “
Investor Rights Agreement
”) in connection with its initial
2017 purchase in a private placement of securities of the Issuer. Pursuant to the Investor Rights Agreement, the Issuer granted
BioLexis certain registration rights with respect to the Shares issuable upon conversion or exercise of such securities, Board
designation rights, and information rights, as well as the right of first offer over future issuances of securities and a right
of participation in future securities issuances. The Issuer also agreed not to file any registration statement to register for
resale the sale of any securities of a third party without BioLexis’ prior consent.
Additionally, the Issuer agreed to appoint
up to four new directors to be designated by BioLexis, such that BioLexis’ designees represent a majority of the Board. As
long as BioLexis maintains beneficial ownership of at least 5% of the Issuer’s outstanding Shares, it shall be entitled to
nominate directors to the Board in proportion to its ownership stake in the Issuer. As long as BioLexis maintains beneficial ownership
of at least 50% of the Issuer’s outstanding Shares but less than or equal to 57%, BioLexis shall be entitled to nominate
a majority of the directors for election to the Board.
In connection with the purchase agreement
entered into between the Issuer and BioLexis on May 11, 2018 (the “
May 2018 Purchase Agreement
”), the Issuer
and BioLexis amended the Investor Rights Agreement in order to provide BioLexis certain registration and other rights with respect
to the Shares acquired pursuant to the May 2018 Purchase Agreement and the Shares that may be issuable upon exercise of the Warrants
acquired pursuant to the May 2018 Purchase Agreement (the “
Investor Rights Agreement Amendment No. 1
”).
In connection with the exchange agreement
entered into between the Issuer and BioLexis on July 18, 2018 (the “
Exchange Agreement
”), the Issuer and BioLexis
amended the Investor Rights Agreement in order to provide BioLexis certain registration and other rights with respect to the Shares
that may be issuable upon conversion of the Preferred Stock acquired pursuant to the Exchange Agreement (the “
Investor
Rights Agreement Amendment No. 2
”).
In connection with the purchase agreement
entered into between the Issuer and BioLexis on November 5, 2018 (the “
November 2018 Purchase Agreement
”), the
Issuer and BioLexis amended the Investor Rights Agreement in order to provide BioLexis certain registration and other rights with
respect to the Shares acquired pursuant to the November 2018 Purchase Agreement (the “
Investor Rights Agreement Amendment
No. 3
”).
CUSIP No. 69012T 206
|
|
Page
9
of
10
Pages
|
The foregoing descriptions of the Investor
Rights Agreement, the Investor Rights Agreement Amendment No. 1, the Investor Rights Agreement Amendment No. 2 and the Investor
Rights Agreement Amendment No. 3, do not purport to be complete and are qualified in their entirety by reference to the full text
of the Investor Rights Agreement, the Investor Rights Agreement Amendment No. 1, the Investor Rights Agreement Amendment No. 2
and the Investor Rights Agreement No. 3, copies of which are filed as Exhibits 2, 3, 4 and 5 to this Schedule 13D, and incorporated
herein by reference.
|
Item 7.
|
Material to be Filed as Exhibits
|
|
1.
|
Joint Filing Agreement, among GMS Tenshi Holdings Pte. Limited, Ghiath M. Sukhtian, and Arun Kumar Pillai, dated April 16, 2019.
|
|
2.
|
Investor Rights Agreement by and between Outlook Therapeutics, Inc. and GMS Tenshi Holdings Pte. Limited, dated September 11, 2017 (incorporated by reference to Exhibit 10.3 to the Issuer’s Form 8-K (SEC File No. 001-37759), filed with the SEC on September 11, 2017).
|
|
3.
|
First Amendment to the Investor Rights Agreement (incorporated by reference to Exhibit 10.2 to the Issuer’s Form 8-K (SEC File No. 001-37759), filed with the SEC on May 15, 2018).
|
|
4
.
|
Second Amendment to Investor
Rights Agreement (incorporated by reference to Exhibit 10.2 to the Issuer’s Form 8-K (SEC File No. 001-37759), filed with
the SEC on July 19, 2018).
|
|
5.
|
Third Amendment to Investor Rights Agreement (incorporated by reference to Exhibit 10.2 to the Issuer’s Form 8-K (SEC File No. 001-37759), filed with the SEC on November 9, 2018).
|
CUSIP No. 69012T 206
|
|
Page
10
of
10
Pages
|
Signatures
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: April 16, 2019
|
BioLexis Pte. Ltd.
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Faisal G. Sukhtian
|
|
|
Name: Faisal G. Sukhtian
|
|
|
Title: Director
|
|
|
|
|
|
|
|
|
|
|
Ghiath M. Sukhtian
|
|
|
|
|
|
|
|
|
|
|
/s/ Ghiath M. Sukhtian
|
|
|
|
|
|
|
|
|
|
|
Arun Kumar Pillai
|
|
|
|
|
|
|
|
|
|
|
/s/ Arun Kumar Pillai
|
|
Schedule I
DIRECTORS AND EXECUTIVE OFFICERS OF
BioLexis
Pte. Ltd
.
The following tables set forth certain information
with respect to the directors and executive officers of BioLexis Pte.Ltd.
Name, Business Address, Position
|
|
Principal Occupation
|
|
Citizenship
|
|
|
|
|
|
Faisal Ghiath Sukhtian
7
th
Circle, Zahran St., Zahran Plaza Building, 4
th
Floor
PO Box 142909
Amman, Jordan 11844
Position: Director
|
|
Executive Director at GMS Holdings
|
|
Jordan
|
|
|
|
|
|
Kwik Poh Choo
5 Ewe Boon Road
Singapore 259316
Position: Director
|
|
Director
|
|
Singapore
|
|
|
|
|
|
Kannan Pudhucode Radhakrishnan
# 30, “Galaxy”, 1
st
Main,
J.P. Nagar, 3
rd
Phase,
Bangalore, India 560078
Position: Director
|
|
Director at Tenshi Life Sciences Private Limited
|
|
India
|
|
|
|
|
|
Lau Yim Chu Nancy
36 Robinson Road
#13-01
City House
Singapore 068877
Position: Corporate Secretary
|
|
Corporate Secretary
|
|
British
|
|
|
|
|
|