SteadyMed (STDY) SC 13D/A SteadyMed Ltd.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 13D

Under the Securities Exchange Act of 1934

(Amendment No. 2)*

SteadyMed Ltd.

(Name of Issuer)

Ordinary Shares, nominal value NIS 0.01 per share

(Title of Class of Securities)

M84920103

(CUSIP Number)

OrbiMed Advisors LLC

OrbiMed Advisors Israel II Limited

OrbiMed Israel GP II, L.P.

OrbiMed Capital GP VI LLC

601 Lexington Avenue, 54th Floor

New York, NY 10022

Telephone: (212) 739-6400

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

January 24, 2018

(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 §§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(b) 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).

CUSIP No.  M84920103

1	Names of Reporting Persons. OrbiMed Advisors LLC
2	Check the Appropriate Box if a Member of a Group (See Instructions). (a) o (b) o
3	SEC Use Only
4	Source of Funds (See Instructions) AF
5	Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)			o
6	Citizenship or Place of Organization Delaware
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	Sole Voting Power 0
		8	Shared Voting Power 3,952,696 (1)
		9	Sole Dispositive Power 0
		10	Shared Dispositive Power 3,952,696 (1)
11	Aggregate Amount Beneficially Owned by Each Reporting Person 3,952,696 (1)
12	Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)			o
13	Percent of Class Represented by Amount in Row (11) 13.9% (2)
14	Type of Reporting Person (See Instructions) IA

(1)Evidenced by (i) 2,123,098 Shares (as defined below) of SteadyMed Ltd., an Israeli corporation (the “Issuer”) and (ii) 1,829,598 Shares issuable upon the exercise of warrants to purchase shares (the “Warrants”).  The Warrants contain an issuance limitation that prohibits the holder from exercising the Warrants to the extent that after giving effect to such issuance after exercise the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates, including the other Reporting Persons), would beneficially own in excess of 19.95% of the Shares outstanding immediately after giving effect to the issuance of the Shares issuable upon exercise of the Warrants.

(2)This percentage is calculated based upon 26,556,052 outstanding Shares of the Issuer, as set forth in the Issuer’s Definitive Proxy Statement filed with the Securities and Exchange Commission on November 20, 2017, and includes 1,829,598 Warrants.

CUSIP No. M84920103

1	Names of Reporting Persons. OrbiMed Advisors Israel II Limited
2	Check the Appropriate Box if a Member of a Group (See Instructions). (a) o (b) o
3	SEC Use Only
4	Source of Funds (See Instructions) AF
5	Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)			o
6	Citizenship or Place of Organization Cayman Islands
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	Sole Voting Power 0
		8	Shared Voting Power 3,952,696 (1)
		9	Sole Dispositive Power 0
		10	Shared Dispositive Power 3,952,696 (1)
11	Aggregate Amount Beneficially Owned by Each Reporting Person 3,952,696 (1)
12	Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)			o
13	Percent of Class Represented by Amount in Row (11) 13.9% (2)
14	Type of Reporting Person (See Instructions) OO

(1)Evidenced by (i) 2,123,098 Shares (as defined below) of SteadyMed Ltd., an Israeli corporation (the “Issuer”) and (ii) 1,829,598 Shares issuable upon the exercise of warrants to purchase shares (the “Warrants”).  The Warrants contain an issuance limitation that prohibits the holder from exercising the Warrants to the extent that after giving effect to such issuance after exercise the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates, including the other Reporting Persons), would beneficially own in excess of 19.95% of the Shares outstanding immediately after giving effect to the issuance of the Shares issuable upon exercise of the Warrants.

(2)          This percentage is calculated based upon 26,556,052 outstanding Shares of the Issuer, as set forth in the Issuer’s Definitive Proxy Statement filed with the Securities and Exchange Commission on November 20, 2017, and includes 1,829,598 Warrants.

CUSIP No. M84920103

1	Names of Reporting Persons. OrbiMed Israel GP II, L.P.
2	Check the Appropriate Box if a Member of a Group (See Instructions). (a) o (b) o
3	SEC Use Only
4	Source of Funds (See Instructions) AF
5	Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)			o
6	Citizenship or Place of Organization Cayman Islands
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	Sole Voting Power 0
		8	Shared Voting Power 3,952,696 (1)
		9	Sole Dispositive Power 0
		10	Shared Dispositive Power 3,952,696 (1)
11	Aggregate Amount Beneficially Owned by Each Reporting Person 3,952,696 (1)
12	Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)			o
13	Percent of Class Represented by Amount in Row (11) 13.9% (2)
14	Type of Reporting Person (See Instructions) OO

(1)Evidenced by (i) 2,123,098 Shares (as defined below) of SteadyMed Ltd., an Israeli corporation (the “Issuer”) and (ii) 1,829,598 Shares issuable upon the exercise of warrants to purchase shares (the “Warrants”).  The Warrants contain an issuance limitation that prohibits the holder from exercising the Warrants to the extent that after giving effect to such issuance after exercise the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates, including the other Reporting Persons), would beneficially own in excess of 19.95% of the Shares outstanding immediately after giving effect to the issuance of the Shares issuable upon exercise of the Warrants.

(2)This percentage is calculated based upon 26,556,052 outstanding Shares of the Issuer, as set forth in the Issuer’s Definitive Proxy Statement filed with the Securities and Exchange Commission on November 20, 2017, and includes 1,829,598 Warrants.

CUSIP No. M84920103

1	Names of Reporting Persons. OrbiMed Capital GP VI LLC
2	Check the Appropriate Box if a Member of a Group (See Instructions). (a) o (b) o
3	SEC Use Only
4	Source of Funds (See Instructions)    ��        AF
5	Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)			o
6	Citizenship or Place of Organization Delaware
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	Sole Voting Power 0
		8	Shared Voting Power 3,952,696 (1)
		9	Sole Dispositive Power 0
		10	Shared Dispositive Power 3,952,696 (1)
11	Aggregate Amount Beneficially Owned by Each Reporting Person 3,952,696 (1)
12	Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)			o
13	Percent of Class Represented by Amount in Row (11) 13.9% (2)
14	Type of Reporting Person (See Instructions) OO

(1)Evidenced by (i) 2,123,098 Shares (as defined below) of SteadyMed Ltd., an Israeli corporation (the “Issuer”) and (ii) 1,829,598 Shares issuable upon the exercise of warrants to purchase shares (the “Warrants”).  The Warrants contain an issuance limitation that prohibits the holder from exercising the Warrants to the extent that after giving effect to such issuance after exercise the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates, including the other Reporting Persons), would beneficially own in excess of 19.95% of the Shares outstanding immediately after giving effect to the issuance of the Shares issuable upon exercise of the Warrants.

(2)This percentage is calculated based upon 26,556,052 outstanding Shares of the Issuer, as set forth in the Issuer’s Definitive Proxy Statement filed with the Securities and Exchange Commission on November 20, 2017, and includes 1,829,598 Warrants.

Item 1.  Security and Issuer

This Amendment No. 2 (“Amendment No. 2”) to Schedule 13D supplements and amends the Statement on Schedule 13D of OrbiMed Advisors LLC, OrbiMed Advisors Israel II Limited, OrbiMed Israel GP II, L.P., OrbiMed Capital GP VI LLC and Samuel D. Isaly with the Securities and Exchange Commission (the “SEC”) on August 12, 2016 (the “Statement”), and amended by Amendment No. 1 thereto filed with the SEC on April 28, 2017.  The Statement relates to the ordinary shares, nominal value NIS 0.01 per share (the “Shares”), of SteadyMed Ltd., an Israeli corporation (the “Issuer”), having its principal executive offices located at 5 Oppenheimer Street Rehovot 7670105, Israel. Information given in response to each item shall be deemed incorporated by reference in all other items, as applicable.

This Amendment No. 2 is being filed to report that Samuel D. Isaly, who was previously identified as a reporting person, has ceased to be the beneficial owner of more than five percent of the outstanding Shares.

Item 2 of the Statement is amended to read in full as set forth below.

Item 2. Identity and Background

(a) This Schedule 13D is being filed by OrbiMed Advisors LLC (“OrbiMed Advisors”), OrbiMed Advisors Israel II Limited (“OrbiMed Limited”), OrbiMed Israel GP II, L.P. (“OrbiMed Israel”), and OrbiMed Capital GP VI LLC (“OrbiMed Capital”) (collectively, the “Reporting Persons”).

 (b) — (c), (f) OrbiMed Advisors, a limited liability company organized under the laws of Delaware and a registered investment adviser under the Investment Advisers Act of 1940, as amended, is the managing member or general partner of certain entities as more particularly described in Item 6 below.  OrbiMed Advisors has its principal offices at 601 Lexington Avenue, 54th Floor, New York, New York 10022.

OrbiMed Limited, a corporation organized under the laws of the Cayman Islands, is the general partner of a limited partnership as more particularly described in Item 6 below.  OrbiMed Limited has its principal offices at 601 Lexington Avenue, 54th Floor, New York, New York 10022.

OrbiMed Israel, a limited partnership organized under the laws of the Cayman Islands, is the general partner of a limited partnership as more particularly described in Item 6 below.  OrbiMed Israel has its principal offices at 601 Lexington Avenue, 54th Floor, New York, New York 10022.

OrbiMed Capital, a limited liability company organized under the laws of Delaware, is the general partner of a limited partnership as more particularly described in Item 6 below.  OrbiMed Capital has its principal offices at 601 Lexington Avenue, 54th Floor, New York, New York 10022.

The directors and executive officers of OrbiMed Advisors, OrbiMed Limited, OrbiMed Israel and OrbiMed Capital are set forth on Schedules I, II, III and IV, respectively, attached hereto.  Schedules I, II, III and IV set forth the following information with respect to each such person:

(i)name;

(ii)business address;

(iii)present principal occupation of employment and the name, principal business and address of any corporation or other organization in which such employment is conducted; and

(iv)citizenship.

(d) — (e) During the last five years, neither the Reporting Persons nor any Person named in Schedules I through IV has been (i) convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors) or (ii) 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.

Item 5 of the Statement is amended to read in full as set forth below.

Item 5.  Interest in Securities of the Issuer

 (a) — (b) The following disclosure is based upon 26,556,052 outstanding Shares of the Issuer, as set forth in the Issuer’s Definitive Proxy Statement filed with the Securities and Exchange Commission on November 20, 2017.

As of the date of this filing, OIP II, a limited partnership organized under the laws of the Cayman Islands, holds 2,123,098 Shares and 1,829,598 Warrants constituting approximately 13.9% of the issued and outstanding Shares plus the Warrants held by OIP II.  OrbiMed Israel is the sole general partner of OIP II pursuant to the terms of the limited partnership agreement of OIP II, and OrbiMed Limited is the sole general partner of OrbiMed Israel pursuant to the terms of the limited partnership agreement of OrbiMed Israel.  As a result, OrbiMed Israel and OrbiMed Limited share the power to direct the vote and disposition of the Shares held by OIP II, and both OrbiMed Israel and OrbiMed Limited may be deemed directly or indirectly, including by reason of their mutual affiliation, to be the beneficial owners of the Shares held by OIP II.  OrbiMed Limited exercises this investment power through an investment committee (the “Committee”) comprised of Carl L. Gordon, Jonathan Silverstein, Nissim Darvish, Anat Naschitz, and Erez Chimovits each of whom disclaims beneficial ownership of the Shares held by OIP II.

As of the date of this filing, OPI VI, a limited partnership organized under the laws of Delaware, holds 2,123,098 Shares and 1,829,598 Warrants constituting approximately 13.9% of the issued and outstanding Shares plus the Warrants held by OPI VI.  OrbiMed Capital is the sole general partner of OPI VI, pursuant to the terms of the limited partnership agreement of OPI VI, and OrbiMed Advisors is the sole managing member of OrbiMed Capital, pursuant to the terms of the limited liability company agreement of OrbiMed Capital.  As a result, OrbiMed Advisors and OrbiMed Capital share power to direct the vote and disposition of the Shares held by OPI VI and may be deemed directly or indirectly, including by reason of their mutual affiliation, to be the beneficial owners of the Shares held by OPI VI.  Each of OrbiMed Advisors and OrbiMed Capital disclaims any beneficial ownership over the shares of the other Reporting Persons.  Advisors exercises this investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho and Jonathan T. Silverstein, each of whom disclaims beneficial ownership of the Shares held by OPI VI.

(c) The Reporting Persons hve not effected any transactions during the past sixty (60) days in any Shares.

(d) Not applicable.

(e) As of January 24, 2018, Samuel D. Isaly, who was previously identified as a reporting person, has ceased to be the beneficial owner of more than five percent of the outstanding Shares.

Item 6 of the Statement is amended to read in full as follows.

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

In addition to the relationships between the Reporting Persons described in Items 2 and 5 above, OrbiMed Capital is the sole general partner of OPI VI, pursuant to the terms of the limited partnership agreement of OPI VI.  Pursuant to this agreement and relationship, OrbiMed Capital has discretionary investment management authority with respect to the assets of OPI VI. Such authority includes the power to vote and otherwise dispose of securities held by OPI VI.  The number of outstanding Shares of the Issuer attributable to OPI VI is 3,952,696. OrbiMed Capital, pursuant to its authority under the limited partnership agreement of OPI VI, may be considered to hold indirectly 3,952,696 Shares.

OrbiMed Advisors is the sole managing member of OrbiMed Capital, pursuant to the terms of the limited liability company agreement of OrbiMed Capital. Pursuant to these agreements and relationships, OrbiMed Advisors and OrbiMed Capital have discretionary investment management authority with respect to the assets of OPI VI.  Such authority includes the power of OrbiMed Capital to vote and otherwise dispose of securities held by OPI VI.  The number of outstanding Shares attributable to OPI VI is 3,952,696  Shares.  OrbiMed Advisors, pursuant to its authority under the terms of the limited liability company agreement of OrbiMed Capital, may also be considered to hold indirectly 3,952,696 Shares.

OrbiMed Israel is the sole general partner of OIP II pursuant to the terms of the limited partnership agreement of OIP II. OrbiMed Limited is the sole general partner of OrbiMed Israel pursuant to the terms of the limited partnership agreement of OrbiMed Israel.  Pursuant to these agreements and relationships, OrbiMed Israel has discretionary investment management authority with respect to the assets of OIP II and such discretionary investment management authority is exercised through OrbiMed Limited by action of the Committee. Such authority includes the power to vote and otherwise dispose of securities held by OIP II. The number of outstanding Shares of the Issuer attributable to OIP II is 3,952,696.  OrbiMed Israel, as the general partner of OIP II, may be considered to hold indirectly 3,952,696 Shares, and OrbiMed Limited, as the general partner of OrbiMed Israel, may be considered to hold indirectly 3,952,696  Shares.

Other than the agreements and the relationships mentioned above, to the best knowledge of the Reporting Persons, there are no contracts, arrangements, understandings or relationships (legal or otherwise) among the persons named in Item 2 and between such persons and any persons with respect to any securities of the Issuer, including, but not limited to, transfer or voting of any of the Shares, finder’s fees, joint ventures, loan or option arrangements, puts or calls, guarantees of profits, division of profits or loss, or the giving of withholding of proxies.        

Item 7.  Material to Be Filed as Exhibits

Exhibit	Title
1	Joint Filing Agreement among OrbiMed Advisors LLC, OrbiMed Advisors Israel II Limited, OrbiMed Israel GP II, L.P., and OrbiMed Capital GP VI LLC.

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: January 26, 2018	ORBIMED ADVISORS LLC
	By:	/s/ Jonathan T. Silverstein
		Name: Jonathan T. Silverstein
		Title: Member of OrbiMed Advisors LLC
	By:	/s/ Sven H. Borho
		Name: Sven H. Borho Title: Member of OrbiMed Advisors LLC
	By:	/s/ Carl L. Gordon
		Name: Carl L. Gordon
		Title: Member of OrbiMed Advisors LLC
	ORBIMED ADVISORS ISRAEL II LIMITED
	By:	/s/ Carl L. Gordon
		Name: Carl L. Gordon
		Title: Director
	ORBIMED ISRAEL GP II, L.P.
	By:	ORBIMED ADVISORS ISRAEL II LIMITED, its general partner
	By:	/s/ Carl L. Gordon
		Name: Carl L. Gordon
		Title: Director
	ORBIMED CAPITAL GP VI LLC
	By:	ORBIMED ADVISORS LLC, its managing member
	By:	/s/ Jonathan T. Silverstein
		Name: Jonathan T. Silverstein
		Title: Member of OrbiMed Advisors LLC
	By:	/s/ Sven H. Borho
		Sven H. Borho
		Member of OrbiMed Advisors LLC
	By:	/s/ Carl L. Gordon
		Carl L. Gordon
		Member of OrbiMed Advisors LLC

SCHEDULE I

The names and present principal occupations of each of the executive officers and directors of OrbiMed Advisors LLC are set forth below. Unless otherwise noted, each of these persons is a United States citizen and has a business address of 601 Lexington Avenue, 54th Floor, New York, NY 10022.

Name	Position with Reporting Person	Principal Occupation
Samuel D. Isaly	Managing Member	Managing Member OrbiMed Advisors LLC
Carl L. Gordon	Member	Member OrbiMed Advisors LLC
Sven H. Borho German and Swedish Citizen	Member	Member OrbiMed Advisors LLC
Jonathan T. Silverstein	Member	Member OrbiMed Advisors LLC
W. Carter Neild	Member	Member OrbiMed Advisors LLC
Geoffrey C. Hsu	Member	Member OrbiMed Advisors LLC
Evan D. Sotiriou	Chief Financial Officer	Chief Financial Officer OrbiMed Advisors LLC

SCHEDULE II

The names and present principal occupations of each of the executive officers and directors of OrbiMed Advisors Israel II Limited are set forth below. Unless otherwise noted, each of these persons is a United States citizen and has a business address of 601 Lexington Avenue, 54th Floor, New York, NY 10022.

Name	Position with Reporting Person	Principal Occupation
Carl L. Gordon	Director	Director OrbiMed Advisors Israel II Limited
Jonathan T. Silverstein	Director	Director OrbiMed Advisors Israel II Limited
Nissim Darvish Israeli Citizen	Director	Director OrbiMed Advisors Israel II Limited

SCHEDULE III

The business and operations of OrbiMed Israel GP II, L.P. are managed by the executive officers and directors of its sole general partner, OrbiMed Advisors Israel II Limited, set forth on Schedule II attached hereto.

SCHEDULE IV 

The business and operations of OrbiMed Capital GP VI LLC are managed by the executive officers and directors of its managing member, OrbiMed Advisors LLC, set forth in Schedule I attached hereto.

 EXHIBIT INDEX

Exhibit	Description
1.	Joint Filing Agreement among OrbiMed Advisors LLC, OrbiMed Advisors Israel II Limited, OrbiMed Israel GP II, L.P., and OrbiMed Capital GP VI LLC.