UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

SCHEDULE 13D
 

Under the Securities Exchange Act of 1934


Prevail Therapeutics Inc.
(Name of Issuer)
                     
COMMON STOCK
(Title of Class of Securities)
                   
74140Y101
(CUSIP Number)
                       
OrbiMed Advisors LLC
 
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 to
Receive Notices and Communications)
                       
June 24, 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 §§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. 74140Y101


         
1
NAME OF REPORTING PERSONS
 
OrbiMed Advisors LLC
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)
(a) ☐
(b) ☐
 
3
SEC USE ONLY
 
 
4
SOURCE OF FUNDS (See Instructions)
 
AF
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
 
0
8
SHARED VOTING POWER
 
13,822,463
9
SOLE DISPOSITIVE POWER
 
0
10
SHARED DISPOSITIVE POWER
 
13,822,463
11
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
 
13,822,463
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)
 
40.7%*
14
TYPE OF REPORTING PERSON (See Instructions)
 
IA


* This percentage is calculated based upon 33,997,131 shares of common stock outstanding of Prevail Therapeutics Inc. (the “Issuer”), as set forth in the Issuer’s Rule 424(b)(4) Prospectus filed with the Securities and Exchange Commission (“SEC”) on June 20, 2019.
 




CUSIP No. 74140Y101


         
1
NAME OF REPORTING PERSONS
 
OrbiMed Capital GP VI LLC
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)
(a) ☐
(b) ☐
 
3
SEC USE ONLY
 
 
4
SOURCE OF FUNDS (See Instructions)
 
AF
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
 
0
8
SHARED VOTING POWER
 
13,822,463
9
SOLE DISPOSITIVE POWER
 
0
10
SHARED DISPOSITIVE POWER
 
13,822,463
11
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
 
13,822,463
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)
 
40.7%*
14
TYPE OF REPORTING PERSON (See Instructions)
 
OO

* This percentage is calculated based upon 33,997,131 shares of common stock outstanding of Prevail Therapeutics Inc. (the “Issuer”), as set forth in the Issuer’s Rule 424(b)(4) Prospectus filed with the Securities and Exchange Commission (“SEC”) on June 20, 2019.






Item 1.  Security and Issuer
 
This Schedule 13D (the “Statement”) relates to the common stock, par value $0.001 per share (the “Shares”) of Prevail Therapeutics Inc., a corporation organized under the laws of Delaware (the “Issuer”), with its principal executive offices located at 430 East 29th Street, Suite 940, New York, NY 10016.  The Shares are listed on the NASDAQ Global Market under the ticker symbol “PRVL”.  Information given in response to each item shall be deemed incorporated by reference in all other items, as applicable.

On June 24, 2019, the Issuer completed its initial public offering pursuant to which the Issuer agreed to issue and sell to the participants 7,353,000 Shares (the “IPO”).  The purchase price for each Share was $17.00.  As a result of the IPO, the Issuer’s total number of outstanding Shares increased to 33,997,131.

Item 2. Identity and Background
 
(a) This Statement is being filed by OrbiMed Advisors LLC (“OrbiMed Advisors”) and OrbiMed Capital GP VI LLC (“OrbiMed GP”) (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 GP, 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 GP has its principal offices at 601 Lexington Avenue, 54th Floor, New York, New York 10022.
 
The directors and executive officers of OrbiMed Advisors and OrbiMed GP are set forth on Schedules I and II, respectively, attached hereto.  Schedules I and II 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 and II 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 3.  Source and Amount of Funds or Other Consideration

In August 2017, OrbiMed Advisors and OrbiMed GP, pursuant to their authority under the limited partnership agreement of OrbiMed Private Investments VI, LP (“OPI VI”), as more particularly referred to in Item 6 below, caused OPI VI to purchase 2,430,000 Shares.
 
In August 2017, OrbiMed Advisors and OrbiMed GP, pursuant to their authority under the limited partnership agreement of OPI VI, as more particularly referred to in Item 6 below, caused OPI VI to purchase 6,399,000 shares of Series Seed Preferred Stock of the Issuer.  In connection with the IPO, shares of Series Seed Preferred Stock were subsequently converted (on the closing of the IPO) into Shares on a 1-for-1 basis.
 



In March and April 2018, OrbiMed Advisors and OrbiMed GP, pursuant to their authority under the limited partnership agreement of OPI VI, as more particularly referred to in Item 6 below, caused OPI VI to purchase 1,769,243 shares of Series A Preferred Stock of the Issuer and to acquire an additional 1,330,369 shares of Series A Preferred Stock of the Issuer upon conversion of a convertible note.  In connection with the IPO, shares of Series A Preferred Stock were subsequently converted (on the closing of the IPO) into Shares on a 1-for-1 basis.
 
In March 2019, OrbiMed Advisors and OrbiMed GP, pursuant to their authority under the limited partnership agreement of OPI VI, as more particularly referred to in Item 6 below, caused OPI VI to purchase 1,011,499 shares of Series B Preferred Stock of the Issuer.  In connection with the IPO, shares of Series B Preferred Stock were subsequently converted (on the closing of the IPO) into Shares on a 1-for-1 basis.
 
On and prior to the close of June 24, 2019, OrbiMed Advisors and OrbiMed GP, pursuant to their authority under the limited partnership agreement of OPI VI, as more particularly referred to in Item 6 below, caused OPI VI to purchase 882,352 Shares in the IPO.

The source of funds for such purchases was the working capital of OPI VI.
 
As a result of the transactions described in this Item 3, OrbiMed Advisors and OrbiMed GP may collectively be deemed to be the beneficial owners of approximately 40.7% of the outstanding Shares.  OrbiMed GP, as the general partner of OPI VI, may be deemed to be the beneficial owner of approximately 40.7% of the outstanding Shares.  OrbiMed Advisors, as the managing member of OrbiMed GP, may be deemed to be the beneficial owner of approximately 40.7% of the outstanding Shares.  None of the Reporting Persons have acquired or disposed of any additional Shares since June 24, 2019.

Item 4.  Purpose of Transaction
 
This Statement relates to the acquisition of Shares by the Reporting Persons. The Shares acquired by the Reporting Persons were acquired for the purpose of making an investment in the Issuer and not with the intention of acquiring control of the Issuer’s business on behalf of the Reporting Persons’ respective advisory clients.
 
The Reporting Persons from time to time intend to review their investment in the Issuer on the basis of various factors, including the Issuer’s business, financial condition, results of operations and prospects, general economic and industry conditions, the securities markets in general and those for the Issuer’s Shares in particular, as well as other developments and other investment opportunities.  Based upon such review, the Reporting Persons will take such actions in the future as the Reporting Persons may deem appropriate in light of the circumstances existing from time to time.  If the Reporting Persons believe that further investment in the Issuer is attractive, whether because of the market price of Shares or otherwise, they may acquire Shares or other securities of the Issuer either in the open market or in privately negotiated transactions.  Similarly, depending on market and other factors, the Reporting Persons may determine to dispose of some or all of the Shares currently owned by the Reporting Persons or otherwise acquired by the Reporting Persons either in the open market or in privately negotiated transactions.
 
Except as set forth in this Statement, 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 of Directors 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) The following disclosure is based upon 33,997,131 outstanding Shares, as set forth in the Issuer’s Rule 424(b)(4) Prospectus filed with the Securities and Exchange Commission on June 20, 2019.

As of the date of this filing, OPI VI, a limited partnership organized under the laws of Delaware, holds 13,822,463 Shares constituting approximately 40.7% of the issued and outstanding Shares.  OrbiMed GP 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 GP, pursuant to the terms of the limited liability company agreement of OrbiMed GP.  As a result, OrbiMed Advisors and OrbiMed GP 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.  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.

In addition, Orbimed Advisors and Orbimed GP, pursuant to their authority under the limited partnership agreements of OPI VI, caused OPI VI to enter into the agreements referred to in Item 6 below.
 
(c) Except as disclosed in Item 3, the Reporting Persons have not effected any transactions during the past sixty (60) days in any Shares.
 
(d) Not applicable.
 
(e) Not applicable.
 
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 GP 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 GP 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 13,822,463. OrbiMed GP, pursuant to its authority under the limited partnership agreement of OPI VI, may be considered to hold indirectly 13,822,463 Shares.
 
OrbiMed Advisors is the sole managing member of OrbiMed GP, pursuant to the terms of the limited liability company agreement of OrbiMed GP. Pursuant to these agreements and relationships, OrbiMed Advisors and OrbiMed GP have discretionary investment management authority with respect to the assets of OPI VI.  Such authority includes the power of OrbiMed GP to vote and otherwise dispose of securities held by OPI VI.  The number of outstanding Shares attributable to OPI VI is 13,822,463 Shares.  OrbiMed Advisors, pursuant to its authority under the terms of the limited liability company agreement of OrbiMed GP, may also be considered to hold indirectly 13,822,463 Shares.
 
Carl L. Gordon (“Gordon”), a member of OrbiMed Advisors, and Peter Thompson (“Thompson”), an employee member of OrbiMed Advisors, are members of the Board of Directors of the Issuer and, accordingly, the Reporting Persons may have the ability to affect and influence control of the Issuer.  From time to time, Gordon and Thompson may receive stock options or other awards of equity-based compensation pursuant to the Issuer’s compensation arrangements for non-employee directors. Pursuant to an agreement with the Reporting Persons, Gordon and Thompson are obligated to transfer any securities issued under any such stock options or other awards, or the economic benefit thereof, to the Reporting Persons, which will in turn ensure that such securities or economic benefits are provided to OPI VI.

Investor Rights Agreement

In addition, OPI VI and certain other stockholders of the Issuer entered into an amended and restated investor rights with the Issuer (the “Investor Rights Agreement”), dated as of March 19, 2019.  Pursuant to the Investors Rights Agreement and subject to the terms and conditions therein, the parties agreed that:




Registration Rights

Following the closing of the IPO, the holders of a certain number of Shares, or their transferees, will be entitled to the registration rights set forth below with respect to registration of the resale of such shares under the Securities Act of 1933, as amended (the “Securities Act”) pursuant to the Investors Rights Agreement. 

Demand Registration Rights

At any time beginning six months following the date of the closing of the IPO, the holders of certain registrable securities then outstanding of the Issuer may make a written request that the Issuer register some or all of their registrable securities, subject to certain specified conditions and exceptions.   Such requirements for registration must cover shares with an anticipated aggregate offering price of at least $15 million.  The Issuer is not obligated to effect more than two of these registrations.

Piggyback Registration Rights

Subject to certain exceptions, whenever the Issuer proposes to file a registration statement under the Securities Act, OPI VI will be entitled to notice of the registration and will have the right to include its shares in the registration.

Form S-3 Registration Rights

At any time after the Issuer is qualified to file a registration statement on Form S-3 under the Securities Act, and subject to limitations and conditions specified in the Investors Rights Agreement, a holder may make a written request that the Issuer prepare and file a registration statement on Form S-3 covering their shares, so long as the aggregate price to the public equal or exceeds $2,500,000. The Issuer is not obligated to effect more than two of these Form S-3 registrations in any 12-month period.

Market-Standoff Agreement

Pursuant to market-standoff agreement in the Investor Rights Agreement, OPI VI agreed that it will not, during the period ending 180 days after the date of the IPO (the “Lock-Up Period”), directly or indirectly (1) sell, assign, transfer, pledge, contract to sell, or otherwise dispose of, any Shares or securities convertible into or exercisable or exchangeable for Shares with respect to which OPI VI has or acquires the power of disposition (other than Shares acquired in the IPO) or (2) enter into any swap or other agreement that transfers, in whole or in part, the economic risk of ownership of any such Shares.

After the Lock-Up Period expires, the Reporting Persons’ Shares will be eligible for sale in the public market, subject to any applicable limitations under Rule 144 under the Securities Act, and other applicable U.S. securities laws.
     
The foregoing description of the Investor Rights Agreement and the Lock-Up Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Investor Rights Agreement, which is filed as Exhibit 2 and incorporated herein by reference.




Item 7.  Material to Be Filed as Exhibits
 
 
Exhibit
Description
1.
Joint Filing Agreement among OrbiMed Advisors LLC, OrbiMed Capital LLC and OrbiMed Capital GP VI LLC.
2.
Investor Rights Agreement by and among the Issuer and each of the persons listed on Schedule A thereto, dated as of March 19, 2019 (incorporated by reference to Exhibit 4.2 to the Issuer’s Registration Statement on Form S-1 (SEC 333-231754).















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: June 27, 2019
ORBIMED ADVISORS LLC
 
 
 
 
 
 
 
 
 
 
By:
/s/ Carl L. Gordon
 
 
 
Name: Carl L. Gordon
 
 
 
Title: Member of OrbiMed Advisors LLC
 
 
 
 
 
 
ORBIMED CAPITAL GP VI LLC
 
 
 
 
 
 
By:
ORBIMED ADVISORS LLC, its managing member
 
 
 
 
 
 
Member of OrbiMed Advisors LLC
 
 
 
 
 
By:
/s/ Carl L. Gordon
 
 
 
Carl L. Gordon
 
 
 
Title: 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
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
C. Scotland Stevens
  Member
 
Member
OrbiMed Advisors LLC
         
Trey Block
  Chief Financial Officer  
Chief Financial Officer
OrbiMed Advisors LLC
 
 



 
 
SCHEDULE II

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 Capital LLC and OrbiMed Capital GP VI LLC.
2.
Investor Rights Agreement by and among the Issuer and each of the persons listed on Schedule A thereto, dated as of March 19, 2019 (incorporated by reference to Exhibit 4.2 to the Issuer’s Registration Statement on Form S-1 (SEC 333-231754).
 



Exhibit 1
JOINT FILING AGREEMENT
                 
 The undersigned hereby agree that the Statement on Schedule 13D, dated June 27, 2019, with respect to the ordinary shares of Prevail Therapeutics Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934, as amended. Each of the undersigned agrees to be responsible for the timely filing of this Statement, and for the completeness and accuracy of the information concerning itself contained therein. This Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument.
    
IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the 27th day of June 2019.
 
 
ORBIMED ADVISORS LLC
 
 
 
 
 
 
 
 
 
 
By:
/s/ Carl L. Gordon
 
 
 
Name: Carl L. Gordon
 
 
 
Title: Member of OrbiMed Advisors LLC
 
 
 
 
 
 
ORBIMED CAPITAL GP VI LLC
 
 
 
 
 
 
By:
ORBIMED ADVISORS LLC, its managing member
 
 
 
 
 
 
Member of OrbiMed Advisors LLC
 
 
 
 
 
By:
/s/ Carl L. Gordon
 
 
 
Carl L. Gordon
 
 
 
Title: Member of OrbiMed Advisors LLC