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

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 21, 2025

 

 

Organovo Holdings, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-35996

27-1488943

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

11555 Sorrento Valley Rd

Suite 100

 

San Diego, California

 

92121

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (858) 224-1000

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.001 par value

 

ONVO

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 


Item 2.01 Completion of Acquisition or Disposition of Assets.

As previously disclosed in the Current Report on Form 8-K filed by Organovo Holdings, Inc., a Delaware corporation (the “Company”), with the Securities and Exchange Commission (the “SEC”) on February 25, 2025, the Company entered into an asset purchase agreement dated February 23, 2025 (the “Purchase Agreement”) with Eli Lilly and Company, an Indiana corporation (“Lilly”), for the sale to and purchase by Lilly of the Company’s FXR program and related assets (the “Asset Sale”).

On March 25, 2025, the Company and Lilly completed the Asset Sale. The consideration for the Asset Sale consists of (i) an upfront cash payment by Lilly to the Company equal to $10.0 million, of which $9.0 million was paid at closing and the remaining $1.0 million was deposited into escrow for 15 months to satisfy any claims for indemnification during such period under the Purchase Agreement, (ii) the assumption by Lilly of certain liabilities related to the FXR program, and (iii) potential milestone payments by Lilly of up to $50.0 million in the aggregate, which are contingent upon the achievement of certain development, regulatory and commercial milestones. In connection with the completion of the Asset Sale, the parties entered into a transition services agreement and certain other ancillary agreements.

The foregoing description of the terms of the Purchase Agreement does not purport to be complete and is subject to, and qualified in its entirety by reference to, the complete text of the Purchase Agreement, which was previously filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 25, 2025, and is incorporated herein by reference.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 21, 2025, Vaidehi Joshi notified the Board of Directors (the “Board”) of the Company that she resigned from the Board and all committees of the Board, effective as of March 21, 2025. Ms. Joshi’s decision to resign was not due to any disagreements with the Company on any matter relating to the Company’s operations, policies or practices.

Item 8.01 Other Events.

On March 25, 2025, the Company issued a press release announcing the closing of the Asset Sale. The press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

 

 

 

Exhibit

No.

Description

2.1* Asset Purchase Agreement, dated February 23, 2025, by and between the Company, Eli Lilly and for certain sections therein, Organovo, Inc. (incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K filed by the Company with the SEC on February 25, 2025).

99.1 Press Release, dated March 25, 2025.

104 Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

* Portions of this exhibit (indicated by [… * * *…]) have been omitted because the Company has determined that the information is both (i) not material and (ii) of the type that the Company treats as private and confidential. In addition, schedules have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule to the SEC upon its request; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934 for any schedule so furnished.

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

ORGANOVO HOLDINGS, INC.

 

 

 

 

Date:

March 26, 2025

By:

 /s/ Keith Murphy

 

 

 

Name: Keith Murphy
Title: Executive Chairman

 


EX-99.1 2 onvo-ex99_1.htm EX-99.1 EX-99.1

 

Exhibit 99.1

 

Organovo Announces Close of the Sale of FXR Program to Eli Lilly and Company

 

San Diego, CA – March 25, 2025 – Organovo Holdings, Inc. (Nasdaq:ONVO) (“Organovo” or the “Company”), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD), today announced the successful close of the sale of its FXR program, including lead asset FXR314, to Eli Lilly and Company (NYSE:LLY) (“Lilly”). The transaction was completed on March 25, 2025.

 

With the closing, Organovo receives an upfront payment, with future milestones to be paid as FXR314 hits key regulatory and commercial milestones. Lilly is acquiring all commercial and intellectual property rights to Organovo’s FXR program for worldwide development and will be responsible for all future clinical development.

 

About Organovo

Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. For more information visit Organovo's website at www.organovo.com.

 

Forward Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 2025 and the Registration Statement on Form S-1 (File No. 333-282841). You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events.

 

Contact

 

Investor Relations

info@organovo.com

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Source: Organovo, Inc.