On April 22, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, and BioLexis Pte Ltd. ("BioLexis"), a strategic shareholder in Outlook Therapeutics, reported that BioLexis is being reorganized (Press release, Outlook Therapeutics, APR 22, 2022, View Source [SID1234616058]). The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder.
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Pursuant to an agreement among BioLexis, GMS Ventures & Investments ("GMS V&I"), and certain of GMS V&I’s affiliates (GMS V&I and its affiliates, "GMS Holdings"), on April 21, 2022, GMS V&I has taken direct ownership of all of the shares of Outlook Therapeutics that were indirectly owned by GMS Holdings through BioLexis.
As the next step in the reorganization, GMS Holdings will cease to be a shareholder in BioLexis and BioLexis will be renamed "Tenshi Healthcare Pte Limited" (or such other name as may be approved by the regulatory authorities in Singapore). GMS Holdings does not have an economic interest in, or voting rights with respect to, the shares of Outlook Therapeutics that are held by BioLexis. BioLexis directly holds the shares beneficially owned by the minority shareholder in BioLexis, Tenshi Life Sciences Private Limited and Tenshi Life Sciences Pte Limited.
Since the initial investment by BioLexis in 2017, Outlook Therapeutics has undergone a significant transformation and has successfully completed three clinical trials which recently culminated in a BLA submission to the U.S. FDA on March 30, 2022. As the largest investor, GMS Holdings actively supported Outlook Therapeutics by leading and participating in multiple capital raises to support the Outlook Therapeutics growth strategy.
"The submission of a Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg) with FDA is a significant milestone to achieve and places Outlook Therapeutics on a path to potential marketing approval for a very promising therapy," said Faisal Sukhtian, Executive Director of GMS Holdings and a member of the Board of Directors of BioLexis. "With this milestone accomplished, the shareholders of BioLexis have fully realized their intended objectives for the joint venture. This reorganization will see the existing partners translate their joint ownership positions in Outlook Therapeutics into direct stakes."
"We appreciate the longstanding support we have received from BioLexis and look forward to executing on our priorities to create value for all shareholders," added Russell Trenary, President and CEO of Outlook Therapeutics.
In connection with the reorganization, Outlook Therapeutics and GMS Holdings entered into an Amended and Restated Investor Rights Agreement, which replaces the previous Investor Rights Agreement among Outlook Therapeutics, BioLexis and GMS V&I. BioLexis no longer has any rights under the Amended and Restated Investor Rights Agreement.