| Item 1.01 | Entry into a Material Definitive Agreement |
On June 19, 2023, Catalyst Pharmaceuticals, Inc. (the “Company”) entered into a License and Collaboration Agreement (the “License Agreement”) and an Investment Agreement (the “Investment Agreement”, and together with the License Agreement, the “Agreements”)) with Santhera Pharmaceuticals Holding AG (“Santhera”), under which the Company will enter into an exclusive North America license, manufacturing and supply agreement for Santhera’s investigational product candidate, vamorolone, a dissociative steroid currently under FDA review for the treatment of Duchenne Muscular Dystrophy (“DMD”).
Under the terms of the License Agreement, the Company will make a $75 million upfront payment for the license for vamorolone. Additionally, pursuant to the terms of the Investment Agreement, the Company will make a $15 million investment into Santhera at a price of CHF 0.9477 ($1.08 USD) per share, a mutually agreed upon volume-weighted average price prior to signing, with the investment proceeds to be used by Santhera for Phase IV studies in DMD and further development of additional indications. Additionally, Santhera may receive future regulatory and commercial milestone payments tied to FDA approval and calendar year sales of vamorolone, as well as commercial royalties. Further, Catalyst and Santhera will enter into a Joint Steering Committee to oversee the development of vamorolone for indications beyond DMD.
The Agreements are structured as all-cash transactions with no financing contingencies. The transaction is expected to be completed in the third quarter of 2023, subject to customary closing conditions and regulatory clearances in the United States.
The foregoing descriptions of the License Agreement and the Investment Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements, copies of which are attached as Exhibit 10.1, and Exhibit 10.2, respectively, to this Form 8-K and are incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the timing and ability of the parties to consummate the transaction contemplated by the Agreements satisfaction of conditions in connection with the Transaction, the parties’ ability to meet expectations regarding the timing and completion of the transaction and any other statements containing the words “believes,” expects,” “anticipates,” “plans,” “estimates,” and similar expressions, are forward-looking statements. These forward-looking statements are based on the Company’s current intentions, beliefs and expectations regarding future events. The Company cannot guarantee that any forward-looking statement will be accurate. The reader should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from expectations. The reader is, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this Form 8-K, and, except as required by law, the Company does not undertake to update any forward-looking statement to reflect new information, events or circumstances.
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