Cidara Therapeutics, Inc. (NASDAQ:CDTX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.
On September 3, 2019, Cidara Therapeutics, Inc. (the “Company”) entered into a Collaboration and License Agreement (the “Collaboration Agreement”) with Mundipharma Medical Company (“Mundipharma”) for a strategic collaboration to develop and commercialize rezafungin in an intravenous formulation (the “Licensed Product”) for the treatment and prevention of invasive fungal infections.
Collaboration.>>Under the Collaboration Agreement, the Company will be responsible for leading the conduct of an agreed global development plan (the “Global Development Plan”) that includes the Company’s ongoing Phase 3 pivotal clinical trial of the Licensed Product for the treatment of candidemia and/or invasive candidiasis (the “ReSTORE Trial”) and the Company’s planned Phase 3 pivotal clinical trial of the Licensed Product for the prophylaxis of invasive fungal infections in adult allogeneic blood and marrow transplant recipients (the “ReSPECT Trial”), as well as specified GLP-compliant non‑clinical studies and chemistry, manufacturing and controls (“CMC”) development activities for the Licensed Product. Mundipharma will be responsible for performing all development activities, other than Global Development Plan activities, that may be necessary to obtain and maintain regulatory approvals for the Licensed Product in the Mundipharma Territory, at Mundipharma’s sole cost.
Licenses.>> to the Collaboration Agreement, the Company granted Mundipharma an exclusive, royalty‑bearing license to develop, register and commercialize the Licensed Product outside of the United States and Japan (the “Mundipharma Territory”), subject to the Company’s retained right to lead a global development program for the Licensed Product in both the Mundipharma Territory and in the United States and Japan (the “Company Territory”) as described below.
The Company also granted Mundipharma an option to obtain exclusive licenses to develop, register and commercialize rezafungin in a formulation for subcutaneous administration (“Subcutaneous Product”) and in formulations for other modes of administration (“Other Products”) in the Mundipharma Territory, subject to similar retained rights of the Company to conduct mutually agreed global development activities for such products. In addition, the Company granted Mundipharma a co‑exclusive, worldwide license to manufacture the Licensed Product and rezafungin.
Until the seventh anniversary of the first commercial sale of the Licensed Product in the Mundipharma Territory, each party has granted the other party an exclusive, time-limited right of first negotiation to obtain a license to any anti-fungal product (other than Licensed Product, Subcutaneous Product and Other Products) that such party proposes to out-license in the other party’s territory. However, in the event of the acquisition of a party by a third party, this right of first negotiation will not apply to any such anti‑fungal product of the acquiring third party prior to consummation of the acquisition of such party, acquired by such acquiring third party from another third party after consummation of the acquisition of such party, or developed internally by the acquiring third party, either before or after consummation of the acquisition of such party, without the use of, reliance upon or reference to any technology of the acquired party that is licensed to the other party under the Collaboration Agreement, any technology of the other party that is licensed to the acquired party under the Collaboration Agreement, or any technology jointly developed by the parties to the Collaboration Agreement.
The Company’s Retained Rights.>>The Company retains the exclusive right to develop, register and commercialize the Licensed Product, Subcutaneous Product and Other Products in the Company Territory, and Mundipharma has granted the Company certain licenses under Mundipharma-controlled technology and jointly-developed technology to develop, register and commercialize Licensed Product, Subcutaneous Product and Other Products in the Company Territory and to manufacture such products and rezafungin worldwide.
Financial Terms.>>The parties have agreed to share equally (50/50) the costs of Global Development Plan activities (“Global Development Costs”), subject to a cap on Mundipharma’s Global Development Cost share of $31.207 million. Cidara would receive additional financial support for Global Development Plan activities through a near-term milestone payment by Mundipharma of $11.145 million. Mundipharma is entitled to credit the full amount of this milestone payment toward future royalties payable to the Company, subject to a limit on the amount by which royalty payments to the Company may be reduced in any quarter. If Mundipharma has not fully credited the amount of such milestone payment toward royalties payable to the Company before the earlier of (i) December 31, 2024 and (ii) termination of the Collaboration Agreement by Mundipharma, the Company will be obligated to refund the uncredited portion of such milestone payment to Mundipharma on the earlier of such dates.
In addition to the cost-sharing and the $11.145 million milestone payment described above, the Company will receive under the Collaboration Agreement a $30 million upfront payment, up to $534.412 million in development, regulatory and commercial milestone payments on the Licensed Product, and double-digit royalties on tiers of annual net sales of the Licensed Product in the Mundipharma Territory in the teens.
Termination.>>Either party may terminate the Collaboration Agreement for uncured material breach by the other party. After September 3, 2020, Mundipharma may terminate the Collaboration Agreement at will, provided that if Mundipharma terminates the Collaboration Agreement in its entirety prior to the last visit of the last patient in both the ReSPECT Trial and the ReSTORE Trial, Mundipharma will continue to be liable for its share of Global Development Costs as described above. The Company may terminate the Agreement if Mundipharma or any of its affiliates or sublicensees, directly or indirectly through any Third Party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any of the Cidara patent rights licensed to Mundipharma, or upon an insolvency event of Mundipharma.
Stock Purchase Agreement
Concurrently with the execution of the Collaboration Agreement, the Company entered into a Stock Purchase Agreement (the “Purchase Agreement”) with Mundipharma AG (the “Purchaser”), to which the Company issued to the Purchaser 4,781,408 shares of its common stock (the “Shares”) in a private placement at a price per share of $1.884 (a 20% premium to the volume weighted average price of the Company’s common stock for the 10 trading days prior to September 3, 2019) for an aggregate purchase price of approximately $9.0 million.
Under the Purchase Agreement, until September 3, 2020 (the “Lock-Up Period”), the Purchaser may not transfer or sell the Shares without the prior written consent of the Company. In addition, the Company agreed to (i) no later than 90 days prior to the expiration of the Lock-Up Period, file a registration statement with the U.S. Securities and Exchange Commission covering the resale by the Purchaser of the Shares, (ii) cause such registration statement to become effective as soon as practicable following the filing thereof and (iii) take all other actions as may be necessary to keep such registration statement continuously effective during the timeframes set forth in the Purchase Agreement. If the Company fails to comply with certain obligations with respect to filing and securing effectiveness of such registration statement, the Company would be obligated to pay liquidated damages to the Purchaser in the amount of 1% of the total purchase price of the Shares for each applicable 30-day period, up to an aggregate maximum of 6% of the purchaser price, so long as the event giving rise to the damages remains uncured.
The foregoing descriptions of the Collaboration Agreement and the Purchase 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 will be attached to the Company’s quarterly report on Form 10-Q for the period ended September 30, 2019.
Item 3.02 Unregistered Sales of Equity Securities.
The description of the sale and issuance of the Company\’s common stock to the Purchase Agreement set forth under Item 1.01 above is incorporated by reference into this Item 3.02. The issuance and sale of the Shares has not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws. The Company has relied on the exemption from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder. In connection with the Purchaser’s execution of the Purchase Agreement, the Purchaser represented to the Company that it is an “accredited investor” as defined in Regulation D of the Securities Act and that the Shares were acquired by the Purchaser solely for its own account and for investment purposes and not with a view to the future sale or distribution. This Current Report on Form 8-K is not an offer to sell or the solicitation of an offer to buy any such Securities.
Item 7.01 Regulation FD Disclosure.
On September 3, 2019, the Company issued a press release regarding the transactions with Mundipharma. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Cidara Therapeutics, Inc. Exhibit
EX-99.1 2 ex991-pressrelease2019x09x.htm PRESS RELEASE Exhibit Exhibit 99.1 Cidara Therapeutics and Mundipharma Form Strategic Partnership to Develop and Commercialize Rezafungin Collaboration combines strengths to develop and commercialize life-saving antifungal treatment and prophylaxis,…
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About Cidara Therapeutics, Inc. (NASDAQ:CDTX)
Cidara Therapeutics, Inc., formerly K2 Therapeutics, Inc., is a clinical-stage biotechnology company. The Company is engaged in the discovery, development and commercialization of anti-infectives. It is developing a pipeline of product and development candidates with a focus on serious fungal infections. Its product portfolio consists of over two formulations of its echinocandin, CD101. CD101 IV is a long-acting therapy for the treatment and prevention of serious, invasive fungal infections. CD101 topical, its second product candidate, is being developed for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. Its immunotherapy technology platform, Cloudbreak, is used to create compounds designed to direct a patient’s immune cells to attack and eliminate pathogens that cause infectious disease.
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