- Transaction provides company with an estimated approximately $128 million in cost savings, including approximately $67 million in clinical development and CMC costs over the next three years and an additional approximately $61 million in forecasted obligations through the patent life of rezafungin
- Cidara to further focus on advancing Cloudbreak development programs, including a planned IND filing for its lead oncology candidate, CBO421, as well as advancing other pipeline assets
Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that it has entered into an asset purchase agreement with its current partner, Mundipharma*, for the divestiture of rezafungin. Mundipharma currently has commercial rights to rezafungin outside the U.S. and Japan. Mundipharma purchased the assets in consideration of its assumption of the ongoing obligation to conduct and fund the ReSPECT Phase 3 clinical trial, the costs of the rezafungin patent portfolio and CMC and regulatory obligations. Cidara estimates that it will achieve approximately $128 million in cost savings over the patent life of rezafungin comprised of approximately $67 million in clinical development expense, including the cost of the potential upsizing of the ReSPECT trial and CMC costs over the next three years, and an additional approximately $61 million in forecasted obligations through the expected patent life of rezafungin.
“We are proud to have advanced rezafungin from preclinical development to approval in the US, EU, and UK for the treatment of patients suffering from life-threatening fungal infections.” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With that accomplished, we believe the substantial cost savings enabled by this transaction will enable us to deploy our capabilities to progress our promising Cloudbreak pipeline and create opportunities to advance potentially transformational new therapies in oncology and other disease areas.”
Under the terms of the asset purchase agreement, all future royalties and milestones from Mundipharma and Melinta Therapeutics that were previously payable to Cidara, will transfer to Mundipharma. The purchased assets also include all rezafungin intellectual property rights, product data, regulatory approvals, rezafungin product and comparator inventory, specified prepaid assets and specified contracts. Prior to the sale, Mundipharma paid Cidara the $2.786 million milestone that became payable for the approval of rezafungin acetate for the treatment of invasive candidiasis in adults by the United Kingdom Medicines and Healthcare products Regulatory Agency. Mundipharma also agreed to waive Cidara’s obligation to reimburse Mundipharma for a $11.145 million milestone advance if Cidara completes transition services and the transfer of assets in accordance with the definitive agreements.
*Assets and rights acquired by Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies.
About Cidara Therapeutics
Cidara is developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases. The Company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including DFCs from its proprietary Cloudbreak® platform targeting oncologic, viral and autoimmune diseases. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Investor Contact
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
Media Contact
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to estimated cost savings in connection with the transaction; our ability to continue to advance our Cloudbreak programs and pipeline assets; and the capabilities of our therapies in oncology and other disease areas. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s pre-clinical or clinical trials, and delays in action by regulatory authorities. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Annual Report on Form 10-K and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
