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Cidara Therapeutics Announces Divestiture of Rezafungin to Mundipharma* to Focus on Advancing the Clinical Development of Cloudbreak DFC Pipeline

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Cidara Therapeutics announced the divestiture of rezafungin to Mundipharma to focus on advancing the Cloudbreak DFC pipeline. The transaction will provide an estimated $128 million in cost savings over the patent life of rezafungin, enabling Cidara to focus on advancing its Cloudbreak development programs, including an IND filing for its lead oncology candidate, CBO421. Mundipharma will now hold commercial rights to rezafungin outside the U.S. and Japan, with ongoing obligations related to the ReSPECT Phase 3 clinical trial and regulatory requirements.
Cidara Therapeutics ha annunciato la cessione di rezafungin a Mundipharma per concentrarsi sullo sviluppo della pipeline Cloudbreak DFC. La transazione porterà a un risparmio stimato di 128 milioni di dollari sui costi, per tutta la durata del brevetto di rezafungin, permettendo a Cidara di dedicarsi allo sviluppo dei suoi programmi Cloudbreak, inclusa la presentazione di una IND per il suo principale candidato in oncologia, CBO421. Mundipharma ora deterrà i diritti commerciali di rezafungin al di fuori degli Stati Uniti e del Giappone, mantenendo impegni in corso relativi alla sperimentazione clinica di fase 3 ReSPECT e agli obblighi regolatori.
Cidara Therapeutics anunció la desinversión de rezafungin a Mundipharma para enfocarse en el avance de la línea de productos Cloudbreak DFC. La transacción proporcionará un ahorro estimado de 128 millones de dólares en costos durante la vida de la patente de rezafungin, permitiendo a Cidara concentrarse en avanzar sus programas de desarrollo Cloudbreak, incluyendo el archivo IND de su principal candidato oncológico, CBO421. Mundipharma ahora poseerá los derechos comerciales de rezafungin fuera de los EE.UU. y Japón, con obligaciones continuas relacionadas con el ensayo clínico de fase 3 ReSPECT y requisitos regulatorios.
Cidara Therapeutics가 Cloudbreak DFC 파이프라인의 발전에 집중하기 위해 Mundipharma에게 레자펀진을 매각하였다고 발표했습니다. 이 거래는 레자펀진의 특허 수명 동안 약 1억 2천8백만 달러의 비용 절감을 제공할 것으로 예상되며, Cidara가 Cloudbreak 개발 프로그램을 진행하는 데 집중할 수 있게 해줄 것입니다. 이에는 주요 종양 후보 CBO421에 대한 IND 제출도 포함됩니다. 이제 Mundipharma는 미국과 일본을 제외한 지역에서 레자펀진의 상업적 권리를 보유하게 되며, ReSPECT 3상 임상 시험 및 규제 요구 사항과 관련된 지속적인 의무를 이행해야 합니다.
Cidara Therapeutics a annoncé la cession de rezafungin à Mundipharma afin de se concentrer sur l'avancement du pipeline Cloudbreak DFC. La transaction devrait permettre une économie de coûts estimée à 128 millions de dollars sur la durée du brevet de rezafungin, permettant à Cidara de concentrer ses efforts sur l'avancement de ses programmes de développement Cloudbreak, y compris le dépôt d'un dossier IND pour son principal candidat en oncologie, CBO421. Mundipharma détiendra désormais les droits commerciaux sur le rezafungin en dehors des États-Unis et du Japon, avec des obligations en cours liées à l'essai clinique de phase 3 ReSPECT et aux exigences réglementaires.
Cidara Therapeutics gab die Veräußerung von Rezafungin an Mundipharma bekannt, um sich auf die Weiterentwicklung der Cloudbreak DFC Pipeline zu konzentrieren. Die Transaktion wird voraussichtlich Einsparungen von 128 Millionen Dollar über die Patentlaufzeit von Rezafungin bringen, wodurch sich Cidara auf die Weiterentwicklung seiner Cloudbreak-Entwicklungsprogramme konzentrieren kann, einschließlich der Einreichung einer IND für seinen führenden Onkologie-Kandidaten, CBO421. Mundipharma wird nun die kommerziellen Rechte an Rezafungin außerhalb der USA und Japans innehaben, mit fortlaufenden Verpflichtungen im Zusammenhang mit der ReSPECT Phase-3-Klinischen Studie und regulatorischen Anforderungen.
Positive
  • Cidara Therapeutics will achieve approximately $128 million in cost savings over the patent life of rezafungin, including $67 million in clinical development expenses and an additional $61 million in forecasted obligations.
  • The divestiture of rezafungin to Mundipharma will allow Cidara to focus on advancing its Cloudbreak development programs, such as advancing its lead oncology candidate, CBO421.
  • Mundipharma will assume commercial rights to rezafungin outside the U.S. and Japan, along with ongoing obligations related to the ReSPECT Phase 3 clinical trial and regulatory responsibilities.
  • Cidara has successfully transitioned rezafungin from preclinical development to approval in the US, EU, and UK for the treatment of life-threatening fungal infections.
  • The asset purchase agreement with Mundipharma includes the transfer of all future royalties and milestones, rezafungin intellectual property rights, product data, regulatory approvals, and specified assets and contracts.
Negative
  • None.

The divestiture of rezafungin by Cidara Therapeutics to Mundipharma signifies a strategic shift for the company, pivoting from antifungal treatments towards the development of its Cloudbreak DFC immunotherapies. The financial implications of this transaction are noteworthy. With an estimated $128 million in cost savings, including $67 million in clinical development and CMC costs over three years, plus an additional $61 million in forecasted obligations, the deal markedly reduces Cidara's expenditure. The cash preservation aspect could enhance their financial position, potentially extending their runway and focusing resources on advancing their lead oncology candidate, CBO421. This shift seems to reflect a strategic decision to prioritize areas with potentially higher margins and market demand. From an investor's viewpoint, the cost savings and the focus on a possibly more lucrative segment could signal a positive outlook, provided the new pipeline demonstrates significant clinical benefits and commercial viability.

Shifting gears from antifungal agent rezafungin to advancing the proprietary Cloudbreak platform, Cidara is playing into the industry's current focus on innovative and targeted therapies. Cloudbreak's drug-Fc conjugate immunotherapies represent an emerging class of treatments that combine the power of biologics with small molecule drugs, aiming to improve patient outcomes in serious diseases. The therapeutic landscape for oncology is especially competitive and rapidly evolving, but the potential for a new and effective therapy can be a game-changer. If the Cloudbreak platform and their lead oncology candidate, CBO421, live up to expectations, Cidara may capture significant market share. However, as with all biotech investments, there is substantial risk as success hinges on clinical trial outcomes and regulatory approvals. Investors should keep an eye on the progress of Cidara's pipeline and be aware of the inherent volatility in the biotech sector.
  • 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

SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- 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.

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.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com

 


FAQ

What is the significance of Cidara Therapeutics divesting rezafungin to Mundipharma?

The divestiture allows Cidara to focus on advancing the Cloudbreak DFC pipeline by achieving an estimated $128 million in cost savings.

Who will now hold commercial rights to rezafungin outside the U.S. and Japan?

Mundipharma will now hold commercial rights to rezafungin outside the U.S. and Japan.

What are the financial benefits Cidara Therapeutics expects from the divestiture?

Cidara expects approximately $128 million in cost savings over the patent life of rezafungin, including $67 million in clinical development expenses and an additional $61 million in forecasted obligations.

What programs will Cidara focus on after divesting rezafungin?

Cidara will focus on advancing its Cloudbreak development programs, including the planned IND filing for its lead oncology candidate, CBO421.

What intellectual property rights and assets were included in the asset purchase agreement with Mundipharma?

The agreement includes the transfer of all rezafungin intellectual property rights, product data, regulatory approvals, and specified assets and contracts.

Cidara Therapeutics, Inc.

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