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Cidara Therapeutics Reacquires Global Development and Commercial Rights to CD388 and Announces Private Placement Financing of $240 Million

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Cidara Therapeutics reacquires global development and commercial rights to CD388 and announces a private placement financing of $240 million. The financing, led by RA Capital Management, aims to fund the Phase 2b clinical trial of CD388, an antiviral drug for influenza A and B. The company plans to develop CD388 as a universal preventative against seasonal and pandemic influenza. Johnson & Johnson has transferred exclusive rights to CD388 back to Cidara in exchange for an $85 million upfront payment and potential milestone payments. The private placement will support the development of CD388 through Phase 2b and beyond, with a focus on providing long-acting, universal protection against all forms of influenza. The company is set to host a business strategy update conference call and webcast to discuss the recent developments.
Cidara Therapeutics riacquista i diritti globali di sviluppo e commercializzazione di CD388 e annuncia un finanziamento tramite placement privato di 240 milioni di dollari. Il finanziamento, guidato da RA Capital Management, è destinato a sostenere la sperimentazione clinica di fase 2b di CD388, un farmaco antivirale per l'influenza di tipo A e B. L'azienda prevede di sviluppare CD388 come un preventivo universale contro l'influenza stagionale e pandemica. Johnson & Johnson ha trasferito i diritti esclusivi a CD388 a Cidara in cambio di un pagamento anticipato di 85 milioni di dollari e potenziali pagamenti per obiettivi raggiunti. Il placement privato supporterà lo sviluppo di CD388 oltre la fase 2b, con l'obiettivo di fornire una protezione universale e di lunga durata contro tutte le forme di influenza. L'azienda organizzerà una conferenza telefonica e un webcast per aggiornare sulla strategia aziendale e discutere gli sviluppi recenti.
Cidara Therapeutics recupera los derechos globales de desarrollo y comercialización de CD388 y anuncia una financiación privada de 240 millones de dólares. La financiación, liderada por RA Capital Management, tiene como objetivo financiar el ensayo clínico de fase 2b de CD388, un medicamento antiviral para la influenza A y B. La empresa planea desarrollar CD388 como un preventivo universal contra la influenza estacional y pandémica. Johnson & Johnson ha transferido los derechos exclusivos de CD388 a Cidara a cambio de un pago inicial de 85 millones de dólares y posibles pagos por hitos alcanzados. La colocación privada respaldará el desarrollo de CD388 a través de la fase 2b y más allá, con un enfoque en brindar protección universal y de larga duración contra todas las formas de influenza. La compañía va a organizar una llamada de conferencia y webcast para actualizar la estrategia empresarial y discutir los desarrollos recientes.
Cidara Therapeutics는 CD388의 글로벌 개발 및 상업화 권리를 재획득하고 2억 4천만 달러의 사적 배치 자금을 발표했습니다. RA Capital Management이 주도하는 이 자금 조달은 CD388의 2b 단계 임상 시험을 위한 것으로, 이는 인플루엔자 A와 B를 대상으로 하는 항바이러스 약물입니다. 회사는 CD388을 계절별 및 전염병성 인플루엔자에 대한 보편적 예방책으로 개발할 계획입니다. Johnson & Johnson은 8500만 달러의 선급금과 잠재적 마일스톤 지급금을 대가로 CD388의 독점 권리를 Cidara에 다시 양도했습니다. 사적 배치는 2b 단계를 넘어 CD388의 개발을 지원할 것이며, 모든 형태의 인플루엔자에 대한 장기적이고 보편적 보호에 초점을 맞출 것입니다. 회사는 최근 발전에 대해 논의하고 비즈니스 전략을 업데이트하는 회의 전화 및 웹캐스트를 주최할 예정입니다.
Cidara Therapeutics récupère les droits mondiaux de développement et de commercialisation de CD388 et annonce un financement privé de 240 millions de dollars. Le financement, dirigé par RA Capital Management, vise à financer l'essai clinique de phase 2b de CD388, un médicament antiviral contre les virus de la grippe A et B. La société prévoit de développer CD388 comme un préventif universel contre la grippe saisonnière et pandémique. Johnson & Johnson a transféré les droits exclusifs sur CD388 à Cidara en échange d'un paiement initial de 85 millions de dollars et de paiements d'étapes potentiels. Le placement privé soutiendra le développement de CD388 au-delà de la phase 2b, avec un accent sur la protection universelle et de longue durée contre toutes les formes de grippe. La société prévoit de tenir une conférence téléphonique et un webcast pour une mise à jour sur la stratégie commerciale et pour discuter des développements récents.
Cidara Therapeutics erwirbt die globalen Entwicklungs- und Vermarktungsrechte für CD388 zurück und kündigt eine private Finanzierung in Höhe von 240 Millionen Dollar an. Die Finanzierung, angeführt von RA Capital Management, zielt darauf ab, die klinische Phase-2b-Studie von CD388 zu finanzieren, ein antivirales Medikament gegen Influenza A und B. Das Unternehmen plant, CD388 als universelle Prävention gegen saisonale und pandemische Grippe zu entwickeln. Johnson & Johnson hat die exklusiven Rechte an CD388 gegen eine Vorabzahlung von 85 Millionen Dollar und potenzielle Meilensteinzahlungen zurück an Cidara übertragen. Die Privatplatzierung wird die Entwicklung von CD388 über die Phase 2b hinaus unterstützen, mit einem Fokus auf langanhaltenden, universellen Schutz gegen alle Formen der Grippe. Das Unternehmen plant, ein Strategie-Update per Telefonkonferenz und Webcast zu geben, um die jüngsten Entwicklungen zu besprechen.
Positive
  • Cidara Therapeutics reacquires global development and commercial rights to CD388 from Johnson & Johnson.
  • Private placement financing of $240 million led by RA Capital Management to fund Phase 2b clinical trial of CD388 for influenza A and B.
  • CD388 is being developed as a universal preventative against seasonal and pandemic influenza under Cidara's Cloudbreak platform.
  • Johnson & Johnson receives $85 million upfront payment and potential milestone payments in exchange for transferring exclusive rights to CD388 back to Cidara.
  • New board appointments and resignations announced in connection with the private placement and reacquisition.
  • Cidara plans to evaluate the efficacy and safety of CD388 in providing season-long, universal protection against influenza in the upcoming Phase 2b study.
  • Business strategy update conference call and webcast scheduled for April 24, 2024, to discuss recent developments.
Negative
  • None.

The closure of a $240 million private placement financing for Cidara Therapeutics marks a strategic shift in the company's funding structure and business focus. The substantial capital influx from reputable investment entities underscores a strong investor confidence in the company's Cloudbreak® platform and its lead product candidate, CD388. Considering the earmarked funds for the advancement of CD388 through Phase 2b clinical trial, investors should monitor closely the deployment and management of these resources for efficient progression of the drug's development timeline.

The reacquisition of CD388's global development and commercial rights from Johnson & Johnson for an upfront payment of $85 million, which is part of the placement financing, indicates a significant commitment by Cidara to steer the project independently. The ability to meet potential future development, regulatory and commercial milestone payments to Johnson & Johnson will hinge on the successful evolution of CD388. Stakeholders should gauge this new liability structure's impact on Cidara's financial health, especially considering potential dilution effects of the preferred stock sale to new investors.

CD388 emerges as a potential game-changer in the influenza prophylactic space by targeting all strains of influenza A and B. Its long-acting, universal preventive properties hold promise, particularly for populations unable to elicit strong immune responses to traditional flu vaccines. As this therapeutic heads into a Phase 2b study for a seasonal and pandemic influenza preventive, the evidence of its efficacy and safety will be under scrutiny. Given that flu vaccines rely on strain prediction, which can lead to mismatches, CD388's strain-agnostic approach could, if successful, disrupt the current preventative model for influenza.

The investment in CD388's development bears substantial risks inherent to clinical trial progression, as history shows many candidates fail to live up to their early promise. Nevertheless, the move to reacquire and independently push for CD388's development suggests strong belief in its differentiation and potential market uptake. Retail investors should watch for trial results and FDA interactions for a clearer assessment of the asset's value proposition and regulatory trajectory.

Repositioning CD388 as the forefront of Cidara Therapeutics' pipeline aligns with a strategic focus on a high-need area in public health. Influenza remains a significant global health burden with an unmet need for broader, more effective prophylaxis, especially in the face of potential pandemics. The timing of these developments coincides with ongoing concerns about influenza preparedness, potentially placing Cidara in a favorable market position should CD388 meet its clinical endpoints.

Investor and analyst attention should now pivot to the company's revised business strategy and operational efficiency. The divestiture of other assets, such as rezafungin to Mundipharma, in conjunction with the reinforcement of the board with experts from RA Capital Management and others, could signal a pivot towards specialization and streamlining of operations. Cidara could be positioning itself either as a niche player with a strong value proposition or as an attractive target for strategic acquisitions, depending on its success with CD388's clinical and commercial milestones.

- $240 million private placement financing led by RA Capital Management with significant participation by Bain Capital Life Sciences as well as BVF Partners and Canaan Partners to fund Phase 2b clinical trial

- CD388, which is active against all strains of influenza A and B, is being developed for pre-exposure prophylactic treatment

- Company to host business strategy update conference call and webcast today at 4:30 PM ET

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 a definitive agreement with Johnson & Johnson1 to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B.

Concurrent with the acquisition, Cidara closed a definitive agreement for the sale of preferred stock in a private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. The private placement provides $240 million in gross proceeds that will be used by Cidara to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with a Phase 2b clinical trial in the upcoming Northern Hemisphere influenza season. The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial.

CD388 is a long-acting antiviral investigational drug invented and developed by Cidara that became the subject of an exclusive worldwide license and collaboration agreement established with Johnson & Johnson in April 2021. In September 2023, Johnson & Johnson delivered to Cidara an Election to Proceed Notice and associated milestone payment for CD388 before beginning a process to transfer its rights and obligations under the agreement to another entity.

In connection with the private placement, Laura Tadvalkar, Ph.D., Managing Director at RA Capital Management, Ryan Spencer, and James Merson, Ph.D. have been appointed to Cidara’s board of directors, while David Gollaher, Ph.D. and Timothy Franson, M.D. will be stepping down. “I thank David and Tim for their invaluable contributions, which have helped facilitate this opportunity for Cidara,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara.

Dr. Stein continued, “This reacquisition of CD388, along with the capital to advance it through Phase 2b development, is transformational for Cidara and especially for those who could benefit from a long-acting, universal preventative against all forms of influenza. In our Phase 2b study later this year, we will evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune response and without the requirement for seasonal influenza strain prediction.”

All responsibility for future development, manufacturing, and commercialization activities of CD388 will be assumed by Cidara. In exchange for reacquiring the exclusive global development and commercial rights to CD388, Johnson & Johnson has received from Cidara a one-time upfront payment of $85 million and is eligible to receive potential additional development, regulatory, and commercial milestone payments.

“We have followed the development of CD388 over time with great interest,” said Dr. Tadvalkar. “As stage-agnostic company builders, we were excited to catalyze this reacquisition and financing – and to leverage the company-building capabilities of our RAVen incubator to support Cidara.”

“The support from this top-tier syndicate of new and existing investors highlights our enthusiasm and potential for CD388, the most advanced member of our Cloudbreak DFC pipeline and the new focus of the company,” added Dr. Stein. “We expect that the capital infusion from this financing, together with existing cash and the expected near-term cost savings associated with our recently announced divestiture of rezafungin to Mundipharma, positions us well to execute on the CD388 development program and advance the key assets in our pipeline.”

Conference Call and Webcast Details
Cidara will host a business strategy update conference call and webcast today, Wednesday, April 24, 2024, at 4:30 PM ET. Details can be found below.

Date:Wednesday, April 24, 2024
  
Time:4:30 PM ET
  
Conference Call Details:
Toll-free: 1-877-407-4018
International: 1-201-689-8471
Conference ID: 13746332
  
Call me™ Feature (avoid waiting for operator):Click Here
  
Webcast:Webcast Link – Click Here
  

About CD388

CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.

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.

About RA Capital

RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital forms and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization. RA Capital's knowledge engine is guided by our TechAtlas internal research division, and our in-house RAVen incubator offers experienced entrepreneurs a collaborative and comprehensive company creation platform to explore both the novel and the re-imagined. For more information, please visit www.racap.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 the proceeds from the private placement being expected to provide runway beyond topline data from CD388’s Phase 2b trial; the reported transactions being transformational for Cidara; whether CD388 may have significant advantages beyond and in addition to flu vaccines; and Cidara’s ability to execute on the CD388 development program and advance the key assets in its pipeline. 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, delays in action by regulatory authorities, and obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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

Jessica Sagers
RA Capital Management
jsagers@racap.com

1 Agreement between Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, and Cidara Therapeutics, Inc.


FAQ

What is the purpose of the $240 million private placement financing led by RA Capital Management?

The financing aims to fund the Phase 2b clinical trial of CD388, an antiviral drug for influenza A and B.

Who has reacquired the exclusive global development and commercial rights to CD388?

Cidara Therapeutics has reacquired the exclusive global development and commercial rights to CD388 from Johnson & Johnson.

What is CD388 being developed for?

CD388 is being developed as a universal preventative against seasonal and pandemic influenza A and B.

What is the upfront payment made by Cidara to Johnson & Johnson in exchange for the rights to CD388?

Cidara made an $85 million upfront payment to Johnson & Johnson in exchange for the exclusive rights to CD388.

When is the business strategy update conference call and webcast scheduled?

The business strategy update conference call and webcast are scheduled for April 24, 2024, at 4:30 PM ET.

Cidara Therapeutics, Inc.

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