Cidara TherapeuticsPharmaceutical SME
Cidara performs less than average in Research & Development when compared to other small and medium-sized enterprises in scope.
Cidara has three antibacterial and antifungal projects for priority pathogens in its pipeline. One candidate (rezafungin) in Phase III that is active against fluconazole-resistant C. auris, which is listed since November 2019 as an urgent pathogen by the US Centers for Disease Control and Prevention (CDC).
Sales & Operations
Therapeutic areas: Anti-infectives
Products on the market: None
R&D grants received since 2016: At least USD 12.4 million, awarded by two funders (CARB-X; NIH). Its latest award, from NIH, worth USD 5.5 million occurred in May 2018. The award was granted to enable the continued research of novel immunotherapy agents for the treatment and prevention of multidrug-resistant Gram-negative bacterial infections in high-risk patient populations, through Cidara’s Cloudbreak anti-infective immunotherapy platform.
Financing and investment structure: Cidara is a publicly listed company. It completed its IPO in April 2015, raising USD 76.8 million, following two funding series, raising USD 74 million. Lead investors were 5AM Ventures, RA Capital Management, and Square 1 Bank.
M&A since 2018: None in the antibacterial and/or antifungal sectors
Pipeline size: 3 projects for priority pathogens* (1 antibacterial medicine; 2 antifungal medicines)
Development stages: 2 clinical projects, including a subcutaneous formulation of its antifungal medicine rezafungin, in Phase I of clinical development, to allow for administration of this medicine outside of hospitals, and 1 discovery project
Novelty: No novel clinical-stage medicine projects
Regulatory approvals: 0 approvals for priority pathogens
Access plans: Its 1 late-stage R&D project has no project-specific access plans
Stewardship plans: Its 1 late-stage R&D medicine project has no project-specific stewardship plans
Opportunities for Cidara
Work with Mundipharma to develop access and stewardship plans for rezafungin. Cidara is developing one antifungal candidate (rezafungin) in late-stage clinical development. In September 2019, Cidara entered into a strategic partnership with Mundipharma, granting Mundipharma exclusive commercialization rights to rezafungin outside the U.S. and Japan. Cidara can work with Mundipharma to ensure that rezafungin will be available and affordable in low- and middle-income countries and appropriately used globally after first market approval. Examples of access and stewardship plans for Cidara and Mundipharma would be developing an equitable pricing strategy and becoming involved in antifungal surveillance activities, respectively.
Changes since 2018
This section lists notable changes in companies’ activities since the 2018 Benchmark. Since Cidara was not in scope for evaluation in 2018, no changes are reported.
Performance by research area
Evaluated: medicine & vaccine pipelines for priority* bacteria & fungi
A.1 R&D investments
Cidara invested USD 91.9 million in the development of antibacterial and antifungal medicines in 2017 and 2018. As with all other SMEs evaluated, Cidara was not scored in this indicator.
A.2.1 Pipeline size of three projects
Cidara reports three projects targeting priority pathogens in its pipeline. The company focuses mainly on antifungal medicine development, with two projects in clinical development (one in Phase III and one in Phase I) and one antibacterial project in discovery stage.
A2.2. No clinical-stage novel projects
Cidara’s clinical-stage medicine pipeline for priority pathogens consists of both new and adapted R&D projects. Cidara is not currently developing clinical-stage medicine projects that are considered novel. However, it is developing rezafungin, a new clinical-stage R&D candidate for the treatment of fungal infections including invasive candidiasis.
A.2.3 No vaccines in the pipeline
Cidara is not eligible for this indicator as it is not active in vaccine development.
A.2.4 Two candidates targeting critical and/or urgent priorities
Cidara’s pipeline includes one discovery candidate (its Cloudbreak antibacterial programme) that targets multi-drug resistant Gram-negative bacteria, including Enterobacteriaceae, A. baumannii and P. aeruginosa. These pathogens are among those that are considered critical and/or urgent R&D priorities for limiting AMR, as identified by WHO and/or US Centers for Disease Control and Prevention (CDC). Furthermore, it has one candidate (rezafungin) in Phase III that is active against fluconazole-resistant C. auris, which is listed since November 2019 as an urgent pathogen by the CDC.
A.3 Intellectual capital sharing
As an SME, Cidara was not scored for this indicator, in line with the external stakeholder consensus defined by the Foundation initiatives.
A.4 No access or stewardship plans in place for late-stage R&D projects targeting priority pathogens
Cidara has one such R&D project. It currently reports no plans that address either the stewardship of or appropriate access to the product, upon reaching the market. After the period of analysis, in September 2019, it was announced that Cidara and Mundipharma formed a strategic partnership to develop and commercialise rezafungin.
Pipeline targeting priority pathogens: 3
As a small- to medium-sized enterprise (SME), Cidara is not evaluated in this Research Area. It has no antibacterial products on the market.
As a small- to medium-sized enterprise (SME), Cidara is not evaluated in this Research Area. It has no antibacterial and/or antifungal products on the market.
Cidara Therapeutics actively supports the SENTRY surveillance program to track antifungal activity against clinical fungal species of interest. Cidara makes all publications involving SENTRY surveillance data publicly available.
Activities in this area are not scored by the Benchmark. This information is provided given the importance of diagnostics, animal health and agriculture on the topic of AMR.
Cidara is currently developing multiple antimicrobial susceptibility testing (AST) devices for its antifungal medicine rezafungin in Phase III of clinical development for the treatment of candidemia and invasive candidiasis.
* Bacteria and fungi that have been identified as priority R&D targets for limiting AMR, by either the WHO and/or the Centers for Disease Control and Prevention (CDC).