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Cidara Therapeutics, Inc. (CDTX), headquartered in San Diego, California, is a pioneering biotechnology company focused on the discovery, development, and commercialization of novel anti-infectives and immunotherapies. The company's mission is to address diseases inadequately treated by current standard of care therapies. Utilizing its proprietary Cloudbreak® platform, Cidara develops drug-Fc conjugates (DFCs) aimed at saving lives and improving patient outcomes for serious diseases such as cancer, viral infections, and autoimmune diseases.
The company's core portfolio includes:
- Rezafungin (REZZAYO™): An FDA and EC-approved treatment for invasive candidiasis, licensed to multiple partners for commercialization in the U.S. and internationally.
- CD101 IV: A potential once-weekly intravenous therapy for systemic fungal infections.
- CD101 Topical: The first topical application of the echinocandin class of anti-fungals for vulvovaginal candidiasis (VVC).
- CD388: A long-acting antiviral investigational drug for the prevention of all strains of influenza A and B, currently in Phase 2b development.
Recent achievements include significant data presentations at prestigious conferences and strategic realignments to focus on the most promising components of their pipeline. Cidara’s financial stability is reinforced by a $240 million private placement led by RA Capital Management, with participation from top-tier investors like Bain Capital Life Sciences and Biotech Value Fund (BVF).
Noteworthy partnerships include collaborations with Johnson & Johnson for CD388 and Mundipharma for the divestiture of rezafungin, which has led to substantial cost savings and allows Cidara to focus on its Cloudbreak platform. The company is also preparing for a Phase 2b clinical trial of CD388, aiming to deliver universal, season-long protection against influenza.
For more information, visit www.cidara.com.
Cidara Therapeutics announced key management appointments, bringing in Preetam Shah, Ph.D., MBA, as Chief Financial Officer and Chief Business Officer, and Shane Ward as Chief Legal Officer and Corporate Secretary. Both bring over 20 years of biotech experience. The company is poised for significant milestones, including top-line data from the pivotal Phase 3 ReSTORE trial of its antifungal candidate, rezafungin, expected by year-end. Inducement awards were granted to Shah and Ward under the 2020 Inducement Incentive Plan, with options covering a total of 561,850 shares.
Cidara Therapeutics has successfully completed recruitment for its pivotal Phase 3 ReSTORE trial, evaluating rezafungin as a potential first-line treatment for candidemia and invasive candidiasis. The trial involved 184 patients, addressing a significant unmet medical need with mortality rates as high as 40%. Top-line data is expected by the end of 2021, with an NDA filing anticipated in mid-2022. Rezafungin aims to offer a once-weekly treatment option for critically ill patients, with Mundipharma responsible for international distribution.
Cidara Therapeutics, Inc. (NASDAQ: CDTX) reported strong Q2 2021 financial results, with revenue of $32.9 million, up from $3.4 million in Q2 2020, largely attributed to a collaboration with Janssen. The company ended Q2 with $53.1 million in cash. Notably, Cidara achieved a net income of $10.7 million in Q2 2021, a significant turnaround from a net loss of $18.3 million the previous year. They anticipate filing an IND for lead candidate CD388 by year-end and report ongoing Phase 3 trials for rezafungin, expecting top-line data availability by year's end.
Cidara Therapeutics (NASDAQ: CDTX) announced that its President and CEO, Jeffrey Stein, Ph.D., will participate in a panel discussion at the 2021 Wedbush PacGrow Healthcare Conference on August 11, 2021, at 4:40 PM ET. The event will feature a live audio webcast available on the company's website. Cidara focuses on developing long-acting therapeutics for serious fungal and viral infections, highlighting its lead antifungal candidate, rezafungin, and its antiviral platform, Cloudbreak®.
Cidara Therapeutics (NASDAQ: CDTX) announced presentations of clinical data on rezafungin at the ISHAM Asia Congress from August 6-8, 2021. Rezafungin, a novel once-weekly echinocandin, aims to treat and prevent serious fungal infections. The presentations will include updated findings from the Phase 2 STRIVE study and activity analysis against Candida and Aspergillus spp. isolates from Asia-Pacific. The Chief Medical Officer, Taylor Sandison, will lead these discussions, showcasing the progress of the ongoing Phase 3 trials.
Cidara Therapeutics (NASDAQ: CDTX) presented new clinical data on rezafungin at the ECCMID 2021, showcasing its effectiveness in treating candidemia. The oral presentation highlighted that a single dose of rezafungin significantly improved infection clearance compared to standard treatments like caspofungin. Critical findings from the STRIVE Phase 2 trial indicated higher rates of negative blood cultures within 24 and 48 hours for patients treated with rezafungin. The ongoing Phase 3 ReSTORE trial aims to validate these results, with top-line data expected by the end of 2021.
Cidara Therapeutics (Nasdaq: CDTX) announced the grant of 172,000 stock options and restricted stock units to eight new employees under its 2020 Inducement Incentive Plan. The options have an exercise price of $2.02 per share, equivalent to the stock's closing price on June 30, 2021. Vesting occurs over four years, with 25% vesting after one year and the remainder in equal monthly installments. These awards are a strategic inducement to attract new talent in line with Nasdaq rules.
Cidara Therapeutics, Inc. (NASDAQ: CDTX) announced the resignation of CFO James Levine, effective July 9, 2021, to pursue new opportunities. Levine will continue to provide consulting support for at least six months. CEO Jeffrey Stein praised Levine for his leadership and contributions to partnerships with Mundipharma and Janssen Pharmaceuticals. In light of this change, Stein will also take on the role of principal financial officer, while Brady Johnson has been promoted to vice president of finance and principal accounting officer, enhancing the company's financial management.
Cidara Therapeutics (NASDAQ: CDTX) is set to present new analyses, including an oral presentation on rezafungin, at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) virtually from July 9-12, 2021. Rezafungin, a once-weekly echinocandin, is currently in Phase 3 trials for treating serious fungal infections in critically ill patients. Highlights include a session on the STRIVE Phase 2 trial's efficacy and safety analysis. The presentations will be accessible via Cidara's website and ECCMID's platform.
Cidara Therapeutics (Nasdaq: CDTX) announced that CEO Jeffrey Stein and CFO James Levine will participate in investor meetings at the Raymond James Human Health Innovation Conference from June 21-23, 2021. The company focuses on developing long-acting therapeutics to address serious fungal and viral infections, with notable products including the antifungal candidate rezafungin and antiviral candidates from its Cloudbreak platform. Cidara is headquartered in San Diego, California.
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