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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, Inc. (CDTX) announced the grant of stock options and restricted stock units totaling 17,000 shares to three new employees under its 2020 Inducement Incentive Plan. The options have an exercise price of $1.27 per share, equal to the stock's closing price on the grant date (December 31, 2021). The awards are intended as inducements for the new hires, in compliance with Nasdaq Listing Rule 5635(c)(4). Cidara focuses on long-acting therapeutics, including its lead Phase 3 antifungal candidate, rezafungin.
Cidara Therapeutics announced positive topline results from the ReSTORE Phase 3 trial of rezafungin, a once-weekly antifungal treatment for candidemia and invasive candidiasis. The trial met FDA's all-cause mortality endpoint at Day 30 and EMA's global cure endpoint at Day 14, demonstrating non-inferiority to the standard daily treatment, caspofungin. Rezafungin was well tolerated, showing a comparable safety profile. The company aims to file for regulatory approvals by mid-2022, highlighting the potential of this novel treatment in critical care settings.
Cidara Therapeutics, Inc. (NASDAQ: CDTX) reported Q3 2021 results, showing revenues of $7.1 million for the quarter, up from $2.4 million in Q3 2020, primarily due to a collaboration with Janssen Pharmaceuticals. Net losses for Q3 2021 were $18.1 million, compared to $17.6 million in Q3 2020. The company raised $38.5 million in equity from public offerings to extend its cash runway. Cidara plans to report top-line data from its ReSTORE Phase 3 trial by year-end 2021 and anticipates filing an NDA for its drug rezafungin in mid-2022.
Cidara Therapeutics, Inc. (Nasdaq: CDTX) has successfully completed its public offerings, raising approximately $38.5 million. This includes 17,064,511 shares of common stock priced at $1.55 per share and 774,194 shares of Series X Convertible Preferred Stock at $15.50 per share. The offerings were managed by Cantor Fitzgerald & Co. and others under an effective SEC shelf registration. The funds will support the development of long-acting therapeutics targeting serious diseases, enhancing patient care through innovative treatments.
Cidara Therapeutics announced the pricing of concurrent public offerings totaling approximately $35.0 million. The offerings consist of 14,838,706 shares of common stock priced at $1.55 per share and 774,194 shares of Series X Convertible Preferred Stock priced at $15.50 per share. Underwriters have a 30-day option to purchase an additional 2,225,805 shares of common stock. The offerings are expected to close around October 13, 2021, subject to customary conditions. Cantor Fitzgerald & Co. is the sole book-running manager.
Cidara Therapeutics (Nasdaq: CDTX) has launched concurrent underwritten public offerings for its common stock and Series X Convertible Preferred Stock. The common stock offering includes a 30-day option for underwriters to purchase additional shares at the offering price. The completion of these offerings is not contingent upon one another and is subject to market conditions. Cantor Fitzgerald & Co. serves as the sole book-running manager for these offerings. The securities are offered under a shelf registration statement with no assurance on the terms or timing of completion.
Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced on October 1, 2021, that its Compensation Committee granted stock options and restricted stock units totaling 169,000 shares to ten new employees. The options have an exercise price of $2.24 per share, equal to the stock's closing price on the grant date. Vesting occurs over four years, with 25% vesting after one year. This initiative is part of the company's 2020 Inducement Incentive Plan and is compliant with Nasdaq Listing Rule 5635(c)(4). Cidara focuses on long-acting therapeutics for serious diseases, including its lead candidate, rezafungin acetate.
Cidara Therapeutics (NASDAQ: CDTX) will present new clinical data at the 10th Congress on Trends in Medical Mycology (TIMM) from October 8-11, 2021, in Aberdeen, Scotland. The focus is on rezafungin, a once-weekly echinocandin in Phase 3 trials for serious fungal infections. Top-line data from the Phase 3 ReSTORE trial is expected by the end of 2021, with a New Drug Application (NDA) anticipated in mid-2022. Key presentations include safety and pharmacokinetics in hepatic impairment and post-antifungal effects against various Candida species.
Cidara Therapeutics (NASDAQ: CDTX) announced its participation in IDWeek from September 29 to October 3, 2021, where it will present new data on rezafungin, a novel once-weekly echinocandin in Phase 3 trials for serious fungal infections. The presentations will cover clinical safety in patients with hepatic impairment and the efficacy of rezafungin against invasive fungal isolates. Top-line data from the Phase 3 ReSTORE trial is expected by year-end 2021, with a New Drug Application (NDA) filing anticipated in mid-2022.