Cidara Therapeutics Announces Multiple Presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

Six poster presentations include new analyses from Phase 2 STRIVE clinical trial of rezafungin

Four oral presentations include first scientific presentation of new data highlighting the potential of its Cloudbreak antiviral conjugates (AVCs) for influenza

SAN DIEGO--()--Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced a total of 10 upcoming presentations summarizing data on the company’s lead antifungal rezafungin and its Cloudbreak antiviral program at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The company and its collaborators will deliver four oral and six poster presentations at the meeting being held in Amsterdam, Netherlands from April 13 to 16, 2019.

“The data to be presented at ECCMID will add to the growing body of evidence demonstrating the potential for improved efficacy and safety of rezafungin over current standard of care for the treatment of severe, invasive infections, and as a prophylactic agent in high-risk patients,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We also look forward to sharing the first scientific presentation of new data that highlight the potential of our Cloudbreak antiviral conjugates (AVCs) for influenza. Our AVCs offer a fundamentally novel approach designed to provide seasonal protection from influenza, including those strains not covered by seasonal vaccines. Because of their unique dual mechanism of action, our AVCs are also, unlike vaccines, expected to protect patients with compromised immune systems. Additionally, our AVCs could potentially be used to treat patients suffering from severe influenza, beyond the limited treatment window offered by currently approved therapies.”

ECCMID convenes leading experts from around the world to present and discuss the latest research findings in infectious diseases, infection control and clinical microbiology. Details of the 10 rezafungin and Cloudbreak presentations are as follows:

Oral Presentations

Title: EUCAST susceptibility testing of rezafungin: MIC data for contemporary Danish clinical yeast isolates
Presenter: K.M. Jørgensen
Date and time: Saturday, April 13, 10:00 a.m. – 12:00 p.m. CET
Presentation time: 11:36 – 11:46 a.m. CET
Location: Hall H
Oral Session: Issues in antifungal treatment

Title: Rezafungin PK/PD in a mouse model of Pneumocystis pneumonia
Presenter: S. Flanagan
Date and time: Saturday, April 13, 2:45 – 3:45 p.m. CET
Presentation time: 3:21 – 3:31 p.m. CET
Location: Hall N
Oral Session: Novel approaches to fungal diseases

Title: Rezafungin is more effective than micafungin in treating of FKS-mutant Candida glabrata intra-abdominal candidiasis
Presenter: M-H. Nguyen
Date and time: Monday, April 15, 11:00 a.m. – 12:00 p.m. CET
Presentation time: 11:48 – 11:53 a.m. CET
Location: Arena 2
Oral Session: Antifungals: novel drugs, novel dosing?

Title: Cloudbreak: a novel approach for the treatment and prevention of influenza virus
Presenter: L. Tari
Date and time: Monday, April 15, 1:30 – 3:30 p.m. CET
Presentation time: 2:18 – 2:28 p.m. CET
Location: Hall M
Oral Session: New therapeutic strategies in viral infections

Poster Presentations

Title: Phase II STRIVE clinical trial of rezafungin for the treatment of candidemia and/or invasive candidiasis: results stratified by baseline renal function
Presenter: S. Flanagan
Date and time: Saturday, April 13, 3:30 – 4:30 p.m. CET
Location: Paper Poster Area
Poster Session: Clinical pharmacokinetics, treatment strategies and prescribing of antifungals

Title: Absorption, distribution and excretion of rezafungin after single-dose intravenous administration in rats and monkeys
Presenter: S. Flanagan
Date and time: Saturday, April 13, 3:30 – 4:30 p.m. CET
Location: Paper Poster Area
Poster Session: Clinical pharmacokinetics, treatment strategies and prescribing of antifungals

Title: Novel Cloudbreak bifunctional molecule protects against Acinetobacter pneumonia
Presenter: A. Ibrahim
Date and time: Monday, April 15, 1:30 – 2:30 p.m. CET
Location: Paper Poster Area
Poster Session: In vitro activity of investigational antibacterial agents

Title: Outcomes in Europe from the STRIVE clinical trial of rezafungin treatment of candidemia and/or invasive candidiasis
Presenter: T. Sandison
Date and time: Tuesday, April 16, 12:30 – 1:30 p.m. CET
Location: Paper Poster Area
Poster Session: Virulence and outcomes of fungal infections

Title: EUCAST reference testing of rezafungin susceptibility: impact of choice of plastic plates
Presenter: M. Arendrup
Date and time: Tuesday, April 16, 12:30 – 1:30 p.m. CET
Location: Paper Poster Area
Poster Session: Antifungal susceptibility and resistance in yeast and molds from around the world

Title: Activity of rezafungin against common and rare Candida species in vitro
Presenter: L. Majoros
Date and time: Tuesday, April 16, 12:30 – 1:30 p.m. CET
Location: Paper Poster Area
Poster Session: Antifungal susceptibility and resistance in yeast and molds from around the world

The abstracts can be accessed through the ECCMID website: www.eccmid.org. Following the meeting, the presentation slides and posters will be available on the Cidara website: www.cidara.com.

About Invasive Fungal Infections

Invasive fungal infections (IFIs) represent a serious global health threat, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15 to 65 percent. These infections are especially relevant for patients whose immune systems have been compromised, such as patients undergoing organ or blood and marrow transplantation or chemotherapy, including patients with hematologic malignancies. Of the most significant IFIs, approximately 90 percent of related deaths are primarily caused by Candida, Aspergillus, and Pneumocystis. Candida species are most common in hospital-acquired infections, while Aspergillus species are predominant in patients with weakened immune systems or lung diseases. Pneumocystis infections also commonly afflict immunocompromised patients.

About Influenza Virus

Influenza, or flu, is a respiratory infection caused by influenza viruses. The flu virus can cause mild to severe illness, and at times can lead to death. Young children, the elderly (over 65 years of age), pregnant women and immunocompromised patients are more prone to infection, but even healthy people are at risk of infection with seasonal flu. While influenza vaccines are critical to global health, they do not provide adequate protection year to year. The U.S. Center for Disease Control and Prevention (CDC) estimates that as many as 646,000 people may die from influenza each year worldwide.

About Cidara Therapeutics

Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial, for the treatment of candidemia and invasive candidiasis and continues to discuss with regulatory authorities its plans for the design and the initiation of a second Phase 3 trial in the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation. Rezafungin is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. Cidara also is leveraging its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for serious infections, including further investigation of the high potency and long half-life observed in its AVCs for influenza. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient’s immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, the potential for rezafungin in high-risk patient populations and Cidara’s ability to successfully develop rezafungin. Such statements also include, but are not limited to, statements regarding the potential for Cidara’s AVCs to treat and prevent influenza and represent an improvement over current vaccines, the efficacy of Cidara’s AVCs in patients with compromised immune systems, and the potential for Cidara’s AVCs to expand the treatment window and represent an improvement over current therapies. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; Cidara’s ability to obtain additional financing; Cidara’s ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara’s Form 10-K most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
(858) 356-5932
robert.uhl@westwicke.com

MEDIA CONTACT:
Andrea Cohen
Sam Brown Inc.
(917) 209-7163
andreacohen@sambrown.com

Contacts

INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
(858) 356-5932
robert.uhl@westwicke.com

MEDIA CONTACT:
Andrea Cohen
Sam Brown Inc.
(917) 209-7163
andreacohen@sambrown.com