Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 29, 2019

 

 

Cidara Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36912   46-1537286

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

6310 Nancy Ridge Drive, Suite 101

San Diego, California

  92121
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 752-6170

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   CDTX   The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01

Regulation FD Disclosure.

On July 29, 2019, Cidara Therapeutics, Inc. (the “Company”) issued a press release announcing the topline results from Part B of its global Phase 2 STRIVE clinical trial evaluating the Company’s lead antifungal candidate, rezafungin (“STRIVE B”). The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. As indicated in the press release, on July 29, 2019 the Company will host a conference call and webcast at 8:00 a.m. Eastern time to discuss the results from STRIVE B. The slide presentation to be presented on the call is attached hereto as Exhibit 99.2.

The information contained in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.

 

Item 8.01

Other Events.

On July 29, 2019, the Company reported topline results from STRIVE B. The Company previously reported topline results from Part A of the STRIVE clinical trial (“STRIVE A”) in March 2018.

STRIVE B was an international, multicenter, double-blind clinical trial evaluating the safety, tolerability and efficacy of once-weekly dosing of rezafungin acetate compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis.

STRIVE B enrolled 91 patients in the microbiological intent-to-treat, or mITT, population. Patients were randomized to receive either 400 mg of rezafungin administered intravenously once weekly for two to four weeks or daily caspofungin administered intravenously according to the approved prescribing information, with an optional step down to oral fluconazole. To align with the chosen dosing regimen in the Phase 3 program, the STRIVE B trial was amended midway for Group 1 to use rezafungin 400 mg for the first week followed by 200 mg once weekly for up to four weeks in total.

The objective of STRIVE B was to show comparability in efficacy and safety of rezafungin dosed once-weekly and caspofungin dosed once-daily. Efficacy measures in the trial included clearance of Candida from the blood or other normally sterile sites, resolution of systemic signs attributed to the Candida infection, investigator assessment of clinical response and overall survival. The trial was not statistically powered to demonstrate superiority or non-inferiority and therefore comparisons of efficacy are directional.

In the STRIVE B trial, rezafungin met all of its objectives for efficacy, safety and tolerability in the treatment of patients with candidemia and/or invasive candidiasis. The trial results show that patients treated with rezafungin had numerically improved outcomes as compared to caspofungin across all efficacy measures at the 400 mg/200 mg dosing regimen. In addition, an analysis combining data across STRIVE A and STRIVE B, demonstrated that rezafungin achieves meaningful improvement in outcomes compared to caspofungin on Clinical Response across all efficacy endpoints at the same 400 mg/200 mg dose.

The charts below illustrate the topline results from STRIVE B and combined results from STRIVE A and STRIVE B for critical measures of efficacy.

All-Cause Mortality – Death through Day 30a

 

LOGO


Clinical Cure at Day 14 b

 

LOGO

Overall Success at Day 14 c

 

LOGO

 

a 

All-Cause Mortality on Day 30 is the primary endpoint for the Phase 3 ReSTORE trial as recommended by the FDA.

b 

Clinical Cure by PI Assessment is the outcome that most closely approximates the primary outcome in prior candidemia/invasive candidiasis clinical trials and primary endpoint for EMA for the Phase 3 ReSTORE trial.

c 

Overall Success is defined as the resolution of attributable systemic signs of candidemia/invasive candidiasis present at baseline plus mycological eradication.

There were no unanticipated or concerning adverse event trends among STRIVE B trial participants. The top-line results indicate that rezafungin was safe and well-tolerated at both dosing regimens. As expected, and observed in STRIVE A, treatment emergent adverse events (TEAEs) in the study population were observed in most patients, though study drug-related adverse events were substantially lower, with a frequency of 6.5 percent, 0 percent and 14.7 percent in the 400 mg/400 mg, 400 mg/200 mg, and caspofungin groups respectively.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

99.1    Press release issued July 29, 2019.
99.2    Slide Presentation, dated July 29, 2019.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    CIDARA THERAPEUTICS, INC.
Dated: July 29, 2019     By:  

/s/ Jeffrey Stein, Ph.D.

    Name:   Jeffrey Stein, Ph.D.
    Title:   President and Chief Executive Officer
EX-99.1

Exhibit 99.1

 

LOGO

Cidara Therapeutics Reports Positive Topline Results

in Phase 2 STRIVE B Trial of Antifungal Rezafungin

Data from second part of successful Phase 2 STRIVE trial further substantiate the efficacy, safety and tolerability of once-weekly rezafungin for first-line treatment of invasive Candida infections

Global Phase 3 ReSTORE trial ongoing

Company to host conference call today at 8:00 a.m. ET/5:00 a.m. PT

SAN DIEGO, July 29, 2019 – Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives, including immunotherapies, today reported positive topline results from Part B of the global Phase 2 STRIVE trial evaluating the company’s lead antifungal candidate rezafungin. In the STRIVE B trial, rezafungin met all of its objectives for efficacy, safety and tolerability in the treatment of patients with candidemia and/or invasive candidiasis. Rezafungin is a novel echinocandin antifungal being developed as a once-weekly therapy for the first-line treatment and prevention of serious invasive fungal infections.

“We extend our sincere thanks to the STRIVE participants, investigators and their site staff for their dedication to this trial. Rezafungin has the potential to be the first safe and effective once-weekly, first-line treatment option for patients with difficult-to-treat and deadly invasive Candida infections, and we believe this trial moves us one step closer to market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Additionally, the combined STRIVE A and B results are aligned with our expectations for the ongoing ReSTORE Phase 3 trial, from which the data, if positive, will be used to support our NDA.”

Cidara reported positive topline results from Part A of the STRIVE trial in March 2018. STRIVE B continues the success of the STRIVE trial to date and adds to the growing body of evidence supporting the efficacy and safety of once-weekly rezafungin. While the objective of STRIVE B was to show comparability in efficacy and safety of rezafungin dosed once-weekly versus caspofungin dosed once-daily, the topline results show that patients treated with rezafungin had numerically improved outcomes compared to caspofungin across all efficacy measures at the 400 mg/200 mg dosing regimen, which is the dosing regimen chosen for Phase 3. In addition, an analysis combining data across STRIVE Parts A and B also demonstrates that rezafungin achieved meaningful improvement in outcomes compared to caspofungin across all efficacy endpoints at the same 400 mg/200 mg dose. The comparisons of efficacy among the treatment


arms in the STRIVE trial are directional, as the STRIVE trial was not powered to show statistically significant differences or non-inferiority between treatment arms.

The charts represent the topline results from the STRIVE Part B trial and combined results from STRIVE A and B, for key measures of efficacy. More detailed results will be presented at an upcoming medical meeting.

All-Cause Mortality – Death through Day 30a

 

LOGO

Clinical Cure at Day 14 b

 

LOGO

Overall Success at Day 14 c

 

LOGO

 

a 

All-Cause Mortality on Day 30 is the primary endpoint for the Phase 3 ReSTORE trial for the FDA.

b 

Clinical Cure by Investigator Assessment is the outcome that most closely approximates the primary outcome in prior candidemia/invasive candidiasis clinical trials and the primary endpoint for the EMA for the Phase 3 ReSTORE trial.

c 

Overall Success is defined as the resolution of attributable systemic signs of candidemia/invasive candidiasis present at baseline plus mycological eradication.


While the difference in outcomes for 400 mg/200 mg are encouraging, and the 400 mg/400 mg findings are consistent with comparator results, the size of the individual trial cohorts precludes any other conclusions pending full assessment of trial data.

There were no unanticipated or concerning adverse event trends among STRIVE B trial participants. The top-line results indicate that rezafungin appeared to be generally safe and well-tolerated at both dosing regimens. As expected, and observed in STRIVE A, treatment emergent adverse events (TEAEs) in the study population were observed in most patients, though study drug-related adverse events were substantially lower, with a frequency of 6.5 percent, zero percent and 14.7 percent in the 400 mg/400 mg, 400 mg/200 mg, and caspofungin groups respectively.

“There have been no new drugs approved for the treatment of serious Candida infections or the prevention of invasive fungal infections in over a decade,” said George Thompson, M.D., associate professor of Clinical Medicine at the University of California, Davis, School of Medicine, and chair of the Mycoses Study Group Education Committee. “The positive outcomes from Part B of the STRIVE trial, which are similar to those from Part A, further substantiate the potential efficacy and safety of rezafungin in extremely ill patients affected by fungal disease. These important data also reinforce the potential of rezafungin as a practical, first-line antifungal treatment option over current standards of care, which are associated with significant limitations.”

STRIVE B Trial Design

STRIVE B was an international, multicenter, double-blind clinical trial evaluating the safety, tolerability and efficacy of once-weekly dosing of rezafungin acetate compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis. Efficacy measures in the trial included clearance of Candida from the blood or other normally sterile sites, resolution of systemic signs attributed to the Candida infection, investigator assessment of clinical response and overall survival.

The trial enrolled 91 patients in the microbiological intent-to-treat, or mITT, population. Patients were randomized to receive either 400 mg of rezafungin administered intravenously once weekly for two to four weeks or daily caspofungin administered intravenously according to the approved prescribing information, with an optional step down to oral fluconazole. To align with the chosen dosing regimen in the Phase 3 program, the STRIVE B trial was amended midway to use rezafungin 400 mg for the first week followed by 200 mg once weekly for up to four weeks in total.


Conference Call and Webcast

Cidara management will host a conference call and webcast at 8:00 a.m. ET/5:00 a.m. PT today. To participate in the conference call by telephone, please dial 844-358-8763 or 703-736-7375 and use the conference ID # 1965968. The webcast will be made available on Cidara’s website at www.cidara.com under the Investors tab in the Events section. Following the live audio webcast, a replay will be available on Cidara’s website.

About Invasive Fungal Infections

Invasive fungal infections (IFIs) represent a serious threat to millions of patients worldwide, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15 to 65 percent. These infections continue to be a global health issue, especially for critically ill patients in hospitals and patients with compromised immune systems, including cancer and transplant patients. Approximately 90 percent of IFI-related deaths are associated with Candida, Aspergillus, and Pneumocystis.

About Rezafungin

Rezafungin is a novel echinocandin antifungal and the only once-weekly drug candidate being developed for the first-line treatment and prevention of serious invasive fungal infections. Rezafungin has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure which, in contrast to all other echinocandins, allows for once-weekly IV therapy for inpatient and outpatient use. The U.S. Food and Drug Administration (FDA) has designated rezafungin as a Qualified Infectious Disease Product (QIDP) with Fast Track status and orphan drug designation related to its use in the treatment of candidemia and invasive candidiasis.

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 first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). A second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) is planned pending adequate funding and approval from the relevant regulatory authorities. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. 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, Cidara’s ability to develop new anti-infectives that are innovative or address unmet needs, the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, whether the success of the STRIVE clinical trial will support a successful outcome in the Phase 3 ReSTORE clinical trial or Cidara’s ability to successfully develop and commercialize rezafungin. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s 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.

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

###

EX-99.2

Slide 1

New Hope for Serious Infections Topline Results: Phase 2 STRIVE Part B Trial for Rezafungin July 29, 2019 © Cidara Therapeutics 2019 | Confidential Exhibit 99.2


Slide 2

Forward-Looking Statements These slides and the accompanying oral presentation contain 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 Cidara’s ability to develop new anti-infectives that are innovative or address unmet needs; the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches; whether the top line results of the STRIVE Part B clinical trial will be supported in the full analysis of the STRIVE Part B clinical data; whether the success of the STRIVE Part B clinical trial indicates a successful outcome in the Phase 3 ReSTORE clinical trial, including whether or not rezafungin will meet the primary endpoints in the ReSTORE trial; and whether Cidara will be able to successfully develop and commercialize rezafungin. This presentation also contains estimates and other statistical data made by independent parties and by Cidara relating to market size and growth and other data about Cidara's industryThese data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Projections, assumptions and estimates of the future performance of the markets in which Cidara operates are necessarily subject to a high degree of uncertainty and risk. Risks that contribute to the uncertain nature of the forward-looking statements include: Cidara’s abilityto obtain additional financing; the success and timing of Cidara’s preclinical studies, clinical trials and other research and development activities; receipt of necessary regulatory approvals for development and commercialization, as well as changes to applicable regulatory laws in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; 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 as most recently filed with the United States Securities and Exchange Commission (SEC), under the heading “Risk Factors.” All forward-looking statements contained in this presentation 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.


Slide 3

Executive Summary STRIVE B results successfully met all efficacy and safety objectives Results corroborate those from STRIVE A Uniform improvement in all efficacy outcomes comparing the 400/200mg dose versus caspofungin comparator Well tolerated with no concerning safety signals Results warrant continuation of ongoing global ReSTORE Phase 3 trial at current 400/200mg dosing regimen


Slide 4

Week 1 2 3 4 5 6 7 8 9 Day 1 5 8 15 22 28 Dose Optional dose Mycological & clinical response Overall Response (Mycological & clinical response): 1° ENDPOINT Mycological & clinical response (IC only) 45 35 42 49 56 59 Mycological & clinical response Week 1 2 3 4 5 6 7 8 9 Day 1 5 8 15 22 28 45 35 42 49 56 59 Dose All cause mortality Analysis Populations: The Intent-to-treat (ITT) population: all randomized subjects The Safety population: all subjects who received any amount of study drug The Microbiological Intent-to-treat population (mITT): all subjects in safety population who had documented Candida infection Randomization 2:1 Caspofungin Rezafungin Optional dose P2 STRIVE Part B: Candidemia & Invasive Candidiasis Not powered for inferential statistics


Slide 5

Week 1 2 3 4 5 6 7 8 9 Day 1 5 8 15 22 28 Dose Optional dose Mycological & clinical response Overall Response (Mycological & clinical response): 1° ENDPOINT Mycological & clinical response (IC only) 45 35 42 49 56 59 Mycological & clinical response Week 1 2 3 4 5 6 7 8 9 Day 1 5 8 15 22 28 45 35 42 49 56 59 Dose All cause mortality Analysis Populations: The Intent-to-treat (ITT) population: all randomized subjects The Safety population: all subjects who received any amount of study drug The Microbiological Intent-to-treat population (mITT): all subjects in safety population who had documented Candida infection P2 STRIVE Part B: Candidemia & Invasive Candidiasis Not powered for inferential statistics Caspofungin Rezafungin Optional dose Randomization 2:1


Slide 6

Rezafungin 400 / 200mg RESTORE (n=184) STRIVE B: the bridge from STRIVE A to ReSTORE Rezafungin 400 / 400mg Caspofungin 2017 2018 2019 2020 STRIVE B (n=91) STRIVE A (n=92) STUDY SIZE: STRIVE A + B (n=183) ≈ RESTORE (n=184) CRITERIA: Similar inclusion/exclusion, except STRIVE B enrolled patients with invasive candidiasis from the beginning STRATEGY: STRIVE B expands safety data; maintains enrollment momentum


Slide 7

Similar to the ReSTORE trial primary endpoint for FDA 30-Day All Cause Mortality STRIVE B STRIVE A + B 7/43 1/15 5/33 12/76 2/46 8/61 n/N= n/N= Death at Day 30 (%) mITT Population 1 2 3 1 2 3 1. 400 mg dose once weekly for two to four weeks. 2. 400 mg dose for the initial week followed by 200 mg dose once weekly for an additional one to three weeks. 3. 70 mg day one, followed by daily doses of 50mg.


Slide 8

Similar to the ReSTORE trial primary endpoint for EMA Investigator assessment of clinical response STRIVE B STRIVE A + B 28/43 13/15 23/33 53/76 37/46 43/61 n/N= n/N= Clinical Cure (%) at Day 14 mITT Population 1. 400 mg dose once weekly for two to four weeks. 2. 400 mg dose for the initial week followed by 200 mg dose once weekly for an additional one to three weeks. 3. 70 mg day one, followed by daily doses of 50mg. 1 2 3 1 2 3


Slide 9

STRIVE B primary endpoint: combination of clinical and mycological responses Overall response STRIVE B STRIVE A + B 27/43 13/15 23/33 46/76 35/46 41/61 n/N= n/N= Overall Success (%) at Day 14 mITT Population 1 2 3 1 2 3 1. 400 mg dose once weekly for two to four weeks. 2. 400 mg dose for the initial week followed by 200 mg dose once weekly for an additional one to three weeks. 3. 70 mg day one, followed by daily doses of 50mg.


Slide 10

Topline summary of adverse events in safety population 400/400 mg (QWk) 400/200 mg (QWk) Pooled Groups N=46 N=18 N=64 n (%) All Related TEAEs 3 (6.5) 0 3 (4.7) Leading to study D/C 2 (4.3) 0 2 (3.1) Serious AE 1 (2.2) 0 1 (1.6) 70/50 mg (QD) N=34 n (%) 5 (14.7) 3 (8.8) 1 (2.9) REZAFUNGIN CASPOFUNGIN As expected and observed in STRIVE A, the majority of subjects had at least one TEAE and 40-50% had at least one Serious AE, reflecting the high morbidity of the underlying population. There were no AE trends; % of TEAEs and SAEs were approximately even across study groups. D/C=discontinuation; TEAE (treatment-emergent adverse event)=AE that occurs after first dose of study drug is administered. N=81 N=53 N=134 All Related TEAEs 7 (8.6) 6 (11.3) 13 (9.7) Leading to study D/C 3 (3.7) 0 3 (2.2) Serious AE 1 (1.2) 1 (1.9) 2 (1.5) N=68 9 (13.2) 1 (1.5) 2 (2.9) STRIVE A + B STRIVE B Study-Drug Related TEAEs


Slide 11

Our Phase 3 trial design mirrors the Phase 2 design Phase 2 Week 1 2 3 4 5 6 7 8 9 1 Dose Optional dose Mycological & clinical response: 1° ENDPOINT All cause mortality Day 8 15 22 28 45 59 Phase 3 Week 1 2 3 4 5 6 7 8 9 Mycological & clinical response: 1° ENDPOINT EMA All cause mortality: 1° ENDPOINT FDA


Slide 12

Rezafungin (STRIVE A + B, 400/200 only) vs. Caspofungin (STRIVE A + B) 30-Day All Cause Mortality – Post Hoc Analysis* SUPERIORITY NON-INFERIORITY 0 -20% 10% -10% -24.7% +0.41% FAVORS REZAFUNGIN FAVORS CASPOFUNGIN -8.8% 20% ReSTORE Phase 3 trial endpoint requires upper limit of confidence interval be below 20% threshold Non-inferiority margin 95% confidence interval *Using the same analysis method as planned for the Phase 3 study, a two-sided 95% confidence interval (CI) for the observed difference in the ACM rate (Rezafungin 400/200 group minus caspofungin group) was calculated using the unadjusted method of Miettinen and Nurminen. Rezafungin mITT: 2/46= 4.4% ACM; Caspofungin mITT: 8/61= 13.1% ACM


Slide 13

Conclusions Positive findings strongly support that once-weekly dosing of rezafungin is comparable to once-daily dosing of caspofungin Caspofungin cure rate at ~70% in both STRIVE A and B for Clinical Response is similar to its outcome in prior studies for candidemia/IC thereby validating the quality of the study Supports the selection of the 400/200 dosing regimen in ReSTORE Enrollment of ReSTORE Phase 3 study globally is underway


Slide 14

New Hope for Serious Infections Topline Results: Phase 2 STRIVE Part B Trial for Rezafungin July 29, 2019 Thank you © Cidara Therapeutics 2019 | Confidential