• Approval triggered by positive results from ReSTORE Phase III clinical trial
• Payment will advance Cidara’s Cloudbreak platform for the development of drug-Fc conjugates (DFCs)

SAN DIEGO, Feb. 12, 2024 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.

This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options.

“The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients.”

Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year.

About Cidara Therapeutics

Cidara is using its proprietary Cloudbreak^® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO^® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About REZZAYO^® (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO appeared first on Cidara Therapeutics.

• The UK MHRA approval follows approvals by the U.S. FDA and the European Commission
• Cidara is entitled to receive a milestone payment of approximately $2.8 million from Mundipharma

SAN DIEGO, Jan. 29, 2024 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults.

“Today’s announcement by the MHRA expands treatment options to even more patients suffering from life-threatening invasive candidiasis infections globally,” said Taylor Sandison, M.D. M.P.H., Chief Medical Officer at Cidara. “Our team, in partnership with Mundipharma, is proud to help bring the first new treatment option in 15 years to patients with this disease.”

This approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Rezafungin is already approved by the United States Food and Drug Administration (FDA) and European Commission (EC).

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. The company is entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval.

About Cidara Therapeutics

Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA and EC approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About invasive candidiasis

Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. IC is characterized as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.

About REZZAYO® (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin, and the likelihood that rezafungin will be prescribed by physicians in the UK. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Announces Approval of REZZAYO by the MHRA for the Treatment of Invasive Candidiasis in Adults appeared first on Cidara Therapeutics.

• Approval based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.
• REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis.
• Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.

SAN DIEGO, Dec. 22, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive nonclinical development program.

Invasive candidiasis is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more. It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays. Over the last 15 years, there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment options.

Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said, “There has been a significant global unmet need for treating people with invasive candidiasis. Today’s announcement by the European Commission marks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option.“

Taylor Sandison, M.D. M.P.H, Chief Medical Officer at Cidara, said, “We welcome the European approval, which makes this treatment option available to patients in Europe alongside patients in the United States following the FDA’s approval earlier this year. This is a great step forward on our journey to help patients with serious Candida infections across the globe.“

Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU.

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Union (EU) approval of rezafungin in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma. Under the licensing agreement, Cidara remains eligible to receive additional potential payments of up to approximately $470 million upon achievement of development and regulatory milestones planned over the next several years, as well as double-digit royalties in the teens on tiers of annual net sales.

About invasive candidiasis
Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.

About REZZAYO^® (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

About Cidara Therapeutics
Cidara is using its proprietary Cloudbreak^® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO^® (rezafungin for injection), which it has licensed to multiple partners to commercialise in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Announces European Approval of REZZAYO® (rezafungin) for the Treatment of Invasive Candidiasis in Adults appeared first on Cidara Therapeutics.

First in class, multi-specific CD73/PD-1 inhibitor DFC, exhibited robust anti-tumor activity in humanized mouse models of colorectal cancer at low doses

CD73/PD-1 DFC demonstrated superior anti-tumor activity to CD73 and PD-1 monotherapies

SAN DIEGO, Dec. 07, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the presentation of new preclinical data on its novel, multi-specific CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress. Cidara also presented new preclinical data on CBO421, its first-in-class CD73-targeting DFC. The conference is taking place December 6-8, 2023, virtually and in-person in Geneva, Switzerland.

“We are thrilled to be presenting promising preclinical data on our novel multi-specific DFC in colorectal cancer for the first time at ESMO-IO this year,” said Jeffrey Stein, Ph.D., president and chief executive officer at Cidara. “Dual inhibition of both CD73 and PD-1 checkpoint pathways with a single DFC contributed to significant tumor growth reduction, highlighting the potential clinical benefits of this first-in-class multi-specific inhibitor derived from our Cloudbreak platform.”

Presentation details are summarized below:

Title: Discovery of a Novel, Dual CD73 & PD-1 Targeting Multi-specific Drug Fc-Conjugate (DFC) for the Treatment of Cancer
Presenter: James Levin, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET
Key highlights:

• CD73/PD-1 DFC is a potent inhibitor of hCD73 and hPD-1
• DFC reduced tumor growth by 56% at 1mg/kg and >70% at 3mg/kg doses
• DFC demonstrated superior activity to a pembrolizumab biosimilar antibody and a matched CD73 DFC at 1/3 the dose of the respective monotherapies

Title: Discovery of CBO421, a First-in-Class Drug Fc-Conjugate (DFC), Targeting CD73 in Cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET
Key highlights:

• CBO421 is a potent, AMP-competitive inhibitor of CD73 that demonstrates a differentiated in vitro activity profile across several assays compared with small molecule and antibody inhibitors of CD73 in clinical development
• The in vitro potency, multiple mechanisms of action, and favorable pharmacokinetics profile of CBO421 translated to antitumor efficacy in monotherapy and in combination with PD-1 therapy

Cidara is currently advancing its dual CD73/PD-1 inhibitor DFC and CBO421 in preclinical studies. The company plans to file an investigational new drug (IND) application in mid-2024 for CBO421.

About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether nonclinical data generated for CBO421 to date will be predictive of activity in humans, whether pharmacokinetics, toxicology, and other nonclinical data being generated for CBO421 will be adequate to support an IND filing with the FDA, and whether a combination CD73 and PD-1 DFC will progress to further nonclinical development. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Presents New Promising Preclincal Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress appeared first on Cidara Therapeutics.

• Top-line data expected in Q2 2024

SAN DIEGO, Dec. 06, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis.

The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis. ReSTORE (NCT03667690) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis.

“The completion of this trial enrollment marks a significant step in our efforts to bring an important treatment option to patients living with difficult to treat candidemia and invasive candidiasis,” said Taylor Sandison, M.D., MPH, chief medical officer of Cidara. “Rezafungin has demonstrated its benefit for patients in the U.S. and E.U., and now there is the potential to target an even broader global patient population who are suffering and in need of a new treatment option.”

Jeffrey Stein, Ph.D., president and chief executive officer of Cidara stated, “We appreciate the hard work of our investigators involved in this trial, and the patients who have helped us achieve this key milestone. Our team looks forward to the availability of the results of this study in the second quarter of next year and the potential to expand the reach of this treatment for patients. Moreover, the completion of this trial will reduce our cash burn longer-term and makes us eligible to receive additional regulatory and commercial milestone payments.”

Rezafungin received U.S. Food and Drug Administration approval in the U.S. earlier this year, as well as a positive CHMP opinion in October for patients in the European Union. A final decision by the European Medicines Agency (EMA) is expected to be delivered next month. Melinta Therapeutics has the exclusive commercialization rights to REZZAYO^TM (rezafungin for injection) in the U.S. and Mundipharma has the commercialization rights to rezafungin in all geographies other than the U.S. and Japan.

About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether rezafungin will be approved for sale in Europe by the European Commission, whether the ReSTORE trial results in China will be similar to those observed in other geographies and whether rezafungin will ultimately be approved and commercialized in China. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Announces Completion of Enrollment in Phase 3 Restore Trial of Rezafungin in China appeared first on Cidara Therapeutics.

The post Cidara Therapeutics to Present New Preclinical Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress appeared first on Cidara Therapeutics.

SAN DIEGO, Nov. 20, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that it has been named a Top Workplace by The San Diego Union-Tribune. Cidara was among the top 100 companies and organizations included in the 2023 Top Workplace list.

“We are proud to once again be considered one of the best places to work in San Diego,” said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. “This reflects Cidara’s commitment to foster a supportive, collaborative and motivating work environment. Our team members are driven by our mission to bring novel therapies to patients, and we are very appreciative of their dedication.”

Top Workplace lists are based solely on employee feedback gathered through a third-party survey administered by employee engagement technology partner Energage LLC. The confidential survey uniquely measured 15 culture drivers that are critical to the success of an organization, including alignment, execution, and connection, among others.

The San Diego Union-Tribune published the complete list of 2023 Top Workplaces on Sunday, November 19, 2023. The list is available here.

About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Named as a San Diego Metro Area Top Workplace appeared first on Cidara Therapeutics.

SAN DIEGO, Nov. 03, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced new preclinical data on its drug-Fc conjugate (DFC) candidate, CBO421, at the Society for Immunotherapy of Cancer (SITC)’s 38^th Annual Meeting. The conference is taking place November 1-5, 2023, both virtually and in-person in San Diego, CA.

“We look forward to sharing data that demonstrate the potential for CBO421 to potently inhibit tumor growth as both a monotherapy and in combination with PD-1 therapies,” said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. “CD73 plays a significant role in contributing to immune evasion in solid tumors. CBO421, our CD73-targeting DFC, combines the strengths of small molecule inhibitors and monoclonal antibodies against CD73 and demonstrates the potential for best-in-class activity to fully exploit the CD73 target to inhibit immune evasion by cancer cells in-vivo. Based on these data, we’re excited to advance this candidate into clinical trials for the treatment of solid tumors.”

Presentation details are summarized below:

Title: Discovery of CBO421, a first-in-class drug Fc-conjugate (DFC), targeting CD73 in cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Session Location: Ground Level Exhibit Halls A and B1
Date and Time: Friday, November 3, 2023, 12:00-1:30 PDT

About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether nonclinical data generated for CBO421 to date will be predictive of activity in humans, whether pharmacokinetics, toxicology, and other nonclinical data being generated for CBO421 will be adequate to support an IND filing with the FDA, and whether and when any clinical trials of CBO421 may be initiated. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Presents Preclinical Data on Novel Drug-Fc Conjugate CBO421 at SITC’s 38th Annual Meeting appeared first on Cidara Therapeutics.

SAN DIEGO, Nov. 02, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company focused on developing targeted therapies designed to save lives and improve the standard of care for patients facing serious diseases, today reported financial results for the third quarter ended September 30, 2023 and provided an update on its corporate activities and product pipeline.

“We are proud of the recent advancements of both the REZZAYO program as well as our Cloudbreak® drug-Fc conjugate (DFC) platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “The US commercial launch of REZZAYO by our partner Melinta as well as the receipt by our ex-US/ex-Japan partner Mundipharma of the positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) demonstrates continued execution of our rezafungin commercial strategy. In addition, we believe the receipt of an Election to Proceed Notice from Janssen for CD388 for the universal prevention of influenza A and B represents a key validation of the significant potential of this clinical program. Finally, the new data on our oncology DFC programs disclosed at our recently held R&D Day indicate that the advantages of the CD388 program for influenza are translating to our Cloudbreak oncology DFC programs.”

Dr. Stein continued, “our oncology clinical development strategy is being led by Nicole Davarpanah, M.D., J.D., who recently joined Cidara as Senior Vice President of Translational Research & Development. Nicole is a practicing oncology physician and joins us from Genentech/Roche where she has had substantial cancer-focused product development experience. Looking ahead, we look forward to filing an Investigational New Drug Application (IND) in mid-2024 for CBO421, a potential best-in-class inhibitor of CD73.”

Recent Corporate Highlights

• Received Positive CHMP Opinion for Rezafungin for the Treatment of Invasive Candidiasis in Adults: In October 2023, Cidara and Mundipharma Medical Company (Mundipharma) announced that the EMA’s CHMP has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on approval by the end of 2023. In October 2023, Melinta Therapeutics, LLC (Melinta) announced receipt from the Centers for Medicare & Medicaid Services (CMS) of both a product-specific J-Code and a new technology add-on payment (NTAP) for REZZAYO. Outside the U.S. and Japan, Cidara’s development and commercial partner is Mundipharma. Although we have shifted our research focus to our proprietary Cloudbreak platform, we continue to execute on the ongoing ReSPECT Phase 3 pivotal clinical trial for the prevention of invasive fungal infections in adult allogeneic blood and marrow transplant recipients. A significant portion of our future royalties and milestones to be received under both Melinta and Mundipharma licensing agreements are tied to the successful completion of the ReSPECT Phase 3 trial.
• Received Election to Proceed Notice from Janssen Pharmaceuticals, Inc. for CD388, which is being developed for the universal prevention of influenza A and B: In September 2023, Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, delivered to Cidara its Election to Proceed Notice for CD388. Responsibility for future development, manufacturing and commercialization activities of CD388 will be assumed by Janssen, which intends to transfer its rights and obligations under the agreement to another entity. Cidara received a $7.0 million milestone payment from Janssen for the election to proceed for CD388 and other influenza DFCs. Under the collaboration agreement, Cidara is eligible to potentially receive an additional $685.0 million in development, regulatory and commercial milestones, plus tiered royalties on worldwide sales.
• Hosted R&D Day on Cloudbreak development pipeline: In September 2023, Cidara hosted an R&D Day during which the company provided an update on Phase 2a data for CD388, as well as a detailed overview of the potential role of DFCs in oncology. Cidara provided an update on its Cloudbreak pipeline using its oncology DFCs, as well as insight into clinical development considerations for DFCs, focusing on CD73, chemokine receptors, and multispecific DFCs targeting solid tumors.
• Presented at IDWeek 2023: In September 2023, Cidara delivered an oral presentation and two poster presentations highlighting the safety and efficacy of CD388.
• Presented at the 25^th Annual H.C. Wainwright Global Investment Conference: In September 2023, Dr. Stein participated in the 25^th Annual H.C. Wainwright Global Investment Conference.
• Appointed Dr. Davarpanah as Senior Vice President of Translational Research & Development: In August 2023, Cidara appointed Dr. Davarpanah to lead the company’s oncology efforts, focusing on the strategy for preclinical, translational, and early clinical development activities to identify and advance drug candidates through human proof-of-concept studies. She has a decade of experience in oncology drug development and joined Cidara from Genentech/Roche where Dr. Davarpanah most recently served as Clinical and Translational Lead in Oncology.

Third Quarter 2023 Financial Results

• Revenue totaled $12.7 million and $46.3 million for the three and nine months ended September 30, 2023, respectively, compared to $40.7 million and $54.1 million for the same periods in 2022, respectively. Revenue for the three and nine months ended September 30, 2023 related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta, royalty revenue recognized following initiation of the commercial launch of REZZAYO in the U.S. on July 31, 2023, as well as product revenue related to shipment of REZZAYO naked vials to Melinta. Revenue for the three and nine months ended September 30, 2022 related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta, and revenue recognized upon transfer of an intellectual property license to Melinta in August 2022.
• Cash and cash equivalents totaled $48.7 million as of September 30, 2023, compared with $32.7 million as of December 31, 2022.
• Research and development expenses were $17.3 million and $53.2 million for the three and nine months ended September 30, 2023, respectively, compared to $20.0 million and $55.5 million for the same periods in 2022, respectively. The research and development expenses for all periods primarily relate to clinical expenses associated with the rezafungin clinical trials and certain drug manufacturing costs before FDA approval, as well as clinical expenses and drug manufacturing costs associated with the Cloudbreak platform, including CD388 for which Cidara is fully reimbursed under the Janssen Collaboration Agreement.
• General and administrative expenses were $3.6 million and $11.2 million for the three and nine months ended September 30, 2023, respectively, compared to $5.8 million and $15.1 million for the same periods in 2022, respectively. The general and administrative expenses for all periods primarily relate to consulting, personnel and legal costs.
• Net loss for the three months ended September 30, 2023 was $8.2 million, compared to a net income of $15.0 million for the same period in 2022. For the nine months ended September 30, 2023 and 2022, net loss was $17.3 million and $16.4 million, respectively.
• During the three months ended September 30, 2023, Cidara did not sell shares of common stock pursuant to its at-the-market (ATM) sales agreement.
• As of September 30, 2023, Cidara had 90,415,944 shares of common stock outstanding and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 21,044,720 shares of common stock.

About Cidara Therapeutics

Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether the advantages of the CD388 program for influenza will continue to translate to our Cloudbreak oncology DFC programs, whether we will file an IND in mid-2024 for CBO421, whether we will achieve future royalties and milestones under both our Melinta and Mundipharma licensing agreements, and whether we will receive additional milestones, and any royalties, from our collaboration agreement with Janssen. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities, and other obstacles on the enrollment of patients or other aspects of rezafungin, CD388, or other DFC development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com

The post Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results appeared first on Cidara Therapeutics.

• The opinion was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.^2,3
• If approved by the European Medicines Agency, rezafungin could be the first new treatment option in over 10 years for patients with invasive candidiasis.⁴

SAN DIEGO and CAMBRIDGE, England, Oct. 13, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, and Mundipharma today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.¹

The CHMP based its positive opinion on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority* for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. This finding was supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.^2,3 The ReSTORE trial provides evidence of the efficacy and safety of rezafungin as a potential new treatment option for invasive candidiasis with a once-weekly dosing schedule.²

Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.^5,6 It affects seriously ill people, especially those with a weakened immune system where the mortality rate can be 40% or more.^7,8 There is a clear need for alternative options to treat this disease, particularly as there have been no new treatment options over the last decade.^4,9

Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said, “This positive opinion is welcome news for patients who suffer from invasive candidiasis in the European Union where the mortality rate for patients with invasive candidiasis remains high. A new treatment option for these serious infections is a much-needed addition.“

“We would like to thank the CHMP for their careful consideration of the use of rezafungin. This positive opinion represents an important step on the journey towards approval and brings us closer to providing clinicians with an alternative treatment option for invasive Candida infections, giving hope to patients battling this infection and their families,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma.

“Following the FDA approval of rezafungin in the United States earlier this year, the positive CHMP opinion reinforces the benefit of rezafungin and marks an important milestone in our drive to help patients with deadly Candida infections in the European Union,” said Taylor Sandison, M.D., M.P.H, Chief Medical Officer at Cidara.

The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasis in adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months.

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

About invasive candidiasis

Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. ^7,8 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.¹⁰

About rezafungin

Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. Cidara has completed a Phase III clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).¹¹

In this ReSTORE trial, rezafungin met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorisation Application (MAA) submission of global cure at Day 14. Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly versus caspofungin dosed once-daily, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.²

Cidara is also currently conducting a second Phase III clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).

Rezafungin was first approved for the treatment of candidemia and invasive candidiasis in individuals with limited or no alternative treatment options by the FDA in March 2023.¹²

About Cidara Therapeutics

Cidara is using its proprietary Cloudbreak^® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialise in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About Mundipharma

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease and consumer healthcare as well as other severe and debilitating disease areas. Their guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin; whether it will be approved for marketing in the EU; and the likelihood that rezafungin, if approved in the EU, will be prescribed by physicians or approved for reimbursement. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:

Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:

Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com

References:

1. CHMP Opinion. Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rezzayo (last accessed October 2023).
2. Thompson GR, et al. Lancet 2023;401(10370):49-59.
3. Soriano A, et al, Patient-level Meta-Analysis of Efficacy and Safety from STRIVE and ReSTORE: Randomized, Double-blinded, Multicenter Phase 2 and Phase 3 Trials of Rezafungin in the Treatment of candidemia and/or invasive candidiasis, Abstract presented at ECCMID 2022.
4. Ham YY, et al. Future Microbiology 2021;16(1):27-36.
5. Pappas PG, et al. Nat Rev Dis Primers 2018;4:18026.
6. CDC. Invasive candidiasis. Available at: https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed October 2023).
7. Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445-56.
8. Bassetti M, et al. Crit Care 2019;23(1):219.
9. Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14-i25 doi:10.1093/jac/dkx445.
10. Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed October 2023).
11. Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and invasive candidiasis. Available at https://www.mundipharma.com/Cidara-Therapeutics-and-Mundipharma-Announce-Positive-Topline-Results-from-the-Global-Phase-3-Pivotal-ReSTORE-Trial-of-Rezafungin-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis (last accessed October 2023).
12. U.S. Food & Drug Administration. Search Orphan Drug Designations and Approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey= 507215 (last accessed October 2023).

The post Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1) appeared first on Cidara Therapeutics.