Data highlights potential of CD388 as a potent, universal antiviral for influenza prevention regardless of immune status SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced the publication of preclinical data assessing CD388, the company's influenza DFC, in the peer-reviewed scientific journal Nature Microbiology. The article, entitled "Dru ...

Exhibit 99.1 Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results SAN DIEGO, March 6, 2025 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies, today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided recent business updates. ® "2024 was a transformational year for Cidara as we rea ...

Core Insights - Cidara Therapeutics reported a transformational year in 2024, highlighted by the reacquisition of rights to the CD388 program and raising a total of $345 million to support its clinical trials [2][6] - The company completed enrollment for the Phase 2b NAVIGATE trial, which evaluates CD388 for the prevention of seasonal influenza, with results expected in mid-2025 [6][9] - Cidara's financial results showed a significant increase in cash reserves, with cash and equivalents totaling $196.2 million as of December 31, 2024, compared to $35.8 million in 2023 [6][15] Recent Corporate Highlights - Cidara completed the enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across the U.S. and UK [6] - The company raised $105 million in a private placement led by Venrock Healthcare Capital Partners [6] - Equity research coverage was significantly expanded with new ratings from Guggenheim, Cantor, and RBC [6] Financial Results - Collaboration revenue was reported as zero for Q4 2024, down from $2.8 million in Q4 2023, and $1.3 million for the full year 2024, down from $23.3 million in 2023 [12][9] - Research and development expenses increased to $46.9 million for Q4 2024 and $71.9 million for the full year, compared to $8.0 million and $36.8 million in 2023, primarily due to the CD388 trial [9][12] - The net loss for Q4 2024 was $52.3 million, compared to $3.2 million in Q4 2023, and the full year net loss was $169.8 million, compared to $22.9 million in 2023 [12][9] Balance Sheet Data - As of December 31, 2024, total assets were $214.8 million, significantly up from $67.0 million in 2023 [15] - Total liabilities decreased to $51.5 million from $75.2 million in 2023, while total stockholders' equity improved to $163.3 million from a deficit of $8.2 million [15]

Financial Position - As of December 31, 2024, the company had cash, cash equivalents, and restricted cash totaling $196.2 million[153]. - The company incurred a net loss of $169.8 million for the year ended December 31, 2024, compared to a net loss of $22.9 million for the year ended December 31, 2023[165]. - The company anticipates significant operating losses will continue for the foreseeable future, with an accumulated deficit of $611.3 million as of December 31, 2024[165]. - The company raised total gross proceeds of $240.0 million from the April 2024 Private Placement, with $85.0 million allocated for a license and technology transfer agreement with J&J Innovative Medicine[159]. - In November 2024, the company received total gross proceeds of $105.0 million from the sale of 3,892,274 shares of common stock and pre-funded warrants[160]. - The company may face challenges in raising additional capital due to current market conditions, which could adversely affect its business and financial condition[154]. Product Development and Clinical Trials - CD388 has completed Phase 2a clinical development, with a Phase 2b NAVIGATE trial initiated in September 2024 and enrollment completed by December 4, 2024[175][177]. - The company received IND clearance for CD388 in March 2022 and for CBO421 in July 2024[175]. - Successful development and commercialization of product candidates are uncertain and depend on various factors, including regulatory approvals and clinical trial outcomes[178][182]. - The company expects to incur substantial expenses related to clinical trials and regulatory approvals, which may impact its financial position[166]. - Delays in patient enrollment for clinical trials could lead to increased development costs and potential abandonment of the CD388 program[181][188]. - The company relies heavily on third-party contractors for clinical trials, and difficulties with these contractors could result in significant delays[180]. - Clinical trials are expensive and time-consuming, with outcomes that are difficult to predict, potentially impacting timelines for marketing approval[182][185]. - The company must demonstrate safety and efficacy in clinical trials to obtain marketing approvals, which may require additional studies[188][186]. Competition and Market Risks - The company faces significant competition from major pharmaceutical and biotechnology companies in the development of treatments for infectious diseases[199]. - Market acceptance of any approved product candidates is uncertain and will depend on factors such as efficacy, pricing, and competition[193][197]. - The company acknowledges that competitors may develop more effective or cost-efficient products, potentially establishing a strong market position before the company can enter[201]. - Many competitors possess greater financial resources and expertise in R&D, which may concentrate resources further through mergers and acquisitions[202]. - The company may face significant delays in obtaining coverage and adequate reimbursement for newly approved products, impacting commercialization efforts[210]. Manufacturing and Supply Chain - The company relies on third-party manufacturers for the production of its product candidates, which poses risks including potential delays in clinical development and marketing approval[226]. - There are limited manufacturers capable of complying with current U.S. Good Manufacturing Practice (cGMP) requirements, which could impact the supply chain[228]. - The company is exposed to supply disruptions and increased costs due to trade tensions between the U.S. and China, affecting its ability to work with certain Chinese biotechnology companies[230]. - The company currently has no alternate manufacturing plans, which could lead to delays and loss of revenue if a change in manufacturers is required[235]. - The company anticipates future dependence on third parties for manufacturing, which may adversely affect profit margins and commercialization timelines[231]. Regulatory and Compliance Challenges - Regulatory approval processes for product candidates are complex and costly, with potential delays impacting commercialization and revenue generation[238]. - The company may face penalties and restrictions if it fails to comply with healthcare laws and regulations, which could harm its operations and profitability[242]. - The pharmaceutical industry in China is highly regulated, and any failure to comply with regulations could result in suspension or termination of clinical activities[284]. - Recent legislative changes, including the Inflation Reduction Act of 2022, may impact pricing and reimbursement for newly approved drugs, affecting profitability[287]. - The Affordable Care Act and subsequent regulations have revised the definition of "average manufacturer price," potentially increasing Medicaid drug rebates[287]. Intellectual Property Risks - The company relies on a combination of patents, trademarks, and trade secret protection to safeguard its intellectual property, which is critical for competitive positioning[295]. - There is uncertainty regarding the strength and breadth of patents in the biotechnology field, which could affect the company's ability to commercialize its product candidates[296]. - The inability to obtain, enforce, and defend patents covering proprietary technologies would materially and adversely affect the company's business prospects[302]. - Noncompliance with patent application requirements could lead to abandonment or lapse of patent rights, impacting the company's competitive position[304]. - Third-party claims of intellectual property infringement may delay the company's drug discovery and development efforts[305]. Cybersecurity and Data Privacy - Cybersecurity threats pose risks to the confidentiality and integrity of sensitive data, potentially leading to regulatory investigations and loss of revenue[247]. - The company is subject to various evolving cybersecurity threats, including ransomware attacks that can significantly disrupt operations and lead to reputational harm[251]. - The company has experienced increased risks to its information technology systems due to remote work, which may expose vulnerabilities in acquired entities' systems[255]. - The company relies on third parties for critical business operations, which introduces additional cybersecurity risks and potential adverse consequences if those third parties experience security incidents[256]. - The company is subject to stringent U.S. and foreign data privacy and security laws, which could lead to regulatory investigations, fines, and reputational harm if not complied with[265]. Management and Operational Risks - The company is highly dependent on its senior management team and may face challenges in retaining qualified personnel amid competition from other firms[337]. - Future expansion plans may lead to difficulties in managing growth, potentially disrupting operations and delaying business plans[340]. - Effective internal controls over financial reporting are necessary to ensure reliable financial statements, and any failure in this area could impair public reporting[346].

Company Overview - Cidara Therapeutics, Inc. is a biotechnology company focused on developing drug-Fc conjugate (DFC) immunotherapies using its proprietary Cloudbreak® platform [1][3] - The company's lead DFC candidate, CD388, is designed for long-acting antiviral treatment aimed at universal prevention of seasonal and pandemic influenza with a single dose [3] Leadership Change - Frank Karbe has been appointed as the Chief Financial Officer (CFO) effective February 24, 2025, succeeding Preetam Shah, who will transition to a consulting role [1][2] - Karbe brings over 25 years of leadership experience in life sciences and healthcare, having previously served as CEO of Better Therapeutics and CFO of Myovant Sciences, where he played a key role in raising over $2 billion in capital [2] Clinical Development - Cidara is advancing its long-acting influenza antiviral drug CD388 through the Phase 2b NAVIGATE study, with plans for Phase 3 and beyond [2] - CD388 received Fast Track Designation from the FDA in June 2023, and a Phase 2b trial was initiated in September 2024 [3] Equity Awards - In connection with Karbe's appointment, Cidara's Compensation Committee granted him stock options and restricted stock units (RSUs) for a total of 172,500 shares, with a vesting schedule over four years [4][5] - The stock options will have an exercise price equal to the closing price of Cidara's common stock on the grant date [4] Inducement Incentive Plan - The equity awards were granted as an inducement for Karbe's employment, in accordance with Nasdaq Listing Rule 5635(c)(4) [5][6]

Core Viewpoint - Cidara Therapeutics is actively participating in the Guggenheim Securities SMID Cap Biotech Conference, showcasing its innovative drug-Fc conjugate (DFC) immunotherapies aimed at improving patient care for serious diseases [1][2]. Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak platform to develop novel DFCs, which consist of targeted small molecules or peptides linked to a human antibody fragment [3]. - The lead DFC candidate, CD388, is designed for long-acting antiviral treatment to provide universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [3]. - CD388 received Fast Track Designation from the U.S. FDA in June 2023, and the company completed Phase 2b enrollment in December 2024 [3]. - Cidara has also developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received IND clearance in July 2024 [3]. Event Participation - Jeffrey Stein, Ph.D., President and CEO of Cidara, will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference on February 5, 2025, at 1:30 PM ET [1]. - Cidara will engage in one-on-one investor meetings during the conference, with interested investors encouraged to contact their Guggenheim representative [2].

Group 1 - Cidara Therapeutics, Inc. (CDTX) has reached a key level of support and is showing potential for a bullish breakout due to a "golden cross" formation, where the 50-day simple moving average has crossed above the 200-day simple moving average [1] - The golden cross indicates a positive trend reversal after a downtrend, consisting of three stages: a downtrend, the crossover of moving averages, and continued upward momentum [1] - CDTX has experienced a significant price increase of 44% over the last four weeks, suggesting a potential breakout [2] Group 2 - The earnings expectations for CDTX have improved, with changes higher compared to none lower over the past 60 days, indicating a positive outlook [2][3] - The Zacks Consensus Estimate for CDTX has also moved up, reinforcing the bullish sentiment among investors [3] - The current technical indicators and positive earnings revisions suggest that investors may want to monitor CDTX for further gains in the near future [3]

Group 1 - Cidara Therapeutics (NASDAQ: CDTX) is advancing its drug-FC conjugate (DFC) utilizing the proprietary Cloudbreak technology platform [2] - The DFC molecules are designed to inhibit the proliferation of targeted pathogens, showcasing the potential of the Cloudbreak platform in drug development [2] Group 2 - The Biotech Analysis Central service offers extensive resources for healthcare investors, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2]

Core Viewpoint - Cidara Therapeutics reported its third-quarter financial results and provided updates on its clinical programs, particularly focusing on the CD388 candidate for influenza prevention, while also announcing organizational changes to enhance resource efficiency [1][2][3]. Corporate Highlights - The initiation of the Phase 2b NAVIGATE clinical trial for CD388 marks a significant milestone, aiming to evaluate its efficacy and safety for seasonal influenza prevention [2][3]. - The trial will enroll 5,000 healthy, unvaccinated adults, comparing the rates of influenza between those receiving CD388 and a placebo [3]. - Positive data from previous studies were presented at conferences, indicating CD388's potential for effective prevention with a single dose [3]. - The Scientific Advisory Board was strengthened with four experts in infectious diseases to support the CD388 trial [3]. - A workforce reduction of approximately 30% was implemented to focus on CD388's clinical development, expected to lower capital needs [3]. Financial Results - As of September 30, 2024, cash and cash equivalents were $127.4 million, a significant increase from $35.8 million at the end of 2023 [4][10]. - Revenue for the third quarter was zero, down from $9.2 million in the same period of 2023, primarily due to the termination of the collaboration agreement with Janssen [4]. - Research and development expenses increased to $12.4 million for the third quarter, compared to $10.4 million in 2023, driven by costs associated with the CD388 trial [4]. - The net loss for the third quarter was $16.0 million, compared to a net loss of $9.1 million in the same period of 2023 [4][9]. - Total assets as of September 30, 2024, were $162.3 million, up from $67.0 million at the end of 2023 [10].

Financial Performance - Revenue was zero for the three months ended September 30, 2024, and $1.3 million for the nine months ended September 30, 2024, compared to $9.2 million and $20.5 million for the same periods in 2023, respectively [3]. - Net loss for the three and nine months ended September 30, 2024, was $16.0 million and $117.5 million, respectively, compared to a net loss of $9.1 million and $19.7 million for the same periods in 2023 [5]. - Total revenues for the three months ended September 30, 2024, were $0, compared to $9,217,000 for the same period in 2023, representing a decrease of 100% [10]. - The net loss for the three months ended September 30, 2024, was $15,985,000, compared to a net loss of $9,107,000 in 2023, indicating a widening of 75.5% [10]. - Basic and diluted net loss per common share from continuing operations was $(2.38) for the three months ended September 30, 2024, compared to $(0.85) in 2023 [10]. - Basic and diluted net loss per common share for the nine months ended September 30, 2024, was $(22.61), compared to $(3.91) in 2023, indicating a significant increase in losses [10]. Expenses - Research and development expenses were $12.4 million for the three months ended September 30, 2024, compared to $10.4 million for the same period in 2023, primarily due to higher expenses associated with the CD388 Phase 2b NAVIGATE study [3]. - Selling, general and administrative (SG&A) expenses were $5.0 million for the three months ended September 30, 2024, compared to $3.3 million for the same period in 2023 [3]. - Total operating expenses for the three months ended September 30, 2024, were $17,394,000, compared to $13,685,000 in 2023, marking an increase of 27.5% [10]. - Research and development expenses increased to $12,429,000 for the three months ended September 30, 2024, up from $10,386,000 in 2023, reflecting a growth of 19.7% [10]. - Acquired in-process research and development expenses were $84.9 million for the nine months ended September 30, 2024, related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement [3]. Cash and Assets - Cash and cash equivalents totaled $127.4 million as of September 30, 2024, compared to $35.8 million as of December 31, 2023 [3]. - Cash and cash equivalents as of September 30, 2024, were $127,386,000, significantly up from $35,778,000 as of December 31, 2023, showing an increase of 255.5% [11]. - Total assets increased to $162,331,000 as of September 30, 2024, compared to $67,030,000 at the end of 2023, representing a growth of 142.5% [11]. - Total liabilities decreased to $46,701,000 as of September 30, 2024, down from $75,240,000 at December 31, 2023, reflecting a reduction of 37.9% [11]. - Total stockholders' equity improved to $115,630,000 as of September 30, 2024, compared to a deficit of $8,210,000 at December 31, 2023 [11]. Clinical Development - Cidara initiated a Phase 2b NAVIGATE trial targeting enrollment of 5,000 healthy, unvaccinated adult subjects for CD388, with subjects being followed for the remainder of the influenza season [1]. - Cidara's lead DFC candidate, CD388, received Fast Track Designation from the FDA in June 2023, and the company announced the initiation of a Phase 2b trial in September 2024 [7]. - Cidara restructured its workforce with an approximate 30% reduction to focus on the clinical development of CD388 [2]. Discontinued Operations - The sale of rezafungin assets to Napp Pharmaceutical Group Limited is classified as discontinued operations, with a net loss from discontinued operations of $0.5 million for the three months ended September 30, 2024 [5].