Cidara Therapeutics(CDTX)

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Phathom Pharmaceuticals Appoints Ted Schroeder to its Board of Directors
Newsfilter· 2025-04-16 12:00
Core Insights - Phathom Pharmaceuticals has appointed Ted Schroeder to its Board of Directors, which is seen as a strategic move during a critical time for the company [1][3]. Company Overview - Phathom Pharmaceuticals is focused on developing and commercializing novel treatments for gastrointestinal diseases, including the first-in-class potassium-competitive acid blocker (PCAB) vonoprazan, marketed as VOQUEZNA® [7]. Leadership Experience - Ted Schroeder brings over 30 years of experience in the biopharmaceutical industry, having held leadership roles in various companies and successfully guiding them through significant milestones and transactions [2][4]. - His previous roles include CEO of Nabriva Therapeutics and co-founder of Cadence Pharmaceuticals, which was acquired for $1.4 billion [4]. Strategic Importance - The appointment of Schroeder is expected to enhance Phathom's operational and commercial capabilities, particularly as the company aims to accelerate its commercial momentum and deliver innovative therapies to patients [3][5].
Cidara Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-04-01 20:05
Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies [3] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [3] - Cidara is headquartered in San Diego, California [3] Recent Developments - Cidara will participate in the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025, at 11:00 AM ET [1] - The company has completed enrollment of its 5000 patient Phase 2b NAVIGATE trial for CD388 in December 2024 [3] - Cidara received Fast Track Designation from the U.S. FDA for CD388 in June 2023 [3] - In July 2024, Cidara received IND clearance for CBO421, targeting CD73 in solid tumors [3] Investor Engagement - Cidara will engage in one-on-one investor meetings during the Needham conference [2] - Investors interested in meetings should contact their Needham representative directly [2]
Wall Street Analysts Predict a 64.5% Upside in Cidara Therapeutics (CDTX): Here's What You Should Know
ZACKS· 2025-03-21 14:55
Summary of Cidara Therapeutics (CDTX) Core Viewpoint - Cidara Therapeutics (CDTX) shows potential for significant upside, with a mean price target of $38 indicating a 64.5% increase from the current price of $23.10 [1]. Price Target Analysis - The average price target consists of six estimates ranging from $33 to $46, with a standard deviation of $5.87, suggesting a consensus among analysts [2]. - The lowest estimate indicates a 42.9% increase, while the highest suggests a 99.1% upside [2]. - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement [7]. Earnings Estimates and Analyst Sentiment - Analysts have shown strong agreement in revising earnings per share (EPS) estimates higher, which correlates with potential stock price increases [9]. - The Zacks Consensus Estimate for the current year has risen by 50.5% over the past month, with no negative revisions [10]. - CDTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11]. Caution on Price Targets - While price targets are a common tool for investors, they can often mislead, and reliance solely on them may not yield favorable returns [5][8]. - Analysts may set optimistic price targets due to business incentives, which can inflate expectations [6].
Cidara Therapeutics to Participate in World Health Organization Meeting on H5N1 Influenza Preparedness and Response
Newsfilter· 2025-03-19 12:00
SAN DIEGO, March 19, 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 participation in the "Other pharmaceuticals as preventive tools" panel at a World Health Organization (WHO) global meeting on H5N1 influenza preparedness and response. The meeting, titled "What research is important to prepare and respond to H5N1 influenza outbreaks," will be held virtuall ...
Cidara Therapeutics Announces Two Presentations on CD388 in Influenza at International Conference on Antiviral Research (ICAR) 2025
Newsfilter· 2025-03-18 12:00
SAN DIEGO, March 18, 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 two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara's presentations will highlight the study design, demographic information, and preliminary safety data from the ongoin ...
Cidara Therapeutics Announces Two Presentations on CD388 in Influenza at International Conference on Antiviral Research (ICAR) 2025
Globenewswire· 2025-03-18 12:00
SAN DIEGO, March 18, 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 two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara’s presentations will highlight the study design, demographic information, and preliminary safety data from the ongoi ...
Cidara Therapeutics Announces Publication of CD388 Preclinical Data in Nature Microbiology
Newsfilter· 2025-03-17 10:00
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 ...
Cidara Therapeutics(CDTX) - 2024 Q4 - Annual Results
2025-03-06 21:40
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 ...
Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results
Globenewswire· 2025-03-06 21:35
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]
Cidara Therapeutics(CDTX) - 2024 Q4 - Annual Report
2025-03-06 21:25
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].