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Cidara Therapeutics (CDTX)
NASDAQ:CDTX
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Cidara Therapeutics
(NASDAQ:CDTX)
Rating:48Neutral
Price Target:
$21.00
▼(-7.33%Downside)
Positive Factors
Clinical Trial Progress
The NAVIGATE Phase 2b trial of drug-Fc conjugate CD388 for flu prevention shows a promising probability-of-success based on pre-clinical and human challenge trial efficacy.
Market Opportunity
CD388 has potential for peak sales >$1.5B in the U.S. for immunocompromised patients, based on estimates.
Product Potential
CD388 promises an end to the Russian Roulette of seasonal flu vaccines, which have ranged from 19% to 60% in protection from flu infection during the last 14 years.
Negative Factors
Regulatory Uncertainty
The company's recent regulatory discussions with the FDA could signal important updates and potential changes to the trial's statistical analysis plan.
Trial Dependency
CDTX is expected to announce topline data from the Ph2b trial evaluating lead asset CD388 as a flu prophylaxis, with the readout being a binary catalyst for the stock.
Cidara Therapeutics (CDTX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$281.19M
Dividend YieldN/A
Average Volume (3M)135.73K
Price to Earnings (P/E)―
Beta (1Y)1.56
Revenue Growth-99.35%
EPS Growth-260.33%
CountryUS
Employees38
SectorHealthcare
Sector Strength42
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.66
Shares Outstanding12,969,823
10 Day Avg. Volume186,371
30 Day Avg. Volume135,731
Financial Highlights & Ratios
PEG Ratio0.04
Price to Book (P/B)1.11
Price to Sales (P/S)0.00
P/FCF Ratio-1.32
Enterprise Value/Market Cap0.17
Enterprise Value/Revenue0.39
Enterprise Value/Gross Profit6.65
Enterprise Value/Ebitda-0.23
Forecast
1Y Price Target
$41.17Price Target Upside81.69% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
Cidara Therapeutics Business Overview & Revenue Model
Company DescriptionCidara Therapeutics, Inc., a biotechnology company, focuses on the discovery, development, and commercialization of long-acting anti-infectives for the treatment and prevention of infectious diseases and oncology in the United States. The company's lead product candidate is rezafungin acetate, a novel molecule in the echinocandin class of antifungals for the treatment and prevention of invasive fungal infections, including candidemia and invasive candidiasis, which are fungal infections associated with high mortality rates. It also advances its Cloudbreak platform to develop conjugates for the prevention and treatment of influenza and other viral infections, such as RSV, HIV, and the SARS-CoV-2 strains causing COVID-19. The company was formerly known as K2 Therapeutics, Inc. and changed its name to Cidara Therapeutics, Inc. in July 2014. Cidara Therapeutics, Inc. was incorporated in 2012 and is based in San Diego, California.
How the Company Makes MoneyCidara Therapeutics generates revenue through a combination of product sales, licensing agreements, and collaborative partnerships. The company earns money by developing and commercializing its drug candidates, particularly its lead product candidates in the areas of antifungal and antiviral treatments. Cidara enters into strategic partnerships with larger pharmaceutical companies to co-develop and market its products, which provides milestone payments and royalties as sources of income. Additionally, the company's collaborations often include research and development funding to advance its pipeline of innovative therapies. These partnerships and licensing agreements are significant factors contributing to Cidara's earnings, allowing it to leverage external resources and expertise to bring its products to market.
Cidara Therapeutics Earnings Call Summary
Earnings Call Date:May 08, 2025
(Q1-2025)
| % Change Since: 18.33%|
Next Earnings Date:Aug 13, 2025
Earnings Call Sentiment Neutral
The earnings call emphasizes significant progress in the development of CD388, demonstrating promising results in early trials and advancing to a phase 2b study. There is optimism around the potential phase 3 study and the commercial opportunity, highlighted by the planned R&D day. However, the company's current non-revenue generating status and challenges with the NAVIGATE study's design and dose-dependent efficacy present notable concerns.Q1-2025 Updates
Positive Updates
Introduction of CD388
CD388 aims to revolutionize the prevention of influenza by offering universal activity against all flu strains, not dependent on the host immune system, and combines a novel multivalent presentation of zanamivir with a human antibody fragment to prolong half-life.
Successful Phase 1 and Phase 2a Trials
Phase 1 single ascending dose study showed CD388 to be well tolerated with an extended half-life. Phase 2a human challenge study showed substantial protective efficacy, supporting its advancement to a phase 2b study.
Progress of NAVIGATE Phase 2b Study
NAVIGATE study completed dosing of 5,041 subjects by December, with top-line data expected by June. The study aims to determine dose selection for phase three.
Potential Phase 3 Study
Based on phase 2b results and FDA discussions, a phase 3 study is planned for February in high-risk comorbid and immune-compromised patients, addressing unmet needs.
R&D Day Announcement
An R&D day is planned for May 22 to provide updates on the NAVIGATE trial, regulatory discussions, and phase 3 plans, emphasizing the potential commercial opportunity for CD388.
Negative Updates
Non-Revenue Generating Status
Cidara Therapeutics is currently a non-revenue generating company, focusing on developing its CD388 program.
NAVIGATE Study Not Powered for Statistical Significance
The initial design of the NAVIGATE study was not powered for statistical significance, requiring discussions with the FDA to adjust the statistical analysis plan.
Challenges in Determining Dose-Dependent Efficacy
There are uncertainties regarding the dose-dependent response due to varying exposure in the NAVIGATE study, impacting data confidence and next steps.
Company Guidance
During the earnings call for the first quarter of 2025, Cidara Therapeutics, Inc. focused on the progress of their lead asset, CD388, a novel drug designed to prevent influenza. The company highlighted the completion of dosing for the phase 2b NAVIGATE study, which involved 5,041 subjects randomized into three dose groups (150 mg, 300 mg, or 450 mg) and one placebo group. Top-line data from this study, which was not initially powered for statistical significance, are expected by June 2025. Due to the severity of the February 2025 flu season, Cidara is in discussions with the FDA to potentially amend the study's statistical analysis to evaluate the statistical significance of CD388's efficacy. CD388 has shown promise in preclinical and early-phase clinical trials, demonstrating substantial protective efficacy and a well-tolerated safety profile, with potential broad applications beyond the initial target populations. The company plans to initiate a phase 3 study in the Southern Hemisphere in February 2026, focusing on high-risk and immune-compromised populations.Cidara Therapeutics Financial Statement Overview
Summary
Cidara Therapeutics faces significant financial challenges with persistent losses and negative cash flows. While the balance sheet shows low leverage, the company relies heavily on external financing to fund operations. The biotechnology industry often requires long-term investment before profitability, yet the current financial trajectory suggests a need for strategic improvements to ensure sustainability.Income Statement
Cidara Therapeutics has experienced a significant revenue decline in the latest year, with a revenue growth rate of -98% from the previous year. The net profit margin is deeply negative, at -13362.04% for 2024, indicating substantial losses relative to revenue. The gross profit margin is also negative, suggesting that the company is selling below cost. While biotechnology companies often face high R&D expenses, the magnitude of losses is concerning.35
Negative
Balance Sheet
The company's debt-to-equity ratio is low due to a relatively high stockholders' equity, indicating low leverage. However, the equity ratio is 76.02%, reflecting a stable capital structure. Despite this, the company has historically negative equity, raising concerns about sustainable financial health. The increase in cash reserves provides some liquidity cushion.40
Negative
Cash Flow
Operating cash flow is significantly negative, although there has been substantial cash inflow from financing activities. Free cash flow remains negative, and the operating cash flow to net income ratio is negative, due to both operating cash flow and net income being negative. The company is heavily dependent on external financing to sustain operations.45
Neutral
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 1.27M | 63.91M | 64.29M | 49.57M | 12.07M | Gross Profit |
| -83.61M | 62.38M | 64.14M | 49.38M | -55.95M | EBIT |
| -176.10M | -24.48M | -29.72M | -42.26M | -71.85M | EBITDA |
| -176.10M | -24.36M | -33.36M | -42.26M | -71.56M | Net Income Common Stockholders |
| -169.83M | -22.93M | -29.80M | -43.91M | -72.37M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 189.82M | 35.78M | 32.73M | 62.27M | 35.91M | Total Assets |
| 214.80M | 67.03M | 47.59M | 75.33M | 60.42M | Total Debt |
| 3.58M | 4.88M | 1.32M | 5.06M | 7.96M | Net Debt |
| -186.25M | -30.90M | -31.41M | -57.21M | -27.95M | Total Liabilities |
| 51.49M | 75.24M | 50.50M | 53.75M | 49.71M | Stockholders Equity |
| 163.31M | -8.21M | -2.90M | 21.57M | 10.71M |
| Cash Flow | Free Cash Flow | |||
| -176.66M | -22.94M | -28.59M | -25.27M | -54.60M | Operating Cash Flow |
| -176.53M | -22.43M | -28.47M | -25.23M | -54.41M | Investing Cash Flow |
| -129.00K | -505.00K | -118.00K | -41.00K | -186.00K | Financing Cash Flow |
| 337.06M | 25.98M | -951.00K | 44.60M | 37.28M |
Cidara Therapeutics Technical Analysis
Positive
22.66
Price Trends
20.98
Positive
21.47
Positive
18.31
Positive
Market Momentum
0.64
Positive
51.64
Neutral
10.16
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CDTX, the sentiment is Positive. The current price of 22.66 is above the 20-day moving average (MA) of 22.26, above the 50-day MA of 20.98, and above the 200-day MA of 18.31, indicating a bullish trend. The MACD of 0.64 indicates Positive momentum. The RSI at 51.64 is Neutral, neither overbought nor oversold. The STOCH value of 10.16 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for CDTX.
Cidara Therapeutics Risk Analysis
Cidara Therapeutics disclosed 60 risk factors in its most recent earnings report. Cidara Therapeutics reported the most risks in the “Finance & Corporate” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 1 New Risks
1.
Due to the delayed filing with the SEC of our Annual Report on Form 10-K for the year ended December 31, 2023, we are not currently eligible to use a registration statement on Form S-3 to register the offer and sale or resale of securities, which may adversely affect our ability to raise future capital. Q4, 2024
Cidara Therapeutics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
60 Neutral | $244.17M | ― | -248.97% | ― | 86.63% | 22.29% | |
53 Neutral | $5.24B | 3.28 | -44.98% | 2.81% | 16.82% | -0.32% | |
51 Neutral | $227.42M | ― | 322.49% | ― | -30.66% | 36.48% | |
48 Neutral | $281.19M | ― | -299.58% | ― | -99.35% | -260.33% | |
41 Neutral | $291.49M | ― | -100.13% | ― | ― | -71.53% | |
41 Neutral | $383.50M | ― | -23.68% | ― | ― | 14.60% | |
33 Underperform | $237.22M | ― | -124.74% | ― | ― | -20.39% |
* Healthcare Sector Average
Performance Comparison
CDTX
Cidara Therapeutics
22.66
10.25
82.59%
OCGN
Ocugen
0.84
-0.86
-50.59%
CRVS
Corvus Pharmaceuticals
4.03
1.82
82.35%
ITOS
iTeos Therapeutics
10.01
-6.97
-41.05%
FHTX
Foghorn Therapeutics
4.17
-2.03
-32.74%
TVGN
Tevogen Bio Holdings
1.29
0.50
63.29%
Cidara Therapeutics Corporate Events
Executive/Board ChangesBusiness Operations and Strategy
Cidara Therapeutics Announces CFO Transition
Neutral
Feb 18, 2025
Cidara Therapeutics announced that its Chief Financial Officer, Dr. Preetam Shah, will be leaving the company effective February 24, 2025, with Frank Karbe appointed as his successor. Dr. Shah’s departure is part of a mutual agreement, and he will serve as a consultant for six months post-departure, while Mr. Karbe joins with a robust background in finance and leadership roles in biopharmaceutical companies, potentially strengthening Cidara’s financial strategy and industry positioning.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.