Cidara Therapeutics Inc (CDTX) Q1 2025 Earnings Call Highlights: Promising Advances in ...
Release Date: May 08, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Cidara Therapeutics Inc (NASDAQ:CDTX) is advancing its CD 388 program, which aims to revolutionize influenza prevention with a novel drug conjugate.
The CD 388 drug has shown promising preclinical data, published in Nature Microbiology, highlighting its potential as a universal antiviral for influenza A and B.
The phase 2B Navigate study for CD 388 is underway, with dosing completed for over 5,000 subjects, and top-line data expected by the end of June.
Cidara Therapeutics Inc (NASDAQ:CDTX) is in discussions with the FDA to potentially evaluate statistical significance in their phase 2B study due to the severity of the flu season.
The company plans to initiate a phase 3 study in high-risk populations, focusing on those underserved by current vaccines and antivirals, in the spring of 2026.
Cidara Therapeutics Inc (NASDAQ:CDTX) is currently a non-revenue generating company, which may pose financial sustainability challenges.
The Navigate study was not initially powered for statistical significance, which could impact the robustness of the results.
There is uncertainty regarding the pricing and market size for CD 388, with discussions on potential pricing above initial estimates.
The company is still finalizing the definition of high-risk patient populations for its phase 3 study, indicating ongoing strategic planning.
The final data for the phase 2B study, including pharmacokinetic data, will not be available until September, delaying comprehensive analysis.
Warning! GuruFocus has detected 8 Warning Signs with CDTX.
Q: Have you had discussions with the FDA regarding the statistical analysis for the Phase 2B study, or are those discussions still ongoing? A: Yes, we have had those discussions and look forward to sharing the statistical analysis plan update at our May 22nd R&D Day event. (Jeff Stein, CEO)
Q: Historically, you've mentioned a potential patient population of 20 million. Do you see a broader opportunity than that, and what about pricing dynamics? A: Our thinking has evolved, and we see a substantial opportunity in high-risk comorbid and immune-compromised populations. We also see potential for pricing above the previously mentioned range, reflecting the product's value. More details will be shared at the R&D Day. (Jeff Stein, CEO and Jim Bidel, Chief Business Officer)
Q: How should we think about CD 388's positioning amidst discussions about vaccines and evolving views on them? A: CD 388 is initially targeted at high-risk populations underserved by vaccines. There's potential for complementarity with vaccines, as CD 388 targets a different mechanism. We aim to develop it in conjunction with existing vaccines. (Jeff Stein, CEO)
Q: Can you provide details on the primary endpoint for the Navigate study and the data collection process? A: The primary endpoint is preventive efficacy, evaluated by centrally confirmed influenza infection, which includes nasopharyngeal PCR positivity, body temperature, and symptom criteria. It's a robust evaluation to confirm symptomatic and severe flu. (Nicole Dorapan, Chief Medical Officer)
Q: Are you expecting a dose-dependent response on efficacy in the Phase 2B study, and how important is it to see this dose response? A: We expect to see a dose dependence, but more importantly, an exposure dependence. The relationship between exposure and efficacy will be crucial, and we hope to discuss this when we disclose top-line data. (Jeff Stein, CEO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
21 minutes ago
- Yahoo
Former head trader of Denver-based investing company pleads guilty to insider trading
DENVER (KDVR) — A Connecticut man pleaded guilty to an insider trading charge on Friday for actions he took while employed at Denver-based firm Irving Investors. Ryan Squillante, 40, of Weston, Connecticut, was employed as the head of equity trading at Irving Investors at the time of the offense, according to the U.S. Attorney's Office for the District of Connecticut. While there, he received 'material non-public information' about some publicly traded companies. Australian hacker sentenced in May arrested by HSI Denver, faces deportation Prosecutors say that Squillante used MNPI on 15 different occasions between August 2022 and May 2023 for his own benefit, profiting about $220,912 from the transactions, according to the attorney's office. The U.S. Attorney's Office for the District of Connecticut provided an example of one of the times Squillante reportedly received MNPI about a clinical-stage biopharmaceutical company called Praxis Precision Medicines. Praxis is traded on the NASDAQ. The prosecutors said that between Feb. 27, 2023, and March 2, 2023, Squillante 'sold short' over 38,000 shares of Praxis for an average price per share of $3.04. On March 3, prosecutors say Squillante announced poor results of the company's drug trial before the market opened. Following that announcement, Squillante 'covered' the same number of shares at an average price of $1.82 per share, making a profit of about $46,421. Squillante pleaded guilty to securities fraud, which has a maximum term of imprisonment of 20 years. He's scheduled to be sentenced on Aug. 29. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
21 minutes ago
- Yahoo
Safeway, Albertsons employees vote to strike as King Soopers negotiations stagnate
DENVER (KDVR) — Another grocery worker strike is in the works after UFCW Local 7 workers at Safeway and Albertsons Companies voted overwhelmingly in favor of the action — some stores voting unanimously in favor of the strike. No strike date has been set, although workers at stores along the Front Range and across Colorado have authorized the union action. The union is alleging unfair labor practices, and says that Safeway and Albertsons is 'holding hands' with King Soopers to try and cut workers' healthcare benefits. Former head trader of Denver-based investing company pleads guilty to insider trading 'Ontop of the concessionary proposals at the negotiating table, Safeway and Albertsons have gone back on their agreements,' said UFCW Local 7 President Kim Cordova in a press release on Friday. The union says the stores are understaffed and that the company is backtracking on an agreement for retroactive pay and benefit increases, which the labor union cited as an unfair labor practice. Bargaining between the union and the company began months ago, but on Sunday, the union said the two grocery giants are working together despite a failed merger that the two companies had proposed. In May, Albertsons provided FOX31 with a statement about its ongoing negotiations with the union. 'At Albertsons Companies, we are committed to productive discussions with UFCW Local 7. We respect the rights of workers to engage in collective bargaining and are negotiating in good faith to reach an agreement that is fair to our employees, good for our customers and allows our company to remain competitive,' the company stated. FOX31 reached out to Safeway and Albertsons for further comment after the strike votes confirmed the impending union action, but has not gotten a response. Earlier this year, workers at King Soopers went on strike for unfair labor practices. In a Facebook post on Sunday, the union noted that its negotiations with the company have not resulted in any new agreements, and the previous peaceful relations agreement that ended the strike in February will expire at midnight. The agreement's end was noted in a bargaining update posted to Facebook. 'More importantly, the Company is continuing to hold hands with Safeway/Albertsons to crush workers at both Safeway/Albertsons and King Soopers/City Market,' the union said in its post. 'These two grocery giants are colluding to ensure workers at both companies are left behind. These mega corporations are in the process of giving away over $9.5 billion to Wall Street fat cats, but are proposing low-cost contracts to workers in Colorado.' The union said it is pressuring both Safeway/Albertsons and King Soopers to address chronic understaffing, remove two-tier discrimination on vacation from the contract and address the night premium, which the union says has fallen below the rest of the Colorado job market. Union accuses King Soopers in lawsuit of violating agreement ending strike 'Safeway/Albertsons sat on the sidelines during the February King Soopers strike, but enough is enough,' the union wrote in its release published Sunday evening. 'If King Soopers and City Market and refusing to move because of Safeway and Albertsons, then workers at Safeway/Albertsons have no choice but to be a tag team partner with you and jump in to the fight!' The union replied to a comment on its Facebook page, asking if both camps of grocery store workers would be able to strike at the same time, clarifying that a strike of both groups of grocery store workers would be possible at the same time. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
26 minutes ago
- Yahoo
Teen TikTok skin care craze may be harmful — and expensive, study finds
Get inspired by a weekly roundup on living well, made simple. Sign up for CNN's Life, But Better newsletter for information and tools designed to improve your well-being. When Ayva Peña got a phone at age 10, her interest in skin care skyrocketed. At first, she bonded over it with her mother, Giselle Peña. Together, they would have spa days with face masks and take occasional shopping trips to try out new products. But when the Rhode Island mother found a $300 anti-aging face cream in Ayva's medicine drawer, it gave her pause. 'I got very upset. … She's 15 years old,' Peña said. 'It says it makes your skin ageless, improves fine lines, wrinkles and firmness. I was like, 'This is not for you, girl.'' Peña is among a growing number of parents concerned about how content on social media platforms is influencing children and teens into trying out elaborate, often age-inappropriate skin care products. Now, a study published Monday in the journal Pediatrics may confirm those parents' worries. After analyzing beauty routines from 100 TikTok videos by content creators ages 7 through 18, researchers found an average of 11 potentially irritating active ingredients among their regimens, many of which carry a risk of developing skin allergies and increased sun sensitivity. Only a quarter of the lengthy product lists contained sunscreens, however. 'The majority of (children) featured in these videos didn't have any visible acne. They had perfect, clear skin,' said Dr. Molly Hales, the first study author and a board-certified dermatologist in the department of dermatology at Northwestern University's Feinberg School of Medicine. 'For many of them, the harms probably outweigh any potential benefits.' Between the dozens of daily serums, moisturizers, toners and cleansers featured in the videos, the average routine was six steps long, costing about $168 — with some more than $500 — for one month's worth of product, according to the study. 'When you have kids waking up at 5:30 in the morning on a school day to have enough time to layer on these complicated regimens, I think it becomes less about health and more (about) pursuing an idea of beauty that is unrealistic and problematic,' said Hales, who is also a postdoctoral research fellow at Feinberg. The findings raise serious ethical questions about how social media content influences young people in their everyday lives, she added A TikTok spokesperson, noting that this type of content is 'common across all media,' said the platform is only for users ages 13 and older, and any creators suspected to be under 13 are removed. Additionally, they said that TikTok works with third-party doctors and experts in adolescent development to implement safeguarding policies. Most of the studied skin care routines lacked a form of sunscreen but contained products that could increase sun sensitivity and risk of skin cancer, the authors found. Common active ingredients found in recommended skin products were alpha hydroxy acids or AHAs, mild chemical exfoliants that help remove top layers of skin cells, Hales said. While they have the intended effect of evening skin tone and creating a more youthful appearance, they are known to make the skin more vulnerable to the sun's ultraviolet rays. 'I would recommend daily sunscreen use for all ages and regimens, but especially for those using these (AHAs),' Hales said. 'It's a necessary step to prevent permanent skin damage.' Those AHAs, as well as vitamin-based ingredients such as niacinamide, are also considered potential irritants, carrying side effects such as redness and dryness, especially with overuse. 'In many cases, the girls may not have realized they were applying the same active ingredient again and again, which just increases the risk of irritation,' said Dr. Tara Lagu, senior study author and adjunct lecturer of medicine and medical social sciences at Feinberg. More than half the products contained fragrance — a common cause of allergic contact dermatitis — and 20 other inactive ingredients that are known allergens, according to the study. 'Misinformation is a big issue on social media, but especially for these content creators younger than 18,' said Dr. Sonal Shah, a board-certified dermatologist in Cleveland and director of pediatric dermatology at University Hospitals Rainbow Babies & Children's Hospital. Shah was not involved in the study. 'These are sources that perhaps don't have a scientific background and are not well read in the science behind a lot of these products, how they work, or what risks they carry,' Shah said, adding that there are board-certified dermatologists on TikTok that could offer more credible advice. Other concerning trends Shah has seen in her practice, but were not mentioned in the study, include mechanical exfoliants, such as scrubbing wands or cleansers containing plastic microbeads, which are often too rough for facial skin. The study also noted that many of the creators were offering tips relevant to those with lighter complexions, which may exclude the unique skin care considerations of darker complexions while perpetuating harmful ideals of 'brighter' skin associated with whiteness. Both Shah and Hales recommend children under 18 who are not dealing with acne use a gentle cleanser with no active ingredients, paired with a fragrance-free moisturizer and a daily mineral sunscreen. In general, children will not benefit from anti-aging products that promise to boost skin elasticity or eliminate fine lines, Shah said. In these young ages, collagen production is at the highest it will ever be. As children reach puberty, however, they may produce more acne-causing hormones. In those cases, Shah recommends adding an over-the-counter product with salicylic acid or a low percentage of benzoyl peroxide. 'Their skin care does not have to be complicated and does not have to be very expensive,' Shah said. Parents 'can talk to a board-certified dermatologist or pediatric dermatologist if there are skin concerns that are significant or don't respond to over-the-counter treatment.' Ultimately, if parents are concerned about their child's skin care regimen, they should talk about it, said Jennifer Harriger, a professor of psychology at Pepperdine University who studies childhood development, in a statement. 'I think that it is always best to have open conversations with children about the messages they see on social media as well as their own intentions behind purchasing particular skincare products,' said Harriger, who was not involved in the study. It's also important to keep an open mind, understanding the social dimension of youth beauty and wellness content, Hales said. 'These videos show a kind of playful self-expression that's very appealing to this age group,' Hales said. 'These are girls who are just starting to develop their own sense of independent identity, how they present (themselves) in the world, their gender identity, and in many cases what it means to be a girl in our society.'
