Adagio Medical Reports First Quarter 2025 Results
Recent Business Highlights:
Received Breakthrough Device Designation from the U.S. Food and Drug Administration (the 'FDA') for the vCLAS™ Cryoablation System ('vCLAS'), for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ('VT') in patients with ischemic or non-ischemic structural heart disease. The vCLAS TM Cryoablation System is currently the subject of the FULCRUM-VT Investigational Device Exemption ('IDE') study designed to support FDA approval. The Breakthrough Device program allows for the FDA to potentially provide Adagio with priority review and interactive communication during the vCLAS TM review phase.
Surpassed 50% enrollment in the FULCRUM-VT pivotal study. The study, which seeks to enroll 206 patients with ischemic and non-ischemic disease at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025.
Adagio's Ultra-Low Temperature Cryoablation ('ULTC') and vCLAS technologies were showcased by leading electrophysiologists during multiple scientific sessions at the recent European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) industry meetings.
Hired industry veteran Deborah Kaster, who has more than 25 years of leadership experience in the medical technology sector, as Chief Business Officer.
Implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and the Company's new product design optimization program, which has been designed to advance faster innovation and iteration to meet market demands.
'This has been a defining quarter for Adagio Medical and for our progress across the company. The FDA's Breakthrough Device Designation, multiple impactful presentations at leading industry conferences, the introduction of our optimized smaller, faster next generation ULTC technology in development and the continued momentum in enrolling patients in our FULCRUM-VT trial all underscore the clinical promise and growing validation of our proprietary ULTC platform technology,' said Todd Usen, Chief Executive Officer of Adagio. 'I am so proud of the Adagio team's accomplishments as we remain resolute in our mission to transform patient treatment and outcomes with our purpose-built solution for the large, underserved population of patients suffering from ventricular tachycardia.'
First Quarter 2025 Financial Results
Cost of revenue was $0.3 million for the three months ended March 31, 2025, compared to $0.5 million for the three months ended March 31, 2024.
Research and development expenses were $3.7 million for the three months ended March 31, 2025, compared to $3.5 million for the three months ended March 31, 2024.
Selling, general and administrative expenses were $3.5 million for the three months ended March 31, 2025, compared to $4.8 million for the three months ended March 31, 2024.
Net loss for the three months ended, March 31, 2025 was $7.7 million, or $(0.50) per share, compared to a net loss of $8.0 million, or $(10.28) per share, for the three months ended, March 31, 2024.
Reported cash and cash equivalents of $13.0 million as of March 31, 2025.
About Adagio Medical Holdings, Inc.
Adagio is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low Temperature Cryoablation (ULTC) technology. ULTC is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. The Company is currently focused on the treatment of ventricular tachycardia (VT) with its purpose-built vCLAS™ Cryoablation System which is CE Marked and is currently under evaluation in the Company's FULCRUM-VT U.S. IDE Pivotal Study.
About FULCRUM VT
FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm study, enrolling 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. The results of the study will be used to apply for FDA premarket approval (PMA) for Adagio's vCLAS™ Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.
Adagio's vCLAS™ Cryoablation System is commercially available for the treatment of monomorphic ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' 'plans,' and 'future' or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential of our vCLAS™ Cryoablation System; our research, development and regulatory plans for our product candidates, including the timing of initiating additional trials and reporting data from our trials; the regulatory pathway for our vCLAS™ Cryoablation System and the potential impacts of the Breakthrough Device Designation; the potential for our product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies; and our current cash resources and the impacts of our corporate prioritization initiative and realignment of resources. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ('SEC') filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2024, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
Condensed Statements of Operations
Three Months Ended March 31
2025
2024
Revenue $
—
$
26
Cost of revenue
253
542
Research and development
3,659
3,469
Selling, general, and administrative
3,485
4,830
Total cost of revenue and operating expenses
7,397
8,841
Loss from operations
(7,397)
(8,815)
Other (income) expenses:
Convertible notes fair value adjustment
190
1,673
Warrant liabilities fair value adjustment
38
(80)
Interest expense
(662)
(754)
Interest income
164
1
Other income (expense), net
(46)
(43)
Total other income, net
(316)
797
Net loss $
(7,713)
$
(8,018)
Basic net loss per share
$
(0.50)
$
(10.28)
Diluted net loss per share $
(0.51)
$
(10.28)
Weighted-average shares outstanding, basic and diluted
15,375,521
779,908
Expand
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNN
9 minutes ago
- CNN
Former FDA chief challenges agency to bar certain ultraprocessed food ingredients
The former head of the US Food and Drug Administration is testing the Trump administration's commitment to 'Make America Healthy Again' with a challenge to crack down on some of the key ingredients in ultraprocessed foods. In a petition filed Wednesday, the former FDA commissioner, Dr. David Kessler, argued that the agency has the authority to declare that certain sweeteners, refined flours and other additives are not 'generally recognized as safe.' Removing that designation, known as GRAS, would force makers of ultraprocessed foods to remove products from the market and reformulate recipes — or try to prove that those ingredients are not harmful. It would be a sweeping change to the food industry and a significant shift in the Trump administration's MAHA strategy. So far, US Health and Human Services Secretary Robert F. Kennedy Jr. has relied on popular food brands to volunteer to remove artificial dyes and other additives from their products. 'Kessler has given the FDA a way to define the vast majority of ultra-processed foods. In doing so, he has handed RFK Jr a huge gift on the path to regulating these products. It's just what MAHA has asked for. I hope they take it seriously,' Marion Nestle, the Paulette Goddard professor emerita of nutrition, food studies and public health at New York University, said in an email. Kessler proposed that companies have 12 months to submit a petition to keep those food additives in their products and then go on to prove they are safe. 'It's a very appropriate, worthy step to shift the burden of proof where it belongs and have the industry meet that burden, or stop using the substances.' said Michael Taylor, a former FDA food regulator and current co-chair of the nonprofit STOP Foodborne Illness. 'It's using the GRAS tool to really drive a serious safety conversation.' HHS did not respond to a request for comment. Federal health officials announced last month that they are looking for input on how to define ultraprocessed foods, a first step in eventually setting up new regulations, which could take months to years to establish. Kessler's petition could put pressure on that ultimately lengthy timeline; the agency is required to respond to the request within 180 days. Kessler, a physician who served as FDA commissioner under presidents Bill Clinton and George H.W. Bush, and advised President Joe Biden during the Covid-19 pandemic, oversaw the agency when it began requiring nutrition labels on food products. He also spearheaded efforts for FDA to regulate tobacco in the 1990s and sees parallels to that fight. 'What was key in tobacco was finding the regulatory hook,' Kessler told CNN. 'It was about asking the right legal question that would frame the issue.' That has been the tricky part of setting up any regulatory standards for sugary and starchy foods, he said. The term ultra processed foods has resonated with the public, he said, but 'it's going to be hard to define, legally, what's in it.' But there is a pressing need to do that, he argues. The FDA allowed these ingredients under GRAS regulations four decades ago, and rates of obesity, diabetes, and heart disease have climbed in the years since, he wrote in his petition. The argument echoes Kennedy's own case for MAHA reforms to food policy. The petition focuses on refined flours and starches — which the body breaks down into sugars — that are subjected to food extrusion technology, including wheat, corn, tapioca, oat and potato flour. It also references refined sugars, including corn syrup, corn solids, dextrose, xylose, maltose, and high-fructose corn syrups. Finally, the petition targets any manufactured sugars, flours and starches that contain additives commonly used in today's ultraprocessed foods. Tackling the issue of too much sugar is a key to better health, experts CNN spoke with agree, but they say the real genius of Kessler's petition is his focus on additives. 'The food industry uses the emulsifiers, the stabilizers, the gels and the rest to make inexpensive, high volume, industrially processed foods,' said Christopher Gardner, director of nutrition studies at the Stanford Prevention Research Center. 'If you take those tools away from industry it's not that foods will taste bad and icky,' Gardner said. 'They won't be as addictive, as flavorful, as tasty — and industry has made these foods as manipulatively flavorful and manipulatively tasty. That's the problem.' Several food and nutrition experts heralded Kessler's petition as a bold move that would, if enacted by FDA, reshape the food industry. 'This is an important proposal that is based on the true meaning of GRAS, which would exclude the majority of foods on our grocery shelves,' said leading nutrition researcher Dr. Walter Willett, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health and professor of medicine at Harvard Medical School in Boston. The GRAS standard, created in 1958, was originally intended to narrowly apply to commonly used ingredients in the nation's food supply, such as oil, vinegar and baking soda. Manufacturers that used those products could rely on existing research to show their safety but are supposed to file GRAS petitions for newer ingredients like refined sugars. FDA updated its system in the late 1990s — amid a backlog of petitions for new additives — allowing companies to voluntarily notify the agency that they had determined their ingredients were generally safe. A 2022 analysis conducted by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food and chemical industry. During that period, food manufacturers asked the FDA's permission to introduce a new substance only 10 times, according to the analysis. Barry Popkin, the W. R. Kenan, Jr. Distinguished Professor at the Gillings School of Global Public Health in Chapel Hill, North Carolina, called Kessler's petition 'a brilliant move.' 'Knowing the FDA like he does - he's put industry in a real bind,' Popkin said. 'They have to show that without a reasonable doubt that carbohydrates, along with additives, are healthy, and do not hurt health. And that's next to impossible. 'It's the strongest play a citizen can do to affect our food supply that I've ever seen.' But Kessler's proposed changes are likely to meet significant pushback from major food brands. Michael Taylor was FDA's deputy commissioner for foods in 2015 when the agency revoked the GRAS status of partially hydrogenated oils, or trans fats, citing extensive research about their links to risks of heart disease and stroke. The agency gave companies three years to comply and remove those oils from their products. But at that time, 'the handwriting was on the wall' for industry and many companies had already stopped using those trans fats, Taylor said. 'Obviously the substances that [Kessler] is describing, it's a lot of … highly processed, fine carbohydrates, and a lot of products.' The petition lands as Trump administration officials, led by Kennedy, prepare to release their second MAHA report. While the MAHA Commission's first dispatch in June singled out potential drivers of chronic illnesses in children — including ingredients in ultraprocessed foods — its second installment is expected to lay out proposed policy changes. The report is due by Tuesday.
Business Upturn
39 minutes ago
- Business Upturn
ROSEN, TOP RANKED GLOBAL COUNSEL, Encourages Capricor Therapeutics, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action
NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) — WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Capricor Therapeutics, Inc. (NASDAQ: CAPR) between October 9, 2024 and July 10, 2025, both dates inclusive (the 'Class Period'), of the important September 15, 2025 lead plaintiff deadline. SO WHAT: If you purchased Capricor securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. WHAT TO DO NEXT: To join the Capricor class action, go to or call Phillip Kim, Esq. at 866-767-3653 or email [email protected] for more information. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 15, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers. DETAILS OF THE CASE: According to the lawsuit, throughout the Class Period, defendants provided investors with material information concerning deramiocel, Capricor's lead cell therapy candidate drug for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Defendants' statements included, among other things, Capricor's ability to obtain a Biologics License Application (BLA) for deramiocel from the U.S. Food and Drug Administration (FDA). Further, defendants provided these overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel. The lawsuit alleges this caused shareholders to purchase Capricor's securities at artificially inflated prices. When the true details entered the market, the lawsuit claims that investors suffered damages. To join the Capricor class action, go to or call Phillip Kim, Esq. at 866-767-3653 or email [email protected] for more information. No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff. Follow us for updates on LinkedIn: on Twitter: or on Facebook: Attorney Advertising. Prior results do not guarantee a similar outcome. ——————————- Contact Information: Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 Toll Free: (866) 767-3653 Fax: (212) 202-3827 [email protected]
Business Upturn
42 minutes ago
- Business Upturn
Etoiles Capital Group Co., Ltd Announces Pricing of US$5.6 million Initial Public Offering
HONG KONG, Aug. 07, 2025 (GLOBE NEWSWIRE) — Etoiles Capital Group Co., Ltd (Nasdaq: EFTY), a Hong Kong-headquartered financial services firm, today priced its initial public offering (the 'Offering') of 1,400,000 Class A ordinary shares at $4.00 per share. The Class A ordinary shares have been approved for listing on the Nasdaq Capital Market and are expected to commence trading on August 8, 2025 under the ticker symbol 'EFTY.' The Company expects to receive aggregate gross proceeds of US$5.6 million from the Offering, before deducting underwriting discounts and other related expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 210,000 Class A ordinary shares at the public offering price, less underwriting discounts. The Offering is expected to close on or about August 11, 2025, subject to the satisfaction of customary closing conditions. Proceeds from the Offering will be used for business expansion, technology infrastructure, strategic marketing, and general corporate purposes. The Offering was conducted on a firm commitment basis. Prime Number Capital, LLC acted as representative underwriter and sole book- runner for the Offering. Loeb & Loeb LLP acted as the U.S. counsel to the Company, Ogier acted as the Cayman Islands counsel to the Company, and Ye & Associates, P.C. acted as the U.S. counsel to the underwriting syndicate in connection with the Offering. A registration statement on Form F-1 relating to the Offering was filed with the U.S. Securities and Exchange Commission ('SEC') (File Number: 333-287302) and was declared effective by the SEC on August 7, 2025. The Offering was made only by means of a prospectus, forming a part of the registration statement. A final prospectus relating to the Offering was filed with the SEC on August 7, 2025, which may be obtained from Prime Number Capital, LLC, 12 E 49 St, Floor 27, New York, NY 10017, Attention: Shenghui Yang by email at [email protected], or by calling +1(347) 329-1575. In addition, copies of the prospectus relating to the Offering may be obtained via the SEC's website at This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall there be any offer, solicitation or sale of any of the Company's securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. Forward-Looking Statements Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company's current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as 'approximates,' 'assesses,' 'believes,' 'hopes,' 'expects,' 'anticipates,' 'estimates,' 'projects,' 'intends,' 'plans,' 'will,' 'would,' 'should,' 'could,' 'may' or similar expressions. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's registration statement and other filings with the SEC. About Etoiles Capital Group Co., Ltd Etoiles Capital Group Co., Ltd (Nasdaq: EFTY) is a Cayman Islands holding company operating through its Hong Kong subsidiary, Etoiles Consultancy Limited. The Company provides comprehensive financial advisory, capital markets services, and integrated solutions—including corporate financing, initial public offering consulting, and investor relations—to clients navigating global capital markets. Contacts Issuer InquiriesEtoiles Capital Group Co., LtdRoom 1109, 11/F, Tai Yau Building181 Johnston Road, Wanchai, Hong Kong Tel: +852 2398 8699 | Email: [email protected]
