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MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function

  • Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired renal function
  • The transdermal GFR (tGFR) methodology has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity
  • More than 800 million people have Chronic Kidney Disease (CKD), one of the world’s leading causes of mortality worldwide, with associated deaths increasing over the past two decades

    1

NEW YORK, Jan. 17, 2025 (GLOBE NEWSWIRE) — INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney function in patients with normal or impaired renal function.

The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient’s bedside or in the outpatient setting.

The TGFR is validated for use in the assessment of Glomerular Filtration Rate (GFR) in patients with stable kidney function at the point of care. The TGFR utilizes an intravenous Lumitrace injection but does not require blood draws or urine analysis, unlike current methodologies requiring multiple blood draws or urine samples. In addition, current clinical practice measured GFR (mGFR) assessment requires sophisticated clinical laboratory analysis away from the patient’s point of care.

“The development of a system such as the TGFR that assesses a patient’s kidney function without the need to use estimating equations is an important milestone for the nephrology community,” said Dr. Mitchell Rosner, chair of the Department of Medicine at University of Virginia and a highly regarded expert who has authored numerous articles on the challenges of assessing kidney function. “We are excited to explore applications of the transdermal GFR methodology in patients where current clinical practice is understood to be suboptimal.”

Dr. Pierre Galichon, an active kidney researcher at the Sorbonne Université and an attending physician in kidney transplantation at Pitié-Salpêtrière Hospital in Paris, said: “It has long been a challenge to understand kidney function in the context of its interaction with other vital organs, such as the heart and lungs. My experience with MediBeacon products in preclinical use, as relayed in Scientific Reports,2 has been exciting, and I look forward to evaluating how transdermal GFR can be applied in clinical practice.”

“The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function,” said Steve Hanley, CEO of MediBeacon. “According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is the under-recognized public health crisis.3 The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings.”

The timing of FDA approval aligns well with the Q4 2024 publication by MediBeacon’s Chief Scientific Officer, Dr. Richard Dorshow, et al. in Kidney International with data that supports the utility of MediBeacon’s patented agent Lumitrace®.

The TGFR met its primary efficacy endpoint as per agreement with the FDA by demonstrating a P30 value of 94% while recruiting patients with a range of GFR values and skin tones. P30 is defined as the percentage of GFR estimation falling within +/- 30% of measured GFR (mGFR) values.

P30 Value Upper 95% Confidence Bounds Lower 95% Confidence Bounds
94.0% 96.9% 89.4%


In clinical studies no serious or severe adverse events have been observed. For more information, including the FDA Summary of Safety and Effectiveness Data, please refer to www.fda.gov.

About INNOVATE

INNOVATE Corp. is a portfolio of best-in-class assets in three key areas of the new economy – Infrastructure, Life Sciences and Spectrum. Dedicated to stakeholder capitalism, INNOVATE employs approximately 4,000 people across its subsidiaries. For more information, please visit: www.INNOVATECorp.com.

About MediBeacon Inc.

MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon’s use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and over 215 granted patents worldwide that provide extensive coverage of the MediBeacon® TGFR, including Lumitrace® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: www.medibeacon.com.

About Lumitrace® (relmapirazin) injection

Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent and have the clearance properties of a GFR tracer agent in the body. Lumitrace injection has been administered to over 850 subjects under Investigational Device Exemptions (IDEs). The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. As noted above, in a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International4 by Dorshow et al.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements generally relate to future events, such as the expected timing of the reverse stock split, the impact of the reverse stock split on the Company’s share price, and the Company’s ability to meet the minimum per share bid price requirement for continued listing on the NYSE. You are cautioned that such statements are not guarantees of future performance and that INNOVATE’s actual results may differ materially from those set forth in the forward-looking statements. All of these forward-looking statements are subject to risks and uncertainties that may change at any time. Factors that could cause INNOVATE’s actual expectations to differ materially from these forward-looking statements include INNOVATE’s ability to continue to comply with applicable listing standards of the NYSE and the other factors under the heading “Risk Factors” set forth in INNOVATE’s Annual Report on Form 10-K, as supplemented by INNOVATE’s quarterly reports on Form 10-Q. Such filings are available on our website or at www.sec.gov. You should not place undue reliance on these forward-looking statements, which are made only as of the date of this press release. INNOVATE undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent developments, events, or circumstances, except as may be required under applicable securities laws.

Investor Contact:

Solebury Strategic Communications
Anthony Rozmus
[email protected]
(212) 235-2691

IMPORTANT SAFETY INFORMATION FOR TGFR

Indication for Use:

The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. The MediBeacon TGFR consists of a monitor and a sensor, which are to be used with the Lumitrace® tracer only. This device has been validated in patients with stable renal function.

The MediBeacon TGFR is not approved for use in patients with GFR <15ml/min/1.73m2, GFR >120ml/min/1.73m2, patients on dialysis or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI).

Contraindications:
There are no known contraindications.

Warnings and Precautions:

  • See ifu.medibeacon.com for full instructions, warnings, and cautions.
  • In clinical studies no serious or severe adverse events have been observed.
  • Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace.
  • Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally-impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing.
  • Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established.
  • During a TGFR session, the patient should be as still as possible, especially during the “Establishing Baseline” stage. The current system is designed to compensate for light activity such as reading or eating after the Baseline stage.

1 Epidemiology of chronic kidney disease: an update 2022, Kidney International Supplement, 2022 Apr;12(1):7-11.
doi: 10.1016/j.kisu.2021.11.003., Csaba P Kovesdy
2 Pulmonary hypertension without heart failure causes cardiorenal syndrome in a porcine model, Scientific Reports (2023) 13:9130, Orieux et al, doi.org/10.1038/s41598-023-36124-1
3 National Kidney Foundation, Fast Facts (2024 Update), Updated as of 8/6/2024
4 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012



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Uniti Group Inc. Announces Pricing of $589 Million Fiber Securitization Notes Offering

LITTLE ROCK, Ark., Jan. 17, 2025 (GLOBE NEWSWIRE) — Uniti Group Inc. (the “Company,” “Uniti,” or “we”) (Nasdaq: UNIT) today announced that Uniti Fiber ABS Issuer LLC and Uniti Fiber TRS Issuer LLC, limited-purpose, bankruptcy remote subsidiaries of Uniti (collectively, the “Issuers”), have priced their offering of $589,000,000 aggregate principal amount of secured fiber network revenue term notes, consisting of $426,000,000 5.9% Series 2025-1, Class A-2 term notes, $65,000,000 6.4% Series 2025-1, Class B term notes and $98,000,000 9.0% Series 2025-1, Class C term notes, each with an anticipated repayment date in April 2030 (collectively, the “Notes”). Collectively, the Notes have a weighted average yield of approximately 6.5%. The Notes will be secured by certain fiber network assets and related customer contracts in the State of Florida and the Gulf Coast region of Louisiana, Mississippi and Alabama. Each of the Issuers and its direct parent entities and subsidiaries have been designated as “unrestricted subsidiaries” under Uniti’s credit agreement and the indentures governing its outstanding senior notes. The offering is expected to close on February 3, 2025.

Uniti intends to use the net proceeds of the offering to, among other things, repay and terminate its existing ABS bridge facility and for general corporate purposes, which may include success-based capital investments and/or repayment of outstanding debt.

The Notes will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act or any applicable state securities laws. The Notes were offered only to persons reasonably believed to be qualified institutional buyers under Rule 144A under the Securities Act and outside the United States in compliance with Regulation S under the Securities Act.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

ABOUT UNITI GROUP INC.

Uniti, an internally managed real estate investment trust, is engaged in the acquisition and construction of mission critical communications infrastructure, and is a leading provider of fiber and other wireless solutions for the communications industry.  As of September 30, 2024, Uniti owns approximately 144,000 fiber route miles, 8.7 million fiber strand miles, and other communications real estate throughout the United States. Additional information about Uniti can be found on its website at www.uniti.com.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended from time to time. Those forward-looking statements include all statements that are not historical statements of fact, including those regarding the proposed offering of the Notes.

Words such as “anticipate(s),” “expect(s),” “intend(s),” “plan(s),” “believe(s),” “may,” “will,” “would,” “could,” “should,” “seek(s)” and similar expressions, or the negative of these terms, are intended to identify such forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties that could lead to actual results differing materially from those projected, forecasted or expected. Although we believe that the assumptions underlying the forward-looking statements are reasonable, we can give no assurance that our expectations will be attained. Factors which could have a material adverse effect on our operations and future prospects or which could cause actual results to differ materially from our expectations include, but are not limited to the Company’s and Windstream’s ability to consummate our merger with Windstream on the expected terms or according to the anticipated timeline, the risk that our merger agreement with Windstream (the “Merger Agreement”) may be modified or terminated, that the conditions to our merger with Windstream may not be satisfied or the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement, the effect of the announcement of our merger with Windstream on relationships with our customers, suppliers, vendors, employees and other stakeholders, our ability to attract employees and our operating results and the operating results of Windstream, the risk that the restrictive covenants in the Merger Agreement applicable to us and our business may limit our ability to take certain actions that would otherwise be necessary or advisable, the diversion of management’s time on issues related to our merger with Windstream, the risk that we fail to fully realize the potential benefits, tax benefits, expected synergies, efficiencies and cost savings from our merger with Windstream within the expected time period (if all all), legal proceedings that may be instituted against Uniti or Windstream following announcement of the merger, if the merger is completed, the risk associated with Windstream’s business, adverse impacts of inflation and higher interest rates on our employees, our business, the business of our customers and other business partners and the global financial markets, the ability and willingness of our customers to meet and/or perform their obligations under any contractual arrangements entered into with us, including master lease arrangements, the ability and willingness of our customers to renew their leases with us upon their expiration, our ability to reach agreement on the price of such renewal or ability to obtain a satisfactory renewal rent from an independent appraisal, and the ability to reposition our properties on the same or better terms in the event of nonrenewal or in the event we replace an existing tenant, the availability of and our ability to identify suitable acquisition opportunities and our ability to acquire and lease the respective properties on favorable terms or operate and integrate the acquired businesses, or to integrate our business with Windstream’s as a result of the merger, our ability to generate sufficient cash flows to service our outstanding indebtedness and fund our capital funding commitments, our ability to access debt and equity capital markets, the impact on our business or the business of our customers as a result of credit rating downgrades and fluctuating interest rates, our ability to retain our key management personnel, changes in the U.S. tax law and other federal, state or local laws, whether or not specific to real estate investment trusts, covenants in our debt agreements that may limit our operational flexibility, the possibility that we may experience equipment failures, natural disasters, cyber-attacks or terrorist attacks for which our insurance may not provide adequate coverage, the risk that we fail to fully realize the potential benefits of or have difficulty in integrating the companies we acquire, other risks inherent in the communications industry and in the ownership of communications distribution systems, including potential liability relating to environmental matters and illiquidity of real estate investments; and additional factors described in our reports filed with the U.S. Securities and Exchange Commission.

Uniti expressly disclaims any obligation to release publicly any updates or revisions to any of the forward-looking statements set forth in this press release to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

INVESTOR AND MEDIA CONTACTS:

Paul Bullington, 251-662-1512
Senior Vice President, Chief Financial Officer & Treasurer
[email protected]

Bill DiTullio, 501-850-0872
Senior Vice President, Investor Relations & Treasury 
[email protected]

This press release was published by a CLEAR® Verified individual.



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Healthcare AI Adoption Accelerates as Industry Eyes $125 Billion Growth by 2028

PR Newswire



USA News Group
 News Commentary 


Issued on behalf of Avant Technologies Inc.


VANCOUVER, BC
, Jan. 17, 2025 /PRNewswire/ — According to experts, soon the integration of artificial intelligence (AI) into healthcare will drastically shift from a novelty, to a critical resource. With over 800 FDA-cleared health AI applications, the new expectation is that AI will be a game changer. In a new article from Fast Company, the author predicts health AI in 2025 will include home testing, AI agents, passive monitoring, ambient documentation, and autonomous coding. The World Economic Forum is also highlighting the ways generative AI could transform clinical trials. According to a new survey from eClinicalWorks, 90% of healthcare professionals report a favorable view of AI. Working to provide these powerful AI tools to the health industry are several innovators, including new developments from Avant Technologies, Inc. (OTCQB: AVAI), Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), Teladoc Health, Inc. (NYSE: TDOC), Butterfly Network, Inc. (NYSE: BFLY), and Absci Corporation (NASDAQ: ABSI).

The article continued: Analysts at market.us are predicting the Generative AI in Healthcare Market to reach US$17.2 billion by 2032, growing at a CAGR of 37% along the way. Researchers at Technavio see an even bigger future, projecting the Smart Healthcare Market (including telemedicine, mHealth, smart pills, and AI) to grow by US$125.7 billion through to 2028.

Avant Technologies and Ainnova Secure Advanced AI Algorithms for Early Detection of Four Additional Diseases in the U.S.

Avant Technologies, Inc. (OTCQB: AVAI), an emerging technology company developing solutions in artificial intelligence in healthcare, today announced its partner, Ainnova Tech, Inc., (Ainnova) a leading healthcare technology company focused on revolutionizing early disease detection using AI, has acquired an exclusive license for 4 groundbreaking, AI-driven algorithms from one of Asia’s most respected and largest healthcare institutions. These solutions, validated across diverse geographies, ethnicities, and socio-economic populations with data from over 2-million patients, will join Ainnova’s existing diabetic retinopathy and retinal disease detection solutions.

The 4 algorithms include early detection for cardiovascular risk, prediabetes and type 2 diabetes, fatty liver disease, and chronic kidney disease. Combined with Ainnova’s existing retinal disease detection tools, these new algorithms will be used with Ainnova’s powerful cutting-edge AI platform, VisionAI, to detect the early markers of these diseases quickly and accurately by applying AI. 

The acquisition of an exclusive license to use 4 advanced algorithms in the Americas offers Ainova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova, a robust platform for primary care providers to streamline early risk screening and improve patient care in the United States.

Ainnova will introduce these cutting-edge solutions in Latin America with strategic partners in primary healthcare services across key markets like Mexico and Brazil. AAC expects to build on Ainnova’s regional expansion by securing clearance from the U.S. Food and Drug Administration(FDA) in 2025 to then introduce these solutions in the U.S. market.

“This license represents a pivotal moment for Ainnova and for its partnership with Avant as it allows us to bring world class, validated solutions to the Americas,” said Vinicio Vargas, CEO of Ainnova. “This effort not only complements our current solutions, but it also aligns with our ongoing R&D initiatives to continue incorporating new diseases that can be detected quickly and affordably, pushing the boundaries of preventive care, and making healthcare more inclusive and accessible to all.”


CONTINUED… Read this and more news for Avant Technologies Inc.


https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
 

Other recent industry developments and happenings in the market include:

Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), a clinical-stage biotechnology company that recently combined with Exscientia, recently reported initial monotherapy dose-escalation data from the Phase 1/2 study (ELUCIDATE) of REC-617, a selective CDK7 inhibitor, in advanced solid tumors. REC-617 was well-tolerated across all dose levels (2-20 mg QD and 1 mg BID), with most adverse events being mild (Grade 1-2) and reversible. Notably, one patient with metastatic, platinum-resistant ovarian cancer achieved a confirmed durable partial response lasting over 6 months, while four others experienced stable disease for up to 6 months.

“These initial findings for REC-617 represent an exciting step forward in the development of CDK7 inhibitors, with a favorable PK/PD profile and a durable confirmed partial response observed in dose escalation in a highly pre-treated patient population,” said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer, Recursion. “Designed using our AI-powered OS platform, REC-617 reflects our focus on enhancing the therapeutic index to deliver more effective and safer treatment options for patients. We are eager to continue this momentum in dose escalation and to initiate the next phase of the program next year.”

Teladoc Health, Inc. (NYSE: TDOC), the global leader in virtual care, recently announced the launch of new AI-enabled capabilities to enhance its Virtual Sitter solution to improve patient safety, address workforce challenges, and enhance care delivery for hospitals and health systems. Teladoc Health’s Virtual Sitter uses AI to allow a single remote staff member to monitor more patients, boosting inpatient team capacity by 25%. This innovation complements Teladoc’s connected care solutions, including virtual nursing, physician consults, and interpretive services, reducing administrative burdens and improving satisfaction for both clinicians and patients.

“For more than a decade, we’ve pioneered new ways for technology to support human interaction in patient care, helping hospitals and health systems transform care delivery and meet their most pressing challenges,” said Andy Puterbaugh, Teladoc Health President of Hospitals and Health Systems. “New applications of AI are now accelerating our impact, supporting continuous improvement of our fully integrated suite of connected care solutions, including Virtual Sitter.”

Butterfly Network, Inc. (NYSE: BFLY), a digital health company transforming care with portable, semiconductor-based ultrasound technology and intuitive software, in partnership with HeartFocus, a revolutionary, AI-enabled heart echo software by data-driven medtech company, recently announced the launch of the HeartFocus Education app. The HeartFocus Education app uses AI-powered, self-paced learning to help healthcare practitioners master 10 essential cardiac views with clinical accuracy in hours. Officially launched at ANCC MagPath 2024, the app integrates seamlessly with Butterfly iQ3 and iQ+ probes on iOS iPads, offering an intuitive, engaging, and high-impact training experience enhanced by gamification.

“HeartFocus is set to make a big impact in cardiac care, and we’re thrilled to partner with DESKi on this pioneering education platform,” said Darius Shahida, Chief Strategy Officer at Butterfly Network. “By combining our cutting-edge ultrasound technology with HeartFocus’ AI-powered training, we’re breaking down barriers to cardiac care, empowering more practitioners to learn how to deliver critical diagnostics on the spot.”

Absci Corporation (NASDAQ: ABSI), a data-first generative AI drug creation company, recently announced updates and progress across its internal pipeline of proprietary Drug Creation programs, as well as new breakthroughs demonstrated by Absci’s AI Integrated Drug Creation™ platform. Absci leadership and a series of distinguished guest speakers will be presenting on these updates today at Absci’s 2024 R&D Day.

“We are excited to showcase the target and significant opportunities we see for ABS-201, present new data for ABS-101 and ABS-301, and introduce ABS-501 to our pipeline. ABS-201, a potential treatment for male and female pattern hair loss, represents an opportunity to unlock an entirely new category of therapy for a substantial consumer-driven market with significant clinical unmet need,” said Sean McClain, Founder and CEO of Absci. “And as we near the end of 2024, we see next year as an opportunity to reach multiple milestones across our internal portfolio, and maintain a robust pipeline of potential partners across the Pharma and broader healthcare industry landscape.”

Source:
https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/

CONTACT:


USA NEWS GROUP


[email protected]


(604) 265-2873

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (“MIQ”). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares Avant Technologies Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avant Technologies Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avant Technologies Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

Cision View original content:https://www.prnewswire.com/news-releases/healthcare-ai-adoption-accelerates-as-industry-eyes-125-billion-growth-by-2028-302354609.html

SOURCE USA News Group

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EZGO ANNOUNCES FINANCIAL RESULTS FOR FISCAL YEAR 2024

PR Newswire


CHANGZHOU, China
, Jan. 17, 2025 /PRNewswire/ — EZGO Technologies Ltd. (Nasdaq: EZGO) (“EZGO” or “we”, “our”, or the “Company”), a leading short-distance transportation solutions provider in China, today announced its audited financial results for the fiscal year ended September 30, 2024 (the “Fiscal Year 2024”).

Fiscal Year 202
4
Financial Highlights (all results compared to the prior year period unless otherwise noted)

  • Revenues were $21.1 million, an increase of 32.7%, which was primarily due to the increase of sales of battery packs resulting from the increased acceptance of our lithium battery packs in the market.
  • Gross profit was $1.5 million, an increase of 32.5%. Gross margin was 7.1%, which remained stable with a slight decrease from 7.2% for the fiscal year 2023.
  • Net loss was $8.1 million, an increase from net loss of $7.3 million for the fiscal year 2023, representing an increase of 11.4%, which was primarily raised from the increase in impairment of long-term equity investment.
  • Basic and diluted loss per share attributable to shareholders was $2.80, compared to $5.91 for the fiscal year 2023.
  • As of September 30, 2024, the Company had cash and cash equivalents of $3.5 million, compared to $17.3 million as of September 30, 2023.

Management Commentary

Mr. Jianhui Ye, Chief Executive Officer of EZGO, stated, “In the past fiscal year, the Company’s operating revenue increased by over 30%, which was attributed to the timely adjustment of business strategies by the Company’s management, their proactive response to new industry and market challenges, and the timely shift of business focusing on the lithium-ion battery (LIB) for low-speed e-bicycles. During the second quarter of this fiscal year, the e-bicycle business experienced a significant decline due to the “Nanjing EV Charging Station Massive Fire” accident, leading most dealers and consumers to adopt a wait-and-see attitude towards the existing stock of e-bicycles in the short term.

In response to changes in the market and regulatory environment, the Company has shifted its business focus towards LIB, intensifying product development efforts and cooperation with LIB manufacturing partners. The Company has also introduced multiple safe and efficient LIB products to the market through various channels, rapidly capturing the LIB market for e-bicycles and e-tricycles. Additionally, the e-bicycle business has transitioned from channel marketing to direct client marketing, with a focus on developing the e-bicycle sharing and rental market.

The aforementioned adjustment of business focus and new business layout have significantly tied up the Company’s working capital, resulting in a substantial year-on-year decline in working capital at the end of this fiscal year. However, as the expansion of new LIB product channels gradually takes shape and the sales of electric vehicle begins to show results, the occupation of operating capital in these two business segments will be effectively alleviated.

During the past fiscal year, the sales of the Company’s electronic control system products declined slightly compared to the previous period, yet the gross profit margin remained high. With the business strategy of increasing research and development expense and continuous market development investment, this business line is expected to contribute persistently to improving the Company’s overall profitability over the next three years. The intelligent robotics business is in the market introduction phase and has not yet formed sustained and stable order support. However, the Company will continue investing in research and development for this business line, aiming to build a new product matrix.”

Fiscal Year 202
4
Financial Review

Net revenues

The following table identifies the disaggregation of our revenue from continuing operations and reportable segments for the fiscal years ended September 30, 2022, 2023 and 2024, respectively:


Years Ended September 30,


Segment


2022


2023


2024

Sales of batteries and
   battery packs

Battery cells and
packs segment

$

6,990,215

$

8,245,966

$

16,318,839

Sales of e-bicycles

E-bicycle sales
segment

9,405,103

4,276,147

2,899,541

Sales of electronic
   control system and
   intelligent robots

Electronic control
system and intelligent
robot sales segment

–

2,344,373

1,401,783

Others

993,899

1,054,173

514,262


Net Revenue

$

17,389,217

$

15,920,659

$


21,134,425

Net revenues from continuing operations for the fiscal year ended September 30, 2024 (the “Fiscal Year 2024”) was $21.1 million, an increase of 32.7% from $15.9 million for the fiscal year ended September 30, 2023 (the “Fiscal Year 2023”). The increase in revenue from Fiscal Year 2023 to Fiscal Year 2024 was mainly due to the increased sales of battery packs and partially offset by the decreased sales of e-bicycles and the decreased sales of electronic control system and intelligent robots.

The revenue from sales of battery packs was $16.3 million for Fiscal Year 2024, an increase of 97.9% from $8.2 million for Fiscal Year 2023, due to the remarkable increase in sales volume derived by several large orders from major customers responding to the heightened market demand for high-performance battery solutions. In addition, such an increase mainly resulted from the increased acceptance of our lithium battery packs in the market and the development of the lead-acid battery market in Sichuan. Overall, our sales volume of lithium battery packs increased by 256.5% for the year ended September 30, 2024, compared to fiscal 2023.

The revenue from sales of e-bicycles was $2.9 million for Fiscal Year 2024, a decrease of 32.2% from $4.3 million for Fiscal Year 2023 due to the decreased sales volume of the e-bicycles resulting from the fierce competition of the e-bicycle industry.  

The revenue from sales of electronic control systems and intelligent robots was $1.4 million for Fiscal Year 2024, a decrease of 40.2% from $2.3 million for Fiscal Year 2023, mainly due to the decrease of $1,510,225 in sales of intelligent robots and offset by the increase of $951,665 in sales of electronic control systems. The revenue from sales of electronic control systems increased significantly by 211.4 % for fiscal 2024 compared to fiscal 2023, primarily due to the increased emphasis on environmental protection and construction safety within the industrial machinery sector. The decrease in sales for intelligent robots is primarily attributed to the fact that our main clients were upgrading and renovating their park facilities, resulting in no demand for intelligent robots during fiscal 2024.

Cost of revenues

Cost of revenues was $19.6 million for Fiscal Year 2024, an increase of 32.8% from $14.8 million for Fiscal Year 2023, which was primarily due to the increase of manufacturing and purchase cost of battery packs for sales of batteries and battery packs, which is in line with the increase of revenues.

Gross profit

Gross profit was $1.5 million for Fiscal Year 2024, an increase of 32.5% from $1.1 million for Fiscal Year 2023.

Gross profit margin remained relatively stable, with a slight decrease from 7.2% in fiscal 2023 to 7.1% in fiscal 2024. The gross profit from electronic control system and intelligent robot sales segment increased from 25.8% for fiscal 2023 to 47.3% for fiscal 2024, predominantly attributable to the enhanced contribution of electronic control system sales business with a higher gross profit margin. The electronic control system developed and manufactured by Changzhou Higgs was embedded with highly complex software and the limited competition in the market results in a relatively high gross profit margin of 47.3% for electronic control system sales, which accounts for 6.6% of our total revenue in fiscal 2024 compared to 5.0% in fiscal 2023.

Selling and marketing expenses

Selling and marketing expenses remained relatively stable at $0.6 million for Fiscal Year 2024, a slight decrease of 9.5% compared to fiscal 2023, primarily due to the decrease in advertisement and business promotion expenses, service expenses and travel expenses. Advertisement and business promotion expenses s decreased by $71,610 or 92.6% to $5,751 in fiscal 2024, mainly due to the reduced advertising demands as our existing customer base and sales force were sufficient to support our business development and expansion. Travel expenses decreased by $13,607 or 15.3% to $75,504 in fiscal 2024; Service expenses decreased by $15,297, or 78.3%, from $19,529 in fiscal 2023 to $4,232 in fiscal 2024.

General and administrative expenses

General and administrative expenses remained relatively stable at $4.3 million for Fiscal Year 2024, a slight decrease of 8.3% from $4.7 million for Fiscal Year 2023. The decrease was primarily attributed to (1) the decrease of the share-based compensation expense of $880,851; (2) the decrease of depreciation and amortization expenses of $257,460, or 76.3%, mainly due to the disposal of Property, plant and equipment, including production lines and buildings of Tianjin Dilang and Tianjin Jiahao and E-bicycle charging piles; (3) the decrease of the professional service fees of $191,352, which was mainly due to the decrease of the investment consultancy fee. The decrease was partially offset by (1) the increase of credit losses expense on accounts receivable of $837,863, or 168.4%, mainly due to the difficulties in collecting accounts receivable from individual dealers of e-bicycles who was facing fierce competition from the industry-leading enterprises, and (2) the liquidated damages expense of $138,806 due to the early termination of a procurement contract.

Research and development expenses

Research and development expenses was $0.9 million for Fiscal Year 2024, an increase of 37.0% from $0.7 million for Fiscal Year 2023. The increase was primarily attributed to (1) the increased expenses in research and development activities for engineering vehicle wireless measurement and control system and construction worker safety positioning system of $84,735; (2) the increased depreciation and amortization expenses of $191,676 due to the patents and software acquired in May 2023, which were partially offset by the decreased expenses of $28,084 in research and development activities due to the disposal of Tianjin Dilang.

Income tax expense/benefit

EZGO incurred an income tax benefit of $786,369 for Fiscal Year 2024. This was a result from the increased deferred tax assets of $681,785, mainly due to the recurring net loss in fiscal 2024.

Net loss

Net loss was $8.1 million for Fiscal Year 2024, compared to $7.3 million for Fiscal Year 2023.

Financial Condition

As of September 30, 2024, the Company had cash and cash equivalents of $3.5 million, and a fixed deposit receipt of $1.5million with a maturity date of December 21, 2024 compared to $17.3 million as of September 30, 2023.

For additional information, please see EZGO’s Annual Report on Form 20-F for the fiscal year ended September 30, 2024, which was filed with the U.S. Securities and Exchange Commission on January 17, 2025.

About EZGO Technologies Ltd.

Leveraging an Internet of Things (IoT) product and service platform and two e-bicycle brands, “EZGO” and “Cenbird,” EZGO has established a business model centered on the design, manufacturing and sale of two-and three-wheeled electric vehicles, intelligent robots, complemented by electric vehicle accessories including batteries, charging piles and electronic control system. For additional information, please visit EZGO’s website at www.ezgotech.com.cn. Investors can visit the “Investor Relations” section of EZGO’s website at www.ezgotech.com.cn/Investor.

Exchange Rate

This announcement contains translations of certain Chinese Renminbi (“RMB”) amounts into U.S. dollars (“US$”) at specified rates solely for the convenience of the readers. Unless otherwise stated, all translations from RMB to US$ were made at the rate of RMB7.0176 to US$1.00, the exchange rate in effect as of September 30, 2024, the middle price of RMB exchange rate announced by the People’s Bank of China. The Company makes no representation that the RMB or US$ amounts referred could be converted into US$ or RMB, as the case may be, at any particular rate or at all.

Safe Harbor Statement

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may,” “will,” “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate,” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s goals and strategies; the Company’s future business development; product and service demand and acceptance; changes in technology; economic conditions; the growth of the short-distance transportation solutions market in China and the other international markets the Company plans to serve; reputation and brand; the impact of competition and pricing; government regulations; fluctuations in general economic and business conditions in China and the international markets the Company plans to serve and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the Securities and Exchange Commission (the “SEC”), including the Company’s most recently filed Annual Report on Form 20-F and its subsequent filings. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

Investor Relations Contact

At the Company:
Shawn Wen
Phone: +86 13502829216
Email: [email protected] 

 

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SOURCE EZGO Technologies Ltd.

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$HAREHOLDER ALERT: The M&A Class Action Firm Investigates the Merger of 180 Degree Capital Corp. – TURN

PR Newswire


NEW YORK
, Jan. 17, 2025 /PRNewswire/ — Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm by ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and are investigating 180 Degree Capital Corp. (Nasdaq: TURN), relating to the proposed merger with Mount Logan Capital Inc. Under the terms of the agreement, the estimated post-merger shareholder ownership would be approximately 40% for current 180 Degree Capital shareholders.

Click here for more
https://monteverdelaw.com/case/180-degree-capital-corp-turn/. It is free and there is no cost or obligation to you.

NOT ALL LAW FIRMS ARE THE SAME. Before you hire a law firm, you should talk to a lawyer and ask:

  1. Do you file class actions and go to Court?
  2. When was the last time you recovered money for shareholders?
  3. What cases did you recover money in and how much?

About Monteverde & Associates PC

Our firm litigates and has recovered money for shareholders…and we do it from our offices in the Empire State Building. We are a national class action securities firm with a successful track record in trial and appellate courts, including the U.S. Supreme Court. 

No company, director or officer is above the law. If you own common stock in the above listed company and have concerns or wish to obtain additional information free of charge, please visit our website or contact Juan Monteverde, Esq. either via e-mail at [email protected] or by telephone at (212) 971-1341.

Contact:
Juan Monteverde, Esq.
MONTEVERDE & ASSOCIATES PC
The Empire State Building
350 Fifth Ave. Suite 4740
New York, NY 10118
United States of America
[email protected]
Tel: (212) 971-1341

Attorney Advertising. (C) 2024 Monteverde & Associates PC. The law firm responsible for this advertisement is Monteverde & Associates PC (www.monteverdelaw.com). Prior results do not guarantee a similar outcome with respect to any future matter.

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SOURCE Monteverde & Associates PC

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Sensient Declares Dividend

Sensient Declares Dividend

MILWAUKEE–(BUSINESS WIRE)–
The Board of Directors of Sensient Technologies Corporation (NYSE: SXT) has declared a regular quarterly cash dividend on its common stock of $0.41 per share. The cash dividend will be paid on March 3, 2025, to shareholders of record on February 4, 2025.

About Sensient Technologies

Sensient Technologies Corporation is a leading global manufacturer and marketer of colors, flavors, and other specialty ingredients. Sensient uses advanced technologies and robust global supply chain capabilities to develop specialized solutions for food and beverages, as well as products that serve the pharmaceutical, nutraceutical, and personal care industries. Sensient’s customers range in size from small entrepreneurial businesses to major international manufacturers representing some of the world’s best-known brands. Sensient is headquartered in Milwaukee, Wisconsin.

www.sensient.com

Category: Dividends

Source: Sensient Technologies Corporation

Amy Agallar

(414) 347-3706

KEYWORDS: United States North America Wisconsin

INDUSTRY KEYWORDS: Pharmaceutical Other Manufacturing Health Chemicals/Plastics Vitamins/Supplements Food/Beverage Manufacturing Retail

MEDIA:

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DATROWAY® (datopotamab deruxtecan-dlnk) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

DATROWAY® (datopotamab deruxtecan-dlnk) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

First approval in the US for AstraZeneca and Daiichi Sankyo’s DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death vs. chemotherapy

DATROWAY is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030

WILMINGTON, Del.–(BUSINESS WIRE)–
DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval by the US Food and Drug Administration (FDA) was based on results from the TROPION-Breast01 Phase III trial.

Aditya Bardia, MD, MPH, Program Director of Breast Oncology and Director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center and Global Principal Investigator for TROPION-Breast01, said: “Despite considerable progress in the HR-positive, HER2-negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy. The approval of datopotamab deruxtecan, a novel TROP2-directed antibody drug conjugate, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy.”

Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, said: “With this first approval of DATROWAY in the US, we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers. We are proud to bring DATROWAY to people living with metastatic HR-positive, HER2-negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030.”

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: “The approval of DATROWAY provides patients with HR-positive, HER2-negative breast cancer previously treated with endocrine-based therapy and traditional chemotherapy with the opportunity to be treated with a new TROP2-directed antibody drug conjugate earlier in the metastatic setting. DATROWAY is the latest addition to our portfolio of innovative cancer treatments and marks the fourth medicine from our oncology pipeline to receive approval in the US.”

Caitlin Lewis, Senior Vice President of Strategy & Mission, Living Beyond Breast Cancer, said: “Only one in three patients with metastatic HR-positive, HER2-negative breast cancer live more than five years following diagnosis, highlighting the urgent need for additional effective therapies. The approval of DATROWAY is a significant advance, offering patients with metastatic HR-positive breast cancer a new and much-needed treatment option.”

In TROPION-Breast01, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR] 0.63; 95% confidence interval [CI] 0.52-0.76; p<0.0001) in patients with HR-positive, HER2-negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy.

The safety profile of DATROWAY was consistent with the known profile of this medicine with no new safety concerns identified. In the DATROWAY arm, the interstitial lung disease (ILD) rate was 4.2% and the majority of events were low grade.

DATROWAY is a specifically engineered TROP2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China and other regions.

DATROWAY U.S. Important Safety Information

Indication

DATROWAY® is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH−) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease/Pneumonitis

DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.

In TROPION-Breast01, ILD/pneumonitis occurred in 4.2% of patients treated with DATROWAY, including 0.5% of patients with Grade 3-4 ILD/pneumonitis, and 0.3% with fatal ILD/pneumonitis. Six patients (1.7%) permanently discontinued DATROWAY due to ILD/pneumonitis. The median time to onset of ILD/pneumonitis was 3.5 months (range: 1.2 months to 10.8 months). Patients were excluded from TROPION-Breast01 for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis.

Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (eg, ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (eg, ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if Grade ≥2 ILD/pneumonitis is confirmed.

Ocular Adverse Reactions

DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision.

In TROPION-Breast01, ocular adverse reactions occurred in 51% of patients treated with DATROWAY. Seven patients (1.9%) experienced Grade 3 ocular adverse reactions, including dry eye, keratitis, and blurred vision. The most common (≥5%) ocular adverse reactions were dry eye (27%), keratitis (24%), blepharitis and increased lacrimation (8% each), and meibomian gland dysfunction (7%). Patients with clinically significant corneal disease were excluded from TROPION-Breast01.

The median time to onset for ocular adverse reactions was 2.1 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular adverse reactions, 45% had complete resolution; 9% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of DATROWAY in 0.8% of patients.

Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, annually while on treatment, at end of treatment, and as clinically indicated.

Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, dose delay, dose reduce, or permanently discontinue DATROWAY based on severity.

Stomatitis

DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis.

In the TROPION-Breast01 study, stomatitis occurred in 59% of patients treated with DATROWAY, including 7% of patients with Grade 3-4 events. Median time to first onset was 0.7 months (range: 0.03 months to 8.8 months). Stomatitis led to interruption of DATROWAY in 1.9%, dosage reductions in 13%, and permanent discontinuation in 0.3% of patients.

In patients who received DATROWAY, 38% used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during the treatment.

Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY.

Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue DATROWAY.

Embryo-Fetal Toxicity

Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells.

Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose.

Adverse Reactions

The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH−) breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast01. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 6.7 months (range: 0.7 months to 16.1 months) for patients who received DATROWAY.

Serious adverse reactions occurred in 15% of patients who received DATROWAY. Serious adverse reactions in >0.5% of patients who received DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients who received DATROWAY and were due to ILD/pneumonitis.

Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 3.1% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD/pneumonitis (1.7%) and fatigue (0.6%). Dosage interruptions of DATROWAY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%). Dose reductions of DATROWAY due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis (59%), nausea (56%), fatigue (44%), decreased leukocytes (41%), decreased calcium (39%), alopecia (38%), decreased lymphocytes (36%), decreased hemoglobin (35%), constipation (34%), decreased neutrophils (30%), dry eye (27%), vomiting (24%), increased ALT (24%), keratitis (24%), increased AST (23%), and increased alkaline phosphatase (23%).

Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis.

Use in Specific Populations

  • Pregnancy: Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus.
  • Lactation: There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose.
  • Females and Males of Reproductive Potential: Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiation of DATROWAY. Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Males: Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. Infertility: Based on findings in animal toxicity studies, DATROWAY may impair male and female reproductive function and fertility. The effects on reproductive organs in animals were irreversible.
  • Pediatric Use: Safety and effectiveness of DATROWAY have not been established in pediatric patients.
  • Geriatric Use: Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6 mg/kg, 25% were ≥65 years of age and 5% were ≥75 years of age. Grade ≥3 and serious adverse reactions were more common in patients ≥65 years (42% and 25%, respectively) compared to patients <65 years (33% and 15%, respectively). In TROPION-Breast01, no other meaningful differences in safety or efficacy were observed between patients ≥65 years of age versus younger patients.
  • Renal Impairment: A higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min). Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. No dosage adjustment is recommended in patients with mild to moderate renal impairment. The effect of severe renal impairment (CLcr <30 mL/min) on the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd is unknown.
  • Hepatic Impairment: No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). Monitor patients with moderate hepatic impairment for increased adverse reactions. The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Please see accompanying full Prescribing Information, including the Medication Guide.

Notes

HR-positive breast cancer

In the US, more than 300,000 cases of breast cancer are diagnosed annually.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2

Approximately 70% of diagnosed cases are considered what has been historically called HR-positive, HER2-negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapies are widely given consecutively in the early lines of treatment for HR-positive metastatic breast cancer.3 However, after initial treatment, further efficacy from endocrine therapy is often limited.3 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.3-6

TROPION-Breast01

TROPION-Breast01is a global, randomized, multicenter, open-label Phase III trial evaluating the efficacy and safety of intravenous DATROWAY (6mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease.

Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in theJournal of Clinical Oncology.

TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

DATROWAY

DATROWAY(datopotamab deruxtecan-dlnk in the US; datopotamab deruxtecan in rest of world) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAYis one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAYis comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY(6mg/kg) is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 Phase III trial.

DATROWAY clinical development program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAYacross multiple cancers, including non-small cell lung cancer, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer. The program includes seven Phase III trials in lung cancer and five Phase III trials in breast cancer evaluatingDATROWAYas a monotherapy and in combination with other anticancer treatments in various settings.

Daiichi Sankyo collaboration

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize fam-trastuzumab deruxtecan-nxkiin March 2019 and DATROWAYin July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of fam-trastuzumab deruxtecan-nxkiand DATROWAY.

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumor environment.

With fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines goserelin and aims to reshape the HR-positive space with first-in-class AKT inhibitor, capivasertib, and next-generation SERD and potential new medicine camizestrant. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, DATROWAY, in this setting.

PARP inhibitor olaparib is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with Merck & Co., Inc. (MSD outside the US and Canada) continue to research olaparib in these settings and to explore its potential in earlier disease.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is evaluating the potential of DATROWAY alone and in combination with immunotherapy durvalumab, capivasertib in combination with chemotherapy, and durvalumab in combination with other oncology medicines, including olaparib andfam-trastuzumab deruxtecan-nxki.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca.

References

  1. American Cancer Society. Key Statistics for Breast Cancer. Available at: https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html. Accessed January 2025.

  2. National Cancer Institute. Surveillance, Epidemiology and End Results Program. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed January 2025.

  3. Manohar P, et al. Updates in endocrine therapy for metastatic breast cancer. Cancer Biol Med. 2022 Feb 15; 19(2):202–212.

  4. Cortes J, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377:914-923.

  5. Yuan P, et al. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019;112:57–65.

  6. Jerusalem G, et al. Everolimus Plus Exemestane vs Everolimus or Capecitabine Monotherapy for Estrogen Receptor–Positive, HER2-Negative Advanced Breast Cancer. JAMA Oncol. 2018;4(10):1367–1374.

PP-US-DTB-0066 | US-96718

 Last Updated 01/25

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Fiona Cookson +1 302 885 2677

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Alliant Energy Corporation Announces Fourth Quarter and Year-End 2024 Earnings Release and Conference Call

Alliant Energy Corporation Announces Fourth Quarter and Year-End 2024 Earnings Release and Conference Call

MADISON, Wis.–(BUSINESS WIRE)–
Alliant Energy Corporation (NASDAQ: LNT) has scheduled its fourth quarter and year end 2024 earnings release for Thursday, February 20th, after market close. A conference call to review the fourth quarter and year end results is scheduled for Friday, February 21st at 9 a.m. CT.

Alliant Energy will webcast the event live at www.alliantenergy.com/investors. The call is open to the public and will be hosted by Lisa Barton, President and CEO; and Robert Durian, Executive Vice President and CFO. Individuals who would like to participate in the conference call can do so by dialing (800) 549-8228 (Toll Free – North America) or (289) 819-1520 (International). The conference ID is 45427.

An archive of the webcast will be available on the company’s website at www.alliantenergy.com/investors.

Alliant Energy Corporation (NASDAQ: LNT) provides regulated energy service to approximately 1,000,000 electric and 425,000 natural gas customers across Iowa and Wisconsin. Alliant Energy’s mission is to deliver energy solutions and exceptional service customers and communities count on – safely, efficiently and responsibly. Interstate Power and Light Company (IPL) and Wisconsin Power and Light Company (WPL) are Alliant Energy’s two public energy companies. Alliant Energy is a component of Bloomberg’s Gender-Equality Index and the S&P 500. For more information, visit alliantenergy.com and follow Alliant Energy on LinkedIn, Facebook, Instagram and X.

Media Contact: Cindy Tomlinson (608) 458-3869

Investor Relations Contact: Susan Gille (608) 458-3956

KEYWORDS: United States North America Wisconsin

INDUSTRY KEYWORDS: Energy Other Energy Utilities Oil/Gas

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Kimbell Royalty Partners Closes $230 Million Acquisition of Midland Basin Mineral and Royalty Interests in Cash Transaction

PR Newswire


FORT WORTH, Texas
, Jan. 17, 2025 /PRNewswire/ — Kimbell Royalty Partners, LP (NYSE: KRP) (“Kimbell” or the “Company”), a leading owner of oil and gas mineral and royalty interests in over 17 million gross acres in 28 states, today announced that it has closed the previously announced purchase of mineral and royalty interests (the “Acquired Assets”) held by a private seller in a cash transaction valued at approximately $230 million, subject to post-closing adjustments (the “Acquisition”).  The purchase price of the Acquisition was funded through a combination of an underwritten public offering of common units and borrowings under its revolving credit facility.  Kimbell is entitled to all cash flow from production attributable to the Acquired Assets since October 1, 2024.  Revenues and certain other operating statistics under generally accepted accounting principles will be recorded for the Acquisition beginning on the closing date of January 17, 2025. 

Kimbell estimates that, as of October 1, 2024, the Acquired Assets produced approximately 1,842 Boe/d (1,125 Bbl/d of oil, 410 Bbl/d of NGLs, and 1,842 Mcf/d of natural gas) (6:1)1.  For the full year 2025, Kimbell estimates that the Acquired Assets will produce approximately 1,842 Boe/d (1,104 Bbl/d of oil, 424 Bbl/d of NGLs, and 1,881 Mcf/d of natural gas) (6:1).  The Acquired Assets are located under the historic Mabee Ranch in the Midland Basin, with oil and gas minerals and royalty interests concentrated in Martin County (63%) and Andrews County (37%).

About Kimbell Royalty Partners

Kimbell (NYSE: KRP) is a leading oil and gas mineral and royalty company based in Fort Worth, Texas.  Kimbell owns mineral and royalty interests in over 17 million gross acres in 28 states and in every major onshore basin in the continental United States, including ownership in more than 130,000 gross wells with over 51,000 wells in the Permian Basin.  To learn more, visit http://www.kimbellrp.com.  

Forward-Looking Statements

This news release includes forward-looking statements. These forward-looking statements, which include statements regarding the anticipated benefits of the Acquisition and operational data with respect to the Acquisition, involve risks and uncertainties, including risks that the anticipated benefits of the Acquisition are not realized; risks relating to Kimbell’s integration of the Acquisition assets; and risks relating to Kimbell’s business, prospects for growth and acquisitions and the securities markets generally. Except as required by law, Kimbell undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this news release. When considering these forward-looking statements, you should keep in mind the risk factors and other cautionary statements in Kimbell’s filings with the Securities and Exchange Commission (“SEC”).  These include risks inherent in oil and natural gas drilling and production activities, including risks with respect to low or declining prices for oil and natural gas that could result in downward revisions to the value of proved reserves or otherwise cause operators to delay or suspend planned drilling and completion operations or reduce production levels, which would adversely impact cash flow; risks relating to the impairment of oil and natural gas properties; risks relating to the availability of capital to fund drilling operations that can be adversely affected by adverse drilling results, production declines and declines in oil and natural gas prices; risks relating to Kimbell’s ability to meet financial covenants under its credit agreement or its ability to obtain amendments or waivers to effect such compliance; risks relating to Kimbell’s hedging activities; risks of fire, explosion, blowouts, pipe failure, casing collapse, unusual or unexpected formation pressures, environmental hazards, and other operating and production risks, which may temporarily or permanently reduce production or cause initial production or test results to not be indicative of future well performance or delay the timing of sales or completion of drilling operations; risks relating to delays in receipt of drilling permits; risks relating to unexpected adverse developments in the status of properties; risks relating to borrowing base redeterminations by Kimbell’s lenders; risks relating to the absence or delay in receipt of government approvals or third-party consents; risks relating to acquisitions, dispositions and drop downs of assets; risks relating to Kimbell’s ability to realize the anticipated benefits from and to integrate acquired assets, including the assets acquired in the Acquisition; and other risks described in Kimbell’s Annual Report on Form 10-K, as amended, and other filings with the SEC, available at the SEC’s website at www.sec.gov.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this news release.

Contact:

Rick Black

Dennard Lascar Investor Relations
[email protected]
(713) 529-6600


1 Shown on 6:1 basis.  Based on estimated Q4 2024 run-rate production for the Acquired Assets as of October 1, 2024, which is the effective date of the Acquisition.

 

Cision View original content:https://www.prnewswire.com/news-releases/kimbell-royalty-partners-closes-230-million-acquisition-of-midland-basin-mineral-and-royalty-interests-in-cash-transaction-302354599.html

SOURCE Kimbell Royalty Partners, LP

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The Palisades and Eaton Fires in Los Angeles Have Destroyed 14% of Homes Within the Fire Perimeters

The Palisades and Eaton Fires in Los Angeles Have Destroyed 14% of Homes Within the Fire Perimeters

Single family homes accounted for 89% of homes destroyed or damaged by the fires

SEATTLE–(BUSINESS WIRE)–
(NASDAQ: RDFN) — Roughly one of every seven (14%) homes within the perimeters of the Palisades and Eaton fires in the Los Angeles area have been destroyed or damaged. That’s a total of 6,354 homes; of those, 5,449 (86%) were destroyed, and 905 (14%) were damaged. This is according to a new analysis from Redfin (redfin.com), the technology-powered real estate brokerage.

Zooming out to all of Los Angeles County, 0.17% of all homes were destroyed or damaged by the Palisades or Eaton fires. While that’s a small fraction of overall housing in the Los Angeles area, Redfin agents report the destruction has created a ripple effect of people searching for housing in a region already struggling with a housing shortage.

“Tons of past clients are reaching out on behalf of friends, seeing if I know of any available rentals. There’s competition for nearly every rental, and it’s not just on price; a lot of people are taking on long leases to secure a place to live. A rental listed for $16,000 per month got bid up to $30,000, and the winners took on a two-year lease. On the buying and selling side, people are pulling back, waiting for the dust to settle. Two buyers have canceled deals because they don’t feel comfortable making such a big purchase with the catastrophe going on. Three clients have canceled their listings, with the homeowners opting to rent their homes out to people impacted by the fires instead.” – Gregory Eubanks, Redfin Premier agent

Of the 6,354 homes that have been destroyed or damaged, just over half of those (56%) were destroyed or damaged by the Eaton fire, and 44% by the Palisades fire.

Single-family homes account for the vast majority (89%; 5,636) of the homes that were destroyed or damaged. Another 11% (707) were units in multi-family properties, and less than 1% (11) were mobile homes.

Roughly 6,000 single-family permits are granted each year across all of Los Angeles County, according to a separate Redfin analysis of county permits from 2013 to 2023. That’s less than the number of homes that have been destroyed by the Palisades and Eaton fires.

“The fires are impacting a lot of deals. I have a $1.7 million home in Altadena that was supposed to close next week but the buyers pulled out, and now my sellers are fighting for the deposit. It’s a real mess. Rentals are a different story. My best advice to families looking for rentals is to move as quickly as possible; call a real estate agent and ask for help.” – Alin Glogovicean, Redfin Premier agent

Redfin’s analysis divided the number of housing units destroyed or damaged by the total number of housing units within the incident perimeters of each fire, as defined by Cal Fire. It does not include commercial structures.

For the latest analysis of the LA fires, as they relate to the housing market, please visit:

https://www.redfin.com/news/los-angeles-wildfires-housing-statistics

About Redfin

Redfin (www.redfin.com) is a technology-powered real estate company. We help people find a place to live with brokerage, rentals, lending, and title insurance services. We run the country’s #1 real estate brokerage site. Our customers can save thousands in fees while working with a top agent. Our home-buying customers see homes first with on-demand tours, and our lending and title services help them close quickly. Our rentals business empowers millions nationwide to find apartments and houses for rent. Since launching in 2006, we’ve saved customers more than $1.6 billion in commissions. We serve approximately 100 markets across the U.S. and Canada and employ over 4,000 people.

Redfin’s subsidiaries and affiliated brands include: Bay Equity Home Loans®, Rent.™, Apartment Guide®, Title Forward® and WalkScore®.

For more information or to contact a local Redfin real estate agent, visit www.redfin.com. To learn about housing market trends and download data, visit the Redfin Data Center. To be added to Redfin’s press release distribution list, email [email protected]. To view Redfin’s press center, click here.

Contact Redfin

Redfin Journalist Services:

Kenneth Applewhaite

[email protected]

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