SAVE THE DATE: NOVAGOLD 2025 First Quarter Report, Conference Call and Video Webcast

VANCOUVER, British Columbia, March 19, 2025 (GLOBE NEWSWIRE) — NOVAGOLD RESOURCES INC. (“NOVAGOLD” or “the Company” (NYSE American, TSX: NG) will release its 2025 first quarter report before market open on April 1, 2025, followed by a conference call and video webcast to discuss the results at 8:00 am PT (9:00 am MT/11:00 am ET).

During the webcast, NOVAGOLD’s President and Chief Executive Officer, Greg Lang; and Vice President and Chief Financial Officer, Peter Adamek, will provide a summary of the Company’s first quarter financial results and an update on the Donlin Gold project.

Questions may be submitted prior to the call at [email protected]. There will also be an opportunity to ask questions during the webcast following the presentation.

The video webcast and conference call-in details are provided below.

Video Webcast:   www.novagold.com/investors/events 
North American callers:   1-833-752-3655
International callers:   1-647-846-8520
     

The webcast will be archived on NOVAGOLD’s website for one year. For a transcript of the call, please see https://www.novagold.com/investors/presentations/ to download or email [email protected].

NOVAGOLD Contacts:

Mélanie Hennessey
Vice President, Corporate Communications

Frank Gagnon
Manager, Investor Relations

604-669-6227 or 1-866-669-6227
www.novagold.com



Acumen Pharmaceuticals Announces Topline Results from Phase 1 Study of Subcutaneous Formulation of Sabirnetug in Healthy Volunteers

  • Weekly subcutaneous administration of sabirnetug was well-tolerated in the Phase 1 study
  • Systemic exposure following subcutaneous administration supports further clinical development
  • Development of sabirnetug delivered subcutaneously has the potential for decreased treatment burden and increased patient convenience

NEWTON, Mass., March 19, 2025 (GLOBE NEWSWIRE) — Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers. Weekly SC administration of sabirnetug was well-tolerated with systemic exposure supporting further clinical development.

“We are pleased that the results of our initial clinical study support further clinical development of sabirnetug administered subcutaneously, underscoring the potential for increasing patient convenience of this formulation relative to intravenous treatment,” said Daniel O’Connell, Chief Executive Officer of Acumen. “The timely completion of this study highlights the strength of our clinical team and partners, and our commitment to advancing our clinical pipeline efficiently and effectively. Based on these data, we believe that further development of subcutaneous sabirnetug as a more convenient administration option for patients is warranted.”

The Phase 1 study in healthy volunteers enrolled 12 subjects who received single IV doses of 2,800 mg and 16 subjects who received four weekly SC doses of 1,200 mg. The most frequently reported adverse events included injection site reactions (62.5%), all of which were mild (Grade 1) in severity and resolved. No other safety signals were identified. Importantly, SC administration of sabirnetug produced sufficient systemic exposure to enable further clinical studies of SC dosing.

Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in patients with AD. The SC formulation of sabirnetug is co-formulated with Halozyme’s proprietary ENHANZE® drug delivery technology (recombinant human hyaluronidase enzyme, rHuPH20) that enables large volume SC injection with increased dispersion and absorption of co-administered therapies. ENHANZE® has been commercially validated as a component of nine approved therapies.

The Phase 2 ALTITUDE-AD study of IV sabirnetug is currently ongoing.

About Sabirnetug (ACU193)

Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.

About ALTITUDE-AD (Phase 2)

Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer’s disease. The study will enroll approximately 540 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD). The global study is currently ongoing at multiple investigative sites located in the United States, Canada, UK, and the European Union. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173.

About Halozyme’s ENHANZE

®

Technology

Halozyme’s commercially validated proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume and delivery rates of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered rapidly in minutes subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections.

About Acumen Pharmaceuticals, Inc.

Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential and potential clinical efficacy of Acumen’s product candidate, sabirnetug (ACU193) and its subcutaneous formulation. l. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.

Investors:

Alex Braun
[email protected]

Media:

Jon Yu
ICR Healthcare
[email protected]



Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress

CINCINNATI, March 19, 2025 (GLOBE NEWSWIRE) — Onconetix, Inc., (Nasdaq: ONCO) (“Onconetix” or the “Company”), (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, today announced that an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain.

The presentation, titled, “Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,” will highlight Proclarix performance results recently obtained from a study including more than 800 patients recruited from Lillebaelt Hospital – University Hospital of Southern Denmark.

“The abstract accepted for presentation at EAU congress will showcase the importance of early detection of prostate cancer, particularly using Proclarix, a biomarker-based blood test,” stated Ralph Schiess, PhD, CEO of Proteomedix, a wholly-owned subsidiary of Onconetix, and added: “Proclarix has already demonstrated in multiple studies that it can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer while minimizing the risk of missing clinically significant cancer when compared to standard of care.”

Details on the presentation are as follows:

Presentation Title: Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort
Presenter: Zedan Raid A.H, Lillebaelt Hospital – University Hospital of Southern Denmark, Department of Oncology, Vejle, Denmark
Session Title: Diagnostic and prognostic biomarkers in prostate cancer
Date and Time: March 23, 2025, from 5:15 PM to 6:45 PM CET

About Proclarix®

Proclarix® is CE-certified under In Vitro Diagnostic Regulation (“IVDR”) and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix® is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix® risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix® is included in both the European (EAU) and American (AUA) guidelines.

About Onconetix, Inc.

Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the IVDR, which we anticipate will be marketed in the U.S. as a lab developed test (“LDT”) through our license agreement with Labcorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor and Media Contact Information:

Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Phone: (513) 620-4101

Investor Contact Information:

Onconetix Investor Relations
Email: [email protected]



PodcastOne (NASDAQ: PODC) Relaunches When Reality Hits Podcast, Brittany Cartwright Named Solo Host

Fan Favorite Totals 8.7 Million Downloads, 100 Episodes Since 2023 Debut

LOS ANGELES, March 19, 2025 (GLOBE NEWSWIRE) — PodcastOne (NASDAQ: PODC), a leading publisher and podcast sales network, announced today that Brittany Cartwright is now the solo host of the When Reality Hits podcast. The popular weekly podcast originally debuted in 2023 and features the Bravolebrity dishing on some of the biggest headlines in reality tv.

What happens when the cameras stop rolling for Brittany Cartwright on The Valley? TRUE reality hits! Brittany takes you inside her crazy life as she explores motherhood, friendship, relationships, dating, and reality TV. Nothing is off-limits in this candid look at her real life with tons of fun, lots of laughs, honest opinions, and plenty of special guests!

“Since launching When Reality Hits two years ago, Brittany has proven herself to be a dynamic voice in podcasting,” said Kit Gray, President and Co-Founder of PodcastOne. “We are excited to continue our partnership with her in this familiar yet new venture and look forward to growing her platform each week.”

“I couldn’t be more pleased to continue to host When Reality Hits. Working alongside the team at PodcastOne to create compelling weekly content and sharing my innermost thoughts and perspective has been a dream come true. I can’t wait to see what the future holds,” said Cartwright.

America’s sweetheart Brittany launched to popularity via the iconic Bravo series Vanderpump Rules and has gone on to co-star in the network’s latest hit series, The Valley. When Reality Hits with Brittany Cartwright joins a lineup of PodcastOne’s top charting programming, including Kharma and Chaos, Bitch Bible, Melissa Gorga On Display, Let’s Talk with Heather Dubrow, Off the Vine with Kaitlyn Bristowe and LadyGang.

PodcastOne continues to develop and produce compelling and entertainment-based content to generate excitement and intrigue in the audio and streaming space. With podcasts being the fastest growing medium by far, PodcastOne is a leader in expanding audiences and forging synergistic relationships for its podcasters. PodcastOne’s full roster of programming is available on PodcastOne, YouTube, Apple Podcasts, Spotify, Amazon and wherever podcasts are heard.


About PodcastOne


PodcastOne
(NASDAQ: PODC) is a leading podcast platform that provides creators and advertisers with a comprehensive 360-degree solution in sales, marketing, public relations, production, and distribution. PodcastOne has surpassed 3.9 billion total downloads with a community of 200 top podcasters, including Adam Carolla, Kaitlyn Bristowe, Jordan Harbinger, LadyGang, A&E’s Cold Case Files, and Varnamtown. PodcastOne has built a distribution network reaching over 1 billion monthly impressions across all channels, including YouTube, Spotify, Apple Podcasts, and iHeartRadio. PodcastOne is also the parent company of PodcastOne Pro which offers fully customizable production packages for brands, professionals, or hobbyists. For more information, visit www.podcastone.com and follow us on Facebook, InstagramYouTube, and X at @podcastone.


Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including: LiveOne’s reliance on its largest OEM customer for a substantial percentage of its revenue; LiveOne’s and PodcastOne’s ability to consummate any proposed financing, acquisition, merger, distribution or other transaction, the timing of the consummation of any such proposed event, including the risks that a condition to the consummation of any such event would not be satisfied within the expected timeframe or at all, or that the consummation of any proposed financing, acquisition, merger, special dividend, distribution or transaction will not occur or whether any such event will enhance shareholder value; PodcastOne’s ability to continue as a going concern; PodcastOne’s ability to attract, maintain and increase the number of its listeners; PodcastOne identifying, acquiring, securing and developing content; LiveOne’s intent to repurchase shares of its and/or PodcastOne’s common stock from time to time under LiveOne’s announced stock repurchase program and the timing, price, and quantity of repurchases, if any, under the program; LiveOne’s ability to maintain compliance with certain financial and other covenants; PodcastOne successfully implementing its growth strategy, including relating to its technology platforms and applications; management’s relationships with industry stakeholders; LiveOne’s ability to extend and/or refinance its indebtedness and/or repay its indebtedness when due; uncertain and unfavorable outcomes in legal proceedings and/or PodcastOne’s and/or LiveOne’s ability to pay any amounts due in connection with any such legal proceedings; changes in economic conditions; competition; risks and uncertainties applicable to the businesses of PodcastOne, LiveOne and/or LiveOne’s other subsidiaries; and other risks, uncertainties and factors including, but not limited to, those described in PodcastOne’s Annual Report on Form 10-K for the fiscal year ended March 31, 2024, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 1, 2024, PodcastOne’s Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2024, filed with the SEC on February 14, 2025, and in PodcastOne’s other filings and submissions with the SEC. These forward-looking statements speak only as of the date hereof, and PodcastOne disclaims any obligation to update these statements, except as may be required by law. PodcastOne intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.


Press Contacts

:

(310) 246-4600
[email protected]


IR Contact

:

Chris Donovan
(914) 352-5853
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/87325d39-40dd-4a41-b728-27fe6d1a0f19



New Global Study Finds: Sleep Apnea Patients Who Use CPAP Live Longer

Largest ever meta-analysis on the long-term benefits of CPAP therapy, published in The Lancet Respiratory Medicine, found that in people with sleep apnea, CPAP therapy lowered the overall chance of dying by 37% and the chance of heart-related death by 55%.

SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) — Resmed (NYSE: RMD, ASX: RMD), the global leader in health technology focused on sleep, breathing, and care delivered in the home, today announced the publication of a landmark meta-analysis in The Lancet Respiratory Medicine, demonstrating that CPAP therapy significantly reduces the risk of death for people with obstructive sleep apnea (OSA). Analyzing data from over 1 million sleep apnea patients worldwide, the study provides the strongest evidence to date that CPAP therapy not only alleviates OSA symptoms but can also prolong life.

OSA affects over one billion people worldwide,1 with over 80% of cases undiagnosed and untreated.2 This chronic sleep-related breathing disorder can impair daily functioning and has been associated with serious health conditions, including hypertension, diabetes, cardiovascular disease, and stroke.3 The study reinforces that untreated OSA is a major but modifiable risk factor for both all-cause and cardiovascular-related death, highlighting the importance of consistent CPAP use. As the gold standard for OSA treatment, CPAP therapy is widely recognized for its effectiveness. When used correctly, it works overnight and only requires air; no drugs, surgery, or invasive procedures.

The study, led by global experts in sleep and respiratory medicine and supported by Resmed, found that people with OSA who use CPAP therapy have:

  • A 37% lower risk of dying from any cause compared to those with OSA who do not use CPAP.
  • A 55% lower risk of dying from cardiovascular disease, reinforcing CPAP’s supportive benefits for heart health in people living with OSA.
  • A dose-response relationship, meaning that the more consistently CPAP is used, the greater the survival benefits for people living with OSA.

“For people with OSA, using CPAP versus not using CPAP can literally be a matter of life or death,” said Carlos Nunez, M.D., Resmed’s Chief Medical Officer. “Decades of research have shown CPAP can improve quality of life, and this study now provides the most comprehensive evidence yet that CPAP also prolongs lives for people living with OSA.”

This meta-analysis is the largest of its kind to date, pooling data from over 1 million OSA patients across 30 studies, including 10 randomized controlled trials (RCTs) and 20 real-world evidence studies (RWEs). Researchers analyzed long-term outcomes over the average follow-up period of nearly five years, testing the hypothesis that CPAP therapy reduces both all-cause and cardiovascular mortality in OSA patients.

“The results of the study strongly suggest that CPAP therapy is a life-saving intervention for people with OSA,” said Atul Malhotra, M.D, senior author of the study, Research Chief of Pulmonary, Critical Care and Sleep Medicine at the University of California San Diego School of Medicine and Pulmonologist at UC San Diego Health. “It’s not only about sleep apnea treatment but also about supporting heart health and extending life.”

“These findings should serve as a wake-up call,” added Jean-Louis Pépin, study co-author, Professor of Clinical Physiology at Grenoble University Hospital and Director of the HP2 Laboratory INSERM U1300. “Every additional hour of CPAP treatment translates to improved chance of survival for people living with OSA. Patients who stay on CPAP therapy aren’t just breathing easier at night; they’re potentially adding years to their lives.”

To read the full study, see the publication in The Lancet Respiratory Medicine.
To learn more about how life-changing CPAP therapy can be, visit www.resmed.com/video-story-gallery.

Study authors: Adam V. Benjafield PhD; Prof Jean-Louis Pepin; Prof Peter A. Cistulli; Alison Wimms PhD; Florent Lavergne MSc; Fatima H. Sert Kuniyoshi PhD, Sibyl H. Munson PhD, Brendan Schuler BS; Shrikar Reddy Badikol MSc; Kelly C. Wolfe BS; Leslee Willes MPH; Colleen Kelly PhD; Tetyana Kendzerska MD; Dayna A. Johnson PhD; Prof Raphael Heinzer MD, Prof Chi-Hang Lee MD, Prof Atul Malhotra MD.

About Resmed

Resmed (NYSE: RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.

For Media   For Investors
     
Caela Shay   Mike Ott or Wendy Wilson
[email protected]   [email protected]


1 Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. PMID: 31300334; PMCID: PMC7007763.
2 Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 ;20(9):705-6
3 Yeghiazarians Y, Jneid H, Tietjens JR, et al. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation 2021; 144(3): e56-e67.



Protara Therapeutics Announces Encore Presentation of Results from THRIVE-1 Prospective Observational Study Evaluating the Prevalence of Choline Deficiency and Liver Injury in Patients Dependent on Parenteral Support

  • Data to be featured during oral presentation at the American Society for Parenteral and Enteral Nutrition 2025 Nutrition Science & Practice Conference
  • Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support expected in 1H 2025

NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) — Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that data from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS), will be featured during an oral session at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2025 Nutrition Science & Practice Conference, taking place March 22 through March 25, 2025 in Columbus, Ohio.

Choline is an important substrate for phospholipids that are critical for healthy liver function. Patients on PS are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Protara is developing intravenous (IV) Choline Chloride, an investigational phospholipid substrate replacement therapy, as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated.

THRIVE-1 was conducted to better understand the prevalence of choline deficiency and liver injury in patients on PS. Results demonstrated that 78% of patients who are dependent on PS were choline deficient, and that 63% of choline deficient participants had liver dysfunction, including steatosis, cholestasis, and hepatobiliary injury, underscoring the need for IV choline replacement therapy in this patient population.

“Findings from this study reinforce that there are a significant number of people dependent on PS who have evidence of liver disease and may potentially benefit from treatment with IV Choline Chloride,” said Dejan Micic M.D., Associate Professor and Division Chief of Gastroenterology and Nutrition at Loyola University Medical Center in Maywood, Illinois. “Choline is an essential micronutrient for patients dependent on PS, as deficiency can lead to liver injury. Access to an IV formulation of choline has the potential to meaningfully impact patients for whom oral or enteral choline supplementation is not an option.”

“Results from THRIVE-1 underscore the significant need for choline among patients on PS,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We remain committed to bringing the first approved IV formulation of choline to the PS community and look forward to initiating our registrational THRIVE-3 trial of IV Choline Chloride in the first half of 2025.”

The Company plans to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the first half of 2025. THRIVE-3 is a seamless Phase 2b/3 trial with an 8-week, dose confirmation phase (n=24) followed by a 24-week double-blinded, randomized, placebo-controlled phase to assess the efficacy and safety of IV Choline Chloride in adolescents and adults on long-term PS (n=100). IV Choline Chloride was previously granted Fast Track designation by the U.S. Food and Drug Administration.

IV choline is recommended for patients receiving PS by ASPEN in its Recommendations for Changes in Commercially Available Parenteral Multivitamin and Multi–Trace Element Products, as well as by the European Society for Clinical Nutrition and Metabolism (ESPEN) in its Guideline on Home Parenteral Nutrition.

Details of the oral presentation are as follows:

  • Abstract Title: THRIVE-1: A Multi-Center, Cross-Sectional, Observational Study to Assess the Prevalence of Choline Deficiency in Patients Dependent on Parenteral Support
  • Session Title: Nutrition and Metabolism Research Paper Session: Parenteral Nutrition Therapy
  • Session Date and Time: Sunday, March 23, 2025, 2:00 p.m. – 3:30 p.m. ET

About IV Choline Chloride

IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is a known important substrate for phospholipids that are critical for healthy liver function that also play an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function, and bone health. PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Approximately 78% of patients dependent on PS are choline-deficient and of those approximately 63% have some degree of liver dysfunction, which can lead to hepatic failure. Every year in the U.S. there are approximately 90,000 people who require PS at home and of those approximately 30,000 are on long-term PS. IV Choline Chloride has the potential to become the first U.S. Food and Drug Administration (FDA) approved IV choline formulation for PS patients. It has been granted Orphan Drug Designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term PN and been granted Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. The U.S. Patent and Trademark Office has issued us a U.S. patent claiming a choline composition and a U.S. patent claiming a method for treating choline deficiency with a choline composition, each with a term expiring in 2041.

About Protara Therapeutics, Inc.

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.

Company Contact:

Justine O’Malley
Protara Therapeutics
[email protected]
646-817-2836



Aqua Metals to Announce Fourth Quarter and Full-Year 2024 Financial Results and Host Investor Conference Call on March 31, 2025

RENO, Nev., March 19, 2025 (GLOBE NEWSWIRE) — Aqua Metals, Inc. (NASDAQ: AQMS), a pioneer in sustainable lithium-ion battery recycling, today announced it will report financial results for the fourth quarter and full-year ended December 31, 2024, and provide a business update on Monday, March 31, 2025, and host a conference call that day at 4:30 p.m. ET.

The live conference call can be accessed at https://event.webcasts.com/aqms or from the investor relations section of the Company’s website at https://ir.aquametals.com/. Alternatively, interested parties can access the audio call by dialing 877-407-9708 (toll-free) or 201-689-8259 (international).

Following the conclusion of the live event, a replay will be available by dialing 877-660-6853 (toll-free) or 201-612-7415 (international) and using passcode 13751716. The webcast replay will also be available in the investor relations section of the Aqua Metals website.

About Aqua Metals

Aqua Metals, Inc. (NASDAQ: AQMS) is reinventing metals recycling with its patented AquaRefining™ technology. The Company is pioneering a sustainable recycling solution for materials strategic to energy storage and electric vehicle manufacturing supply chains. AquaRefining™ is a low-emissions, closed-loop recycling technology that replaces polluting furnaces and hazardous chemicals with electricity-powered electroplating to recover valuable metals and materials from spent batteries with higher purity, lower emissions, and minimal waste. Aqua Metals is based in Reno, NV and operates the first sustainable lithium battery recycling facility at the Company’s Innovation Center in the Tahoe-Reno Industrial Center. To learn more, please visit www.aquametals.com.

Aqua Metals Social Media

Aqua Metals has used, and intends to continue using, its investor relations website (https://ir.aquametals.com), in addition to its X, Threads, LinkedIn and YouTube accounts at https://x.com/AquaMetalsInc (@AquaMetalsInc), https://www.threads.net/@aquametalsinc (@aquametalsinc), https://www.linkedin.com/company/aqua-metals-limited and https://www.youtube.com/@AquaMetals respectively, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contact Information

Investor Relations

Bob Meyers & Rob Fink
FNK IR
646-878-9204
[email protected]

Media

David Regan
Aqua Metals
415-336-3553
[email protected]

Source: Aqua Metals



Behr Paint Company Reveals its 2025 Exterior Stain Colour of the Year, “Cedar,” Alongside Annual Curb Appeal Collection

The announcement comes as 76% of Canadian homeowners plan to tackle exterior home renovations in 2025, according to a new study by Behr1

TORONTO, March 19, 2025 (GLOBE NEWSWIRE) — Behr Paint Company has selected Cedar, a warm, earthy hue inspired by the natural tones of cedarwood, as the 2025 Exterior Stain Colour of the Year. The launch comes as 66% of homeowners are choosing to update their home’s exterior instead of selling this year, according to a new Behr study.

“As the spring season turns consumer attention to outdoor projects, Cedar is the perfect choice for homeowners looking to apply an inviting shade to exterior wood surfaces,” said Andy Lopez, Senior Vice President, Head of Marketing at Behr Paint Company. “Cedar not only reflects the current consumer desire for natural, earthy tones, but it also combines classic characteristics with durable performance that will stand the test of time.”

Alongside the Exterior Stain Colour of the Year, Behr is also unveiling its second annual Curb Appeal Collection to help homeowners simplify the colour selection process and amplify the exterior aesthetics of their homes. In fact, 78% of homeowners say they would consider painting the exterior of their home a different colour, but nearly half (48%) of homeowners believe there are too many factors when making an exterior paint choice. That is why Behr curated a collection of 45 on-trend exterior paint colours to take the guesswork out of the painting journey — whether a homeowner is planning a full home exterior transformation or tackling smaller projects like refreshing their front door or window trim. The colours draw inspiration from emerging trends shaping home exterior environments today and showcase a range of hues from natural, earthy tones to vibrant pops of colour. As the desire for more personalized home design grows, the collection blends timeless elegance with contemporary vitality to meet diverse tastes.

“Cedar is a warm and earthy light golden-brown. It holds a richness and depth that enhances the natural beauty of wood for an elevated experience,” said Erika Woelfel, Vice President of Colour and Creative Services at Behr Paint Company. “Its tonality complements a variety of architectural styles, from minimalist modern to casual craftsman, and pairs perfectly with our latest Curb Appeal Collection.”

Homeowners can seamlessly pair Cedar with the Curb Appeal Collection colours to achieve a cohesive look when updating their decks, pergolas, porches, fences, doors and more. In fact, Behr has further simplified your colour exploration by providing four sub-palettes within the Curb Appeal Collection that reflect different design styles:

  • Classic Haven: Blends soft neutrals like whites and beiges with bold hues like deep greys, blues, and reds, including the BEHR® Colour of the Year, Rumors. This sophisticated palette creates a timeless, refined curb appeal for heritage or classic-style homes.
  • Modern Escape: Features bold, lively hues like yellow, teal, and orange, paired with subtle whites and greys. This palette creates a fresh, modern, and inviting look that is perfect for sleek, contemporary homes.
  • Casual Oasis: Offers a laid-back, tranquil atmosphere with soft greys, creamy whites, and gentle blues. This coastal-inspired palette creates a light, airy exterior, perfect for a relaxed and inviting curb appeal.
  • Artisan Retreat: Showcases earthy neutrals, warm browns, and subtle greys, accented by vibrant oranges and reds. This grounding, textured palette evokes the handcrafted beauty of homes, creating a warm, welcoming exterior.

As the most trusted paint brand in Canada*, BEHR® offers its 2025 Exterior Stain Colour of the Year exclusively at The Home Depot Canada in a variety of products including BEHR PREMIUM® Solid Colour Waterproofing Exterior StainBEHR PREMIUM® Semi-Transparent Waterproofing Exterior StainBEHR PREMIUM® ADVANCED DECKOVER®, BEHR® Solid Colour House & Fence Wood Stain, and BEHR® DECKPLUS®.

To learn more about Cedar and the Curb Appeal Collection, visit behr.ca/2025staincoty.


About Behr Paint Company


Founded in 1947, Behr Paint Company is one of the largest manufacturers of paints, primers, decorative finishes, stains, surface preparation and application products for do-it-yourselfers and professionals in the United States, Canada, and Mexico. The Santa Ana, Calif.-based company, and maker of BEHR®, KILZ® and WHIZZ® brands, is dedicated to meeting the project needs of DIYers, designers and professional paint contractors with an unwavering commitment to quality, innovation, and value. For more information, visit Behr.ca. Professional paint contractors and designers can visit BehrPro.ca to learn about products, colour tools and services. Behr Paint Company is a subsidiary of Masco Corporation (NYSE: MAS).

*Based on the 2025 BrandSpark® Canadian Trust Study. Visit www.BrandSparkMostTrusted.com.

Behr and the Behr logo are registered trademarks of Behr Process LLC.

For inquiries, questions and/or high-res images, please contact:

Samantha Machan
[email protected]


1 Behr Paint commissioned an online survey among n=1,000 Canadian homeowners 18 years of age and older. Data is balanced across age, gender, race/ethnicity, and region. The survey was fielded between February 20-26, 2025. The margin of error (MOE) for the total sample is +/- 3 percentage points

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/ddbf28aa-eab2-4063-86dc-45aad722b2bc

https://www.globenewswire.com/NewsRoom/AttachmentNg/eddf58e5-e0b6-4ad8-a0ae-0ca68511e535



BioAtla to Announce Fourth Quarter and Full-Year 2024 Financial Results and Provide Business Highlights on March 27, 2025

SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) — BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that it plans to host a conference call and webcast on Thursday, March 27, 2025 at 4:30 p.m. ET to discuss its financial results for the fourth quarter and full-year ended December 31, 2024 and provide business highlights.

Conference Call and Webcast Information        
Date: Thursday, March 27, 2025
Time: 4:30 p.m. ET
Webcast Link: BioAtla Fourth Quarter and Full-Year 2024 Earnings Conference Call
Dial-in Numbers: (800) 245-3047 (domestic), (203) 518-9765 (international)
Conference ID: BIOATLA

The press release with the financial results will be accessible prior to the conference call through “News Releases” in the News & Events section of the company’s website. A replay of the call will also be available through “Events & Presentations” in the Investors section of the company’s website.

About BioAtla®, Inc. 
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody, evalstotug, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. The Company’s first dual CAB bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. To learn more about BioAtla, Inc. visit www.bioatla.com

Internal Contact:

Richard Waldron
Chief Financial Officer
BioAtla, Inc.
[email protected]
858.356.8945

External Contact:

Bruce Mackle
LifeSci Advisors, LLC
[email protected]



Gogo announces Gulfstream GV and Gulfstream G550 STC for Plane Simple Ka-band terminal

Broomfield, CO., March 19, 2025 (GLOBE NEWSWIRE) — Gogo (NASDAQ: GOGO) has confirmed Supplemental Type Certificate (STC) approval by the Federal Aviation Administration (FAA) for its Plane Simple® Ka-band tail mount terminal for Gulfstream GV and Gulfstream G550 aircraft. This latest development marks another significant milestone in the Plane Simple antenna series rollout.

Gulfstream Aerospace Corp. developed the STC at its Savannah, Georgia, headquarters in collaboration with Gogo. This adds to the existing Plane Simple Ka-band STCs already available on Gulfstream G650 and Gulfstream G650ER aircraft. The terminal optimizes the SD Modem Unit (SMU), which is integrated with the SD Gateway Router to distribute high-speed broadband to passenger and crew devices. The Ka-band hardware is available now for installation through authorized Gulfstream and Jet Aviation service centers. Work continues on an aftermarket STC for Gulfstream G500 and Gulfstream G600 models, with completion expected later in the year.

Connecting with existing Viasat GX satellites powering the Jet ConneX service, the Ka-band antenna is the first terminal in business aviation built to optimize compatibility with Viasat next-generation GX satellites. These will transmit dual polarity signals, more than doubling the volume of data transmitted and received to deliver an enhanced connectivity experience supporting video conferences, streaming and increased network priority for business aviation users.

“The latest STC in our growing portfolio gives Gulfstream GV and G550 owners and operators access to more speed, more data, and more service plan flexibility and facilitates dual-dissimilar options for optimized global connectivity through our multi-orbit, multi-band strategy,” says Gogo CEO, Chris Moore.  “At the same time, forward compatibility with Viasat’s next-generation GX satellites helps operators to future-proof their connectivity fit, which is complemented by the added value delivered through the Gogo ecosystem, including expert global customer support, unparalleled cybersecurity services, and a connectivity portfolio designed to evolve with the changing connectivity landscape.” 

Gogo provides cabin connectivity service plans on both in-production and in-service legacy aircraft for the Gulfstream Connectivity Service program.  

Photo Caption: Gogo Plane Simple® Ka-band terminal certified for Gulfstream G550

__________________________________________________________________________
About Gogo

Gogo is the only multi-orbit, multi-band in-flight connectivity provider offering connectivity technology purpose-built for business and military/government aviation. Its industry-leading product portfolio offers best-in-class solutions for all aircraft types, from small to large, heavy jets, and beyond.

The Gogo offering uniquely incorporates Air-to-Ground technology with high-speed satellite networks to deliver consistent, global tip-to-tail connectivity through a sophisticated suite of software, hardware, and advanced infrastructure supported by a 24/7/365 in-person customer support team. 

Gogo consistently strives to set new standards for reliability, security and innovation, and is shaping the future of inflight aviation to make it easier for every customer to stay connected beyond all expectations. 
           
Cautionary Note Regarding Forward-Looking Statements

Certain disclosures in this press release include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding our business outlook, industry, business strategy, plans, goals and expectations concerning our market position, international expansion, future technologies, future operations, margins, profitability, future efficiencies, capital expenditures, liquidity and capital resources and other financial and operating information. When used in this discussion, the words “anticipate,” “assume,” “believe,” “budget,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “future” and the negative of these or similar terms and phrases are intended to identify forward-looking statements in this press release. 

Forward-looking statements are based on our current expectations regarding future events, results or outcomes. These expectations may or may not be realized. Although we believe the expectations reflected in the forward-looking statements are reasonable, we can give you no assurance these expectations will prove to have been correct. Some of these expectations may be based upon assumptions, data or judgments that prove to be incorrect. Actual events, results and outcomes may differ materially from our expectations due to a variety of known and unknown risks, uncertainties and other factors. Although it is not possible to identify all of these risks and factors, they include, among others, our ability to effectively evaluate and pursue strategic opportunities. 

Additional information concerning these and other factors can be found under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2025. 

Any one of these factors or a combination of these factors could materially affect our financial condition or future results of operations and could influence whether any forward-looking statements contained in this report ultimately prove to be accurate. Our forward-looking statements are not guarantees of future performance, and you should not place undue reliance on them. All forward-looking statements speak only as of the date made and we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Attachments



Jane Stanbury
Gogo 
+1 4389981668
[email protected]