Market Newsdesk

CAMBRIDGE, Mass. , Feb. 24, 2025 (GLOBE NEWSWIRE) — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that Keith Gottesdiener, M.D., President and Chief Executive Officer of Prime Medicine, will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 11:10 a.m. ET in Boston, MA.

A live audio webcast of the presentation will be available under “Events & Presentations” in the News & Events section of the Company’s website at www.primemedicine.com. A replay of the webcast will be available on the Prime Medicine website for 30 days following the presentation.

About Prime Medicine

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology and oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential, as well as the modularity of the Prime Editing platform, to rapidly and efficiently expand beyond the diseases in its current pipeline, potentially including additional genetic diseases, immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.

© 2025 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.

Investor Contact

Hannah Deresiewicz
Precision AQ
212-362-1200
[email protected]

Media Contact

Dan Budwick, 1AB
[email protected]

DUBLIN, Feb. 24, 2025 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that Kevin Springman has joined the company as Vice President of Sales. Mr. Springman is an accomplished executive with experience leading sales, market access and commercial teams, and executing rare disease drug launches in competitive markets.

“We’re delighted to welcome Kevin to Avadel – he’s a great addition to our team with the deep experience to help us drive success at this important time,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “Kevin’s expertise and proven track record in building and leading specialized sales teams will be invaluable as we continue building momentum behind the launch of LUMRYZ, our FDA-approved innovative treatment for narcolepsy.”

Avadel is executing a comprehensive commercial strategy to increase demand for LUMRYZ™, with the goal of enhancing the experience for both patients and providers and unlocking the billion-dollar market potential of LUMRYZ. Avadel’s commercial launch in narcolepsy and ongoing progress in its investigational, Phase 3 trial in idiopathic hypersomnia (IH) positions the company to solidify its leadership in the sleep space and transform care for patients with sleep disorders.

Mr. Springman brings more than 25 years of sales, marketing and market access leadership to Avadel. He started his sales career at AstraZeneca, where he spent 22 years, rising to become Franchise Head, Infectious Disease. Later, Mr. Springman was Vice President, Head of Immunology & Rare Disease Franchises at Sobi – North America. After that, he was President of the Americas at Albireo Pharma, where he helped build the company’s commercial infrastructure and led a specialized sales and market access team. Most recently, Mr. Springman was an independent consultant to rare disease and specialty pharma companies.

“I’m excited to join Avadel at such a pivotal moment in the launch of LUMRYZ,” said Mr. Springman. “Avadel has an exceptional opportunity with LUMRYZ, built on a strong foundation in sleep medicine. I look forward to optimizing our sales strategy and execution to drive LUMRYZ’s continued growth and market leadership while improving patients’ lives.”

Avadel is intent on further strengthening its executive team and is progressing its search for a new leader of its commercial organization.

About LUMRYZ
™
(sodium oxybate) for extended-release oral suspension
 

LUMRYZ, is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.  

The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians’ overall assessment of patients’ functioning (CGI-I) and cataplexy attacks, for all three evaluated doses when compared to placebo.  

With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.

About Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ™, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. For more information, please visit www.avadel.com.

IMPORTANT SAFETY INFORMATION

WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope) and death. The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these serious side effects. Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029.

INDICATIONS

LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years of age and older with narcolepsy:

• sudden onset of weak or paralyzed muscles (cataplexy)
• excessive daytime sleepiness (EDS)

Do not take LUMRYZ if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency.

Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.

Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.

LUMRYZ can cause serious side effects, including the following:

• Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.
• Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself. Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.
• Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child start sleepwalking.

Tell your doctor if you or your child are on a salt-restricted diet or have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.

The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ.

For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including BOXED Warning.

Cautionary Disclosure Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, statements regarding our plans and strategies for LUMRYZ; expectations regarding the potential market opportunity for LUMRYZ; expectations regarding Avadel’s ability to seek and obtain FDA approval for, as well as, commercially launch LUMRYZ for indications beyond narcolepsy; and expectations regarding the anticipated contribution of new employees to our operations and progress. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable).

The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include final audit adjustments and other developments that may arise that would cause the Company’s expectations with respect to the estimate of revenue for the fourth quarter of 2024 and cash as of December 31, 2024 to differ, perhaps materially, from the financial results that will be reflected in the Company’s audited consolidated financial statements for the fiscal year ended December 31, 2024, and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, and subsequent SEC filings.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Investor Contact:

Austin Murtagh
Precision AQ
[email protected]
(212) 698-8696

Media Contact:

Lesley Stanley
Real Chemistry
[email protected]
(609) 273-3162

Tokyo, Japan, Feb. 24, 2025 (GLOBE NEWSWIRE) — Tokyo Lifestyle Co., Ltd. (“Tokyo Lifestyle” or the “Company”) (Nasdaq: TKLF), a retailer and wholesaler of Japanese beauty and health products, sundry products, luxury products, electronic products, as well as other products in Hong Kong, Japan, North America and the United Kingdom, today announced the opening of a new franchise store under its proprietary “Reiwatakiya” brand (the “Store”) in Bangkok, Thailand. This expansion is expected to reinforce the Company’s market presence and strengthens its franchise sales network in Southeast Asia.

Located at Park Silom, the Store officially opened on February 6, 2025, spanning 137 square meters. It offers a modern and convenient shopping experience featuring Tokyo Lifestyle’s high-quality products and fashionable, engaging store designs.

Mr. Mei Kanayama, Principal Executive Officer of Tokyo Lifestyle, commented: “Thailand and Southeast Asia are key components of our long-term global expansion strategy due to their significant growth potential and dynamic market environment. We are highly optimistic about our expansion efforts, including existing partnerships and franchise networks. The Park Silom store represents a milestone in extending our market footprint and strengthening brand recognition. Furthermore, we believe our steady and strategic expansion in Thailand will accelerate our presence across Southeast Asia and beyond. Looking ahead, we expect our business to maintain a robust growth trajectory, driven by thoughtful strategic planning and careful execution.”

About Tokyo Lifestyle Co., Ltd.

Headquartered in Tokyo, Japan, Tokyo Lifestyle Co., Ltd. (formerly known as Yoshitsu Co., Ltd) is a retailer and wholesaler of Japanese beauty and health products, sundry products, luxury products, electronic products, and other products in Hong Kong, Japan, North America, and the United Kingdom. The Company offers various beauty products (including cosmetics, skincare, fragrance, and body care products), health products (including over-the-counter drugs, nutritional supplements, and medical supplies and devices), sundry products (including home goods), and other products (including food and alcoholic beverages). The Company currently sells its products through directly-operated physical stores, through online stores, and to franchise stores and wholesale customers. For more information, please visit the Company’s website at https://www.ystbek.co.jp/irlibrary/.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to,” or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s registration statement and in its other filings with the U.S. Securities and Exchange Commission.

For more information, please contact:

Tokyo Lifestyle
Co., Ltd.

Investor Relations Department
Email: [email protected]

Ascent Investor Relations LLC

Tina Xiao
President
Phone: +1-646-932-7242
Email: [email protected]

SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) — aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at the Leerink Partners Global Healthcare Conference, which is scheduled to take place March 9 – 12, 2025, in Miami, FL.

Details of the presentation appear below:

Conference: Leerink Partners Global Healthcare Conference
Date: Monday, March 10, 2025
Time: 1:40pm EDT
Location: Miami, FL
Format: Fireside Chat

In addition to the presentation, company management will be available to participate in one-on-one meetings with investors who are registered attendees of the conference. A webcast of the presentation will be available on the Investor’s section of the company’s website at www.atyrpharma.com. Following the event, a replay of the presentation will be available on the aTyr website for at least 90 days. For more information, contact [email protected].

Abo
ut aTyr

aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com.

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

[email protected]

SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) — LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that company management will participate in the following upcoming investor conferences:

TD Cowen 45

^th

Annual Health Care Conference (Boston, MA)

Management is scheduled to provide a corporate presentation at Monday, March 3^rd, 2025 at 9:50am ET, and will participate in one-on-one meetings from Monday, March 3^rd through Wednesday, March 5^th, 2025.

Leerink Partners Global Healthcare Conference (Miami, FL)

Management is scheduled to participate in a fireside chat on Tuesday, March 11^th at 2:20pm ET and will participate in one-on-one meetings.

A live audio webcast of the TD Cowen 45^th Annual Health Care Conference presentation can be accessed here and on the LENZ Therapeutics website at www.LENZ-tx.com in the Investors & Media section. A replay of the webcast will be available on the Company’s website for 12 months following the event.

About LENZ Therapeutics

LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.

Contacts:

Dan Chevallard
LENZ Therapeutics
[email protected]

PARIS, Feb. 24, 2025 (GLOBE NEWSWIRE) — Constellium SE (NYSE: CSTM) announced its participation in ‘Project M-LightEn,’ an ambitious new initiative to develop ultra-lightweight, sustainable vehicle chassis structures. Led by Gordon Murray Group (GMG), the initiative is supported by Innovate UK and the Advanced Propulsion Centre (APC), and includes as partners Constellium, Carbon ThreeSixty, and Brunel University London. Over the next three years, the consortium aims to achieve breakthrough innovations in unibody vehicle architecture that reduce carbon intensity by 50% while being 25% lighter.

As part of Project M-LightEn, Constellium will supply ultra-high-strength aluminum solutions made with 80% recycled UK consumer scrap. These advanced materials will form the foundation of the unibody structure, enhancing the structural integrity of the unibody while reducing weight and carbon emissions. Brunel University London will collaborate with Constellium on advanced material research and testing, ensuring that every component meets the highest standards for performance and sustainability.

“Alongside Gordon Murray Automotive’s niche supercar application, Project M-LightEn will enable decarbonization across the wider automotive industry by shortening and de-risking the path to market for innovative new materials and processes,” stated GMG’s Strategy and Business Director, Jean-Phillipe Launberg.

“Through Project M-LightEn, Constellium reaffirms its commitment to pushing the boundaries of lightweighting technologies,” stated Martin Jarrett, Director Technology and Innovation at Constellium’s AS&I business unit. “This initiative allows us to develop cutting-edge aluminum solutions that redefine vehicle performance while combining innovation with sustainability and circularity.”

The first phase of Project M-LightEn is underway, focusing on the exploration of new materials and joining techniques. By late 2027, the consortium’s innovations are expected to be available for low-volume commercial applications, with broader adoption in mainstream manufacturing to follow.

About Constellium

Constellium (NYSE: CSTM) is a global sector leader that develops innovative, value-added aluminum products for a broad scope of markets and applications, including aerospace, packaging and automotive. Constellium generated $7.3 billion of revenue in 2024.

www.constellium.com

Investor Relations		Communications
Jason Hershiser		Delphine Dahan-Kocher
Phone: +1 443 988-0600		Phone: +1 443 420 7860
[email protected]		[email protected]

        

SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) — Singular Genomics Systems, Inc., an innovator in high-throughput spatial multiomics technologies designed to advance precision medicine, today announced key development milestones for its G4X™ Spatial Sequencer at the Advances in Genome Biology and Technology (AGBT) conference in Marco Island, Florida.

G4X Early Access Program Ongoing and Broader Availability on Track

The G4X Early Access Program is currently underway at Beth Israel Deaconess Medical Center and Vanderbilt University Medical Center, providing valuable feedback highlighting the platform’s real-world potential.

“As the first early access site, we’ve had the chance to appreciate the impact of the very high throughput of the G4X, along with its ability to generate high-quality data across multiple sample types, right from the start,” said Dr. Ioannis Vlachos, Director of the Spatial Technologies Unit (www.spatialtechnology.org) at Beth Israel Deaconess Medical Center, and Associate Professor of Pathology at Harvard Medical School. “The system’s higher throughput is squarely aligned with current needs of the spatial biology field, where increased sample volumes and lower turnaround times can enable larger studies, adoption into translational or clinical trial settings, as well as higher return-of-investment and reduced costs for researchers and core facilities.”

“We’re excited to have the G4X in our lab, and the data we’ve seen so far is promising for our work with the Human Tumor Atlas Network,” said Dr. Tae Hwang, Founding Director of the Molecular Artificial Intelligence Initiatives at Vanderbilt University Medical Center. “The reproducibility, speed, and cost-efficiency allow us to scale 3D spatial analyses in larger retrospective clinical cohorts. Integrating the high-throughput spatial multimodal analysis of samples on G4X with AI can provide us critical insights into disease mechanisms and therapeutic biomarkers, ultimately advancing patient care.”

Singular plans to expand its early access program to a few more sites in Q2. Meanwhile, pre-orders for the G4X are now open, and initial shipments are on track for June 2025. Researchers wishing to start generating multiomic data can use Singular’s technology access services in the meantime.

“The G4X data we received back from Singular on our head and neck cancer sample cohort was highly informative,” remarked Dr. Shanye Yin, Assistant Professor in the Department of Pathology at Albert Einstein College of Medicine and Director of the Pathology Single-Cell Core Laboratory. “Integrating transcript, protein, and fH&E data allowed us to identify cell populations and complex tumor-immune interactions with single-cell precision. Additionally, the system’s robustness is confirmed as the results are fully validated by other multi-plex imaging platforms.”

Exceptional Multiomic Performance and 3D Reconstruction Showcased

At AGBT, Singular Genomics presented data demonstrating the G4X platform’s robust integrated multiomic performance. Immune-oncology-focused lung, kidney, colon, and breast panels showed high sensitivity, specificity, and reproducibility in FFPE samples, providing comprehensive spatial insights into cancerous and healthy tissues.

Building on these data, Singular showcased advanced 3D multi-omic reconstruction and niche detection from 10 serial renal cell carcinoma FFPE sections, over 6.2 million cells, and 438 million transcripts—all from a single G4X flow cell.

“The high throughput on the G4X ensures exceptional consistency across FFPE samples, while simultaneously measuring transcripts, proteins, and fH&E within the same sample provides strong reproducibility across modalities. This unique combination makes 3D reconstruction surprisingly straightforward,” said Michael Lawson, Director, R&D at Singular Genomics. “Analyzing tissues in a higher dimension facilitates advanced spatial neighborhood analyses of immune-tumor interactions, something we believe will translate into more robust biomarker identification.”

Additional Highlights

• Direct Sequencing in Tissues: Singular advanced its proprietary Direct-Seq technology, enabling the sequencing of variable regions within cells in tissue. During AGBT, the company demonstrated accurate T- and B-cell receptor sequencing in FFPE tonsil samples.
• Data Availability: Researchers can access raw and demo datasets from Singular’s multi-tissue performance studies to explore the platform’s capabilities and validate real-world spatial data.

About Singular 
Singular Genomics is a life science technology company that develops next-generation sequencing and multiomics technologies. The commercially available G4® Sequencing Platform is a powerful, highly versatile benchtop genomic sequencer designed to produce fast and accurate results. In addition, the Company is currently developing the G4X™ Spatial Sequencer, which will leverage its proprietary sequencing technology, applying it as an in situ readout for transcriptomics, proteomics and fluorescent H&E in tissue, with spatial context and on the same platform as the G4. Singular Genomics’ mission is to empower researchers and clinicians to advance science and medicine. Visit www.singulargenomics.com for more information.

Media Contact

Darius Fugere
[email protected]

Kissimmee, FL, Feb. 24, 2025 (GLOBE NEWSWIRE) — Aureus Greenway Holdings Inc. (the “Company”) (NASDAQ: AGH), an owner and operator of daily fee golf country clubs in the state of Florida, today announced that the Company will ring the closing bell at the Nasdaq MarketSite in Times Square, New York, on Tuesday, February 25, 2025.

Mr. ChiPing Cheung, co-Founder and Chief Executive Officer, will be joined by members of the Company’s management team to ring the closing bell in celebration of the Company’s successful initial public offering and listing on the Nasdaq Capital Market.

“We are honored to ring the Nasdaq closing bell as we mark this significant milestone in Aureus Greenway’s history,” said Mr. ChiPing Cheung. “Since acquiring our golf properties in 2014, we have transformed them into premier daily fee golf destinations in the greater Orlando region. This celebration reflects our commitment to delivering exceptional golfing experiences while creating value for our shareholders.”

The Company owns and operates two public golf country clubs in Florida – the Kissimmee Bay Country Club and the Remington Golf Club – featuring over 289 acres of recreational property, including two golf courses with more than 13,000 yards of combined fairways. Located in the heart of Central Florida’s tourism corridor, both properties offer accessible, high-quality golf experiences complemented by full-service clubhouses, aquatic golf ranges, and professional instruction.

The bell ringing ceremony will be broadcast live starting at 3:45 p.m. Eastern Time from the Nasdaq MarketSite Tower in New York City. A live webcast of the ceremony will be available at: https://www.nasdaq.com/marketsite/bell-ringing-ceremony.

About Aureus Greenway Holdings Inc.

Aureus Greenway Holdings Inc. owns and operates daily fee golf country clubs in the state of Florida that are designed to appeal to a wide-ranging population. The combination of our strategic locations and approachable golf-courses attracts both local and tourist demographics, allowing us to offer a variety of golf experiences while capturing a broad share of discretionary leisure spending. For more information, please visit our website at www.aureusgreenway.com.

Forward-Looking Statements

This press release contains forward-looking statements. 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. These forward-looking statements include, without limitation, the Company’s statements regarding the expected trading of its common stock on the Nasdaq Capital Market and the closing of the Offering. 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 uncertainties related to market conditions and the completion of the initial public offering on the anticipated terms or at all, and other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. 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:

Matthew Abenante, IRC
President
Strategic Investor Relations, LLC
Tel: 347-947-2093
Email: [email protected]

Data confirms Versamune

^®

HPV has potential as a broadly effective treatment of HPV16-associated cancers – Initiation of Phase 3 trial in HPV16-positive HNSCC planned for Q1 2025

Versamune

^®

HPV + CRT was associated with greater and earlier clearance of blood-circulating HPV16-positive cancer cells (circulating tumor DNA/ctDNA) vs. CRT alone

100% of patients with locally advanced HPV16 cervical cancer treated with Versamune

^®

HPV + CRT had no detectable HPV16 ctDNA at 3-4 months vs. 50% of patients on standard-of-care CRT

Undetectable HPV ctDNA at 3-4 months was associated with improved 2-year recurrence-free survival (RFS) of 93% vs only 30% in patients with detectable HPV ctDNA

PRINCETON, N.J., Feb. 24, 2025 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the publication of circulating tumor DNA (ctDNA) results for its lead immunotherapy candidate, Versamune^® HPV, in Clinical Cancer Research, a journal of the American Association for Cancer Research.

The trial demonstrated that Versamune^® HPV was associated with greater and earlier clearance of HPV16-positive cancer cells from the bloodstream in patients with locally advanced cervical cancer. Notably, the elimination of HPV16-positive ctDNA correlated with extended patient survival without cancer recurrence, reinforcing its potential to improve long-term outcomes. The data underscore the potential of Versamune^® HPV in HPV16-positive cancers as the Company prepares to initiate a Phase 3 clinical trial for Versamune^® HPV in HPV16-positive head and neck squamous cell carcinoma (HNSCC) in the first quarter of this year.

“These findings highlight the transformative potential of Versamune^® HPV in broadly treating various HPV16-associated cancers. Combining Versamune^® HPV with chemoradiation (CRT) was linked to rapid HPV16 ctDNA decline,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We believe that such results showing a strong correlation between a biomarker such as ctDNA and survival may allow us to initiate discussions with the U.S. Food and Drug Administration regarding the potential for an accelerated regulatory pathway such as Breakthrough Therapy designation in cervical cancer. We also think this finding that links the reduction of ctDNA level with improved survival may apply to other HPV16-positive cancers like HNSCC. This endpoint is currently included within our VERSATILE-003 Phase 3 clinical trial.”

A total of 66 patients with locally advanced cervical cancer were enrolled, with 49 receiving CRT and 17 receiving a combination of CRT and Versamune^® HPV. Patient blood was collected at baseline, weeks 1, 3, and 5 of CRT, and 3 to 4 months after CRT to measure HPV ctDNA. MRI was performed at baseline and before brachytherapy to determine tumor shrinkage.

Median follow-up was 23 months. At 3-4 months follow-up, 5/5 (100%) HPV16-positive patients receiving CRT + Versamune^® HPV had no detectable HPV16-positive ctDNA, whereas 3/6 (50%) of patients receiving only CRT had no detectable ctDNA.

HPV ctDNA clearance at 3-4 months correlated with better 2-year recurrence free survival (RFS) (92.9% vs. 30%, log-rank; P = 0.0067). The strongest predictor of RFS was HPV ctDNA clearance at 3-4 months follow-up, achieving a concordance index score of 0.83.

The 36-month overall survival (OS) and progression free survival rates were earlier reported to be 100% for the 8 patients in the trial who received 5 doses of Versamune^® HPV + CRT and an 84.4% 36-month OS rate for 17 patients who received at least 2 doses of Versamune^® HPV + CRT.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune^® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com.

Forward-Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune^® HPV, PDS01ADC and other Versamune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune^® HPV, PDS01ADC and other Versamune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark of PDS Biotechnology Corporation.

Investor Contact:

Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: [email protected]

Media Contact:

Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: [email protected]

BURLINGTON, Mass. and JERUSALEM, Israel, Feb. 24, 2025 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it will report its fourth quarter and full year 2024 financial results, as well as operational highlights, before the open of the U.S. financial markets on Tuesday, March 11, 2025. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

Conference Call Dial-In & Webcast Information

Date:	Tuesday, March 11, 2025
Time:	8:30 AM Eastern Time
United States:	1-877-300-8521
International:	1-412-317-6026
Israel:	1-80-921-2373
Conference ID:	10196869
Webcast:	https://viavid.webcasts.com/starthere.jsp?ei=1707646&tp_key=bc6ba78957

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in Israel and the U.S., BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Contacts:

BrainsWay:

Ido Marom
Chief Financial Officer
[email protected] 

Investors:

Brian Ritchie
LifeSci Advisors
[email protected]