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The Radoff-JEC Group Nominates Three Highly Qualified Candidates for Election to the Atea Pharmaceuticals Board of Directors

Issues Open Letter to Atea’s Stockholders Outlining the Case for Boardroom Change Based on Years of Stock Price Underperformance, Poor Decision-Making and Entrenchment Maneuvers

Believes its Three Highly Qualified Director Candidates Possess the Necessary Ownership Perspectives, Scientific Credibility and Public Company Board Experience to Create Value for Stockholders

HOUSTON–(BUSINESS WIRE)–
Bradley L. Radoff and Michael Torok (together with certain of their affiliates, the “Radoff-JEC Group”), who collectively own approximately 5.4% of the outstanding stock of Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) (“Atea” or the “Company”), today announced that they have nominated three highly qualified director candidates – Howard H. Berman, James Flynn and Mr. Torok – for election to the Company’s Board of Directors (the “Board”) at the 2025 Annual Meeting of Stockholders (the “Annual Meeting”). In connection with its nomination, the Radoff-JEC Group issued the following open letter to stockholders outlining the urgent need for boardroom change:

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Fellow Stockholders,

Over the past four months, we have expressed concerns to Atea’s Board about the Company’s stock price performance, strategy, capital allocation and governance practices. Specifically, we have highlighted several key facts:

• Atea’s shares have traded below their net cash value since November 2021.

• In May 2023, the Board rejected a bid from Tang Capital Partners, LP (“Tang Capital”) that would have paid Atea stockholders $5.75 per share in cash, plus a contingent value right through which stockholders would be eligible to receive 80% of the net proceeds from the Company’s drug programs.¹ In the 18 months since it rejected Tang Capital’s buyout offer, Atea has burned ~$175 million in cash, or approximately $2.00 per share. Atea’s stock now trades at approximately $3.20, reflecting the current leadership’s inability to create value for stockholders.²
  
  
  
• During this time, there have been numerous stock sales from insiders at valuations below the price per share offered by Tang Capital, including by Board Chair and CEO Jean-Pierre Sommadossi. Most recently, Lead Independent Director Franklin Berger sold 359,606 shares at or near the Company’s all-time-low share price, immediately before the Company announced it had retained Evercore to advise on an exploration of strategic partnerships and during what would normally be a closed window for insider trading.3

• After we repeatedly asked the Board to dismiss Mr. Berger and replace him with a qualified, stockholder-oriented Lead Independent Director, the Board appointed Arthur Kirsch in February 2025. As we understand it, the addition of Mr. Kirsch is another example of Mr. Sommadossi continuing to populate the boardroom with long-time and loyal friends. In fact, Mr. Kirsch’s son – who is an Atea stockholder – informed us during a standard investor-to-investor conversation that (a.) he requested a seat on the Atea Board prior to his father Arthur’s appointment and (b.) he and his family are long-time friends of Mr. Sommadossi and his wife.

In addition to highlighting the above fundamental issues, we have also made suggestions to the Board that we believe would ensure proper governance and management of the business while resulting in significant and immediate value for stockholders. The Board has ignored or rejected our ideas.

Accordingly, and with all stockholders’ interests in mind, we have nominated three highly qualified director candidates – Howard H. Berman, James Flynn and Michael Torok – for election to the Board at the Annual Meeting. Our nominees collectively possess corporate governance expertise, an ownership mindset and biotechnology backgrounds. We believe they have the right skillsets and experience to address the issues plaguing Atea today.

With a refreshed Board that is committed to objectively overseeing management and focused on creating stockholder value, we believe Atea can immediately return up to $250 million in cash to stockholders while it continues to evaluate strategic alternatives for its only asset. We look forward to providing stockholders with the opportunity to add fresh perspectives and relevant expertise to the Board at this critical time for the Company. We’ll be in touch over the coming weeks with more details on how to vote for change.

Sincerely,

Bradley L. Radoff and Michael Torok

***

DIRECTOR NOMINEE BIOGRAPHIES

Howard H. Berman, Ph.D.

Dr. Berman brings a unique combination of business acumen and scientific credibility with successful company exits coupled with his experience as Co-Founder, CEO and Chairman of a public biotechnology company.

• Founder and Executive Chairman of the board of directors of Coya Therapeutics, Inc. (NASDAQ: COYA), a clinical-stage biotechnology company where he previously served as Chairman of the board of directors and CEO.

• Founder and former member of the board of directors of Imaware Inc., a private company focused on at-home health testing and diagnostics and which was acquired in 2024.

• Former Medical Science Liaison at AbbVie Inc. (NYSE: ABBV), a research-based biopharmaceutical company engaging in the research, development and sale of medicines.

• Previously held leadership roles at Eli Lilly and Company (NYSE: LLY) and Novartis Pharmaceuticals Corporation (NYSE: NVS), global pharmaceutical companies that discover, develop, manufacture and market pharmaceutical products for humans and animals.

James Flynn

Mr. Flynn possesses extensive public board service experience at several biopharmaceutical companies, alongside deep business development and financial expertise.

• Managing Member of Nerium Capital LLC, an investment adviser, and Chief Investment Officer of Nerium Partners LP, an investment partnership.

• Former Therapeutics Analyst at Aptigon Capital, an investment firm and division of Citadel LLC, a financial services company.

• Previously served in various roles at Amici Capital, LLC, an investment management firm, including as Healthcare Portfolio Manager.

• Member of the boards of directors of MEI Pharma, Inc. (NASDAQ: MEIP), a clinical-stage pharmaceutical company, Synlogic, Inc. (NASDAQ: SYBX), a biopharmaceutical company with a focus on rare metabolic disorders, RiceBran Technologies (OTC: RIBT), an innovative specialty ingredients company, and Axiom Health, Inc., a provider of software and big-data solutions to the healthcare industry.

Michael Torok

Mr. Torok is a stockholder of the Company with significant financial, accounting and capital markets expertise, as well as experience as a c-suite executive and as a director of publicly traded companies in the biopharmaceutical industry.

• Co-Founder and Managing Director of JEC Capital Partners, LLC, an investment company with offices in the U.S. and Germany, and Manager of JEC II Associates, LLC, an investment company.

• Former CFO of Integrated Dynamics Engineering Inc., a semiconductor equipment technology company that was acquired by Aalberts Industries (AMS: AALB).

• Previously served in various positions at PricewaterhouseCoopers LLP, a multinational professional services network of firms.

• Former member of the boards of directors of Carisma Therapeutics Inc. (NASDAQ: CARM), a clinical-stage biopharmaceutical company focused on developing immunotherapies to treat cancer and other serious diseases, Photon Control Inc. (formerly TSX: PHO), a designer, manufacturer and distributor of a wide range of optical sensors and systems to measure temperature and position, and Symbility Solutions Inc., a software company focused on the insurance industry.

***

CERTAIN INFORMATION CONCERNING THE PARTICIPANTS

Bradley L. Radoff and Michael Torok, together with the other participants named herein (collectively, the “Radoff-JEC Group”), intends to file a preliminary proxy statement and accompanying BLUE universal proxy card with the Securities and Exchange Commission (“SEC”) to be used to solicit votes for the election of its slate of highly qualified director nominees at the 2025 annual meeting of stockholders of Atea Pharmaceuticals, Inc., a Delaware corporation (the “Company”).

THE RADOFF-JEC GROUP STRONGLY ADVISES ALL STOCKHOLDERS OF THE COMPANY TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS, INCLUDING A PROXY CARD, AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS WILL BE AVAILABLE AT NO CHARGE ON THE SEC’S WEB SITE AT HTTP://WWW.SEC.GOV. IN ADDITION, THE PARTICIPANTS IN THIS PROXY SOLICITATION WILL PROVIDE COPIES OF THE PROXY STATEMENT WITHOUT CHARGE, WHEN AVAILABLE, UPON REQUEST. REQUESTS FOR COPIES SHOULD BE DIRECTED TO THE PARTICIPANTS’ PROXY SOLICITOR.

The participants in the anticipated proxy solicitation are expected to be The Radoff Family Foundation (“Radoff Foundation”), Bradley L. Radoff, JEC II Associates, LLC (“JEC II”), The MOS Trust (“MOS Trust”), MOS PTC, LLC (“MOS PTC”), Michael Torok, Nerium Partners LP (“Nerium Partners”), Nerium Capital LLC (“Nerium Capital”), James Flynn and Howard H. Berman.

As of the date hereof, Radoff Foundation directly beneficially owns 175,000 shares of Common Stock, $0.001 par value per share, of the Company (“Common Stock”). As of the date hereof, Mr. Radoff directly beneficially owns 2,900,100 shares of Common Stock. As of the date hereof, 30,000 shares of Common Stock are held in a certain donor advised charitable account advised by Mr. Radoff (the “Charitable Account”). Mr. Radoff, as a director of Radoff Foundation, may be deemed to beneficially own the 175,000 shares of Common Stock directly beneficially owned by Radoff Foundation, and as an advisor to the Charitable Account, may be deemed to beneficially own the 30,000 shares of Common Stock held in the Charitable Account, which, together with the 2,900,100 shares of Common Stock he directly beneficially owns, constitutes an aggregate of 3,105,100 shares of Common Stock beneficially owned by Mr. Radoff. As of the date hereof, JEC II directly beneficially owns 1,300,000 shares of Common Stock. As of the date hereof, MOS Trust directly beneficially owns 100,000 shares of Common Stock. MOS PTC, as the trustee of MOS Trust, may be deemed to beneficially own the 100,000 shares of Common Stock directly beneficially owned by MOS Trust. As of the date hereof, Mr. Torok directly beneficially owns 100,000 shares of Common Stock. Mr. Torok, as the Manager of JEC II and a Manager of MOS PTC, may be deemed to beneficially own the 1,400,000 shares of Common Stock directly beneficially owned in the aggregate by JEC II and MOS Trust, which, together with the 100,000 shares of Common Stock he directly beneficially owns, constitutes an aggregate of 1,500,000 shares of Common Stock beneficially owned by Mr. Torok. As of the date hereof, Nerium Partners directly beneficially owns 54,000 shares of Common Stock. Nerium Capital, as the general partner of and investment advisor to Nerium Partners, may be deemed to beneficially own the 54,000 shares of Common Stock directly beneficially owned by Nerium Partners. Mr. Flynn, as the Chief Investment Officer of Nerium Partners and the Managing Member of Nerium Capital, may be deemed to beneficially own the 54,000 shares of Common Stock directly beneficially owned by Nerium Partners. As of the date hereof, Mr. Berman does not beneficially own any shares of Common Stock.

1 Company press release dated May 30, 2023 (link).
2 Company’s cash burn for the six reported quarters since it rejected Tang Capital’s bid (beginning July 1, 2023 through December 31, 2024).
3 Form 4 filed by Mr. Berger, dated December 12, 2024 (link). Company press release dated December 16, 2024 (link).

 

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Greg Lempel

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Pharmaceutical Professional Services Health Business

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Posted on March 26, 2025 8:06 am

Starboard Delivers Letter to Autodesk Shareholders

Starboard Delivers Letter to Autodesk Shareholders

Nominates Slate of Highly Qualified Director Candidates for Election at Autodesk’s 2025 Annual Meeting: Geoff Ribar, Christie Simons, and Jeff Smith

Believes the Company’s Misleading Response Regarding TSR Performance and Investor Day Targets Underscores the Need for Change and Improved Accountability on the Board

NEW YORK–(BUSINESS WIRE)–
Starboard Value LP (together with its affiliates, “Starboard”), a significant stockholder of Autodesk, Inc. (“Autodesk” or the “Company”) (NASDAQ: ADSK), with an ownership stake valued at more than $500 million, today announced that it has delivered a letter to the Company’s shareholders.

The full text of the letter to the Company’s shareholders can be viewed here.

About Starboard Value LP

Starboard Value LP is an investment adviser with a focused and differentiated fundamental approach to investing in publicly traded companies. Starboard invests in deeply undervalued companies and actively engages with management teams and boards of directors to identify and execute on opportunities to unlock value for the benefit of all shareholders.

CERTAIN INFORMATION CONCERNING THE PARTICIPANTS

Starboard Value LP, together with the other participants named herein (collectively, “Starboard”), intends to file a preliminary proxy statement and accompanying WHITE universal proxy card with the Securities and Exchange Commission (“SEC”) to be used to solicit votes for the election of a slate of director nominees at the 2025 annual meeting of stockholders of Autodesk, Inc., a Delaware corporation (the “Company”).

STARBOARD STRONGLY ADVISES ALL STOCKHOLDERS OF THE COMPANY TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS WILL BE AVAILABLE AT NO CHARGE ON THE SEC’S WEB SITE AT HTTP://WWW.SEC.GOV [sec.gov]. IN ADDITION, THE PARTICIPANTS IN THIS PROXY SOLICITATION WILL PROVIDE COPIES OF THE PROXY STATEMENT WITHOUT CHARGE, WHEN AVAILABLE, UPON REQUEST. REQUESTS FOR COPIES SHOULD BE DIRECTED TO THE PARTICIPANTS’ PROXY SOLICITOR.

The participants in the proxy solicitation are anticipated to be Starboard Value and Opportunity Master Fund Ltd (“Starboard V&O Fund”), Starboard Value and Opportunity S LLC (“Starboard S LLC”), Starboard Value and Opportunity C LP (“Starboard C LP”), Starboard Value and Opportunity Master Fund L LP (“Starboard L Master”), Starboard Value L LP (“Starboard L GP”), Starboard Value R LP (“Starboard R LP”), Starboard Value R GP LLC (“Starboard R GP”), Starboard X Master Fund Ltd (“Starboard X Master”), Starboard Value LP, Starboard Value GP LLC (“Starboard Value GP”), Starboard Principal Co LP (“Principal Co”), Starboard Principal Co GP LLC (“Principal GP”), Jeffrey C. Smith, Peter A. Feld, Geoff Ribar and Anna Christine Simons.

As of the close of business on March 25, 2025, Starboard V&O Fund beneficially owned directly 1,073,546 shares of Common Stock, par value $0.01 per share, of the Company (the “Common Stock”). As of the close of business on March 25, 2025, Starboard S LLC directly owned 143,171 shares of Common Stock. As of the close of business on March 25, 2025, Starboard C LP directly owned 111,652 shares of Common Stock. Starboard R LP, as the general partner of Starboard C LP, may be deemed the beneficial owner of the 111,652 shares of Common Stock owned by Starboard C LP. As of the close of business on March 25, 2025, Starboard L Master directly owned 58,395 shares of Common Stock. Starboard L GP, as the general partner of Starboard L Master, may be deemed the beneficial owner of the 58,395 shares of Common Stock owned by Starboard L Master. Starboard R GP, as the general partner of Starboard R LP and Starboard L GP, may be deemed the beneficial owner of an aggregate of 170,047 shares of Common Stock owned by Starboard C LP and Starboard L Master. As of the close of business on March 25, 2025, Starboard X Master directly owned 365,781 shares of Common Stock. As of the close of business on March 25, 2025, 247,455 shares of Common Stock were held in an account managed by Starboard Value LP (the “Starboard Value LP Account”). Starboard Value LP, as the investment manager of each of Starboard V&O Fund, Starboard C LP, Starboard L Master and Starboard X Master and the Starboard Value LP Account and the manager of Starboard S LLC, may be deemed the beneficial owner of an aggregate of 2,000,000 shares of Common Stock directly owned by Starboard V&O Fund, Starboard S LLC, Starboard C LP, Starboard L Master, Starboard X Master and held in the Starboard Value LP Account. Each of Starboard Value GP, as the general partner of Starboard Value LP, Principal Co, as a member of Starboard Value GP, Principal GP, as the general partner of Principal Co and Messrs. Smith and Feld, as members of Principal GP and as members of each of the Management Committee of Starboard Value GP and the Management Committee of Principal GP, may be deemed the beneficial owner of 2,000,000 shares of Common Stock directly owned by Starboard V&O Fund, Starboard S LLC, Starboard C LP, Starboard L Master, Starboard X Master and held in the Starboard Value LP Account. As of the close of business on March 25, 2025, none of Mr. Ribar or Ms. Simons owned any shares of Common Stock.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250326243987/en/

Investor contacts:

Peter Feld, (212) 201-4878

Gavin Molinelli, (212) 201-4828

http://www.starboardvalue.com

Media contacts:

Longacre Square Partners

Joe Germani / Ashley Areopagita, (646) 386-0091

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Professional Services Finance

MEDIA:

Posted on March 26, 2025 8:06 am

POTTERY BARN BRANDS EXPAND COLLABORATION WITH LOVESHACKFANCY

POTTERY BARN BRANDS EXPAND COLLABORATION WITH LOVESHACKFANCY

Expansion Includes a Debut Collaboration with Pottery Barn Following Successful Collections with Pottery Barn Kids and Pottery Barn Teen

SAN FRANCISCO–(BUSINESS WIRE)–
Pottery Barn, Pottery Barn Kids and Pottery Barn Teen, portfolio brands of Williams-Sonoma, Inc. (NYSE: WSM), today announce an expansion of the popular collaboration with beloved fashion and lifestyle brand, LoveShackFancy. The expansion includes new collections that build on the popularity of the existing partnership with Pottery Barn Kids and Pottery Barn Teen and includes a debut collaboration with Pottery Barn.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250326426675/en/

LoveShackFancy x Pottery Barn (Photo: Pottery Barn)

The new LoveShackFancy for Pottery Barn collection combines LoveShackFancy’s beloved romantic style with Pottery Barn’s craftsmanship, resulting in products designed for the entire home. Adorned with bows, ruffles, and lace, the inaugural LoveShackFancy for Pottery Barn collection takes inspiration from vintage pieces, and layers in LoveShackFancy’s signature prints and patterns on an assortment that includes tabletop, bedding, bath textiles, decor, wall and window coverings, flooring, and seating. The collaboration features a range of design details, including delicate lace crochet on the sheets, pillows, and napkins, diamond-stitched quilting for a luxurious texture on the bedding, embroidered embellishments on the towels and pillows, and glassware with etchings and hand-cut patterns.

Pottery Barn Kids and Pottery Barn Teen expand their collections with new designs drawing inspiration from LoveShackFancy’s beloved pastel ombre fashion capsule and delicate floral prints. The new collections are designed with eco-minded materials and quality craftsmanship, including GREENGUARD Gold Certified furniture, organic cotton bedding, dorm décor, textiles for nursery, kids and teen rooms and outdoor accessories to complement the summer season in LoveShackFancy’s signature feminine style.

“Together with LoveShackFancy, we’ve created a truly special collection that celebrates both heritage and quality design,” says Monica Bhargava, President, Pottery Barn. “Our debut collection blends timeless elegance with whimsical charm and quality craftsmanship creating thoughtfully crafted pieces that inspire everyday moments of beauty.”

“The LoveShackFancy aesthetic continues to inspire us to innovate our collaboration for baby, kids, teen and dorm,” said Jennifer Kellor, President, Pottery Barn Kids and Pottery Barn Teen. “The response has been overwhelmingly positive, and we’re excited to expand our collection with beautiful summer and dorm designs in new product categories that embody the LoveShackFancy lifestyle for all life stages.”

“Years in the making, I’m beyond excited to finally share our LoveShackFancy x Pottery Barn collaboration, building on the success of our collections with Pottery Barn Kids and Pottery Barn Teen,” said Rebecca Hessel Cohen, Creative Director and Founder, LoveShackFancy. “This collection is my dream home—made for you. It’s the ultimate expression of our lifestyle, where vintage romance meets everyday elegance. Partnering with the Pottery Barn brands over the years has been such an incredible experience, allowing us to expand our vision for the home in new and inspiring ways—from dreamy china to charming furniture and thoughtful pieces for kids, baby teen and dorm spaces. It’s been an absolute joy to bring this world to life together.”

The collections are now available exclusively in select stores, and online at potterybarn.com, potterybarnkids.com and potterybarnteen.com. Follow along on social @potterybarn, @potterybarnkids, @potterybarnteen.

ABOUT POTTERY BARN

Pottery Barn, a member of the Williams-Sonoma, Inc. (NYSE: WSM) portfolio of brands, is a premier specialty retailer for casual, comfortable and stylish home furnishings. The brand is dedicated to beautiful ideas for real life, quality products that are crafted to last, sustainability and service. Key product categories include furniture, bedding, bath, rugs, window treatments, tabletop, lighting and decorative accessories. Nearly all Pottery Barn products are designed in-house and are exclusive to its catalogs, stores and website. Pottery Barn is also part of The Key Rewards, a free-to-join loyalty program that offers members exclusive benefits across the Williams-Sonoma family of brands, the world’s largest digital-first, design-led and sustainable home retailer. The company is headquartered in San Francisco, California.

ABOUT POTTERY BARN KIDS

Introduced in 1999, Pottery Barn Kids offers exclusive home furnishings available online and in stores globally to create kid-friendly, eco-conscious, stylish, and innovative spaces. Pottery Barn Kids’ mission is to bring the utmost in quality design, sustainability, and safety into every family’s home. Products are rigorously tested to meet the highest child safety standards and are expertly crafted from the best materials to last beyond the childhood years. Pottery Barn Kids is a member of Williams-Sonoma, Inc. (NYSE:WSM) and participates in The Key Rewards, a free-to-join loyalty program that offers members exclusive benefits across the family of brands.

ABOUT POTTERY BARN TEEN

Introduced in 2003, Pottery Barn Teen offers home furnishings and solutions to create spaces that reflect who teens are and how they live. Available online and in stores globally, Pottery Barn Teen brings the best in quality design with a focus on eco-friendly and sustainable materials that have a low impact on the environment. Pottery Barn Dorm, launched in 2010, is Pottery Barn Teen’s offering of dorm furniture and essentials with the same quality and commitment to style. Pottery Barn Teen is a member of Williams-Sonoma, Inc. (NYSE:WSM) and participates in The Key Rewards, a free-to-join loyalty program that offers members exclusive benefits across the family of brands.

ABOUT WILLIAMS-SONOMA. INC.

Williams-Sonoma, Inc. is dedicated to enhancing the quality of life at home and at all places our customers work, stay and play. The company’s brands — Williams Sonoma, Pottery Barn, Pottery Barn Kids, Pottery Barn Teen, West Elm, Williams Sonoma Home, Rejuvenation, Mark and Graham, and GreenRow — represent distinct merchandise strategies that are marketed through e-commerce, direct-mail catalogs and retail stores. These brands collectively support The Key Rewards, our loyalty and credit card program that offers members exclusive benefits. We operate in the U.S., Puerto Rico, Canada, Australia and the United Kingdom and have unaffiliated franchisees that operate stores in the Middle East, the Philippines, Mexico, South Korea and India.

ABOUT LOVESHACKFANCY

LoveShackFancy is a global fashion, beauty, home and lifestyle brand founded by Rebecca Hessel Cohen in 2013. It was created to celebrate love and revel in the beauty of a flower-filled, rose-colored world. Here, everyday is an occasion and your wildest dreams can become reality.

The LoveShackFancy aesthetic marries vintage inspiration with a fun and modern take on femininity: An overflow of pink, prints, ruffles and lace that speaks not just to romantics at heart but anyone who wants to feel beautiful and confident in their own skin. The bows that can be found across LoveShackFancy clothing, perfume, bedding and kids collections perfectly encapsulate the spirit of the brand—a balance of softness and strength, and an undeniable charm that has no age or time limit.

Today, LoveShackFancy is an award-winning and family-owned company with 20 stores worldwide and 450 retail partners. LoveShackFancy has received the WWD Award for The Best Performing Fashion Company and Rebecca has been honored with the Entrepreneurship Award at the Fashion Institute Annual Awards Gala and Visionary Of The Year at The Guild Hall Visionaries Event, and featured on the cover of the New York Times Style section. Millions of friends have joined the party, sharing in the belief that being in love with love is a state of mind that can take you farther than you ever imagined.

WSM-PR

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[email protected]

[email protected]

[email protected]

KEYWORDS: United States North America Canada California

INDUSTRY KEYWORDS: Luxury Textiles Construction & Property Specialty Home Goods Interior Design Manufacturing Retail Online Retail

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LoveShackFancy x Pottery Barn (Photo: Pottery Barn)

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LoveShackFancy x Pottery Barn Kids (Photo: Pottery Barn Kids)

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LoveShackFancy x Pottery Barn Teen (Photo: Pottery Barn Teen)

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TriSalus Life Sciences Announces New CMS HCPCS Code for TriNav® Infusion System Mapping

DENVER–(BUSINESS WIRE)–
TriSalus Life Sciences®, Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), which seeks to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies and our investigational immunotherapy, announced today that the Centers for Medicare & Medicaid Services (CMS) has established a new Level II HCPCS code for the TriNav® Infusion System, effective April 1, 2025. This new code, C8004, provides reimbursement clarity for simulation angiograms—commonly known as mapping procedures—conducted prior to transarterial radioembolization (TARE).

The introduction of C8004 provides validation of TriNav’s growing role in pre-treatment mapping for Transarterial Radioembolization, reinforcing its value in optimizing Y90 dose delivery.

“With this new code, Interventional Radiologists and Medicare patients have access to PEDD for radioembolization procedures with full reimbursement for both mapping and treatment,” said Mary Szela, CEO of TriSalus. “Using PEDD technology for both the mapping and treatment procedures in radioembolization helps ensure accurate treatment planning and delivery which is crucial for delivering the radioactive microspheres to the tumor with precision.”

Dr. Richard Marshall, who serves as Medical Director for TriSalus, stated:

“In my current practice, using the same catheter for both mapping and treatment helps enhance the accuracy of Y90 dose delivery.I can achieve a higher T:N ratio with the TriNav Infusion System, and I have seen that its high concordance between mapping and treatment allows better prediction of the dose which can improve personalized dosimetry.”

HCPCS Code C8004 Details

• Description: Simulation angiogram utilizing a pressure-generating catheter (e.g., one-way valve, intermittently occluding), including all radiological supervision and interpretation, intraprocedural road mapping, and imaging guidance necessary for subsequent therapeutic radioembolization of tumors.
• Effective Date: April 1, 2025
• Eligible Reporting Facilities: Hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs)
• Medicare Payment Rate: $11,341 under APC 5193

TriSalus’ initial analysis indicates that the reimbursement level under C8004, combined with standard Medicare payment adjustments, will support continued adoption of TriNav for both mapping and treatment.

For more information, the full CMS Quarterly Update can be found [here].

About TriSalus Life Sciences

TriSalus Life Sciences® is a growing, oncology focused medical technology business bringing disruptive drug delivery technology with the goal of improving therapeutic delivery to liver and pancreatic tumors. Additionally, we are exploring the integration of our technology with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of liver and pancreatic indications. Our ultimate goal is to transform the treatment paradigm for patients battling liver and pancreatic tumors. We have developed an innovative organ-specific platform that is designed to overcome two of the most significant challenges that prevent optimal delivery and performance of therapeutics in these difficult-to-treat diseases: (i) high intratumoral pressure caused by tumor growth and collapsed vasculature restricting the delivery of oncology therapeutics and (ii) the immunosuppressive properties of liver and pancreatic tumor immune cells. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes.

In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby under the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “become,” “may,” “intend,” “will,” “expect,” “anticipate,” “believe” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding TriSalus’s business, the commercial potential of its TriNav Infusion System, TriSalus’s proprietary PEDD approach, the potential therapeutic benefits and commercial potential of Nelitolimod, and TriSalus’s technologies and other products in development. Such statements are subject to certain risks and uncertainties, including, but not limited to, those inherent in the process of developing and commercializing medical devices that are safe and effective for human use, discovering, developing and commercializing medicines that are safe and effective to use as human therapeutics, and the endeavor of building a business around such medical devices and medicines.

TriSalus’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although TriSalus’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by TriSalus. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning TriSalus’s products and programs are described in additional detail in TriSalus’s annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission (the “SEC”) and available at the SEC’s website (www.SEC.gov). These forward-looking statements are made as of the date of this press release, and TriSalus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/quarterly-update

View source version on businesswire.com: https://www.businesswire.com/news/home/20250326932769/en/

For Media Inquiries:

Jeremy Feffer, Managing Director

LifeSci Advisors

917.749.1494

[email protected]

For Investor Inquiries:

James Young

Chief Financial Officer

847.337.0655

[email protected]

KEYWORDS: United States North America Colorado

INDUSTRY KEYWORDS: Research Medical Devices Health Technology Biotechnology Radiology Health Pharmaceutical Science Oncology

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Posted on March 26, 2025 8:05 am

LivaNova to Announce First-Quarter 2025 Results

LivaNova to Announce First-Quarter 2025 Results

LONDON–(BUSINESS WIRE)–
LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, will host a conference call to discuss its first-quarter 2025 results on Wednesday, May 7, 2025 at 1 p.m. London time (8 a.m. Eastern Time). The Company will release its first-quarter 2025 results prior to the call.

The audiocast will be accessible at www.livanova.com/events. Listeners should log on approximately 10 minutes in advance to ensure proper setup to receive the audiocast. To listen to the conference call by telephone, dial +1 833 470 1428 (if dialing from within the U.S.) or +1 929 526 1599 (if dialing from outside the U.S.). The conference call access code is 047836. A replay will be available on the LivaNova website for 90 days following the call.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit www.livanova.com.

Safe Harbor Statement

This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the next Company conference call. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

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LivaNova Investor Relations and Media Contacts

+1 281-895-2382

Briana Gotlin

VP, Investor Relations

[email protected]

Deanna Wilke

VP, Corporate Communications

[email protected]

KEYWORDS: Europe United States United Kingdom North America

INDUSTRY KEYWORDS: Other Health Research Telemedicine/Virtual Medicine Medical Devices Hospitals Health Technology Clinical Trials Science Surgery Biotechnology FDA Health

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RenovoRx Pre-Clinical Results Supporting TAMP™ as a Targeted Locoregional Drug Delivery Platform to Receive Award at SIR 2025 Annual Scientific Meeting

Peer-reviewed paper will be honored as a Journal of Vascular and Interventional Radiology Award-Winning Paper

Pre-clinical data show that TAMP increases intra-arterial pressure, improving drug delivery with 100-fold increase in local tissue concentration of the therapy

TAMP offers the potential to increase efficacy, improve safety and widen therapeutic window of existing and new treatments

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared drug-delivery device, is proud to announce that a publication supporting the Company’s proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for targeted locoregional drug delivery will be recognized in the Journal of Vascular and Interventional Radiology (JVIR) Award-Winning Paper Scientific Session during the upcoming Society of Interventional Radiology (SIR) 2025 Annual Scientific Meeting.

The peer-reviewed paper, published in the July 2024 edition of JVIR, is being honored during the conference’s JVIR Award-Winning Paper Scientific Session in Nashville, TN, scheduled at 3:00-4:30 PM CT on Tuesday, April 1, 2025. The session will be moderated by Daniel Sze, MD, PhD, Stanford University. This paper is one of nine 2024 JVIR papers to be awarded for outstanding laboratory investigation during the conference.

The JVIR Award-Winning Paper, titled “Double-Balloon Catheter–Mediated Transarterial Chemotherapy Delivery in a Swine Model: A Mechanism Recruiting the Vasa Vasorum for Localized Therapies,” is authored by Khashayar Farsad, MD, PhD of the Department of Interventional Radiology at Oregon Health and Science University, and co-authored by Paula M. Novelli, MD, of the University of Pittsburgh Hillman Cancer Center, together with other researchers, including RenovoRx’s founder and Chief Medical Officer, Dr. Ramtin Agah. During JVIR Award-Winning Paper Scientific Session, Dr. Agah will present the findings of the paper. The JVIR abstract can be accessed here: https://pubmed.ncbi.nlm.nih.gov/38508449/.

“We are deeply honored to be recognized for our research at SIR 2025 Annual Scientific Meeting in the JVIR Award-Winning Paper Scientific Session,” said Dr. Agah. “This recognition reflects RenovoRx’s innovation and treatment paradigm that may translate to benefits in treatment of patients with solid tumors. I look forward to presenting these findings at the upcoming conference, and my colleagues and I are grateful for this recognition and validation of our commitment to advancing the field of interventional oncology.”

Currently, most cancer patients with solid tumors receive chemotherapy intravenously, introducing the drug systemically into the entire body. This is well-known to cause adverse side effects. RenovoRx’s patented TAMP therapy platform is designed to bypass traditional systemic delivery methods and provide targeted delivery to bathe the target solid tumor in chemotherapy. This locoregional delivery also creates the potential to minimize a therapy’s systemic toxicities.

The pre-clinical data published in JVIR showed a 100-fold (two orders of magnitude) increase in local tissue concentration of the therapy with TAMP compared to conventional intravenous (IV) delivery. TAMP also showed advantages compared to historically available intra-arterial (IA) delivery approaches. TAMP’s novel approach to treatment offers the potential to increase an oncology therapy’s efficacy, improve safety, and widen its therapeutic window by focusing its distribution uniformly in target tissue.

“TAMP has the potential to provide a valuable treatment option to patients who have been diagnosed with solid tumors that may be difficult-to-treat,” said Dr. Farsad. “This platform also has the potential to extend across a variety of unmet needs for localized therapeutic drug delivery. This study shows a possible mechanism for how TAMP can increase local therapeutic tissue concentration in solid tumors that is independent from traditional catheter-directed therapy. We are awaiting final outcomes from RenovoRx’s TIGeR-PaC Phase III clinical trial, currently underway, to further validate this benefit.”

“We believe this award further supports our decision to accelerate the commercialization of our proprietary RenovoCath as a standalone device,” said Shaun Bagai, CEO of RenovoRx. “We are rapidly expanding efforts and forging stronger relationships with leading oncology centers nationwide who are using RenovoCath. This progress not only positions our company for growth but also reinforces our growing leadership in the oncology space, unlocking substantial value-creation opportunities. We continue to scale our commercialization efforts and, in tandem, progress our Phase III TIGeR-PaC trial in the most capital efficient manner.”

About RenovoCath

Based on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath^® device for the intra-arterial administration of chemotherapy, gemcitabine (IAG).

About RenovoRx, Inc.

RenovoRx (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath^®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.

In addition to the RenovoCath device, RenovoRx is also evaluating our novel Phase III drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG). IAG is being evaluated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational IAG utilizes RenovoCath, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of chemotherapy, gemcitabine, utilizing the RenovoCath device is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).

The combination product candidate, which is enabled the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon new drug application approval by the FDA.

RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase orders, including several esteemed, high volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.

Cautionary Note Regarding Forward-Looking Statements

This press release, the fireside chat referred to herein, and statements of the Company’s management made in connection therewith contain 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, including but not limited to statements regarding (i) our pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts and full patient enrollment for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath^® or TAMP™ as standalone commercial products, our anticipated timing for and levels of revenue generation from RenovoCath sales, and our commercialization plans in general, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) our efforts to explore commercialization strategies utilizing our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, commercial plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our execution of our commercial strategy for RenovoCath or our TAMP technology may not lead to viable or repeating revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of TIGeR-PaC and any other preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

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KCSA Strategic Communications

Valter Pinto or Jack Perkins

T:212-896-1254

[email protected]

KEYWORDS: United States North America California Tennessee

INDUSTRY KEYWORDS: Research Medical Devices Clinical Trials Health Technology Biotechnology Health Pharmaceutical Science Oncology

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BlackRock Goes Live with First-of-its-Kind Public-Private Model Portfolios, Enabling Easier Access to Private Markets

• Simplified Access Made Possible by GeoWealth and iCapital’s Technology
• Models provide customizable access to private markets alongside public markets in a single account

NEW YORK–(BUSINESS WIRE)–
BlackRock (NYSE: BLK) today has gone live with a first-of-its-kind customizable public-private model portfolio within a Unified Managed Account (UMA). The models are powered by GeoWealth’s UMA technology and supported by iCapital’s underlying technology capabilities.

The launch marks the first time a customizable model portfolio that includes access to both private and public market assets is available through a UMA, featuring streamlined administration and custodial integration.

Advisors are increasingly turning to models-based solutions to meet demands for more tailored products and access to diversified exposures. This collaboration is designed to simplify and enhance advisors’ ability to allocate across public and private markets.

“This launch represents a significant step forward, helping advisors allocate across both public and private markets all in one unified, professionally managed portfolio,” said Jaime Magyera, Co-Head of BlackRock’s U.S. Wealth Advisory Business. “BlackRock’s mission is to make investing easier and help more people access the full power of capital markets. Through our partnership with GeoWealth and iCapital, we are doing just that, helping advisors deliver differentiated service and outcomes for their clients across their whole portfolio.”

BlackRock is a leading provider of models, with approximately $300 billion in assets in such models, globally. As more RIAs adopt model portfolios into their practices, managed models present a significant growth opportunity, driven by the customization, efficiency and scalability of these solutions. BlackRock expects managed model portfolios to roughly double in assets over the next four years, growing from $5 trillion today into a $10 trillion business. BlackRock’s custom models business is its fastest growing models segment, accounting for $50 billion in new assets over the past 5 years.

“We are proud to support the launch of the first customizable public-private model portfolio within a Unified Managed Account (UMA). This innovative solution enables advisors to easily incorporate alternative investments into their investment strategies for their clients in a simplified way, within a single account,” said Lawrence Calcano, Chairman and CEO of iCapital. “We believe models will be an important way for advisors to allocate to private markets, and iCapital’s underlying technology allows our clients to customize what they want to buy or deliver into the market.”

Tech enhancements to better enable portfolio management and data analytics are also driving the growing adoption of model portfolios among RIAs. This growing theme underscores the broader benefits of the collaboration with iCapital, a global fintech platform helping drive the world’s alternative investment marketplace, and GeoWealth, a proprietary technology and turnkey asset management platform (TAMP) serving RIAs.

“Advisors and asset managers have long understood the role of private markets investments, the challenge has been the inability to systematically integrate and implement at scale in a wealth management practice,” said Colin Falls, CEO of GeoWealth. “GeoWealth’s UMA technology and workflow solutions, in partnership with BlackRock and iCapital, creates an entirely new paradigm for advisors considering a public-private portfolio.”

These models will provide advisors with intuitive workflows, efficient reporting tools, and comprehensive investment management capabilities throughout the investment’s lifecycle. iCapital’s Multi-Investment Workflow Tool streamlines the entire alternative assets investing experience.

BlackRock sees significant growth opportunity in the U.S. wealth market and is actively positioning the firm to become an integral, whole portfolio partner to advisors in an increasingly complex environment. Overall, BlackRock’s U.S. Wealth Advisory business is a key growth-driver for the firm, generating a quarter of BlackRock’s revenues in 2024.

BlackRock, GeoWealth and iCapital are separate and non-affiliated companies. GeoWealth provides rebalancing capabilities for portfolios containing private market vehicles. iCapital offers streamlined subscription document processing to invest in the private market vehicles. BlackRock is a strategic investor in GeoWealth and iCapital.

Incorporating products providing private market exposure into a portfolio presents the opportunity for significant losses, including in some cases losses which exceed the principal amount invested. Funds that seek to provide exposure to private assets (“private investment funds”) may have experienced periods of high volatility and in general, are not suitable for all investors. Asset allocation and diversification strategies do not ensure profit or protect against loss in declining markets. An investment in shares of the private investment funds should be considered illiquid. In addition, the securities in which the private investment funds invest may be valued at prices that the funds are unable to obtain upon sale due to factors such as incomplete data or market instability. Such private investment funds may not be able to realize the investment at the latest fair value price. End client account performance may differ due to the illiquidity of the private investment funds.

Forward-Looking Statements

This press release, and other statements that BlackRock may make, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act, with respect to BlackRock’s future financial or business performance, strategies or expectations. Forward-looking statements are typically identified by words or phrases such as “trend,” “potential,” “opportunity,” “pipeline,” “believe,” “comfortable,” “expect,” “anticipate,” “current,” “intention,” “estimate,” “position,” “assume,” “outlook,” “continue,” “remain,” “maintain,” “sustain,” “seek,” “achieve,” and similar expressions, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may” and similar expressions.

BlackRock cautions that forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and BlackRock assumes no duty to and does not undertake to update forward-looking statements. Actual results could differ materially from those anticipated in forward-looking statements and future results could differ materially from historical performance.

About BlackRock

BlackRock’s purpose is to help more and more people experience financial well-being. As a fiduciary to investors and a leading provider of financial technology, we help millions of people build savings that serve them throughout their lives by making investing easier and more affordable. For additional information on BlackRock, please visit www.blackrock.com/corporate | Twitter: @blackrock | LinkedIn: www.linkedin.com/company/blackrock

About GeoWealth

GeoWealth is a turnkey asset management platform (TAMP) and financial technology solution built specifically for the needs of modern RIAs. GeoWealth’s user-friendly, cost-efficient, integrated technology enables advisors to access a diversified lineup of model portfolios and fully offload mid-and back-office responsibilities, including performance reporting, billing, portfolio accounting and more. Via its customizable open-architecture platform, GeoWealth enables advisors and firms to grow faster and serve clients more efficiently. Founded in 2010, GeoWealth is headquartered in Chicago, IL. Visit us at geowealth.com and follow us on LinkedIn.

About iCapital

iCapital powers the world’s alternative investment marketplace, offering a complete suite of tools, end-to-end enterprise solutions, data management and distribution capabilities, and an innovative operating system. iCapital is the trusted technology partner to financial advisors, wealth managers, asset managers, as well as other participants in this ecosystem, and offers unrivaled access, technology, and education to incorporate alternative assets, structured investments (SI), and annuities into the core portfolio strategies for their clients.

At the forefront of the digital transformation in alternative investing, iCapital’s secure platform delivers a complete portfolio of management capabilities for education, transactions, data flows, analytics, and client support throughout the investment lifecycle. With $880 billion of global volume activity on platform, inclusive of $220 billion in global alternative assets, the iCapital operating system automates and streamlines the complex process of private market investing and seamlessly integrates with clients’ existing infrastructure platform and tools.

iCapital employs more than 1,750 people globally and has 16 offices worldwide, including New York, Greenwich, Zurich, Lisbon, London, Hong Kong, Singapore, Tokyo, and Toronto. iCapital has consistently been recognized for its outstanding innovation, fintech industry leadership, and performance, including CNBC World Top Fintech Companies for 2024, and Forbes Fintech 50 for seven consecutive years since 2018.

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For media inquiries, please contact:

BlackRock: Reem Jazar, 646-357-6135, [email protected]

iCapital: 919-602-2806, [email protected]

GeoWealth: Will Ruben, 847 208 8289, [email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Finance Consulting Banking Accounting Professional Services

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Wabtec Announces First Quarter 2025 Earnings Release Date

PITTSBURGH–(BUSINESS WIRE)–Wabtec Corporation (NYSE: WAB) announced it will report 2025 first quarter results before the U.S. financial markets open on April 23, 2025. The company will conduct a conference call to discuss those results with analysts and investors at 8:30 a.m. ET the same day. To listen to the call via webcast, visit Wabtec’s website at www.WabtecCorp.com and click on “Events & Presentations” in the “Investor Relations” section. An audio replay of the call will be available by calling 1-877-344-7529 or 1-412-317-0088 (access code: 1346315).

About Wabtec Corporation

Wabtec Corporation is revolutionizing the way the world moves for future generations. The Company is a leading global provider of equipment, systems, digital solutions and value-added services for the freight and transit rail industries, as well as the mining, marine and industrial markets. Wabtec has been a leader in the rail industry for 155 years and has a vision to achieve a zero-emission rail system in the U.S. and worldwide. Visit Wabtec’s website at www.wabteccorp.com.

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Wabtec Investor Contact

Kyra Yates / [email protected] / 817-349-2735

Wabtec Media Contact

Tim Bader / [email protected] / 682-319-7925

KEYWORDS: United States North America Canada Pennsylvania

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Allurion Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides Business Update

NATICK, Mass.–(BUSINESS WIRE)–
Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a company dedicated to ending obesity, today announced its financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update.

Recent Company Highlights and Outlook

• Reported initial data on the combination of the Allurion Program with low-dose GLP-1s showing optimization of muscle mass and GLP-1 adherence and announced plans to perform additional prospective studies on the combination approach
• Fourth quarter 2024 revenue of $5.6 million and full year revenue of $32.1 million, consistent with preannouncement on January 14, 2025
• Fourth quarter 2024 operating expenses of $19.6 million, a decrease of 39% compared to the same period in the prior year, and included one-time restructuring charges of $3.8 million
• Full-year 2024 procedure volume growth of 4%, above previously issued guidance, despite the reduction in operating expenses compared to prior year
• Cleared to resume sales in France on February 12, 2025
• Positive topline readout for AUDACITY FDA clinical trial, setting stage for submission of pre-market approval (“PMA”) application
• Recent financings expected to fund business through potential FDA approval of the Allurion Balloon in 2026
• Advanced R&D pipeline with the launch of next-generation Allurion Balloon with smaller capsule size and increased radiopacity
• 2025 revenue guidance of approximately $30 million with a reduction of approximately 50% in operating expenses compared to 2024

“In 2024, we restructured and refocused Allurion for the future and have been thrilled with the recent milestones we have achieved,” said Dr. Shantanu Gaur, Founder and Chief Executive Officer. “The initial results on the combination of the Allurion Program with low-dose GLP-1s, clearance to resume sales in France, and positive topline readout from the AUDACITY trial were all significant moments for our company. Momentum built in the fourth quarter as our new commercial strategy began to take hold, and procedure volume grew most in regions where GLP-1s are relatively mature in the market, suggesting, we believe, that patients are entering the funnel seeking either an alternative or combination approach to weight loss.

“As the first quarter comes to a close, we see further momentum building and a 2025 that is rich in potential catalysts,” continued Dr. Gaur. “With our recent financings complete, we believe we have a cash runway through becoming EBITDA positive and receiving FDA approval of the Allurion Balloon. And, as we initiate prospective studies on our combination approach, advance our PMA application through the FDA, and set the stage for profitability, I have no doubt we are building out an exciting future for Allurion.”

Fourth Quarter Financial Results

Total revenue for the quarter ended December 31, 2024 was $5.6 million, compared to $8.2 million for the same period in 2023. The year-over-year decrease in revenue was primarily due to the temporary suspension of sales in France and macroeconomic headwinds in certain markets leading to lower re-order rates.

Gross profit for the fourth quarter ended December 31, 2024 was $2.5 million, or 45% of revenue, compared to $6.4 million, or 78% of revenue, for the same period in 2023. Gross profit for the fourth quarter ended December 31, 2024 was negatively impacted by the reduction in revenue in the period and lower production volumes, which resulted in less manufacturing labor and overhead being absorbed into inventory costs. We also recorded an adjustment of excess and obsolete scrap related to inventory on hand with a shelf life of less than six months, which was primarily due to the reduction in revenue and temporary suspension of sales in France.

For the full-year ended December 31, 2024, gross profit was $21.5 million, or 67% of revenue. Gross profit margin is expected to expand in 2025 with inventory levels normalizing and sales resuming in France.

Sales and marketing expenses for the fourth quarter of 2024 were $7.9 million, compared to $10.7 million for the same period in 2023, and included $3.1 million of restructuring costs. The reduction in expense was primarily driven by increased operating efficiency and the restructuring initiatives implemented during the fourth quarter of 2024, which re-focused spend on more efficient channels.

R&D expenses for the fourth quarter of 2024 were $4.1 million, compared to $6.1 million for the same period in 2023, and included $0.3 million of restructuring costs. The reduction was primarily driven by reduced costs related to the AUDACITY trial and restructuring initiatives implemented during the fourth quarter.

G&A expenses for the fourth quarter of 2024 were $7.7 million, compared to $15.4 million for the same period in 2023, and included restructuring and financing costs of $1.1 million. The reduction was primarily driven by decreases in bad debt expense and in stock-based compensation and the restructuring initiatives implemented during the fourth quarter.

Loss from operations for the fourth quarter was $17.1 million, compared to $25.7 million for the same period in 2023, and included $4.6 million of restructuring and financing costs. The reduction was driven by restructuring initiatives implemented during the fourth quarter.

Cash balance on December 31, 2024 was $15.4 million.

Conference Call and Webcast Details

Company management will host a conference call to discuss financial results and provide a business update on March 26, 2025 at 8:30 AM ET.

To access the conference call by telephone, please dial (888) 330-3417 (domestic) or +1 646 960 0804 (international) and use Conference ID 1905455. To listen to the conference call via live audio webcast, please visit the Events section of Allurion’s Investor Relations website at Allurion – Events & Presentations.

About Allurion

Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less™ intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.

Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.

Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although Allurion believes that it has a reasonable basis for each forward-looking statement contained in this press release, Allurion cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain.

Forward-looking statements in this press release include, but are not limited to, statements regarding: the Company’s financial outlook for 2025 and future years, including the anticipated impact of the 2024 restructuring plan on the Company’s operating expenses and its ability to achieve profitability and be EBITDA positive in 2026; the expected impact of resumed sales in France; anticipated procedural volume growth; the Company’s ability, through the implementation of the 2024 restructuring plan, refocused strategy, and use of capital from financings, to increase operational and financial flexibility, position itself to navigate an evolving economic landscape, and extend its financial runway for sustained future growth in 2025 and beyond; ; the Company’s beliefs with respect to the shift in commercial strategy, including with respect to sales and marketing; the outcome of the Company’s PMA seeking FDA approval of the Allurion Balloon following the topline readout of the AUDACITY clinical trial; the performance and market acceptance of products, including VCS and the Coach Iris feature, for patients using different weight loss therapies both outside and within the United States, as well as the Company’s ability to expand these aspects of its business further in 2025; the outcomes of anticipated studies on the combination of GLP-1s with the Allurion Balloon and the impact on demand for our products and services; ; and the market and demand for our products and weight-loss solutions in general, including GLP-1 drugs and elective procedures.

Allurion cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, general economic, political and business conditions; the ability of Allurion to obtain and maintain regulatory approval for, and successfully commercialize, the Allurion Program; the timing of, and results from, its clinical studies and trials, including with respect to the combination of GLP-1s with the Allurion Balloon; the evolution of the markets in which Allurion competes, including the impact of GLP-1 drugs; the ability of Allurion to maintain its listing on the New York Stock Exchange;, the Russia and Ukraine war and the Israel-Hamas war on Allurion’s business and financial results; the outcome of any legal proceedings against Allurion; the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion competes; and those factors discussed under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024, its Annual Report on Form 10-K filed with the SEC on March 26, 2024, and other filings with the SEC. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that Allurion will achieve its objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent Allurion’s views as of the date of this press release. Allurion anticipates that subsequent events and developments will cause its views to change. However, while Allurion may elect to update these forward-looking statements at some point in the future, Allurion has no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing Allurion’s views as of any date subsequent to the date of this press release.

Consolidated Statements of Operations
(dollars in thousands, except per share amounts)(unaudited)
		Three Months Ended December 31,								Year Ended December 31,
		2024				2023				2024				2023
Revenue		$	5,591			$	8,235			$	32,110			$	53,467
Cost of revenue			3,058				1,805				10,607				11,970
Gross profit			2,533				6,430				21,503				41,497
Operating expenses:
Sales and marketing			7,873				10,730				25,933				46,857
Research and development			4,122				6,071				17,369				27,694
General and administrative			7,653				15,367				28,399				46,024
Total operating expenses:			19,648				32,168				71,701				120,575
Loss from operations			(17,115	)			(25,738	)			(50,198	)			(79,078	)
Other income (expense):
Interest expense			—				(3,235	)			(2,264	)			(10,566	)
Changes in fair value of warrants			2,814				6,175				17,024				8,364
Changes in fair value of debt			(1,330	)			—				8,690				(3,751	)
Changes in fair value of Revenue Interest Financing and PIPE Conversion Option			(4,713	)			(152	)			(14,321	)			(2,192	)
Changes in fair value of earn-out liabilities			760				4,720				22,900				29,050
Termination of convertible note side letters			—				—				—				(17,598	)
Loss on extinguishment of debt			—				—				(8,713	)			(3,929	)
Other income (expense), net			(477	)			(776	)			1,452				(643	)
Total other income (expense):			(2,946	)			6,732				24,768				(1,265	)
Loss before income taxes			(20,061	)			(19,006	)			(25,430	)			(80,343	)
Provision for income taxes			(508	)			(174	)			(718	)			(264	)
Net loss			(20,569	)			(19,180	)			(26,148	)			(80,607	)
Cumulative undeclared preferred dividends			—				—				—				(1,697	)
Net loss attributable to common shareholders		$	(20,569	)		$	(19,180	)		$	(26,148	)		$	(82,304	)
Net loss per share
Basic and diluted		$	(7.95	)		$	(10.09	)		$	(11.64	)		$	(57.83	)
Weighted-average shares outstanding
Basic and diluted			2,588,912				1,900,816				2,247,164				1,423,275

Consolidated Balance Sheets
(dollars in thousands)(unaudited)
		December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	15,379			$	38,037
Accounts receivable, net of allowance of doubtful accounts of $6,701 and $12,671, respectively			7,134				18,194
Inventory, net			3,400				6,171
Prepaid expenses and other current assets			1,243				2,414
Total current assets			27,156				64,816
Property and equipment, net			2,469				3,381
Right-of-use asset			2,079				3,010
Other long-term assets			1,109				505
Total assets		$	32,813			$	71,712
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable		$	6,572			$	10,379
Current portion of term loan			—				38,643
Current portion of lease liabilities			869				908
Accrued expenses and other current liabilities			11,422				15,495
Total current liabilities			18,863				65,425
Convertible notes payable			35,710				—
Warrant liabilities			4,567				6,765
Revenue Interest Financing liability			49,200				36,200
Earn-out liabilities			1,090				23,990
Lease liabilities, net of current portion			1,344				2,306
Other liabilities			17				7,513
Total liabilities			110,791				142,199
Commitments and Contingencies
Stockholders’ deficit:
Preferred stock, $0.0001 par value — 100,000,000 shares authorized as of December 31, 2024; and no shares issued and outstanding as of December 31, 2024 and December 31, 2023			—				—
Common stock, $0.0001 par value – 1,000,000,000 shares authorized as of December 31, 2024; 2,710,607 and 1,907,529 shares issued and outstanding as of December 31, 2024 and 2023, respectively		3					2
Additional paid-in capital			152,596				143,010
Accumulated other comprehensive income (loss)			8,370				(700	)
Accumulated deficit			(238,947	)			(212,799	)
Total stockholders’ deficit			(77,978	)			(70,487	)
Total liabilities and stockholders’ deficit		$	32,813			$	71,712

 

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Investor / Media Contact

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology Surgery General Health Health FDA Medical Devices Health Technology Fitness & Nutrition

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Quantum-Si Begins Shipping Platinum^® Pro, Advancing Accessibility in Next-Gen Protein Sequencing™

BRANFORD, Conn.–(BUSINESS WIRE)–Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), The Protein Sequencing Company^™, announces the start of shipments for its latest benchtop sequencer, Platinum^® Pro. This groundbreaking instrument offers protein analysis with single-molecule precision, aiming to make Next-Gen Protein Sequencing™ more accessible to laboratories worldwide.

Platinum Pro delivers a comprehensive solution for sequencing and analyzing proteins through a simple, integrated workflow. Building upon the foundation of innovation established by the original Platinum, the new system introduces advanced features tailored to the evolving needs of researchers and biopharmaceutical customers. Key innovations include:

• Streamlined User Experience: An enlarged touchscreen with an intuitive user interface guides users through each run, supporting diverse applications from proteoform analysis to protein barcoding.
• Flexible Data Analysis: Options for local or cloud-based data analysis provide versatility to suit various research environments.
• Pro Mode: This feature empowers custom application development, offered through a Technology Access Program, positioning Platinum Pro as a platform for biopharmaceutical innovation and application co-development.

“We are committed to delivering tools that advance proteomics research,” said Jeff Hawkins, President and Chief Executive Officer of Quantum-Si. “The introduction of Platinum Pro provides researchers with additional features and capabilities to enable insights which we believe will positively impact scientific research and lead to the discoveries of new biomarkers in the future.”

Platinum Pro exemplifies Quantum-Si’s dedication to progressive innovation that delivers solutions for Next-Gen Protein Sequencing. With its robust capabilities, the system is expected to drive new opportunities for breakthrough discoveries. Platinum Pro shipments have started, and the system is available in more than 30 countries through Quantum-Si’s direct and channel partner network, marking a significant milestone in making advanced proteomics tools more accessible to every lab, everywhere.

For more information or to place an order, visit: Quantum-Si

About Quantum-Si Incorporated

Quantum-Si, The Protein Sequencing Company™, is focused on revolutionizing the growing field of proteomics. The Company’s Platinum^® line of instruments enables Next-Gen Protein Sequencing™ that advances proteomic research, drug discovery, and diagnostics beyond what has been possible with existing proteomic tools. Learn more at quantum-si.com or follow us on LinkedIn or X.

Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. The actual results of the Company may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to future performance and development and commercialization of products and services, its anticipated cash runway and its financial guidance for the full year 2025. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the Company’s Class A common stock on The Nasdaq Stock Market; the ability of the Company to grow and manage growth profitably and retain its key employees; the Company’s ongoing leadership transitions; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the success, cost and timing of the Company’s product development and commercialization activities; the commercialization and adoption of the Company’s existing products and the success of any product the Company may offer in the future; the potential attributes and benefits of the Company’s commercialized Platinum® protein sequencing instruments and kits and the Company’s other products once commercialized; the Company’s ability to obtain and maintain regulatory approval for its products, and any related restrictions and limitations of any approved product; the Company’s ability to identify, in-license or acquire additional technology; the Company’s ability to maintain its existing lease, license, manufacture and supply agreements; the Company’s ability to compete with other companies currently marketing or engaged in the development or commercialization of products and services that serve customers engaged in proteomic analysis, many of which have greater financial and marketing resources than the Company; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets once commercialized, either alone or in partnership with others; the Company’s estimates regarding future expenses, future revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties described under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and in the Company’s other filings with the SEC. The Company cautions that the foregoing list of factors is not exclusive. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.

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Investor Contact

Jeff Keyes

Chief Financial Officer

[email protected]

Media Contact

Katherine Atkinson

SVP, Commercial Marketing

[email protected]

KEYWORDS: United States North America Connecticut

INDUSTRY KEYWORDS: Research Pharmaceutical Hardware Data Management Apps/Applications Technology Genetics Health Technology Science Biotechnology Other Science Health

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