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PALO ALTO, Calif., March 10, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, neurodegenerative and cardiometabolic disease, today announced that its Board of Directors has approved changing the previously announced record date of January 28, 2025 for its previously announced dividend of Scilex preferred stock (the “Dividend”) to its stockholders and certain other securityholders of Scilex. The new record date for the Dividend will be April 11, 2025 (the “New Record Date”). Subject to the Board’s right to further change the New Record Date, the payment date (the “Payment Date”) will be determined by subsequent resolutions of the Board, which will be within 60 days following the New Record Date.

For more information on Scilex Holding Company, refer to www.scilexholding.com.

For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com.

For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability.

For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.

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[email protected]

About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.

Scilex Holding Company is headquartered in Palo Alto, California.

About Semnur Pharmaceuticals, Inc.

Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica.

Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s declaration and payment of the Dividend and timing thereof (including that the Board may change the New Record Date and, as a result, the Payment Date), Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease.

Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the Board’s right to change the New Record Date and/or revoke the Dividend, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.

Contacts:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: [email protected]

Website: www.scilexholding.com

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

ELYXYB® is a registered trademark owned by Scilex Holding Company.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.

Smoker Friendly Adds Both VLN and Smoker Friendly Branded VLN Reduced Nicotine Content Products to its Store Lineup

MOCKSVILLE, N.C., March 10, 2025 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine by offering smokers a choice about their nicotine consumption, today announced that it has signed an agreement with Smoker Friendly, one of its largest customers, to launch Smoker Friendly VLN branded reduced nicotine content cigarette products that will become the first VLN partner brand.

The introduction of Smoker Friendly VLN and 22nd Century VLN in Smoker Friendly outlets will be one of the first presentations of gold and menthol SKU’s that introduce the new VLN branding.

The addition of Smoker Friendly branded VLN and 22nd Century Group’s VLN products builds on a customer relationship of over 10 years, as does the recent addition of the Smoker Friendly Black Label style cigarette. The Companies are currently obtaining state approvals for these products and expect to begin shipping in the second quarter of 2025.

Larry Firestone, Chief Executive Officer of 22nd Century, said, “We are very excited to have Smoker Friendly adopt our first VLN partner brand and also add our newly rebranded VLN products to the Smoker Friendly product offerings in their stores. This is a foundational building block to advancing VLN in the market, and will be a staged rollout as we garner state approvals. Equally important to expanding distribution will be measuring rate of sale once VLN is on the shelf.”

Terry Gallagher, President and Chief Executive, Smoker Friendly said, “We are excited to expand our relationship and product portfolio to include the VLN lineup under our brand as well as the updated 22nd Century VLN brand products. This is an important step for the future of our partnership.”

About The Cigarette Store LLC dba Smoker Friendly

Boulder, Colorado based Smoker Friendly operates 344 stores in 13 states. The stores are a mix of tobacco stores, cigar lounges, liquor stores, and fueling locations under the names Smoker Friendly, Tobacco Depot, Smoke ‘N Go, Havana Manor, and Gasamat.

The Smoker Friendly team also manages the Smoker Friendly Authorized Dealer program. This program provides a total tobacco private label portfolio, industry expertise, a well-known name, and geographic exclusivity to tobacco retailers desiring an alternative to the contracts offered by big tobacco.

About 22nd Century Group, Inc.

22nd Century Group is the pioneering nicotine harm reduction company in the tobacco industry enabling smokers to take control of their nicotine consumption. 

We created our flagship product, the VLN^® cigarette, to give traditional cigarette smokers an authentic and familiar alternative that helps them take control of their nicotine consumption. VLN^® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to greatly reduce nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. 

Our wholly owned subsidiaries include a leading cigarette manufacturer that produces all VLN^® products and provides turnkey contract manufacturing for other tobacco brands both domestically and internationally. The 60,000 square foot facility in Mocksville, North Carolina has the capacity to produce more than 45 million cartons of combustible tobacco products annually with additional space for expansion. 

Our proprietary reduced nicotine tobacco blends are made possible by comprehensive and patented technologies that regulate nicotine biosynthesis activities in the tobacco plant, resulting in full flavor and high yield with 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets.

VLN^® is a registered trademark of 22nd Century Limited LLC.

Learn more at xxiicentury.com, on X (formerly Twitter), on LinkedIn, and on YouTube.

Learn more about VLN^® at tryvln.com.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements, including but not limited to our full year business outlook. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Forward-looking statements include, but are not limited to, statements regarding (i) our cost reduction initiatives, (ii) our expectations regarding regulatory enforcement, including our ability to receive an exemption from new regulations, (iii) our financial and operating performance and (iv) our expectations for our business interruption insurance claim. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 28, 2024, and in the Company’s Quarterly Reports filed on May 15, 2024, August 13, 2024, and November 11, 2024. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact

Matt Kreps
Investor Relations
22nd Century Group
[email protected]
214-597-8200

Southlake, TX, March 10, 2025 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, announced today that it has engaged Integrous Communications, a premier investor relations firm, to enhance communication channels with investors and the investment community.

Under the expert guidance of Integrous Communications, HeartSciences will embark on a comprehensive investor relations program, benefiting from Integrous Communications’ proven track record in collaborating with leading medical companies to develop and execute an effective investor relations program.

“We are excited to be working with Integrous Communications to elevate our communication with investors and the market,” stated Andrew Simpson, Chairman and Chief Executive Officer. “As we continue to transform cardiovascular screening using AI-ECG, radically increasing the clinical value of the ECG, it is imperative that we possess a robust investor relations program to convey our strategy to the market.”

“We are thrilled to be working with HeartSciences to enhance its investor relations program,” said Mark Komonoski, Partner of Integrous Communications. “Our team looks forward to partnering with the Company to articulate its growth strategy and value proposition to investors, fostering long-term relationships with the investment community.”

About HeartSciences

HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG’s clinical utility. Millions of ECGs are performed every week and the Company’s objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and intends to provide these AI-ECG algorithms on a device agnostic cloud-based solution as well as a low-cost ECG hardware platform. Working with clinical experts, HeartSciences ensures that all solutions are designed to work within existing clinical care pathways, making it easier for clinicians to use AI-ECG technology to improve their patient’s care and lead to better outcomes. HeartSciences’ first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® wavECG™ also provides conventional ECG information in the same test.

For more information, please visit: HeartSciences X: @HeartSciences

About Integrous Communications

Integrous Communications is an independent communications and investor relations consulting firm providing a single source solution for financial, corporate governance, applied technology, and integrated corporate communications services. Headquartered in Austin, Texas with personnel situated across North America, the firm’s diverse team of professionals has more than 100 years of combined experience. Integrous serves both domestic and international clients, including companies listed on the U.S., Canadian, Australian, and European exchanges.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 29, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2024, filed with the SEC on September 12, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2024, filed with the SEC on December 16, 2024 and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Investor Relations:

Integrous Communications
Mark Komonoski
Partner
Phone: 877-255-8483
Email: [email protected]  

SANTA MONICA, Calif., March 10, 2025 (GLOBE NEWSWIRE) — JAKKS Pacific (NASDAQ: JAKK) is thrilled to introduce Roxy Dolls, an all-new fashion and action sports-inspired doll line launching exclusively at Target in June 2025. Get ready to roll, ride, and shred in style!

Designed for kids ages 4 and up, these 7.5-inch articulated fashion dolls bring the excitement of skateboarding, snowboarding, roller skating, and surfing into the world of play. Each doll comes with a signature Roxy outfit and on-trend sports accessories, including a skateboard, snowboard, roller skates, or surfboard.

“With Roxy Dolls, we are merging fashion, creativity, and adventure to provide kids with an exciting way to showcase their passion for action sports,” said Debbie Haag, SVP of Marketing at JAKKS Pacific. “In collaboration with Authentic Brands Group, we have meticulously designed these Roxy-branded dolls to be both stylish and highly posable—perfect for hitting the streets, slopes, and waves with confidence and flair.”

Each 7.5-inch articulated doll is designed for easy posing and imaginative play. Outfitted in Roxy-inspired fashions, these dolls are always dressed for adventure. Every set includes a sticker sheet, a comb, and a signature Roxy sport accessory, such as a skateboard, snowboard, roller skates, or surfboard, making them the ultimate companions for stylish and sporty fun.

With an MSRP of $19.99, Roxy Dolls are set to be the ultimate must-have for action sports enthusiasts and fashion lovers alike.

Roxy Dolls will be available exclusively in Target stores and on Target.com starting June 2025. Get ready to ride in style and unleash your creativity with Roxy!

About JAKKS Pacific, Inc.:

JAKKS Pacific, Inc. is a leading designer, manufacturer and marketer of toys and consumer products sold throughout the world, with its headquarters in Santa Monica, California. JAKKS Pacific’s popular proprietary brands include: AirTitans®, Disguise®, Fly Wheels®, JAKKS Wild Games®, Moose Mountain®, Maui®, Perfectly Cute®, ReDo® Skateboard Co., Sky Ball®, SportsZone™, Xtreme Power Dozer®, WeeeDo®, and Wild Manes™ as well as a wide range of entertainment-inspired products featuring premier licensed properties. Through our products and our charitable donations, JAKKS is helping to make a positive impact on the lives of children. Visit us at www.jakks.com and follow us on Instagram (@jakkspacific.toys), Twitter (@jakkstoys) and Facebook (@jakkspacific.toys).
©2025 JAKKS Pacific, Inc. All rights reserved.

About Authentic Brands Group

Authentic Brands Group (Authentic) is a unified platform that integrates M&A, brand strategy, creativity and digital innovation to unlock the power of its global portfolio. It connects iconic sports, lifestyle, entertainment and media brands with best-in-class partners to optimize long-term value in the marketplace. Generating more than $29 billion in global annual retail sales, Authentic’s brands have an expansive retail footprint in 150 countries, including 13,000-plus freestanding stores and shop-in-shops and 400,000 points of sale. 

Authentic’s brand portfolio includes Shaquille O’Neal®, David Beckham®, Sports Illustrated®, Dr. J®, Greg Norman®, Neil Lane®, Thalia®, Marilyn Monroe®, Elvis Presley®, Muhammad Ali®, Reebok®, Brooks Brothers®, Barneys New York®, Judith Leiber®, Ted Baker®, Hunter®, Vince®, Hervé Léger®, Frye®, Nautica®, Juicy Couture®, Vince Camuto®, Lucky Brand®, Aéropostale®, Forever 21®, Nine West®, Sperry®, Rockport®, Eddie Bauer®, Boardriders®, Quiksilver®, Billabong®, Roxy®, DC Shoes®, RVCA®, Spyder®, Volcom®, Prince®, Izod®, Van Heusen®, Hart Schaffner Marx® and Thomasville®.

For more information, visit authentic.com.
Follow Authentic on LinkedIn, Instagram, X and WeChat.

MEDIA CONTACT:
Whitney Hatfield
[email protected]