Market Newsdesk

PHOENIX, Jan. 13, 2025 (GLOBE NEWSWIRE) — Global Water Resources, Inc. (NASDAQ: GWRS), a pure-play water resource management company, has appointed Robert J. Kuta to the new position of executive vice president of engineering and environmental resources.

The strategic hire supports the company’s ongoing efforts to further enhance its water and wastewater services for customers in Arizona’s booming economy and prepare for growth and regional expansion. The new position provides numerous benefits with the combination of engineering and environmental resources, including helping to ensure Global Water Resources maintains its exceptional compliance record as the company continues to acquire troubled utilities and manage new regulatory standards.

Kuta brings to Global Water Resources more than 35 years of experience in the water industry, from operations, project delivery and strategic planning to developing and delivering innovative business performance models and regulatory strategies. He also has considerable executive experience within the southwest U.S. regulated utility space.

Kuta has led large and diverse water industry organizations in both domestic and international business settings. This has included managing large and complex water and wastewater design-build-operate projects around the world which have involved food processing, mining, oil & gas, energy production and other high-growth industries.

“We welcome Rob’s extensive experience and exceptional record of achievement as we prepare to implement what could be our largest capital improvement program in the years to come,” stated Global Water Resources CEO, Ron Fleming. “We have great confidence in Rob’s ability to use his diverse skill set to enhance our organizational performance.

“In coordination with our exceptional existing team, Rob will develop and execute on infrastructure and environmental programs designed to benefit our growing regional communities while maintaining compliance as our top mandate. We look forward to Rob’s contributions as we apply our unique approach to Total Water Management in solving today’s infrastructure renewal and environmental challenges.”

Kuta previously served as vice president of engineering and chief water quality and environmental affairs compliance officer at California Water Service Company (Cal Water), the country’s third largest investor-owned water utility. At Cal Water, he oversaw capital expenditures of $1.4 billion under a three-year development and infrastructure expansion program.

“I respect Global Water’s approach to the water utility sector and what they have been able to achieve in its relatively short history,” said Kuta. “Global Water has a tremendous opportunity to make an even greater difference in providing reliable water resource management to Arizona communities. This mission has become increasingly vital as the region continues to experience unprecedented growth. I look forward to leading our engineering, construction, and environmental resources departments, including our new industrial division, with a focus on creating successful outcomes for all stakeholders.”

Prior to Cal Water, Kuta served as senior vice president of Operations Management Service – Water, Environment & Nuclear at the engineering firm, CH2M HILL (subsequently acquired by Jacobs). At CH2M, he led 1,400 skilled associates in delivering $250 million in annual service contract work that included site-based operations, maintenance and consulting services for public and private sector clients. He also helped lead infrastructure improvement programs and project management services valued at over $2 billion, including alternative delivery water/wastewater projects and U.S. military utility privatization programs.

Before CH2M HILL, Kuta served in several roles of increasing responsibility at American Water Works, including president of its Arizona American Water Company subsidiary. He also served as regional vice president of Service Delivery at Western Region Company, another subsidiary of American Water, where he managed a rolling 5-year gross capital budget of over $1 billion while maintaining close alignment with the region’s rate recovery plan.

He currently serves on the board for the Design-Build Institute of America’s Western Pacific Region, which provides ‘design-build done right’ education and professional certification opportunities that advance industry best practices.

Kuta previously served as a member of the board of directors of the Bay Area Water Supply and Conservation Agency, which represents the interests of 24 cities and water districts and two private utilities in Alameda, Santa Clara and San Mateo counties.

He is also an active member of several other industry groups, including American Water Works Association, National Association of Water Companies, National Council for Public-Private Partnerships, Water Environment Federation, Water for People, Living Water, and WateReuse Association.

He earned his Bachelor of Science degree in Biology from Central Michigan University and MBA from University of Phoenix. He completed graduate studies in Hydrology/Civil Engineering at Arizona State University and earned an Advanced Certificate for Executives in Management, Innovation, and Technology from MIT.

About Global Water Resources

Global Water Resources, Inc. is a leading water resource management company that owns and operates 32 systems which provide water, wastewater, and recycled water services. The company’s service areas are located primarily in growth corridors around metropolitan Phoenix. Global Water recycles over 1 billion gallons of water annually with 17.4 billion gallons recycled since 2004.

The company has been recognized for its highly effective implementation of Total Water Management (TWM). TWM is an integrated approach to managing the entire water cycle that involves owning and operating water, wastewater and recycled water utilities within the same geographic area in order to maximize the beneficial use of recycled water. It enables smart water management programs such as remote metering infrastructure and other advanced technologies, rate designs, and incentives that result in real conservation. TWM helps protect water supplies in water-scarce areas experiencing population growth.

Global Water has received numerous industry awards, including national recognition as a ‘Utility of the Future Today’ for its superior water reuse practices by a national consortium of water and conservation organizations led by the Water Environment Federation (WEF). The company also received Cityworks’ Excellence in Departmental Practice Award for demonstrating leadership and creativity in applying public asset management strategies to daily operations and long-term planning.

To learn more, visit www.gwresources.com.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release include certain forward-looking statements which reflect the company’s expectations regarding future events. The forward-looking statements involve a number of assumptions, risks, uncertainties, and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. These forward-looking statements include, but are not limited to, statements about our strategies; expectations about future business plans, prospective performance, growth, and opportunities; future financial performance; technologies; plans and expectations for capital expenditures and regulatory compliance; and other statements that are not historical facts, as well as statements identified by words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates”, or the negative of these terms, or other words of similar meaning. These statements are based on our current beliefs or expectations and are inherently subject to a number of risks, uncertainties, and assumptions, most of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from these expectations due to changes in political, economic, business, market, regulatory, and other factors. Factors that may also affect future results are disclosed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our filings with the Securities and Exchange Commission (the “SEC”), which are available at the SEC’s website at www.sec.gov. This includes, but is not limited to, our most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. Accordingly, investors are cautioned not to place undue reliance on any forward-looking statements, which reflect management’s views as of the date hereof. We undertake no obligation to publicly update any forward-looking statement, except as required by law, whether as a result of new information, future developments or otherwise.

Company Contact:

Michael Liebman
CFO and SVP
Tel (480) 999-5104
Email Contact

Investor Relations Contact:

Ron Both or Grant Stude
CMA
Tel (949) 432-7566
Email contact

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b8a50220-88d9-40ec-8e31-2212059dbc82

BOCA RATON, Fla., Jan. 13, 2025 (GLOBE NEWSWIRE) — FlexShopper, Inc. (Nasdaq: FPAY), a prominent national online lease-to-own retailer and payment solutions provider, today announced the preliminary results of its previously disclosed unit rights offering (the “Rights Offering”), which expired at 5:00 pm ET on January 10, 2025 (the “Expiration Date”). The Company also announced that the holder of the Company’s subordinated debt has elected to convert 25%, or $2.5 million of the outstanding principal balance in the Rights Offering. The units sold at $1.70 were at a 15% discount to the 3-day volume weighted average price and included a share and 3 additional rights to purchase shares at discounts to the trading price.

Preliminary Proceeds

According to Continental Stock Transfer & Trust Company (the “Subscription Agent”), as of the Expiration Date, approximately 5,547,993 subscription rights (the “Subscription Rights”) have been exercised to purchase approximately 21% of the Company’s common stock.   Through the initial portion of the Subscription Rights offering, FlexShopper raised $9.4 million in gross proceeds.   There are an additional 21 million rights that can be exercised over the next 90 days at 30-day intervals for additional shares.

“I want to thank all of my fellow shareholders who subscribed to our subscription rights for their continuing support, confidence, and above all, trust in FlexShopper,” said Russ Heiser, CEO of FlexShopper. “The Rights Offering is an efficient, shareholder friendly, and accretive way to raise capital. At the end of the 2024 third quarter, our stock closed at $1.03 per share, representing a market cap of $22.1 million, compared to FlexShopper’s closing stock price at January 10, 2025 of $1.90 per share, representing a market cap over $54 million.   We believe this appreciation reflects the accretive nature of the Rights Offering’s use of proceeds, as well as the growing strength of our financial and operating results.”

Mr. Heiser continued: “Shareholders that participated in the Subscription Rights now have access to additional opportunities to increase their FlexShopper investment through the upcoming Series A, B, and C rights that expire over the next 30, 60, and 90 days, respectively. The same level of participation in the Series A, B, and C rights would raise a total of approximately $48 million, which we estimate would save approximately $8.5 million in annual dividend and interest expense.”

The Company intends to use the proceeds from the Rights Offering to repurchase over 90% of its Series 2 Convertible Preferred Stock, and by repaying a portion of its credit facility and other outstanding debt facilities. Any remaining proceeds will be used for general corporate purposes, including potential acquisitions of other companies. The shares subscribed for in the Subscription Rights are expected to be issued to participating stockholders on or about January 15, 2025.

Subordinated Debt Conversion

NRNS Capital Holdings LLC (“NRNS”), the manager of which is the Chairman of FlexShopper’s Board of Directors, has elected to convert $2.5 million of the $10.75 million debt principal outstanding as of September 30, 2024 in the Rights Offering. At September 30, 2024, amounts outstanding under the NRNS Note bear interest at a rate of 19.21%. With the partial conversion of the NRNS subordinated debt the proforma outstanding balance is $8.25 million. FlexShopper estimates it will save approximately $0.5 million in annual interest expense as a result of the conversion.

Mr. Heiser concluded, “I’m excited by the direction FlexShopper is headed, as we increase our market share and execute against our growth oriented strategic plan. Equitizing our balance sheet is a powerful opportunity to expand earnings for our equity shareholders. I look forward to providing additional updates on our success in the coming months.”

FlexShopper encourages holders of the Series A, B, and C Rights to contact their broker or financial advisor’s Corporate Actions Department to participate in these subsequent rights. Rights offering information can be found at https://www.sec.gov and https://investors.flexshopper.com.

The offering was made pursuant to the Corporation’s registration statement on Form S-1 (File No. 333-282857), which was declared effective by the U.S. Securities and Exchange Commission on November 29, 2024. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC on December 2, 2024, and is available on the SEC’s website at

www.sec.gov

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

About FlexShopper, Inc.:

FlexShopper, Inc. (Nasdaq: FPAY) is a leading national financial technology company that provides payment options to consumers. FlexShopper provides a variety of flexible funding options for underserved consumers through its online direct to consumer marketplace at flexshopper.com and in partnership with partner merchants both online as well as at brick and mortar locations. FlexShopper’s solutions are designed to meet the needs of a wide range of consumer segments via lease-to-own and lending products.

Forward-Looking Statements

All statements in this release that are not based on historical fact are “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. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate,” or other comparable terms. Examples of forward-looking statements include, among others, statements we make regarding expectations of lease originations, the expansion of our lease-to-own program; expectations concerning our partnerships with retail partners; investments in, and the success of, our underwriting technology and risk analytics platform; our ability to collect payments due from customers; expected future operating results and expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: our ability to obtain adequate financing to fund our business operations in the future; the failure to successfully manage and grow our FlexShopper.com e-commerce platform; our ability to maintain compliance with financial covenants under our credit agreement; our dependence on the success of our third-party retail partners and our continued relationships with them; our compliance with various federal, state and local laws and regulations, including those related to consumer protection; the failure to protect the integrity and security of customer and employee information; and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q. The forward-looking statements made in this release speak only as of the date of this release, and FlexShopper assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

Company Contact:

FlexShopper, Inc.
Investor Relations
[email protected]

Investor and Media Contact

Andrew Berger
Managing Director
SM Berger & Company, Inc.
Tel (216) 464-6400
[email protected]

White Label Partnership Enters its 2



^nd



Year

SCHAUMBURG, IL, Jan. 13, 2025 (GLOBE NEWSWIRE) — Giftify, Inc. (NASDAQ: GIFT) (the “Company”), the owner and operator of leading digital platforms, CardCash.com and Restaurant.com, with a focus on incentives and rewards in retail, dining & entertainment experiences, is pleased to announce its white label partnership with CVS, powering their CVS Gift Card Exchange is now entering its 2^nd year.

The platform that enables CVS to accept unwanted gift cards for store e-credit is accessible here:
https://cvs.cardcash.com.

Ketan Thakker, Chief Executive Officer of Giftify, Inc., commented, “We are pleased to enter our second year working together with CVS in enabling their gift card exchange program. More and more retailers are aligning with our vision in that when they’re well-chosen, gift cards are probably the best, most versatile gifts anyone could receive. But if you’ve been given a gift card to a store or restaurant that you don’t enjoy, it can feel like a burden weighing down your wallet. The option to trade in your unwanted gift cards online is a win-win for all.”

About Giftify, Inc.

Giftify, Inc. is a pioneer in the incentive and rewards industry with a focus on retail, dining & entertainment experiences, as the owner and operator of leading digital platforms, CardCash.com and Restaurant.com. CardCash.com is a leading secondary gift card exchange platform, allowing consumers and retailers to realize value by buying and selling gift cards at various scales. Its Restaurant.com is the nation’s largest restaurant-focused digital deals brand. Restaurant.com and our Corporate Incentives division connect digital consumers, businesses and communities offering thousands of dining, retail and entertainment deals options nationwide at over 184,000 restaurants and retailers. Restaurant.com prides itself on offering the best deal, every meal. Our gift cards and restaurant certificates allow customers to save at thousands of restaurants across the country with just a few clicks.

For more information, visit: www.giftifyinc.com and www.cardcash.com and https://www.restaurant.com.

Forward-Looking Statements

Press Releases may include forward-looking statements. In particular, the words “believe,” “may,” “could,” “should,” “expect,” “anticipate,” “estimate,” “project,” “propose,” “plan,” “intend,” and similar conditional words and expressions are intended to identify forward-looking statements. Any statements made in this news release about an action, event or development, are forward-looking statements. Such statements are based upon assumptions that in the future may prove not to have been accurate and are subject to significant risks and uncertainties. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the company. Accordingly, you should not place undue reliance on these forward-looking statements. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, it can give no assurance that its forward-looking statements will prove to be correct. Investors are cautioned that any forward-looking statements are not guarantees of future performance and actual results or developments may differ materially from those projected. The forward-looking statements in this press release are made as of the date hereof. The company takes no obligation to update or correct its own forward-looking statements, except as required by law or those prepared by third parties that are not paid by the company. Statements in this press release that are not historical fact may be deemed 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. Although Giftify, Inc. believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, Giftify, Inc. is unable to give any assurance that its expectations will be attained. Factors that could cause actual results to differ materially from expectations include the company’s ability identify a suitable business model for the corporation.

Investors Contacts:


[email protected]

MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Jan. 13, 2025 (GLOBE NEWSWIRE) — Lifeward Ltd. (Nasdaq: LFWD) (“Lifeward” or the “Company”), today issued an open letter from Larry Jasinski, Chief Executive Officer, to shareholders highlighting the Company’s significant achievements in 2024 and outlining the key objectives for 2025. The full letter is published below.

Dear Shareholders and other Stakeholders,

From our founding in 2001, the Company has collectively poured its collaborative efforts into achieving our mission:

To relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love.

What we do for patients is utterly life-changing, and they routinely tell us this.  I invite you to remind yourselves of these stories from the voices of our customers in our testimonials section. You’ll see in these testimonials why we are so committed to our mission and our imperative for success.

In this spirit, 2024 was a transformational year in our history. In January, after years of effort, we succeeded in achieving an industry-establishing milestone with the enactment of a defined Exoskeleton category as an orthotic brace that was classified for lump sum payment with the Centers for Medicare & Medicaid Services (“CMS”). Key results include:

• In April, we achieved a defined payment to provide ReWalk systems to Medicare beneficiaries.
• Over the course of the year, we delivered over 70 new ReWalk systems, more than twice our prior year total.
• By year-end, we established a pipeline of approximately 100 qualified users for future ReWalk submissions.
• During 2024, Lifeward was actively engaged with the ITEM coalition with CMS policy efforts and legislation to expand support for VA policy.
• In June, we successfully launched the NEO and NEO+ additions to the AlterG product line which we believe will allow greater penetration to a broader range of clinics.
• During 2024, Lifeward accomplished successful operational consolidation of AlterG, including closure of our Fremont facility, which we expect will reduce our overhead and operating costs.
• Despite initial headwinds in the U.S. capital equipment market earlier in 2024, the AlterG product offering recovered in Q4 with over 140 units placed, up about 90% sequentially.
• We added Mike Swinford and Robert Marshall to our Board of Directors, which provides depth within our industry and in financial operations as we achieve the next level of commercial operations.

Highlights of Commercial and Operational Priorities for 2025:

• 
  Commercial focus with Exoskeletons.
     We are maximizing execution of our current leads, driving new leads through digital marketing, building relationships and a referral base with key centers, streamlining the patient experience from screening to delivery, and expanding physician education for patient selection.
• 
  AlterG penetration.
  Our new NEO and NEO+ offerings are growth drivers. We are expanding to national chains and with more international distributors.
• 
  Technology development.
  We seek to complete FDA and CE clearance in the first half of 2025 for ReWalk 7. This next generation exoskeleton with cloud connectivity enables data collection and better service to our customers, multiple walking speeds, a crutch-based control for safer and more intuitive use, and significantly improved batteries for extended use.
• 
  Financial.
  Our financial priorities are driving efficient, sustainable growth, increasing our margins and reducing our expenses.

The actions completed in 2024 and our commercial strategies for 2025 are the drivers towards profitability. On our year-end earnings call, we look forward to sharing our final 2024 financial results and our outlook for 2025. The preliminary results for 2024 met our revised revenue guidance. In early January 2025, the Company successfully raised $5 million in additional capital to support investment in driving Exoskeleton and AlterG continued awareness and adoption, and to supplement the Company’s liquidity position as a bridge to positive free cash flows. Our goal remains to reach non-GAAP operating profitability at some point during the second half of 2026. To provide more in-depth information and interaction, the company will hold an investor event in New York City on February 20. Details on the session location and time will be provided subsequently.

On behalf of Lifeward and our Board of Directors, I want to wish everyone a happy, healthy, and safe new year. We look forward to further successes and communications with you in 2025.

Regards,

Larry Jasinski
Lifeward CEO

About Lifeward

Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity System, the MyoCycle FES System, and the ReStore Exo-Suit.

Founded in 2001, Lifeward has operations in the United States, Israel, and Germany. For more information on the Lifeward product portfolio, please visit GoLifeward.com.

Lifeward^®, ReWalk^®, ReStore^® and Alter G^® are registered trademarks of Lifeward Ltd. and/or its affiliates.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. Such forward-looking statements may include projections regarding Lifeward’s future performance and future regulatory interactions and other statements that are not statements of historical fact and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “should,” “would,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Lifeward’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward-looking statements are more fully discussed in the Company’s periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described under the heading “Risk Factors” in the Company’s annual report on Form 10-K and 10-K/A for the year ended December 31, 2023 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, Lifeward undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Lifeward Media Relations:

Kathleen O’Donnell
VP Marketing & New Business Development
Lifeward Ltd.
E: [email protected]

Lifeward Investor Contact:
Mike Lawless
Chief Financial Officer
Lifeward Ltd.
E: [email protected]

SAN FRANCISCO, Jan. 13, 2025 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ:IRTC) a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today announced preliminary fourth quarter operational highlights and a business update at the 43rd Annual J.P. Morgan Healthcare Conference.

Recent Operational Highlights and Financial Outlook

• Anticipate full year 2024 revenue slightly above high end of previously stated guidance range of $587.5 million provided in October 2024
• Record quarter of new account openings for both Zio monitor and Zio AT during the fourth quarter 2024 as well as strong volume contributions from large national accounts
• Launched first four health care systems on Epic Aura during the fourth quarter 2024 with broad commercial roll out for Epic health systems across the U.S. beginning in 2025
• Initiated Zio monitor shipments for home enrollment patients during the fourth quarter 2024
• Five studies presented at the American Heart Association highlight Zio Monitor’s high patient satisfaction, engagement and compliance with the patient MyZio app and digital tools, health economic impact of early arrhythmia detection in type 2 diabetes and respiratory disease, and AI insights on sleep and activity patterns¹
• Expect revenue for the full year 2025 of approximately $675 million to $685 million

“This past year was a period of significant growth and transformation for iRhythm,” said Quentin Blackford, iRhythm’s President and CEO. “In our core U.S. business, we achieved a record number of Zio registrations from across different channels – serving over 2 million patients, advancing Zio utilization earlier in the patient care pathway, and growing our market penetration within ambulatory cardiac monitoring. Notably, we secured FDA clearance for two 510(k) submissions related to our Zio AT device, further advancing our technology for the benefit of patients, physicians, and healthcare systems who rely on our Zio AT services. To enable future growth on a global scale, we also expanded into four European countries, earned Japanese regulatory approval, signed a strategic technology licensing agreement with BioIntelliSense, and launched the initial phase of manufacturing automation for Zio monitor. Lastly, we implemented several sustainable operational efficiencies throughout the business, driving profitability expansion and positioning us to continue to grow efficiently into the future.”

“With this strong foundation of execution in 2024, we are well positioned to continue transforming iRhythm through a commitment to excellence, innovation, and value creation,” Blackford continued. “In 2025, our top priority will be on ensuring that our quality systems are best-in-class. Commercially, we plan to expand further into primary care channels through our land-and-expand strategy and by continuing to drive momentum within risk-bearing entities as Zio becomes a key tool in population health management. Internationally, we are also excited to drive further penetration within international markets where we are earlier in the commercial adoption curve. With our recent achievements and the opportunities ahead, we remain focused on delivering sustainable value for patients, clinicians, healthcare systems, and shareholders,” concluded Mr. Blackford.

Webcast and Conference Presentation Information

At the upcoming 43^rd Annual J.P. Morgan Healthcare Conference, iRhythm’s management is scheduled to present on Monday, January 13, 2025, at 7:30 p.m. Eastern Time/4:30 p.m. Pacific Time. Interested parties may access a live and archived webcast of the presentation on the “Events & Presentations” section of the company’s investor website at investors.irhythmtech.com.

About iRhythm Technologies, Inc.

iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats² into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, including its portfolio of Zio products and services, please visit irhythmtech.com.

Forward-Looking Statements

This press release 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, and the Private Securities Litigation Reform Act of 1995. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future actions or operating or financial performance. In particular, these statements include statements regarding financial guidance, market opportunity, ability to penetrate the market, anticipated productivity and quality improvements and expectations for growth. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled “Risk Factors” and elsewhere in our filings made with the Securities and Exchange Commission, including those in iRhythm’s most recent filings on Form 10-K, Form 10-Q and other SEC filings, all of which are available on iRhythm’s website. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. iRhythm disclaims any obligation to update these forward-looking statements.

Investor Contact

Stephanie Zhadkevich
[email protected]

Media Contact

Kassandra Perry
[email protected]

1. The accelerometer data and the sleep and activity classification algorithm presented at AHA in November 2024 are intended exclusively for research purposes and are not available for any commercial use.
2. Based on the US and UK data using Zio ECG monitors. Data on file. iRhythm Technologies, 2025.

Study to be conducted under $3.6 million NIH grant 

DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) —

SeaStar Medical Holding Corporation
(Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to evaluate the safety and initial efficacy of SeaStar Medical’s Selective Cytopheretic Device (SCD-ADULT) in reducing inflammation in adult patients with acute heart failure with worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting a left ventricular assist device (LVAD) implantation.

This feasibility study is expected to enroll 20 patients at up to five clinical sites and will be funded by a previously announced $3.6 million National Institutes of Health (NIH) grant awarded to Innovative BioTherapies (IBT), which is led by SCD inventor H. David Humes, MD, Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor. Dr. Humes will serve as lead investigator for the study and SeaStar Medical will act as clinical research organization (CRO). The FDA’s Center for Biologics Evaluation and Research (CBER) granted Breakthrough Device Designation for the SCD in cardiorenal syndrome with LVAD in September 2023.

“Oftentimes patients with cardiorenal syndrome and worsening renal or cardiac function are ineligible for lifesaving LVAD implantation due to the severity of their condition,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “This study is designed to determine whether employing the SCD-ADULT to reduce hyperinflammation in these extremely ill patients can sufficiently improve their condition to bridge to LVAD implantation. Findings from this study could inform a future pivotal study in this population.”

“We estimate the total addressable U.S. market for the SCD-ADULT in cardiorenal syndrome at more than $1 billion annually, making this a significant commercial opportunity for our company,” said Eric Schlorff, SeaStar Medical CEO. “As acting CRO for this study, we will receive a portion of the NIH grant while gaining valuable experience that may serve us well in future studies.”

About Hyperinflammation

Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic or damaging to vital organs, and result in multi-organ failure and even death. This is known as the cytokine storm.

Selective Cytopheretic Device

The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future renal replacement therapy (RRT), including dialysis.

In addition to cardiorenal syndrome with LVAD, the SCD has been awarded FDA Breakthrough Device Designation in the following indications:

• Adult Acute Kidney Injury
• Hepatorenal Syndrome
• Chronic Dialysis

About Innovative BioTherapies (IBT)

IBT is a privately held biotechnology company founded to facilitate the commercialization of technology developed in Dr. H. David Humes’ academic laboratory. IBT’s research and development program is primarily supported by federal grants and contracts that focus on developing cell therapy devices utilizing human progenitor cells, biomimetic materials and micro-electromechanical systems (MEMs) technology. More information is available at http://www.innbio.com/.

About SeaStar Medical

SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, the ability of the SCD-ADULT to treat patients with cardiorenal syndrome or severe right ventricular failure awaiting a LVAD implantation; the expected patient enrollments and clinical sites for the feasibility study and other diseases; the expected benefits of the feasibility study and the total addressable market for the SCD-ADULT in cardiorenal syndrome. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:

Alliance Advisors IR
Jody Cain
(310) 691-7100
[email protected]

# # #

TOKYO, Jan. 13, 2025 (GLOBE NEWSWIRE) — Lead Real Estate Co., Ltd. (Nasdaq: LRE) (“LRE” or “the Company”), a Japanese real estate developer of luxury residential properties including single-family homes and condominiums across Tokyo, Kanagawa prefecture and Sapporo, today announced that in December 2024, it completed the sale and delivery of two newly built luxury income-producing condominium buildings in prime locations in Tokyo.

A 3-unit property, Excelsior Nishi Azabu 2 Chome, in Minato-ku, Nishi Azabu, is made from reinforced concrete, has one basement floor and three floors above ground. It has a building area of 4,985 square feet and a land area of 2,238 square feet. A high-end residential neighborhood surrounded by traditional stores, Nishi Azabu has convenient access to financial centers and elegant shopping districts.

The Real Building Nishi Waseda, in Shinjuku-ku, Nishi Waseda, is a 5-unit property made with steel frame construction. It has five floors above ground, a building area of 3,220 square feet, and a land area of 726 square feet. Located near several parks, the prestigious Waseda University and two subway stations, Nishi Waseda has a friendly atmosphere amidst the world’s largest city.

Due to a confidentiality agreement in place, both the identity of the seller and the sale price will not be disclosed. There are no capital, personal, or business relationships between the Company and the seller, and there are no special interests between the Company and the seller. 

About Lead Real Estate Co., Ltd

Lead Real Estate Co., Ltd is a Japanese developer of luxury residential properties, including single-family homes and condominiums, across Tokyo, Kanagawa prefecture, and Sapporo. In addition, the Company operates hotels in Tokyo and leases apartment building units to individual customers in Japan and Dallas, Texas.

The Company’s mission is to serve its customers by offering stylish, safe, and luxurious living. The Company’s vision is to adopt the Kaizen (continuous improvement) approach to seek to improve its operations, and to leverage its nationally recognized, award-winning luxury homes and strong market position in the luxury residential property market in Tokyo, Kanagawa prefecture, and Sapporo to create a global transaction platform allowing access to prime Japanese condominiums as well as overseas condominiums, including in the U.S. and Hong Kong.

For more information, please visit the Company’s website at https://www.lead-real.co.jp/en/.

Forward-looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors that may affect its future results in the Company’s registration statement and in its other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact Information:

For Media and Investor Relations

Daisuke Takahashi
Chief Financial Officer
Lead Real Estate Co., Ltd
[email protected] 
+81 3-5784-5127

Skyline Corporate Communications Group, LLC 

Scott Powell, President
1177 Avenue of the America’s, 5th Floor 
New York, NY 10036
Office: (646) 893-5835
Email: [email protected]

CHICAGO, Jan. 13, 2025 (GLOBE NEWSWIRE) — Rush Street Interactive, Inc. (NYSE: RSI) (“RSI”), a premier online casino and sports betting operator, is thrilled to announce a new exclusive partnership with Phil Hellmuth, the world-renowned professional poker player and record-holder for the most World Series of Poker (WSOP) tournament wins. Known as one of the most skilled gamblers in the world, Hellmuth will join the BetRivers team as a brand and content partner bringing his unparalleled expertise and charisma to deliver a variety of exciting and exclusive player experiences and entertainment across RSI’s Casino, Sportsbook, and Poker verticals, as well as throughout RSI’s media-owned productions such as the BetRivers Network and our long-running Poker Night in America poker show.

Hellmuth’s legendary career has made him one of the most recognizable figures in the poker world. With an unmatched 17 WSOP bracelets, he has cemented his status as a skilled gambler, captivating gambling audiences with his pride, passion, and larger-than-life persona. Beyond his accolades, Hellmuth’s engaging presence and entertaining personality have inspired countless fans and players worldwide.

This partnership will see Hellmuth integrated across RSI’s platforms and media production properties, delivering a mix of thrilling entertainment and engaging player opportunities.

Highlights of the partnership will include:

• In-App Promotions: Exclusive themed casino, sportsbook, and poker events and challenges for players to test their skills and enjoy unique rewards.
• Interactive Entertainment: Hellmuth will host Live Casino Dealer events, provide sports betting commentary, and lead interactive sessions for players and fans. He will also participate in unique engaging poker events with VIPs.
• VIP Events and Experiences: Appearances at in-person and online VIP tournaments and events, offering players a chance to compete with, be entertained by, and learn from one of poker’s greatest. In the upcoming weeks, VIPs will have the opportunity go to the Super Bowl in New Orleans with the poker legend.
• Brick-and-Mortar Activations: Hellmuth will headline events at BetRivers land-based casino partners, creating unforgettable moments for attendees. In the coming months, Hellmuth will be participating in various tournaments at our casino partners including Rivers Casino and Little River Casino.
• BetRivers Network Collaborations: Hellmuth will play a prominent role in RSI’s entertainment media property, BetRivers Network, including appearances on flagship poker show production Poker Night in America, exclusive streaming events, and other branded activations. Be on the lookout for upcoming shoots and promotions including Hellmuth’s signed legendary BetRivers hat.
• BetRivers Online Poker: Dedicated tournaments and exclusive branded content designed to captivate online poker enthusiasts and casual players alike. Including, promoting RSI’s recently launched online poker platform developed in collaboration with acclaimed poker professional Phil Galfond.

“Phil Hellmuth is a living legend whose influence extends far beyond the poker table to all gamblers, and we are excited to welcome him to the BetRivers family,” said Richard Schwartz, CEO of Rush Street Interactive. “Phil’s unmatched passion, dynamic personality, and flair for entertainment make him the perfect ambassador as we continue to expand our offerings and elevate player experiences across our platforms. His expanded role in the BetRivers Network, including increased appearances on Poker Night in America, and his contributions to promoting our new online poker platform, will bring unparalleled excitement to our players. Additionally, his involvement with our best-in-class mobile casino and sportsbook promotional games will create unforgettable moments for players and fans alike.”

“Partnering with Rush Street Interactive and BetRivers is an exciting new chapter for me,” said Hellmuth. “Ever since meeting the Rush Street Interactive executive team in 2012, I have been a fan. I have been impressed with RSI’s moxie, will, and determination to build a beautiful product—an online gaming experience that people love to use and play on. Today, I am proud to announce that we will elevate our collaboration to share my experience and love of poker, gambling, and entertainment with BetRivers players and fans, both online and in person. First up, I will attend the Super Bowl in New Orleans with BetRivers VIP players!”

This partnership reinforces RSI’s dedication to delivering premium content, unforgettable events, and dynamic entertainment experiences for its players. By aligning with Hellmuth, RSI continues to solidify its position as a leader in the online casino, sportsbook, and poker industries.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. RSI’s actual results may differ from their 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 are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, RSI’s expectations about its arrangement with Hellmuth, what RSI’s anticipated offerings and benefits arising from that arrangement will include and its future performance with respect to that arrangement. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside RSI’s control and are difficult to predict. Factors that may cause such differences include, without limitation, changes in applicable laws or regulations, unanticipated product or service delays, and other risks and uncertainties indicated from time to time in RSI’s most recent Annual Report on Form 10-K, including those under “Risk Factors” therein, and in RSI’s other filings with the SEC. RSI cautions that the foregoing list of factors is not exclusive. RSI cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. RSI 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.

About Rush Street Interactive

RSI is a trusted online gaming and sports entertainment company focused on markets in the United States, Canada and Latin America. Through its brands, BetRivers, PlaySugarHouse and RushBet, RSI was an early entrant in many regulated jurisdictions. It currently offers real-money mobile and online operations in fifteen U.S. states: New Jersey, Pennsylvania, Indiana, Colorado, Illinois, Iowa, Michigan, Virginia, West Virginia, Arizona, New York, Louisiana, Maryland, Ohio and Delaware, as well as in the regulated international markets of Colombia, Ontario (Canada), Mexico and Peru. RSI offers, through its proprietary online gaming platform, some of the most popular online casino games and sports betting options in the United States. Founded in 2012 by gaming industry veterans, RSI was named the EGR North America Awards Customer Services Operator of the Year five years in a row (2020-2024), the 2022 EGR North America Awards Operator of the Year and Social Gaming Operator of the Year, and the SBC Latin-American Awards 2024 Casino Operator of the Year and 2021 Sportsbook Operator of the Year. RSI was the first U.S.-based online casino and sports betting operator to receive RG Check iGaming Accreditation from the Responsible Gaming Council. For more information, visit www.rushstreetinteractive.com.

About Phil Hellmuth

Phil Hellmuth is one of the most celebrated poker players in history, holding a record-breaking 17 World Series of Poker bracelets. Known for his competitive spirit, engaging personality, and entertaining presence, Hellmuth is a global ambassador for poker and remains a dominant force in the game.

Contacts

Media:
[email protected]

Investors:
[email protected]

• Achieves 35% year-over-year growth to 209,900 members on Jan. 1, showing how Medicare Advantage can be done right
• Announces year-end 2025 health plan membership of 225,000 to 231,000 and reiterates confidence in achieving consensus adjusted EBITDA of $40 million in 2025

ORANGE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — Alignment Healthcare, Inc. (NASDAQ: ALHC), an award-winning Medicare Advantage (MA) company, today announced Jan. 1 health plan membership of approximately 209,900, representing a 35% year-over-year increase in health plan membership when compared to membership as of Jan. 1, 2024. Additionally, the company expects to have 225,000 to 231,000 health plan members as of Dec. 31, 2025, representing growth of approximately 22% to 25% relative to the midpoint of its year-end 2024 membership guidance provided on Oct. 29, 2024.

Furthermore, the company is reaffirming its full-year 2024 guidance ranges on health plan membership, revenue, adjusted gross profit and adjusted EBITDA provided Oct. 29, 2024. It also reiterates confidence in attaining consensus adjusted EBITDA of approximately $40 million in 2025. 2025 guidance will be provided at its fourth-quarter 2024 earnings call.

“By continuing to put seniors first in everything we do, Alignment is Medicare Advantage done right,” said John Kao, founder and CEO. “Another strong year of 35% growth underscores the effectiveness of our model through a steadfast commitment to operational excellence and EBITDA performance. Our ability to scale profitably and achieve solid growth outside of California demonstrates that we are not just growing – we are winning, and we are poised to take Alignment to the next level.”

To drive this next phase of growth, Dawn Maroney has been promoted to President of Alignment Healthcare, Inc., effective immediately. In this role, she will oversee Alignment’s day-to-day operations, focusing on optimizing member experiences, deepening provider engagement and ensuring seamless execution across all markets. Maroney’s leadership as President of Markets and CEO of Alignment Health Plan has been instrumental in achieving record enrollment growth, launching innovative products and fostering strong partnerships with key stakeholders.

“Dawn has been a cornerstone of Alignment’s success for over a decade, leading with vision and dedication,” Kao added. “Her promotion is well-deserved, recognizing her contributions to our growth and operational excellence. I am confident her leadership as president will further elevate our member experience, strengthen provider relationships and optimize market execution, ensuring we continue scaling profitably while delivering on our mission.”

In 2024, Alignment received numerous recognitions, including:

• Having 98% of health plan members enrolled in plans rated 4 stars or above for 2025.
• Retaining a 5-star rating from the Centers for Medicare & Medicaid Services (CMS) for its North Carolina and Nevada HMO contract for three straight years in 2025, making it one of only nine plans nationwide to garner the top rating.
• Earning 4.5 stars from CMS for its California PPO in 2025, and 4 stars for its California HMO, marking the HMO’s 8^th consecutive year as a 4-star or greater plan.
• Being named a Newsweek World’s Most Trustworthy Company 2024.
• Earning a 4.9- out of 5-star rating on Google based on more than 7,000 Google reviews.

“Every milestone we’ve achieved stems from our unwavering focus on operational excellence and member satisfaction,” Maroney said. “We believe our approach is helping to restore the promise of MA, which is to deliver high-quality care and better health outcomes at lower costs.”

Non-GAAP Measures

Adjusted gross profit is a non-GAAP financial measure that is presented as supplemental disclosure, that we define as loss from operations before depreciation and amortization, clinical equity-based compensation expense, clinical restructuring costs and selling, general, and administrative expenses. We cannot reconcile our estimated ranges for adjusted gross profit to loss from operations, the most directly comparable GAAP measure, and cannot provide estimated ranges for loss from operations, without unreasonable efforts because of the uncertainty around certain items that may impact loss from operations, including equity-based compensation expense and depreciation and amortization, that are not within our control or cannot be reasonably predicted.

Adjusted EBITDA is a non-GAAP financial measure that is presented as supplemental disclosure, that we define as net loss before interest expense, income taxes, depreciation and amortization expense, acquisition expenses, certain litigation costs, gains or losses on right of use (“ROU”) assets, gains or losses on sale of property and equipment, restructuring costs and equity-based compensation expense. We cannot reconcile our estimated ranges for Adjusted EBITDA to net loss, the most directly comparable GAAP measure, and cannot provide estimated ranges for net loss, without unreasonable efforts because of the uncertainty around certain items that may impact net loss, including equity-based compensation expense and depreciation and amortization, that are not within our control or cannot be reasonably predicted.

About Alignment Healthcare

Alignment Health is championing a new path in senior care that empowers members to age well and live their most vibrant lives. A consumer brand name of Alignment Healthcare (NASDAQ: ALHC), Alignment Health’s mission-focused team makes high-quality, low-cost care a reality for its Medicare Advantage members every day. Based in California, the company partners with nationally recognized and trusted local providers to deliver coordinated care, powered by its customized care model, 24/7 concierge care team and purpose-built technology, AVA^®. As it expands its offerings and grows its national footprint, Alignment upholds its core values of leading with a serving heart and putting the senior first. For more information, visit www.alignmenthealth.com.

Forward-Looking Statements

This release 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, and the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are subject to risks and uncertainties and are based on assumptions that may prove to be inaccurate, which could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results may differ materially from the results predicted, and reported results should not be considered as an indication of future performance. Important risks and uncertainties that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to attract new members and enter new markets, including the need for certain governmental approvals; our ability to maintain a high rating for our plans on the Five Star Quality Rating System; our ability to develop and maintain satisfactory relationships with care providers that service our members; risks associated with being a government contractor; changes in laws and regulations applicable to our business model; risks related to our indebtedness; changes in market or industry conditions and receptivity to our technology and services; results of litigation or a security incident; and the impact of shortages of qualified personnel and related increases in our labor costs.  For a detailed discussion of the risk factors that could affect our actual results, please refer to the risk factors identified in our Annual Report on Form 10-K for the year ended December 31, 2023, and the other periodic reports we file with the SEC. All information provided in this release and in the attachments is as of the date hereof, and we undertake no duty to update or revise this information unless required by law.

Investor Contact

Harrison Zhuo
[email protected]

Media Contact

Priya Shah
mPR, Inc. for Alignment Healthcare
[email protected]

– Topline data from the first Phase 3 FOS study anticipated in H2 2025 representing major milestone in support of NDA filing and potential launch of azetukalner

– First of three planned Phase 3 MDD studies now initiated

– Expanding ion channel portfolio includes Kv7 and Nav1.7 candidates advancing towards IND filings in 2025

VANCOUVER, British Columbia and BOSTON, Jan. 13, 2025 (GLOBE NEWSWIRE) — Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today outlined progress within its pipeline programs and key milestones for 2025.

“Reflecting on our accomplishments in 2024, we are proud of the advancements in our late-stage clinical programs, culminating in a strong presence at AES where we presented new long-term azetukalner data from our ongoing X-TOLE open-label extension study showing sustained monthly reduction in seizure frequency and impressive seizure freedom rates in patients with epilepsy,” said Ian Mortimer, President and Chief Executive Officer of Xenon. “We also made significant progress within our early-stage portfolio, progressing multiple drug candidates targeting Kv7 and Nav1.7 into IND-enabling studies.”

“Looking ahead to 2025, we anticipate a number of important milestones, particularly the first Phase 3 topline readout of azetukalner in focal onset seizures expected in the second half of 2025, representing a major inflection point for Xenon as we evolve from a clinical to commercial stage organization. Beyond epilepsy, we continue to advance azetukalner in MDD with the recent launch of our first Phase 3 study. Lastly, we expect multiple IND filings in 2025 in our early-stage programs, with the goal of initiating first-in-human trials across multiple targets,” stated Mr. Mortimer.

Program Updates and Anticipated Milestones

• Phase 3 azetukalner clinical studies in focal onset seizures (FOS) continue to advance, with the first topline data readout anticipated in the second half of 2025.
• Building upon more than 600 patient-years of data to date from the ongoing X-TOLE open-label extension study, Xenon continues to generate long-term scientific evidence supporting azetukalner’s compelling efficacy and safety profile.
• The Phase 3 X-ACKT clinical study continues to enroll patients and is intended to support potential regulatory submissions in an additional epilepsy indication of primary generalized tonic-clonic seizures (PGTCS).
• The first of three planned Phase 3 clinical trials evaluating azetukalner in patients with MDD, X-NOVA2, has been initiated to support indication expansion of azetukalner in neuropsychiatry. In addition, topline results from the Mount Sinai investigator-led study of azetukalner in MDD are anticipated in the first half of 2025.
• Xenon continues to expand its portfolio with pre-clinical candidates targeting Kv7, Nav1.7, and Nav1.1 across various indications and anticipates filing multiple INDs, or equivalent, in 2025.
• Within Xenon’s partnered program, Neurocrine Biosciences is now focusing its efforts on progressing a Nav1.2/1.6 inhibitor towards human clinical trials in 2025 as a potential treatment for epilepsy.

About Azetukalner Phase 3 Epilepsy Program

Xenon’s Phase 3 epilepsy program includes three Phase 3 clinical trials in focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS). Designed closely after the Phase 2b X-TOLE clinical trial, the Phase 3 X-TOLE clinical trials are multicenter, randomized, double-blind, placebo-controlled studies evaluating the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of azetukalner administered orally with food as adjunctive treatment in approximately 360 patients with FOS per study. The primary efficacy endpoint is the median percent change (MPC) in monthly seizure frequency from baseline through the 12-week double-blind period (DBP) of azetukalner compared to placebo. X-ACKT is a multicenter, randomized, double-blind, placebo-controlled study evaluating the clinical efficacy, safety, and tolerability of 25 mg of azetukalner administered with food as adjunctive treatment in approximately 160 patients with PGTCS. The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the 12-week DBP of azetukalner compared to placebo. Upon completion of the DBP in the Phase 3 epilepsy studies, eligible patients may enter an OLE study for up to three years.

About Azetukalner Phase 3 MDD Program

Xenon’s Phase 3 MDD program includes three multicenter, randomized, double-blind, placebo-controlled clinical trials to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period (DBP) as monotherapy treatment in approximately 450 patients with moderate-to-severe major depressive disorder (MDD) per study. The primary efficacy endpoint is the change from baseline in the HAM-D17 score at week 6 in patients who received azetukalner compared to placebo. Upon completion of the DBP, eligible patients may enter an OLE study for up to 12 months.

About Xenon Pharmaceuticals Inc.

Xenon Pharmaceuticals (Nasdaq: XENE) is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics. We are advancing an ion channel product portfolio to address areas of high unmet medical need, including epilepsy and depression. Azetukalner, a novel, highly potent, selective Kv7 potassium channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. For more information, please visit www.xenon-pharma.com.

Safe Harbor Statement

This press release 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, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and potential results from clinical trials; the potential efficacy, safety profile, future development plans in current and anticipated indications, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in our azetukalner and other pipeline and development programs, including the anticipated filing of INDs; the timing and results of our interactions with regulators; our ability to successfully develop and obtain regulatory approval of azetukalner and our other product candidates; and anticipated timing of topline data readout from our clinical trials of azetukalner. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including azetukalner, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of market, industry, and regulatory conditions on clinical trial enrollment; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; the impact of unstable economic conditions in the general domestic and global economic markets; adverse conditions from geopolitical events; as well as the other risks identified in our filings with the U.S. Securities and Exchange Commission and the securities commissions in British Columbia, Alberta, and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

“Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

Contacts:

For Investors:

Chad Fugere
Vice President, Investor Relations
(857) 675-7275
[email protected]

For Media:

Colleen Alabiso
Senior Vice President, Corporate Affairs
(617) 671-9238
[email protected]