Cycurion Announces Launch of Cyber Shield, a Comprehensive Managed Security Services Platform

MCLEAN, Va., March 25, 2025 (GLOBE NEWSWIRE) — Cycurion (Nasdaq: CYCU) (“Cycurion” or the “Company”), a trusted leader in IT cybersecurity solutions and AI, is proud to announce the launch of its new Managed Security Services Platform (MSSP), Cyber Shield™.

Kevin Kelly, Cycurion CEO stated, “Cyber Shield is the result of an extensive research and development process that optimizes our leading threat discovery and cybersecurity tools. The resulting best-in-class suite offers our customers a proven, all-encompassing solution to their security challenges. Cyber Shield is the optimal solution to address rapidly evolving security compliance requirements, significant increases in major data breaches and loss severity, and a lack of awareness of existing threats and vulnerabilities.”  

Cycurion’s Cyber Shield package includes the following capabilities and services:

  • SOC as a Service: 24/7/365 security monitoring, Managed Detection and Response (MDR), Endpoint Detection and Response (EDR), and Threat and Vulnerability Management
  • External Attack Surface Management (EASM): Identifying and managing vulnerabilities exposed to the external environment
  • Cybersecurity Awareness and Training: Empowering employees with the knowledge to recognize and respond to threats
  • Web Application Firewall: Utilizing the ARx Security Platform with AI for advanced protection, including integration with Cycurion’s SOC as a Service, C-Suite Dashboard, API protection, geo-gating, intelligent bot-mitigation, and AI enhancements
  • Virtual CISO Support and Consulting: Expert advisory services tailored to meet the unique needs of diverse industries

“Many key industries, including healthcare, financial services, education, public safety, and state & local governments continue to face a severe shortage of trained and certified cybersecurity experts. Moreover, most businesses lack a full understanding of cybersecurity needs with limited funding, little protected IT infrastructure, and few policies in place to execute on these challenges. We believe that Cyber Shield is an integrated tool that provides the solution to many of these dilemmas,” concluded Mr. Kelly.

Cyber Shield is a competitive offering, designed for businesses of all sizes, including non-profits and associations. Please contact Cycurion to arrange for a demonstration of this next-generation, leading MSPP.

About Cycurion

Based in McLean, Virginia, Cycurion (NASDAQ: CYCU) is a forward-thinking provider of IT cybersecurity solutions and AI, committed to delivering secure, reliable, and innovative services to clients worldwide. Specializing in cybersecurity, program management, and business continuity, Cycurion harnesses its AI-enhanced ARx platform and expert team to empower clients and safeguard their operations. Along with its subsidiaries, Axxum Technologies, Cloudburst Security, and Cycurion Innovation, Inc., Cycurion serves government, healthcare, and corporate clients with a commitment to securing the digital future.

Forward-Looking Statements

This letter to our stockholders and press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the operations and prospective growth of Cycurion’s business. 

Many factors could cause Cycurion’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements described in this press release, including words such as “continue”, “expect”, “intend”, “will”, “hope”, “should”, “would”, “may”, “potential”, and other similar expressions. Such factors could include, among others, those detailed in its Registration Statement on Form S-4, as filed with the Securities and Exchange Commission (the “SEC”). Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in that filing with the SEC underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and Cycurion does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. Cycurion cannot assure that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Individuals are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.

Investor Contact:

CORE IR
[email protected]

Media Contact:

Phone: (703) 555-0123
Email: [email protected]



Quoin Pharmaceuticals Files U.S. Patent Application for Novel Topical Formulations to Treat Netherton Syndrome and Other Skin Diseases

  • Target Indications Also Include Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma and Severe Atopic Dermatitis
  • Third Quoin Patent Application for Netherton Syndrome
  • If Granted Company Would have Patent Protection for QRX003 for Netherton Syndrome Until 2045

ASHBURN, Va., March 25, 2025 (GLOBE NEWSWIRE) — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late-stage clinical, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announced it has filed a U.S. patent application for novel topical formulations to treat a number of skin diseases, including Netherton Syndrome (NS). Quoin’s lead product, QRX003, is currently being tested in four Netherton Syndrome clinical trials. Three of these trials are being conducted under Quoin’s open Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). QRX003 is also currently being tested in a pediatric NS patient at the Children’s Hospital in Dublin, Ireland and the Company intends to expand this study to include additional children with NS in Spain, the United Kingdom and potentially other countries. The Company has recently reported positive initial clinical data from the two open label studies for which data is available. This patent application also includes Peeling Skin Syndrome for which Quoin has an ongoing Investigator Clinical Study in a pediatric patient in New Zealand. There are currently no FDA approved treatments for either Netherton Syndrome or Peeling Skin Syndrome.

“While we are fully focused on completing clinical testing for QRX003 in NS, we are also taking multiple steps to ensure that we have the broadest and most extensive patent protection around the product for this disease as well for other rare skin disease applications that we are pursuing or intend to pursue. If granted, this application would provide broad patent protection for our product until 2045.” said Dr. Michael Myers, Chief Executive Officer of Quoin.

Quoin is currently enrolling patients in three clinical trials being conducted under its open Investigational New Drug (IND) application, evaluating its QRX003 topical lotion as a potential treatment for Netherton Syndrome as well as in an Investigator led pediatric study. To date, Quoin remains the only company actively recruiting and testing subjects in multiple NS clinical trials that are being conducted under an open IND.

To find out more about Quoin’s clinical studies relating to Netherton Syndrome, please visit http://www.nethertonsyndromeclinicaltrials.com/.

About Quoin Pharmaceuticals Ltd.

Quoin Pharmaceuticals Ltd. is a clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises five products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, go to: www.quoinpharma.com.

Cautionary Note Regarding Forward Looking Statements

The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “hope,” “plan,” “potential,” “anticipate,” “look forward,” “believe,” “may,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the Company obtaining patent protection for its Netherton Syndrome product until 2045; QRX003 having the potential to become the first approved treatment for Netherton Syndrome; the potential efficacy of QRX003 as a treatment for Netherton Syndrome; the progress or success of Quoin’s ongoing clinical trials; and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to protect its assets with the new patent applications; the Company’s ability to obtain regulatory approvals for the commercialization of its product candidates or to comply with ongoing regulatory requirements; the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome; the Company may be unable to submit applications and initiate clinical development as and when planned; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

For further information, contact:

Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
[email protected]

Investor Relations
PCG Advisory
Jeff Ramson
[email protected]
(646) 863-6341



Relmada Therapeutics Licenses Phase 2 Bladder Cancer Candidate, NDV-01, from Trigone Pharma, Ltd.

NDV-01 is a novel, sustained-release, intravesical gemcitabine/docetaxel, ready-for-use product candidate for the treatment of non-muscle invasive bladder cancer (NMIBC, U.S. prevalence of ~600,000 patients, with ~62,000 newly diagnosed patients annually)

Topline efficacy and safety Phase 2 data expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas

NDV-01 has the potential to be a first-line therapy for NMIBC,

presenting attractive clinical benefits for clinicians and patients

CORAL GABLES, Fla., March 25, 2025 (GLOBE NEWSWIRE) — Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, or “the Company”), a clinical-stage biotechnology company committed to advancing innovative breakthrough therapies, today announced the completion of an exclusive licensing agreement with Trigone Pharma, Ltd. (Trigone) for NDV-01, a novel sustained-release intravesical formulation of gemcitabine and docetaxel (gem/doce) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). The efficacy and safety of the NDV-01 are being evaluated in a Phase 2 study. First data are expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas.

“We are delighted to add NDV-01 to our pipeline as we believe it represents an exceptional value-creation opportunity for Relmada and our investors. The drug development expertise of our Team provides flexibility to be opportunistic and consider programs that have the potential to be high-value assets and that can demonstrate proof-of-concept in the near-term, regardless of therapeutic area. NDV-01 is an excellent fit with that profile,” said Sergio Traversa, CEO of Relmada Therapeutics.

“We believe Trigone’s novel intravesicular sustained-release formulation could enable NDV-01 to be a first-line therapy for non-muscle invasive bladder cancer, supported by several differentiators including robust published clinical evidence with the gem/doce combination, NDV-01’s good safety profile, easy dosing procedure, and superior drug delivery profile. Together, we believe these features could enable both inpatient and outpatient clinic use, sustained delivery out to 10 days, versus hours for conventional gem-doce delivery, and lead to NDV-01’s rapid and broad adoption,” continued Dr. Traversa.

Maged Shenouda, CFO of Relmada added, “We believe NDV-01 is an excellent strategic complement to our recently acquired asset, sepranolone, a unique, Phase 2b-ready neurosteroid with potential applications in the treatment of compulsion-related disorders. The addition of both NDV-01 and sepranolone to our development portfolio achieves our principal objectives of diversifying our pipeline while balancing its risk and upside potential. Our goal is to bring both programs to patients as soon as possible.”  

“There is a significant unmet need for effective treatments for patients with non-muscle invasive bladder cancer who don’t respond to BCG1 therapy,” said Yair Lotan, MD, Professor of Urology, and Chief of Urologic Oncology at UT Southwestern Medical Center at Dallas, Texas. “Based on multiple clinical studies, the combination of gemcitabine and docetaxel has shown impressive efficacy with a manageable safety profile.”

“What makes NDV-01 particularly promising is its sustained-release formulation, securing prolonged dwell time and extensive treatment exposure to bladder tumors and enhancing anti-cancer effects. This innovative approach has the potential not only to improve treatment effectiveness but also to improve patient compliance by offering a convenient in-office treatment alternative to current hospital-based therapies, significantly reducing the burden on patients and healthcare systems,” said Dan Touitou, B Pharm, MBA, CEO of Trigone.

  1. BCG = Bacillus Calmette-Guerin

About the Clinical Program for NDV-01

NDV-01 is currently being evaluated in a Phase 2, Single-Arm Study (NCT06663137) to assess safety and efficacy in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC). The study was designed to enroll up to 70 subjects with localized, non-metastatic, HG-NMIBC (ECOG score of 2 of less).

Topline data from the first 20 patients in the study are expected to be presented at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas.

Strategic Outlook

Relmada continues to evaluate additional strategic product opportunities to leverage the extensive development capability that the Company has built over the past several years. Relmada anticipates hosting an investor update on NDV-01’s next development steps later in 2025.

About the NDV-01 License Agreement

Under the terms of the agreement, Relmada will make a $3.5 million upfront payment and issue 3,017,420 shares of our common stock, which represent 10% of Relmada’s outstanding shares, for exclusive worldwide rights to NDV-01, excluding Israel, India and South Africa. (The shares will be locked up for 12 months unless we agree otherwise.) In addition, Relmada will pay up to $200 million in development, regulatory and sales milestones pending successful commercialization. Relmada will also pay a royalty of 3% on any net sales. Following the completion of the ongoing Phase 2 study, Relmada will assume responsibility for NDV-01’s development, manufacturing and commercialization.  

About NDV-01

NDV-01 is an investigational, innovative sustained-release formulation of two complementary, well-established, chemotherapy agents, gemcitabine and docetaxel (gem/doce). It is designed for intravesical dosing and intended to be an in-office ready-to-use therapy that is administered rapidly and requires no anesthesia or new or dedicated equipment to employ. NDV-01 forms a spherical soft matrix within the bladder that sequesters drug and releases it as the matrix gradually dissolves.

NDV-01’s formulation is specifically designed to maximize local drug concentration and prolong exposure to gem/doce, while minimizing systemic toxicity. Unlike conventional intravesical instillations, NDV-01 is designed to avoid peaks and troughs in drug concentration, ensuring a gradual and sustained release of gem/doce over a 10-day period. This approach may potentially improve overall efficacy, reduce side effects, reduce the frequency of dosing and improve patient compliance and outcomes. NDV-01 has the potential to be a first line (1L) therapy for HG-NMIBC, with further potential for use in patients who have failed other therapies, including BCG immunotherapy, and expansion into other NMIBC subtypes, including intermediate-grade disease.

NDV-01 is protected by several patents related to methods of treatment and formulation whose terms go out to 2038.

About Gem/Doce in HG-NMIBC

Gemcitabine and docetaxel (Gem/Doce) therapy in HG-NMIBC has been widely adopted in clinical practice. The highest efficacy has been demonstrated in sequential intravesical treatment (Kates et al., 2020). A literature review suggests that there have been no major side effects reported in published studies or real-world experience. The combination has not been approved by the FDA or EMA.

A Large and Growing Market for NMIBC Therapies

More than 90% of the approximately 83,000 new U.S. cases of urothelial cancer are estimated to be bladder cancer. For the overall bladder cancer population, 5-year survival ranges from 70 to 96% of patients, moving to 6% for patients with advanced disease. Roughly 75% of bladder cancer cases are classified as non-muscle invasive (NMIBC) and approximately 50% of cases are classified as high-grade disease, considered to have increased risk of progression and recurrence. Sources indicate that NMIBC has a 50-75% recurrence rate (over seven years) and that the U.S. prevalence of NMIBC is approximately 450,000 patients.

The US NMIBC market is estimated to be a multi-billion opportunity. Global numbers are higher, in line with projections for significant growth due to the increasing incidence of bladder cancer and the demand for effective, minimally invasive potential therapies like NDV-01. Approved treatment options remain limited (mainly the immunotherapy, BCG, which has been supply constrained for some time), with high recurrence rates leading to frequent re-treatment and progression. Other emerging programs include immunotherapy combinations, single agent chemotherapy formulations and targeted therapies. NDV-01 stands out based on the large body of published data that support the efficacy of treatment with gemcitabine and docetaxel, its ease of administration and potential for durability of action. Expansion beyond first-line treatment into use as a salvage treatment or in other subgroups of NMIBC, including naïve patients, could further increase the opportunity for NDV-01.

About Trigone Pharma Ltd.

Trigone Pharma Ltd. is a privately-held specialty pharmaceutical company focused on the development of a proprietary sustained-release platform designed to enhance the efficacy and safety of established therapeutic agents for urologic diseases into the urinary bladder with clear unmet medical needs.

For more information, please visit https://trigonepharma.com/

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage biotechnology company committed to advancing innovative breakthrough therapies that have the potential to bring meaningful clinical benefits to targeted patient populations.

Lead investigational program, NDV-01, for High-Grade Non-Muscle Invasive Bladder Cancer, is being evaluated in a Phase 2 study. In addition, preparations are underway to advance sepranolone, a Phase 2b-ready investigational program for compulsion-related disorders including Tourette’s Syndrome, into further studies.

For more information, visit www.relmada.com.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “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. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Phase 2 data to be presented at an upcoming medical conference, potential for Phase 2 data to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for NDV-01 or that future NDV-01 clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 drug supply and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.

Investor Contact:

Brian Ritchie
LifeSci Advisors
[email protected]

Media Inquiries:

Corporate Communications
[email protected]



Creative Realities Completes SOC 2 Type 1 Compliance Audit Process

This confirms CRI as a SaaS provider that ensures security, stability, and privacy in its products.

LOUISVILLE, Ky., March 25, 2025 (GLOBE NEWSWIRE) — Creative Realities, Inc. (“Creative Realities,” “CRI,” or the “Company”) (NASDAQ: CREX), a leading provider of digital signage and media solutions, is pleased to announce the successful completion of its Systems and Organizations Controls (SOC) 2 Type 1 audit. This audit achieved compliance with the leading industry standards for customer data security. This report shows CRI’s ongoing commitment to providing our customers with secure and reliable SaaS products.

“This is a significant achievement for our company and our customers. To reach this point, CRI has matured and grown as an organization, improving everything we do. We’ve enhanced our software and cloud infrastructure to make them more secure and highly available. These changes ensure we stay compliant with best practices and provide great products for our clients,” said Bart Massey, Executive Vice President of Software Development at CRI.

Developed by the American Institute of Certified Public Accountants (AICPA), a SOC 2 information security standard is a report that validates controls relevant to security, availability, integrity, confidentiality, and privacy. The audit was completed with the help of Johanson Group LLP, a premier certification body that helps organizations obtain and maintain global compliance standards. Ensuring that all parts of CRI’s applications and business processes were compliant with SOC 2 requirements took around nine months.

“Partnering with Johanson Group LLP has brought in a third-party auditor to validate our policies and ensure we follow best practices. We take our commitment to SOC II principles seriously, and with the completion of this report, we have a qualified independent auditor who confirms it,” Massey added.

SOC 2 has a rigorous requirement on how companies handle customer data and information, so compliance guarantees that established and implemented organizational practices are in place to safeguard customer data. CRI’s case involves its software products and all the administrative functions needed to support them.

CRI is actively working to complete Type 2 compliance. Type 1 focuses on evaluating processes, infrastructure and policies. Type 2 provides independent verification that the company’s ongoing operations continue to follow the practices and principles specified and required by Type 1.

More information on Creative Realities’ SOC 2 Type 1 compliance process will be available soon on cri.com.

About Creative Realities, Inc.

Creative Realities designs, develops and deploys digital signage-based experiences for enterprise-level networks utilizing its Clarity™, ReflectView™, and iShowroom™ Content Management System (CMS) platforms. The Company is actively providing recurring SaaS and support services across diverse vertical markets, including but not limited to retail, automotive, digital-out-of-home (DOOH) advertising networks, convenience stores, foodservice/QSR, gaming, theater, and stadium venues. In addition, the Company assists clients in utilizing place-based digital media to achieve business objectives such as increased revenue, enhanced customer experiences, and improved productivity. This includes the design, deployment, and day to day management of Retail Media Networks to monetize on-premise foot traffic utilizing its AdLogic™ and AdLogic CPM+™ programmatic advertising platforms.

Contacts

Media Inquiries

Breanne Ngo
[email protected]

Investor Relations

Chris Witty
[email protected] 
646-438-9385
[email protected]
https://investors.cri.com/ 



ADN Telecom signs multi-year Telesat Lightspeed partnership agreement

OTTAWA, Ontario and DHAKA, Bangladesh, March 25, 2025 (GLOBE NEWSWIRE) — Telesat (NASDAQ and TSX: TSAT), one of the world’s largest and most innovative satellite operators, and ADN Telecom Limited (DSE & CSE: ADNTEL), a leading telecommunications company, providing the latest digital communications and satellite services in Bangladesh, signed and jointly announced today a multi-year partnership to deliver Telesat Lightspeed low earth orbit (LEO) connectivity solutions across Bangladesh and South Asia.

Leveraging over 55 years of satellite operations and engineering excellence, Telesat designed its state-of-the-art LEO network to meet the resilient, mission-critical connectivity requirements of telecom, enterprise and government customers. The fully funded Telesat Lightspeed constellation is well underway, with the first satellite launches beginning in the second half of next year.

Through this partnership, Telesat will provide Telesat Lightspeed services and a Smart Virtual Network Operator (VNO) capability for ADN Telecom to manage and deliver innovative, customized connectivity solutions for their enterprise, maritime and government customers. ADN Telecom will participate in early field trial testing of Telesat Lightspeed services and commence full-time services in late 2027 with industry-leading committed information rates and guaranteed SLAs.

“We are honored to be selected by ADN Telecom to provide multi-Gbps connectivity and unique service advantages to enhance their operations and drive profitable, long-term growth,” said Glenn Katz, Telesat’s Chief Commercial Officer. “Our MEF 3.0 standards-based LEO services will be seamlessly integrated with ADN’s terrestrial network to expand the reach of their offerings in Bangladesh and internationally.”

“Integrating the highly advanced Telesat Lightspeed enterprise-class LEO network capabilities into our leading service offerings is another example of our commitment to delivering innovative technologies to help our customers thrive,” stated Asif Mahmood, Chairman of ADN Telecom Limited. “After a thorough review of next-generation satellite technologies, we believe the Telesat Lightspeed services will provide the most flexible, secure and resilient architecture to power our future offerings.”

Telesat and ADN Telecom will work collaboratively to secure local regulatory approvals for Telesat Lightspeed services in the country.

About Telesat

Backed by a legacy of engineering excellence, reliability and industry-leading customer service, Telesat (NASDAQ and TSX: TSAT) is one of the largest and most innovative global satellite operators. Telesat works collaboratively with its customers to deliver critical connectivity solutions that tackle the world’s most complex communications challenges, providing powerful advantages that improve their operations and drive profitable growth.

Continuously innovating to meet the connectivity demands of the future, Telesat Lightspeed, the company’s state-of-the-art Low Earth Orbit (LEO) satellite network, has been optimized to meet the rigorous requirements of telecom, government, maritime and aeronautical customers. Telesat Lightspeed will redefine global satellite connectivity with ubiquitous, affordable, high-capacity, secure and resilient links with fibre-like speeds. For updates on Telesat, follow us on LinkedIn, X, or visit www.telesat.com.

About ADN Telecom Limited

ADN Telecom Limited (DSE & CSE: ADNTEL), the flagship entity of ADN Group, is a pioneer in advanced telecommunications services and satellite communication in Bangladesh. ADN Telecom’s advanced infrastructure and forward-thinking technology solutions are crafted to meet the complex demands of local and international markets, with consistently connecting people and businesses through dependable and cutting-edge next-generation enterprise-class digital services and solutions.

With over 23 years of experience in innovative Telecom services , ADN Telecom serves a broad spectrum of industries and enterprises, including government agencies, defense entities, and the financial sectors. Renowned for its excellence in satellite communications and other digital solutions, the company is instrumental in developing latest digital network infrastructure delivering critical communication solutions, even in challenging terrains and during national emergencies. To learn more and stay updated on ADN Telecom, please follow us on LinkedIn, or visit https://adntel.com.bd/.

Media Contacts:

W2 Communications for Telesat
[email protected]

Tanvir Hafiz for ADN Telecom
[email protected]

Forward-Looking Statements Safe Harbor

This news release contains statements that are not based on historical fact and are “forward-looking statements’’ within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. When used herein, statements which are not historical in nature, or which contain the words “will,” “ensures” or similar expressions, are forward-looking statements. Actual results may differ materially from the expectations expressed or implied in the forward-looking statements as a result of known and unknown risks and uncertainties. All statements made in this press release are made only as of the date set forth at the beginning of this release. Telesat Corporation undertakes no obligation to update the information made in this release in the event facts or circumstances subsequently change after the date of this press release.

These forward-looking statements are based on Telesat Corporation’s current expectations and are subject to a number of risks, uncertainties and assumptions. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond Telesat Corporation’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. There are numerous risks and uncertainties associated with Telesat’s business and the Telesat Lightspeed constellation. Known risks and uncertainties include but are not limited to: inflation and rising interest rates; Telesat’s ability to meet the funding conditions of its funding agreements with the Government of Canada and Government of Quebec; technological hurdles, including our and our contractors’ development and deployment of the new technologies required to complete the constellation in time to meet our schedule, or at all; the availability of services and components from our and our contractors’ supply chains; competition; risks associated with domestic and foreign government regulation, including access to sufficient orbital spectrum to be able to deliver services effectively and access to sufficient geographic markets in which to sell those services; Telesat’s ability to develop significant commercial and operational capabilities; risks associated with operating satellites and providing satellite services, including satellite construction or launch delays, launch failures, in-orbit failures or impaired satellite performance; and volatility in exchange rates. The foregoing list of important factors is not exhaustive. Investors should review the other risk factors discussed in Telesat Corporation’s annual report on Form 20-F for the year ended December 31, 2023, that was filed on March 28, 2024, with the United States Securities and Exchange Commission (“SEC”) and the Canadian securities regulatory authorities at the System for Electronic Document Analysis and Retrieval (“SEDAR”), and may be accessed on the SEC’s website at https://www.sec.gov/ and SEDAR’s website at https://www.sedarplus.ca/ as well as our subsequent reports on Form 6-K filed with the SEC and also available on SEDAR.



CorMedix Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

‒ Q4 2024 Net Revenue of $31.2mm; 2024 Net Revenue of $43.5mm ‒

‒ Q4 Net Income of $13.5mm and Adjusted EBITDA of $15.3mm ‒

‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒

BERKELEY HEIGHTS, N.J., March 25, 2025 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided an update on its business.

Recent Corporate Highlights:

  • CorMedix today reports its second full quarter of DefenCath sales since commencing outpatient launch in July 2024 and first partial year of DefenCath sales. The Company reported net sales of $31.2 million for the fourth quarter and $43.5 million for full year 2024, largely driven by successful implementation by its outpatient dialysis customers.
  • The Company’s fourth quarter of 2024 was the first profitable commercial quarter in CorMedix history, with net income of $13.5 million and adjusted EBITDA of $15.3 million.
  • The Company previously announced a partnership with Syneos Health to build a dedicated inpatient sales team. The staffing of this team is nearly complete and the Company expects the team to initiate activity in the early part of the second quarter. CorMedix has started to see increased DefenCath utilization at a number of larger hospitals and anticipates further inpatient growth throughout 2025 as the new field team commences activity.
  • CorMedix previously announced a partnership with WSI to provide marketing and promotional support for DefenCath to VA facilities and this team has commenced activities in the first quarter.
  • CorMedix began identifying investigator sites for its Phase 3 study of DefenCath in patients receiving Total Parenteral Nutrition, or TPN, and expects patient enrollment to commence in the second quarter of 2025. In addition, the Company recently submitted an application for Orphan Drug Status for this indication to the FDA.
  • CorMedix is announcing preliminary net revenue guidance for first half of 2025 of $50 – $60 million, based on the run rate of current purchasing customers, with more than $33 million expected in first quarter. In addition, the Company reiterates its previously announced cash operating expense guidance for 2025 of $72 – $78 million.
  • Cash and short-term investments, excluding restricted cash, at December 31, 2024 amounted to $51.7 million. The Company currently anticipates ending first quarter of 2025 with more than $75 million in cash and short-term investments.

Joe Todisco, CorMedix CEO, commented, “I am proud of the Company’s recent progress as we execute on our launch objectives and increase patient access to DefenCath across settings of care. We have seen continued growth from existing customers throughout the first quarter and we are focused on growing our patient base in 2025 with both existing and new accounts.”

4

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Quarter and Full Year 2024 Financial Highlights

For the fourth quarter of 2024, CorMedix recorded $31.2 million in net revenue from sales of DefenCath, and recorded net income of $13.5 million, or $0.22 per share, compared with a net loss of $14.8 million, or $0.26 per share, in the fourth quarter of 2023. The net income was driven primarily by the launch of DefenCath and net sales in the period.

Operating expenses in the fourth quarter 2024 were $17.1 million, compared with $15.7 million in the fourth quarter of 2023, an increase of approximately 9%.  The increase was driven primarily by higher general and administrative (G&A) expenses, which increased approximately 36% and to a lesser extent by an increase in selling and marketing (S&M), which increased approximately 1%. These increases were partially offset by a decrease in research and development (R&D) expenses of approximately 26%. The increases in S&M and G&A were primarily driven by new personnel hired in late 2023 or throughout 2024, inclusive of our sales force and support for the commercial launch of DefenCath during 2024. Additionally, as a result of the transition to commercial operations, certain medical affairs, other personnel and consulting expenses previously classified in R&D are included in G&A expense in 2024.

For the year ended December 31, 2024, CorMedix recorded $43.5 million in net revenue from sales of DefenCath, and recorded a net loss of $17.9 million, or $0.30 per share, compared with a net loss during the year ended December 31, 2023 of $46.3 million, or $0.91 per share. The decrease in net loss was driven primarily by DefenCath net revenue, offset by an increase in operating expenses, primarily due to increased commercial activities for DefenCath.

Operating expenses during the year ended December 31, 2024 amounted to $62.6 million compared with $49.0 million during 2023, an increase of $13.6 million, or 28%. The increase was primarily due to costs related to marketing and commercial activities in support of the launch of DefenCath, partially offset by a decrease in R&D expenses, attributable to the marketing approval of DefenCath.

Total cash on hand, cash equivalents and short-term investments as of December 31, 2024 amounted to $51.7 million, excluding restricted cash of $0.1 million. The Company believes that it has sufficient resources to fund operations for at least twelve months from the filing of its Annual Report on Form 10-K.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 25, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:



Tuesday, March 25





th





@ 8:30am EDT

Domestic: 1-844-481-2557
International:  1-412-317-0561
Conference ID: 10197392
Webcast: Webcast Link
   

About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other therapeutic areas. For more information visit: www.cormedix.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA and adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance.

The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results and facilitate an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors
[email protected]
(617) 430-7576

CORMEDIX INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS

(Unaudited)
 
  For the Three Months Ended

December 31,
  For the Years Ended

December 31,
    2024   2023   2024   2023
Revenue                
Revenue, net $ 31,209,936   $   $ 43,472,170   $  
Cost of revenues   (1,175,559 )       (3,190,534 )    
Gross profit   30,034,377         40,281,636      
Operating Expenses                
Research and development   (1,726,719 )   (2,288,889 )   (3,942,270 )   (13,155,125 )
Selling and marketing   (8,263,644 )   (8,159,662 )   (28,736,605 )   (18,115,313 )
General and administrative   (7,108,006 )   (5,220,192 )   (29,959,150 )   (17,687,350 )
Total operating expenses   (17,098,369 )   (15,668,743 )   (62,638,025 )   (48,957,788 )
Income (Loss) from Operations   12,936,008     (15,668,743 )   (22,356,389 )   (48,957,788 )
Other Income (Expense)                
Total other income   528,396     914,713     3,031,599     2,618,561  
Net Income (Loss) Before Income Taxes   13,464,404     (14,754,030 )   (19,324,790 )   (46,339,227 )
Tax benefit           1,394,770      
Net Income (Loss)   13,464,404     (14,754,030 )   (17,930,020 )   (46,339,227 )
Other Comprehensive Income (Loss)                
Total other comprehensive income (loss)   1,526     9,710     (3,462 )   11,365  
Other Comprehensive Income (Loss) $ 13,465,930   $ (14,744,320 ) $ (17,933,482 ) $ (46,327,862 )
Net Income (Loss) Per Common Share – Basic $ 0.22   $ (0.26 ) $ (0.30 ) $ (0.91 )
Weighted Average Common Shares Outstanding – Basic   61,508,510     57,393,542     58,871,582     50,902,931  

CORMEDIX INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEET DATA

(Audited)
  For the Years Ended
December 31,
    2024   2023
         
ASSETS      
Cash, cash equivalents and restricted cash $ 40,756,138   $ 43,823,192  
Short-term investments $ 11,036,857   $ 32,388,130  
Total Assets $ 118,845,673   $ 82,059,957  
         
Total Liabilities $ 34,188,723   $ 11,917,528  
Accumulated deficit $ (339,630,033 ) $ (321,700,013 )
Total Stockholders’ Equity $ 84,656,950   $ 70,142,429  

CORMEDIX INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Audited)
 
  For the Years Ended
December 31,
    2024       2023  
       
Cash Flows from Operating Activities:      
Net loss $ (17,930,020 )   $ (46,339,227 )
Net cash used in operating activities   (50,614,653 )     (38,409,480 )
Cash Flows Used in Investing Activities:      
Net cash provided by (used in) investing activities   21,230,713       (17,061,685 )
Cash Flows from Financing Activities:      
Net cash provided by financing activities   26,318,595       55,916,804  
Net (Decrease) Increase in Cash and Cash Equivalents   (3,067,054 )     448,447  
Cash and Cash Equivalents and Restricted Cash – Beginning of Period   43,823,192       43,374,745  
Cash and Cash Equivalents and Restricted Cash – End of Period $ 40,756,138     $ 43,823,192  

CORMEDIX INC. AND SUBSIDIARIES

Non-GAAP Reconciliations

(Unaudited)
 
    Three Months Ended
December 31, 2024
  Year Ended
December 31, 2024
Net income (loss)   $ 13,464,404     $ (17,930,020 )
Adjusted to add (deduct):        
Interest expense (income), net     (500,377 )   (2,542,387 )
Provision for (benefit from) income taxes           (1,394,770 )
Depreciation and amortization     133,675       309,781  
EBITDA (Non-GAAP)   $ 13,097,702     $ (21,557,396 )
Adjusted to add (deduct):        
Stock-based compensation expense     1,193,908       6,129,408  
Sales force reorganization expense     1,055,300       1,055,300  
Other Income     (20,000 )     (520,000 )
Adjusted EBITDA (Non-GAAP)   $ 15,326,910     $ (14,892,688 )



Traws Pharma’s COVID-19 Candidate, Ratutrelvir, Presented at ICAR

  • Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimen
  • Preparations are underway for FDA interactions and initiation of Phase 2 studies
  • Data presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET

NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced that positive data supporting the potential for ratutrelvir, a main protease inhibitor, as a treatment for COVID-19, were presented on March 20, 2025 in a poster at the International Conference for Antiviral Research (ICAR 2025), held in Las Vegas, Nevada.

Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC), commented, “Traws designed ratutrelvir to overcome the limitations of current COVID treatments. COVID continues to be a significant cause of mortality for older adults with underlying medical conditions and people who are immunocompromised1. Requirement to use the boosting agent ritonavir with widely used treatment2 increases drug-drug interaction risk for patients with complex medical conditions and may limit patient eligibility for therapy3. Data presented at ICAR provide support that ratutrelvir treatment does not require co-administration of a metabolism inhibitor such as ritonavir, significantly simplifying ease of use, a key potential differentiator.”

C. David Pauza, PhD, Chief Science Officer for Traws Pharma, added: “Recent publications cite a relationship between the probability of slow viral clearance being associated with higher risk for long COVID4. Ratutrelvir suppressed replication of 18 different strains of SARS-CoV-2 in laboratory tests, maintained human blood levels within the predicted therapeutic window (>EC90), and did not require coadministration of ritonavir. Data presented at ICAR 2025 shows that ratutrelvir is highly active against native virus and nirmatrelvir-resistant strains and omicron variants. Additionally, we know that the patterns of drug resistance mutations selected in vitro using ratutrelvir are largely distinct from the emerging clinical data on drug resistance to nirmatrelvir (protease inhibitor in Paxlovid™)4 and ensitrelvir5. Ratutrelvir is differentiated from these drugs in terms of in vitro potency, human pharmacokinetics, and drug resistance patterns.”

“We believe ratutrelvir has the potential to be a highly differentiated, broadly active treatment for COVID. Preparations are underway to meet with the FDA to align on a path forward and initiate Phase 2 studies,” noted Werner Cautreels, PhD, Chief Executive Officer for Traws Pharma. “We plan to host an Investor Event on Monday, March 31, 2025 at 10:00 AM ET to present an overview of preclinical and human data on ratutrelvir and outline potential next steps towards approval.”

To register for the virtual Investor Event, click here.

Ratutrelvir poster:

Poster Title: Phase I Clinical Study of Ratutrelvir, a Potent Inhibitor of the SARS-CoV-2 Main Protease (Mpro/3CL): Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Poster Date: March 20, 2025
   

Data in the poster suggest that ratutrelvir could be used for COVID-19 therapy without ritonavir. Phase 1 results helped Traws define a target Phase 2 dose and treatment regimen and demonstrated excellent overall safety and tolerability:

  • Potent Preclinical Suppression of Resistant Virus: Laboratory studies show that ratutrelvir is a highly active suppressor of COVID-19 replication of original and Omicron variants
  • Pharmacokinetic (PK) Results Do Not Require a Metabolism Inhibitor: Drug exposure studies show that ratutrelvir metabolism is not induced by ten days of treatment at 600 mg/day and trough blood plasma levels of drug are maintained at four times the EC90. These data provide support that ratutrelvir treatment does not require coadministration of a metabolism inhibitor such as ritonavir, significantly simplifying ease of use, a key differentiator
  • Phase 1 data also show potential safety and attractive PK for a 10-day regimen: Data from single- and multiple ascending dose (SAD, MAD) studies demonstrated excellent safety/tolerability at all doses tests

At the selected Phase 2 dose and regimen of 600 mg/day for 10 days, ratutrelvir established and maintained 24-hour trough blood levels of approximately 13-times the EC50 and drug levels remained above the EC90 for 2 days after treatments cessation. The 10-day dosing regimen is intended to achieve optimal viral suppression and reduce the rates for clinical rebound

About Ratutrelvir

Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19, to be used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions3, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for long COVID.4 Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity7,8.

Source information:

  1. https://www.cdc.gov/covid/risk-factors/index.html
  2. https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-PFE-Earnings-Release-Final.pdf

  3. https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2646
  4. Carly Herbert et al. (2025) Clinical Infectious Diseases.

    https://doi.org/10.1093/cid/ciae539
  5. Tamura, T.J, et al., 2024, JAMA Network Open

    7

    :
    e2435431-e2435431
  6. Uehara, T., H.et al., (2025). “Ensitrelvir treatment–emergent amino acid substitutions in SARS-CoV-2 3CLpro detected in the SCORPIO-SR phase 3 trial.”

    Antiviral Research


    236

    : 106097
  7. Pfizer.com 10K report 2024, Feb 27, 2025 ;
  8. Merck.& Co 10K, Feb 25 2025

Paxlovid is a registered trademark of Pfizer Inc.

About Traws Pharma, Inc.

Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We are advancing novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimens. We strive to utilize accelerated clinical trial strategies with a commitment to patients who are especially vulnerable.

The Company’s two antiviral programs are investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a COVID treatment, targeting the Main protease (Mpro or 3CL protease), without the need for co-administration of ritonavir.

For more information, please visit www.trawspharma.com and follow us on LinkedIn.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, Traws’ interactions with and guidance from the FDA, collaborations, market conditions, regulatory requirements and pathways for approval, the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for long COVID, and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law.

Traws Pharma Contact:

Nora Brennan
Traws Pharma, Inc.
[email protected]
www.trawspharma.com

Investor Contact:

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]   



Core & Main Announces Fiscal 2024 Fourth Quarter and Full-Year Results

Core & Main Announces Fiscal 2024 Fourth Quarter and Full-Year Results

ST. LOUIS–(BUSINESS WIRE)–Core & Main, Inc. (NYSE: CNM) (“Core & Main”), a leading specialty distributor dedicated to advancing reliable infrastructure with local service, nationwide, today announced financial results for the fourth quarter and fiscal year ended February 2, 2025. The fourth quarter and fiscal year ended February 2, 2025 represents 14 and 53-week periods, respectively, compared with 13 and 52-week periods for the fourth quarter and fiscal year ended January 28, 2024.

Fiscal 2024 Fourth Quarter Results (Compared with Fiscal 2023 Fourth Quarter)

  • Net sales increased 17.9% to $1,698 million
  • Gross profit increased 17.4% to $451 million; gross profit margin of 26.6%
  • Net income decreased 11.8% to $67 million
  • Diluted earnings decreased 2.9% to $0.33
  • Adjusted EBITDA (Non-GAAP) increased 11.9% to $179 million
  • Net cash provided by operating activities of $235 million

Fiscal 2024 Results (Compared with Fiscal 2023)

  • Net sales increased 11.0% to $7,441 million
  • Gross profit increased 8.9% to $1,980 million; gross profit margin of 26.6%
  • Net income decreased 18.3% to $434 million
  • Diluted earnings per share decreased 0.9% to $2.13
  • Adjusted EBITDA (Non-GAAP) increased 2.2% to $930 million
  • Net cash provided by operating activities of $621 million
  • Repurchased $176 million of shares at an average per share price of approximately $44.31

“Our teams across the country executed at a high level in the fourth quarter, delivering our fifteenth consecutive year of positive sales growth,” said Steve LeClair, chair and CEO of Core & Main.

“These consistently strong results are driven by our balanced business mix, the investments we have made to support and execute our growth strategy, and the expertise and dedication of our associates. With growing demand for innovative water infrastructure solutions, we continue to add new products, branches and capabilities to strengthen our leadership position in the industry. We also completed ten acquisitions to expand our presence in important geographies, gain access to new product lines and add key talent. Our strong cash flow generation and flexible balance sheet allow us to invest in organic growth and consolidate our fragmented markets through acquisitions, while returning capital to shareholders.

I am confident in our outlook for fiscal 2025 as the team continues to execute our sales strategies and improve operating leverage across our business. We will continue delivering exceptional service to our customers and pursue growth through attractive product categories and end markets, while investing capital and resources into the business to drive profitable growth over the long-term.”

Three Months Ended February 2, 2025

Net sales for the three months ended February 2, 2025 increased $258 million, or 17.9%, to $1,698 million compared with $1,440 million for the three months ended January 28, 2024. Net sales increased primarily due to acquisitions, higher volumes, and contributions from the 53rd selling week in the current year partially offset by slightly lower selling prices. Net sales increased for pipes, valves & fittings due to acquisitions and higher volumes partially offset by slightly lower selling prices. Net sales increased for storm drainage due to acquisitions and our ability to drive the adoption of advanced stormwater management systems. Net sales for fire protection products declined due to lower selling prices and lower end-market volumes partially offset by acquisitions. Net sales of meter products benefited from our ability to drive the adoption of smart meter technology through municipalities, increased product availability and acquisitions.

Gross profit for the three months ended February 2, 2025 increased $67 million, or 17.4%, to $451 million compared with $384 million for the three months ended January 28, 2024. Gross profit as a percentage of net sales for the three months ended February 2, 2025 was 26.6% compared with 26.7% for the three months ended January 28, 2024. The overall decrease in gross profit as a percentage of net sales was primarily attributable to larger prior year benefits from strategic inventory investments during an inflationary period partially offset by favorable impacts from the execution of our gross margin initiatives and accretive acquisitions.

Selling, general and administrative (“SG&A”) expenses for the three months ended February 2, 2025 increased $49 million, or 21.3%, to $279 million compared with $230 million for the three months ended January 28, 2024. The increase was primarily attributable to an increase of $37 million in personnel expenses primarily related to acquisitions. The remaining increase was driven by acquisitions, inflation, other growth investments and additional costs from the 53rd week in the current year. SG&A expenses as a percentage of net sales was 16.4% for the three months ended February 2, 2025 compared with 16.0% for the three months ended January 28, 2024. The increase was primarily attributable to acquisitions, investments in growth and inflationary cost impacts.

Operating income for the three months ended February 2, 2025 increased $8 million, or 6.9%, to $124 million compared with $116 million for the three months ended January 28, 2024. The increase in operating income was primarily attributable to higher gross profit partially offset by higher SG&A and amortization expenses.

Net income for the three months ended February 2, 2025 decreased $9 million, or 11.8%, to $67 million compared with $76 million for the three months ended January 28, 2024. The decrease in net income was primarily attributable to an increase in interest expense and income tax expense partially offset by an increase in operating income.

The Class A common stock basic earnings per share for the three months ended February 2, 2025 decreased $0.01, or 2.9%, to $0.34 compared with $0.35 for the three months ended January 28, 2024. The Class A common stock diluted earnings per share for the three months ended February 2, 2025 decreased $0.01, or 2.9%, to $0.33 compared with $0.34 for the three months ended January 28, 2024. The basic earnings per share decreased due to higher Class A share counts from exchanges of limited partner interests of Core & Main Holdings, LP (“Partnership Interests”). The diluted earnings per share decreased due to a decline in net income partially offset by lower share counts following the share repurchase transactions executed throughout fiscal 2023 and fiscal 2024.

Adjusted EBITDA for the three months ended February 2, 2025 increased $19 million, or 11.9%, to $179 million compared with $160 million for the three months ended January 28, 2024. The increase in Adjusted EBITDA was primarily attributable to higher gross profit, in part due to contributions from the 53rd selling week, partially offset by higher SG&A expenses. For a reconciliation of Adjusted EBITDA to net income or net income attributable to Core & Main, Inc., the most comparable GAAP (as defined below) financial metric, as applicable, see “Non-GAAP Financial Measures” below.

Fiscal Year Ended February 2, 2025

Net sales for fiscal 2024 increased $739 million, or 11.0%, to $7,441 million compared with $6,702 million for fiscal 2023. Net sales increased primarily due to acquisitions, higher volumes and contributions from the 53rd selling week in the current year partially offset by slightly lower selling prices. Net sales increased for pipes, valves & fittings due to acquisitions partially offset by slightly lower selling prices. Net sales increased for storm drainage due to acquisitions and our ability to drive the adoption of advanced storm water management systems. Net sales for fire protection products declined due to lower selling prices and lower end-market volumes partially offset by acquisitions. Net sales of meter products benefited from our ability to drive the adoption of smart meter technology through municipalities, increased product availability and acquisitions.

Gross profit for fiscal 2024 increased $162 million, or 8.9%, to $1,980 million compared with $1,818 million for fiscal 2023. Gross profit as a percentage of net sales for fiscal 2024 was 26.6% compared with 27.1% for fiscal 2023. The overall decrease in gross profit as a percentage of net sales was primarily attributable to larger prior year benefits from strategic inventory investments during an inflationary period partially offset by favorable impacts from the execution of our gross margin initiatives and accretive acquisitions.

SG&A expenses for fiscal 2024 increased $147 million, or 15.8%, to $1,078 million compared with $931 million during fiscal 2023. The increase includes $105 million in personnel expenses primarily related to acquisitions. The remaining increase is driven by acquisitions, inflation, other growth investments and additional costs from the 53rd week in the current year. SG&A expenses as a percentage of net sales was 14.5% for fiscal 2024 compared with 13.9% for fiscal 2023. The increase was primarily attributable to acquisitions, investments in growth and inflationary cost impacts.

Operating income for fiscal 2024 decreased $21 million, or 2.8%, to $719 million compared with $740 million during fiscal 2023. The decrease in operating income was primarily attributable to higher SG&A and depreciation and amortization expenses partially offset by higher gross profit.

Net income for fiscal 2024 decreased $97 million, or 18.3%, to $434 million compared with $531 million for fiscal 2023. The decrease in net income was primarily attributable to an increase in interest expense, related to increased borrowings to support acquisitions in fiscal 2024, and an increase in income tax expense related to an increase in the allocation of net income to taxable entities. The remaining decrease is related to a 2.8% decline in operating income.

The Class A common stock basic earnings per share for fiscal 2024 decreased 0.5% to $2.14 compared with $2.15 for fiscal 2023. The Class A common stock diluted earnings per share for fiscal 2024 decreased 0.9% to $2.13 compared with $2.15 for fiscal 2023. The basic earnings per share decreased due to higher Class A share counts from exchanges of Partnership Interests partially offset by an increase in net income attributable to Core & Main, Inc. Diluted earnings per share decreased due to a decline in net income partially offset by lower share counts following the share repurchase transactions executed throughout fiscal 2023 and fiscal 2024.

Adjusted EBITDA for fiscal 2024 increased $20 million, or 2.2%, to $930 million compared with $910 million for fiscal 2023. The increase in Adjusted EBITDA was primarily attributable to higher gross profit, in part due to contributions from the 53rd selling week partially offset by higher SG&A expenses. For a reconciliation of Adjusted EBITDA to net income or net income attributable to Core & Main, Inc., the most comparable GAAP financial metric, as applicable, see “Non-GAAP Financial Measures” below.

Liquidity and Capital Resources

Net cash provided by operating activities decreased by $448 million to $621 million for fiscal 2024 compared with $1,069 million for fiscal 2023. The decrease in cash provided by operating activities was primarily driven by more typical investment in working capital in fiscal 2024 compared with a reduction in inventory during fiscal 2023 due to inventory optimization subsequent to supply chain improvements. Increased interest payments and higher income tax payments due to higher taxable income of Core & Main, Inc. following exchanges of Partnership Interests throughout fiscal 2023 also reduced operating cash flows.

Net debt, calculated as gross consolidated debt net of cash and cash equivalents, as February 2, 2025 was $2,275 million compared with $1,892 million as of January 28, 2024. Net debt increased due to higher borrowings to fund investments in organic growth, acquisitions and share repurchases.

As of February 2, 2025, we had $93 million outstanding borrowings on our senior asset-based revolving credit facility (“Senior ABL Credit Facility”), which provides for borrowings of up to $1,250 million, subject to borrowing base availability. As of February 2, 2025, after giving effect to approximately $15 million of letters of credit issued under the Senior ABL Credit Facility, Core & Main LP would have been able to borrow approximately $1,142 million under the Senior ABL Credit Facility, subject to borrowing base availability.

On December 17, 2024, we amended the terms of the $750 million senior term loan in order to increase the principal balance by $200 million to $944 million with the proceeds utilized to repay outstanding borrowings under the $1,500 million senior term loan. In addition, the amendment reduced the effective applicable margin from 2.25% to 2.00%.

Fiscal 2025 Outlook

Core & Main provides the following guidance for fiscal 2025, a 52-week year compared to fiscal 2024, a 53-week year.

  • Net sales of $7,600 to $7,800 million
  • Net sales growth of 2% to 5%, reflecting average daily sales growth of 4% to 7%
  • Adjusted EBITDA (Non-GAAP) of $950 to $1,000 million
  • Adjusted EBITDA margin (Non-GAAP) of 12.5% to 12.8%
  • Operating Cash Flow of $570 to $650 million

“As we enter fiscal 2025, we expect overall demand in our industry to be flat to slightly positive with modest growth in municipal repair and replacement activity,” said Mark Witkowski, CFO of Core & Main.

“We offer a strong value proposition to the industry and intend to deliver above market sales growth and market share gains from the execution of our product, customer and geographic expansion initiatives. After a period of normalization, we expect to drive gross margin expansion in fiscal 2025, supported by our private label, sourcing optimization and pricing initiatives.

We anticipate strong operating cash flow generation and will continue deploying capital that results in accelerated growth and value creation for our shareholders in what we expect will be another year of profitable growth for Core & Main.”

Leadership Transition

As announced separately on March 25, 2025, Steve LeClair, Core & Main’s chief executive officer, will transition to the role of executive chair, where he will act as an advisor to the business, while continuing to lead the board of directors of Core & Main as chair. Mark Witkowski, Core & Main’s current chief financial officer, will succeed Steve LeClair as chief executive officer and become a member of the board. Additionally, Robyn Bradbury, Core & Main’s current senior vice president of finance and investor relations, will succeed Witkowski as chief financial officer. Each of these executives will assume their new roles on March 31, 2025.

Conference Call & Webcast Information

Core & Main will host a conference call and webcast on March 25, 2025 at 8:30 a.m. ET to discuss the company’s financial results. The live webcast will be accessible via the events calendar at ir.coreandmain.com. The conference call may also be accessed by dialing (833) 470-1428 or +1 (404) 975-4839 (international). The passcode for the live call is 121316. To ensure participants are connected for the full call, please dial in at least 10 minutes prior to the start of the call.

An archived version of the webcast will be available immediately following the call. A slide presentation highlighting Core & Main’s results will also be made available on the Investor Relations section of Core & Main’s website prior to the call.

About Core & Main

Based in St. Louis, Core & Main is a leader in advancing reliable infrastructure™ with local service, nationwide®. As a specialty distributor with a focus on water, wastewater, storm drainage and fire protection products and related services, Core & Main provides solutions to municipalities, private water companies and professional contractors across municipal, non-residential and residential end markets, nationwide. With over 370 locations across the U.S., the company provides its customers local expertise backed by a national supply chain. Core & Main’s 5,700 associates are committed to helping their communities thrive with safe and reliable infrastructure. Visit coreandmain.com to learn more.

Cautionary Note Regarding 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. Forward-looking statements include, without limitation, all statements other than statements of historical facts contained in this press release, including statements relating to our intentions, beliefs, assumptions or current expectations concerning, among other things, our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding expected growth, future capital expenditures, capital allocation and debt service obligations, and the anticipated impact on our business.

Some of the forward-looking statements can be identified by the use of forward-looking terms such as “believes,” “expects,” “may,” “will,” “shall,” “should,” “would,” “could,” “seeks,” “aims,” “projects,” “is optimistic,” “intends,” “plans,” “estimates,” “anticipates” or the negative versions of these words or other comparable terms.

Forward-looking statements are subject to known and unknown risks and uncertainties, many of which may be outside our control. We caution you that forward-looking statements are not guarantees of future performance or outcomes and that actual performance and outcomes, including, without limitation, our actual results of operations, financial condition and liquidity, and the development of the market in which we operate, may differ materially from those made in or suggested by the forward-looking statements contained in this press release. In addition, even if our results of operations, financial condition, cash flows and the development of the market in which we operate are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in subsequent periods. A number of important factors, including, without limitation, the risks and uncertainties discussed under the captions “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended February 2, 2025 and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended February 2, 2025, could cause actual results and outcomes to differ materially from those reflected in the forward-looking statements. Furthermore, new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release.

Factors that could cause actual results and outcomes to differ from those reflected in forward-looking statements include, without limitation, declines, volatility and cyclicality in the U.S. residential and non-residential construction markets; slowdowns in municipal infrastructure spending and delays in appropriations of federal funds; our ability to competitively bid for municipal contracts; price fluctuations in our product costs (including effects of tariffs); our ability to manage our inventory effectively, including during periods of supply chain disruptions; risks involved with acquisitions and other strategic transactions, including our ability to identify, acquire, close or integrate acquisition targets successfully; the fragmented and highly competitive markets in which we compete and consolidation within our industry; the development of alternatives to distributors of our products in the supply chain; our ability to hire, engage and retain key personnel, including sales representatives, qualified branch, district and regional managers and senior management; our ability to identify, develop and maintain relationships with a sufficient number of qualified suppliers and the potential that our exclusive or restrictive supplier distribution rights are terminated; the availability of freight; the ability of our customers to make payments on credit sales; changes in supplier rebates or other terms of our supplier agreements; our ability to identify and introduce new products and product lines effectively; the spread of, and response to, public health crises, and the inability to predict the ultimate impact on us; costs and potential liabilities or obligations imposed by environmental, health and safety laws and requirements; regulatory change and the costs of compliance with regulation; changes in stakeholder expectations in respect of environmental, social and governance and sustainability practices; exposure to product liability, construction defect and warranty claims and other litigation and legal proceedings; potential harm to our reputation; difficulties with or interruptions of our fabrication services; safety and labor risks associated with the distribution of our products; interruptions in the proper functioning of our and our third-party service providers’ information technology systems, including from cybersecurity threats; impairment in the carrying value of goodwill, intangible assets or other long-lived assets; our ability to continue our customer relationships with short-term contracts; risks associated with exporting our products internationally; our indebtedness and the potential that we may incur additional indebtedness that might restrict our operating flexibility; the limitations and restrictions in the agreements governing our indebtedness, the Amended and Restated Limited Partnership Agreement of Core & Main Holdings, LP, as amended, and the Tax Receivable Agreements (each as defined in our Annual Report on Form 10-K for the fiscal year ended February 2, 2025); increases in interest rates; changes in our credit ratings and outlook; our ability to generate the significant amount of cash needed to service our indebtedness; our organizational structure, including our payment obligations under the Tax Receivable Agreements, which may be significant; our ability to sustain an active, liquid trading market for our Class A common stock; and risks related to other factors discussed under “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended February 2, 2025.

Additional information concerning these and other factors can be found in our filings with the Securities and Exchange Commission. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements. All such statements speak only as of the date made and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

CORE & MAIN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

Amounts in millions (except share and per share data)

 

 

Three Months Ended

 

Fiscal Years Ended

 

February 2,

2025

 

January 28,

2024

 

February 2,

2025

 

January 28,

2024

 

 

 

 

 

 

 

 

Net sales

$

1,698

 

$

1,440

 

$

7,441

 

$

6,702

Cost of sales

 

1,247

 

 

1,056

 

 

5,461

 

 

4,884

Gross profit

 

451

 

 

384

 

 

1,980

 

 

1,818

Operating expenses:

 

 

 

 

 

 

 

Selling, general and administrative

 

279

 

 

230

 

 

1,078

 

 

931

Depreciation and amortization

 

48

 

 

38

 

 

183

 

 

147

Total operating expenses

 

327

 

 

268

 

 

1,261

 

 

1,078

Operating income

 

124

 

 

116

 

 

719

 

 

740

Interest expense

 

36

 

 

22

 

 

142

 

 

81

Income before provision for income taxes

 

88

 

 

94

 

 

577

 

 

659

Provision for income taxes

 

21

 

 

18

 

 

143

 

 

128

Net income

 

67

 

 

76

 

 

434

 

 

531

Less: net income attributable to

non-controlling interests

 

3

 

 

13

 

 

23

 

 

160

Net income attributable to Core & Main, Inc.

$

64

 

$

63

 

$

411

 

$

371

 

 

 

 

 

 

 

 

Earnings per share

 

 

 

 

 

 

 

Basic

$

0.34

 

$

0.35

 

$

2.14

 

$

2.15

Diluted

$

0.33

 

$

0.34

 

$

2.13

 

$

2.15

Number of shares used in computing

EPS

 

 

 

 

 

 

 

Basic

 

190,063,322

 

 

181,333,247

 

 

191,617,275

 

 

172,839,836

Diluted

 

199,474,771

 

 

213,854,692

 

 

201,442,750

 

 

227,818,077

CORE & MAIN, INC.

CONSOLIDATED BALANCE SHEETS

Amounts in millions (except share and per share data)

 

 

February 2,

2025

 

January 28,

2024

ASSETS

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

8

 

$

1

Receivables, net of allowance for credit losses of $18 and $12

 

1,066

 

 

973

Inventories

 

908

 

 

766

Prepaid expenses and other current assets

 

43

 

 

33

Total current assets

 

2,025

 

 

1,773

Property, plant and equipment, net

 

168

 

 

151

Operating lease right-of-use assets

 

244

 

 

192

Intangible assets, net

 

935

 

 

784

Goodwill

 

1,898

 

 

1,561

Deferred income taxes

 

558

 

 

542

Other assets

 

42

 

 

66

Total assets

$

5,870

 

$

5,069

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities:

 

 

 

Current maturities of long-term debt

$

24

 

$

15

Accounts payable

 

562

 

 

504

Accrued compensation and benefits

 

123

 

 

106

Current operating lease liabilities

 

67

 

 

55

Other current liabilities

 

90

 

 

94

Total current liabilities

 

866

 

 

774

Long-term debt

 

2,237

 

 

1,863

Non-current operating lease liabilities

 

178

 

 

138

Deferred income taxes

 

87

 

 

48

Tax receivable agreement liabilities

 

706

 

 

706

Other liabilities

 

22

 

 

16

Total liabilities

 

4,096

 

 

3,545

Commitments and contingencies

 

 

 

Class A common stock, par value $0.01 per share, 1,000,000,000 shares authorized, 189,815,899 and 191,663,608 shares issued and outstanding as of February 2, 2025 and January 28, 2024, respectively

 

2

 

 

2

Class B common stock, par value $0.01 per share, 500,000,000 shares authorized,

7,936,061 and 9,630,186 shares issued and outstanding as of February 2, 2025

and January 28, 2024, respectively

 

 

 

Additional paid-in capital

 

1,220

 

 

1,214

Retained earnings

 

449

 

 

189

Accumulated other comprehensive income

 

27

 

 

46

Total stockholders’ equity attributable to Core & Main, Inc.

 

1,698

 

 

1,451

Non-controlling interests

 

76

 

 

73

Total stockholders’ equity

 

1,774

 

 

1,524

Total liabilities and stockholders’ equity

$

5,870

 

$

5,069

CORE & MAIN, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

Amounts in millions

 

 

Fiscal Years Ended

 

February 2,

2025

 

January 28,

2024

Cash Flows From Operating Activities:

 

 

 

Net income

$

434

 

 

$

531

 

Adjustments to reconcile net cash from operating activities:

 

 

 

Depreciation and amortization

 

194

 

 

 

154

 

Equity-based compensation expense

 

14

 

 

 

10

 

Deferred income tax expense

 

13

 

 

 

2

 

Other

 

8

 

 

 

5

 

Changes in assets and liabilities:

 

 

 

(Increase) decrease in receivables

 

(2

)

 

 

21

 

(Increase) decrease in inventories

 

(36

)

 

 

328

 

(Increase) decrease in other assets

 

(13

)

 

 

2

 

Increase (decrease) in accounts payable

 

14

 

 

 

11

 

Increase (decrease) in accrued liabilities

 

(5

)

 

 

5

 

Net cash provided by operating activities

 

621

 

 

 

1,069

 

Cash Flows From Investing Activities:

 

 

 

Capital expenditures

 

(35

)

 

 

(39

)

Acquisitions of businesses, net of cash acquired

 

(741

)

 

 

(231

)

Other

 

(12

)

 

 

 

Net cash used in investing activities

 

(788

)

 

 

(270

)

Cash Flows From Financing Activities:

 

 

 

Repurchase and retirement of equity interests

 

(176

)

 

 

(1,344

)

Distributions to non-controlling interest holders

 

(11

)

 

 

(41

)

Payments pursuant to Tax Receivable Agreements

 

(11

)

 

 

(5

)

Borrowings on asset-based revolving credit facility

 

774

 

 

 

665

 

Repayments on asset-based revolving credit facility

 

(1,110

)

 

 

(235

)

Issuance of long-term debt

 

950

 

 

 

 

Repayments of long-term debt

 

(223

)

 

 

(15

)

Debt issuance costs

 

(15

)

 

 

 

Other

 

(4

)

 

 

 

Net cash provided by (used in) financing activities

 

174

 

 

 

(975

)

Increase (decrease) in cash and cash equivalents

 

7

 

 

 

(176

)

Cash and cash equivalents at the beginning of the period

 

1

 

 

 

177

 

Cash and cash equivalents at the end of the period

$

8

 

 

$

1

 

 

 

 

 

Cash paid for interest (excluding effects of interest rate swap)

$

197

 

 

$

105

 

Cash paid for income taxes

 

143

 

 

 

116

 

Non-GAAP Financial Measures

In addition to providing results that are determined in accordance with accounting principles generally accepted in the United States of America (“GAAP”), we present EBITDA, Adjusted EBITDA, Adjusted EBITDA margin and Net Debt, all of which are non-GAAP financial measures. These measures are not considered measures of financial performance or liquidity under GAAP and the items excluded therefrom are significant components in understanding and assessing our financial performance or liquidity. These measures should not be considered in isolation or as alternatives to GAAP measures such as net income or net income attributable to Core & Main, Inc., as applicable, or other financial statement data presented in our financial statements as an indicator of our financial performance or liquidity.

We define EBITDA as net income or net income attributable to Core & Main, Inc., as applicable, adjusted for non-controlling interests, depreciation and amortization, provision for income taxes and interest expense. We define Adjusted EBITDA as EBITDA as further adjusted for certain items management believes are not reflective of the underlying operations of our business, including but not limited to (a) loss on debt modification and extinguishment, (b) equity-based compensation, (c) expenses associated with the initial public offering and subsequent offerings and (d) expenses associated with acquisition activities. Net income attributable to Core & Main, Inc. is the most directly comparable GAAP measure to EBITDA and Adjusted EBITDA. We define Adjusted EBITDA margin as Adjusted EBITDA divided by net sales. We define Net Debt as total consolidated debt (gross of unamortized discounts and debt issuance costs) net of cash and cash equivalents.

We use EBITDA, Adjusted EBITDA, Adjusted EBITDA margin and Net Debt to assess the operating results and effectiveness and efficiency of our business. Adjusted EBITDA includes amounts otherwise attributable to non-controlling interests as we manage the consolidated Company and evaluate operating performance in a similar manner. We present these non-GAAP financial measures because we believe that investors consider them to be important supplemental measures of performance, and we believe that these measures are frequently used by securities analysts, investors and other interested parties in the evaluation of companies in our industry. Non-GAAP financial measures as reported by us may not be comparable to similarly titled metrics reported by other companies and may not be calculated in the same manner. These measures have limitations as analytical tools, and you should not consider them in isolation or as substitutes for analysis of our results as reported under GAAP. For example, EBITDA and Adjusted EBITDA:

  • do not reflect the significant interest expense or the cash requirements necessary to service interest or principal payments on debt;
  • do not reflect income tax expenses, the cash requirements to pay taxes or related distributions;
  • do not reflect cash requirements to replace in the future any assets being depreciated and amortized; and
  • exclude certain transactions or expenses as allowed by the various agreements governing our indebtedness.

EBITDA, Adjusted EBITDA, Adjusted EBITDA margin and Net Debt are not alternative measures of financial performance or liquidity under GAAP and therefore should be considered in conjunction with net income, net income attributable to Core & Main, Inc. and other performance measures such as gross profit or net cash provided by or used in operating, investing or financing activities and not as alternatives to such GAAP measures. In evaluating Adjusted EBITDA, you should be aware that, in the future, we may incur expenses similar to those eliminated in this presentation.

No reconciliation of the estimated range for Adjusted EBITDA or Adjusted EBITDA margin for fiscal 2025 is included herein because we are unable to quantify certain amounts that would be required to be included in net income attributable to Core & Main, Inc., the most directly comparable GAAP measure, without unreasonable efforts due to the high variability and difficulty to predict certain items excluded from Adjusted EBITDA. Consequently, we believe such reconciliation would imply a degree of precision that would be misleading to investors. In particular, the effects of acquisition expenses cannot be reasonably predicted in light of the inherent difficulty in quantifying such items on a forward-looking basis. We expect the variability of these excluded items may have an unpredictable, and potentially significant, impact on our future GAAP financial results.

The following table sets forth a reconciliation of net income or net income attributable to Core & Main, Inc. to EBITDA and Adjusted EBITDA for the periods presented:

(Amounts in millions)

Three Months Ended

 

Fiscal Years Ended

 

February 2,

2025

 

January 28,

2024

 

February 2,

2025

 

January 28,

2024

Net income attributable to Core & Main, Inc.

$

64

 

$

63

 

$

411

 

$

371

Plus: net income attributable to non-controlling interests

 

3

 

 

13

 

 

23

 

 

160

Net income

 

67

 

 

76

 

 

434

 

 

531

Depreciation and amortization (1)

 

49

 

 

38

 

 

186

 

 

149

Provision for income taxes

 

21

 

 

18

 

 

143

 

 

128

Interest expense

 

36

 

 

22

 

 

142

 

 

81

EBITDA

$

173

 

$

154

 

$

905

 

$

889

Equity-based compensation

 

3

 

 

2

 

 

14

 

 

10

Acquisition expenses (2)

 

3

 

 

2

 

 

11

 

 

6

Offering expenses (3)

 

 

 

2

 

 

 

 

5

Adjusted EBITDA

$

179

 

$

160

 

$

930

 

$

910

(1)

Includes depreciation of certain assets which is reflected in “cost of sales” in our Statement of Operations.

(2)

Represents expenses associated with acquisition activities, including transaction costs, post-acquisition employee retention bonuses, severance payments, expense recognition of purchase accounting fair value adjustments (excluding amortization) and contingent consideration adjustments.

(3)

Represents costs related to secondary offerings reflected in SG&A expenses in our Statement of Operations.

The following table sets forth a calculation of Net Debt for the periods presented:

(Amounts in millions)

 

Fiscal Years Ended

 

 

February 2,

2025

 

January 28,

2024

Senior ABL Credit Facility due February 2029

 

$

93

 

 

$

430

 

Senior Term Loan due July 2028

 

 

1,248

 

 

 

1,463

 

Senior Term Loan due February 2031

 

 

942

 

 

 

 

Total Debt

 

$

2,283

 

 

$

1,893

 

Less: Cash & Cash Equivalents

 

 

(8

)

 

 

(1

)

Net Debt

 

$

2,275

 

 

$

1,892

 

 

Investor Relations:

Robyn Bradbury, 314-995-9116

[email protected]

KEYWORDS: United States North America Missouri

INDUSTRY KEYWORDS: Other Manufacturing Commercial Building & Real Estate Construction & Property Engineering Urban Planning Landscape Building Systems Manufacturing Other Construction & Property Residential Building & Real Estate

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Kezar Life Sciences Announces Positive Topline Results from the PORTOLA Phase 2a Trial Evaluating Zetomipzomib for the Treatment of Patients with Autoimmune Hepatitis (AIH) and Reports Fourth Quarter and Year End 2024 Financial Results

Kezar Life Sciences Announces Positive Topline Results from the PORTOLA Phase 2a Trial Evaluating Zetomipzomib for the Treatment of Patients with Autoimmune Hepatitis (AIH) and Reports Fourth Quarter and Year End 2024 Financial Results

Company-hosted conference call and webcast to be held today at 8:00 a.m. ET

  • Zetomipzomib treatment results in steroid-sparing biochemical remissions in accordance with AASLD treatment guidelines in a difficult-to-treat, refractory AIH patient population.
  • In relapsed, steroid-dependent AIH patients, of the 21 of 24 entering screening on steroid-based therapy, 36% (5 of14) of zetomipzomib-treated patients achieved a complete biochemical response (CR) and clinically significant steroid taper to 5 mg/day or less, compared to 0 of 7 of placebo patients.
  • In the intention-to-treat (ITT) population, 31% (5 of 16) of zetomipzomib patients achieved a CR and steroid taper (≤5 mg/day), compared to 1 of 8 placebo patients.
  • Median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension), and no disease flares were reported in any zetomipzomib-treated patient achieving CR during study.
  • Favorable safety profile was observed during the 6-month, blinded treatment period.
  • Cash, cash equivalents and marketable securities totaled $132 million as of December 31, 2024

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today reported positive topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a novel, first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH) and reported fourth quarter and year end 2024 financial results.

“We are pleased to announce these exciting results from the PORTOLA trial, the first successful randomized study in treatment-refractory AIH,” said Chris Kirk, CEO and co-founder of Kezar. “We are encouraged by the safety and efficacy data in this difficult-to-treat patient population, specifically durable and steroid-sparing remissions experienced by patients treated with zetomipzomib. We are eager to work with the FDA Division of Hepatology and Nutrition to remove the partial clinical hold and align on an appropriate trial design to demonstrate the clinical benefit of zetomipzomib in AIH. I’d like to thank the team at Kezar, the physicians and staff at our clinical trial sites, and most importantly, the patients and their caregivers, for their participation, sacrifice and hard work.”

“I am impressed by the totality of efficacy and safety data from the PORTOLA study,” said Gideon Hirschfield, Chair of Autoimmune Liver Disease Research and Director of the Francis Family Liver Clinic, at the Toronto General Hospital. “Zetomipzomib represents a potent and targeted therapy for patients, and I believe these results will positively contribute to the design of a registrational trial of zetomipzomib in AIH, where patients are in need of better treatment options.”

PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed from a previous CR. The trial enrolled 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper. All patients were required to receive a starting daily steroid dose of 20-40 mg/day of prednisone (or budesonide equivalent) and physicians were encouraged to taper daily steroid usage to 5 mg/day consistent with AIH treatment guidelines established by the American Association for the Study of Liver Diseases (AASLD).

The primary efficacy endpoint of PORTOLA, which was not powered for efficacy, evaluated the proportion of patients who achieved a CR by Week 24, measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline. A key secondary endpoint was the proportion of patients who achieved a CR by Week 24 with a steroid dose of 5 mg/day or less. The PORTOLA trial included a pre-specified subgroup analysis of patients who were on steroid-based therapy at the time of screening, which represents a patient population with unmet medical needs for a potential future registrational study. Additional exploratory endpoints included changes in histologic assessment of AIH as measured in biopsies taken within six months of screening and repeated at Week 24 of the trial.

Summary of Topline Results

PORTOLA enrolled 24 patients as the ITT population. Consistent with the AASLD treatment goals, zetomipzomib treatment resulted in higher rates of complete biochemical responses (CR) combined with reduction of steroid dosage to 5 mg/day or less, compared to placebo. In the ITT population:

  • Without regard to steroid taper, 50.0% (8 of 16) of zetomipzomib patients achieved a CR, compared to 37.5% (3 of 8) of placebo patients.
  • 31.3% (5 of 16) of zetomipzomib patients achieved both a CR and steroid taper to 5 mg/day or less, compared to 12.5% (1 of 8) of placebo patients.
  • 18.8% (3 of 16) of zetomipzomib patients achieved both a CR and complete steroid withdrawal to zero mg/day, compared to 0% (0 of 8) of placebo patients.
  • Median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension), and no disease flares were reported in any zetomipzomib-treated patient achieving CR. Disease flares were defined as a sustained increase in ALT values to 25% above the CR value or 1.25-fold higher than the upper limit of normal for more than one week and requiring a restart or increase in steroid dose.

In the pre-specified subgroup analysis, 21 of the 24 patients entered the study on a steroid-based therapy at the time of screening. One patient in the placebo arm and two patients in the zetomipzomib arm were not receiving steroids at screening. All patients on study were required to initiate treatment with an initial prednisone dose of 20–40 mg/day. Of the 21 patients in this subgroup analysis:

  • Median steroid use at screening was 20 mg/day for patients enrolled in the zetomipzomib arm, compared to 10 mg/day in the placebo arm, indicating that the zetomipzomib-treated arm was more refractory than the placebo arm.
  • Without regard to steroid taper, 57.1% (8 of 14) of zetomipzomib patients achieved a CR, compared to 28.6% (2 of 7) of placebo patients.
  • 35.7% (5 of 14) of patients on the zetomipzomib arm achieved a CR and steroid taper to 5 mg/day or less, compared to 0% (0 of 7) of placebo patients.
  • 21.4% (3 of 14) of patients on the zetomipzomib arm achieved a CR and complete steroid withdrawal to zero mg/day, compared to 0% (0 of 7) of placebo patients.

Safety

Treatment-emergent adverse events (TEAEs) were seen in all patients, with injection site reactions (ISRs) being the most commonly reported TEAE in both arms. Systemic injection reactions (SIRs), with onset occurring 8 to 24 hours post-dose and usually resolving within 48 hours, were all Grade 1 and Grade 2. SIRs are a protocol-defined set of specific adverse events (AEs) consisting of one or more of the following signs/symptoms: hypotension, tachycardia, nausea, vomiting, dizziness, headache, pyrexia, rigors and/or chills.

Three patients experienced treatment-emergent serious adverse events (SAEs): one in the placebo arm, a Grade 3 variceal bleeding with hematemesis and atrial fibrillation; and two in the zetomipzomib arm, a Grade 3 fever occurring after the Week 24 liver biopsy, and a Grade 3 influenza infection that fully resolved during study. All SAEs were considered unrelated to study treatment, and all three patients completed the double-blind treatment period. Infectious AEs were reported in 85.7% (6 of 7) of patients in the placebo arm and 56.3% (9 of 16) of patients in the zetomipzomib arm. One patient discontinued from the placebo arm for a UTI requiring antibiotic treatment prior to receiving a dose on study, and three patients discontinued on the zetomipzomib arm for a Grade 1 fatigue, Grade 2 hives and a Grade 2 AIH disease flare. The safety population (n=23) includes all patients who received at least one dose of study treatment:

 

Placebo

Zetomipzomib

 

n=7

n=16

Adverse Events in Double-blind Treatment Period

n (%)

n (%)

Participants with at least 1 Treatment Emergent Adverse Event (TEAE)

7 (100.0)

16 (100.0)

Most common TEAE:

 

 

Injection Site Reaction (ISR)

4 (57.1)

15 (93.8)

Systemic Injection Reaction (SIR)

1 (14.3)

12 (75.0)

TEAE leading to study drug discontinuation

0 (0)

3 (18.8)

Grade 3 TEAE (no Grade 4 or 5 TEAEs reported)

1 (14.3)

3 (18.8)

Serious TEAE

1 (14.3)

2 (12.5)

Infectious TEAE

6 (85.7)

9 (56.3)

Grade ≥3 Infectious TEAE

0 (0)

1 (6.3)

Opportunistic Infections

0 (0)

0 (0)

Death

0 (0)

0 (0)

Financial Results

  • Cash, cash equivalents and marketable securities totaled $132.2 million as of December 31, 2024, compared to $201.4 million as of December 31, 2023. The decrease was primarily attributable to cash used in operations to advance clinical-stage programs.
  • Revenue decreased by $7.0 million in 2024 compared to 2023 due to the October 2023 upfront payment received under the collaboration and license agreement with Everest Medicines.
  • Research and development (R&D) expenses for the fourth quarter of 2024 decreased by $6.6 million to $16.0 million, compared to $22.6 million in the fourth quarter of 2023. Full year R&D expenses decreased by $20.0 million to $65.7 million in 2024, compared to $85.7 million in 2023. This decrease was primarily due to the Company’s strategic restructuring in October 2023 to prioritize its clinical-stage programs, reducing personnel-related costs and spending in its early-stage research activities, and a $5.0 million milestone payment made in 2023 under Kezar’s exclusive license agreement with Onyx Therapeutics. The decrease was partially offset by the increased clinical trial costs related to the PALIZADE and PORTOLA trials.
  • General and administrative (G&A) expenses for the fourth quarter of 2024 decreased by $0.3 million to $5.5 million compared to $5.8 million in the fourth quarter of 2023. Full year G&A expenses decreased by $3.1 million to $23.4 million in 2024, compared to $26.5 million in 2023. The decrease was primarily due to a decrease in legal and professional service expenses and non-cash stock-based compensation.
  • Restructuring and impairment charges decreased by $4.7 million to $1.5 million in 2024, compared to $6.2 million in 2023. The decrease was primarily related to one-time severance-related costs made in 2023 and higher impairment costs recognized in 2023 than 2024 on the right-of-use asset for the vacated floor in the leased office facility and certain equipment no longer utilized.
  • Net loss for the fourth quarter of 2024 was $20.2 million, or $2.77 per basic and diluted common share, compared to a net loss of $32.3 million, or $4.44 per basic and diluted common share, for the fourth quarter of 2023. Net loss for 2024 was $83.7 million, or $11.49 per basic and diluted common share, compared to a net loss of $101.9 million, or $14.04 per basic and diluted common share in 2023. The weighted-average shares used to compute net loss per basic and diluted common share have been retroactively adjusted to reflect the one-for-ten reverse stock split completed on October 29, 2024.
  • Total shares of common stock outstanding was 7.3 million shares as of December 31, 2024, after taking into effect the one-for-ten reverse stock split completed on October 29, 2024.

Conference Call and Webcast

Kezar Life Sciences will host a webcast and conference call today, March 25, 2025, at 8:00 a.m. ET to discuss topline results from the PORTOLA Phase 2a clinical trial. To access the live audio webcast with slides and dial-in information as needed, please register here: https://kezar-life-sciences-portola-phase-2a-topline-results.open-exchange.net/.

A live webcast of the event can also be found on the Kezar website at https://ir.kezarlifesciences.com/news-events/events-presentations. A replay of the event will be available for 90 days following the presentation.

About Zetomipzomib

Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from completed clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from use of corticosteroids.

About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, Twitter and Instagram.

Cautionary Note on Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “can,” “should,” “expect,” “believe,” “potential,” “anticipate” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, initiation, progress, timing, scope and results of ongoing and potential future clinical trials, preliminary nature of topline data from our clinical trials, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes, expectations regarding the removal of the partial clinical hold in the PORTOLA trial and the initiation of a registrational trial of zetomipzomib in AIH, and the likelihood of obtaining regulatory approval of zetomipzomib. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

KEZAR LIFE SCIENCES, INC.

Selected Balance Sheets Data

(In thousands)

 

 

 

December 31, 2024

 

December 31, 2023

Cash, cash equivalents and marketable securities

$

132,245

 

$

201,372

 

Total assets

 

144,682

 

 

221,235

 

Total current liabilities

 

20,329

 

 

17,744

 

Total noncurrent liabilities

 

7,437

 

 

15,921

 

Total stockholders’ equity

 

116,916

 

 

187,570

 

 

Summary of Operations Data

(In thousands except share and per share data)

 

Three Months Ended

 

Year Ended

December 31

 

December 31

2024

 

2023

 

2024

 

2023

Collaboration revenue

$

 

$

 

$

 

$

7,000

 

Operating expenses:

Research and development

 

16,030

 

 

22,643

 

 

65,742

 

 

85,697

 

General and administrative

 

5,545

 

 

5,759

 

 

23,393

 

 

26,540

 

Impairment charge

 

(12

)

 

6,187

 

 

1,470

 

 

6,187

 

Total operating expenses

 

21,563

 

 

34,589

 

 

90,605

 

 

118,424

 

Loss from operations

 

(21,563

)

 

(34,589

)

 

(90,605

)

 

(111,424

)

Interest income

 

1,734

 

 

2,728

 

 

8,462

 

 

11,104

 

Interest expense

 

(389

)

 

(399

)

 

(1,593

)

 

(1,550

)

Net loss

$

(20,218

)

$

(32,260

)

$

(83,736

)

$

(101,870

)

Net loss per common share, basic and diluted

$

(2.77

)

$

(4.44

)

$

(11.49

)

$

(14.04

)

Weighted-average shares used to compute net loss per common share, basic and diluted (1)

 

7,300,007

 

 

7,273,696

 

 

7,290,245

 

 

7,255,365

 

(1)

Shares outstanding have been retroactively adjusted to reflect the one-for-ten reverse stock split completed on October 29, 2024.

 

Investor and Media Contact:

Gitanjali Jain

Senior Vice President, Investor Relations and External Affairs

Kezar Life Sciences, Inc.

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Biotechnology Infectious Diseases Health Pharmaceutical Clinical Trials

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XCharge North America Partners With Hypercharge to Deploy First GridLink Chargers Across Canada

XCharge North America Partners With Hypercharge to Deploy First GridLink Chargers Across Canada

GridLink will help enhance EV charging and energy management across British Columbiaand Ontario

VANCOUVER, British Columbia–(BUSINESS WIRE)–XCharge North America (“XCharge NA”), a provider of high-power EV charging and battery-integrated solutions designed to strengthen the North American electrical grid, announced a strategic partnership with Hypercharge Networks Corp. (OTC: HCNWF; TSXV: HC; FSE: PB7) (“Hypercharge”), a North American EV solutions provider, to extend its global footprint and bring XCharge NA’s GridLink chargers to Canada.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250325120057/en/

To support the development of EV charging infrastructure in Canada, XCharge NA will supply GridLinks to Hypercharge, who will distribute the chargers to automotive dealerships and other customers across British Columbia and Ontario. As part of this partnership, Hypercharge will handle software and customer support maintenance, while XCharge NA will oversee preventive hardware maintenance under the unit warranty. Additionally, the Hypercharge team will receive training and certification to manage corrective hardware maintenance, ensuring long-term operational efficiency.

“GridLink’s bidirectional, battery-integrated system offers businesses a smarter way to fast EV charging success, eliminating demand charges and avoiding costly grid upgrades,” said Chris Koch, Head of Growth & Partnerships at Hypercharge. “By introducing this solution alongside Hypercharge’s innovative network solutions and 24/7 customer support, we’re helping our customers improve charging accessibility while supporting energy infrastructure across Canada.”

Despite growing demand for EVs in Canada, much of the country still requires additional power infrastructure to support rapid charging. Built with serviceability and flexibility in mind, GridLink by XCharge NA allows for a wide range of input power to achieve maximum output performance by offering a base capacity of 215 kilowatt-hours that can be expanded to 430 kilowatt-hours. This flexibility ensures optimal performance across a wide range of deployment scenarios, and provides businesses with the reassurance and confidence they need in their energy technology solutions. Other notable features include:

  • GridLink provides advanced bidirectional charging technology, seamless grid integration, and renewable energy support.
  • The bidirectional charging technology allows power to flow back into the grid or act as an off-grid energy source, enhancing overall grid stability.
  • The grid integration feature enables the charger to support direct integration with photovoltaics.
  • GridLink not only promotes electric transportation but also strengthens each region’s sustainable energy infrastructure.

“Redefining energy interaction is at the heart of what we do—from changing how people think about energy, to opening up new revenue streams for small and large businesses in the process,” said Aatish Patel, cofounder and president of XCharge NA. “Our partnership with Hypercharge is a significant step in furthering that mission. We look forward to seeing how our GridLinks can help strengthen Canada’s grid stability, particularly in rural deployments, while also addressing the region’s growing demand for EVs and supporting electric transportation needs.”

For more information on GridLink by XCharge, visit: xcharge.us/product/gridlink.

About Hypercharge Networks Corp.

Hypercharge Networks Corp. (TSXV: HC; OTC: HCNWF; FSE: PB7) is a leading provider of smart electric vehicle (EV) charging solutions for residential and commercial buildings, fleet operations, and other rapidly growing sectors. Driven by its mission to accelerate EV adoption and enable the shift towards a carbon neutral economy, Hypercharge is committed to offering seamless, simple solutions including industry-leading hardware, innovative and integrated software, and comprehensive services, backed by a robust network of public and private charging stations. Learn more: https://hypercharge.com/.

About XCharge North America

XCharge North America (XCharge NA) specializes in high-power EV charging and battery-integrated solutions tailored to the North American electrical grid. With solutions that store energy, improve grid resilience, and create new revenue streams, XCharge NA is the first scalable open-access EV charging solution designed to strengthen the country’s electrical grid and broader energy infrastructure while providing charging solutions for EVs from individual to fleet.

About XCharge

XCharge (NASDAQ: XCH), founded in 2015, is a global leader in integrated EV charging solutions. The company offers comprehensive EV charging solutions, which primarily include the DC fast chargers and the advanced battery-integrated DC fast chargers as well as its accompanying services. Through the combination of XCharge’s proprietary charging technology, energy storage system technology and accompanying services, the company enhances EV charging efficiency and unlocks the value of energy storage and management. Committed to providing innovative and efficient EV charging solutions, XCharge is actively working toward establishing a global green future that is critical to long-term growth and development.

Safe harbor statement

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the company’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release, and the company does not undertake any duty to update such information, except as required under applicable law.

XCharge North America contact: Alex Urist, Vice President

[email protected]

Media contact: Katie Jacobs, Quarter Horse PR

Email: [email protected]

Hypercharge contact: Kyle Kingsnorth, Head of Marketing

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Environment Technology EV/Electric Vehicles Automotive Utilities Other Technology Alternative Energy Green Technology Energy Hardware

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