SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that the National Medical Products Administration (NMPA) of the People’s Republic of China (“PRC”) has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung injury (RILI), with or without immune-related pneumonitis (CIP).
This regulatory milestone marks the expansion of pirfenidone beyond its established role in idiopathic pulmonary fibrosis (IPF) into the oncology supportive care space, offering a novel lung-protective strategy for cancer patients undergoing radiation therapy or immunotherapy.
In accordance with the NMPA approval, Gyre intends to pursue an adaptive Phase 2/3 clinical trial design, combining dose exploration with efficacy confirmation, to efficiently evaluate pirfenidone’s potential in this new indication.
Radiation-Induced Lung Injury (RILI): Radiation therapy is a cornerstone of lung cancer treatment. However, 5%–25% of patients experience lung damage due to radiation exposure, limiting the ability to escalate doses and thereby compromising treatment efficacy.
Checkpoint Inhibitor Pneumonitis (CIP): Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, but 13%–19% of patients develop CIP. This condition accounts for approximately 35% of immune-related adverse event (irAE) deaths and often necessitates treatment discontinuation.
Currently, no targeted therapies exist for lung injuries caused by radiation or immunotherapy. Distinguishing between RILI and CIP is challenging, particularly when both occur concurrently. Corticosteroids remain the standard of care despite significant long-term side effects. By targeting and inhibiting fibrotic pathways, pirfenidone may address the root cause of lung injury progression, offering a new treatment option for patients receiving radiation or immunotherapy.
Gyre anticipates initiating the trial in the second half of 2025 at leading academic and oncology centers across the PRC.
About Pirfenidone Pirfenidone is an orally administered small molecule approved for the treatment of IPF. It works by inhibiting TGF-β signaling and fibroblast proliferation. The drug has demonstrated clinical benefit in slowing lung function decline in IPF and is now being evaluated for oncology-related pulmonary complications. Gyre has held first-in-class status for pirfenidone in the PRC since its original approval in 2011, underscoring its pioneering role in treating fibrotic lung diseases.
About Gyre Therapeutics Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of F351 (Hydronidone) for MASH-associated fibrosis in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical trials, including timing of a clinical trial initiation in the second half of 2025. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
BOTHELL, Wash., March 31, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the 12 months ended December 31, 2024, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.
“Our novel, potent antiviral compounds for norovirus, influenza and coronavirus address critical gaps in global health where effective treatments or vaccines are currently lacking,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “We plan to initiate a norovirus human challenge study in the U.S. later this year to evaluate our pan-viral protease inhibitor CDI-988 for the potential treatment and prevention of norovirus infection. The big surge in reported norovirus outbreaks is possibly due to norovirus variants switching from GII.4 to GII.17, as well as increased social gathering after the COVID-19 pandemic. Norovirus is the most common cause of acute gastroenteritis and there are no approved therapeutics or vaccines, making it a compelling target.
“We are optimistic that our oral PB2 inhibitor CC-42344 will have potential as a treatment for seasonal influenza A infection and pandemic avian influenza,” he added. “Following the unexpected low infection rate from the Phase 2a challenge study that precluded us from obtaining meaningful human efficacy data, we plan to continue the influenza challenge study.”
“News coverage in recent months of norovirus and avian flu outbreaks underscore the urgent need for new antiviral solutions,” said James Martin, CFO and co-CEO of Cocrystal. “We are advancing our first- and best-in-class antiviral drug compounds that were designed using our Nobel Prize-winning structure-based technologies for these high-value viral targets that address multibillion-dollar markets.”
Antiviral Product Pipeline Overview
We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit viral replication. By designing and selecting candidates that target highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations of the virus, while reducing off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.
Oral CC-42344 for the treatment of pandemic and seasonal influenza A
Our novel PB2 inhibitor CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
In May 2024 we completed enrollment in the Phase 2a human challenge study.
In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
In December 2024 we announced a plan to extend the CC-42344 human challenge study due to unexpectedly low influenza infection among study participants.
Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
Our preclinical testing showed superior pulmonary pharmacology with CC-42344 including high exposure to drug and a long half-life.
We have completed CC-42344 inhalation formulation development and GLP toxicology studies.
Influenza A/B program
Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing.
Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.
CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.
In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy volunteers.
In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses.
In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a higher-dose cohort.
We expect to report topline results from the high-dose healthy volunteer cohort with CDI-988 in the second quarter of 2025.
We plan to initiate a human challenge study in the U.S. in 2025 to evaluate CDI-988 as a norovirus treatment and prophylaxis.
SARS-CoV-2 and Other Coronavirus Programs
By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031.
Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohort in the Phase 1 study.
In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a higher-dose cohort.
We expect to report topline results from the higher dose cohort in the CDI-988 Phase 1 study in the second quarter of 2025.
2024 Financial Results
Research and development (R&D) expenses for 2024 were $12.5 million, compared with $15.2 million for 2023. The decrease was primarily due to the timing of clinical study costs. General and administrative (G&A) expenses for 2024 were $5.3 million, compared with $6.0 million for 2023, with the $0.7 million decrease primarily due to a reduction of insurance costs and other expenses.
During 2023 the Company received $2.6 million related to litigation with an insurer.
The net loss for 2024 was $17.5 million, or $1.72 per share, compared with the net loss for 2023 of $18.0 million, or $1.87 per share. For 2024 the year over-year-net loss was reduced by $3.1 million exclusive of the $2.6 million received in 2023 noted above.
Cocrystal reported unrestricted cash as of December 31, 2024 of $9.9 million, compared with $26.4 million as of December 31, 2023. Net cash used in operating activities for 2024 was $16.5 million, compared with $14.7 million for 2023. The Company had working capital of $9.2 million and 10.2 million common shares outstanding as of December 31, 2024.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2025, our plans regarding further clinical development of such product candidates, and the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, and expectations for the markets for certain therapeutics. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, and the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Investor Contact: Alliance Advisors IR Jody Cain 310-691-7100 [email protected]
NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a global leader in providing augmented reality (“AR”) and artificial intelligence (“AI”) solutions to consumers, beauty and fashion industries, today announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2024. The annual report can be accessed under the SEC Filing section on the Company’s investor relations website at https://ir.perfectcorp.com.
The Company will provide a hard copy of its annual report containing the audited consolidated financial statements, free of charge, to its shareholders upon request. Requests should be directed to 14F, No. 98 Minquan Road, Xindian District, New Taipei City 231, Taiwan, or via email at [email protected].
About Perfect Corp.
Perfect Corp. (NYSE: PERF) leverages ‘Beautiful AI’ innovations to make our world more beautiful. As a pioneer and leader in the space, Perfect Corp. works with over 650 partners around the globe to empower brands to embrace the digital-first world by transforming shopping journeys through digital tech innovations. Perfect Corp.’s suite of enterprise solutions delivers synergistic, technology-driven experiences that facilitate sustainable, ultra-personalized, and engaging shopping journeys through hyper-realistic virtual try-ons, AI-powered skin analyses, personalized product recommendation tools and many more Beautiful AI innovations. For more information, visit https://ir.perfectcorp.com.
RESTON, Va., March 26, 2025 /PRNewswire/ — V2X (NYSE: VVX) Inc., announced its selection as a winner on the Bridge to Enduring Synthetic Training Environment Tactical Engagement Simulation Systems (TESS) Multiple-Award Contract (BEST MAC) Lot 1. This contract supports the U.S. Army’s TESS devices, a vital component of its live training capabilities, by extending their product life and ensuring they meet the Army’s evolving requirements.
The indefinite-delivery, indefinite-quantity contract includes a ten-year period of performance consisting of a five-year base period and two options (three-year option and a two-year option), with a ceiling value of $921 million.
Under this award, V2X will support the U.S. Army’s TESS products that are designed to enable simulated engagements, either as weapons or targets, during live collective military training exercises. These devices include weapons, vehicles, and aviation systems. Existing TESS must be modified to stay relevant as changes to weapon systems evolve.
“The BEST MAC contract perfectly complements the work we perform under our $3.7 billion Warfighter-Training Readiness Solutions task order,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “Both programs demonstrate our commitment to the warfighter and our expertise in delivering readiness capabilities that enhance Army training and strengthen national security.”
“As the prime contractor for the Army’s largest training services program, V2X is uniquely positioned to deliver superior services that align with BEST MAC future requirements,” said Ken Shreves, Senior Vice President of Mission Support at V2X. “Our dedication to the Army goes beyond operational excellence—we are committed to reinforcing national security through mission-critical initiatives and ensuring troops are prepared worldwide.”
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations [email protected] 719-637-5773
Media Contact Angelica Spanos Deoudes Senior Director, Marketing and Communications [email protected] 571-338-5195
VIRGINIA CITY, NEVADA, March 25, 2025 – Comstock Inc. (NYSE: LODE) (“Comstock,” “our” and the “Company”), today announced the timely completion of two successful settlements of prior outstanding strategic commitments. These commitments originated from prior acquisitions of foundational assets and intellectual property that have been instrumental in advancing Comstock’s renewable fuels and metals businesses. Comstock has eliminated regular cash payments and reinforced its financial position to support the Company’s long-term commercialization strategy.
“Both of these equity-based settlements were with the original founders and resulted in material, restructured savings, enhanced liquidity and increased financial flexibility,” said Corrado De Gasperis, Comstock’s Executive Chairman and CEO. “We are grateful to the founders, their innovations, partnering, flexibility, and confidence in our equity and its value.”
The settlements align with Comstock’s ongoing efforts to simplify and strengthen its balance sheet, enhance liquidity, and position its differentiated technology and businesses for rapid, scalable, and long-term growth. With the metals segment achieving full operational status and remarkable, real-time revenue growth and the fuels segment securing multiple commercial, operational and jurisdictional support agreements, and direct strategic investments, both businesses remain focused on driving continued revenue generation and expanding their globally relevant network of supply chain partners.
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.
Comstock Social Media Policy
Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Contacts
For investor inquiries: RB Milestone Group LLC Tel (203) 487-2759 [email protected]
For media inquiries or questions: Comstock Inc., Tracy Saville Tel (775) 847-7573 [email protected]
Forward-Looking Statements
This press release and any related calls or discussions may include 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. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.
Poster highlights potential predictive biomarker for therapeutic response in advanced non-small cell lung cancer (NSCLC)
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that an abstract detailing a potential predictive biomarker for THIO treatment was selected for poster presentation at the European Lung Cancer Congress 2025 (ELCC 2025) taking place, March 26-29, in Paris, France. ELCC is a program of the European Society for Medical Oncology (ESMO).
“We are proud to join ELCC 2025, a premier conference focused directly on the science of thoracic oncology,” said Vlad Vitoc, M.D., CEO of MAIA. “Our poster features our latest findings on cytokine Interleukin-6 (IL-6) as a potential predictive immune response biomarker for THIO sequenced with a checkpoint inhibitor. Predictive biomarkers can further illuminate THIO’s unique mechanisms of action which have shown exceptional efficacy in our Phase 2 clinical trial.”
Presentation details:
Title:
Phase 2 Study of Telomere-Targeting Agent THIO Sequenced by Cemiplimab in Immune Checkpoint Inhibitor-Resistant Advanced NSCLC: Interleukin-6 as a Potential Predictive Biomarker
Abstract number:
997
Date:
March 28, 2025
Time:
12:00 p.m. CET
Presenter:
Tomasz Jankowski, M.D., Ph.D. – Lead investigator for THIO-101 Phase 2 clinical trial
The European Lung Cancer Congress is a collaborative effort of the most important multidisciplinary societies representing thoracic oncology specialists, working together to advance science, disseminate education and improve the practice of lung cancer specialists worldwide.
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) — Xcel Brands (NASDAQ: XELB), an industry leading media and consumer products company specializing in building influencer-driven brands through social commerce and livestreaming, is proud to announce an exciting partnership with internationally renowned baker and chef, best-selling author, and creator of Bigger Bolder Baking, Gemma Stafford. Together, they will launch an innovative bakeware, food, and home brand designed to bring professional-quality tools and delicious foods to home bakers and entertainers everywhere—without sacrificing design quality or affordability.
This launch marks Gemma Stafford’s first-ever venture into developing her own product line, a milestone moment for her brand and community. For the first time, Gemma is bringing her expertise beyond the screen and into homes worldwide, carefully curating a line of bakeware, cookware, kitchen tools, and home essentials that embody her joyful and approachable philosophy. To ensure the highest quality and thoughtful design, she has chosen to partner with Xcel Brands. Together, they are creating a collection that blends functionality with timeless style, inspired by Gemma’s Irish heritage, vintage charm, and bold creativity. From beautifully crafted tools to simple yet delicious food products, this collection makes baking, cooking, and entertaining at home more elevated, effortless, and accessible than ever before.
“Over the past 11 years, I’ve reached millions of home bakers, learning firsthand what excites them, what challenges them, and what they truly need in their kitchens to be bold, confident bakers. Partnering with Xcel Brands allows me to create products that are practical, delightful, and designed to spark creativity for bakers everywhere—drawing from my professional expertise and years of hands-on experience to make them indispensable in any home kitchen.”
Xcel Brands, known for its expertise in building powerful lifestyle brands, sees this partnership as a natural fit. With millions of devoted fans across YouTube, social media, and BiggerBolderBaking.com, Gemma has built a global community of passionate home bakers. Her engaging content inspires both beginners and seasoned bakers to create with confidence.
“We are thrilled to partner with Gemma Stafford to launch this brand. Her expertise and deep love of baking and her influence align perfectly with Xcel’s vision of creating innovative, lifestyle-driven consumer brands,” stated Robert W. D’Loren, Chairman and Chief Executive Officer of Xcel Brands. “This collaboration brings us one step closer to our goal of reaching over 100 million social media followers across our brand portfolio, reinforcing our commitment to transforming how consumers engage with the brands they love.”
The home baking and entertaining market offers strong potential for a brand focused on quality, accessibility, and expertise. This partnership will provide high-quality products and educational resources for all bakers. By combining practical design with Gemma Stafford’s style, the brand aims to establish itself in the growing culinary market, addressing the needs of home cooks and entertainers. The brand is set to launch in Spring 2026 with availability through select retailers, e-commerce platforms, and live shopping channels. Stay updated on this exciting journey at www.xcelbrands.com
About Xcel Brands Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the Tower Hill by Christie Brinkley co-branded collaboration, and holds noncontrolling interests in the Isaac Mizrahi brand and Orme Live. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC. Xcel has recently announced the launch of new pet brand, Trust-Respect-Love by Cesar Millan. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone, growing social media presence of 35+ million followers across their brand profile and talent, and over 20,000 hours of livestream content production time and social commerce. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. www.xcelbrands.com
About Gemma Stafford For more than a decade, Irish-born chef Gemma Stafford has been bringing her passion for teaching people how to bake with confidence to her top online baking show and brand, Bigger Bolder Baking. Today, with more than 8 million followers (“Bold Bakers”) and half a billion video views to date, Bigger Bolder Baking has become the leading – and indispensable – multimedia destination for bakers. Gemma’s unique combination of expertise, bold recipes, and approachable techniques have led to appearances as a judge on Netflix’s Nailed It!, Food Network’s Best Baker in America, and Hulu’s Baker’s Dozen, along with appearances on national and local TV nationwide. Gemma is also the co-creator and host of the #1 baking entertainment podcast, Knead To Know, which releases every week in partnership with HRN. In 2025, she will launch the first-ever baking TV network, the Bold Baking Network, on connected television (CTV) and free ad-supported streaming television (FAST) platforms dedicated to educating and entertaining home bakers 24/7.
For further information please contact: Seth Burroughs Xcel Brands [email protected]
CULVER CITY, Calif., March 25, 2025 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, announced today that it will report financial results for the fourth quarter and full year ended December 31, 2024 on Wednesday, March 26, 2025. Management will host a conference call and webcast on the same day at 4:30 p.m. ET to discuss the results.
Participants may listen to the live webcast and replay on the Company’s investor relations website at https://investor.snail.com/.
About Snail, Inc. Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
Sales of SKYX’s Advanced and Smart Home Related Products Surge Over 1,000%; SKYX Expects its products to be in 20,000 Units/Homes by Q1 2025 and an Additional Tens of Thousands of Units/Homes in 2025
Company Expects Significant Projects and Orders and to Become Cash Flow Positive in Second Half of 2025
SKYX Achieves Revenue Growth in Four Consecutive Quarters for 2024 Q1: $19M | Q2: $21M | Q3: $22.2M | Q4: $23.7M Record Sales
SKYX’s Safety Code Standardization Team Anticipates Support from Additional Safety Organizations and Leading Members for a Safety Mandatory Standardization of its Ceiling Technology
MIAMI, March 24, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), an award winning highly disruptive advanced and smart home platform technology company with over 97 U.S. and Global pending and issued patents and a portfolio of over 60 lighting and home décor websites, with a mission to make homes and buildings become advanced-safe-smart instantly as the new standard, today reported its financial and operational results for the Fourth Quarter and Fiscal Year ended December 31, 2024.
SKYX will hold a conference call today, March 24, 2025, at 4:30 p.m. Eastern Time to discuss the results. See below for dial-in information.
Fourth Quarter 2024 and Subsequent Highlights
SKYX Reports 48% Growth in 2024 Revenues From $58.8 million in 2023 to $86.3 million in 2024
Generated a record $23.7 million in revenue in Q-4 2024 compared to $22.2M in Q-4 2023.
Reported $15.5 million in cash, cash equivalents, and restricted cash, as of December 31, 2024, compared to $13.0 million as of September 30, 2024.
In March 2025, Company secured additional $1.45 million funding including from a strategic investor through its $2.00 Series A-1 Preferred Offering.
As common with companies such as ours when sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, the Company continues to leverage its trades payable to finance its operations, to enhance its cash position and to lower its cost of capital.
Management anticipates significant orders and to become cash flow positive during the second half of 2025.
Reported a reduction in General and Administrative expense by $5.7 million to $31.4 million as of December 31, 2024 from $37.0 million as of December 31, 2023.
SKYX reported a $3.3 million decrease in total liabilities and a reduction of $3.9 million in net loss.
Net loss per share decreased by $0.09 to ($0.36) per share in 2024 compared to ($0.45) in 2023. Adjusted EBITDA loss per share, a non-GAAP measure, amounted to $(0.13) per share in 2024, as compared to $(0.17) per share, in 2023.
In 2024, Company Secured $11 million equity preferred stock investment led by the Shaner Group, a leading Marriott hotel owner with over 70 hotels, including significant insider investing by SKYX’s President Steve Schmidt, who invested $500,000, Co-CEO Lenny Sokolow and Co-CEO John Campi, who each invested $250,000. Preferred investment representing $2.00 per share of common stock with NO warrants.
Market Acceptance and Recent Events:
Company expects to continue increasing units and grow its revenue to pro, builders, and retail segment. Company continues to grow its market penetration of its advanced and smart plug & play products, expecting its products to be in 20,000 U.S. and Canadian units/homes by the end of Q-1 2025.
Company expects its products to be in tens of thousands additional homes, incrementally in 2025.
SKYX’s technologies provide opportunities for recurring revenues through interchangeability, upgrades, monitoring, and subscriptions.
Company is focused on the “Razor & Blades” model and its product range includes its advanced ceiling electrical outlet (Razor) and its advance and smart home plug & play products (Blades) including lighting, Chandeliers/Pendants, ceiling fans, recessed lights, down lights, exit signs, emergency lights, holiday/kids/themes lights, indoor/outdoor wall lights among others smart products.
Company continues to utilize its e-commerce platform of over 60 websites for lighting and home décor to educate and enhance its market penetration to both retail and professional segments.
SKYX collaborates with Home Depot for its Advanced and Smart Plug & Play Products for both retail and professional segments. SKYX’s product offering will include a variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and more.
Company collaborates with Wayfair for Its Advanced and Smart Plug & Play Products for both retail and professional segments. SKYX’s product offering will include a variety of its advanced and Smart Plug & Play products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and more.
SKYX collaborates with U.S. and world leading lighting companies including Kichler Quoizel, European leading company, EGLO, and worlding lighting manufacturer Ruee.
Collaborated with Cavco Homes, a leading U.S. prefabricated home manufacturer, for integrating our advanced and smart plug & play technologies into Cavco’s high-end premium homes shown at the builder show. Cavco is a public company that has sold nearly one million homes and continues to deliver close to 20,000 annually.
Three luxury developments by Forte Developments, including an 80-story high-rise in Miami’s Brickell District and projects in Clearwater Beach and Jupiter, Florida, will feature SKYX’s technology. More than 12,000 smart plug & play products, including ceiling outlets, lighting, fans, and emergency fixtures, will be supplied across 400+ units.
A 1,000-unit mixed-use development by Jeremiah Baron Companies will incorporate smart plug & play technologies, with 140 units receiving initial product supply. This product rollout will include ceiling outlets, lighting, fans, and emergency fixtures, with deliveries continuing throughout construction.
A strategic partnership with JIT Electrical Supply, a leading builder supplier, will expand SKYX’s footprint in electrical, lighting, and ceiling fan markets. JIT, which has supplied over 100,000 U.S. homes, will distribute SKYX’s lighting solutions, ceiling fans, recessed lights, emergency lights, exit signs, and indoor/outdoor wall lights beginning early 2025.
Huey Long, former Amazon E-Commerce Director and executive at Walmart and Ashley Furniture, has joined as head of SKYX’s e-commerce platform. He will collaborate with the existing team to expand market penetration across 60 lighting and home décor websites and other key e-commerce channels in the U.S. and Canada.
Greg St. John, former Home Depot lighting head and CEO of Eglo and Cordelia Lighting, has been appointed President of Lighting, Fans, and Smart Home Products. With 30+ years of industry experience, he will lead expansion efforts in retail, homebuilder, and commercial markets, overseeing partnerships with Home Depot, Wayfair, and other major retailers.
Safety Standardization Mandatory Code / Insurance Specification and Recommendation
SKYX’s code team, led by industry veterans Mark Earley, former head of the National Electrical Code (NEC), and Eric Jacobson, former President and CEO of the American Lighting Association (ALA). Company’s safety Code Standardization team believes it will achieve assistance from additional safety organizations with its code mandatory safety standardization efforts based on the product’s significant safety aspects. Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries. Both strongly believe that, in light of the Company’s standardization progress including its product specification approval voting for by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturers Association) and being voted into 10 segments in the NEC Code Book, it has met the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings.
Insurance Companies. Company strongly believes its products can save insurance companies many billions of dollars annually by reducing fires, ladder falls, and electrocutions among other things. Management expects that once it completes an entire range and variations of its safe advanced plug & play products it will start being recommended by insurance companies.
2024 Financial Results:
Revenue in 2024 increased to a record $86.3 million including record sales of $23.7 million which were realized in the fourth quarter including e-commerce sales, smart home products and advanced plug & play products. Gross profit in 2024 increased to $24.6 million, or 28% of revenue. Gross profit was positively impacted by the gross profit from the acquisition of the Belami e-commerce platform, which contained over 60 websites for lighting and home décor. Cash, cash equivalents and restricted cash, amounted to $15.5 million as of December 31, 2024, as compared to 13.0 million as of September 30, 2024. Cash used in operating activities for 2024 amounted to $18.3 million, as compared to $13.0 million in 2023. Net loss per share decreased by $0.09 to $0.36 per share in 2024 when compared to 2023. Adjusted EBITDA loss per share, a non-GAAP measure, amounted to $(0.13) per share in 2024, as compared to $(0.17) per share, in 2023.
The Company’s annual report on Form 10-K will be filed with the SEC and will be made available on the Company’s investor relations website: https://ir.skyplug.com/sec-filings/.
Management Commentary
Our year ended December 31, 2024 was highlighted by our four quarters of consecutive growth including sales and rollout of our advanced ceiling smart and standard plug & play platform products on many leading U.S. and Canadian websites. We believe we have accelerated our cadence of sales with a robust gross margin profile, notably managing the cash burn of SKYX. Our e-commerce platform with over 60 websites is expected to continue providing additional cash flow to the Company. Management anticipates that the Company will become cash flow positive during the second half of 2025.
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s ability to achieve positive cash flows; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
Non-GAAP Financial Measures
Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense, amortization expense, and impairment charges associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.
Please dial in at least 10 minutes before the start of the call to ensure timely participation.
A playback of the call will be available until April 24, 2025. To listen, call within the United States and Canada or when calling internationally. Please use the replay pin number 10197998. A webcast is also available at the following link: https://viavid.webcasts.com/starthere.jsp?ei=1713008&tp_key=5deb952af5
SAN DIEGO, March 24, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in the Defense, National Security and Global Markets, announced today that it has been added to the S&P SmallCap 600 Index. This milestone reflects Kratos’ continued growth, strong market position, and strategic investments in critical national security capabilities.
The S&P SmallCap 600 Index includes companies that meet specific criteria for financial stability, performance, and market capitalization, representing key players in the small-cap market segment. Kratos’ inclusion in the index underscores the company’s success in driving innovation, affordability, and operational readiness across defense and aerospace domains, including unmanned systems, space, hypersonics, and propulsion technologies.
Eric DeMarco, President and CEO of Kratos, said, “Being added to the S&P SmallCap 600 is a testament to the incredible work of our team and the trust our customers and investors place in Kratos. Our strategy of developing and rapidly fielding disruptive, affordable defense solutions continues to drive our organic growth and market leadership. We are committed to supporting the warfighter with real capabilities, not just concepts, and this recognition further validates our mission.”
Kratos remains focused on delivering cutting-edge defense technologies at an accelerated pace, leveraging its commercial approach to drive affordability and agility in support of the U.S. Department of Defense and allied partners worldwide. For more information about Kratos and its industry-leading solutions, visit www.KratosDefense.com.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, advanced vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
ATLANTA, GA, March 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor for the purchase and sale of 3,435,115 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 3,435,115 shares of common stock in a registered direct offering (the “Offering”) at a combined purchase price of $1.31 per share and accompanying warrant, priced at-the-market under Nasdaq rules. The warrants will have an exercise price of $1.31 per share, will be exercisable upon shareholder approval and will expire 5 years from shareholder approval.
The closing of the Offering is expected to occur on or about March 25, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $4.5 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.
A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering.
The Offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-277585) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). A prospectus supplement describing the terms of the proposed Offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].
In connection with the offering, the Company also agreed to amend existing warrants to purchase up to 2,675,610 shares of the Company’s common stock, with an exercise price of $5.00 per share, that were previously issued to the investor participating in this offering. Effective upon closing of this Offering, such existing warrants will be amended to reduce the exercise price to $1.31 per share and the term of such existing warrants will be amended to 5 years from the closing date of the offering.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
TNX-102 SL is a non-opioid analgesic; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years
Commercial planning for TNX-102 SL underway for launch in the fourth quarter of 2025
CHATHAM, N.J., March 24, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the Company’s New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. If approved, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) would be the first new treatment option for fibromyalgia patients in 15 years.
“We are pleased that FDA will not require an advisory committee meeting as part of the regulatory review process for TNX-102 SL,” said Seth Lederman, M.D., President, and Chief Executive Officer of Tonix Pharmaceuticals. “We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. We believe we are well positioned to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of 2025 if approved by the FDA.”
The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
About Fibromyalgia
Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC) 1–3. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions that include chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.
1Fitzcharles MA, et al. Lancet. 2021;397:2098-110
2Clauw DJ. Ann Rheum Dis. Published Online First: 2024
3Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. TNX-1500 has completed a positive Phase I trial. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
NEW YORK, March 24, 2025 (GLOBE NEWSWIRE) — Xcel Brands (NASDAQ: XELB), an industry leading media and consumer products company specializing in building influencer-driven brands through social commerce and livestreaming, is partnering with renowned dog behaviorist, New York Times best-selling author, and global television star Cesar Millan to launch an innovative pet brand, “Trust-Respect-Love by Cesar Millan,” that will redefine the pet industry. Spanning multiple pet categories, this new brand will introduce a collection of high-quality, purpose-driven products designed and developed in collaboration with Cesar Millan to enhance the bond between pets and their owners through trust, respect, and love.
Cesar Millan brings over two decades of experience to this exciting new venture. The brand will feature premium pet essentials, including toys, training tools, and accessories. Every product reflects Cesar’s core values of trust, respect, and love—offering solutions that are both functional and deeply aligned with the principles of balanced relationships between dogs and humans.
By combining Cesar’s expertise in canine psychology with Xcel Brands’ proven success in brand building, licensing, content creation, and social commerce, Xcel Brands is creating a transformative pet brand that delivers innovation, quality, and education to pet owners worldwide.
“We are thrilled to partner with Cesar Millan to launch this brand. His unparalleled expertise, deep connection with pet owners, and global influence align perfectly with Xcel’s vision of creating innovative, lifestyle-driven consumer brands,” stated Robert W. D’Loren, Chairman and Chief Executive Officer of Xcel Brands. “This collaboration brings us one step closer to our goal of reaching over 100 million social followers across our brand portfolio, reinforcing our commitment to transforming how consumers engage with the brands they love.”
With over 21 million loyal followers across social media and a presence in more than 120+ countries through his hit TV series, Cesar Millan is uniquely positioned to lead the next wave of pet care innovation. With Cesar’s heritage and global influence, the brand will uniquely resonate with both English and Spanish-speaking markets, fostering inclusivity and connection.
“I am looking forward to this collaboration with Xcel and can’t wait to share “Trust-Respect-Love by Cesar Millan” with dog lovers everywhere; to offer our philosophy and guidance to them, and lead humans and their pets into the beautiful discovery of balance and nurture,” expressed Millan.
The new brand, “Trust-Respect-Love by Cesar Millan,” will also serve as an educational platform, combining top-tier products with expert guidance helping pet owners nurture balanced, happy pets. With the expanding pet industry, this partnership is strategically positioned to set new trends and create an engaging community of pet owners. As part of its anticipated debut, Xcel will be showcasing the brand at Global Pet Expo, the pet industry’s premier event on March 26 – 28, 2025. The brand is set to launch in Spring 2026, with availability through select retailers, e-commerce platforms, and live-stream shopping. Stay updated on this exciting journey at www.xcelbrands.com.
About Xcel Brands Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the Tower Hill by Christie Brinkley co-branded collaboration, and holds noncontrolling interests in the Isaac Mizrahi brand and Orme Live. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC. Xcel has recently announced the launch of new pet brand, Trust-Respect-Love by Cesar Millan. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone, growing social media presence of 27+ million followers across their brand profile and talent, and over 20,000 hours of livestream content production time and social commerce. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. www.xcelbrands.com
About Cesar Millan Cesar Millan is a world-renowned dog behaviorist with over 25 years of experience transforming relationships between humans and their dogs. From his original hit TV series, the Dog Whisperer, to his most recent TV series Better Human, Better Dog, to his best-selling books and iconic workshops, Cesar has become a trusted guide for millions of dog lovers worldwide. With a social media following of over 21 million people and a legacy that spans two decades on U.S. television, Cesar’s influence extends far and wide. Trusted by celebrities, world leaders, and first-time pet owners alike, Cesar is committed to helping you achieve lasting harmony with your dog. Cesar moves forward in his journey with purpose and you can follow this journey at www.cesarmillan.com.
For further information please contact: Seth Burroughs Xcel Brands [email protected]
Blanca Lassalle Publicity Contact for Cesar Millan [email protected]
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