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 IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Senior Director, Marketing and Communications Angelica.Deoudes@goV2X.com 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 ir@comstockinc.com
For media inquiries or questions: Comstock Inc., Tracy Saville Tel (775) 847-7573 media@comstockinc.com
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.
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.
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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 prospectus@allianceg.com.
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.
Experienced Financial Leader Joins Bitcoin ATM Pioneer to Drive Growth and Financial Strategy
ATLANTA, March 24, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, announced today that David Gray has been appointed Chief Financial Officer (CFO), effective immediately. Gray brings over 20 years of financial leadership experience, with a proven track record of success in driving business transformation, optimizing financial performance, leading high-value mergers and acquisitions, and advising on the impacts of complex strategic initiatives.
As CFO, Gray will oversee Bitcoin Depot’s financial strategy, treasury, and corporate development, ensuring the company remains well-positioned for continued growth amid an evolving cryptocurrency landscape.
Gray joins Bitcoin Depot from Aviat Networks, where he served as CFO and helped lead the company’s growth from $275 million to nearly $500 million in revenue through strategic acquisitions and financial transformation initiatives. Previously, he held CFO and senior finance leadership roles at Superior Essex, Eaton Corporation, and Newell Brands.
“David’s expertise in financial strategy, operational excellence, and strategic planning makes him a valuable addition to our leadership team,” said Brandon Mintz, CEO of Bitcoin Depot. “His experience navigating complex financial landscapes and driving sustainable growth will be crucial as we continue to expand Bitcoin access, scale our operations, and reinforce our market leadership.”
Commenting on his appointment, Gray said: “Bitcoin Depot has built a strong foundation as a leader in the Bitcoin ATM sector, and I’m eager to contribute to its financial strategy during a time of rapid innovation and expansion. I look forward to collaborating with the leadership team to enhance Bitcoin Depot’s financial strength, drive strategic growth, and support its mission of expanding access to Bitcoin.”
Gray holds a B.S. in Accounting from Penn State University and is a Certified Management Accountant (CMA) and a Certified Public Accountant (CPA).
About Bitcoin Depot
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 8,400 kiosk locations as of December 31, 2024. Learn more at www.bitcoindepot.com.
This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, and worldwide growth in the adoption and use of cryptocurrencies. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,“ ”plan,“ ”potential,“ ”priorities,“ ”project,“ ”pursue,“ ”seek,“ ”should,“ ”target,“ ”when,“ ”will,“ ”would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.
These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.
PDF Version 1-for-10 reverse stock split to become effective as of the opening of trading on March 25, 2025
NEW YORK, March 21, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel Brands” or the “Company”), a media and consumer products company with significant expertise in livestream shopping and social commerce, today announced that it will effect a 1-for-10 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding common stock par value $0.001 per share (the “Common Stock”), effective with the opening of trading on March 25, 2025.
Xcel Brands’ Common Stock will continue to trade on the Nasdaq Capital Market (“Nasdaq”) under the symbol “XELB”. The new CUSIP number for the Common Stock following the Reverse Stock Split will be 98400M200.
The material effects of the Reverse Stock Split are for every ten shares (the “Reverse Stock Split Number”) of Xcel Brands’ issued and outstanding Common Stock have been combined into one (1) share of Common Stock. The ownership percentage of each Xcel Brands stockholder will remain unchanged, other than as a result of fractional shares. No fractional shares of Common Stock will be issued in connection with the Reverse Stock Split. Instead, stockholders who otherwise would have been entitled to receive fractional shares were entitled to receive a cash payment (without interest and subject to applicable withholding taxes) in lieu of such fractional shares equal to the fraction of a share of common stock to which such stockholder would otherwise be entitled multiplied by (i) the closing price per share of the common stock on the Nasdaq Capital Market at the close of business on the trading day preceding the date of the Certificate of Amendment, multiplied by (ii) the Reverse Stock Split Number.
The shares of Common Stock underlying the Company’s outstanding stock options and warrants will be proportionately adjusted along with corresponding adjustments to their exercise prices.
At the special meeting of stockholders held on March 12, 2025, the stockholders of the Company approved a proposal to authorize the Company’s Board of Directors (the “Board”) to file a Certificate of Amendment to effect the Reverse Stock Split at a ratio between 1-for-2 and 1-for-10, as determined by the Chairman of the Board in his sole discretion.
The combination of, and reduction in, the number of issued shares of Common Stock as a result of the Reverse Stock Split will occur automatically on March 25, 2025, without any additional action on the part of Xcel Brands’ stockholders. The Company’s transfer agent, Continental Stock Transfer & Trust Company, is the exchange agent for the Reverse Stock Split and will correspond with stockholders of record regarding the Reverse Stock Split. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split.
Among other considerations, the Reverse Stock Split is intended to assist in bringing Xcel Brands into compliance with the $1.00 minimum bid price requirement for maintaining the listing of its Common Stock on the Nasdaq Capital Market.
Additional information regarding the Reverse Stock Split can be found in the Company’s Definitive Proxy Statement on Schedule 14A, filed with the U.S. Securities and Exchange Commission on February 14, 2025. A link to this document is available at https://www.sec.gov and on Xcel Brands’ website at https://www.xcelbrands.com/pages/sec-filings.
For more information about Xcel Brands, visit www.xcelbrands.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.
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 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, and over 20,000 hours of live-stream 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.
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “ongoing,” “could,” “estimates,” “expects,” “intends,” “may,” “appears,” “suggests,” “future,” “likely,” “goal,” “plans,” “potential,” “projects,” “predicts,” “seeks,” “should,” “would,” “guidance,” “confident” or “will” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding our anticipated revenue, expenses, profitability, strategic plans and capital needs. These statements are based on information available to us on the date hereof and our current expectations, estimates and projections and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors, including, without limitation, the risks discussed in the “Risk Factors” section and elsewhere in the Company’s Annual Report on form 10-K for the year ended December 31, 2021 and its other filings with the SEC, which may cause our or our industry’s actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws, we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.
Tegoprubart used as a key component of immunosuppression regimen in the second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital
Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine
Topline results from Phase 2 BESTOW trial of tegoprubart in kidney transplantation expected in fourth quarter of 2025
Proceeds from oversubscribed $85 million underwritten offering extend cash runway to end of 2026
IRVINE, Calif., March 20, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2024 operating and financial results and reviewed recent business highlights.
“We have recently made great strides in expanding our role in bringing new options in organ transplantation to patients. Tegoprubart was a cornerstone immunosuppression component in recent historic procedures including kidney xenotransplant and islet transplants in patients with type 1 diabetes,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The results from these landmark studies together with the encouraging allograft kidney transplant clinical data we have shared continue to reinforce tegoprubart’s broad potential to protect transplanted organs and cells, regardless of the transplant type and the organ source. We are entering 2025 from a position of balance sheet strength and we are on track to deliver on multiple key milestones in the coming months, including topline results from our Phase 2 BESTOW trial in the fourth quarter of 2025.”
Fourth Quarter 2024 and Recent Business Highlights
Announced the use of tegoprubart as a lead component of the immunosuppression treatment regimen following the second transplant of a genetically modified pig kidney into a human in a study conducted at Massachusetts General Hospital. Following the successful transplant on January 25, 2025, the patient was discharged from the hospital without need for continued treatment with dialysis for the first time in over two years.
Reported positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first in human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard for care for prevention of transplant rejection.
Completed an oversubscribed, underwritten offering of common stock and pre-funded warrants for total gross proceeds of $85.0 million and net proceeds of approximately $79.5 million after deducting underwriting discounts, commissions, and offering expenses. The offering, which priced at a premium, included participation from both new and existing investors.
Anticipated Upcoming Milestones
Summer 2025: Report updated interim clinical data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients.
4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
2025: Report updated interim clinical data from the investigator-led clinical trial with UChicago Medicine for pancreatic islet transplantation in subjects with type 1 diabetes.
Fourth Quarter 2024 Financial Results
Cash, cash equivalents and short-term investments totaled $140.2 million as of December 31, 2024 compared to $78.2 million at September 30, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.
Research and development (R&D) expenses for the fourth quarter of 2024 were $17.9 million, including $2.7 million of non-cash stock-based compensation expense, compared to $7.1 million, including $0.3 million of non-cash stock-based compensation expense, for the comparable period in 2023.
General and administrative expenses for the fourth quarter of 2024 were $6.8 million, including $3.9 million of non-cash stock-based compensation expense, compared to $3.3 million, including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2023.
Net loss for the fourth quarter of 2024 was $44.6 million, or $0.64 per basic share, compared with a net loss of $30.1 million, or $1.00 per basic share, for the comparable period in 2023. Both periods included a non-cash loss from changes in the fair value of warrant liabilities, totaling $20.9 million in 2024 and $20.5 million in 2023.
Full Year 2024 Financial Results
Research and development (R&D) expenses for the year ended December 31, 2024 were $52.0 million, including $4.3 million of non-cash stock-based compensation expense, compared to $30.3 million, including $1.5 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b, Phase 2 BESTOW and Phase 2 open-label extension trials for kidney transplantation, an increase in manufacturing costs for drug substance and drug product clinical trial supply, an increase in stock-based compensation expense and employee compensation and benefits related to increased headcount.
General and administrative expenses for the year ended December 31, 2024 were $18.6 million, including $8.8 million of non-cash stock-based compensation expense, compared to $12.7 million, including $5.0 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by an increase in stock-based compensation expense, professional services and employee compensation and benefits.
Net loss for the year ended December 31, 2024 was $36.2 million, or $0.75 per basic share, compared with a net loss of $116.5 million, or $4.73 per basic share, in 2023. The 2024 net loss included a non-cash gain of $30.9 million from changes in the fair value of warrant liabilities, whereas the 2023 net loss included a non-cash loss of $76.2 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, the company would have recorded a net loss of $67.1 million for the year ended December 31, 2024 and a net loss of $40.3 million for the year ended December 31, 2023.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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