Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Converts the majority of its debt. The company announced that it has converted $25.0 million of its roughly $34.4 million in debt into a perpetual Series A Preferred Convertible Stock. The Preferred Stock will carry a cumulative annual 10% dividend, based on board of approval, and will be convertible at $2.50 per Class A common share. Following the transaction, the company will have roughly $9.4 million debt remaining under its Term Loan Facility. The move is viewed favorably.
Significant, but manageable restrictions. The company will be required to maintain total leverage below 3.5 to1 declining to 3.25 to 1. In addition, the company will need to maintain a fixed charge coverage of 1.25 to 1 rising to 1.5 to 1. In addition, the company must maintain $1.5 million in unrestricted cash. Finally, the company must maintain a minimum of consolidated EBITDA of $1.0 million for fiscal quarters end Sept. 2025 and then $500,000 thereafter.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
CFO Will Transition To CEO. Nutriband CEO and Co-Founder Gareth Sheridan has announced plans to take a three-month leave from the company to run for President of the Republic of Ireland. The current CFO and Co-Founder, Serguei Melnik, will become Acting CEO as Mr. Sheridan campaigns. The election is expected to be held in late September or early October. If elected, Sergeui will become CEO. If Mr. Sheridan is not elected, he may return to the company.
We Wish Gareth Sheridan Well In The Election. As a Co-founder and CEO of the company, Gareth Sheridan has guided the company from an idea to becoming a NASDAQ-listed company with three divisions. Nutriband’s financial planning has allowed it to develop the AVERSA technology with low operating losses, keeping the share base low.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Expand the Brand. With the recent Pennsylvania and Maine announcements, MariMed continues to implement its Expand the Brand strategy, which is focused on making the Company’s products accessible to as many consumers as possible. We expect the Company to look at additional new markets, such as New York and New Jersey, for additional expansion.
Market Remains Mixed. There remains a lot of near-term uncertainty in the cannabis industry. Pricing pressures, market saturation, and the lack of federal reform still pose a challenge that MariMed will need to navigate. Entering into established cannabis markets that are expanding into the adult recreational use market enables the Company to quickly capture share in proven markets.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Cadrenal Reports 2Q With Product News. Cadrenal reported a 2Q25 loss of $3.7 million or $(1.87) per share. During the quarter, the company announced a design modification for the upcoming tecarfarin clinical trial. The company also transferred its manufacturing technology to a CDMO and completed production scale-up in preparation for clinical trials. Cash on June 30, 2025 was $5.6 million.
New Trial Focuses On First Months Of Dialysis. As described in our Research Note on August 7 , the new trial design reflects recent research showing the first four to six months after the start of renal dialysis are an ultra-high-risk period for cardiac events including myocardial infarction, stroke, embolism, and death. The design change will be testing tecarfarin as an anticoagulant to reduce these events. The clinical site activation and trial enrollment are expected to begin around year-end.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
In a bold move to consolidate its position in the rapidly evolving digital payments landscape, Ripple has announced its intent to acquire Rail, a Toronto-based stablecoin payment platform, for $200 million. This strategic acquisition represents more than just another corporate deal—it signals Ripple’s commitment to capturing the explosive growth in stablecoin-powered international business payments.
The timing of this acquisition is particularly significant. As traditional financial institutions grapple with the inefficiencies of legacy cross-border payment systems, stablecoins have emerged as a compelling alternative, offering the speed and cost advantages of blockchain technology while maintaining price stability through fiat currency backing. Rail’s impressive market penetration—processing an anticipated 10% of the $36 billion global business-to-business stablecoin payment market in 2025—demonstrates the platform’s ability to execute at scale in this burgeoning sector.
Rail’s value proposition extends beyond mere transaction processing. The platform has built sophisticated infrastructure that addresses critical pain points in international business payments. Its virtual account system eliminates the need for companies to maintain dedicated cryptocurrency bank accounts or exchange wallets, significantly lowering barriers to entry for traditional businesses hesitant to directly hold digital assets. This approach has proven particularly attractive to enterprises seeking the benefits of blockchain-based payments without the operational complexity typically associated with cryptocurrency management.
For Ripple, this acquisition represents a natural evolution of its enterprise-focused strategy. While the company has established itself as a leader in institutional digital asset solutions, Rail’s automated back-office infrastructure and comprehensive fiat-to-stablecoin bridging capabilities fill crucial gaps in Ripple’s service offering. The combination creates what executives describe as the most comprehensive stablecoin payment solution available in the current market.
The strategic synergies between the two companies are immediately apparent. Ripple brings extensive regulatory compliance infrastructure, including over 60 licenses across multiple jurisdictions, along with established relationships with major financial institutions. Rail contributes technical innovation in virtual account management and a proven track record in stablecoin payment processing. Together, they can offer clients a seamless experience spanning traditional banking rails and cutting-edge blockchain infrastructure.
The acquisition also reflects broader industry trends toward consolidation in the fintech space. As regulatory frameworks for digital assets mature and institutional adoption accelerates, companies with complementary capabilities are increasingly seeking to combine forces rather than compete across overlapping territories. Ripple’s approach of acquiring rather than building these capabilities internally suggests confidence in Rail’s existing technology and team.
From a competitive standpoint, this deal positions Ripple to challenge established players in the international payments space more effectively. Traditional providers like SWIFT and correspondent banking networks have struggled to match the speed and cost efficiency of blockchain-based alternatives. By combining Ripple’s liquidity network with Rail’s operational infrastructure, the merged entity can offer enterprise clients a genuinely differentiated value proposition.
The $200 million price tag, while substantial, represents a strategic investment in Ripple’s long-term vision of blockchain-powered global finance. With the acquisition expected to close in the fourth quarter of 2025, pending regulatory approvals, both companies will have time to integrate their operations and prepare for what promises to be an increasingly competitive landscape in digital payments infrastructure.
FDA PDUFA goal date ofAugust15, 2025, for TNX‑102SL for fibromyalgia: if approved by FDA, TNX‑102SL would be the first new drug for fibromyalgia in more than 16years
InJune2025, the Company was added to the Russell3000® and Russell2000® Indexes following the annual reconstitution
Phase3RESILIENT results published in peer-reviewed journal, PainMedicine, including statistically significant reduction in fibromyalgia pain with once‑nightly TNX‑102SL; generally well tolerated
Cash and cash equivalents of $125.3million reported as ofJune 30, 2025; current cash runway expected to fund operations into the third quarterof2026
CHATHAM, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced financial results for the second quarter ended June 30, 2025, and provided an overview of recent operational highlights.
“With the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, we are excited about the potential to make this important new therapy available to patients in the fourth quarter of this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “FDA considers fibromyalgia a serious condition and awarded TNX-102 SL Fast Track designation last year. There has been no new treatment for this debilitating condition approved in over 16 years. Additionally, our RESILIENT Phase 3 study results were recently published in the peer-reviewed journal, Pain Medicine.”
Dr. Lederman continued, “Our pipeline momentum remains strong. In the second quarter, we dosed the first patient in the U.S. Department of Defense (DoD)-funded, investigator-initiated, OASIS trial of TNX-102 SL for acute stress reaction. We also presented new data for our live-virus vaccine, TNX-801, which demonstrated durable single-dose protection against mpox and rabbitpox in animal models. We previously reported positive Phase 1 safety and pharmacokinetic data for TNX-1500, advancing this next-generation anti-CD40L antibody toward a Phase 2 kidney-transplant study. We are well-positioned to translate these milestones into meaningful value for patients and shareholders alike.”
Key Investigational Product Candidates
Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets 2.8 mg): two tablets (5.6 mg), once-daily at bedtime for fibromyalgia (FM) – a centrally-acting, non-opioid analgesic.
In June 2025, Tonix presented a poster at the European Congress of Rheumatology (EULAR 2025) demonstrating that TNX‑102 SL produced statistically significant, durable (14‑week) pain reduction across two Phase 3 trials.
In July 2025, Tonix announced online publication of full results from the confirmatory Phase 3 RESILIENT trial of TNX‑102 SL in the peer-reviewed journal Pain Medicine, showing once‑nightly 5.6 mg achieved a statistically significant reduction in fibromyalgia pain versus placebo and was well tolerated; the data confirm the earlier RELIEF study and support the ongoing New Drug Application (NDA) review with an August 15, 2025 PDUFA goal date.
TNX-102 SL in development for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)
In May 2025, the first patient was dosed in the Phase 2 investigator initiated OASIS trial evaluating a two week course of TNX102 SL 5.6 mg to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD); the study is sponsored by the University of North Carolina and supported by a $3 million U.S. Department of Defense grant, with topline results expected in the second half of 2026.
Immunology Pipeline
TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection and treatment of autoimmune disorders
In May 2025, Tonix reported positive topline data from a Phase 1 single‑ascending‑dose study in healthy volunteers: TNX‑1500 met all safety, pharmacokinetic and pharmacodynamic goals, blocked primary and secondary antibody responses at 10 mg/kg and 30 mg/kg doses with intravenous (i.v.) administration, and showed a 34–38‑day mean half‑life that supports monthly i.v. dosing—supporting the path for a planned Phase 2 study to evaluate TNX-1500 for prevention of rejection in kidney allogeneic transplant.
TNX-801 (recombinant horsepox virus, minimally replicative live-virus vaccine): potential vaccine to protect against mpox and smallpox.
In April 2025, Tonix presented new preclinical data on TNX-801 at the World Vaccine Congress Washington 2025 showing a single subcutaneous (s.c.) dose protected animals from mpox and rabbitpox for at least six months, remained well tolerated even in immunocompromised models, and met key attributes in the WHO’s preferred target product profile for mpox vaccines.
Corporate and Partnerships
In May 2025, Tonix appointed Joseph Hand, Esq. as General Counsel and Executive Vice President of Operations, adding more than two decades of legal and operational expertise as the Company prepares for potential TNX‑102 SL commercialization.
In June 2025, Tonix announced that commercial veteran James Hunter joined its Board of Directors, bringing forty years of go‑to‑market experience to strengthen strategy and governance ahead of the expected TNX‑102 SL launch.
In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution, broadening visibility among institutional investors as Tonix approaches key regulatory milestones.
Financials
As of June 30, 2025, Tonix had $125.3 million in cash and cash equivalents, compared with $98.8 million as of December 31, 2024. Net cash used in operations was approximately $31.4 million for the six months ended June 30, 2025, compared to $27.5 million for the same period in 2024.
The Company believes that, based on its current operating plan, its cash on hand at June 30, 2025, together with $51.5 million in net proceeds received from equity offerings during the third quarter 2025, will fund planned operating and capital expenditures into the third quarter of 2026.
Second Quarter 2025 Financial Results
Net product revenue for the three months ended June 30, 2025 was approximately $2.0 million, compared to $2.2 million for the same period in 2024; revenue again reflected combined net sales of Zembrace® SymTouch® and Tosymra®. Cost of sales for the three months ended June 30, 2025 was approximately $3.3 million, compared to $3.4 million for the same period in 2024.
Research and development expenses for the three months ended June 30, 2025 were $10.8 million, compared to $9.7 million for the same period in 2024. The increase was predominately due to increased clinical expenses, nonclinical expenses and manufacturing expenses, reflecting spend on pipeline priorities.
Selling, general and administrative expenses for the three months ended June 30, 2025 were $16.2 million, compared to $7.5 million in 2024. The increase is predominately due to spend on sales and marketing to progress pre-launch activities related to the potential FDA approval of TNX-102 SL for fibromyalgia.
Net loss available to common stockholders was $28.3 million, or $3.86 per share (basic and diluted), for the second quarter 2025, compared to a net loss of $78.8 million, or $1,920.85 per share, for the same period in 2024. The basic and diluted weighted-average common shares outstanding for the second quarter 2025 were 7,327,257 compared to 41,011 for the same period in 2024.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotechnology 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 fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for fibromyalgia and for which a PDUFA goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA had also granted Fast Track designation to TNX-102 SL for 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 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. 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.
Brian Korb astr partners (917) 653-5122 brian.korb@astrpartners.com
Media Contact Ray Jordan Putnam Insights ray@putnaminsights.com (949) 245-5432
Indication and Usage
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.
Accelerates growth strategy with access to new opportunities in the Intelligence Community
Provides specialized data engineering, intel mission support and cyber solutions
Brings highly skilled talent supporting critical national security missions
Enhances ability to deliver improved mission solutions across all domains
RESTON, Va., Aug. 11, 2025 /PRNewswire/ — V2X Inc. (NYSE: VVX), announced today that it has entered into an agreement to acquire a specialized data engineering, intel mission support and cyber solutions business serving the Intelligence Community. This move brings access to new channels, capabilities, and further strengthens V2X’s position within the national security space, expanding its solutions to support mission-critical operations in the cyber domain.
The acquisition advances V2X’s strategic growth objectives and further extends its reach beyond traditional defense markets, enabling the company to pursue a greater share of the National Intelligence Program budget and related opportunities.
“I am thrilled to welcome approximately 70 highly skilled professionals to the V2X family,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “This acquisition marks an important milestone in V2X’s evolution, adding complementary capabilities, opening doors to new customers, and delivering solutions that accelerate our growth strategy.”
“It also demonstrates how we are transforming V2X into a leader in data-enabled mission solutions. Expanding our presence in the Intelligence Community reinforces our commitment to national security, innovation, and delivering greater value to our customers and shareholders.”
The transaction is valued at approximately $24 million net of estimated tax benefits and will be integrated into V2X’s national security portfolio in the coming months. Macquarie Capital acted as financial advisor to the seller.
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 Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million
Ping Zhang, Executive Chairman, appointed interim CEO as Dr. Han Ying transitions to scientific leadership role
Revenue of $26.8 million and $48.8 million for the three and six months ended June 30, 2025, respectively
GAAP basic EPS: $0.00 and $0.04 for the three and six months ended June 30, 2025, respectively
Pivotal Phase 3 trial of Hydronidone (F351) in CHB-associated liver fibrosis demonstrated statistically significant fibrosis regression after 52 weeks of treatment; Phase 2 trial in the United States evaluating Hydronidone for the treatment of MASH-associated liver fibrosis expected to initiate in 2H 2025, pending regulatory approval
Successfully launched Etorel (nintedanib ethanesulfonate soft capsules) in the PRC for the treatment of SSc-ILD and PF-ILD
Announced NMPA approval for clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications with Phase 2/3 trial anticipated in 2H 2025
First volunteer dosed in Phase 1 clinical trial of F230 for treatment of PAH
SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the second quarter ended June 30, 2025 and provided a business and leadership update.
Dr. Han Ying has stepped down as Chief Executive Officer and will transition into the role of Senior Vice President, Science and will oversee research and discovery activities to support Gyre’s fibrosis focused pipeline. Ping Zhang, Executive Chairman, has been appointed Interim Chief Executive Officer, and will lead the company’s day-to-day operations and strategic global expansion.
“I want to thank Dr. Ying for his contributions and dedication during his tenure as CEO. His deep background in research and discovery will be invaluable to advance our science and continued innovation,” said Mr. Zhang. “As interim CEO, I am excited to work closely with our leadership team to strengthen Gyre’s global footprint and accelerate our progress toward delivering transformative therapies to patients.”
“Looking ahead, we are thrilled with the rapid progress we have made towards expanding our commercial footprint and advancing our pipeline of fibrosis-first therapies. Our lead compound, Hydronidone, demonstrated statistically significant fibrosis regression in patients with CHB-associated liver fibrosis in a pivotal Phase 3 trial in the PRC, a critical step that not only underscores the potential of Hydronidone, but also lays the foundation to expand into additional fibrotic indications,” continued Mr. Zhang. “In the second half of 2025 we are well-positioned to grow our footprint in the United States with our planned Phase 2 trial evaluating Hydronidone in MASH-associated liver fibrosis, while continuing to advance our robust pipeline in the PRC, highlighted by a new Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications expected to initiate later this year. In addition, Gyre Pharmaceuticals remains on track to file an NDA for Hydronidone with the NMPA in the third quarter of 2025 to potentially support our growing commercial portfolio.”
Second Quarter Business Highlights and Upcoming Milestones
Commercial Portfolio Expansion
ETUARY® (pirfenidone): Generated $23.5 million in sales of ETUARY® for the quarter ended June 30, 2025, compared to $25.1 million for the same period in 2024.
Etorel (nintedanib ethanesulfonate soft capsules): In June 2025, Gyre launched Etorel in the PRC for the treatment of systemic sclerosis-associated ILD, and progressive fibrosing ILD, and generated sales of $1.6 million in the first partial quarter of launch.
Contiva (avatrombopag maleate tablets): In March 2025, Gyre initiated commercialization of Contiva in the PRC for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, and generated sales for $1.5 million in the second quarter of 2025.
Pipeline Development Updates
Hydronidone:
In May 2025, Gyre reported positive results from its pivotal Phase 3 trial of Hydronidone for chronic hepatitis B (“CHB”)-associated liver fibrosis in the PRC, which demonstrated statistically significant regression in liver fibrosis after 52 weeks compared to placebo. In addition, Hydronidone met a key secondary endpoint with statistically significant inflammation improvement without fibrosis progression at Week 52 versus the placebo arm. Hydronidone was well tolerated with a comparable incidence of serious adverse events (4.88% vs. 6.45% in the placebo group) and no discontinuations due to adverse events in either group. Gyre plans to submit primary results for publication in a peer-reviewed journal and present full trial results at a future medical conference. Based on these results, Gyre intends to file a New Drug Application (“NDA”) with the PRC’s National Medical Products Administration (“NMPA”) in the third quarter of 2025.
Gyre previously submitted an investigational new drug application (“IND”) for the treatment of liver fibrosis associated with a broad spectrum of chronic liver diseases with the U.S. Food and Drug Administration and conducted a Phase 1 trial of Hydronidone in healthy volunteers for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis. The Company is currently conducting an internal review to determine whether a new IND will be required for a Phase 2 trial in MASH-associated liver fibrosis. The Phase 2 trial is expected to start in the second half of 2025, subject to regulatory feedback.
ETUARY® (Pirfenidone):
Gyre plans to initiate an adaptive Phase 2/3 trial of pirfenidone for radiation-induced lung injury (“RILI”), including cases complicated by immune-related pneumonitis across top oncology centers in the PRC in the second half of 2025.
F573:
F573 is a caspase inhibitor and potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”). Completion of the Phase 2 clinical trial of F573 for ALF/ACLF is expected by the end of 2026.
F230:
In June 2025, the first volunteer was successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A receptor agonist, for the treatment of pulmonary arterial hypertension (“PAH”) in the PRC.
F528:
F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026.
Corporate Updates
In August 2025, Ping Zhang was appointed interim CEO as Dr. Han Ying transitions to a scientific leadership role. Mr. Zhang, who was appointed Executive Chairman in March 2025, has served on Gyre’s Board of Directors since January 2025.
In May 2025, Gyre completed an underwritten public offering of 2,555,555 shares of its common stock at a public offering price of $9.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $23.0 million.
In the third quarter of 2025, BJContinent Pharmaceuticals Limited increased its capital contribution in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.) by $1.28 million in exchange for 9,184,910 additional shares. As a result, the Company’s indirect interest in Gyre Pharmaceuticals increased from 65.2% to 69.7%.
Financial Results
Cash Position
As of June 30, 2025, Gyre held $36.5 million in cash and cash equivalents, $17.9 million in short-term bank deposits, and $21.5 million in long-term certificates of deposit, totaling $75.9 million. The increase of cash and cash equivalents mainly includes net proceeds of approximately $21.3 million received from the May 2025 underwritten public offering.
Financial Results for the Three Months Ended June 30, 2025
Revenues: Revenues for the three months ended June 30, 2025 were $26.8 million, compared to $25.2 million for the same period in 2024. The $1.6 million increase was primarily driven by a $1.6 million increase in revenue as a result of Etorel’s commercial launch in June 2025 and a $1.5 million increase in revenue from the sales of Contiva. These increases were offset by a $1.5 million decline in ETUARY® sales.
Gyre anticipates revenue growth over the remainder of the year, driven by the commercial launch of Etorel in June 2025 and the continued expansion of Contiva.
Cost of Revenues: For the three months ended June 30, 2025, cost of revenues was $1.2 million, compared to $0.8 million for the same period in 2024. The $0.4 million increase was primarily driven by a $0.2 million increase in the costs associated with Contiva and Etorel, in line with the corresponding increase in their sales, and a $0.2 million increase in ETUARY®’s cost due to the higher plant, property and equipment depreciation from a plant renovation.
Selling and Marketing Expense: For the three months ended June 30, 2025, selling and marketing expense was $15.2 million, compared to $14.4 million for the same period in 2024. The $0.8 million increase was primarily attributable to a $0.9 million increase in payroll costs, driven by higher headcount and increase of sales in the three months ended June 30, 2025, partially offset by $0.1 million decrease in promotion and conference expenses.
Research and Development Expense: For the three months ended June 30, 2025, research and development expense was $3.4 million, compared to $3.3 million for the same period in 2024. The $0.1 million increase was primarily attributable to a $0.1 million increase in clinical trial costs, primarily related to data analysis costs for Hydronidone, and a $0.1 million increase in staff costs. These increases were partially offset by a $0.1 million decrease in materials and utilities expenses.
General and Administrative Expense: For the three months ended June 30, 2025, general and administrative expense was $4.8 million, compared to $3.4 million for the same period in 2024. The $1.4 million increase was primarily driven a $0.5 million increase in professional fees, and a $0.9 million increase in functional and administrative department’s personnel and stock compensation costs.
Income from Operations: For the three months ended June 30, 2025, income from operations was $2.2 million, compared to $3.2 million income from operation for the same period in 2024. The $1.0 million decrease was primarily driven by $2.6 million increase in total operating expenses, partially offset by a $1.6 million increase in revenue.
Net Income: For the three months ended June 30, 2025, net income was $1.6 million, compared to $4.5 million net income for the same period in 2024.
Non-GAAP Adjusted Net Income: For the three months ended June 30, 2025, non-GAAP adjusted net income was $2.9 million, compared to $3.1 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the increase in operating expenses of $1.7 million, partially offset by an increase in revenue of $1.6 million.
Financial Results for the Six Months Ended June 30, 2025
Revenues: Revenues for the six months ended June 30, 2025 were $48.8 million, compared to $52.4 million for the same period in 2024. The $3.6 million decrease was primarily driven by a $6.8 million decline in ETUARY® sales, partially offset by the increase in new product sales of Contiva by $1.8 million and Etorel by $1.6 million. The decrease in ETUARY® sales was mainly due to lower sales volume compared to the first half of 2024, when revenues were elevated by a one-time rural marketing campaign that was not repeated in 2025. Additionally, weaker economic conditions in China and increased competition in the IPF treatment market also contributed to the decline. During the first half of 2025, marketing funds were intentionally shifted to support the launches of Etorel and Contiva.
Gyre anticipates revenue growth over the remainder of the year, driven by the continued expansion of Contiva in March 2025 and the commercial launch of Etorel in June 2025.
Cost of Revenues: For the six months ended June 30, 2025, cost of revenues was $2.0 million, compared to $1.7 million for the same period in 2024. The $0.3 million increase was primarily driven by a $0.1 million increase in stock-based compensation and a $0.2 million increase in the costs of Etorel and Contiva, in line with the corresponding increase in their sales.
Selling and Marketing Expense: For the six months ended June 30, 2025, selling and marketing expense was $26.0 million, compared to $26.9 million for the same period in 2024. The $0.9 million decrease was primarily driven by a reduction in commission costs due to the decrease of sales.
Research and Development Expense: For the six months ended June 30, 2025, research and development expense was $6.5 million, compared to $5.5 million for the same period in 2024. The $1.0 million increase was primarily attributable to a $1.5 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone. This increase was offset by a $0.3 million decrease in materials and utilities expenses and a $0.1 million decrease in facilities, depreciation and other.
General and Administrative Expense: For the six months ended June 30, 2025, general and administrative expense was $9.8 million, compared to $6.8 million for the same period in 2024. The $3.0 million increase was primarily driven a $0.6 million increase in professional fees, a $1.6 million increase in functional and administrative department’s personnel and stock compensation costs, and a $0.8 million increase in miscellaneous expense, mainly due to the increase for the annual meeting expense.
Income from Operations: For the six months ended June 30, 2025, income from operations was $4.4 million, compared to $11.3 million income from operation for the same period in 2024. The $6.9 million decrease was primarily driven by a $3.6 million decrease in revenue and $3.3 million increase in total operating expenses.
Net Income: For the six months ended June 30, 2025, net income was $5.3 million, compared to $14.5 million net income for the same period in 2024.
Non-GAAP Adjusted Net Income: For the six months ended June 30, 2025, non-GAAP adjusted net income was $5.8 million, compared to $11.3 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the decline in revenue of $3.6 million and increase in operating expenses of $1.9 million.
Full Year 2025 Financial Guidance
For the full year 2025, the Company expects to generate revenues of $118 to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of Etorel and Contiva and sales of ETUARY®.
Guidance Range
Total Revenue
$118 to $128 million
Please note that total revenue guidance assumes a constant foreign currency exchange rate and no significant economic disruption or downturn.
Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.0 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021 and NDA filing is expected in the third quarter of 2025. Gyre Pharmaceuticals is also developing treatments for PD, DKD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest of 65.2% in Gyre Pharmaceuticals. In the third quarter of 2025, this indirect interest was increased from 65.2% to 69.7% through the increased capital contribution from BJContinent Pharmaceuticals Limited to Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including timing of the initiation of Gyre’s Phase 2 trial in the U.S. for Hydronidone for the treatment of MASH-associated liver fibrosis, the initiation of Gyre’s Phase 2/3 trial in the PRC for pirfenidone capsules for the treatment of RILI, including cases complicated by immune-related pneumonitis, the filing of an NDA with the NMPA for Hydronidone for the treatment of CHB-related liver fibrosis, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, and IND submission of F528 in COPD, the expectations regarding commercial revenues from the sales of Etorel and Contiva maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors: David Zhang Gyre Therapeutics david.zhang@gyretx.com
NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB), a media and consumer products company known for building influential, creator-led brands, today announced a strategic partnership with TSC Product Lab to launch GemmaMade by Gemma Stafford—a new kitchenware brand created in close collaboration with chef and baking expert Gemma Stafford, designed to bring stylish, functional, and approachable tools to everyday bakers and home cooks.
This collaboration blends Xcel’s omnichannel brand-building capabilities with TSC Product Lab’s innovation-driven product development, delivering a thoughtfully designed assortment of kitchen products that reflect Stafford’s personal passion for joyful, stress-free cooking and baking at home. The product line will include bakeware, kitchen tools, food storage solutions, mixing bowls, and more—each created to support everyday needs with ease, charm, and reliability.
“GemmaMade is a celebration of the home kitchen,” said Robert W. D’Loren, Chairman and CEO of Xcel Brands. “We’re thrilled to partner with Gemma and TSC Product Lab to bring her vision to life through products that are as inviting and dependable as the content she shares with her loyal audience.”
With millions of fans and years of experience as a professionally trained chef, Gemma Stafford has built one of the most trusted and beloved baking communities in the world through her digital brand Bigger Bolder Baking. As both the creator and namesake behind GemmaMade, Gemma has worked hands-on with Xcel and TSC to develop a line that reflects her bold baking philosophy, her Irish heritage, and her belief that anyone can create delicious food with the right tools and a little confidence
“At the heart of GemmaMade is a simple promise: to super-serve home bakers and cooks with tools they can trust and love,” said Gemma Stafford. “I created this line for the everyday bakers and cooks who show up for birthdays, holidays, after-school snacks, and Sunday mornings—because they deserve products that are as joyful and reliable as they are. With Xcel and TSC, I’m excited to share the warmth of Irish hospitality through every bowl, pan, and spatula. In my kitchen, everyone’s welcome—because in a way, everyone is Irish.”
Rick Lapine, President of TSC Product Lab, added: “We are proud to be working with Gemma and Xcel to launch a brand that blends tradition and GemmaMade by Gemma Stafford reinforces Xcel Brands’ ongoing mission to build creator-led businesses that resonate with modern consumers and support how people live, cook, and share today.”
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 co-branded collaboration brands TowerHill by Christie Brinkley, LB70 by Lloyd Boston, Trust. Respect. Love by Cesar Millan, GemmaMade by Gemma Stafford, and a brand in development with Coco Rocha and also holds noncontrolling interests or long-term license agreements in the Isaac Mizrahi brand, Orme Live and Mesa Mia by Jenny Martinez brands. 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 retailers, 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 consisting of over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches in excess of 43 million social media followers with broadcast reach into 200 million households. 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. For more information, visit www.xcelbrands.com.
About TSC Lab Products The Sneaky Chef Product Lab (“TSC”) is a cost-effective product development and sourcing company specializing in innovative solutions for the home. The Company’s mission is to create products and brands for leading retailers. Since 2007, TSC has built a diverse portfolio of owned, private label and exclusively licensed brands and has partnered with such legacy names such as Martha Stewart, Sodastream, GreenPan and Calvin Klein. Its network of retail partners includes HSN, QVC, Walmart, Amazon and TJX Companies among others.
Led by Rick Lapine, an industry veteran with decades of experience, TSC is supported by a full-time team of passionate experts, bringing over 30 years of combined expertise in sourcing and production. This team has helped establish TSC as a trusted partner for efficient product development, manufacturing, and logistics, with the capability to execute projects rapidly and reliably.
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.
HOUSTON, Aug. 11, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the issuance of $25 million of a new series of Series A Convertible Preferred Stock, at a premium conversion price of $2.50 per share of Class A Common Stock. The investment was made through the conversion of a portion of existing debt into the new class of perpetual convertible preferred stock. The preferred stock is redeemable in whole or in part at the Company’s direction, votes on an as-converted basis with the Class A common stock, and carries a 10% cumulative annual dividend payable if, as and when declared by the Company’s board of directors.
The investment results in a $25 million increase in the Company’s stockholders’ equity from a deficit of $24.6 million at June 30, 2025 to an estimated positive shareholders’ equity of approximately $0.4 million (subject to any other period adjustments). It further reduces the Company’s ongoing debt service by more than $3.5 million and significantly reduces maturing debt obligations in December 2026.
Mark Walker, CEO of Direct Digital Holdings, commented, “This investment bolsters our balance sheet, provides financial flexibility to support our growth strategy, and significantly closes the gap on the shareholders’ equity needed to regain compliance with Nasdaq’s listing requirement regarding minimum stockholders’ equity. We continue to actively seek additional funding and strategic opportunities that maximize shareholder value.”
Further details of the terms of the new preferred stock are disclosed in the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on the date hereof.
This press release contains forward-looking statements within the meaning of federal securities laws that are subject to certain risks, trends and uncertainties. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Form 10-K”) and subsequent periodic and or current reports filed with the Securities and Exchange Commission (the “SEC”).
The forward-looking statements contained in this press release are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this press release, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control) and assumptions.
Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements. We believe these factors include, but are not limited to, the following: ability to service debt or dividend payment obligations; the restrictions and covenants imposed upon us by our credit facilities; the substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing; our ability to secure additional financing to meet our capital needs; our ineligibility to file short-form registration statements on Form S-3, which may impair our ability to raise capital; our failure to satisfy applicable listing standards of the Nasdaq Capital Market resulting in a potential delisting of our common stock; costs, risks and uncertainties related to restatement of certain prior period financial statements; any significant fluctuations caused by our high customer concentration; risks related to non-payment by our clients; reputational and other harms caused by our failure to detect advertising fraud; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; our failure to manage our growth effectively; the difficulty in identifying and integrating any future acquisitions or strategic investments; any changes or developments in legislative, judicial, regulatory or cultural environments related to information collection, use and processing; challenges related to our buy-side clients that are destination marketing organizations and that operate as public/private partnerships; any strain on our resources or diversion of our management’s attention as a result of being a public company; the intense competition of the digital advertising industry and our ability to effectively compete against current and future competitors; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; as a holding company, we depend on distributions from Direct Digital Holdings, LLC (“DDH LLC”) to pay our taxes, expenses (including payments under the Tax Receivable Agreement) and any amount of any dividends we may pay to the holders of our common stock; the fact that DDH LLC is controlled by DDM, whose interest may differ from those of our public stockholders; any failure by us to maintain or implement effective internal controls or to detect fraud; and other factors and assumptions discussed in our Form 10-K and subsequent periodic and current reports we may file with the SEC.
Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
About Direct Digital Holdings Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Energy, Healthcare, Travel & Tourism, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences.
At Direct Digital Holdings, we prioritize personal relationships by humanizing technology, ensuring each client receives dedicated support and tailored digital marketing solutions regardless of company size. This empowers everyone to thrive by generating billions of monthly impressions across display, CTV, in-app, and emerging media channels through advanced targeting, comprehensive data insights, and cross-platform activation. DDH is “Digital advertising built for everyone.”
Sheridan will temporarily step aside as CEO to enter the Irish Presidential Election.
Company Chairman and President, Serguei Melnik will take over as interim CEO over the course of the campaign and election period.
ORLANDO, Fla., Aug. 11, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) has announced that Company CEO, Gareth Sheridan will be stepping aside from his role for three months to enter the Irish Presidential election. The Nomination Hearings followed by the Election will take place over the course of September and October.
During this period, Co-Founder and Chairman, Serguei Melnik will take over the responsibilities of CEO and guide the company through the final 2025 framework towards the target NDA filing in 2026. Mr. Melnik, a corporate strategy expert will continue to execute the Company’s strategic development and focus on shareholder value. Mr. Melnik has over 20 years experience in Capital markets.
“I have made the decision to temporarily step aside as CEO following the support and encouragement I have received asking me to put my name forward for the election for President of Ireland. Rest assured, Nutriband is in very safe hands. While most often we talk about AVERSA as our big opportunity, it is our tight knit team that is really our core asset. I look forward to watching Nutriband continue to hit its planned targets between now and December,” said Mr. Sheridan.
The FDA recently granted Nutriband’s meeting request for AVERSA Fentanyl
AVERSA FENTANYL has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA FENTANYL has the potential to reach peak annual US sales of $80 million to $200 million.1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and our goal is to make AVERSA FENTANYL available in all major medical markets in the world.
The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
____________________________________________________ 1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS) (the “Company”),a leading provider of thoughtful expressions designed to help inspire customers to give more, connect more, and build more and better relationships, today announced that the Company will release financial results for its fiscal 2025 fourth quarter and year end on Thursday, September 4, 2025. The press release will be issued before the market opens and will be followed by a conference call with members of senior management at 8:00 a.m. (ET).
The conference call will be available via live webcast from the Investors section of the Company’s website at www.1800flowersinc.com/investors. A replay of the webcast will be available shortly after the live event has concluded. A telephonic replay of the call can be accessed beginning at 2:00 p.m. (ET) on September 4, 2025, through September 11, 2025, by dialing (877) 344-7529 or (412) 317-0088 for international callers; the passcode is 9381429.
Special Note Regarding Forward-Looking Statements:
Some of the statements contained in the Company’s scheduled Thursday, September 4, 2025, press release and conference call regarding its results for its fiscal 2025 fourth quarter and year end, other than statements of historical fact, may be forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements. For a more detailed description of these and other risk factors, please refer to the Company’s SEC filings including its Annual Reports and Forms 10K and 10Q available at the Investor Relations section of the Company’s website at 1800flowersinc.com. The Company expressly disclaims any intent or obligation to update any of the forward-looking statements made in the scheduled conference call and any recordings thereof, or in any of its SEC filings, except as may be otherwise stated by the Company.
About 1-800-FLOWERS.COM, Inc.
1-800-FLOWERS.COM, Inc. is a leading provider of thoughtful expressions designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®, Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, Simply Chocolate® and Scharffen Berger®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge on eligible products across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; DesignPac Gifts, LLC, a manufacturer of gift baskets and towers; Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country; and Card Isle®, an e-commerce greeting card service. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek. 1-800-FLOWERS.COM, Inc. was also recognized as one of America’s Most Admired Workplaces for 2025 by Newsweek and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com.
NEW YORK, August 11, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), in New York, announced today that it will release its Second Quarter 2025 results on Thursday, August 14, 2025, after the stock market closes. Senior management will host a live webcast and conference call to review on August 15, 2025, at 10:00 a.m. ET.
To register for the earnings call, please click here. Additionally, participants can join the conference call by dialing 1-800-289-0462 (passcode: 423774).
The Company will issue a press release regarding Second Quarter 2025 earnings prior to the conference call. The press release will be posted on the Bit Digital website at www.bit-digital.com.
About Bit Digital Bit Digital is a publicly traded digital asset platform focused on Ethereum-native treasury and staking strategies. The Company began accumulating and staking ETH in 2022 and now operates one of the largest institutional Ethereum staking infrastructures globally. Bit Digital’s platform includes advanced validator operations, institutional-grade custody, active protocol governance, and yield optimization. Through strategic partnerships across the Ethereum ecosystem, Bit Digital aims to deliver exposure to secure, scalable, and compliant access to onchain yield. For additional information, please contact ir@bit-digital.com, visit our website at www.bit-digital.com, or follow us on LinkedIn or X.
Investor Notice Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report) and any subsequently filed quarterly reports on Form 10-Q and any Current Reports on Form 8-K. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. See “Safe Harbor Statement” below.
Safe Harbor Statement This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
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