Author: aweinsoff@channelchek.com

Release – Cadrenal Therapeutics Enhances Anticoagulation Pipeline Through Acquisition of eXIthera’s Portfolio of Factor XIa Inhibitors

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  • Acquisition significantly enhances the Company’s pipeline by adding novel assets in acute and chronic anticoagulation settings
  • Company is strategically poised to deliver differentiated therapeutics across the spectrum of cardiovascular thrombotic risk

PONTE VEDRA, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy, today announced the acquisition of the assets of eXIthera Pharmaceuticals (“eXIthera”), including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors. The acquisition significantly enhances Cadrenal’s pipeline, adding drug candidates that address large and underserved segments of the current $38 billion global anticoagulation market.

eXIthera’s lead asset, frunexian, is a first-in-class, Phase 2-ready intravenous (IV) Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted cardiac devices. The acquisition also includes EP-7327, an oral Factor XIa inhibitor, for the prevention and treatment of major thrombotic conditions.

“With this acquisition, Cadrenal is the only company in the world developing a novel vitamin K antagonist (tecarfarin) and Factor XIa inhibitors, a promising new class of anticoagulants,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “These newly acquired assets will expand Cadrenal’s capabilities in an effort to address even more critical gaps in current antithrombotic treatment, especially for patients for whom current therapies are unreliable or carry excessive bleeding risk.”

Unlike current anticoagulants on the market, which increase the risk of bleeding by broadly impairing coagulation, eXIthera’s compounds are mechanism-based inhibitors of Factor XIa, offering high potency, selectivity, and tunable pharmacokinetics. Factor XIa inhibition is one of the most active and exciting areas of current thrombosis research.

“This acquisition reinforces Cadrenal’s long-term vision of becoming a category leader in anticoagulation,” added Pham. “With tecarfarin planning a trial in patients with end-stage kidney disease transitioning to dialysis, our plans for LVAD patients, and the current addition of frunexian and EP-7327, we believe that Cadrenal is strategically positioned to deliver differentiated therapeutics across the entire spectrum of patients with cardiovascular thrombotic risk.”

Assets Acquired:

  • Frunexian: Phase 2-ready IV Factor XIa agent for acute anticoagulation
  • EP-7327: IND-ready oral small molecule candidate for chronic indications
  • Extensive portfolio of additional novel FXIa small molecules

Under a pre-existing license agreement, Sichuan Haisco Pharmaceuticals retains rights to frunexian in China, having completed a successful Phase 1 trial there. Under the terms of the license, Cadrenal will be entitled to receive royalties on future sales of frunexian in China.

Deal Terms Overview:

Under the terms of the acquisition agreement, eXIthera will receive milestone payments from Cadrenal totaling up to $15 million, contingent upon the realization of certain future clinical and regulatory milestones. Additionally, eXIthera will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy. Cadrenal’s lead investigational product is tecarfarin, a novel oral Vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal aims to reduce the clinical complexities of managing Vitamin K antagonists, particularly where direct-acting oral anticoagulants (DOACs) remain inadequate or unproven.

Tecarfarin received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The Company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the acquisition significantly enhancing Cadrenal’s pipeline and addressing large and underserved segments of the global anticoagulation market; the size of the global anticoagulation market; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment with the acquisition; Cadrenal becoming a leader in anticoagulation; commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; Cadrenal’s receipt of royalties on future sales of frunexian in China; the payment to eXIthera of milestone payments by the Company totaling up to $15 million contingent upon the realization of certain future clinical and regulatory milestones as well as global sales of the acquired assets upon future commercialization; Cadrenal’s ability to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets; and tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment; the payment of milestone payments and royalties; Cadrenal successfully advancing tecarfarin and the acquired assets into clinical practice; the commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Release – Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

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Research News and Market Data on OCGN

September 15, 2025

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  • Upfront fees and near-term development milestone payments totaling up to $7.5 million
  • Potential sales milestones of $180 million or more in first 10 years of commercialization
  • Royalties equaling 25% of net sales
  • Ocugen to manufacture and supply OCU400

MALVERN, Pa., Sept. 15, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today executed a licensing agreement with Kwangdong Pharmaceutical, Co., Ltd., (“Kwangdong”) one of the leading pharmaceutical companies in Korea, for the exclusive Korean rights to OCU400—Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).

Pursuant to the License Agreement, Ocugen will receive upfront license fees and near-term development milestones equaling up to $7.5 million. The Company will be entitled to sales milestones of $1.5 million for every $15 million of sales in Korea, projected to reach $180 million or more in the first 10 years of commercialization. Additionally, Ocugen will receive a royalty of 25% on net sales of OCU400 generated by Kwangdong. Ocugen will manufacture the commercial supply of OCU400 under terms of a supply agreement.

There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately 7% of the U.S. market. OCU400 provides the opportunity for our partner to help thousands of patients facing vision loss. Upon regulatory approval of OCU400 in Korea, we believe Kwangdong will become a leader in the field of ophthalmic gene therapy in Korea.

“We are excited to partner with Kwangdong as our first regional partner in the development and commercialization of our modifier gene therapies across the globe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “OCU400 is a potential one-time therapy for life to treat RP and upon local regulatory approval, patients in Korea with this devastating condition will be able to access OCU400 through Kwangdong.”

Kwangdong, a top five pharmaceutical and healthcare company in Korea, has a diverse portfolio of products including prescription pharmaceuticals and over-the-counter healthcare products. The company is actively involved in research and development innovation including transformational late-stage, high-impact technologies.

“Kwangdong is very excited to have the opportunity to provide a new treatment option to Korean patients suffering from RP and the healthcare professionals treating them,” said SungWon Choi, CEO & Chairman of Kwangdong. “From the company’s perspective, this deal with Ocugen is especially meaningful as it allows us to further strengthen our ophthalmology portfolio, alongside our existing pipeline for presbyopia and pediatric myopia. Once the ongoing clinical trial of OCU400 is completed, Kwangdong will make every effort to bring the product to the Korean market as quickly as possible.”

Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. Biologics License Application (BLA) filing in 2026.

Kwangdong intends to utilize Ocugen’s clinical data and BLA filing as part of their regulatory submission for approval in Korea.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

About Kwangdong Pharmaceutical Co., Ltd
Kwangdong Pharmaceutical Co., Ltd is a South Korean human healthcare company founded in 1963. The company focuses on the development, manufacture, and sale of pharmaceutical products, as well as health drinks and functional foods. The company’s business is segmented into Pharmacy Sales, Hospital Sales, Distribution Sales, and Water Sales, each focusing on different aspects of the healthcare market. Kwangdong Pharmaceutical’s vision is to become a leading human healthcare brand company with a strong focus on innovation, research, and development. Kwangdong is consistently ranked as one of the top 10 pharmaceutical and healthcare companies in Korea by multiple metrics.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated benefits to Ocugen of the definitive license agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that the license agreement with Kwangdong will not lead to the current anticipated benefits to Ocugen, including projected sales royalties and milestones, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Release – Cocrystal Pharma, Inc. Announces Up To $13 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

September 12, 2025

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$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants

BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced that it has entered into definitive agreements for the purchase and sale of 2,764,710 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.70 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 5,529,420 shares of common stock at an exercise price of $1.50 per share that will be exercisable upon issuance and will expire twenty-four months from the effective date of the registration statement covering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about September 15, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $4.7 million. The potential additional gross proceeds to the Company from the warrants, if fully-exercised on a cash basis, will be approximately $8.3 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The common stock (or common stock equivalents in lieu thereof, but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-271883) that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 26, 2023. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Forward-Looking Statements

The information in this press release includes “forward-looking statements.” Any statements other than statements of historical fact contained herein, including statements as to the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

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Source: Cocrystal Pharma, Inc.

Released September 12, 2025

Release – Cocrystal Pharma Showcases CDI-988, the First Oral Antiviral in Development for Norovirus Infection, in a Podium Presentation at the International Calicivirus Conference

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Research News and Market Data on COCP

September 12, 2025

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BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9th International Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a potential first oral antiviral for the prevention and treatment of norovirus infection.

“It was an honor to share highlights of our CDI-988 Phase 1 data with global norovirus experts at the leading calicivirus scientific meeting,” said Dr. Lee. “The recent completion of Phase 1 study and U.S. Food and Drug Administration’s (FDA) Investigation New Drug (IND) clearance for the next study mark significant milestones for our clinical development of CDI-988.”

In “Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results,” Dr. Lee emphasized CDI-988’s favorable safety profile in human intestinal tissue, the primary site of norovirus infection, along with its high exposure in small intestine, suggesting a potential GI-targeted norovirus antiviral.

CDI-988 was rationally designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In vitro potency data and high-resolution crystal structures have shown broad-spectrum antiviral activity against multiple norovirus genogroups including GII.4 and GII.17, the strain responsible for the majority of circulating infections.

Dr. Lee also discussed previously reported Phase 1 results demonstrating CDI-988’s favorable safety and tolerability profile, with no serious adverse events. Earlier this week, Cocrystal announced FDA authorization to proceed with a Phase 1b human challenge study to evaluate CDI-988 as a potential norovirus prophylaxis and treatment. The study is expected to begin before year end.

The Calicivirus Conference is held every three years and unites scientists from across the globe who study calicivirus virology, evolution, pathogenesis, structural biology, diagnosis, epidemiology, treatment and prevention. The conference aims to foster open discussions, spark new collaborations and explore groundbreaking research. Delegates at this year’s conference engaged with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.

Protease Inhibitor CDI-988
CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. It targets a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases.

Norovirus Infection
Norovirus, the leading cause of viral gastroenteritis worldwide, spreads rapidly in community settings such as hospitals, nursing homes, childcare facilities, schools and cruise ships. It causes nausea, vomiting, diarrhea, abdominal pain and dehydration, and is responsible for an estimated $60 billion worldwide in direct healthcare costs and lost productivity.

Cocrystal Structure-Based Platform Technology
CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CDI-988 as a potential antiviral for the prevention and treatment of norovirus infection, and the Company’s plan to initiate a Phase 1b study in 2025. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, the risks and uncertainties arising from the ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials and our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

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Source: Cocrystal Pharma, Inc.

Released September 12, 2025

Release – Vince Holding Corp. Reports Second Quarter 2025 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on VNCE

09/10/2025

Net Sales of $73.2 Million
Net Income of $12.1 Million; Adjusted Net Income of $4.9 Million
Adjusted EBITDA of $6.7 Million, an increase of $4.0 Million vs. Q2 FY2024

NEW YORK–(BUSINESS WIRE)– Vince Holding Corp. (NYSE: VNCE) (“VNCE” or the “Company”), a global contemporary retailer, today reported its financial results for the second quarter ended August 2, 2025.

Brendan Hoffman, Chief Executive Officer of VNCE said, “We are very proud of our second quarter performance which reflects disciplined execution and strong customer reception to our product offerings especially as we elongated our full-price selling season. As we remain mindful of the dynamic macro environment, our ability to navigate today’s challenges while preserving product quality and customer loyalty remains our utmost priority. Given the strength of our underlying trends, we are pleased to be in a position to begin to reinvest in the business as we remain focused on the growth opportunities ahead for the Vince brand as well as the Vince Holding Corp. platform.”

In this press release, the Company is presenting its financial results in conformity with U.S. generally accepted accounting principles (“GAAP”) as well as on an “adjusted” basis. Adjusted results presented in this press release are non-GAAP financial measures. See “Non-GAAP Financial Measures” below for more information about the Company’s use of non-GAAP financial measures and Exhibit 3 and Exhibit 4 to this press release for a reconciliation of GAAP measures to such non-GAAP measures.

For the second quarter ended August 2, 2025:

  • Total Company net sales decreased 1.3% to $73.2 million compared to $74.2 million in the second quarter of fiscal 2024. The year-over-year decrease was driven by a 5.1% decline in the wholesale segment partially offset by a 5.5% increase in direct-to-consumer segment. The decline in the wholesale segment was primarily due to the shift in timing of fall shipments compared to the prior year as a result of the earlier uncertainty with respect to tariff policies and impact.
  • Gross profit was $36.9 million, or 50.4% of net sales, compared to gross profit of $35.1 million, or 47.4% of net sales, in the second quarter of fiscal 2024. The increase in gross margin rate was primarily driven by approximately 340 basis points due to the favorable impact of lower product costing and higher pricing, and approximately 210 basis points due to the favorable impact of lower discounting, partially offset by approximately 170 basis points due to higher tariffs, and approximately 100 basis points due to increased freight costs.
  • Selling, general, and administrative expenses were $25.8 million, or 35.2% of sales, compared to $34.0 million, or 45.8% of sales, in the second quarter of fiscal 2024. The decrease in SG&A dollars was primarily driven by the receipt of payroll tax credit payments from the U.S. Department of the Treasury under the Employee Retention Credit program (the “ERC benefit”). The ERC benefit was approximately $7.2 million, of which $5.6 million related to the original payroll tax credit claims and was recorded in SG&A as an offset to compensation expenses, with the remaining $1.6 million of interest payments recorded as Other income.
  • Income from operations was $11.2 million compared to income from operations of $1.1 million in the same period last year. Excluding the payments from the ERC benefit, Adjusted income from operations* was $5.5 million for the second quarter of fiscal 2025.
  • Income tax expense was $0.1 million, which represents a discrete tax expense relating to interest received in connection with the ERC benefit. The Company has year-to-date ordinary pre-tax losses and is anticipating annual ordinary pre-tax income for the fiscal year. The Company has determined that it is more likely than not that the tax benefit of the year-to-date ordinary pre-tax loss will not be realized in the current or future years and as such, tax provisions for the interim periods should not be recognized until the Company has year-to-date ordinary pre-tax income. The tax provision in the second quarter of fiscal 2025 compares to an income tax benefit of $0.8 million in the same period last year.
  • Net income was $12.1 million or $0.93 per diluted share compared to net income of $0.6 million or $0.05 per diluted share in the same period last year. Excluding the payments from the ERC benefit and its discrete tax effect, the Adjusted net income* was $4.9 million or $0.38 per diluted share in the second quarter of fiscal 2025.
  • Adjusted EBITDA* was $6.7 million compared to $2.7 million in the same period last year.
  • The Company ended the quarter with 58 company-operated Vince stores, a net decrease of 3 stores since the second quarter of fiscal 2024.

Second Quarter Review

  • Net sales decreased 1.3% to $73.2 million as compared to the second quarter of fiscal 2024.
  • Wholesale segment sales decreased 5.1% to $44.8 million compared to the second quarter of fiscal 2024.
  • Direct-to-consumer segment sales increased 5.5% to $28.5 million compared to the second quarter of fiscal 2024.
  • Income from operations excluding unallocated corporate expenses was $17.3 million compared to income from operations of $15.3 million in the same period last year.

Net Sales and Operating Results by Segment:

Balance Sheet

At the end of the second quarter of fiscal 2025, total borrowings under the Company’s debt agreements totaled $31.1 million and the Company had $42.6 million of excess availability under its revolving credit facility.

Net inventory at the end of the second quarter of fiscal 2025 was $76.7 million compared to $66.3 million at the end of the second quarter of fiscal 2024. The year-over-year increase in inventory was driven by approximately $5.2 million higher inventory carrying value due to tariffs as well as our strategic decision to ship goods earlier in advance of the expiration of reciprocal tariff extensions.

During the quarter ended August 2, 2025, the Company did not issue shares of common stock under the ATM program. The Company continues to have shares available under the program to exercise with proceeds to be used as sources, along with cash from operations, to fund future growth.

Outlook

For the third quarter of fiscal 2025 the Company expects the following:

• Net sales to be approximately flat to up 3% compared to the prior year period.

• Adjusted operating income as a percentage of net sales to be approximately 1% to 4%.

• Adjusted EBITDA as a percentage of net sales to be approximately 2% to 5%.

The above guidance assumes $4 million to $5 million in expected incremental tariff costs, of which the Company expects to mitigate approximately 50% through changes to country of origin, vendor negotiations as well as select and strategic price increases.

Given the uncertainty related to the potential impact and duration of current tariff policy, the Company is not providing guidance for the full year fiscal 2025.

Strategic Partnership with Authentic Brands Group

On May 25, 2023, the Company announced that it completed the previously announced transaction (the “Authentic Transaction”) with Authentic Brands Group (“Authentic”).

In connection with the Authentic Transaction, VNCE entered into an exclusive, long-term license agreement (the “License Agreement”) with Authentic for usage of the contributed intellectual property for VNCE’s existing business in a manner consistent with the Company’s current wholesale, retail and e-commerce operations. The License Agreement contains an initial ten-year term and eight ten-year renewal options allowing VNCE to renew the agreement.

*Non-GAAP Financial Measures

In addition to reporting financial results in accordance with GAAP, the Company has provided, with respect to the financial results relating to the three and six months ended August 2, 2025 and August 3, 2024, adjusted EBITDA, which is a non-GAAP measure. Adjusted EBITDA is calculated as earnings before interest, taxes, depreciation and amortization, share-based compensation, capitalized cloud computing amortization, ERC benefit, and gain on sale of Rebecca Taylor, Inc. and its wholly owned subsidiary (“Gain on Sale of Subsidiary”). For the three and six months ended August 2, 2025 and August 3, 2024, respectively, the Company has provided adjusted income (loss) from operations, adjusted income (loss) before income taxes and equity in net income (loss) of equity method investment, adjusted income (loss) before equity in net income (loss) of equity method investment, adjusted net income (loss), and adjusted earnings (loss) per share, which are non-GAAP measures, in order to eliminate the effect of the ERC benefit, Discrete Tax Effect Associated with ERC benefit, and Gain on Sale of Subsidiary.

The Company believes that the presentation of these non-GAAP measures facilitates an understanding of the Company’s continuing operations without the impact associated with the aforementioned items. While these types of events can and do recur periodically, they are excluded from the indicated financial information due to their impact on the comparability of earnings across periods. Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. A reconciliation of GAAP to non-GAAP results has been provided in Exhibit 3 and Exhibit 4 to this press release.

Conference Call

A conference call to discuss the first quarter results will be held today, September 10, 2025, at 4:30 p.m. ET, hosted by Vince Holding Corp. Chief Executive Officer, Brendan Hoffman, and Chief Financial Officer, Yuji Okumura. During the conference call, the Company may make comments concerning business and financial developments, trends and other business or financial matters. The Company’s comments, as well as other matters discussed during the conference call, may contain or constitute information that has not been previously disclosed.

Those who wish to participate in the call may do so by dialing (833) 470-1428, conference ID 030527. Any interested party will also have the opportunity to access the call via the Internet at http://investors.vince.com/. To listen to the live call, please go to the website at least 15 minutes early to register and download any necessary audio software. For those who cannot listen to the live broadcast, a recording will be available for 12 months after the date of the event. Recordings may be accessed at http://investors.vince.com.

ABOUT VINCE HOLDING CORP.

Vince Holding Corp. is a global retail company that operates the Vince brand women’s and men’s ready to wear business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince Holding Corp. operates 45 full-price retail stores, 14 outlet stores, and its e-commerce site, as well as through premium wholesale channels globally. Please visit www.vince.com for more information.

Forward-Looking Statements: This document, and any statements incorporated by reference herein contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include the statements under “Outlook” above as well as statements regarding, among other things, our current expectations about possible or assumed future results of operations of the Company and are indicated by words or phrases such as “may,” “will,” “should,” “believe,” “expect,” “seek,” “anticipate,” “intend,” “estimate,” “plan,” “target,” “project,” “forecast,” “envision” and other similar phrases. Although we believe the assumptions and expectations reflected in these forward-looking statements are reasonable, these assumptions and expectations may not prove to be correct and we may not achieve the results or benefits anticipated. These forward-looking statements are not guarantees of actual results, and our actual results may differ materially from those suggested in the forward-looking statements. These forward-looking statements involve a number of risks and uncertainties, some of which are beyond our control, including, without limitation: changes to and unpredictability in the trade policies and tariffs imposed by the U.S. and the governments of other nations; our ability to maintain adequate cash flow from operations or availability under our revolving credit facility to meet our liquidity needs; general economic conditions; restrictions on our operations under our credit facilities; our ability to improve our profitability; our ability to maintain our larger wholesale partners; our ability to accurately forecast customer demand for our products; our ability to maintain the license agreement with ABG Vince, a subsidiary of Authentic Brands Group; ABG Vince’s expansion of the Vince brand into other categories and territories; ABG Vince’s approval rights and other actions; our ability to realize the benefits of our strategic initiatives; the execution of our customer strategy; our ability to make lease payments when due; our ability to open retail stores under favorable lease terms and operate and maintain new and existing retail stores successfully; our operating experience and brand recognition in international markets; our ability to remediate the identified material weakness in our internal control over financial reporting; our ability to comply with domestic and international laws, regulations and orders; increased scrutiny regarding our approach to sustainability matters and environmental, social and governance practices; competition in the apparel and fashion industry; the transition associated with the appointment of new chief executive officer and new chief financial officer; our ability to attract and retain key personnel; seasonal and quarterly variations in our revenue and income; the protection and enforcement of intellectual property rights relating to the Vince brand; our ability to successfully conclude remaining matters following the wind down of the Rebecca Taylor business; the extent of our foreign sourcing; our reliance on independent manufacturers; our ability to ensure the proper operation of the distribution facilities by third-party logistics providers; fluctuations in the price, availability and quality of raw materials; the ethical business and compliance practices of our independent manufacturers; our ability to mitigate system or data security issues, such as cyber or malware attacks, as well as other major system failures; our ability to adopt, optimize and improve our information technology systems, processes and functions; our ability to comply with privacy-related obligations; our ability to regain compliance with the New York Stock Exchange (the “NYSE”) Listed Company Manual and maintain a listing of our common stock on the NYSE; our status as a “controlled company”; our status as a “smaller reporting company”; and other factors as set forth from time to time in our Securities and Exchange Commission filings, including those described under “Item 1A—Risk Factors” in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We intend these forward-looking statements to speak only as of the time of this release and do not undertake to update or revise them as more information becomes available, except as required by law.

Investor Relations:
ICR, Inc.
Caitlin Churchill, 646-277-1274
Caitlin.Churchill@icrinc.com

Source: Vince Holding Corp.

View full release here.

Release – MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

September 11, 2025 9:27am EDT

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CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care therapy regimens.

As of June 30, 2025,

  • Estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months. The comparable PFS threshold in standard of care treatments is 2.5 months1.
  • Estimated median overall survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months, consistent with the prior data readout (May 15, 2025).
  • Across patients of all treatment lines, 2 patients have completed 33 cycles of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer patient survival.

“THIO-101 continues to reveal impressive efficacy with observed progression free survival of 5.6 months, which is more than double the standard of care PFS of just 2.5 months. The data also demonstrates the durability of ateganosine treatment through extended treatment cycles, which is in line with consistent tolerability and low toxicity,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are seeking further validation of ateganosine’s strong efficacy in our THIO-101 Phase 2 expansion trial, which began enrolling patients in July 2025.”

Details of THIO-101, including efficacy data and safety findings, are included in MAIA’s poster for the 2025 IASLC World Conference on Lung Cancer (WCLC), available at maiabiotech.com/publications.

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 of 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 THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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 (THIO), 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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

1 Shepherd F, et al. N Engl J Med 2005;353:123-132, Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

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Source: MAIA Biotechnology, Inc.

Released September 11, 2025

Release – Nutriband Inc. Quarterly Report Highlights Record Revenue for Q2, 2025 up 50.87% YOY and Strategic Progress Toward NDA Filing for AVERSA Fentanyl

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NTRB

September 10, 2025 09:15 ET | Source: Nutriband Inc.

    ORLANDO, Fla., Sept. 10, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) reported its financial results for the six months ended July 31, 2025. The company reported a strong cash position at quarter end, reinforcing its ability to advance the development of its lead product, AVERSA™ Fentanyl which has been granted a Type C meeting on September 18th.

    Nutriband is continuing to expand its kinesiology tape contract manufacturing services through its Pocono Pharma subsidiary. The company produced a record six months, reporting revenue of $1,289,884, up 50.87% YOY.

    Progress continues on the development of AVERSA Fentanyl, Nutriband is reminding exiting shareholders and updating new shareholders on its development pathway, emphasizing that the NDA will primarily rely on data from a single phase 1 Human Abuse Potential study. Importantly, no Phase 2 or Phase 3 clinical trials will be required before submission.

    If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch available globally. AVERSA Fentanyl is estimated to have the potential to reach peak annual sales of $80-$200 million, according to a market analysis report from Health Advances.

    AVERSA Buprenorphine, which is the company’s second application for AVERSA, is projected to reach peak annual sales of up to $130 million.

    As of July 31, 2025, Nutriband’s cash reserves stand at $6.9 million, supporting the company’s ongoing development and commercialization efforts for AVERSA Fentanyl. The company’s total assets are valued at $10.17 million, with stockholders’ equity amounting to $8.5 million.

    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 Company’s websites or any other website if 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, Form 10-K for the year ended January, 2025, filed April 28, 2025, the Forms 10-Q’s filed subsequent to the Form 10-K in 2025, 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.

    For more information, contact:

    Nutriband Inc.
    Phone: 407-377-6695
    Email: info@nutriband.com

    Release – Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on GLSI

     Download as PDF

    September 10, 2025 6:00am EDT

    STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population.

    The designation specifically states that “GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival meets the criteria for Fast Track designation.”

    The Fast Track designation for GLSI-100 may lead to earlier drug approval as the Company and the FDA can communicate more frequently to expedite the Biologic License Application (BLA) filing of the clinical and manufacturing data from FLAMINGO-01. The Company may be able to utilize a rolling review process, where completed parts of the BLA can be submitted for review, even though other parts of the application are still being completed.

    Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, “Greenwich is pleased that the FDA sees the potential of GLSI-100 to change important clinical outcomes in this population of breast cancer patients. We continue to work earnestly to collect data to support a BLA filing demonstrating this benefit.”

    CEO Snehal Patel commented, “We are excited to have received Fast Track designation. The FDA review of our Fast Track application included a review of the potential of GLSI-100 as a new drug to treat serious conditions and to fill unmet medical need. By showing the potential of GLSI-100 to prevent metastatic breast cancer recurrence in the patient population that we are studying, we were able to estimate the potential lives that could be saved. The Company plans to continue discussions with the FDA, and potentially the European regulatory authorities, to explore additional ways to make GP2 and GLSI-100 available to larger populations.”

    A description of the Fast Track criteria and process is available on the FDA website:
    https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

    As described by the FDA website:

    “Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions…Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy…Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.”

    The FDA website further states:

    “Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

    • Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
    • Avoiding serious side effects of an available therapy
    • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
    • Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
    • Ability to address emerging or anticipated public health need

    A drug that receives Fast Track designation is eligible for some or all of the following:

    • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
    • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
    • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
    • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA”

    Previously Published Phase IIb Data

    In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

    • 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved products
    • Peak immune response at 6 months
    • No reported serious adverse events attributable to treatment
    • Well-tolerated safety profile

    Full immunization was received in the Primary Immunization Series (PIS), which included the first 6 GLSI-100 injections over the first 6 months. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. Further, booster injections given every 6 months prolonged the immune response, thereby providing longer-term protection. In the Phase IIb and three Phase I clinical trials, where 146 patients were treated, the GP2 immunotherapy was well tolerated, and there were no reported serious adverse events related to GLSI-100.

    About FLAMINGO-01 and GLSI-100

    FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

    For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com

    About Breast Cancer and HER2/neu Positivity

    One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

    About Greenwich LifeSciences, Inc.

    Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

    Forward-Looking Statement Disclaimer

    Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

    Company Contact
    Snehal Patel
    Investor Relations
    Office: (832) 819-3232
    Email: info@greenwichlifesciences.com

    Investor & Public Relations Contact for Greenwich LifeSciences
    Dave Gentry
    RedChip Companies Inc.
    Office: 1-800-RED CHIP (733 2447)
    Email: dave@redchip.com

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    Source: Greenwich LifeSciences, Inc.

    Released September 10, 2025

    Release – MustGrow Secures $2 Million Line of Credit with CIBC; Guaranteed by EDC

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MGRO

    SASKATOON, Saskatchewan, Canada, September 10, 2025 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow”), is pleased to announce it has secured a $2.0 million line of credit with Canadian Imperial Bank of Commerce, guaranteed by Canada’s Export Development Canada (“EDC”) (the “LOC”).

    Access to funds will allow MustGrow to produce its organic mustard-derived biofertility product TerraSanteTM to meet growing demand from U.S. commercial farming operations.  In addition, the LOC will help support working capital requirements for its Canadian sales and distribution division, NexusBioAg.

    The LOC carries a interest rate linked to Canada’s prime rate plus 1.00%, per annum. The current Canadian prime rate is 4.95%.  EDC has guaranteed the LOC on MustGrow’s behalf.  MustGrow will endeavour to increase the LOC size to support accelerating TerraSanteTM product demand in the U.S.

    “We are seeing significant uptake from large U.S. commercial farming operations which further validates the effectivess, efficiency, and economics of our organic biofertility product TerraSanteTM,” asserted Corey Giasson, President and CEO of MustGrow.  “Utilizing our LOC on such favourable terms will enable us to build inventory to meet increasing U.S. demand for TerraSanteTM and support NexusBioAg’s growing operations here in Canada.” 

    About MustGrow

    MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 109 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 58.9 million common shares issued and outstanding and 67.5 million shares fully diluted. For further details, please visit www.mustgrow.ca.

    Contact Information

    Corey Giasson Director & CEO
    Phone: +1-306-668-2652
    info@mustgrow.ca

    MustGrow Forward-Looking Statements

    Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

    Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: the receipt of final approval by the TSXV and those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

    Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

    © 2025 MustGrow Biologics Corp. All rights reserved.

    Release – V2X, General Motors, and U.S. Army Celebrate 11 Years of the Shifting Gears Automotive Technician Training Program

    Posted on by aweinsoff@channelchek.com
    V2X (PRNewsfoto/V2X, Inc.)

    Research News and Market Data on VVX

    September 09, 2025

    FORT HOOD, Texas, Sept. 9, 2025 /PRNewswire/ — This month marks the 11th anniversary of the Shifting Gears Automotive Technician Training Program, a collaborative initiative between V2X Inc. (NYSE: VVX), General Motors (GM), and the U.S. Army at Fort Hood. For more than a decade, this innovative program has provided transitioning service members with valuable hands-on training and career pathways as certified GM service technicians.

    Since its inception, more than 50 graduating cohorts have completed the eight-week program, that’s about 1,000 students, equipping veterans with in-demand technical skills and preparing them for careers at GM dealerships nationwide. Every graduate has been successfully placed at a GM dealership, with many advancing to achieve World Class Technician status, the highest certification level available to GM technicians.

    “Celebrating 11 years of Shifting Gears is more than just recognizing a program, it’s honoring the service members whose dedication continues beyond the uniform,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X.  “Through this partnership, we’re ensuring that our nation’s veterans have the skills, stability, and opportunity they deserve as they transition into civilian careers.”

    The program represents a cornerstone of V2X’s commitment to supporting warfighters throughout their journey, from delivering world-class training under the Army’s largest training contract (W-TRS), to preparing them for civilian success.

    “This program not only builds financial stability for veterans but also ensures dealerships across the country benefit from the discipline, technical expertise, and problem-solving skills of those who have served,” said Wensinger.

    The Shifting Gears Automotive Technician Training Program stands as a model of public-private collaboration, providing enduring value for veterans, industry, and communities nationwide.

    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

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-general-motors-and-us-army-celebrate-11-years-of-the-shifting-gears-automotive-technician-training-program-302550185.html

    SOURCE V2X, Inc.

    Release – Nicola Mining Commences Shipping Of Gold Concentrate Under Partnership With Talisker Resources

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on HUSIF

    September 8, 2025

    News Releases

    VANCOUVER, BC, September 8, 2025 – Nicola Mining Inc. (the “Company” or “Nicola”) (TSX: NIM) (OTCQB: HUSIF) (FSE: HLIA) announces that it has commenced shipping of gold concentrate via a partnership with Talisker Resources Ltd. (TSX: TSK) (OTCQX: TSKFF) (“Talisker”). Under a Mining, Milling and Smelting Agreement, the parties sold 707 ounces of gold in August, generating gross proceeds of approximately US$2.3 million. 

    Production benefited from extensive upgrades that included automation of several aspects of concentrate production, for the purpose of flotation recovery.  In addition, the Company’s installation of a large concentrator optimized free gold recovery, which is important for ore from Talisker and the Company’s Dominion Gold Project.  The Company confluence of numerous upgrades clearly impacted recovery and highlights Nicola’s ability to ramp up future production.

    Pre-Processed Ore and Bagged Flotation Concentrate

    Mr. Peter Espig, CEO of the Company, commented: “The culmination of our continuous multiple mill facility upgrades is the solidification of Nicola becoming a producer that is poised to benefit from gold and silver prices.  The Company continues to conduct work at its 100% of Treasure Mountain, a high-grade silver mine for which the mill was originally constructed.  The permitting and production of our partners highlights BC’s Ministry of Mining and Critical Minerals active support of smaller projects, for which we believe Nicola will become a hub.

    Bagged Gravity Concentrate and Gravity Concentrate Close Up

    About Nicola Mining

    Nicola Mining Inc. is a junior mining company listed on the Exchange and Frankfurt Exchange that maintains a 100% owned mill and tailings facility, located near Merritt, British Columbia It has signed Mining and Milling Profit Share Agreements with high grade gold projects. Nicola’s fully permitted mill can process both gold and silver mill feed via gravity and flotation processes.

    The Company owns 100% of the New Craigmont Project, a high-grade copper property, which covers an area of over 10,800 hectares along the southern end of the Guichon Batholith and is adjacent to Highland Valley Copper, Canada’s largest copper mine. The Company also owns 100% of the Treasure Mountain Property, which includes 30 mineral claims and a mineral lease, spanning an area exceeding 2,200 hectares.

    On behalf of the Board of Directors

    “Peter Espig”
    Peter Espig CEO & Director

    For additional information
    Contact: Bill Cawker
    Phone: (604) 649 0080
    Email: info@nicolamining.com

    Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Release – FreightCar America, Inc. Adopts Limited Duration Stockholder Rights Plan

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on RAIL

    09/08/2025

    Protects Long-Term Value for All Stockholders

    CHICAGO, Sept. 08, 2025 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (the “Company” or “FreightCar”) announced today that its Board of Directors (the “Board”) has adopted a limited duration stockholder rights plan (the “Rights Plan”) to protect the best interests of all FreightCar America, Inc. stockholders. The Rights Plan is effective immediately and will expire on August 5, 2026, unless terminated earlier by the Board.

    The plan is intended to enable all stockholders to realize the long-term value of their investment and protect against any potential efforts to obtain control of the Company that are inconsistent with the best interests of its stockholders.

    “Over the past several years, we have fully re-engineered our business and are now actively executing on a strategic plan to deliver substantial growth and long-term value creation. Following an analysis of our current position, the Board determined it was appropriate to adopt a rights plan to promote the fair and equal treatment of all the Company’s stockholders,” said Jim Meyer, Chairman of FreightCar America.

    “We believe that there is significant upside ahead as we drive execution across our business, particularly given our leading margin profile and continued growth in market share,” said Nick Randall, President and Chief Executive Officer of FreightCar America. “Our management team is focused on advancing our commercial strategy with the inclusion of tank car conversions and other value-add solutions, while also continuing to support our flexible manufacturing model, which has proved itself to be a key competitive advantage for us and a hallmark of our approach.”

    The Board adopted the Rights Plan following a review of the Company’s current ownership structure. The Rights Plan is intended to reduce the likelihood that any person or group gains control of the Company through open-market accumulation or other tactics without paying an appropriate control premium or providing the Board sufficient time to make informed decisions that are in the best interests of the Company and all FreightCar America stockholders. The Rights Plan is not intended to deter offers or preclude the Board from considering offers that are in the best interest of the stockholders.

    About the Rights Plan
    The Rights Plan is similar to plans adopted by other publicly-traded companies. In connection with the adoption of the Rights Plan, the Board of Directors declared a non-cash dividend distribution of one preferred share purchase right for each share of the Company’s common stock outstanding as of September 2, 2025, the record date. In general terms, the rights will become exercisable only if a person or group acquires 15% or more of the outstanding common stock of the Company without the approval of the Board (or 20% or more in the case of passive investors who are eligible to, and do, report their holdings on Schedule 13G). In the event that the rights become exercisable, each right will entitle stockholders (other than the acquiring person or group) to buy shares of FreightCar’s common stock at a 50% discount. The rights of the acquiring person or group in that event will become void and not exercisable.

    This announcement is a summary only and is qualified by reference to the full text of the Rights Plan. Additional details regarding the Rights Plan will be contained in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

    About FreightCar America

    FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com. 

    Forward-Looking Statements

    This press release contains statements relating to our expected financial performance, financial condition, and/or future business prospects, events and/or plans that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. These risks and uncertainties relate to, among other things, the cyclical nature of our business; adverse geopolitical, economic and market conditions, including inflation; material disruption in the movement of rail traffic for deliveries; fluctuating costs of raw materials, including steel and aluminum; delays in the delivery of raw materials; our ability to maintain relationships with our suppliers of railcar components; our reliance upon a small number of customers that represent a large percentage of our sales; the variable purchase patterns of our customers and the timing of completion; delivery and customer acceptance of orders; the highly competitive nature of our industry; the risk of lack of acceptance of our new railcar offerings; potential unexpected changes in laws, rules, and regulatory requirements, including tariffs and trade barriers (including recent United States tariffs imposed or threatened to be imposed on China, Canada, Mexico and other countries and any retaliatory actions taken by such countries); and other competitive factors. The factors listed above are not exhaustive. New factors emerge from time to time that may cause our business not to develop as we expect, and it is not possible for us to predict all of them. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.

    For more information, please contact:
    RAILIR@Riveron.com

    Primary Logo

    Source: FreightCar America, Inc.

    View all news

    Release – The ONE Group Hospitality, Inc. Appoints Nicole Thaung as Chief Financial Officer

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on STKS

     Download as PDF September 08, 2025

    Seven-Year Benihana CFO to Lead Accounting and Finance Organization

    DENVER–(BUSINESS WIRE)– The ONE Group Hospitality, Inc. (“The ONE Group” or the “Company”) (Nasdaq: STKS) today announced the appointment of Nicole Thaung as Chief Financial Officer effective, September 8, 2025. Ms. Thaung will succeed Tyler Loy, who is departing the Company to pursue other opportunities.

    “Nicole’s extensive financial knowledge and deep understanding of our business make her the ideal leader for our finance organization,” said Emanuel “Manny” Hilario, Chief Executive Officer. “Her leadership has been instrumental in the seamless integration of the Benihana acquisition. Nicole’s expertise will be invaluable as we continue realizing the $20 million in expected synergies from this transformative acquisition, which now represents over 55% of our total revenues. We remain on track to capture the full value of these synergies by the end of 2026.”

    Ms. Thaung has over 15 years of experience with Benihana, where she has served as CFO since August 2018. Prior to her CFO role, Ms. Thaung held progressive leadership positions at Benihana including Vice President of Finance and Controller. Before joining Benihana in 2009, she spent nearly eight years at Ernst & Young LLP, with her last role being that of Audit Manager. Ms. Thaung holds bachelor’s and master’s degrees in accounting from the University of Florida.

    “We thank Tyler for his contributions over the years with The ONE Group,” added Hilario. “We wish him success in his future endeavors.”

    About The ONE Group

    The ONE Group Hospitality, Inc. (Nasdaq: STKS) is an international restaurant company that develops and operates upscale and polished casual, high-energy restaurants and lounges and provides hospitality management services for hotels, casinos and other high-end venues both in the U.S. and internationally. The ONE Group’s focus is to be the global leader in Vibe Dining, and its primary restaurant brands and operations are:

    • STK, a modern twist on the American steakhouse concept with restaurants in major metropolitan cities in the U.S., Europe and the Middle East, featuring premium steaks, seafood and specialty cocktails in an energetic upscale atmosphere.
    • Benihana, an interactive dining destination with highly skilled chefs preparing food right in front of guests and served in an energetic atmosphere alongside fresh sushi and innovative cocktails. The Company franchises Benihanas in the U.S., Caribbean, Central America, and South America.
    • Benihana Express, a small footprint casual concept showcasing the best of Benihana but without teppanyaki tables or bar.
    • Kona Grill, a polished casual, bar-centric grill concept with restaurants in the U.S., featuring American favorites, award-winning sushi, and specialty cocktails in an upscale casual atmosphere.
    • RA Sushi, a Japanese cuisine concept that offers a fun-filled, bar-forward, upbeat, and vibrant dining atmosphere with restaurants in the U.S. anchored by creative sushi, inventive drinks, and outstanding service.
    • Salt Water Social is your gateway to the seven seas, featuring an array of signature and unique fresh seafood items, complemented by the highest quality beef dishes and elegant, delicious cocktails.
    • Samurai, an interactive dining experience located in sunny Miami, FL, provides a distinctive dining experience where skilled personal chefs masterfully perform the ancient art of teppanyaki right before your eyes.
    • ONE Hospitality, The ONE Group’s food and beverage hospitality services business develops, manages and operates premier restaurants and turnkey food and beverage services within high-end hotels and casinos currently operating venues in the U.S. and Europe.

    Additional information about The ONE Group can be found at www.togrp.com.

    Cautionary Statement on Forward-Looking Statements

    This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including with respect to the impact of the Benihana Inc. acquisition, restaurant openings and 2025 financial targets. Forward-looking statements may be identified by the use of words such as “target,” “intend,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements, including but not limited to: (1) our ability to integrate the new or acquired restaurants into our operations without disruptions to operations; (2) our ability to capture anticipated synergies; (3) our ability to open new restaurants and food and beverage locations in current and additional markets, grow and manage growth profitably, maintain relationships with suppliers and obtain adequate supply of products and retain employees; (4) factors beyond our control that affect the number and timing of new restaurant openings, including weather conditions and factors under the control of landlords, contractors and regulatory and/or licensing authorities; (5) our ability to successfully improve performance and cost, realize the benefits of our marketing efforts and achieve improved results as we focus on developing new management and license deals; (6) changes in applicable laws or regulations; (7) the possibility that The ONE Group may be adversely affected by other economic, business, and/or competitive factors, including economic downturns; (8) the impact of actual and potential changes in immigration policies, including potential labor shortages; (9) the potential impact of the imposition of tariffs, including increases in food prices and inflation and any resulting negative impacts on the macro-economic environment; and (10) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q.

    Investors are referred to the most recent reports filed with the Securities and Exchange Commission by The ONE Group Hospitality, Inc. Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and we undertake no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

    Investors:
    ICR
    Michelle Michalski or Raphael Gross
    (646) 277-1224
    Michelle.Michalski@icrinc.com

    Media:
    ICR
    Judy Lee
    (646) 277-1242
    judy.lee@icrinc.com

    Source: The ONE Group Hospitality, Inc.

    Released September 8, 2025