Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
AVERSA Fentanyl Is Moving Forward. Nutriband reported results from 2Q26, ended July 31, 2025, with a loss of $2.12 per share. Revenues for 2Q26 were $0.6 million compared with $0.4 million in 2Q25. The increase was attributed to the expansion of contract manufacturing services in the Pocono Pharma division that produces kinesiology tape. Net loss was $2.0 million before Preferred Dividends of $21.8 million, bringing Net Loss Available To Shareholders to $23.8 million. Cash at the end of the quarter was $6.9 million.
Meeting With The FDA Later In September. The company has scheduled a meeting with the FDA on September 18, 2025, to discuss the upcoming Phase 1 clinical trial for AVERSA Fentanyl. This is a Type C Meeting, requested by the company to discuss product development. The meeting agenda includes the CMC (Chemistry, Manufacturing, and Controls) and other aspects of the Investigational New Drug Application (IND) using the 505(b)(2) route of regulatory approval.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Initiation of coverage with Outperform rating and $20 price target. We are initiating coverage on SEGG Media (NASDAQ: SEGG) with an Outperform rating and $20 target. The company is a development-stage operator of international sports and gaming businesses, anchored by valuable brand assets including Sports.com, Lottery.com, TicketStub.com, and Concerts.com.
Developmental stage. Formed out of Lottery.com’s collapse, SEGG has been reconstituted under new leadership with a defined focus on leveraging globally recognized brands. Management is pursuing an asset-light model combining digital platforms, sports media rights, and consumer venues. We believe this strategy positions SEGG to re-establish credibility and execute a compelling growth plan.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The wave of cryptocurrency-linked companies hitting the public markets this year gained fresh momentum on Friday, as Gemini Space Station made its long-awaited debut on the Nasdaq.
Shares in the exchange, founded by Cameron and Tyler Winklevoss, opened at $37.01 after its initial public offering was priced at $28. Within minutes, the stock soared above $45 before retreating to trade around $35 by mid-afternoon. Even after paring gains, Gemini shares were still up more than 20% from their offering price, valuing the company at roughly $1.5 billion.
The trading session wasn’t without drama. A sharp spike in volatility triggered an automatic 10-minute halt shortly after the open, a common safeguard for new listings experiencing outsized swings.
The offering itself raised approximately $425 million, reflecting robust investor demand. Pricing came in well above early estimates of $17 to $19, which were later raised to $24 to $26. By the time Gemini hit the market, enthusiasm had pushed the IPO into the upper range of expectations.
Gemini enters public trading during an especially fertile period for crypto-related IPOs. In June, stablecoin operator Circle Internet Group priced its shares at $31 before closing its first day at $83. Two months later, fintech exchange Bullish went public at $37 and ended its first session near $68. Just yesterday, Figure Technologies, another blockchain player, surged more than 40% in its debut.
These strong first-day performances reflect a broader investor appetite for digital-asset infrastructure, even amid lingering questions around regulation and long-term adoption. Data shows tech IPOs overall have averaged a 36% first-day return over the past year, but crypto-linked listings have consistently outpaced that benchmark.
For Gemini, the IPO marks both a validation and an expansion opportunity. The firm currently manages more than $21 billion in assets and serves approximately 10,000 institutional clients worldwide. Beyond its core exchange platform, the company has diversified into stablecoins, a U.S. credit card product, and a studio dedicated to nonfungible tokens (NFTs).
The timing is strategic. With digital assets edging closer to mainstream financial adoption and institutional participation rising, public investors are eager to gain direct exposure to companies positioned at the center of this ecosystem. Gemini’s listing provides exactly that.
The company’s trajectory also underscores how far the Winklevoss brothers have come since their early public battles in the tech world. Once known primarily for their legal dispute with Facebook founder Mark Zuckerberg, the twins have steadily built Gemini into a brand synonymous with regulatory compliance, security, and user trust in crypto markets.
As the stock settles in the days ahead, traders and analysts will be watching closely to see whether Gemini can maintain momentum — and whether this latest IPO is another signal that crypto finance is entering a new phase of market maturity.
Barrick Mining Corporation (NYSE:B)(TSX:ABX) has agreed to sell its Hemlo Gold Mine in Ontario, Canada, to Carcetti Capital Corp., which will be renamed Hemlo Mining Corp. (HMC) upon closing. The deal, valued at up to $1.09 billion, underscores Barrick’s ongoing strategy of streamlining its portfolio to focus on Tier One gold and copper assets.
The transaction includes $875 million in cash upon closing, $50 million in HMC shares, and up to $165 million in additional cash payments linked to production and gold prices over a five-year period beginning in 2027. This structured consideration provides Barrick with near-term liquidity while also allowing exposure to Hemlo’s future performance through contingent payments.
HMC, currently listed on the NEX Board of the TSX Venture Exchange, plans to graduate to the main TSXV board in connection with the acquisition. The company is backed by a consortium of well-known investors in the mining sector, including Wheaton Precious Metals and Orion Mine Finance. Its management team brings strong credentials, highlighted by industry veteran Robert Quartermain, who played a role in the original discovery of Hemlo and later built SSR Mining and Pretium Resources into respected gold producers.
For Barrick, the Hemlo divestiture reflects a disciplined capital allocation strategy. Proceeds will be used to strengthen the company’s balance sheet and return capital to shareholders, aligning with its broader plan to prioritize Tier One operations that deliver the largest scale, lowest cost, and longest life. With the sale of Hemlo, alongside earlier transactions involving Donlin and Alturas, Barrick expects to generate more than $2 billion from non-core asset sales in 2025 alone.
Despite the divestment, Canada remains a core part of Barrick’s global footprint. The company continues to advance exploration projects and early-stage opportunities across the country, underscoring its commitment to discovering and developing world-class gold and copper mines within the region.
The sale also positions Hemlo for a new phase of growth under HMC. With dedicated focus, a seasoned leadership team, and the backing of strategic investors, Hemlo may benefit from renewed investment and operational improvements that could unlock further value.
Subject to customary regulatory approvals and closing conditions, the transaction is expected to close in the fourth quarter of 2025. CIBC World Markets acted as Barrick’s financial advisor, while Davies Ward Phillips & Vineberg LLP and Blake, Cassels & Graydon LLP provided legal counsel.
Barrick remains one of the world’s leading gold producers, with a global portfolio spanning 18 countries and six of the industry’s Tier One mines. The Hemlo sale marks the end of a long chapter for Barrick in northern Ontario, while reinforcing its commitment to building shareholder value through operational excellence and portfolio discipline.
U.S. inflation edged higher in August, complicating the Federal Reserve’s decision-making as it prepares for its September policy meeting. The Consumer Price Index (CPI) rose 2.9% year-over-year, up from July’s 2.7% pace, while monthly prices climbed 0.4%—a faster increase than the prior month. The uptick was fueled by persistently high gasoline prices and firmer food costs, underscoring the challenge of controlling inflation while navigating a slowing economy.
Core inflation, which excludes food and energy, held steady at 3.1% year-over-year. On a monthly basis, core prices rose 0.3%, marking the strongest two-month stretch in half a year. Travel and transportation costs stood out as particular pressure points, with airfares jumping nearly 6% in August after a strong gain the previous month. Vehicle prices, both new and used, also reversed earlier declines. Meanwhile, some categories showed moderation, such as medical care and communication services, which provided modest relief.
While the inflation data reflects lingering price pressures, the labor market tells a different story. Weekly jobless claims surged to 263,000—the highest level in nearly four years—suggesting that hiring momentum continues to cool. This comes on the heels of government revisions showing that the economy added 911,000 fewer jobs than previously reported between March 2024 and March 2025. Taken together, the data points to a labor market losing steam even as certain costs remain stubborn.
Markets are betting that the Fed will still cut interest rates next week, with traders pricing in an 88% probability of a quarter-point reduction and an 11% chance of a half-point move. By year-end, expectations remain for a total of 75 basis points in cuts. For policymakers, the dilemma is clear: inflation is not fully under control, but economic softness is becoming too pronounced to ignore.
The inflation numbers also highlight the effect of tariffs imposed by the Trump administration, which are filtering into consumer prices unevenly. Gasoline and travel costs remain elevated, while categories such as lodging and some services show weakness, pointing to households feeling the pinch in essential spending areas. At the same time, producer prices declined 0.1% in August, suggesting that businesses are absorbing some of the additional costs rather than passing them entirely to consumers.
The Federal Reserve now faces a delicate balancing act. Cutting rates too aggressively could risk reigniting inflationary pressures, especially if energy and trade-related costs remain sticky. Moving too cautiously, however, could deepen the strain on employment and consumer confidence, potentially tipping the economy toward recessionary conditions.
Investors are watching closely not only for the rate decision but also for Fed Chair Jerome Powell’s messaging. With both inflation and unemployment data pulling in different directions, the September meeting will serve as a pivotal moment for how the Fed charts its course through a complex and fragile economic backdrop.
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.
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.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Solid Q2 Results. The company reported Q2 revenue of $73.2 million, modestly beating our estimate of $72.0 million, and adj. EBITDA of $6.7 million, which strongly outperformed our estimate of $0.85 million by 685%, as illustrated in Figure #1 Q2 Results. The strong adj. EBITDA was largely driven by management’s ability to execute on its tariff mitigation strategies, resulting in an improved gross profit margin.
Mitigating tariff impacts. Importantly, the company’s gross profit margin increased 300 basis points over the prior year period. The improvement was driven by lower product costing and higher pricing, contributing a 340 basis point improvement, as well as less discounting, which resulted in a 210 basis point improvement. However, the positive margin contributions were softened by tariff and freight impacts of 170 basis points and 100 basis points, respectively.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Lucky Strike Entertainment is one of the world’s premier location-based entertainment platforms. With over 360 locations across North America, Lucky Strike Entertainment provides experiential offerings in bowling, amusements, water parks, and family entertainment centers. The company also owns the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Lucky Strike Entertainment, please visit ir.luckystrikeent.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Strategic update. On September 10, the company announced that its wholly-owned subsidiary Kingpin Intermediate Holdings LLC initiated a private offering of $700 million in new senior secured notes, due in 2032. Concurrently, the company launched a refinancing of its corporate term loan and revolving credit facility. The company expects the initial amount of the refinanced term loan and revolving credit facility to be $1 billion and $400 million, respectively.
Use of capital. Importantly, the net proceeds from the new debt offering and the refinanced credit facilities are earmarked for retiring the company’s existing term loan, revolving credit facility, and bridge loan, which was used to acquire 58 real estate assets in July. Furthermore, the remaining proceeds will be used to fund the company’s strategic initiatives.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Vimeo (NASDAQ: VMEO) has entered into a definitive agreement to be acquired by Bending Spoons in an all-cash transaction valued at approximately $1.38 billion. Under the terms of the deal, Vimeo shareholders will receive $7.85 per share, a price that reflects a 91% premium over the company’s 60-day volume-weighted average stock price as of September 9, 2025.
The decision to sell follows a comprehensive review of strategic options by Vimeo’s board. The agreement positions Vimeo to accelerate its long-term goals while providing shareholders with immediate and certain value. Once the deal is finalized, Vimeo will become a privately held company, and its stock will no longer be traded on public exchanges.
For Vimeo, the acquisition represents both a fresh chapter and a return to its roots. As a public company, it faced increasing pressure to balance growth initiatives with short-term financial expectations. Transitioning to private ownership under Bending Spoons is expected to provide greater flexibility to invest in innovation across self-serve tools, enterprise services, and streaming solutions. The company is also expected to expand its portfolio of AI-enabled features, reflecting the growing role of artificial intelligence in video production, editing, and distribution.
Bending Spoons, headquartered in Milan, has built a reputation for acquiring and scaling digital platforms with global reach. Its portfolio already includes well-known names such as Evernote, WeTransfer, Brightcove, Meetup, and Remini. By adding Vimeo, the company is signaling a strong commitment to video as a cornerstone of digital business. The firm has stated its intention to make significant investments in Vimeo’s operations, particularly in the U.S. and other priority markets, to enhance performance, reliability, and user experience.
The timing of the deal also reflects the rising strategic importance of video platforms. Businesses, creators, and enterprises increasingly rely on video for communication, marketing, and engagement. With demand for professional-grade video tools surging, Vimeo’s integration into the Bending Spoons ecosystem could help it compete more effectively with rivals while scaling globally.
From an investor standpoint, the acquisition delivers a substantial return at a time when Vimeo’s share price had struggled to reflect its long-term potential. The 91% premium on the stock’s recent trading average underscores the confidence Bending Spoons has in Vimeo’s future growth and the value of its established brand and customer base.
The transaction, unanimously approved by Vimeo’s board, is expected to close in the fourth quarter of 2025, pending shareholder approval and regulatory clearance. In the meantime, Vimeo will continue to meet its reporting obligations but will not host a third-quarter earnings call as it transitions toward private ownership.
By aligning with Bending Spoons, Vimeo is expected to gain the resources and strategic support needed to expand its role in the rapidly evolving video market. As global demand for high-quality, AI-driven video solutions continues to rise, this acquisition positions Vimeo for renewed growth and relevance in a highly competitive digital landscape.
Gold is having a remarkable year, climbing 39% year-to-date and setting records as investors increasingly seek safety outside of traditional markets. While the surge has sparked comparisons to past market dislocations, this rally is shaped by a unique combination of monetary policy shifts, debt concerns, and political uncertainty.
At the center of the story is the Federal Reserve. After holding rates at restrictive levels for longer than many expected, the Fed has pivoted toward easing. Markets are now pricing in further rate cuts as inflation cools but economic momentum slows. Lower borrowing costs typically reduce the opportunity cost of holding non-yielding assets like gold, fueling demand. But interest rates alone don’t explain the intensity of this rally.
A bigger factor is the growing anxiety around government debt. The United States, along with Germany, France, and the UK, is facing ballooning debt-to-GDP ratios. Once considered the safest of all havens, government bonds are losing their luster. Investors are increasingly asking: if sovereign debt is no longer risk-free, where should capital be parked? For many, the answer is gold. Unlike paper assets, gold cannot be debased by policy or politics. That reallocation of assets—away from Treasuries and into bullion—is one of the key drivers of today’s market.
Politics has only added fuel. Former President Trump’s legal battle over tariffs, which is now under review by the Supreme Court, could have major consequences. If the Court rejects the tariffs, the U.S. may be forced to refund billions of dollars to trading partners. Such a ruling would undermine the tariff regime entirely, creating both a short-term hit to government finances and long-term uncertainty over trade policy. International companies benefiting from freer trade might welcome the decision, but for the U.S. it could add to fiscal pressures and accelerate debt growth. That prospect strengthens the case for gold as a hedge against political and fiscal instability.
Investors also see echoes of history. In October 1987, during the dot-com bust, and again in the 2008 financial crisis, gold proved resilient when other assets collapsed. Those moments are often described as “black swan” events—rare and unpredictable shocks that reshape markets. Today’s surge suggests investors are bracing for another unforeseen disruption. What’s different this time is that the flight to gold isn’t just a reaction to crisis—it’s happening preemptively, driven by structural concerns over debt, politics, and the durability of fiat money.
The result is an unprecedented rush. For the first time, gold is not just a defensive asset but a proactive store of value that investors are chasing in anticipation of turbulence ahead. With rates heading lower, fiscal balances worsening, and political battles creating new risks, gold has emerged as the one constant—an asset that transcends borders, politics, and policy.
Whether this marks the beginning of a new golden era or simply another speculative peak remains to be seen. But one thing is clear: gold’s role in global markets is being redefined, not as a hedge of last resort, but as a safe haven of first choice.
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
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.”
“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.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
