The Russell 2000 hit a fresh record as investors rotated into small-cap equities on renewed optimism that looser monetary policy could be on the horizon. The benchmark’s leadership reflects a market dynamic in which hopes for easier financial conditions are outweighing pockets of economic strength that have pushed yields higher across parts of the curve.
A string of private and partial data released ahead of the Federal Reserve’s final policy decision for the year painted a mixed picture of the U.S. economy. Weekly payroll indicators showed a marked improvement compared with recent losses, reversing a short stretch of weak readings and signaling that private-sector hiring has regained momentum in recent weeks. Meanwhile, labor demand metrics measuring job openings remained elevated, with vacancies concentrated in sectors such as retail, healthcare, transportation and manufacturing. That combination suggests employers are still searching for workers even as the pace of hiring fluctuates month to month.
Small business sentiment also ticked up, ending a multi-month slide and reflecting firmer revenue expectations and plans to add staff. At the same time, concerns persist about capital spending intentions and tight credit conditions, factors that temper enthusiasm for a broad-based recovery. Taken together, the data show a labor market that remains resilient in parts, but uneven across industries and firm sizes.
Market participants have zeroed in on how the Fed will interpret this mosaic of signals. Stronger-than-expected reads in select indicators have pushed short-term yields higher in a curve-flattening move that suggests traders are re-pricing the odds for near-term policy easing. The level of dissent within the Federal Open Market Committee will be closely watched; a higher number of officials opposing a December cut would signal persistent caution and could damp investor expectations for aggressive easing next year.
The Russell 2000’s rebound is notable because small caps tend to be more sensitive to financial conditions and credit availability. In an environment where rate-cut prospects rise, borrowing costs for smaller companies fall relative to a no-cut scenario, improving the outlook for earnings growth and refinancing. That dynamic has attracted reallocations away from megacap tech names and toward cyclical and domestically focused firms that stand to benefit from cheaper financing and a healthier consumer.
Yet the backdrop is not without risk. A recent pick-up in yield volatility and signs that some central banks are nearing the end of their easing cycles in other economies add uncertainty for global liquidity. Additional data surprises could quickly recalibrate expectations, and market pricing already reflects a degree of vulnerability to upside surprises in inflation or employment.
For investors, the current market action underscores the importance of monitoring both macro signals and monetary policy cues. Small caps have led the charge on the upside, but their outperformance is tied to the narrative of easier policy ahead. Should that narrative unravel, leadership could shift again.
As the Fed approaches its next meeting, markets will continue to weigh the tug of mixed economic data against the growing desire for lower interest rates. The Russell 2000’s new high is as much a reflection of positioning for future policy as it is a barometer of confidence in the domestic economic cycle.
SpaceX’s potential IPO is shaping up to be one of the most pivotal market events of the decade, with implications that reach far beyond the company itself. Analysts estimate that a SpaceX listing could help unlock nearly $3 trillion worth of value tied up in large private companies that have avoided the public markets for years. The anticipation surrounding this single event is already pushing investors, bankers, and late-stage startups to rethink the divide between private and public valuations.
After the blockbuster IPO wave of 2021, the market grew unusually quiet. Many of the world’s most valuable private companies, including SpaceX, Stripe, and ByteDance, chose to continue raising funds privately. This allowed them to grow far larger than the typical public-market debutant while sidestepping the scrutiny of quarterly reporting. SpaceX sits at the top of this group, with private valuations ranging from $800 billion to a possible $1.5 trillion. A listing of that size would instantly become the largest in history and would test the limits of both investor appetite and market infrastructure.
Despite the concerns, the demand appears strong. SpaceX is viewed as a company that combines scale, technological leadership, and global relevance. Its advancements in reusable rockets, crewed orbital launches, and satellite internet have created capabilities unmatched in the private sector. Starlink alone now provides high-speed connectivity to millions of users, and the company’s planned direct-to-cell network has gained additional momentum through strategic spectrum acquisitions.
The company’s revenue trajectory adds to the optimism. Estimates place 2025 revenue at roughly $15 billion, with expectations of reaching more than $22 billion the following year. These figures put SpaceX among the highest-earning private firms in the world, though some observers argue that such revenue still leaves questions about trillion-dollar valuations. For many investors, the financials need to support not only growth but also profitability and scale under the discipline of the public markets.
Governance is another area under scrutiny. SpaceX operates in a unique position, driven by an aggressive engineering culture and long-term missions that include the development of Starship and eventual human flights to Mars. These projects are capital-intensive and often involve timelines that do not align naturally with short-term shareholder expectations. Going public would introduce new oversight, regulatory obligations, and investor influence, potentially altering the company’s traditionally independent operating style.
Another open question is what path SpaceX might take to enter the public markets. A traditional IPO would require raising tens of billions of dollars if even a small percentage of the company were sold. Some market participants believe a direct listing could be more practical, especially for a company that does not need to raise fresh capital and already has a large institutional shareholder base.
Regardless of the route, a SpaceX listing in 2026 would represent a watershed moment. It could reopen the window for many large private firms that have delayed going public and force a reevaluation of how extreme private-market valuations translate to public markets. If successful, it may trigger a wave of mega-IPOs that reshape market dynamics for years to come.
NEW YORK–(BUSINESS WIRE)– Vince Holding Corp. (Nasdaq: VNCE) (“VNCE” or the “Company”), a global contemporary retailer, today reported its financial results for the third quarter ended November 1, 2025.
Brendan Hoffman, Chief Executive Officer of VNCE said, “We are extremely proud of our third quarter performance, delivering healthy sales growth across all channels while exceeding expectations for both top and bottom line results. Our direct-to-consumer segment is showing broad-based strength benefiting from enhancements we have made to the customer experience. This includes the store renovations from earlier this year, as well as an e-commerce site refresh, increased marketing support, and the launch of drop-ship capabilities expanding the breadth and depth of our assortment online in the third quarter. This momentum has continued into the fourth quarter with a record holiday sales weekend in direct-to-consumer. As we look ahead, I’m more confident than ever in our trajectory as we successfully balance disciplined execution with strategic reinvestment to position the Vince Holding Corp. platform for sustained long-term profitable growth.”
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 third quarter ended November 1, 2025:
Total Company net sales increased 6.2% to $85.1 million compared to $80.2 million in the third quarter of fiscal 2024. The year-over-year increase was driven by a 6.7% increase in the wholesale segment and a 5.5% increase in direct-to-consumer segment.
Gross profit was $41.9 million, or 49.2% of net sales, compared to gross profit of $40.1 million, or 50.0% of net sales, in the third quarter of fiscal 2024. The decrease in gross margin rate was primarily driven by approximately 260 basis points due to the unfavorable impact of higher tariffs and approximately 100 basis points due to increased freight costs, partially offset by a 140 basis points increase due to the favorable impact of lower product costing and higher pricing, and approximately 110 basis points due to the favorable impact of lower discounting.
Selling, general, and administrative expenses were $36.5 million, or 42.8% of sales, compared to $34.3 million, or 42.8% of sales, in the third quarter of fiscal 2024. The increase in SG&A dollars was primarily driven by compensation and benefits and marketing and advertising costs.
Income from operations was $5.4 million compared to income from operations of $5.8 million in the same period last year.
Income tax expense was $2.0 million compared to an income tax expense of $0 in the same period last year. The increase is due to the impact of applying the Company’s estimated annual effective tax rate to the year-to-date ordinary pre-tax income. In the prior comparative period, the Company had year-to-date ordinary pre-tax losses for the interim period and as such, the Company did not record any tax expense.
Net income was $2.7 million or $0.21 per diluted share compared to net income of $4.3 million or $0.34 per diluted share in the same period last year.
Adjusted EBITDA* was $6.5 million compared to $7.4 million in the same period last year.
The Company ended the quarter with 60 company-operated Vince stores, a net decrease of 1 store since the third quarter of fiscal 2024.
Third Quarter Review
Net sales increased 6.2% to $85.1 million as compared to the third quarter of fiscal 2024.
Wholesale segment sales increased 6.7% to $52.0 million compared to the third quarter of fiscal 2024.
Direct-to-consumer segment sales increased 5.5% to $33.1 million compared to the third quarter of fiscal 2024.
Income from operations excluding unallocated corporate expenses was $19.6 million compared to income from operations of $18.8 million in the same period last year.
Balance Sheet
At the end of the third quarter of fiscal 2025, total borrowings under the Company’s debt agreements totaled $36.1 million and the Company had $47.3 million of excess availability under its revolving credit facility.
Net inventory at the end of the third quarter of fiscal 2025 was $75.9 million compared to $63.8 million at the end of the third quarter of fiscal 2024. The year-over-year increase in inventory includes approximately $4.2 million of higher inventory carrying value due to tariffs.
During the quarter ended November 1, 2025, the Company issued and sold 370,878 shares of common stock under the Virtu At-the-Market Offering for aggregate net proceeds of $1,291 at an average price of $3.55 per share. 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 fourth quarter of fiscal 2025 the Company expects the following:
Net sales to increase approximately 3% to 7% compared to the prior year period.
Adjusted operating income as a percentage of net sales to be approximately 0% to 2%.
Adjusted EBITDA as a percentage of net sales to be approximately 2% to 4%.
For fiscal 2025 the Company expects the following:
Net sales to increase approximately 2% to 3% compared to the prior year.
Adjusted operating income as a percentage of net sales to be approximately 2% to 3%.
Adjusted EBITDA as a percentage of net sales to be approximately 4% to 5%.
The above guidance for the fourth quarter of fiscal 2025 assumes $4 million to $5 million in expected incremental tariff costs, of which the Company expects to continue to partially offset through its mitigation strategies.
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 nine months ended November 1, 2025 and November 2, 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 nine months ended November 1, 2025 and November 2, 2024, respectively, the Company has provided adjusted income from operations, adjusted income (loss) before income taxes and equity in net income of equity method investment, adjusted income before equity in net income of equity method investment, adjusted net income, and adjusted earnings 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 third quarter results will be held today, December 9, 2025, at 8:30 a.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 579552. 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 46 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 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.
Patent Protects Novel Application of Gedeptin Therapy Across Multiple Solid Tumor Types; Supports Expansion of Gedeptin Product Platform
ATLANTA, GA – December 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against cancers and infectious diseases, today announced the issuance of U.S. Patent No. 12,453,760, titled “Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug”, by the United States Patent and Trademark Office (USPTO). The patent provides composition-of-matter and method-of-use protection for GeoVax’s Gedeptin® platform in combination with targeted delivery approaches for solid tumors, including head and neck cancer.
The newly issued patent, which extends through 2045, enhances the Company’s intellectual property estate for Gedeptin and its use across a range of solid tumor cancers — consolidating GeoVax’s leadership in the field of targeted gene therapies and supporting ongoing clinical development plans.
“The issuance of this patent marks an important milestone in the advancement and protection of GeoVax’s oncology pipeline,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “It underscores our commitment to progressing Gedeptin, both as a monotherapy and in synergistic combination with other oncology treatment approaches as we work to deliver meaningful treatment options for patients with difficult-to-treat solid tumors.”
The Company is actively preparing for a Phase 2 clinical trial evaluating Gedeptin as a first-line therapy in combination with pembrolizumab (Keytruda®) in resectable head and neck cancer, in line with the recent shift toward neoadjuvant checkpoint strategies. Additional preclinical programs are assessing Gedeptin across other tumor types, including breast and cutaneous cancers.
About Gedeptin®
Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) designed for targeted use in solid tumors. Delivered via a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP) and followed by systemic fludarabine, Gedeptin generates localized cytotoxic activity within tumors while minimizing systemic toxicity. The therapy has demonstrated safety and disease control in a multi-center Phase 1/2 trial in patients with advanced head and neck cancer and has received FDA Orphan Drug Designation for oral and pharyngeal cancers.
GeoVax plans to advance Gedeptin into a Phase 2 trial in combination with pembrolizumab (Keytruda®) as a neoadjuvant regimen for resectable head and neck squamous cell carcinoma, supported by recent clinical data validating the role of immune checkpoint inhibitors in perioperative settings. Additional preclinical work is underway to assess Gedeptin combinations across other solid tumors.
Key Advantages of Gedeptin
Localized, tumor-selective cytotoxicity
Tumor agnostic – expansion potential across multiple solid tumors
Synergistic potential with checkpoint inhibitors
Favorable safety profile and orphan drug designation
Strong patent protection through 2045
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industry
CHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix’s legal, corporate governance, and compliance functions.
“Irina is a highly accomplished corporate and commercial attorney whose experience spans public and private life sciences companies, as well as advising life sciences investors,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “Her deep background in complex transactions, public company matters, and governance will be a significant asset as we commercialize our marketed products, advance our pipeline, manage our partnerships, and continue to execute on Tonix’s long-term strategy.”
Ms. Ishak joins Tonix from Lowenstein Sandler LLP, where she served since 2013 as Senior Counsel, and has advised Tonix since 2017 in structuring and negotiating financings, licensing and other strategic transactions, key commercial agreements, and employment-related contracts, and advising senior management and the Board of Directors on corporate strategy, governance, risk, and securities offerings and filings. In addition to Tonix, Ms. Ishak acted as outside general counsel, corporate secretary, and advisor to certain other public and private life sciences companies, as well as to investors. Previously, she was Senior Director, Legal and Assistant Corporate Secretary at Savient Pharmaceuticals, Inc., which developed, won US Food and Drug Administration (FDA) approval for, and launched KRYSTEXXA® (pegloticase), a biologic treatment for chronic gout in adults. Earlier in her career Ms. Ishak was a corporate associate at Fried, Frank, Harris, Shriver & Jacobson LLP. She received her J.D. from New York University School of Law and her B.A., with highest honors, from Rutgers College in New Brunswick, N.J.
“I am honored to join Tonix as General Counsel at such a pivotal moment in the Company’s evolution,” said Ms. Ishak. “Tonix has just launched the first therapy approved by the FDA for treating fibromyalgia in more than 15 years. Now the company is maximizing that science to expand into other conditions. It’s an exciting time at Tonix and there is immense opportunity to make a valuable contribution. I look forward to working closely with Seth, the leadership team, and the Board to support the Company’s next phase of growth.”
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication under development.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
VIRGINIA CITY, NEVADA, December 9, 2025 — Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) and Comstock Metals LLC (“Comstock Metals”), a leader in the responsible recycling of end-of-life solar panels with the only certified, North American, zero-landfill solution, announced today that Comstock Metals has been recognized for exceptional growth, innovation, workforce excellence, and community partnerships that strengthen and diversify the regional economy.
“Comstock has historic and genuine roots in the communities of northern Nevada, and we are honored with EDAWN’s recognition of our continued commitment to innovation, growth and sustainability in the region,” stated Corrado De Gasperis, Comstock’s Executive Chairman and CEO. “Our team’s dedication to excellence, combined with our rapidly growing investments in the region’s workforce and community, reflects our longstanding belief in the tremendous potential of this area. This award affirms our mission to help build a sustainable and thriving future for northern Nevada.”
Comstock Metals was also honored to receive official recognition from U.S. Senator Catherine Cortez Masto, U.S. Senator Jacky Rosen, and Nevada Governor Joe Lombardo. Their acknowledgments celebrate Comstock Metals achievements, leadership, and ongoing commitment to the people and economy of northern Nevada. This recognition from the Nevada leadership further recognizes the positive impact of Comstock Metals’ continued investment, innovation, and public-private partnerships within all of the communities of northern Nevada.
“Comstock Metals has positioned itself in the absolute best Nevada locations, for serving the southwest region of the U.S., where tens and ultimately hundreds of millions of end-of-life solar panels will otherwise endanger our lands, water and community ecosystems,” stated Dr. Fortunato Villamagna, President of Comstock Metals. “Our solutions cleanly repurpose and reuse all of these materials and prevent these hazardous wastes from contaminating our communities.”
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies, systems and supply chains that enable, support and sustain clean energy systems by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable metals, like silver, aluminum, gold, and other critical minerals, primarily from end-of-life photovoltaics. To learn more, please visit www.comstock.inc.
Comstock Social Media Policy
Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Contacts
For investor inquiries: Judd B. Merrill, Chief Financial Officer Tel (775) 413-6222 ir@comstockinc.com
For media inquiries: Zach Spencer, Director of External Relations Tel (775) 847-7573 media@comstockinc.com
Forward-Looking Statements
This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; divestitures, spin-offs or similar distribution transactions, future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, divestitures, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.
Michael Burry, the famed investor known for predicting the 2008 housing market crash, is once again at the center of attention — this time for a surprisingly bullish stance on Fannie Mae and Freddie Mac. In a lengthy blog post published Monday, Burry revealed he holds sizable positions in both government-sponsored enterprises and believes their long-awaited return to public markets may be close. The disclosure has fueled excitement among investors who have followed the Fannie and Freddie saga for more than a decade.
According to Burry, a relisting of the mortgage-finance giants is “nearly upon us.” His detailed post explored the political, regulatory, and financial steps that must occur before the companies can be fully released from government control. Both Fannie Mae and Freddie Mac were placed into conservatorship during the 2008 crisis, and since then, multiple administrations have debated how to reform or privatize them. Burry argues that conditions are finally shifting toward a path back to Wall Street.
Michael Burry’s renewed interest in the housing-finance sector is significant given his historical role in identifying weaknesses in the mortgage market before the financial collapse. He reminded readers of this history by including excerpts from an older note in which he criticized the agencies and described his earlier investments in credit-default swaps tied to their debt. This time, however, Burry says he did not become bullish on their common stock until after Donald Trump’s presidential win last year, which he believes increased the likelihood of policy changes that benefit shareholders.
In the post, Burry stated that he owns both Fannie Mae and Freddie Mac common stock “in good size,” and suggested that the offering price in any IPO will play a major role in determining their true intrinsic value. He highlighted three major changes regulators would need to make before a public offering could occur: easing capital requirements, converting certain preferred shares into common stock, and reducing the government’s senior claims on future profits. Without addressing the last issue, Burry warned that common shares could be “worthless.”
Despite the optimism, he also cautioned that the path to an IPO remains “steep, windy, and rocky,” noting that the political process could still slow progress. Shares of Fannie Mae and Freddie Mac reacted positively to his commentary, rising more than 3% on Tuesday and gaining over 15% so far this month. The stocks, which trade over-the-counter, remain highly volatile as investors digest shifting expectations.
Burry’s views arrive shortly after longtime shareholder Bill Ackman proposed a plan on social media to relist the companies on the New York Stock Exchange. Meanwhile, analysts such as Bose George at Keefe Bruyette & Woods remain cautious, arguing that common shareholders still face significant downside risks if reforms stall or if the government opts to convert preferred shares in a way that dilutes existing holders.
Whether Michael Burry’s thesis proves correct remains to be seen, but his involvement has injected new momentum into one of the most closely watched restructuring stories in U.S. finance.
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.
Discussions Of Clinical Trials, Regulatory Developments, Partnerships. NeuroSense held a webinar to review recent regulatory developments related to its Phase 3 PARAGON trial, early approval for ALS in Canada, the Phase 2 study in Alzheimer’s Disease, and product partnerships. There was also a detailed discussion of the Phase 3 PARAGON trial design and milestones for the coming year.
Phase 3 PARAGON Trial Is Expected To Begin In Mid-2026. NeuroSense has received clearance from the FDA to begin the Phase 3 trial testing PrimeC in ALS (Amyotrophic Lateral Sclerosis). The trial design is based on the data from the Phase 2b PARDIGM trial that showed improved survival with biomarkers correlating with slowing disease progression and reduction in markers of the disease process.
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.
Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Bioleum Expands Feedstock Capabilities with Hexas Acquisition. Bioleum Corporation, of which Comstock is a strategic investor, acquired Hexas Biomass Inc. for approximately $6.5 million in stock, cash, and convertible debt, securing ownership of all Hexas intellectual property and associated high-yield energy crop technologies. Hexas’ crops deliver 25–30 dry metric tons per acre, above conventional forestry yields, and can be cultivated on marginal lands without competing with food production. When paired with Bioleum’s refining platform, these crops enable production of more than 100 barrels of biofuel per acre per year, strengthening long-term supply certainty and improving economics for Bioleum’s facilities.
Strategic Value of an Integrated Feedstock Model. Bioleum expects Hexas’ scalable, low-cost feedstock model to “anchor” each refinery deployment, reducing regional biomass variability and improving reliability, pricing, and throughput across its system. Management emphasized that pairing purpose-grown crops with Bioleum’s refining technology materially improves risk-adjusted economics across future projects and accelerates commercialization.
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.
Office Depot, Inc., together with its subsidiaries, supplies a range of office products and services. It offers merchandise, such as general office supplies, computer supplies, business machines and related supplies, and office furniture through its chain of office supply stores under the Office Depot, Foray, Ativa, Break Escapes, Worklife, and Christopher Lowell brand names. The company also provides graphic design, printing, reproduction, mailing, shipping, and other services through design, print, and ship centers. It has operations throughout North America, Europe, Asia, and Central America. The company also sells its products and services through direct mail catalogs, contract sales force, Internet sites, and retail stores, through a mix of company-owned operations, joint ventures, licensing and franchise agreements, alliances, and other arrangements. As of December 31, 2008, Office Depot operated 1,267 North American retail division office supply stores and 162 international division retail stores, as well as participated under licensing and merchandise arrangements in 98 stores. The company was founded in 1986 and is based in Boca Raton, Florida.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Acquisition Approved. On December 5th, The ODP Corporation held a special meeting of stockholders at which holders of ODP’s common stock approved the acquisition of ODP by an affiliate of Atlas Holdings for $28 per share. With shareholder approval, the acquisition is expected to be completed on December 10th, at which time ODP common shares will cease to trade.
Details. Of the 30,117,856 shares of ODP Common Stock issued and outstanding at the close of business on October 21, 2025, the record date for the ODP Special Meeting, 22,656,187 shares were present or represented by proxy at the ODP Special Meeting. A total of 22,540,259 shares voted in favor of the acquisition.
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.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
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.
NobleCon21. On December 3rd, management presented at NobleCon21 at Florida Atlantic University (FAU) in Boca Raton, Florida. The presentation, conducted by Heidi Chow, CFO, and Jim Tsai, Board Member and Advisor, highlighted the company’s established franchise strength, near-term catalysts, and its Stablecoin strategy. A replay of the presentation can be viewed here.
Sustainable franchise power. The company’s core franchise is ARK, a premier survival game with over 4.2 billion hours played. This franchise provides a durable revenue base through game sales, downloadable content (DLC) sales, and in-game purchases. Notably, a favorable near-term catalyst is the release of the Lost Colony DLC, which demonstrated strong pre-sales since June.
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.
Saga Communications, Inc. is a broadcast company whose business is primarily devoted to acquiring, developing and operating radio stations. Saga currently owns or operates broadcast properties in 27 markets, including 79 FM and 33 AM radio stations. Saga’s strategy is to operate top billing radio stations in mid sized markets, defined as markets ranked (by market revenues) from 20 to 200. Saga’s radio stations employ a myriad of programming formats, including Active Rock, Adult Album Alternative, Adult Contemporary, Country, Classic Country, Classic Hits, Classic Rock, Contemporary Hits Radio, News/Talk, Oldies and Urban Contemporary. In operating its stations, Saga concentrates on the development of strong decentralized local management, which is responsible for the day-to-day operations of the stations in their market area and is compensated based on their financial performance as well as other performance factors that are deemed to effect the long-term ability of the stations to achieve financial objectives. Saga began operations in 1986 and became a publicly traded company in December 1992. The stock trades on NASDAQ under the ticker symbol “SGA”.
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.
NobleCon21. On December 3rd, management presented at NobleCon21 at Florida Atlantic University (FAU) in Boca Raton, Florida. The presentation, conducted by Sam Bush, CFO, and Chris Forgi, President & CEO, highlighted the company’s digital pivot, pristine balance sheet, and capital return strategy. A replay of the presentation can be viewed here.
Hyper-local focus. The company operates in 27 small-to-medium markets, which allows for deep integration with local advertisers. Furthermore, the company is positioned as a trustworthy guide in a confusing digital ad landscape, offering simple and consistent messaging across both traditional radio and digital mediums, utilizing its unique blended approach.
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.
Phase 1/2 trial confirms safety with repeated dosing supporting further development in early-stage disease and combination treatment settings
ATLANTA, GA – December 8, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing novel immunotherapies and vaccines for solid tumor cancers and infectious diseases, today announced the publication of a peer-reviewed article in JCO Oncology Advances, the American Society of Clinical Oncology’s (ASCO) open-access journal.
The manuscript, titled “A Phase 1/2 Study of Intratumoral Ad/PNP (Gedeptin) with Fludarabine Phosphate in Subjects with Recurrent Head and Neck Cancer”, reports findings from a multi-center clinical trial evaluating repeated cycles of Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT), administered via intratumoral injection followed by systemic fludarabine.
Study Overview: Evaluating Repeated Dosing in a Highly Refractory Population
The Phase 1/2 trial enrolled patients with recurrent head and neck cancers who had exhausted all standard treatment options and had undergone a median of four prior lines of systemic therapy. Patients received therapy on a 28 day schedule, each consisting of intratumoral Gedeptin injections followed by intravenous fludarabine.
Key results from the publication include:
Acceptable safety profile with no new safety signals: Serious adverse events were uncommon and generally unrelated to treatment. No deaths were attributed to study therapy.
Clinical evidence of disease stability: Three of eight patients (37.5%) in this cohort of patients with end-stage disease achieved stable disease.
Successful tumor transduction and PNP transgene expression: Tumor biopsies confirmed uptake and expression of the therapeutic E. coli PNP transgene in all evaluable patients, supporting the mechanistic foundation of the Gedeptin platform.
Study results suggest that earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy (e.g., with immune checkpoint inhibitors) may further increase efficacy. Preclinical findings cited in the manuscript show that Gedeptin-mediated tumor destruction may sensitize tumors to checkpoint inhibitors, offering a promising path forward.
J. Marc Pipas, MD, Executive Medical Director, Oncology of GeoVax, stated: “This publication reinforces the strong scientific rationale underpinning the Gedeptin platform. Even in a highly refractory patient population with extensive prior treatment, repeated intratumoral dosing of Gedeptin demonstrated a favorable safety profile and evidence of disease stability. Importantly, correlative analyses confirmed robust tumor transduction and PNP expression, a critical mechanistic milestone for gene-directed enzyme prodrug therapy.”
Kelly T. McKee, MD, MPH, Chief Medical Officer of GeoVax, added: “These results support the continued development of Gedeptin in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies, particularly with immune checkpoint inhibitors, may amplify therapeutic benefit. This aligns with our strategy to advance Gedeptin into neoadjuvant studies for surgically resectable recurrent head and neck cancers.”
David Dodd, Chairman & CEO of GeoVax, stated: “The publication in the ASCO journal underscores both the scientific significance of this trial and the need for new approaches to treat recurrent head and neck cancers. Gedeptin’s targeted mechanism, combined with its repeat-dosing feasibility, offers a promising therapeutic option for patients. We look forward to expanding development into earlier disease settings and into rational combination regimens.”
About the Gedeptin® Platform
Gedeptin is a non-replicating adenoviral vector delivering the E. coli purine nucleoside phosphorylase (PNP) gene directly into tumor tissue. Following intratumoral injection, patients receive systemic fludarabine, which is converted in PNP-expressing tumor cells into a potent cytotoxic metabolite (2-fluoroadenine, F-Ade).
Key characteristics include:
Tumor-agnostic mechanism of action, driven by localized intratumoral activation of fludarabine into the potent cytotoxin F-Ade, enabling activity independent of tumor histology or proliferation rate.
Strong bystander effect, in which the activated F-Ade diffuses to neighboring cancer cells – allowing Gedeptin to kill tumor cells even when only a small fraction is directly transduced.
Immune-sensitizing properties that enhance tumor antigen visibility and may improve responses to immune checkpoint inhibitors.
Favorable safety profile, demonstrated across early Phase 1 and Phase 1/2 studies and supported by consistent tolerability in heavily pretreated solid tumor patients.
Gedeptin is now progressing toward combination-therapy in a neoadjuvant clinical program. Building on robust preclinical data showing that Gedeptin enhances tumor sensitivity to immune checkpoint blockade, GeoVax is advancing plans to evaluate Gedeptin with agents such as pembrolizumab aiming to strengthen antitumor immune activation.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumors. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received mRNA vaccines. In oncology, the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
