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<a href="https://www.geovax.com/investors/press-releases/geovax-announces-british-journal-of-haematology-publication-highlighting-superior-t-cell-responses-of-geo-cm04s1-in-cll-patients#"></a>



DSMB Ends Comparator Arm; Trial Proceeds Exclusively With GEO-CM04S1 Following mRNA Vaccine’s Failure to Meet Primary Endpoint



Phase 2 Data Reinforce GEO-CM04S1 as an Important Next-generation Vaccine Candidate for the 40 Million U.S. and 400 Million Global Immunocompromised Patients Underserved by First-generation COVID-19 Vaccines



ATLANTA, GA - December 15, 2025 -&nbsp;GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced the publication of interim Phase 2 clinical data on its next-generation COVID-19 vaccine in patients with chronic lymphocytic leukemia (CLL). &nbsp;



The Research Letter in the&nbsp;British Journal of Haematology&nbsp;reports that GEO-CM04S1 met the study’s primary immunologic endpoint, generating significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 (Pfizer-BioNTech) in patients with chronic lymphocytic leukemia (CLL) - a population known for poor vaccine responsiveness.



Importantly, following interim analysis, the trial’s Data and Safety Monitoring Board (DSMB) ruled to discontinue the randomized, double-blind comparator arm after the mRNA vaccine failed to meet the predefined primary immunogenicity endpoint. Enrollment is now proceeding exclusively in a single-arm cohort receiving GEO-CM04S1, as previously described in GeoVax’s clinical update at the European Hematology Association (EHA) 2025 Conference.



GEO-CM04S1’s superior performance in enhancing cellular immune response against SARS-CoV-2 in individuals with CLL, a patient population that generally responds sub optimally to vaccines designed to induce humoral (antibody) responses, underscores its potential to fill a protection gap for profoundly immunocompromised patients. More than 40 million adults in the U.S. and 400 million globally have some degree of compromised immunity, many of whom fail to mount meaningful responses to currently authorized COVID-19 vaccines. GEO-CM04S1 is specifically designed to address this gap through its dual-antigen (Spike + Nucleocapsid), MVA-based platform, which promotes robust, durable T-cell responses that are less impacted by immune dysfunction and viral variation.



Phase 2 Study Overview (NCT05672355)



<ul class="wp-block-list">
<li>CLL patients previously vaccinated with mRNA vaccines</li>



<li>31 enrolled; 27 evaluable for primary analysis</li>



<li>Primary endpoint: ≥3-fold rise in antigen-specific IFN-γ–secreting T cells at Day 56</li>



<li>Assessments: T-cell responses, binding/neutralizing antibodies, safety</li>



<li>No Grade ≥3 adverse events reported</li>
</ul>



Key Findings Published in&nbsp;BJH



1. GEO-CM04S1 achieved superior T-cell responses



<ul class="wp-block-list">
<li>40% of GEO-CM04S1 recipients met the primary endpoint vs. 14.3% for BNT162b2</li>



<li>Higher Spike-specific IFN-γ responses at Days 28, 56, and 84</li>
</ul>



2. Durable activation of Nucleocapsid-specific T cells



<ul class="wp-block-list">
<li>~10-fold higher N-specific CD4 T-cell activation vs. BNT162b2</li>



<li>Responses maintained through Day 180</li>
</ul>



3. Broader immune engagement in spite of CLL-associated humoral defects



<ul class="wp-block-list">
<li>GEO-CM04S1 generated sustained N-IgG and a correlation between N-specific antibodies and T-cell activation</li>



<li>mRNA vaccination produced higher early RBD-IgG titers but limited cellular immunity</li>
</ul>



Kelly T. McKee, MD, MPH, Chief Medical Officer, stated: “These results demonstrate GEO-CM04S1’s ability to address the immune limitations of CLL patients by inducing strong, durable T-cell responses to both spike and nucleocapsid proteins of SARS-CoV-2. The DSMB’s decision to discontinue the comparator arm further validates the vaccine’s clinical relevance for immunocompromised individuals.”



David Dodd, Chairman &amp; CEO, added: “With more than 40 million immunocompromised Americans, many of whom lack durable protection from first-generation vaccines, GEO-CM04S1 represents a purpose-built solution for high-risk patients. This peer-reviewed publication strengthens our regulatory and partnering strategy as we advance toward potential commercialization.”



Medical and Commercial Significance



The findings published in&nbsp;BJH, combined with the DSMB’s action, reinforce the value of the differentiated profile of GEO-CM04S1 across multiple dimensions:



<ol start="1" class="wp-block-list">
<li>Critical unmet need: Immunocompromised individuals remain vulnerable and, in many cases, sub optimally protected from the threat of SARS-CoV-2.</li>



<li>Multi-antigen design: GEO-CM04S1’s dual-antigen design stimulates immune responses that appear to be more durable and variant-resilient than single-antigen mRNA approaches.</li>



<li>These segments represent a $30B+ annual potential commercial market.</li>
</ol>



About GEO-CM04S1



GEO-CM04S1 is a dual-antigen MVA-vectored COVID-19 vaccine being evaluated in multiple Phase 2 trials, including a primary vaccination for immunocompromised individuals, and a booster vaccination for CLL patients.



The vaccine has generated robust immune responses in difficult-to-vaccinate populations including CAR-T and stem-cell transplant recipients, who typically fail to respond well to first-generation vaccines.



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:&nbsp;<a href="http://www.geovax.com/">www.geovax.com</a>.



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.



Company Contact:



<a href="mailto:info@geovax.com">info@geovax.com</a>



678-384-7220



Media Contact:



Jessica Starman



<a href="mailto:media@geovax.com">media@geovax.com</a>&nbsp;

Research News and Market Data on GOVX 







DSMB Ends Comparator Arm; Trial Proceeds Exclusively With GEO-CM04S1 Following mRNA Vaccine’s Failure to Meet Primary Endpoint



Phase 2 Data Reinforce GEO-CM04S1 as an Important Next-generation Vaccine Candidate for the 40 Million U.S. and 400 Million Global Immunocompromised Patients Underserved by First-generation COVID-19 Vaccines



ATLANTA, GA &#8211; December 15, 2025 &#8211;&nbsp;GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced the publication of interim Phase 2 clinical data on its next-generation COVID-19 vaccine in patients with chronic lymphocytic leukemia (CLL). &nbsp;



The Research Letter in the&nbsp;British Journal of Haematology&nbsp;reports that GEO-CM04S1 met the study’s primary immunologic endpoint, generating significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 (Pfizer-BioNTech) in patients with chronic lymphocytic leukemia (CLL) &#8211; a population known for poor vaccine responsiveness.



Importantly, following interim analysis, the trial’s Data and Safety Monitoring Board (DSMB) ruled to discontinue the randomized, double-blind comparator arm after the mRNA vaccine failed to meet the predefined primary immunogenicity endpoint. Enrollment is now proceeding exclusively in a single-arm cohort receiving GEO-CM04S1, as previously described in GeoVax’s clinical update at the European Hematology Association (EHA) 2025 Conference.



GEO-CM04S1’s superior performance in enhancing cellular immune response against SARS-CoV-2 in individuals with CLL, a patient population that generally responds sub optimally to vaccines designed to induce humoral (antibody) responses, underscores its potential to fill a protection gap for profoundly immunocompromised patients. More than 40 million adults in the U.S. and 400 million globally have some degree of compromised immunity, many of whom fail to mount meaningful responses to currently authorized COVID-19 vaccines. GEO-CM04S1 is specifically designed to address this gap through its dual-antigen (Spike + Nucleocapsid), MVA-based platform, which promotes robust, durable T-cell responses that are less impacted by immune dysfunction and viral variation.



Phase 2 Study Overview (NCT05672355)




CLL patients previously vaccinated with mRNA vaccines



31 enrolled; 27 evaluable for primary analysis



Primary endpoint: ≥3-fold rise in antigen-specific IFN-γ–secreting T cells at Day 56



Assessments: T-cell responses, binding/neutralizing antibodies, safety



No Grade ≥3 adverse events reported




Key Findings Published in&nbsp;BJH



1. GEO-CM04S1 achieved superior T-cell responses




40% of GEO-CM04S1 recipients met the primary endpoint vs. 14.3% for BNT162b2



Higher Spike-specific IFN-γ responses at Days 28, 56, and 84




2. Durable activation of Nucleocapsid-specific T cells




~10-fold higher N-specific CD4 T-cell activation vs. BNT162b2



Responses maintained through Day 180




3. Broader immune engagement in spite of CLL-associated humoral defects




GEO-CM04S1 generated sustained N-IgG and a correlation between N-specific antibodies and T-cell activation



mRNA vaccination produced higher early RBD-IgG titers but limited cellular immunity




Kelly T. McKee, MD, MPH, Chief Medical Officer, stated: “These results demonstrate GEO-CM04S1’s ability to address the immune limitations of CLL patients by inducing strong, durable T-cell responses to both spike and nucleocapsid proteins of SARS-CoV-2. The DSMB’s decision to discontinue the comparator arm further validates the vaccine’s clinical relevance for immunocompromised individuals.”



David Dodd, Chairman &amp; CEO, added: “With more than 40 million immunocompromised Americans, many of whom lack durable protection from first-generation vaccines, GEO-CM04S1 represents a purpose-built solution for high-risk patients. This peer-reviewed publication strengthens our regulatory and partnering strategy as we advance toward potential commercialization.”



Medical and Commercial Significance



The findings published in&nbsp;BJH, combined with the DSMB’s action, reinforce the value of the differentiated profile of GEO-CM04S1 across multiple dimensions:




Critical unmet need: Immunocompromised individuals remain vulnerable and, in many cases, sub optimally protected from the threat of SARS-CoV-2.



Multi-antigen design: GEO-CM04S1’s dual-antigen design stimulates immune responses that appear to be more durable and variant-resilient than single-antigen mRNA approaches.



These segments represent a $30B+ annual potential commercial market.




About GEO-CM04S1



GEO-CM04S1 is a dual-antigen MVA-vectored COVID-19 vaccine being evaluated in multiple Phase 2 trials, including a primary vaccination for immunocompromised individuals, and a booster vaccination for CLL patients.



The vaccine has generated robust immune responses in difficult-to-vaccinate populations including CAR-T and stem-cell transplant recipients, who typically fail to respond well to first-generation vaccines.



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:&nbsp;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.



Company Contact:



info@geovax.com



678-384-7220



Media Contact:



Jessica Starman



media@geovax.com&nbsp;

Release - GeoVax Announces British Journal of Haematology Publication Highlighting Superior T-Cell Responses of GEO-CM04S1 in CLL Patients

Biotechnology

GeoVax Labs

GOVX

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<a href="http://www.channelchek.com/company/glsi">Research News and Market Data on GLSI </a>



<a href="https://d1io3yog0oux5.cloudfront.net/_045bcd755a4a285dc8d7333d81734a10/greenwichlifesciences/news/2025-12-15_Greenwich_LifeSciences_Announces_Preliminary_109.pdf" target="_blank" rel="noreferrer noopener"> Download as PDF</a> 



December 15, 2025 6:00am EST



STAFFORD, Texas, Dec. 15, 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 an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01.



<ul class="wp-block-list">
<li>A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient non-HLA-A*02 arm of FLAMINGO-01. This arm does not have a direct placebo comparator arm, thus these two methods were used.</li>



<li>This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. See the summary of the Phase IIb results below.</li>



<li>The first non-HLA-A*02 patient has completed the 11 primary and booster vaccinations over the first 3 years. </li>
</ul>



In addition to announcing this first analysis of the recurrence rate data in the open label non-HLA-A*02 arm of FLAMINGO-01, the Company previously reported promising observations showing that the immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the primary immunization series, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.



The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.



In the 250 patient non-HLA-A*02 data set, all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. Since the 250 non-HLA-A*02 patients do not have a placebo arm for a direct comparison, the following two methods were used, yielding the 80% reduction in recurrence rate observation:



<ul class="wp-block-list">
<li>Method 1: The recurrence rate of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for this population in the Katherine study who received TDM1 (Kadcyla), which is about 3.5-4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100. The data suggests an approximately 80% reduction in recurrence rate after the GLSI-100 PIS is completed as compared to the TDM1 arm of the Katherine study at a similar timepoint.</li>



<li>Method 2: The recurrence rate during the first 6 months of vaccination or PIS period when the patient may not be fully protected or protected at all, which covered an exposure period of 100 patient years, was compared to the recurrence rate after the PIS is completed and after peak immunity is believed to be achieved, which covered an exposure period of 132 patient years. The exposure period (patient years) is defined as the cumulative number of years all patients are followed in a period. The data suggests that the peak immunity is lowering the recurrence rate by approximately 80% after the PIS is completed as compared to the recurrence rate during the PIS period.
<ul class="wp-block-list">
<li>For the first 6 months of vaccination or PIS, the theoretical maximum patient years would be 250 patients at 0.5 years each or 125 patient years. Thus 100 completed patient years represents 80% of the maximum potential patient years and within 3 to 6 months all vaccinations during this period may be completed.</li>



<li>For the period after the PIS is completed, the theoretical maximum patient years would be 250 patients at 3.5 years of follow-up each or 875 patient years. Thus 132 completed patient years represents 15% of the maximum potential patient years and represents an average of 9 months of follow-up time after the PIS for patients who have completed the PIS.</li>
</ul>
</li>
</ul>



Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.



CEO Snehal Patel commented, "We are very excited to announce in our 100th&nbsp;press release since going public that the first patient has completed the full primary and booster vaccination series in FLAMINGO-01. We are equally excited to see a positive trend in the recurrence rate in the non-HLA-A*02 arm of FLAMINGO-01, as assessed multiple ways, that is trending similarly to the Phase IIb trial results where HLA-A*02 patients were treated. Despite these being preliminary results that will mature and can change with time, seeing a reduction in expected recurrence rates that is trending towards a low HR of 0.2, which represents an 80% reduction in recurrence rate, is very encouraging and which is why along with the similarly promising safety and immune response data to date, we will seek to continue to treat non-HLA-A*02 patients in a placebo controlled manner in the study. We will continue to analyze the data and may provide updates at any time."



Previously Published Phase IIb Data



In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by&nbsp;MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46&nbsp;HER2/neu&nbsp;3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were&nbsp;treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in&nbsp;cancer recurrences in the HER2/neu&nbsp;3+ patients who were treated with GLSI-100, followed, and&nbsp;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:



<ul class="wp-block-list">
<li>80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.</li>



<li>The PIS elicited a potent immune response as measured by local skin tests and immunological assays. </li>
</ul>



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 are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to 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&nbsp;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&nbsp;<a href="https://www.globenewswire.com/Tracker?data=9FBMJGbFp41Bh0ALAWfDNsWftdeSygC7cC0nIbnMVubxs0USvZTN-NdN8ucXko4fBxHjiyN-QDyyc894NpcO5uLSNm9UUylMyEC0y3RCFyXgFCliFjgCyuzK5drjCfCTDBrC8nvY31cD_V-iHdDTBO4gRSywrJvspbgKbyFC-P8=" rel="noreferrer noopener" target="_blank">here</a>&nbsp;and clinicaltrials.gov&nbsp;<a href="https://www.globenewswire.com/Tracker?data=9FBMJGbFp41Bh0ALAWfDNnUqhN3sEbuDqqyXy0vid3Cahz84y5gGiRcW1JgvZYdHtZixXRTU-EYEJRfOSt7HrKj-tQvdYLvpaKuD4Rg5-Jo=" rel="noreferrer noopener" target="_blank">here</a>. Contact information and an interactive&nbsp;map of the majority of participating clinical sites can be viewed&nbsp;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: <a href="https://www.globenewswire.com/Tracker?data=iFyHPqtwqqNXxsZhkVLwpiSRTFkvLW4zHtIQrHgOm5OivBh5TRWvgPgCsjxJgIOFaoefgsQMXppj0QUJC83Ll4nseUcXMSY4iIH6aviCBtSBnNNdVXdso8CeERov2-_H050tnyQCu7cl8m_W-J9a0w==" rel="noreferrer noopener" target="_blank">flamingo-01@greenwichlifesciences.com</a>



About Breast Cancer and HER2/neu&nbsp;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&nbsp;<a href="https://www.globenewswire.com/Tracker?data=3CBxn-hQu1EMo4jLoxsv8Sdkg3VoG5I6190t7EGGEeLZXnLN-5-Rd_y4dX0_hC1qYJqeghs9rOPsh9Q6w3IhOgFIzxTdWNaNgjmT6QAk8UZKOcq0gfXji8Mw25VHGGEP" rel="noreferrer noopener" target="_blank">www.greenwichlifesciences.com</a>&nbsp;and follow the Company's Twitter at&nbsp;<a href="https://www.globenewswire.com/Tracker?data=Iyk-3V_FN2bQWM7CrngltiBC4nQxVdN9D0F1XDCtPDPvBp9gXW0JpyP_42Ws577rlKZ6KkKjx8Frw3X1j8xtPjd6q2kd85KkqAA6gfUIbQzMl8oLgPYKF8iDYFAGcwVf" rel="noreferrer noopener" target="_blank">https://twitter.com/GreenwichLS</a>.



Forward-Looking Statement Disclaimer



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



Company Contact Snehal Patel Investor Relations Office: (832) 819-3232 Email:&nbsp;<a href="https://www.globenewswire.com/Tracker?data=4M0VGjsPp1JVjI0EMtu5b1aeGbR_5WiCpBzrYD9ZfRwxZ_aRLr0hc_DznC8ZALcstc0sGgk_K3i6SKQ-ehxN7i_xFL7GAgldu2CyjY6DusPQb-H01xcf7w16BaerZmIJ" rel="noreferrer noopener" target="_blank">info@greenwichlifesciences.com</a>



Investor &amp; Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email:&nbsp;<a href="https://www.globenewswire.com/Tracker?data=zDpzyQ_xt5-qxMevp3EPazivs1GS58PWfnBwmqj4tQgjiaW6yTrTuAaJiRh9KDTDKTiurwiCdv4IgYLL29HLCQC-lXnOREEDV1EKDWoZ3wI=" rel="noreferrer noopener" target="_blank">dave@redchip.com</a>



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Source: Greenwich LifeSciences, Inc.



Released December 15, 2025

Research News and Market Data on GLSI 



 Download as PDF 



December 15, 2025 6:00am EST



STAFFORD, Texas, Dec. 15, 2025 (GLOBE NEWSWIRE) &#8212; Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the &#8220;Company&#8221;), 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 an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01.




A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient non-HLA-A*02 arm of FLAMINGO-01. This arm does not have a direct placebo comparator arm, thus these two methods were used.



This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. See the summary of the Phase IIb results below.



The first non-HLA-A*02 patient has completed the 11 primary and booster vaccinations over the first 3 years.




In addition to announcing this first analysis of the recurrence rate data in the open label non-HLA-A*02 arm of FLAMINGO-01, the Company previously reported promising observations showing that the immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the primary immunization series, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.



The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.



In the 250 patient non-HLA-A*02 data set, all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. Since the 250 non-HLA-A*02 patients do not have a placebo arm for a direct comparison, the following two methods were used, yielding the 80% reduction in recurrence rate observation:




Method 1: The recurrence rate of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for this population in the Katherine study who received TDM1 (Kadcyla), which is about 3.5-4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100. The data suggests an approximately 80% reduction in recurrence rate after the GLSI-100 PIS is completed as compared to the TDM1 arm of the Katherine study at a similar timepoint.



Method 2: The recurrence rate during the first 6 months of vaccination or PIS period when the patient may not be fully protected or protected at all, which covered an exposure period of 100 patient years, was compared to the recurrence rate after the PIS is completed and after peak immunity is believed to be achieved, which covered an exposure period of 132 patient years. The exposure period (patient years) is defined as the cumulative number of years all patients are followed in a period. The data suggests that the peak immunity is lowering the recurrence rate by approximately 80% after the PIS is completed as compared to the recurrence rate during the PIS period.

For the first 6 months of vaccination or PIS, the theoretical maximum patient years would be 250 patients at 0.5 years each or 125 patient years. Thus 100 completed patient years represents 80% of the maximum potential patient years and within 3 to 6 months all vaccinations during this period may be completed.



For the period after the PIS is completed, the theoretical maximum patient years would be 250 patients at 3.5 years of follow-up each or 875 patient years. Thus 132 completed patient years represents 15% of the maximum potential patient years and represents an average of 9 months of follow-up time after the PIS for patients who have completed the PIS.






Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.



CEO Snehal Patel commented, &#8220;We are very excited to announce in our 100th&nbsp;press release since going public that the first patient has completed the full primary and booster vaccination series in FLAMINGO-01. We are equally excited to see a positive trend in the recurrence rate in the non-HLA-A*02 arm of FLAMINGO-01, as assessed multiple ways, that is trending similarly to the Phase IIb trial results where HLA-A*02 patients were treated. Despite these being preliminary results that will mature and can change with time, seeing a reduction in expected recurrence rates that is trending towards a low HR of 0.2, which represents an 80% reduction in recurrence rate, is very encouraging and which is why along with the similarly promising safety and immune response data to date, we will seek to continue to treat non-HLA-A*02 patients in a placebo controlled manner in the study. We will continue to analyze the data and may provide updates at any time.&#8221;



Previously Published Phase IIb Data



In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by&nbsp;MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46&nbsp;HER2/neu&nbsp;3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were&nbsp;treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in&nbsp;cancer recurrences in the HER2/neu&nbsp;3+ patients who were treated with GLSI-100, followed, and&nbsp;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 with a peak immune response at 6 months and well-tolerated safety profile.



The PIS elicited a potent immune response as measured by local skin tests and immunological assays.




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 are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to 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&nbsp;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&#8217;s website&nbsp;here&nbsp;and clinicaltrials.gov&nbsp;here. Contact information and an interactive&nbsp;map of the majority of participating clinical sites can be viewed&nbsp;under the &#8220;Contacts and Locations&#8221; 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&nbsp;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&#8217;s website at&nbsp;www.greenwichlifesciences.com&nbsp;and follow the Company&#8217;s Twitter at&nbsp;https://twitter.com/GreenwichLS.



Forward-Looking Statement Disclaimer



Statements in this press release contain &#8220;forward-looking statements&#8221; 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 &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;contemplate,&#8221; &#8220;could,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;intend,&#8221; &#8220;seek,&#8221; &#8220;may,&#8221; &#8220;might,&#8221; &#8220;plan,&#8221; &#8220;potential,&#8221; &#8220;predict,&#8221; &#8220;project,&#8221; &#8220;target,&#8221; &#8220;aim,&#8221; &#8220;should,&#8221; &#8220;will,&#8221; &#8220;would,&#8221; 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.&#8217;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 &#8220;Risk Factors&#8221; in Greenwich LifeSciences&#8217; Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.



Company ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email:&nbsp;info@greenwichlifesciences.com



Investor &amp; Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email:&nbsp;dave@redchip.com







Source: Greenwich LifeSciences, Inc.



Released December 15, 2025

Release - Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01

Biopharmaceuticals

GLSI

Greenwich Life Sciences

The United States is throwing its support behind a major new critical minerals investment as Korea Zinc moves forward with plans to build a $7.4 billion smelting facility on U.S. soil. The project underscores Washington’s growing urgency to secure domestic and allied supply chains for materials vital to semiconductors, defense systems, aerospace applications, and advanced manufacturing.



Korea Zinc, the world’s largest zinc smelter, has approved the creation of a U.S.-based joint venture, Crucible JV LLC, to develop what it describes as a state-of-the-art, fully integrated large-scale smelting complex. The venture will be backed by a mix of U.S. government funding, strategic investors, and Korea Zinc itself, with roughly $1.94 billion of the total project cost coming from this public-private partnership.



The planned facility will be built on the site of the existing Clarksville, Tennessee smelter currently operated by Nyrstar USA, a subsidiary of commodities trader Trafigura. Korea Zinc plans to acquire the plant and significantly expand its capabilities, transforming it into a multi-metal processing hub. Once completed, the site is expected to refine zinc, lead, copper, gold, and silver, along with strategically sensitive minerals such as antimony, germanium, and gallium.



Those three minerals have taken on heightened geopolitical importance following China’s recent export restrictions, which were widely viewed as retaliation for U.S. technology curbs. Antimony, germanium, and gallium are essential inputs for products ranging from semiconductors and satellite systems to night-vision equipment and advanced defense electronics. By developing domestic refining capacity, the U.S. aims to reduce reliance on Chinese-controlled supply chains and strengthen its industrial resilience.



The deal highlights how critical minerals policy has become a bipartisan priority in Washington. Even as incentives for electric vehicles face political headwinds, securing non-China sources of strategic materials has gained momentum. For Korea Zinc, the U.S. investment represents a shift in positioning — from a company tied closely to the electric vehicle and clean energy cycle to one that plays a broader role in national security and defense supply chains.



JPMorgan Chase advised Korea Zinc on the structure of the public-private partnership and helped finance the transaction through its Security and Resiliency Initiative, a program designed to channel capital into industries that reinforce economic security. The involvement of major financial institutions further signals confidence in the long-term demand for domestically refined critical minerals.



Still, the announcement comes amid internal corporate tensions. Korea Zinc is navigating an ongoing ownership dispute after its largest shareholder, Young Poong, alongside MBK Partners, launched an unsolicited takeover bid. Critics argue the U.S. smelter plan could be as much about consolidating management control as it is about long-term strategy. Supporters counter that the project positions Korea Zinc at the center of a global realignment in industrial supply chains.



Market reaction suggests investors see strategic value in the move. Korea Zinc shares surged following the announcement, reflecting optimism that geopolitical tailwinds and government backing could translate into durable growth. As global competition for critical minerals intensifies, the U.S.-Korea Zinc partnership marks a significant step in reshaping how and where essential materials are produced.

The United States is throwing its support behind a major new critical minerals investment as Korea Zinc moves forward with plans to build a $7.4 billion smelting facility on U.S. soil. The project underscores Washington’s growing urgency to secure domestic and allied supply chains for materials vital to semiconductors, defense systems, aerospace applications, and advanced manufacturing.



Korea Zinc, the world’s largest zinc smelter, has approved the creation of a U.S.-based joint venture, Crucible JV LLC, to develop what it describes as a state-of-the-art, fully integrated large-scale smelting complex. The venture will be backed by a mix of U.S. government funding, strategic investors, and Korea Zinc itself, with roughly $1.94 billion of the total project cost coming from this public-private partnership.



The planned facility will be built on the site of the existing Clarksville, Tennessee smelter currently operated by Nyrstar USA, a subsidiary of commodities trader Trafigura. Korea Zinc plans to acquire the plant and significantly expand its capabilities, transforming it into a multi-metal processing hub. Once completed, the site is expected to refine zinc, lead, copper, gold, and silver, along with strategically sensitive minerals such as antimony, germanium, and gallium.



Those three minerals have taken on heightened geopolitical importance following China’s recent export restrictions, which were widely viewed as retaliation for U.S. technology curbs. Antimony, germanium, and gallium are essential inputs for products ranging from semiconductors and satellite systems to night-vision equipment and advanced defense electronics. By developing domestic refining capacity, the U.S. aims to reduce reliance on Chinese-controlled supply chains and strengthen its industrial resilience.



The deal highlights how critical minerals policy has become a bipartisan priority in Washington. Even as incentives for electric vehicles face political headwinds, securing non-China sources of strategic materials has gained momentum. For Korea Zinc, the U.S. investment represents a shift in positioning — from a company tied closely to the electric vehicle and clean energy cycle to one that plays a broader role in national security and defense supply chains.



JPMorgan Chase advised Korea Zinc on the structure of the public-private partnership and helped finance the transaction through its Security and Resiliency Initiative, a program designed to channel capital into industries that reinforce economic security. The involvement of major financial institutions further signals confidence in the long-term demand for domestically refined critical minerals.



Still, the announcement comes amid internal corporate tensions. Korea Zinc is navigating an ongoing ownership dispute after its largest shareholder, Young Poong, alongside MBK Partners, launched an unsolicited takeover bid. Critics argue the U.S. smelter plan could be as much about consolidating management control as it is about long-term strategy. Supporters counter that the project positions Korea Zinc at the center of a global realignment in industrial supply chains.



Market reaction suggests investors see strategic value in the move. Korea Zinc shares surged following the announcement, reflecting optimism that geopolitical tailwinds and government backing could translate into durable growth. As global competition for critical minerals intensifies, the U.S.-Korea Zinc partnership marks a significant step in reshaping how and where essential materials are produced.

U.S. Supports $7.4 Billion Korea Zinc Plant to Secure Critical Minerals Supply

Critical Minerals

Metals &amp; Mining

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 Monday, December 15, 2025



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.



Strategic Committee.&nbsp;On Friday, NN announced&nbsp;the Board of Directors has formed a Strategic Committee to oversee a review of strategic and financial alternatives to further enhance shareholder value. Given the success to date of management's transformation plan, the Board feels now is the time to take a fresh&nbsp;comprehensive look at additional ways to unlock value for shareholders.



Committee Details.&nbsp;The Strategic Committee is comprised of three independent directors,&nbsp;&nbsp;Raynard Benvenuti,&nbsp;&nbsp;Jeri Harman,&nbsp;and&nbsp;&nbsp;Thomas Wilson. All have been tasked with evaluating a broad spectrum of strategic, financial and business configuration options for the Company. The Board has engaged Houlihan Lokey, as the Company’s financial advisor.



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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.&nbsp;NOTE: investment decisions should not be based upon the content of this research summary.&nbsp;Proper due diligence is required before making any investment decision.&nbsp;

Monday, December 15, 2025



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.



Strategic Committee.&nbsp;On Friday, NN announced&nbsp;the Board of Directors has formed a Strategic Committee to oversee a review of strategic and financial alternatives to further enhance shareholder value. Given the success to date of management&#8217;s transformation plan, the Board feels now is the time to take a fresh&nbsp;comprehensive look at additional ways to unlock value for shareholders.



Committee Details.&nbsp;The Strategic Committee is comprised of three independent directors,&nbsp;&nbsp;Raynard Benvenuti,&nbsp;&nbsp;Jeri Harman,&nbsp;and&nbsp;&nbsp;Thomas Wilson. All have been tasked with evaluating a broad spectrum of strategic, financial and business configuration options for the Company. The Board has engaged Houlihan Lokey, as the Company’s financial advisor.



Get the Full Report



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.&nbsp;NOTE: investment decisions should not be based upon the content of this research summary.&nbsp;Proper due diligence is required before making any investment decision.&nbsp;

NN (NNBR) - Forms Strategic Committee

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The E.W. Scripps Company (NASDAQ: SSP) is a diversified media company focused on creating a better-informed world. As one of the nation’s largest local TV broadcasters, Scripps serves communities with quality, objective local journalism and operates a portfolio of 61 stations in 41 markets. The Scripps Networks reach nearly every American through the national news outlets Court TV and Newsy and popular entertainment brands ION, Bounce, Defy TV, Grit, ION Mystery, Laff and TrueReal. Scripps is the nation’s largest holder of broadcast spectrum. Scripps runs an award-winning investigative reporting newsroom in Washington, D.C., and is the longtime steward of the Scripps National Spelling Bee. Founded in 1878, Scripps has held for decades to the motto, “Give light and the people will find their own way.”



Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media &amp; Technology , Noble Capital Markets, Inc.



Refer to the full report for the price target, fundamental analysis, and rating.



NobleCon21. On December 3rd, management participated in a fireside chat at NobleCon21 at Florida Atlantic University (FAU) in Boca Raton, Florida. The discussion featured Jason Combes, CFO, and focused on the company's operational resilience, strategic growth initiatives, and the evaluation of a recent takeover offer. A replay of the fireside chat is available&nbsp;<a href="https://www.channelchek.com/videos/the-e-w-scripps-company-noblecon21-presentation-replay">here</a>.



Strategic portfolio pivots are driving outperformance.&nbsp;The company has decisively shifted key assets toward growth verticals to counter industry headwinds. A focused sports strategy adding NHL teams locally and the WNBA/NWSL on its national ION network is delivering results, with core advertising guided to be&nbsp;up 10% in Q4, against a declining sector. Concurrently, its digital transition is accelerating, with connected TV revenue for its networks growing 35% and expected to reach $120 million this year.



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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 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.&nbsp;NOTE: investment decisions should not be based upon the content of this research summary.&nbsp;Proper due diligence is required before making any investment decision.&nbsp;

Monday, December 15, 2025



The E.W. Scripps Company (NASDAQ: SSP) is a diversified media company focused on creating a better-informed world. As one of the nation’s largest local TV broadcasters, Scripps serves communities with quality, objective local journalism and operates a portfolio of 61 stations in 41 markets. The Scripps Networks reach nearly every American through the national news outlets Court TV and Newsy and popular entertainment brands ION, Bounce, Defy TV, Grit, ION Mystery, Laff and TrueReal. Scripps is the nation’s largest holder of broadcast spectrum. Scripps runs an award-winning investigative reporting newsroom in Washington, D.C., and is the longtime steward of the Scripps National Spelling Bee. Founded in 1878, Scripps has held for decades to the motto, “Give light and the people will find their own way.”



Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media &amp; Technology , Noble Capital Markets, Inc.



Refer to the full report for the price target, fundamental analysis, and rating.



NobleCon21. On December 3rd, management participated in a fireside chat at NobleCon21 at Florida Atlantic University (FAU) in Boca Raton, Florida. The discussion featured Jason Combes, CFO, and focused on the company&#8217;s operational resilience, strategic growth initiatives, and the evaluation of a recent takeover offer. A replay of the fireside chat is available&nbsp;here.



Strategic portfolio pivots are driving outperformance.&nbsp;The company has decisively shifted key assets toward growth verticals to counter industry headwinds. A focused sports strategy adding NHL teams locally and the WNBA/NWSL on its national ION network is delivering results, with core advertising guided to be&nbsp;up 10% in Q4, against a declining sector. Concurrently, its digital transition is accelerating, with connected TV revenue for its networks growing 35% and expected to reach $120 million this year.



Get the Full Report



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 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.&nbsp;NOTE: investment decisions should not be based upon the content of this research summary.&nbsp;Proper due diligence is required before making any investment decision.&nbsp;

E.W. Scripps (SSP) - Highlights From NobleCon21

E.W. Scripps

Media

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 Monday, December 15, 2025



DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.



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.



Overview.&nbsp;Fiscal 2025, and the start of fiscal 2026, continued the loss of contracts to small business set asides. While the loss of the Head Start contract and the expected eventual loss of all of the CMOP locations is impacting operating results today, we believe the resolution of these set aside contracts removes a big overhang from the business and enables the Company to grow from a solid base of higher value-added technology-powered applications business.



4Q25. Revenue fell 15.8% y-o-y to $81.2 million, driven by the loss of CMOP locations, as well as other set aside contracts. Gross margin fell to 17.1% from 19.9% a year ago. DLH reported a net loss of $920,000, or a loss of $0.06/sh., compared with net income of $2.3 million, or EPS of $0.16, in 4Q24. Adjusted EBITDA fell to $6.6 million from $10.7 million. We were at $83.5 million, $250,000, $0.02/sh., and $8.15 million, respectively.



<h2 class="wp-block-heading"> <a href="https://www.channelchek.com/research-reports/27942">Get the Full Report</a></h2>



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.&nbsp;NOTE: investment decisions should not be based upon the content of this research summary.&nbsp;Proper due diligence is required before making any investment decision.&nbsp;

Monday, December 15, 2025



DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.



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.



Overview.&nbsp;Fiscal 2025, and the start of fiscal 2026, continued the loss of contracts to small business set asides. While the loss of the Head Start contract and the expected eventual loss of all of the CMOP locations is impacting operating results today, we believe the resolution of these set aside contracts removes a big overhang from the business and enables the Company to grow from a solid base of higher value-added technology-powered applications business.



4Q25. Revenue fell 15.8% y-o-y to $81.2 million, driven by the loss of CMOP locations, as well as other set aside contracts. Gross margin fell to 17.1% from 19.9% a year ago. DLH reported a net loss of $920,000, or a loss of $0.06/sh., compared with net income of $2.3 million, or EPS of $0.16, in 4Q24. Adjusted EBITDA fell to $6.6 million from $10.7 million. We were at $83.5 million, $250,000, $0.02/sh., and $8.15 million, respectively.



Get the Full Report



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.&nbsp;NOTE: investment decisions should not be based upon the content of this research summary.&nbsp;Proper due diligence is required before making any investment decision.&nbsp;

DLH Holdings (DLHC) - Looking Toward a Brighter Future

DLH Holdings

DLHC

Noble Capital Markets Research Morning Call

Tesla shares moved sharply higher Monday after confirmation that the company has begun testing its Robotaxi service without a safety driver, a milestone that investors and analysts see as a major step toward fully autonomous transportation.



The rally followed social media footage showing a Tesla Robotaxi operating in Austin, Texas with no human driver inside the vehicle. The video quickly gained traction after Ashok Elluswamy, who leads Tesla’s AI and autonomous driving efforts, acknowledged the clip with a brief but telling comment: “And so it begins.” Tesla CEO Elon Musk later confirmed the development, stating that testing is underway with no occupants in the car.



Shares of Tesla rose roughly 4% following the confirmation, pushing the stock closer to its prior all-time highs and reinforcing renewed optimism around the company’s long-promised autonomy strategy. The move lends credibility to Musk’s recent claim that Tesla is only weeks away from unsupervised robotaxi operations.



Austin has emerged as the proving ground for Tesla’s Robotaxi ambitions, with limited deployments already underway using safety drivers. The latest test suggests the company is moving closer to removing that final safeguard, a critical hurdle before broader commercial expansion. Musk has previously said Tesla plans to expand Robotaxi testing beyond Austin and the San Francisco Bay Area into markets such as Phoenix and Nevada.



Wall Street bulls were quick to seize on the news. Wedbush analyst Dan Ives reiterated his long-standing optimism on Tesla, describing the development as the beginning of the company’s “autonomous chapter.” In a note to clients, Ives said 2026 could be a defining year for Tesla as autonomous driving and robotics move from concept to scale.



According to Ives, Tesla is on track for an accelerated Robotaxi rollout across the U.S., with volume production of the company’s purpose-built Cybercab expected to begin in the spring. The futuristic two-seat vehicle, unveiled last year without a steering wheel or pedals, has become central to Tesla’s long-term autonomous strategy.



Early feedback on Tesla’s latest Full Self-Driving software has also added fuel to the rally. Automotive reviewers and journalists who have tested the newest version report smoother driving behavior and fewer required interventions compared with prior iterations. While competitors like Alphabet-backed Waymo still lead in publicly reported safety metrics, the gap appears to be narrowing.



The market reaction highlights a broader shift in how investors are valuing Tesla. Rather than focusing solely on vehicle deliveries and margins, attention is increasingly turning to software, AI, and recurring revenue opportunities tied to autonomy. Wedbush maintains an Outperform rating on the stock and a $600 price target, arguing that autonomous driving could unlock a path toward a multi-trillion-dollar valuation.



Still, challenges remain. Regulatory approval, public trust, and demonstrable safety performance will be essential before Tesla can scale Robotaxi services nationwide. But for the first time in years, tangible evidence appears to support Tesla’s autonomy narrative.



For investors, the confirmation of driverless Robotaxi testing marks more than just a technical achievement — it signals that Tesla’s long-awaited autonomous future may finally be arriving.

Tesla shares moved sharply higher Monday after confirmation that the company has begun testing its Robotaxi service without a safety driver, a milestone that investors and analysts see as a major step toward fully autonomous transportation.



The rally followed social media footage showing a Tesla Robotaxi operating in Austin, Texas with no human driver inside the vehicle. The video quickly gained traction after Ashok Elluswamy, who leads Tesla’s AI and autonomous driving efforts, acknowledged the clip with a brief but telling comment: “And so it begins.” Tesla CEO Elon Musk later confirmed the development, stating that testing is underway with no occupants in the car.



Shares of Tesla rose roughly 4% following the confirmation, pushing the stock closer to its prior all-time highs and reinforcing renewed optimism around the company’s long-promised autonomy strategy. The move lends credibility to Musk’s recent claim that Tesla is only weeks away from unsupervised robotaxi operations.



Austin has emerged as the proving ground for Tesla’s Robotaxi ambitions, with limited deployments already underway using safety drivers. The latest test suggests the company is moving closer to removing that final safeguard, a critical hurdle before broader commercial expansion. Musk has previously said Tesla plans to expand Robotaxi testing beyond Austin and the San Francisco Bay Area into markets such as Phoenix and Nevada.



Wall Street bulls were quick to seize on the news. Wedbush analyst Dan Ives reiterated his long-standing optimism on Tesla, describing the development as the beginning of the company’s “autonomous chapter.” In a note to clients, Ives said 2026 could be a defining year for Tesla as autonomous driving and robotics move from concept to scale.



According to Ives, Tesla is on track for an accelerated Robotaxi rollout across the U.S., with volume production of the company’s purpose-built Cybercab expected to begin in the spring. The futuristic two-seat vehicle, unveiled last year without a steering wheel or pedals, has become central to Tesla’s long-term autonomous strategy.



Early feedback on Tesla’s latest Full Self-Driving software has also added fuel to the rally. Automotive reviewers and journalists who have tested the newest version report smoother driving behavior and fewer required interventions compared with prior iterations. While competitors like Alphabet-backed Waymo still lead in publicly reported safety metrics, the gap appears to be narrowing.



The market reaction highlights a broader shift in how investors are valuing Tesla. Rather than focusing solely on vehicle deliveries and margins, attention is increasingly turning to software, AI, and recurring revenue opportunities tied to autonomy. Wedbush maintains an Outperform rating on the stock and a $600 price target, arguing that autonomous driving could unlock a path toward a multi-trillion-dollar valuation.



Still, challenges remain. Regulatory approval, public trust, and demonstrable safety performance will be essential before Tesla can scale Robotaxi services nationwide. But for the first time in years, tangible evidence appears to support Tesla’s autonomy narrative.



For investors, the confirmation of driverless Robotaxi testing marks more than just a technical achievement — it signals that Tesla’s long-awaited autonomous future may finally be arriving.

Tesla Stock Jumps as Robotaxi Testing Without Safety Driver Signals Autonomous Breakthrough

Autonomous Vehicles

Self-Driving Cars

Tesla

<figure class="wp-block-image aligncenter size-full is-resized"><img src="https://dashboard.channelchek.com/wp-content/uploads/2025/10/image-7.png" alt="" class="wp-image-98083" style="width:420px;height:auto"/></figure>



<a href="http://www.channelchek.com/company/aent">Research News and Market Data on AENT</a>



PLANTATION, Fla., Dec. 12, 2025 (GLOBE NEWSWIRE) — Alliance Entertainment Holding Corporation (Nasdaq: AENT), a premier distributor and omnichannel fulfillment partner to the entertainment and pop culture collectibles industry, supplying more than 340,000 unique SKUs across music, video, video games, licensed merchandise, and exclusive collectibles to over 35,000 retail and e-commerce storefronts, today announced that&nbsp;<a href="https://www.globenewswire.com/Tracker?data=PAEjOXhWZ4YEGvPAoxAaqYmvGnns8DVLM855d5fOtne8bte0l19lMcp7oDpo3vQbjNe-HxOZbS_IoX2umhQFh8uNV5WPcWk5Tw8yu-uSqSRj94MMwEWGZF36jALSLM3L" rel="noreferrer noopener" target="_blank">Handmade by Robots™</a>, its rapidly expanding vinyl-collectibles brand, has appointed industry veteran Brian Maggio as Vice President of Sales. The appointment marks a key step in accelerating the brand’s next phase of commercial growth following its strong performance since joining the Alliance portfolio last year.



“We are thrilled to welcome this exceptional sales leader to our growing team,” said Tony Moyers, SVP Collectibles at Alliance Entertainment. “With extensive history working with Handmade by Robots in previous roles and a track record of driving sales through every major North American retailer and key licensors in toys, gaming, and electronics, Brian steps into the Vice President of Sales role ready to accelerate our momentum.”



Handmade by Robots, known for its signature vinyl figures sculpted to resemble knitted and crocheted characters, has continued to gain momentum across major retailers and fan communities. With licensing partnerships spanning iconic entertainment franchises and a loyal global collector base, the brand is primed for expanded retail penetration, elevated product innovation, and scaled fan engagement.



Maggio brings decades of experience in building and executing sales strategies for licensed products across mass, specialty, and ecommerce channels. His appointment is designed to deepen retail partnerships; strengthen engagement with licensors; and support the brand’s expanding roadmap of character franchises, limited chase variants, and new product formats.



“As a collectibles geek, I’ve been watching the evolution of Handmade by Robots since its inception seven years ago,” said Maggio, incoming Vice President of Sales. “With an origin story that sets it apart, the lore of the Handmade by Robots brand really resonates with fans. The whimsical form factor was-and continues to be-unique and compelling in a sea of licensed vinyl figures. Handmade by Robots has tremendous potential through creative licensing, format variants, and expanding on the handmade aesthetic in innovative ways. I’m excited to play a role in the growth story of Handmade by Robots and equally thrilled to be a part of the passionate team at Alliance Entertainment.”



About Alliance Entertainment



Alliance Entertainment (NASDAQ: AENT) is a premier distributor and fulfillment partner for the entertainment and pop culture collectibles industry. With more than 340,000 unique in-stock SKUs – including over 57,300 exclusive titles across compact discs, vinyl LPs, DVDs, Blu-rays, and video games – Alliance offers the largest selection of physical media in the market. Our vast catalog also includes licensed merchandise, toys, retro gaming products, and collectibles, serving over 35,000 retail locations and powering e-commerce fulfillment for leading retailers. The company’s growing collectibles portfolio includes Handmade by Robots™, a stylized vinyl figure line featuring licensed characters from leading entertainment franchises. Leveraging decades of operational expertise, exclusive licensing partnerships, and a capital-light, scalable infrastructure, Alliance is a trusted partner to the world’s top entertainment brands and retailers. Our omnichannel platform connects collectors and fans to the products, franchises, and experiences they love – across formats and generations. For more information, visit&nbsp;<a href="https://www.globenewswire.com/Tracker?data=9ybz74Gi-b8u-DV8TmiUOp9KDG3UBxo_iCULjQ_MJWiYxskpD5cFN83ik66sfrA9_sToDg_V8lpqFFy-9YV3mPNKnFhcRjvYhjiKkEFlAAtVsjhzbBGb3BJN2OFvLhPYDZV0YgARiJA3zAAatssvY480jjkSNzs8UpS7S6FuJU9t-6YxhCsKxi1QMay9tnFi0y2C6SH8QkYn9s_WSUwyN_5c0CPSJ7XDeJGXFFUzCw0=" rel="noreferrer noopener" target="_blank">www.aent.com</a>.



Forward Looking Statements



Certain statements included in this Press Release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity. These statements are based on various assumptions, whether identified in this Press Release, and on the current expectations of Alliance’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Alliance. These forward-looking statements are subject to a number of risks and uncertainties, including risks relating to the anticipated growth rates and market opportunities; changes in applicable laws or regulations; the ability of Alliance to execute its business model, including market acceptance of its systems and related services; Alliance’s reliance on a concentration of suppliers for its products and services; increases in Alliance’s costs, disruption of supply, or shortage of products and materials; Alliance’s dependence on a concentration of customers, and failure to add new customers or expand sales to Alliance’s existing customers; increased Alliance inventory and risk of obsolescence; Alliance’s significant amount of indebtedness; our ability to refinance our existing indebtedness; our ability to continue as a going concern absent access to sources of liquidity; risks that a breach of the revolving credit facility could result in the lender declaring a default and that the full outstanding amount under the revolving credit facility could be immediately due in full, which would have severe adverse consequences for the Company; known or future litigation and regulatory enforcement risks, including the diversion of time and attention and the additional costs and demands on Alliance’s resources; Alliance’s business being adversely affected by increased inflation, uncertainty regarding tariffs, higher interest rates and other adverse economic, business, and/or competitive factors; geopolitical risk and changes in applicable laws or regulations; as well as our financial condition and results of operations; substantial regulations, which are evolving, and unfavorable changes or failure by Alliance to comply with these regulations; product liability claims, which could harm Alliance’s financial condition and liquidity if Alliance is not able to successfully defend or insure against such claims; availability of additional capital to support business growth; and the inability of Alliance to develop and maintain effective internal controls.



For investor inquiries, please contact:



Dave Gentry RedChip Companies, Inc. 1-407-644-4256 <a href="https://www.globenewswire.com/Tracker?data=SqeFTQMWUB-CkG6Wwz7nM1o0_m6Kf3WZN6_ToigolHfjEFoq3AyoFdHd2n92qbsVvQxoKqD99IojPY_nIJtpVKAXFV__E164BwcMz4-7F0o=" rel="noreferrer noopener" target="_blank">AENT@redchip.com</a>



<figure class="wp-block-image"><img src="https://www.globenewswire.com/newsroom/ti?nf=OTYwMTM2NSM3MzE5NDI1IzIxOTI4NzQ=" alt=""/></figure>



<figure class="wp-block-image"><img src="https://ml.globenewswire.com/media/N2MwMmZiMGQtZjU1NS00MTI3LTg1NDctZDYwMjMyNDAwMjVlLTEyMDQ0MjctMjAyNS0xMi0xMi1lbg==/tiny/Alliance-Entertainment.png" alt=""/></figure>



<figure class="wp-block-image"><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/e9493940-cd31-4d38-88e6-42414bc9ed35"><img src="https://ml.globenewswire.com/media/e9493940-cd31-4d38-88e6-42414bc9ed35/small/aent-logo-1-jpg.jpg" alt="Primary Logo"/></a></figure>

Research News and Market Data on AENT



PLANTATION, Fla., Dec. 12, 2025 (GLOBE NEWSWIRE) — Alliance Entertainment Holding Corporation (Nasdaq: AENT), a premier distributor and omnichannel fulfillment partner to the entertainment and pop culture collectibles industry, supplying more than 340,000 unique SKUs across music, video, video games, licensed merchandise, and exclusive collectibles to over 35,000 retail and e-commerce storefronts, today announced that&nbsp;Handmade by Robots™, its rapidly expanding vinyl-collectibles brand, has appointed industry veteran Brian Maggio as Vice President of Sales. The appointment marks a key step in accelerating the brand’s next phase of commercial growth following its strong performance since joining the Alliance portfolio last year.



“We are thrilled to welcome this exceptional sales leader to our growing team,” said Tony Moyers, SVP Collectibles at Alliance Entertainment. “With extensive history working with Handmade by Robots in previous roles and a track record of driving sales through every major North American retailer and key licensors in toys, gaming, and electronics, Brian steps into the Vice President of Sales role ready to accelerate our momentum.”



Handmade by Robots, known for its signature vinyl figures sculpted to resemble knitted and crocheted characters, has continued to gain momentum across major retailers and fan communities. With licensing partnerships spanning iconic entertainment franchises and a loyal global collector base, the brand is primed for expanded retail penetration, elevated product innovation, and scaled fan engagement.



Maggio brings decades of experience in building and executing sales strategies for licensed products across mass, specialty, and ecommerce channels. His appointment is designed to deepen retail partnerships; strengthen engagement with licensors; and support the brand’s expanding roadmap of character franchises, limited chase variants, and new product formats.



“As a collectibles geek, I’ve been watching the evolution of Handmade by Robots since its inception seven years ago,” said Maggio, incoming Vice President of Sales. “With an origin story that sets it apart, the lore of the Handmade by Robots brand really resonates with fans. The whimsical form factor was-and continues to be-unique and compelling in a sea of licensed vinyl figures. Handmade by Robots has tremendous potential through creative licensing, format variants, and expanding on the handmade aesthetic in innovative ways. I’m excited to play a role in the growth story of Handmade by Robots and equally thrilled to be a part of the passionate team at Alliance Entertainment.”



About Alliance Entertainment



Alliance Entertainment (NASDAQ: AENT) is a premier distributor and fulfillment partner for the entertainment and pop culture collectibles industry. With more than 340,000 unique in-stock SKUs – including over 57,300 exclusive titles across compact discs, vinyl LPs, DVDs, Blu-rays, and video games – Alliance offers the largest selection of physical media in the market. Our vast catalog also includes licensed merchandise, toys, retro gaming products, and collectibles, serving over 35,000 retail locations and powering e-commerce fulfillment for leading retailers. The company’s growing collectibles portfolio includes Handmade by Robots™, a stylized vinyl figure line featuring licensed characters from leading entertainment franchises. Leveraging decades of operational expertise, exclusive licensing partnerships, and a capital-light, scalable infrastructure, Alliance is a trusted partner to the world’s top entertainment brands and retailers. Our omnichannel platform connects collectors and fans to the products, franchises, and experiences they love – across formats and generations. For more information, visit&nbsp;www.aent.com.



Forward Looking Statements



Certain statements included in this Press Release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity. These statements are based on various assumptions, whether identified in this Press Release, and on the current expectations of Alliance’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Alliance. These forward-looking statements are subject to a number of risks and uncertainties, including risks relating to the anticipated growth rates and market opportunities; changes in applicable laws or regulations; the ability of Alliance to execute its business model, including market acceptance of its systems and related services; Alliance’s reliance on a concentration of suppliers for its products and services; increases in Alliance’s costs, disruption of supply, or shortage of products and materials; Alliance’s dependence on a concentration of customers, and failure to add new customers or expand sales to Alliance’s existing customers; increased Alliance inventory and risk of obsolescence; Alliance’s significant amount of indebtedness; our ability to refinance our existing indebtedness; our ability to continue as a going concern absent access to sources of liquidity; risks that a breach of the revolving credit facility could result in the lender declaring a default and that the full outstanding amount under the revolving credit facility could be immediately due in full, which would have severe adverse consequences for the Company; known or future litigation and regulatory enforcement risks, including the diversion of time and attention and the additional costs and demands on Alliance’s resources; Alliance’s business being adversely affected by increased inflation, uncertainty regarding tariffs, higher interest rates and other adverse economic, business, and/or competitive factors; geopolitical risk and changes in applicable laws or regulations; as well as our financial condition and results of operations; substantial regulations, which are evolving, and unfavorable changes or failure by Alliance to comply with these regulations; product liability claims, which could harm Alliance’s financial condition and liquidity if Alliance is not able to successfully defend or insure against such claims; availability of additional capital to support business growth; and the inability of Alliance to develop and maintain effective internal controls.



For investor inquiries, please contact:



Dave GentryRedChip Companies, Inc.1-407-644-4256AENT@redchip.com

Alliance Entertainment's Handmade by Robots™ Welcomes Seasoned Sales Executive Brian Maggio to Drive Next Phase of Growth

AENT

Alliance Entertainment

Entertaintment

<figure class="wp-block-image aligncenter size-full is-resized"><img src="https://dashboard.channelchek.com/wp-content/uploads/2023/08/cvkd_logo.png" alt="" class="wp-image-74250" style="width:134px;height:auto"/></figure>



<a href="http://www.channelchek.com/company/cvkd">Research News and Market Data on CVKD</a>



PONTE VEDRA, FL /&nbsp;<a href="https://www.accessnewswire.com/">ACCESS Newswire</a>&nbsp;/ December 12, 2025 /&nbsp;Cadrenal Therapeutics&nbsp;<a href="https://pr.report/gxg0">(NASDAQ:CVKD)</a>&nbsp;believes it continues to be misread by the market. Yes, the Company is intentionally narrowly focused. However, the lane it occupies is among the most undertreated areas in medicine. Anticoagulation for difficult-to-treat patients has not seen meaningful reinvention in decades. Warfarin persists due to a lack of innovation. DOACs dominate because alternatives have not evolved. Cadrenal is stepping into that void with therapeutics being designed for the specific patient groups who struggle most with a 70-year-old drug (warfarin).



Tecarfarin, the Company’s late-stage asset, is the kind of drug candidate you notice only after you understand how fragile the current standard really is. Patients with end-stage kidney disease plus atrial fibrillation and advanced comorbidities do not get predictable outcomes from existing anticoagulants. Tecarfarin was engineered to solve that problem. Stable. Controlled. Reversible. The design reflects clinical demands that have gone unanswered for years. This is where Cadrenal begins to differ. It is not trying to win a popularity contest. It is trying to find a better solution to the shortcomings of current therapies.



That shift has been visible since August. Cadrenal advanced manufacturing readiness. It added clinical depth inside the leadership ranks. And it expanded the pipeline in a way that instantly upgraded the company’s strategic position. The&nbsp;<a href="https://pr.report/gxg1">acquisition of VLX-1005</a>, a Phase 2 program with Orphan Drug and Fast Track designations for Heparin-Induced Thrombocytopenia (“HIT”), is expected to be a game changer. It is a signal that Cadrenal intends to play on a larger scale.



Expansion That Changes the Stakes



With that, Cadrenal no longer behaves like a one-asset microcap. It behaves like a company constructing a multi-shot clinical platform inside the $40 billion anticoagulation market. The acquisition of a Factor XIa portfolio opened the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed. When you combine that with tecarfarin’s chronic-care positioning, you get a company with meaningful reach across multiple high-value treatment environments.



The addition of VLX-1005 further expands the pipeline. HIT is one of the most dangerous complications in hospital care, and treatment options remain limited. A Phase 2 asset with existing regulatory advantages gives Cadrenal an immediate foothold in a space where clinicians are hungry for better solutions. This kind of diversification is not common among companies of this size. It changes the conversation about Cadrenal’s potential.



The valuation does not appear to have kept pace with the expansion. The stock still appears to trade as if the Company is a single-asset story with a narrow path ahead. Meanwhile, Cadrenal sits on a portfolio with three mechanistic approaches and multiple clinical catalysts. That gap between perception and reality is where opportunity usually forms. It does not stay open forever.



Underdog Periods Have an Expiration Date



Investors are beginning to rediscover the story. Still, it appears the market continues to price Cadrenal for what it was, not for what it is building. Companies that solve real problems in anticoagulation do not stay in microcap territory. Not when they have differentiated assets, expanding clinical programs, and designations that potentially derisk the regulatory pathway. Cadrenal has put all those elements in motion.



This could be the last period during which anyone can underestimate the Company.&nbsp;<a href="https://pr.report/gxg2">Tecarfarin</a>&nbsp;is approaching Phase 3 trial readiness. VLX-1005 is entering a phase where clinical data becomes increasingly important. The Factor XIa platform gives the company hospital relevance that most microcaps never achieve. These are not theoretical advantages. They exist today. And bigger companies are hungry to add late-stage assets to their portfolios, and many of their drugs are coming off patent in this decade.



The underdog label still fits, but potentially not for long. Cadrenal is preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival. The market has been slow to adjust, but pipelines like this eventually speak loudly. When Cadrenal’s data hits, the story could flip from overlooked to obvious, and the window for catching the mispricing could close fast.



About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.



Safe Harbor



Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the Company being misread by the market; Warfarin persisting due to a lack of innovation; designing therapeutics for patient groups who struggle most with a 70-year-old drug; finding a better solution to the shortcomings of current therapies; the acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for HIT being a game changer; signaling Cadrenal intends to play on a larger scale; the acquisition of a Factor XIa portfolio opening the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the conversation about Cadrenal’s potential; the gap between perception and reality being where opportunity usually forms; investors beginning to rediscover the story; this being the last period during which anyone can underestimate the Company; Tecarfarin approaching Phase 3 trial readiness; the underdog label still fitting, but potentially not for long; preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival, and the story flipping from overlooked to obvious; and the window for catching the mispricing closing fast when Cadrenal’s data hits. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to use the acquisition of a Factor XIa portfolio to open the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.



Accuracy &amp; Disclosure Statement:&nbsp;Hawk Point Media Group, LLC (HPM) has been retained by IR Agency, Inc. to provide press releases, editorial insights, and digital media production for Cadrenal Therapeutics. This content is sponsored. For services rendered from December 12, 2025 through December 16, 2025, HPM has been compensated ten thousand dollars (USD) via wire transfer for content creation and syndication related to Cadrenal Therapeutics. The information contained herein is based on sources believed to be accurate and reliable at the time of creation, including publicly available filings, company disclosures, and direct website content. This material is provided for informational purposes only and should not be interpreted as investment advice, a recommendation, or an offer to buy or sell any security.



At the time of publication, HPM does not own, buy, sell, or trade securities of the companies covered. However, individuals or organizations that have retained HPM&nbsp;may&nbsp;hold shares of Cadrenal Therapeutics and&nbsp;may&nbsp;sell those shares during the coverage period. Such sales could place downward pressure on the stock price and result in financial loss for investors.



Any reproduction, redistribution, or syndication of this content must include this disclosure in full. This statement is provided in accordance with Section 17(b) of the Securities Act of 1933, the Federal Trade Commission’s Endorsement Guides, and other applicable laws governing sponsored communications and paid investor content.



Contact for this content:



<a href="mailto:info@hawkpointmedia.com">info@hawkpointmedia.com</a>



SOURCE:&nbsp;Cadrenal Therapeutics

Research News and Market Data on CVKD



PONTE VEDRA, FL /&nbsp;ACCESS Newswire&nbsp;/ December 12, 2025 /&nbsp;Cadrenal Therapeutics&nbsp;(NASDAQ:CVKD)&nbsp;believes it continues to be misread by the market. Yes, the Company is intentionally narrowly focused. However, the lane it occupies is among the most undertreated areas in medicine. Anticoagulation for difficult-to-treat patients has not seen meaningful reinvention in decades. Warfarin persists due to a lack of innovation. DOACs dominate because alternatives have not evolved. Cadrenal is stepping into that void with therapeutics being designed for the specific patient groups who struggle most with a 70-year-old drug (warfarin).



Tecarfarin, the Company’s late-stage asset, is the kind of drug candidate you notice only after you understand how fragile the current standard really is. Patients with end-stage kidney disease plus atrial fibrillation and advanced comorbidities do not get predictable outcomes from existing anticoagulants. Tecarfarin was engineered to solve that problem. Stable. Controlled. Reversible. The design reflects clinical demands that have gone unanswered for years. This is where Cadrenal begins to differ. It is not trying to win a popularity contest. It is trying to find a better solution to the shortcomings of current therapies.



That shift has been visible since August. Cadrenal advanced manufacturing readiness. It added clinical depth inside the leadership ranks. And it expanded the pipeline in a way that instantly upgraded the company’s strategic position. The&nbsp;acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for Heparin-Induced Thrombocytopenia (“HIT”), is expected to be a game changer. It is a signal that Cadrenal intends to play on a larger scale.



Expansion That Changes the Stakes



With that, Cadrenal no longer behaves like a one-asset microcap. It behaves like a company constructing a multi-shot clinical platform inside the $40 billion anticoagulation market. The acquisition of a Factor XIa portfolio opened the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed. When you combine that with tecarfarin’s chronic-care positioning, you get a company with meaningful reach across multiple high-value treatment environments.



The addition of VLX-1005 further expands the pipeline. HIT is one of the most dangerous complications in hospital care, and treatment options remain limited. A Phase 2 asset with existing regulatory advantages gives Cadrenal an immediate foothold in a space where clinicians are hungry for better solutions. This kind of diversification is not common among companies of this size. It changes the conversation about Cadrenal’s potential.



The valuation does not appear to have kept pace with the expansion. The stock still appears to trade as if the Company is a single-asset story with a narrow path ahead. Meanwhile, Cadrenal sits on a portfolio with three mechanistic approaches and multiple clinical catalysts. That gap between perception and reality is where opportunity usually forms. It does not stay open forever.



Underdog Periods Have an Expiration Date



Investors are beginning to rediscover the story. Still, it appears the market continues to price Cadrenal for what it was, not for what it is building. Companies that solve real problems in anticoagulation do not stay in microcap territory. Not when they have differentiated assets, expanding clinical programs, and designations that potentially derisk the regulatory pathway. Cadrenal has put all those elements in motion.



This could be the last period during which anyone can underestimate the Company.&nbsp;Tecarfarin&nbsp;is approaching Phase 3 trial readiness. VLX-1005 is entering a phase where clinical data becomes increasingly important. The Factor XIa platform gives the company hospital relevance that most microcaps never achieve. These are not theoretical advantages. They exist today. And bigger companies are hungry to add late-stage assets to their portfolios, and many of their drugs are coming off patent in this decade.



The underdog label still fits, but potentially not for long. Cadrenal is preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival. The market has been slow to adjust, but pipelines like this eventually speak loudly. When Cadrenal’s data hits, the story could flip from overlooked to obvious, and the window for catching the mispricing could close fast.



About Cadrenal Therapeutics, Inc.Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.



Safe Harbor



Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the Company being misread by the market; Warfarin persisting due to a lack of innovation; designing therapeutics for patient groups who struggle most with a 70-year-old drug; finding a better solution to the shortcomings of current therapies; the acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for HIT being a game changer; signaling Cadrenal intends to play on a larger scale; the acquisition of a Factor XIa portfolio opening the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the conversation about Cadrenal’s potential; the gap between perception and reality being where opportunity usually forms; investors beginning to rediscover the story; this being the last period during which anyone can underestimate the Company; Tecarfarin approaching Phase 3 trial readiness; the underdog label still fitting, but potentially not for long; preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival, and the story flipping from overlooked to obvious; and the window for catching the mispricing closing fast when Cadrenal’s data hits. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to use the acquisition of a Factor XIa portfolio to open the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.



Accuracy &amp; Disclosure Statement:&nbsp;Hawk Point Media Group, LLC (HPM) has been retained by IR Agency, Inc. to provide press releases, editorial insights, and digital media production for Cadrenal Therapeutics. This content is sponsored. For services rendered from December 12, 2025 through December 16, 2025, HPM has been compensated ten thousand dollars (USD) via wire transfer for content creation and syndication related to Cadrenal Therapeutics. The information contained herein is based on sources believed to be accurate and reliable at the time of creation, including publicly available filings, company disclosures, and direct website content. This material is provided for informational purposes only and should not be interpreted as investment advice, a recommendation, or an offer to buy or sell any security.



At the time of publication, HPM does not own, buy, sell, or trade securities of the companies covered. However, individuals or organizations that have retained HPM&nbsp;may&nbsp;hold shares of Cadrenal Therapeutics and&nbsp;may&nbsp;sell those shares during the coverage period. Such sales could place downward pressure on the stock price and result in financial loss for investors.



Any reproduction, redistribution, or syndication of this content must include this disclosure in full. This statement is provided in accordance with Section 17(b) of the Securities Act of 1933, the Federal Trade Commission’s Endorsement Guides, and other applicable laws governing sponsored communications and paid investor content.



Contact for this content:



info@hawkpointmedia.com



SOURCE:&nbsp;Cadrenal Therapeutics

Release - Cadrenal’s Anticoagulation Platform Is Expanding in a $40 Billion Market

Cadrenal Therapeutics

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