PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Several Data Presentations With New Trials Expected In 2024. PDS Biotech reported a 3Q loss of $10.8 million or $(0.35) per share, ending the quarter with $54.3 million in cash. The company reviewed several clinical data presentations made during the quarter and gave updates on the expected milestones for its clinical trials and pipeline products.
VERSATILE-003 Is On Schedule To Begin In 1Q24. The Phase 3 VERSATILE-003 trial has received FDA comments on the amended IND and final study design. Clinical supplies have been made for the trial to start in 1Q23. The trial will test the combination of PDS0101 with Keytruda (pembrolizumab, from Merck) against Keytruda alone in patients with HPV16+ recurrent or metastatic head and neck cancer.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Clinical Milestones For Narazaciclib and Rigosertib Expected In 2024. Onconova reported a 3Q23 loss of $4.7 million or $(0.23) per share. Cash on hand at the end of the quarter was $25.2 million, which we believe is sufficient to fund operations through 3Q24. The company reviewed several recent data presentations and the clinical milestones ahead for 2024.
An Additional Dose Level Has Been Added To The Narazaciclib Phase 1/2 Study. As expected, Onconova announced that an additional dosing cohort has been added to the Phase 1/2 dose-escalation trial in solid tumors. The maximum tolerated dose (MTD) was not reached in the first 6 cohorts, and did not show neutropenia and diarrhea commonly seen in other CDK4/6 inhibitors. This allows a higher dose level to be tested. The Phase 1/2 trial is expected to continue into 1Q23, followed by Phase 2 dose selection.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
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Strong Q3 results. The company reported Q3 revenue of $9.0 million, exceeding our forecast of $5.8 million. Adj. EBITDA for the quarter was a loss of $5.1 million, in line with our forecast.
Impressive launch. In October, the company launched ARK: Survival Ascended, which was the #1 selling game on the PC gaming platform, Steam, on launch day. Management noted that, so far, the game is performing 60% better than expectations, in terms of units sold.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
One Stop Systems, Inc. (OSS) designs and manufactures innovative AI Transportable edge computing modules and systems, including ruggedized servers, compute accelerators, expansion systems, flash storage arrays, and Ion Accelerator™ SAN, NAS, and data recording software for AI workflows. These products are used for AI data set capture, training, and large-scale inference in the defense, oil and gas, mining, autonomous vehicles, and rugged entertainment applications. OSS utilizes the power of PCI Express, the latest GPU accelerators and NVMe storage to build award-winning systems, including many industry firsts, for industrial OEMs and government customers. The company enables AI on the Fly® by bringing AI datacenter performance to ‘the edge,’ especially on mobile platforms, and by addressing the entire AI workflow, from high-speed data acquisition to deep learning, training, and inference. OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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New Win. One Stop Systems, Inc. (OSS), has won a multi-million-dollar program with Leidos’ Dynetics, a provider of mission-critical solutions for the U.S. government. The new award with a new client illustrates management’s focus on broadening end markets and client relationships, in our view.
Contract Details. Valued at approximately $2.5 million to $3.5 million over the next three years, with an initial award of $500,000, the award is the first multi-year win OSS has secured with this prime contractor. OSS will provide its proprietary transportable compute and storage technology designed to power an emerging specialized mobile AI signal collection application.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Blackboxstocks, Inc. is a financial technology and social media hybrid platform offering real-time proprietary analytics and news for stock and options traders of all levels. Our web-based software employs “predictive technology” enhanced by artificial intelligence to find volatility and unusual market activity that may result in the rapid change in the price of a stock or option. Blackbox continuously scans the NASDAQ, New York Stock Exchange, CBOE, and all other options markets, analyzing over 10,000 stocks and up to 1,500,000 options contracts multiple times per second. We provide our users with a fully interactive social media platform that is integrated into our dashboard, enabling our users to exchange information and ideas quickly and efficiently through a common network. We recently introduced a live audio/video feature that allows our members to broadcast on their own channels to share trade strategies and market insight within the Blackbox community. Blackbox is a SaaS company with a growing base of users that spans 42 countries; current subscription fees are $99.97 per month or $959.00 annually. For more information, go to: www.blackboxstocks.com .
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q2023 Results. Revenue for the Company was $728,468 compared to $1.2 million last year. Average monthly revenue per user was $76.37 for the quarter compared to $78.19 in the prior year period. Operating expenses totaled $1.3 million compared to $1.9 million last year. Blackboxstocks reported a net loss of $671,745 or EPS loss of $0.21, compared to a net loss of $1.3 million or $0.40 EPS loss last year. Adjusted EBITDA was a negative $513,026 versus a negative $1.1 million in the prior year.
Member Count. Blackboxstocks had an average member count of 3,174 at the end of the quarter, down from 3,937 at the end of the second quarter and 5,197 last year. This continues a trend of decreasing users experienced by the company on its products for the year. The Company is exploring strategic marketing partnerships to increase the growth of its products.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
ARLP is a diversified natural resource company that generates operating and royalty income from coal produced by its mining complexes and royalty income from mineral interests it owns in strategic oil & gas producing regions in the United States, primarily the Permian, Anadarko and Williston basins. ARLP currently produces coal from seven mining complexes its subsidiaries operate in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana. ARLP markets its coal production to major domestic and international utilities and industrial users and is currently the second largest coal producer in the eastern United States. In addition, ARLP is positioning itself as an energy provider for the future by leveraging its core technology and operating competencies to make strategic investments in the fast growing energy and infrastructure transition.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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Refining estimates. We have increased our 2023 EBITDA and EPU estimates to $4.96 and $975.2 million from $966.2 million and $4.89. We decided to increase our total coal sales estimates which are now at the midpoint of guidance instead of at the low end. We also modestly increased our coal sales price per ton estimate to $65.15 from $65.00 but still within the guidance range of $64.50 to $66.00. We have lowered our 2024 EBITDA and EPU estimates to $998.1 million and $5.05 from $1.0 billion and $5.15 based on modestly lower commodity prices.
Why the revisions? Alliance has committed and priced 35.0 million tons in 2023, including 29.7 million tons in the domestic market and 5.3 million tonnes in export markets. While a portion of higher priced export volumes could be deferred into 2024, we think our previous estimate was too conservative. As part of our review, we also adjusted quarterly and full year 2024 estimates and refined both years’ estimates associated with equity method investments.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
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Solid Q3 results. The company reported Q3 revenue of $4.7 million, which was in-line with our estimate of $4.8 million and adj. EBITDA of $719,547, which was modestly below our estimate of $849,000, illustrated in Figure #1 Q3 Results. The slight adj. EBITDA miss was attributed to revenue mix and slightly higher than expected operating expenses. Notably, revenue and adj. EBITDA increased by 8.5% and 7.3%, respectively, from the prior year period.
Interactive Growth. The company’s interactive business had a strong quarter as revenue increased 16% from the prior year period, and does not include deferred revenue which increased 76% over the same period. Management attributed the favorable increase in revenue to large contracts that were recently signed. The company remains focused on signing larger clients, and has increased its headcount in its sales and marketing departments to support that goal.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Microsoft made waves this week by unveiling its first ever custom-designed chips at the Ignite conference. The tech giant introduced two new processors: the Maia 100 chip for artificial intelligence workloads and the Cobalt 100 chip for general computing purposes. These new silicon offerings have the potential to shake up the chip industry and cloud computing markets.
The Maia 100 is Microsoft’s answer to the AI accelerators from rivals like Nvidia and Amazon. It is tailored to boost performance for AI tasks like natural language processing. During Ignite, Microsoft demonstrated Maia handling queries for its Bing search engine, powering the Copilot coding assistant, and running large OpenAI language models.
Microsoft has been collaborating closely with OpenAI and is a major investor in the AI research company. OpenAI’s popular ChatGPT was trained on Azure using Nvidia GPUs. By designing its own chip, Microsoft aims to reduce reliance on third-party silicon for AI workloads.
Though performance details remain unclear, Microsoft stated that Maia handles AI tasks with high throughput and low latency. It emphasized efficiency as a key design goal. The chip was engineered in close consultation with Microsoft’s internal AI teams to ensure it fits their requirements.
Microsoft has created novel liquid cooling technology called Sidekicks to work alongside Maia server racks. This advanced thermal management unlocks Maia’s full processing capacity while avoiding the overheating issues that often plague GPU-powered data centers.
When available on Azure, Maia will provide customers access to specialized AI hardware on demand instead of buying dedicated GPUs. Microsoft did not provide a timeline for Maia’s availability or pricing. But offering it as a cloud service instead of a physical product sets Maia apart from AI chips from Intel, Nvidia and others.
The second new chip announced at Ignite was the Cobalt 100 ARM-based processor for general computing. It is expected to deliver a 40% performance boost over existing Azure ARM chips from Ampere.
Microsoft believes Cobalt will provide a compelling alternative to Intel’s server CPUs for cloud workloads. Companies like Amazon have already demonstrated success in cloud data centers by transitioning from Intel to custom ARM chips.
Virtual machines powered by Cobalt will become available on Azure in 2024. Microsoft is currently testing it for key services like Teams and Azure SQL database. More efficient ARM servers can translate to lower costs for cloud customers.
The Cobalt announcement highlights Microsoft’s growing reliance on ARM architecture across its cloud infrastructure. ARM chips are known for power efficiency in mobile devices, but companies like Amazon, Microsoft and Apple now recognize their benefits for data centers too.
By designing its own server-class ARM processor, Microsoft can optimize performance and features specifically for its cloud services. With both Maia and Cobalt, Microsoft aims to give Azure a competitive edge over rivals like AWS and Google Cloud.
Microsoft has lagged behind in cloud infrastructure market share, but introducing unique silicon could help close the gap. Its vertically integrated approach produces chips tailor-made for AI and its cloud platform. With demand for AI compute and cloud services booming, Microsoft’s gambit on custom chips could soon pay dividends.
With a government shutdown set to hit at the end of this week if new funding legislation wasn’t passed, Congress has acted swiftly to approve a short-term spending bill. The so-called “continuing resolution” will keep federal agencies open and running until January 19 for some programs and February 2 for others.
The bill easily cleared the Democratic-controlled House on Tuesday with bipartisan support. This followed the backing of Republican House Speaker Mike Johnson, who had proposed the novel “laddered” approach to stagger program expiration dates. The bill now heads to the Senate, where both Majority Leader Chuck Schumer and Minority Leader Mitch McConnell have voiced support. With President Biden also signaling he will sign it, a shutdown appears to have been averted.
For investors, the passage of this stopgap bill means reduced short-term economic uncertainty. A shutdown would have disrupted many key government services as hundreds of thousands of federal workers are furloughed. This can dampen consumer and business sentiment. While the stock market has mostly shaken off prior shutdowns, an extended one could still eventually take a toll.
Yet longer-term risks remain on the horizon, especially regarding the fast-approaching debt ceiling. Come June, the government will hit its statutory borrowing limit, which could set up an intense fiscal battle. If the ceiling isn’t raised or suspended in time, the U.S. could default on its debt for the first time ever. Such an unprecedented event would surely roil markets.
With Speaker Johnson facing pressure from the right flank of his Republican caucus to extract steep spending cuts and other concessions in exchange for lifting the borrowing cap, the stage is set for a high-stakes showdown. Democrats have adamantly opposed using the debt limit as a bargaining chip.
For now, investors may breathe a small sigh of relief. But the reprieve could be short-lived. Once the government funding issue is settled, focus will shift to addressing the debt ceiling well before the June deadline. Otherwise, a far more damaging crisis than a temporary shutdown could be on tap, potentially threatening the full faith and credit of the United States along with the stability of financial markets.
Beyond the recurring fiscal battles, investors will continue monitoring the overall health of the U.S. economy amid rising interest rates and stubborn inflation. Though job growth and consumer spending have been bright spots, risks of recession still loom. Stock market volatility reflects these crosscurrents. For long-term investors, diversification and temperance remain key as policy uncertainty persists.
Looking ahead, the specter of a government default looms large. The debt ceiling debate is a critical juncture that could have widespread implications not just for the financial markets but for the broader economy. The potential fallout from a failure to raise the debt ceiling includes disruptions in government payments, increased borrowing costs, and a loss of confidence in the U.S. financial system.
The debt ceiling has been a recurrent point of contention in recent years, with temporary agreements often reached to avert a crisis. However, the underlying issues of fiscal responsibility, spending priorities, and partisan gridlock persist. The consequences of a protracted deadlock on the debt ceiling could be severe, with ripple effects felt globally.
In the midst of these challenges, investors must navigate an environment marked by uncertainty. While the short-term resolution of the government funding issue provides a momentary sense of stability, the underlying risks and complexities of fiscal policy remain. As the nation grapples with these fiscal challenges, market participants should remain vigilant and adapt their strategies to navigate potential shifts in the economic landscape.
In conclusion, the recent passage of the short-term spending bill averted an immediate government shutdown, providing a respite for investors. However, the focus now turns to the looming debt ceiling debate, introducing a new set of challenges and uncertainties. As events unfold, market participants will need to carefully assess the evolving situation and make informed decisions to mitigate risks in an ever-changing economic and political landscape.
CULVER CITY, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL), a leading, global independent developer and publisher of interactive digital entertainment, announced today that it will report financial results for the third quarter ended September 30, 2023, today, November 14, 2023, after the U.S. stock market closes. Management will host a conference call and webcast today at 5:00 p.m. ET to discuss the results.
Participants may listen to the live webcast and replay on the Company’s investor relations website at https://investor.snail.com/.
About Snail, Inc. Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices.
LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands (NYSE: ACCO), a world leader in branded consumer and end user products, was named one of America’s Safest Companies in 2023 by EHS Today. The magazine for environment, health, and safety leaders, announced its list of the 2023 America’s Safest Companies last month with 10 companies on the list. These companies are involved in a broad range of activities, from industrial contracting to robotics, from packaging to cabinetry, from consumer packaged goods to electrical construction, and more.
ACCO Brands was among the outstanding companies being honored because of a committed understanding of the value that safety brings to an organization. This is the third time that ACCO Brands has been awarded this title, something only six other companies have achieved.
For more than 20 years, the America’s Safest Companies competition has sought to identify those characteristics that differentiate good safety programs from great ones, and to then celebrate the best practices and procedures that exemplify safety excellence.
“Every America’s Safest Company winner is a standard-bearer of safety excellence. Each winning company has engrained into their culture and their employees a consistent and constant need to keep every person and every situation free from harm,” said EHS Today Editor-in-Chief Dave Blanchard.
To be considered as one of America’s Safest Companies, organizations must complete an application that requires them to demonstrate excellence in several areas: support from leadership and management for EHS efforts; employee involvement in the EHS process; innovative solutions to safety challenges; injury and illness rates lower than the average for their industries; comprehensive training programs; evidence that prevention of incidents is the cornerstone of the safety process; good communication about the value of safety; and a way to substantiate the benefits of the safety process.
As a company with a personal stake in all things ergonomic, ACCO Brands understands the discomfort of aches and pains. That is why the company provides on-site massages using the certified active release technique (ART) to all U.S. manufacturing and distribution center employees—regardless of whether those aches and pains are job-related or not.
“While there is a significant cost to providing the ART benefit to our employees, we believe we have prevented many minor employee issues from becoming more serious medical issues and have a healthier workforce as a result of this program,” says James Edwards, senior director of environmental, health and safety, ACCO Brands.
The best practices from the 2023 America’s Safest Companies are featured in a special section in the July/August 2023 issue of EHS Today magazine and on the brand’s website, www.ehstoday.com. Since 2002, America’s Safest Companies has honored more than 250 organizations for their unwavering commitment to worker safety, health, and environmental stewardship.
About ACCO Brands ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play, and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.
About EHS Today Owned by Endeavor Business Media, EHS Today is an American occupational safety, and health media brand. It is the leading US magazine for environmental, health and safety management professionals in the manufacturing, construction, and service sectors.
Single-Dose Protection Demonstrated Against Multiple SARS-CoV-2 Variants
Atlanta, GA, November 14, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen investigational SARS-CoV-2 vaccine. The data were presented during the Vaccines Summit 2023 conference, being held in Boston, MA on November 13-15, 2023. The presentation, titled “MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models,” was delivered by Mukesh Kumar, PhD, Associate Professor, Department of Biology, Georgia State University.
“We are thrilled to continue to demonstrate the robust efficacy profile of GEO-CM02 with the presentation of preclinical data at this year’s Vaccine Summit,” said David Dodd, GeoVax’s Chairman and CEO. “Together, these data indicate that immunization with the multi-antigen GEO-CM02 vaccine can protect against severe disease and death induced by SARS-CoV-2 infection and regardless of the variant. Along with a demonstrated safety profile, we believe GEO-CM02 has potential as a transformative universal coronavirus vaccine.”
First-generation SARS-CoV-2 vaccines based on the spike (S) protein have demonstrated that they induce neutralizing antibodies, providing effective, albeit short-term levels of immune protection. Unfortunately, with the existing authorized vaccines, efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring continuous updating and booster doses. To address this limitation, GeoVax is currently evaluating its dual antigen COVID-19 vaccine, GEO-CM04S1 in three Phase 2 clinical trials. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating. Moreover, GEO-CM04S1 is being developed specifically as a COVID-19 vaccine in support of patients with compromised immune systems, for whom the current authorized vaccines appear inadequate in providing protective immunity.
GEO-CM02 is a multi-antigen SARS-CoV-2 vaccine, based on the S, membrane (M), and envelope (E) proteins, which are designed to also engage both the humoral (antibody) and cellular (T-cell) arms of the immune system and to broaden both the function and specificity, potentially as a universal coronavirus vaccine. Efficacy of this investigational vaccine was tested using the industry standard, lethal hACE2 transgenic mouse model.
Data highlights from the Vaccine Summit 2023 presentation are as follows:
The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
Animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution.
GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals.
The data generated in the GEO-CM02 studies validate GeoVax’s hypothesis that vaccines designed to induce both antibodies and T-cells to multiple viral structural proteins can address the issue of viral variation and escape from the immune system. GEO-CM02 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose.
GeoVax’s more advanced, next-generation COVID-19 vaccine, GEO-CM04S1, is being evaluated in three ongoing Phase 2 clinical trials:
As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. GeoVax recently announced clinical site expansion for this trial.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has fully enrolled.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
The Last Great Hamburger Stand Set to Debut in Hidalgo County
LOS ANGELES, Nov. 14, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Fatburger and 17 other restaurant concepts, announces a new development deal set to bring six additional franchised Fatburger locations to Hidalgo County, Texas in the next five years. The news comes on the heels of the recent opening of the first co-branded Fatburger and Round Table Pizza restaurant in Lantana, Texas.
“The Fatburger brand continues to expand in Texas,” said Taylor Wiederhorn, Chief Development Officer of FAT Brands. “Fatburger has a pipeline of approximately 50 restaurants to be built in Texas alone and the franchisee demand to develop more Fatburger restaurants throughout the state has not slowed down. We look forward to adding six more restaurants to our existing development pipeline in Texas with further growth near the southern border.”
Ever since the first Fatburger opened in Los Angeles 70 years ago, the chain has been known for its delicious, grilled-to-perfection and cooked-to-order burgers. Founder Lovie Yancey believed that a big burger with everything on it is a meal in itself; at Fatburger “everything” is not just the usual roster of toppings. Burgers can be customized with everything from bacon and eggs to chili and onion rings. In addition to its famous burgers, the Fatburger menu also includes Fat and Skinny Fries, sweet potato fries, scratch-made onion rings, Impossible™ Burgers, turkeyburgers, hand-breaded crispy chicken sandwiches, and hand-scooped milkshakes made from 100 percent real ice cream.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, quick-service, casual and polished casual dining restaurant concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.
About Fatburger An all-American, Hollywood favorite, Fatburger is a fast-casual restaurant serving big, juicy, tasty burgers, crafted specifically to each customer’s liking. With a legacy spanning 70 years, Fatburger’s extraordinary quality and taste inspire fierce loyalty amongst its fan base, which includes a number of A-list celebrities and athletes. Featuring a contemporary design and ambiance, Fatburger offers an unparalleled dining experience, demonstrating the same dedication to serving gourmet, homemade, custom-built burgers as it has since 1952 – The Last Great Hamburger Stand™.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the future financial and operating results of the Company, estimates of future EBITDA, the timing and performance of new store openings, future reductions in cost of capital and leverage ratio, our ability to conduct future accretive acquisitions and our pipeline of new store locations. Forward-looking statements generally use words such as “expect,” “foresee,” “anticipate,” “believe,” “project,” “should,” “estimate,” “will,” “plans,” “forecast,” and similar expressions, and reflect our expectations concerning the future. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents that we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks and uncertainties that could cause our actual results to differ materially from our current expectations and from the forward-looking statements contained in this press release. We undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of this press release.
