VANCOUVER, BC, March 4, 2024 /PRNewswire/ – Defense Metals Corp. (“Defense Metals” or the “Company“; (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce that samples of mixed rare earth carbonate (“MREC“) have been shipped to two major Rare Earth Element (“REE“) companies. Samples generated by SGS Canada Inc. in Lakefield, Ontario during 2023 hydrometallurgical piloting test work performed on concentrate produced by earlier flotation pilot plant testing of a 26-tonne bulk sample taken from the Company’s wholly-owned Wicheeda deposit have now been sent to almost every REE separator in the world.
MREC samples shipped to the recipients are independently verifying the high-quality of the REE product from the Wicheeda deposit, and further establishing Defense Metals’ Wicheeda REE Project as a critically important, future North American source of rare earths.
Craig Taylor, CEO of Defense Metals, commented:
“Defense Metals continues to advance the Wicheeda Project, establishing it as one of the few western world REE projects that has the key characteristics required for a viable REE project including: (1) location and superior logistics, (2) minerology, metallurgy, and grade, (3) the ability to produce a REE product as established by pilot plant operations , (4) significant potential mine life, and (5) social licence and support of the McLeod Lake Indian Band. Defense Metals believes strongly that Wicheeda will play a key role in establishing North American REE supply chains; first and foremost, with respect to mining and hydrometallurgical processing, and ultimately with respect to the onshoring of downstream REE separation, refining and metallizing capabilities. Defense Metals is positioned as one of the very few North American REE companies having true ability to achieve this vision.”
Defense Metals to Attend the Prospectors & Developers Association of Canada Convention
Defense Metals will be attending the Prospectors & Developers Association of Canada (PDAC) Convention in Toronto, Canada from March 3 to March 6, 2024, and invites interested parties to visit the Company at Booth #2500 and at Discovery Group’s Booth #2630.
Qualified Person
This news release has been reviewed and approved by Kristopher J. Raffle, P.Geo. (B.C.), a Principal of APEX Geoscience Ltd., of Edmonton, Alberta, a technical consultant to the Company, and a “Qualified Person” as defined in NI 43-101.
About Defense Metals Corp. and its Wicheeda Rare Earth Element Project
Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned, 8,301-hectare (~20,534-acre) Wicheeda REE Project that is located on the traditional territory of the McLeod Lake Indian Band in British Columbia, Canada.
The Wicheeda REE Project, approximately 80 kilometres (~50 miles) northeast of the city of Prince George, is readily accessible by a paved highway and all-weather gravel roads and is close to infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.
Defense Metals is a proud member of Discovery Group. For more information please visit: www.discoverygroup.ca.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
Cautionary Statement Regarding “Forward-Looking” Information
This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to attending PDAC and related meetings, advancing the Wicheeda REE Project, the expectations and plans for the Wicheeda REE Project, the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR+ (www.sedarplus.com). While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain or obtain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical, engineering and pricing assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, restriction on labour and international travel and supply chains, loss of key employees, consultants, officers or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–loo
LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
“We are pleased to announce that the FDA has granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation, an unmet medical need for which there are no FDA-approved drugs,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Obtaining ODD is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. DGF is one of the most serious complications resulting from kidney transplantation, and we believe that the mechanism of action of UNI-494 is ideally suited for the prevention of this orphan condition.”
The FDA, through its Office of Orphan Products Development (OOPD), grants orphan drug designation to agents that have the potential to offer a safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 individuals in the United States.
As previously announced, on March 12, 2024, Unicycive will present data on the efficacy of UNI-494 in animal models of DGF and a poster describing the ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024.
About Delayed Graft Function
Delayed Graft Function (DGF) refers to the acute kidney injury (AKI) that occurs in the first week after kidney transplantation, which necessitates dialysis intervention. As the name indicates, DGF can result in sub-optimal or impaired graft function and is one of the most common and serious complications of kidney transplantation. Poor kidney function in the first week of graft life is detrimental to the longevity of the allograft. DGF is also associated with higher rates of tissue rejection and decreased patient survival. Currently, there are no FDA approved drugs for the treatment of DGF.
Ischemia/reperfusion injury (IRI) is known to be a major causative factor for the AKI that results in DGF during kidney transplantation. Ischemic preconditioning, that works by activating KATP channels in mitochondria, is a natural endogenous mechanism which protects cells from IRI in the heart, kidney, liver, and other organs. UNI-494 is a pharmacological approach that emulates and enhances this natural phenomenon of ischemic preconditioning.
About UNI-494
UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in 2H of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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.
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PDSB Has Clinical Trial Milestones For 2024. We expect PDS Biotech is expecting to start the Phase 3 trial for PDS0101in head and neck cancer in 1Q24. This follows strong data from the Phase 2 trial presented during 2023. Several Investigator-initiated trials (IITs) testing PDS0101 in other indications have presented data showing improvements over current standards of care, its mechanism of action, and its potential use in related cancers. The second product, PDS01ADC, has also shown strong data in a Triple Combination trial. In our opinion, the stock has not reflected these results in the stock price.
A Phase 3 Trial For PDS0101 Is Expected Shortly. The Phase 3 VERSAMUNE-003 trial for PDS0101will enroll patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have failed treatment with standard chemotherapy but have not been treated with an immune checkpoint inhibitor (ICI naïve). The trial design follows the Phase 2 VERSAMUNE-002, which showed strong improvements in overall response rate (ORR) and overall survival (OS) benefits compared with current treatments.
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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.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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Progress. In 2023 Orion transformed into a more focused, more competitive and more driven company. Management implemented a disciplined project bidding and delivery strategy, attracted high-caliber business development executives, invested in systems, training and tools, secured a three-year, $103 million credit facility, and closed over $25 million in equipment and real estate sale-leaseback transactions.
Marine Segment. Segment revenue was up 40.3% to $135.2 million, while operating income was $4.3 million, compared to $234,000 in 4Q22. The revenue growth was primarily related to the Pearl Harbor project.
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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.
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile application. Codere currently operates in its core markets of Spain, Italy, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence in the region.
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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Solid Q4 results. The company reported Q4 revenue of €50.1 million, handily beating our estimate of €39.0 million by 28.5%. Adj. EBITDA in the quarter was a loss of €4.1 million, better than our estimate of a loss of €6.2 million.
Growth in key markets. The company’s solid Q4 performance was driven by year over year revenue growth of 56% in Mexico and 17% in Spain. In both countries, the number of users and spend per customer increased compared with Q3. Notably, the company displayed year-over-year growth, in spite of tough comps in Q4 against such big events as the World Cup.
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.
Progress across the pipeline in multiple clinical trials, including
Phase 2 program of GEO-CM04S1, next-generation Covid-19 vaccine, and
multicenter Phase 1/2 study of Gedeptin®, targeting advanced head and neck cancer
Catalyst-rich 2024 with data readouts planned throughout the year
Company to host conference call and webcast today at 4:30 p.m. ET
ATLANTA, GA, February 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.
“2023 marked another year of advancement of our ongoing clinical programs for GEO-CM04S1, our next-generation Covid-19 vaccine, and for Gedeptin® in cancer therapy,” stated David Dodd, GeoVax’s Chairman and CEO. “This past year, we completed enrollment for the Phase 2 clinical trial assessing GEO-CM04S1 as a universal booster for the mRNA Covid vaccines, while expanding to multiple sites for our Phase 2 trial among immunocompromised/stem cell transplant patients, evaluating GEO-CM04S1 as a primary vaccine, in direct comparison to mRNA vaccines. In addition, the third Phase 2 trial of GEO-CM04S1 was initiated, evaluating our vaccine among immunocompromised/Chronic Lymphocytic Leukemia patients as a booster for such patients having initially received a mRNA vaccine, also in a direct comparison to a mRNA vaccine.
“Results released during 2023 demonstrated the safety and efficacy of GEO-CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection,” Dodd continued. “Perhaps of most importance, the results to date have demonstrated potential protective immunity of GEO-CM04S1 against multiple strains of SARS-CoV-2, from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5, without the need for vaccine reconfiguration. This critically important potential feature appears unique to our Covid-19 vaccine.”
Dodd concluded, “Relative to our oncology progress, GeoVax completed enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors. During first half 2024, we anticipate reporting additional results from the Gedeptin Phase 1/2 clinical trial, as well as our plans for an expanded Phase 2 clinical trial. Overall, these achievements can be attributed to the successful execution of our long-term strategy, with an end goal to bring unique, patented products to market, addressing unmet medical needs. We look forward to reporting further progress in these studies and are encouraged to be entering into a data-rich 2024.”
2023 Clinical Trial Progress and Operational Developments
GEO-CM04S1
Enrollment completed for the Phase 2 clinicaltrial assessing GEO-CM04S1 as a potential universal booster for patients previously vaccinated with Pfizer or Moderna vaccines. The data presented during this period showcased promising results, indicating the potential of GEO-CM04S1 as a versatile Covid-19 vaccine capable of providing immunity against various strains, including the Wuhan, Delta, and Omicron variants. The trial involves 63 healthy adults who previously received mRNA vaccines as their primary vaccine. The data showed no serious adverse events and significant increases in neutralizing antibody, as well as cellular immune responses against multiple SARS-CoV-2 variants. Final results from this trial are anticipated during the fourth quarter of 2024.
Initiation of a Phase 2 booster trial targeting immunocompromised patients with chronic lymphocytic leukemia (CLL), who typically have reduced immune responses to mRNA vaccines due to their medical condition. This investigator-initiated trial expects to enroll 80 patients and directly compare GEO-CM04S1 with the Pfizer/BioNTech Bivalent vaccine. Results from an interim analysis are anticipated during the first half of 2024.
Data presentations from the immunocompromised/stem cell transplant patient Phase 2 trial of GEO-CM04S1 at the World Vaccine Congress, as well as initial results published in the peer-reviewed journal, Vaccines. The findings demonstrated robust immunogenicity, illustrating the vaccine’s ability to induce both antibody and T cell responses, essential for conferring protection, particularly in immunocompromised individuals. The article also highlighted the unique feature of GEO-CM04S1 providing protective immune levels from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5 variant. This study has been expanded to a multi-site trial, with further results anticipated throughout 2024.
Gedeptin®
Completion of patient enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. The data presented at the AACR-AHNS Head and Neck Cancer Conference emphasized the safety and feasibility of Gedeptin therapy, providing insights into its potential as a treatment option for patients with limited therapeutic alternatives. The initial Phase 1/2 trial aims to guide future studies, potentially expanding the application of Gedeptin in other solid tumor areas and in combination with immune checkpoint inhibitors. During 2024, we expect to announce plans relative to an expanded Phase 2 study among advanced head and cancer patients, following discussions with regulatory authorities. In addition, we plan to outline plans for further Gedeptin clinical development, both in additional monotherapy and in combination-therapy (e.g., Gedeptin + immune-checkpoint inhibitor) indications.
Advanced Vaccine Manufacturing Process
Significant advancements made in MVA manufacturing capabilities focused on implementing a transformative manufacturing process in support of MVA-based vaccines and immunotherapies. The multi-product license with ProBioGen involving the AGE1.CR.PIX® suspension cell line enhances GeoVax’s capacity to produce MVA-based vaccines and immunotherapies at an unprecedented scale. Additionally, the agreement with Advanced Bioscience Laboratories, Inc. (ABL) secures cGMP production capabilities in support of GeoVax transitioning to worldwide commercialization capability. These developments signify GeoVax’s commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes. Our intent is to successfully develop our products for worldwide commercialization and distribution, in conjunction with partnering and collaborative relationships.
Corporate and Intellectual Property Developments
Achieved notable milestones in intellectual property development, securing multiple patents covering a range of vaccine candidates. The expanded rights under the NIH Covid-19 license to include Mpox and smallpox further diversify GeoVax’s vaccine portfolio, potentially offering broader protection against infectious diseases. Additionally, the issuance of patents for Ebola, Marburg, Malaria, and HIV vaccines underscores GeoVax’s innovative approach to vaccine development and its dedication to advancing global health initiatives. As of February 2024, the following actions were taken by global patent offices, further strengthening the Company’s intellectual property assets:
The Japanese Patent Office issued a Decision of Grant notifying GeoVax of the allowance of the Company’s Patent Application No. 2022-153352 titled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.” The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax’s MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims.
The U.S. Patent and Trademark Office issued Patent No. 11,896,657 to GeoVax, pursuant to the Company’s patent application No. 17/584,231 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
The U.S. Patent and Trademark Office issued Patent No. 11,897,919 pursuant to the Company’s patent application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
Appointed J. Marc Pipas, M.D., as Executive Medical Director, Oncology. Dr. Pipas has extensive clinical, research, and leadership expertise in oncology, built on a long and successful academic career at Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, an NCI Comprehensive Cancer Center. He brings a deep understanding of oncologic therapeutics and clinical trial management, as well as a network of research contacts and leadership skills honed by many years of experience.
2023 Full Year Financial Results
Net Loss: Net loss for the year ended December 31, 2023, was $26.0 million, as compared to $14.0 million for the year ended December 31, 2022.
R&D Expenses: Research and development expenses were $20.7 million for 2023, compared to $9.1 million in 2022, with the increase primarily due to the costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, technology license fees, personnel costs, costs of preclinical research activities and higher travel costs.
G&A Expenses: General and administrative expenses were $6.0 million for 2023, compared to $5.0 million in 2022, with the increase primarily attributable to higher personnel costs, investor relations consulting costs, legal fees, patent costs and travel expenses.
Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.
Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.
Conference Call Details
Management will host a conference call scheduled to begin at 4:30 p.m. ET today, February 29, 2024, to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.
A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.
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.
HOUSTON, Feb. 29, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the Company will report financial results for the fourth quarter and fiscal year 2023 ended December 31, 2023 on Thursday, March 21, 2024 after the U.S. stock market closes.
Management will host a conference call and webcast on the same day at 5:00 PM ET to discuss the results. The live webcast and replay can be accessed at https://ir.directdigitalholdings.com/.
About Direct Digital Holdings Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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Labrador Gold investor webinar. Labrador Gold recently hosted an investor webinar to discuss its Hopedale Project, a district-scale gold and critical metals property in Labrador that covers a 43-kilometer strike length of the Florence Lake greenstone belt. Hopedale is comprised of five licenses covering 785 claims. In addition to gold, the property has nickel and copper potential.
Nine mineral occurrences to date. To date, nine mineral occurrences have been identified within three license areas, including five gold, two nickel, one copper and one zinc. Within the Thurber License, five occurrences have been identified that include: 1) TD 500, 2) Thurber Dog, 3) Thurber South, 4) Thurber North, and 5) Kaapak. Within the Southern License area, three mineral occurrences have been identified, including: 1) Fire Ant, 2) Rusty Ridge, and 3) Last Resort. The ninth occurrence is Jasmine. Targets within the Thurber license area have the highest priority for drilling with TD 500 being the highest priority drill target in 2024 following an IP geophysical survey to guide the drilling.
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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.
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.
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.
Full Year Loss Was Less Than Expected. GeoVax reported a FY2023 loss of $26.0 million or $(14.29) per share, adjusted for a 1-for-15 reverse split in January 2024. The loss for 4Q23 was $7.6 million or $(4.29) per share, compared with our estimated loss of $9.0 million. Cash on December 31 was $6.5 million. On its quarterly conference call, the company reviewed progress in its clinical programs and confirmed milestones for 2024.
Gedeptin Program Is Moving Forward. In July 2023, GeoVax reported initial data from the Phase 1/2 trial testing Gedeptin head and neck cancer. The data showed successful delivery of the PNP gene, with safety, tumor reduction, and stable disease. Enrollment was completed in 2Q23, with additional results expected in 1H24. Expansion of Phase 2 of trial is planned during 2024. Additional trials using Gedeptin as a neoadjuvant at earlier stages of disease or in combination with immune checkpoint inhibitors may be added.
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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.
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile application. Codere currently operates in its core markets of Spain, Italy, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence in the region.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Solid Q4 results. The company reported Q4 revenue of €50.1 million, handily beating our estimate of €39.0 million by 28.5%. Adj. EBITDA in the quarter was a loss of $4.1 million, better than our estimate of a loss of €6.2 million, illustrated in Figure #1 Q4 Results. The better than expected Q4 results were driven by strong revenue growth in Mexico and Spain.
Market performances. The company’s solid Q4 performance was driven by year over year revenue growth of 56% in Mexico and 17% in Spain. In both Mexico and Spain, the number of users and spend per customer increased compared with Q3. Notably, the company displayed strong year-over-year growth, in spite of tough comps in Q4 against such big events as the World Cup.
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.
Humanoid robotics startup Figure AI recently closed a massive $675 million funding round, providing a glimpse into the future of automation. The round drew investment from major tech names like Jeff Bezos, Nvidia, Microsoft, and OpenAI. It highlights the enormous potential in advanced robotics for investors focused on high-growth emerging technologies.
Figure AI is developing a human-shaped robot called Figure 01 designed for commercial use. With lifelike appearance and motion, Figure 01 is targeting deployment in industries struggling with labor shortages like manufacturing, logistics, and warehousing. This could automate dangerous and repetitive jobs to boost productivity.
The multi-hundred-million-dollar funding round led by prominent tech investors signals confidence in Figure AI’s ambitious goals. We are likely still years away from advanced humanoid robots becoming mainstream. But the capital injection provides Figure AI fuel to push the envelope on development of robotic capabilities.
For small cap investors, early stage robotics companies like Figure AI represent a high-risk, high-reward proposition. The total addressable market for humanoid robots could reach $38 billion by 2035 per Goldman Sachs forecasts. That’s up from virtually zero today.
Figure AI is not alone in pursuing this opportunity. Deep-pocketed tech giants like Amazon and Tesla have their own humanoid robot initiatives. Competition will be fierce. But Figure AI’s partnerships with AI leaders OpenAI and Microsoft provide an edge. Its tech could set it apart if successfully commercialized.
The catch is that costs remain extremely high. Figure 01 robot units likely run from $30,000 to $150,000 each for now. Hardware and production expenses will need to come down significantly for mass adoption. But rapid advances in AI, cloud computing, and cheaper components should drive down costs over time.
For small cap investors with patience and high risk tolerance, Figure AI represents an early-stage bet on transformative innovation. It offers exposure to a potential multi-billion dollar humanoid robotics industry of the future.
While commercial viability remains uncertain, the technology promise is immense. Companies that can crack cost and production barriers first will be positioned to dominate the market. Figure AI now has ample capital to pursue that goal.
Its partnerships with AI and cloud infrastructure leaders provide unique advantages. And high-profile backers like Bezos and Nvidia give Figure AI added legitimacy versus competitors.
Investing in pre-revenue robotics startups is not for the faint of heart. Expect setbacks and delays on the long road to commercialization. But the total addressable market makes it a worthwhile speculative bet for those focused on investing in emerging tech.
Figure AI faces risks typical of any early stage hardware startup. Its humanoid robotics technology could fail or a competitor could bring superior products to market faster. Execution challenges abound.
But with its new war chest and high-powered partnerships, Figure AI has a fighting chance to be a leader if and when humanoid robots transition from R&D to mainstream adoption. For small cap investors, it represents the type of high-upside moonshot that could pay off big if the stars align.
Oil prices have staged a strong rally over the last few trading sessions, with both Brent and West Texas Intermediate (WTI) crude futures settling above $80 and $83 per barrel respectively on Friday. This marks the highest level for oil prices since November 2023. The recent surge has been driven by growing signs of tightness in global oil supplies along with heightened geopolitical risks in the Middle East.
For investors in the oil and gas sector, the combination of bullish supply and demand fundamentals and rising geopolitical tensions point to potential upside in oil prices through 2024. Here are some of the key factors driving the latest rally:
Supply Fundamentals Point to Tightness
On the supply side, oil prices are being lifted by OPEC+’s continued restraint on production increases. The group of major oil producers is expected to extend production cuts beyond their planned exit in March, tightening global supplies. Additionally, near-term futures contracts are trading at a premium to later dated contracts, a condition known as backwardation which signals tight supplies.
Asia Demand Exceeding Expectations
At the same time, oil demand has proved resilient, especially in Asia. Demand out of Asia has exceed expectations in recent months, even as parts of Europe remain locked down. With economies reopening as vaccine rollouts accelerate, pent-up travel demand in Asia is set to further boost oil consumption over 2023. The combination of robust demand growth and limited supply increases has led to a rapid drawdown of global oil inventories since the start of the year.
Middle East Tensions Creating Geopolitical Risk Premium
On top of bullish market fundamentals, ongoing tensions in the Middle East are layering fears of potential supply disruptions. Attacks on oil tankers transiting through the critical Red Sea route has rerouted tanker traffic and added to insurance costs. Escalating violence between Israel and Hamas has raised concerns over stability in the region.
Most importantly, oil prices could spike dramatically if Iran-backed Houthis were to target vessels travelling through the Strait of Hormuz. This critical passageway between Oman and Iran handles around 30% of all seaborne-traded crude oil globally. Any military clashes or outright closure of the Strait would severely constrain global oil flows and lead to a price spike.
Upside Risks Outweigh Downsides for Oil Prices
In summary, investors should be aware of the multitude of upside risks supporting higher oil prices as we progress through 2024. While oil demand may moderate as economies eventually normalize post-pandemic, OPEC+ restraint and the risk of supply disruptions look set to keep the market tight.
As leading investment banks like Goldman Sachs have noted, their base case forecast of $70-90 per barrel for Brent could easily see upside, with geopolitics posing the main risk. For investors, oil exploration and production companies as well as oil services firms stand to benefit most from higher prices. Integrated majors may lag on share price gains though due to their downstream refining exposure. Overall, oil markets appear set to tighten further, making the case for investors to overweight the energy sector.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which is designed to inhibit formation of multiple types of inflammasomes, including NLRP3, and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation associated with obesity and numerous other conditions.
WESTON, Fla., Feb. 29, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of inflammatory and renal diseases with high unmet medical needs, announces that on February 26, 2024, the company generated approximately $2.7 Million from existing investors’ exercise of previously issued warrants. This was following excitement around news issued by NodThera on February 19, 2024, that their NLRP3 inflammasome inhibitors have potential to treat obesity with weight loss efficacy similar to the GLP-1 receptor agonist, Wegovy, but with added cardiovascular benefits. This news became viral among financial reporters, driving high volume trading and increased stock prices for companies developing inflammasome inhibitors, including ZyVersa.
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP3, and AIM2, to address inflammatory diseases in which multiple inflammasome pathways are activated. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the spread and perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About ZyVersa Therapeutics, Inc.
ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate, Media, and IR Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
