On October 30th, President Biden signed a landmark executive order to increase oversight and regulation of artificial intelligence (AI) systems and technologies. This sweeping regulatory action has major implications for tech companies and investors in the AI space.
The order establishes new security and accountability standards for AI that companies must meet before releasing new systems. Powerful AI models from leading developers like Microsoft, Amazon, and Google will need to undergo government safety reviews first.
It also aims to curb harmful AI impacts on consumers by mandating privacy protections and anti-bias guardrails when algorithms are used in areas like housing, government benefits programs, and criminal justice.
For investors, this secures a leadership role for the U.S. in guiding AI development. It follows $1.6 billion in federal AI investments this fiscal year and supports American competitiveness versus China in critical tech sectors.
Here are the key takeaways for investors and industries affected:
Tech Giants – For AI leaders like Alphabet, Meta, and Microsoft, compliance costs may increase to meet new standards. But early buy-in by these companies helped shape the order to be achievable. The upfront reviews could also reduce downstream AI risks.
Chipmakers – Companies like Nvidia and Intel providing AI hardware should see continued demand with U.S. positioning as an AI hub. But if smaller competitors struggle with new rules, consolidation may occur.
Defense – AI has become vital for advanced weapons systems and national security. The order may add procurement delays but boosts accountability in this sensitive area. Northrop Grumman, Lockheed Martin and other defense contractors will adapt.
Automotive – Self-driving capabilities rely on AI. Mandating safety reviews for AI systems helps build public trust. Automakers investing heavily in autonomy like GM, Ford and Waymo will benefit.
Healthcare – AI holds promise for improving patient care and outcomes. But bias concerns have arisen, making regulation welcome. Medical AI developers and adopters such as IBM Watson Health now have clearer guidelines.
Startups – Early-stage AI innovators may face added hurdles competing as regulations rise. But they can tout adherence to government standards as a competitive advantage to enterprises adopting AI.
China Competition – China aims to lead in AI by 2030. This order counters with U.S. investment, tech sector support, and global cooperation on AI ethics. Investors can have confidence America won’t cede this key industry.
While adaptation will be required, investors can find opportunities within the AI landscape as it evolves. Companies leaning into the new rules and transparency demands can realize strategic gains.
But those lagging in ethics and accountability may see valuations suffer. disciplines like algorithmic bias auditing will now become critical enterprise functions.
Overall the AI executive order puts guardrails in place against unchecked AI harms. Done right, it can increases trust and spur responsible innovation. That’s a bullish signal for tech investors looking to deploy capital into this transformative sector.
Detroit automaker General Motors (GM) has reached a tentative labor agreement with the United Auto Workers (UAW) union, bringing an end to 6 weeks of strikes that idled tens of thousands of autoworkers across the United States.
The 4-year deal was announced Monday after marathon negotiating sessions over the weekend. It follows similar tentative agreements reached last week by the UAW with Ford Motor Co. and Fiat Chrysler Automobiles.
With contracts now in place with all Detroit Three automakers, the UAW can turn its focus to ratification votes. The agreements are expected to add hundreds of millions in new labor costs, but deliver significant gains to autoworkers who made concessions during the Great Recession to help stabilize the industry.
Key improvements include an accelerated path to top hourly wages of over $32, pay increases of 3-4% each year, cost of living adjustments, $11,000 ratification bonuses, and restored rights to strike over plant shutdowns. The deals also hold healthcare costs steady without increased worker premiums.
For the automakers, the additional labor expenses come as the industry already faces rising costs for technology investments in electric vehicles and autonomy. But the end of strikes brings relief after 6 extremely costly weeks of lost production.
Ford pegged the financial impact of the work stoppage at $1.3 billion. The company expects its new deal to increase per vehicle labor costs by $850-$900. GM lost about $2 billion according to estimates, over $1 billion of that in the United States.
The sacrifices by both sides reflect just how damaging an extended strike could have been. A 2-day strike last year cost GM an estimated $400 million alone. With U.S. auto sales plateauing, neither side could afford an extended plant shutdown.
For Wall Street, the end of uncertainty from the labor disputes will be welcomed. GM stock gained 0.75% Monday after details emerged, while Ford’s share price rose 1.2%. Investors see the short-term costs of the deals as outweighed by the benefits of resumed production and sales.
Moody’s auto analyst Bruce Clark said the deals are “credit negative but containable” for the automakers, allowing them to remain competitive. Labor peace also helps attract talent and productivity gains.
The question now is whether rank-and-file UAW members will ratify the tentative contracts. Ford and GM workers are expected to start voting within 2 weeks, once the agreements are finalized and presented to members.
UAW leaders face pressure to avoid the rejection they suffered in 2015, when Fiat Chrysler workers initially voted down a proposed deal. But the united front displayed by the UAW in pursuing coordinated strikes gives momentum.
With U.S. unemployment at historic lows, workers leveraged a tight labor market and the automakers’ need for labor stability into significant gains after years of minimal increases. For the UAW, it represents a big win and reprieve from scandal.
The new contracts set the stage for a productive new era of labor-management relations in the auto industry, vital to the American manufacturing sector. As the UAW’s most profitable bargaining partners, Detroit now aims to move beyond the strikes and shift focus to the future of transportation.
Designed to Protect Immunocompromised Patients Against Severe COVID-19
ATLANTA, GA, October 30, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has commenced the planned site expansion for the Phase 2 clinical trial investigating its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as a primary vaccine in immunocompromised patients. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial will be initiating enrollment of eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and Fred Hutchinson Cancer Research Center (Seattle, Washington).
The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients with hematologic malignancies who have received either an allogeneic hematopoietic stem cell transplant, an autologous hematopoietic stem cell transplant or chimeric antigen receptor (CAR) T cell therapy. Such patients often have difficulty mounting an adequate protective antibody response after receiving currently available COVID-19 vaccines.
David Dodd, GeoVax Chairman and CEO, commented, “We are pleased with these site activations to expand the scope and reach of this trial, which we expect will accelerate patient enrollment for this important study in one of the highest at-risk patient populations, currently underserved by available vaccines. We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a vaccine for highly vulnerable immunocompromised patients for whom the currently authorized mRNA vaccines may be inadequate, but also potentially for healthy patients as a universal booster vaccine to the mRNA vaccines. In the U.S., there are approximately 15 million individuals who, as a result of their compromised immune systems, often do not adequately respond to the current authorized vaccines. Worldwide, there are an estimated 240+ million such patients. Our hope is that GEO-CM04S1 provides robust, durable immune protection for such patients, while also providing a critically important alternative to COVID-19 booster vaccines for healthy individuals.”
A recent publication in Vaccines (https://doi.org/10.3390/vaccines11091492) from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses against ancestral as well as recently evolved SARS-CoV-2 virus strains. These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.
About GEO-CM04S1
GEO-CM04S1 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. 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.
In addition to this ongoing study, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:
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.
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.
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.
VANCOUVER, BC, Oct. 30, 2023 /CNW/ – Defense Metals Corp. (“Defense Metals” or the “Company“) (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce that it has filed the detailed Technical Report (the “Technical Report“) of its updated Mineral Resource Estimate (“2023 MRE“) for its 100% owned Wicheeda Rare Earth Element (REE) deposit located in British Columbia, Canada. The Technical Report is dated October 27, 2023, effective August 28, 2023, is entitled “Technical Report on the Wicheeda Property, British Columbia, Canada”, and was prepared by APEX Geoscience Ltd.
Figure 1: Cross Section of the Wicheeda RE Deposits 2023 MRE (CNW Group/Defense Metals Corp.)
The results of the updated 2023 MRE were previously disclosed in summary form in the Company’s news release dated September 12, 2023. The Technical Report was prepared in accordance with the Canadian Securities Administrators’ National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101“) and is available for review under the Company’s profile on SEDAR+ at www.sedarplus.ca and on the Company’s website at www.defensemetals.com. Readers are encouraged to read the Technical Report in its entirety, including all qualifications, assumptions, and exclusions.
Highlights of the 2023 Wicheeda REE Deposit Mineral Resource Estimate
The 2023 MRE comprises a:
6.4 million tonne Measured Mineral Resource, averaging 2.86% Total Rare Earth Oxide (TREO1);
a 27.8 million tonne Indicated Mineral Resource, averaging 1.84 % TREO;
and an 11.1 million tonne Inferred Mineral Resource, averaging 1.02% TREO, all reported at a cut-off grade of 0.5% TREO within a conceptual open pit shell (Figure 1);
Total Measured and Indicated (M+I) Mineral Resources of 34.2 million tonnes, averaging 2.02% TREO, is a significant upgrade representing a conversion of 101% of the 2021 MRE comprising some indicated and mostly inferred resources (see Defense Metals’ news release of November 24, 2021) to M+I on a contained metal basis;
Measured and Indicated resources are inclusive of 17.8 million tonnes of dolomite carbonatite, averaging 2.92% TREO;
The 2023 MRE represents a 17% increase in TREO on a contained metal basis, or 31% tonnage increase, in comparison to the prior 2021 MRE.
The 2023 MRE is based on an updated geological model that incorporates an additional 10,350 metres of drillhole data, from 45 holes drilled by Defense Metals during 2021 and 2022.
___________________________ 1 TREO % is the sum of CeO2, La2O3, Nd2O3, Pr6O11, Sm2O3, Eu2O3, Gd2O3, Tb4O7, Dy2O3 and Ho2O3 %.
Defense Metals to Attend New Orleans Investment Conference
Defense Metals also announces that it will be attending in the New Orleans Investment Conference in New Orleans, U.S., from November 1-4, 2023.
For additional information on the conference please visit the following link:
The scientific and technical information contained in this news release as it relates to the Wicheeda REE Project has been reviewed and approved by Kristopher J. Raffle, P.Geo. (B.C.), Principal and Consultant of APEX Geoscience Ltd. of Edmonton, Alberta, who is a director of Defense Metals and a “Qualified Person” as defined in NI 43-101.
About the Wicheeda REE Property
Defense Metals 100% owned, 6,759-hectare (~16,702-acre) Wicheeda Project is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda REE Project is readily accessible by all-weather gravel roads and is near 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.
About Defense Metals Corp.
Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned Wicheeda Rare Earth Element Deposit located near Prince George, British Columbia, Canada. Defense Metals Corp. trades on the TSX Venture Exchange under the symbol “DEFN”, in the United States, trading symbol “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.
Defense Metals is a proud member of Discovery Group. For more information please visit: http://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
The Company previously completed a preliminary economic assessment NI 43-101 technical report on January 6, 2022, effective November 21, 2021 (“PEA”), however, given the exploration work completed since and the new mineral resource estimate of August 28, 2023 and included in the Technical Report, the Company does not consider the PEA current and therefore the Wicheeda REE Project is no longer considered an “advanced property” as that term is defined under applicable securities laws.
This news release contains “forward‐looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to advancing the Wicheeda REE Project, the Technical Report and the 2023 MRE, 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, accuracy of assay results, performance of available laboratory and other related services, future operating costs, interpretation of geological and metallurgical data, 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, metallurgy and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR+ at www.sedarplus.ca. 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 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 and engineering 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, an inability to predict and counteract the effects of COVID-19 and other viruses and diseases on the business of the Company, the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, 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‐looking statements or forward‐looking information, except as required by law.
Study results warrant further in vivo in-depth investigation of THIO conjugates as second generation cancer therapies
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer,today announced positive results from an investigational new drug-enabling study of the Company’s second-generation telomere-targeting agents derived from lipid-modified THIO molecules. MAIA’s second-generation telomere-targeting molecule program seeks to discover new compounds with improved specificity towards cancer cells relative to normal cells, potentially increased anticancer activity, and stronger chemistry manufacturing control characteristics.
“In this study we demonstrated broad-spectrum therapeutically-attractive opportunities for specific telomeric stress-inducing treatments. The results demonstrate an increase in innate sensing and adaptive antitumor immunity via the self-produced chemical modification of cancer cell telomeres by THIO,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D.
The new THIO prodrugs are lipid conjugated compounds derived from THIO. The prodrugs are pharmacologically inactive compounds that, after intake, are metabolized into a pharmacologically active drug. In vitro, these compounds were able to induce telomeric DNA damage responses that were similar or more profound than those for THIO, as assessed by quantitative Telomere Damage Induced Foci assays (TIF formation). Efficient formation of micronuclei structures was also observed. Initial in vivo evaluation of the anticancer activity, conducted in human xenografts and murine syngeneic models of colorectal cancer, demonstrated potent anticancer activity at relatively low dose levels for one of the lead lipid conjugates.
“Our findings from this study demonstrate the significance of telomeric DNA structural and functional integrity for cancer cell survival. The high potency of these THIO-like agents warrants further in vivo in-depth investigation as a potential next generation of telomerase-mediated telomere-targeting compounds,” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer.
The findings were presented by Dr. Gryaznov at the International Biochemistry Congress 2023, organized by the Turkish Biochemical Society and held in Turkey. The findings are detailed in the abstract available in the event website under Speakers, Sergei M. Gryaznov and Lecture Abstract sections.
The telomere-centric action of MAIA’s lead candidate THIO is being evaluated in Phase 2 clinical trials (THIO-101) in non-small-cell lung carcinoma (NSCLC) patients.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
DENVER, Oct. 30, 2023 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), will host a conference call on Tuesday, November 14, 2023 at 5:00 p.m. Eastern time to discuss its financial and operational results for the third quarter ended September 30, 2023. The Company’s results will be reported in a press release prior to the call.
The Schwazze management team will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.
Date: Tuesday, November 14, 2023 Time: 5:00 p.m. Eastern time Toll-free dial-in: (888) 664-6383 International dial-in: (416) 764-8650 Conference ID: 64450430 Webcast: SHWZ Q3 2023 Earnings Call
The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.
If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.
About Schwazze
Schwazze (OTCQX: SHWZ) (NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.
Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.
Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit www.schwazze.com.
Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital
TNX-1500 is currently in Phase 1 Clinical Development
Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication; Multiple Other Indications, including Autoimmune Disorders, are Planned
CHATHAM, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced data from two oral presentations which were delivered recently at the American College of Surgeons (ACS) Clinical Congress 2023, and The International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in October 2023. The data involve Tonix’s TNX-1500 (Fc-modified dimeric anti-CD40L monoclonal antibody [mAb]) which is currently in Phase 1 development for the prevention of organ transplant rejection. Copies of the presentations are available under the Scientific Presentations tab of the Tonix Pharmaceuticals website at www.tonixpharma.com.
The oral presentations titled, “Pilot Evaluation of a Clinical Xeno Heart Transplant Regimen in a Preclinical Model” and “Extended Survival of 9- and 10-Gene Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression” by Dr. Ikechukwu Ileka et al. include data demonstrating the use of TNX-1500 as maintenance therapy after xeno heart transplant in non-human primates. In both studies, genetically engineered (GE) pigs in baboon transplants were treated with cold-perfused ischemia minimization and a novel costimulation-based immunosuppressive regimen including TNX-1500. The multi-GE pigs were provided by eGenesis and Revivicor.
“The results of these preclinical studies are encouraging and demonstrate the potential of genetically engineered pig hearts in the context of a clinically applicable regimen,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Because anti-CD40L treatment is widely recognized as critical to the success of xeno organ transplant, no animals were transplanted without anti-CD40L treatment.”
“These and other data1,2,3 confirm the rationale for us to pursue development of TNX-1500 to prevent rejection in human transplantation,” said Dr. Lederman. “We are currently enrolling in a Phase 1 trial in healthy volunteers to support the development of TNX-1500 for the prevention of allograft rejection. However, long term we hope to develop TNX-1500 for xenotransplantation in which the donor organ comes from genetically engineered pigs.”
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 study in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the mu-opioid receptor while maintaining activity and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and the clinical phase of a Phase 2 proof-of-concept study is now completed with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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.
Momentum. While top line in the third quarter was impacted by a more measured pace of award roll-out and the withdrawal from the Central Texas market, operating momentum continued, driven by implementation of management’s operating plan and an increasing mix of higher margin projects. We expect the momentum to continue going forward.
Marine Segment. Marine segment revenue was up 6.3% y-o-y driven by the Hawaii contract. Partly due to recognition of outstanding claims in the year-ago quarter, segment operating profit fell to $2.0 million, or a 2.5% margin, from $5.2 million, or a 6.8% margin last year. Orion is winning new awards in the segment at higher margins, but the Army Corps continues to award business at a slower than historical rate.
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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.
Newrange is focused on district-scale exploration for precious metals in the prolific Red Lake District of northwestern Ontario. The past-producing high-grade Argosy Gold Mine is open to depth, while the adjacent North Birch Project offers additional blue-sky potential. Focused on developing shareholder value through exploration and development of key projects, the Company is committed to building sustainable value for all stakeholders. Further information can be found on our website at www.newrangegold.com .
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Transaction wins shareholder approval. In May,Newrange executed a binding Scheme Implementation Deed (SID) to acquire 100% of Mithril Resources Limited (ASX: MTH) in a reverse takeover (RTO). Pending approval by the TSX Venture Exchange, the resulting company will be named Pinnacle Silver & Gold Corp. and will be listed on the TSX Venture exchange under the symbol “PINN.” During their respective special meetings, Newrange and Mithril shareholders approved the merger between Newrange and Mithril to form Pinnacle Silver & Gold Corporation. Assuming that all requirements are satisfied, the transaction is expected to close in mid-November.
Key conditions remain. Although both sets of shareholders have approved the transaction, several requirements remain outstanding. These include: 1) the Federal Court of Australia must approve the transaction at a hearing scheduled for November 6, 2) an Independent Expert must affirm that in the absence of a superior offer, the share and option schemes are in the best interests of Mithril shareholders and option holders, 3) completion of Newrange Gold’s concurrent financing, 4) Newrange Gold receiving unconditional approval to re-list on the TSX Venture Exchange, and 5) satisfaction or waiver of any remaining conditions prior to the Court Hearing.
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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.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, 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.
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.
3Q23 Results. FAT Brands reported 3Q23 revenue of $109.4 million, up 6% y-o-y from $103.2 million in the year ago quarter. System-wide sales growth was 0.8%. FAT reported adjusted EBITDA of $21.9 million in the quarter, compared to $24.6 million in 3Q22 (which included $7.2 million of tax credits). Net loss for the quarter was $26.5 million, or $1.59/sh, compared to a net loss of $25.1 million, or $1.52/sh last year. Adjusted net loss for the quarter was $18.9 million, or $1.14/sh, compared to a net loss of $17.9 million, or a loss of $1.08/sh, last year. We had projected revenue of $107 million and a net loss of $28.4 million, or a loss of $1.71/sh.
Ongoing Development. YTD, FAT has opened 96 restaurants, including 30 in 3Q. The Company expects to see 150 openings 2023. YTD, over 200 new franchise agreements have been signed, bringing the total pipeline to over 1,100 signed agreements. This pipeline will add some $60 million to adjusted EBITDA.
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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.
Cumulus Media (NASDAQ: CMLS) is an audio-first media company delivering premium content to over a quarter billion people every month — wherever and whenever they want it. Cumulus Media engages listeners with high-quality local programming through 406 owned-and-operated radio stations across 86 markets; delivers nationally-syndicated sports, news, talk, and entertainment programming from iconic brands including the NFL, the NCAA, the Masters, CNN, the AP, the Academy of Country Music Awards, and many other world-class partners across more than 9,500 affiliated stations through Westwood One, the largest audio network in America; and inspires listeners through the Cumulus Podcast Network, its rapidly growing network of original podcasts that are smart, entertaining and thought-provoking. Cumulus Media provides advertisers with personal connections, local impact and national reach through broadcast and on-demand digital, mobile, social, and voice-activated platforms, as well as integrated digital marketing services, powerful influencers, full-service audio solutions, industry-leading research and insights, and live event experiences. Cumulus Media is the only audio media company to provide marketers with local and national advertising performance guarantees. For more information visit www.cumulusmedia.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
In-line quarter. Revenues of $207.4 million, down 11.2% from year earlier levels, were in line with our $207.8 million estimate. Costs came in lower than expected, and, as a result, adj. EBITDA was 14.1% better than expected at $26.9 million versus our $23.6 million estimate.
Green shoots? The company completed a successful upfront with strong Network sales. We believe that cancellations will be much less than the 50% that it experienced last year, which should provide for the prospect for a meaningful turnaround in its high margin Network business in 2024.
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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.
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.
Refer to the full report for the price target, fundamental analysis, and rating.
Third quarter financial results. Alliance reported third quarter EBITDA and earnings per unit (EPU) of $227.6 million and $1.18, respectively, compared to $253.8 million and $1.25 during the prior year period. We had forecast EBITDA and EPU of $240.3 million and $1.20. Revenue increased 0.6% to $636.5 million, while income from operations declined 8.7% to $165.4 million. The company generated free cash flow of $123.7 million and distributable cash flow provided quarterly cash distribution coverage of 1.75x. Third quarter financial results were negatively impacted by lower coal sales volumes and higher costs at its coal operations in Appalachia.
Refined management guidance. Alliance provided updated guidance for the remainder of the year which we have incorporated into our estimates as detailed in the body of this note. Total coal sales are expected to be in the range of 34.5 million to 35.0 million tons compared to previous expectations of 35.5 million to 36.0 million tons, while the coal sales price per ton is expected to be in the range of $64.50 to $66.00 compared to previous guidance of $65.00 to $66.00. Segmented adjusted EBITDA expense per ton sold is expected to be $39.50 to $40.50 compared to previous guidance of $38.00 to $41.00.
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.
Portsmouth, New Hampshire-based medical device manufacturer Laborie Medical Technologies announced it has acquired Minnesota company Urotronic in a deal worth up to $600 million. The acquisition provides Laborie entry into the interventional urology market and adds Urotronic’s novel Optilume drug-coated balloon technology to its product portfolio.
The definitive agreement was signed on September 6, 2023 with an upfront payment of $255 million in cash to close the deal. Up to $345 million more is payable based on certain commercial and reimbursement milestones being achieved.
Optilume is a minimally invasive surgical therapy (MIST) that combines mechanical dilation with delivery of the chemotherapy drug paclitaxel to treat urinary tract conditions like urethral strictures and benign prostatic hyperplasia (BPH), also known as enlarged prostate.
BPH affects over 40 million men in the United States alone and the global market for BPH treatment is valued at over $4 billion. Current surgical interventions for BPH like transurethral resection of the prostate (TURP) or laser procedures can have side effects and long recovery times.
Optilume has already gained FDA approval and CE Mark in Europe for treating BPH. This regulatory clearance, along with positive clinical data showing good safety and efficacy, were key factors in Laborie’s decision to acquire Urotronic.
The Optilume technology represents a paradigm shift in how urologists can treat patients suffering from BPH and urethral strictures. Rather than invasive surgery or permanent implants, the drug-coated balloon can be inserted cystoscopically and then inflated to dilate the urethra and deliver the paclitaxel to the tissue. The minimally invasive approach leads to fast patient recovery compared to other options.
According to Laborie Medical President and CEO Michael Frazzette, “There has never been a minimally invasive, combination drug-device therapy like Optilume before, leading to a highly disruptive, paradigm change for physicians treating urethral strictures and BPH.”
Urotronic CEO David Perry likewise noted that “Backed by positive clinical data, the Optilume BPH therapy is truly groundbreaking as the only MIST option that doesn’t require cutting, burning, steaming or a permanent implant.”
The Urotronic acquisition represents a strategic move for Laborie Medical Technologies to push further into the global urology market. Laborie is focused on high-growth segments including urology, gastroenterology, gynecology, and obstetrics.
According to Patricia Industries, which owns Laborie, the deal furthers Laborie’s long-term growth strategy by adding an innovative product with strong potential to its portfolio. Urotronic’s employees and assets will be fully integrated into Laborie Medical after the acquisition.
Laborie itself was acquired by Patricia Industries in 2017 for an estimated $2.4 billion and has gone through a period of rapid growth since then. The company manufactures a range of diagnostic equipment like urodynamic systems as well as therapy products such as electrodes for pelvic floor stimulation.
The global medical device market has seen a surge of M&A activity in recent years. Strategic mergers and acquisitions allow companies to expand their product lines, access new technology, enter new geographic markets, and consolidate to gain economies of scale.
Medtech titan Boston Scientific for example has made 10 acquisitions in the past 5 years totaling over $10 billion to become a leading player in less invasive device treatments. Teleflex likewise acquired Neotract and its novel UroLift system for treating BPH in a $1 billion purchase in 2017.
The closing of the Urotronic acquisition provides another growth milestone for Laborie Medical as it executes its strategy of providing innovative therapeutic solutions to physicians and hospitals involved in urological procedures. Adding Optilume’s promising technology gives it a differentiated offering in the nonsurgical treatment of enlarged prostate and strengthens Laborie’s portfolio for continued expansion in the urology device sector.
