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MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing On Early Clinical Efficacy Demonstration For Neuropathic Pain In 2025

MIRA Pharmaceuticals, Inc.

By Meg Flippin, Benzinga MIRA Pharmaceuticals (NASDAQ: MIRA), the pre-clinical-stage pharmaceutical company focused on transforming the treatment of neuropathic pain and mental health disorders through scientific research and technological advancements, is making progress in its clinical development planning for Ketamir-2, its novel oral ketamine analog. So much so that the company said that, as part of its strategic development plan, it’s prioritizing early demonstration of Ketamir-2’s clinical efficacy. That could come as early as 2025 through innovative phase 1/2 study designs. What’s more, the company said it's on track for Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) in December 2024. "Our primary goal is to demonstrate efficacy in humans as quickly as possible," says MIRA Pharmaceuticals chairperson and CEO Erez Aminov. "By implementing specific study designs and leveraging our ongoing preclinical research, we aim to gather early evidence of clinical benefits, positioning our treatment as a transformative option for neuropathic pain." To bolster its approach to clinical and regulatory approval, MIRA said it brought on a consultant with expertise in navigating academia and regulatory bodies, including the Federal Drug Administration. The company said this addition demonstrates that it is serious about meeting the highest standards in clinical development and regulatory compliance. Ketamir-2’s Approach To Fighting Neuropathic Pain and Depression Ketamir-2 is an oral ketamine analog designed to be taken as a pill. It is being investigated for the treatment of neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDDSI) and PTSD. Unlike traditional ketamine, which requires intravenous administration, posing accessibility and safety challenges, Ketamir-2 could potentially simplify and improve the treatment experience. The company is exploring Ketamir-2's potential efficacy in treating chemotherapy-induced depression, cancer-related neuropathic pain and diabetic neuropathy. These conditions often have limited treatment options and significant patient populations needing effective therapies. Neuropathic pain alone is a big market, poised to reach over $14 billion by 2034, growing at a CAGR of 5.7% from now until then. Driving demand for drugs to relieve pain is an aging population in the U.S. and an increase in chronic diseases. Collaborating To Speed Time To Market To get testing underway, MIRA Pharmaceuticals said it is collaborating with Formulex, a nano-technology-based drug delivery company, to develop ways to deliver Ketamir-2. The two focus on a spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience. A deterrent to more people using ketamine to treat mental health issues and chronic pain is the delivery. Traditional ketamine treatment for depression requires a Risk Evaluation and Mitigation Strategy (REMS) protocol due to its potential for abuse and severe side effects. This involves strict regulations, including requiring intravenous administration under medical supervision, making it less accessible and more costly for patients. In contrast, Ketamir-2, as an oral formulation, aims to provide a more convenient and less intimidating treatment option. By reducing the need for medical supervision and hospital visits, MIRA Pharmaceuticals says Ketamir-2 could enhance patient compliance and decrease overall treatment costs. Phase I Trial Kicking Off Soon Through the phase I/II study designs MIRA is focused on demonstrating the clinical activity in treating neuropathic pain and potentially other neurologic conditions. The idea is to gather data that can drive faster decision-making and potentially expedite patient access, the company said. The phase 1 clinical trial is slated to kick off in the first quarter of 2025 and will be used to assess safety, tolerability and pharmacokinetics in humans. MIRA says that lays the groundwork for subsequent efficacy studies. MIRA collaborates with international academic research institutes to refine and enhance its clinical development strategy. “We are excited to move smoothly forward with our IND-enabling pre-clinical studies towards Phase I trials, which are designed to provide critical insights into the safety and pharmacokinetic profile of our candidate,” said Dr. Angel, chief scientific advisor at MIRA Pharmaceuticals. “This trial is a pivotal step in our journey to bring novel treatment options for neuropathic pain to patients, and we are committed to executing it with the highest scientific and regulatory standards.” Featured photo by Towfiqu barbhuiya on Unsplash. MIRA Pharmaceuticals, Inc., is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (“TRD”), major depressive disorder with suicidal ideation (MDSI), and potentially post-traumatic stress disorder (“PTSD”). The statements of the Company's management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2 and MIRA-55. Any forward-looking statements are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michelle Yanez +1 305-340-8988 Myanez@mirapharma.com Company Website http://www.mirapharmaceuticals.com/

September 19, 2024 09:00 AM Eastern Daylight Time

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Frontieras Launches Investment Opportunity in a “Rockefeller Moment for Coal”

Frontieras

Frontieras has officially announced the launch of their Regulation CF investment opportunity. The company is commercializing its patented technology to transform coal into a thermal fuel that burns as clean as natural gas, while extracting valuable by-products like hydrogen, diesel, jet fuel, fertilizer, industrial chemicals, and more. This is a unique opportunity for individual investors to join them in the early stages. The company calls their innovation the “Rockefeller Moment” for coal, comparing it to John D. Rockefeller’s famed breakthrough innovation in oil-refining technology. While coal has traditionally simply been burned to create energy, Frontieras’ FASForm technology reforms coal into a fuel source that burns cleaner and more efficiently than natural gas, while extracting additional byproducts that are highly valued in global commodities markets. Why invest in Frontieras? Market Potential: The global market for energy and chemicals exceeds $2.1 trillion, encompassing sectors like diesel, hydrogen, jet fuel, and more. Expansion Plan: The company is set to build a state-of-the-art facility in Mason County, West Virginia, with an investment of $850 million. This facility will create 200 full-time jobs and 2,000 construction jobs, boosting the local economy. Proven Track Record: With over $7 million raised from investors to date, Frontieras is already demonstrating strong investor confidence. Matt McKean, Co-Founder & CEO of Frontieras, commented, “Our Reg CF offering is an exciting opportunity for investors to participate in a groundbreaking venture set to redefine the entire global coal industry. These opportunities in the energy sector are rare for individual investors –– they’re typically only available to large institutions. We’re thrilled to give the average investor an opportunity to invest in a major innovation in the global energy industry.” Frontieras Investment Opportunity The Reg CF offering is now accepting investments for a limited time. To learn more about investing in Frontieras and to access the offering details, you can visit their website here. About Frontieras Frontieras specializes in clean coal processing technologies. Their patented FASForm technology transforms coal into high-value commodities, providing a sustainable solution to meet global energy demands while generating substantial economic benefits. To learn more about the company, visit their website at www.frontieras.com. Contact Information: Matthew T McKean CEO, Frontieras North America invest@frontieras.com (304) 316-2060 Frontieras specializes in clean coal processing technologies. Their patented FASForm technology transforms coal into high-value commodities, providing a sustainable solution to meet global energy demands while generating substantial economic benefits. To learn more about the company, visit their website at www.frontieras.com. The Reg CF offering is now accepting investments for a limited time. To learn more about investing in Frontieras and to access the offering details, you can visit their website. Contact Details Matthew T McKean invest@frontieras.com Company Website https://invest.frontieras.com/

September 19, 2024 09:00 AM Eastern Daylight Time

New Horizon Aircraft (NASDAQ: HOVR) Poised For Growth With Hybrid Aircraft Technology Amid Small-Cap Strength

Benzinga

By Gerelyn Terzo, Benzinga The future has arrived, thanks to electric Vertical Take-Off and Landing (eVTOL) aircraft. eVTOLs are aircraft that launch vertically, similar to a helicopter, rather than a conventional takeoff. Hybrid-electric eVTOL designs have the potential to enable greater speed, range and cargo capacity than fully electric versions and could play an important role in the future of aviation. While eVTOL is still in its early days, with the industry currently in the testing phase, its value is predicted to surpass $30 billion by the next decade amid a CAGR of 15.3% since last year. And while Tesla (NASDAQ: TSLA) is playing a key role with electric vehicles, New Horizon Aircraft (NASDAQ: HOVR) hopes to take on a leadership position in the eVTOL aircraft market segment. Toronto-based New Horizon says it has been an early mover in eVTOL technology with its Cavorite X7 prototype aircraft, a hybrid model built for real-world use cases. Its aircraft takes off vertically, true to eVTOL form. However, once in flight, it reverts to the configuration of a conventional airplane, owing to the company’s patented HOVR wing system. The Cavorite X7 is built to reach speeds of 250 miles per hour, with a fuel capacity of more than 500 miles, making it appropriate for real-world applications like travel when the time comes. Learn more about New Horizon Aircraft’s technology here. New Horizon Puts Pedal To The Metal On eVTOL Aircraft Led by a team of operators, aviators and aerospace engineers, New Horizon has been going full throttle of late as it prepares to fully transition its large-scale prototype aircraft by the end of this year. Chief among New Horizon’s priorities is advancing the development of its hybrid-powered eVTOL aircraft. The company has been making strides from a technical standpoint while also building out its team internally. Flight test program: Among the technical highlights, New Horizon has published results on its flight test program, which it says are surpassing its expectations. The company has performed hundreds of flight tests and is nearing full transition speed, which it anticipates achieving by year-end. Full-scale aircraft development: New Horizon says it is innovating the proprietary patent technologies that are critical to its unique aircraft, including full-scale propulsion units that are essential to its HOVR wing technology. Cooling system and power tests for its full-scale propulsion units continue to unfold and it says the outcomes are positive so far. Encouraging test results extend to the company’s Cavorite X7’s patented HOVR wing design, which the company says enables safer, more durable performance even in the most forbidding conditions. Digital twin development: New Horizon harnesses a hardware-in-the-loop (HITL) digital twin technology to test its aircraft, supporting the rapid testing of large-scale prototype aircraft like the Cavorite X7. Its hybrid technology is fueled by its HOVR wing technology, allowing the aircraft to fly nearly all of its missions in a formation that closely resembles that of a conventional aircraft. Meanwhile, the company says the hybrid power system delivers greater range, speed and payloads in its class. When the Cavorite X7 reaches commercialization, New Horizon expects it to have the power to disrupt the travel industry with its speed, efficiency and cost savings over traditional aircraft. However, its potential use cases also extend to medical evacuation, critical supply delivery, disaster relief and special military missions. “Our unique, customer-first approach prioritizes building a tough eVTOL aircraft that can operate in bad weather, icing conditions and other challenging operational environments. This strategy is gaining strong traction with operators, driving substantial demand,” said Horizon Aircraft CEO Brandon Robinson. To keep pace with this ongoing innovation, New Horizon recently expanded its team with the addition of seasoned engineer Tom Brassington as Chief Technology Officer. New Horizon Says It Could Be Poised To Benefit From Possible Small-Cap Stock Demand Earlier this year, New Horizon made its debut in the publicly traded markets amid a business combination with special purpose acquisition company (SPAC) Pono Capital Three. Most recently, New Horizon returned to the equity capital markets with a $2.9 million public offering. The deal, the closing for which was announced in August, comprised 2.8 million Class A ordinary shares with various types of warrants. New Horizon’s timing is no coincidence, as the company says it could be poised to benefit from an expected ongoing rotation in the equity markets into small cap stocks. While small cap stocks have been gaining attention of late, New Horizon took matters into its own hands. It commissioned its own global poll of investment managers to uncover evidence of investor demand for small- and micro-cap names working with more sustainable technologies, where the upside potential is considered greater than larger companies because they are coming from a lower base. The aerospace company says it found that investor demand is in fact there, with more than three-quarters of survey participants demonstrating an expectation for exposure to these asset classes among institutional investors to increase in the next six to twelve months. Slightly more than one-third (34%) of them say allocations to these stocks could increase by at least 25%. Investors who are interested in participating in New Horizon’s growth story can learn more about this company’s financials here. Read more about New Horizon Aircraft: Pilotless Planes Are Coming, But Not Just Yet, Says New Horizon Aircraft CEO On The Horizon: How One Company Plans To Use Its Innovative Aircraft Design To Revolutionize Regional Air Travel From Stage To Stage: How New Horizon Aircraft's eVTOLs Could Simplify Tour Logistics For Taylor Swift Sustainably Featured photo by ELG21 on Pixabay Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 19, 2024 08:45 AM Eastern Daylight Time

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Brand Engagement Network Brings AI Assistants To Medical Coaching And The $6.7 Billion Concierge Medicine Market Following The Expansion Of Its Board

Benzinga

By Anthony Termini, Benzinga The world of healthcare is rapidly changing, with holistic, accessible care as a key element. In the aftermath of a global pandemic, many patients are demanding a wider range of services that meet a broader range of needs. We may even potentially be entering a golden age of healthcare where patients are being prioritized more than ever, and technology is rapidly advancing to assist physicians in achieving these goals. Brand Engagement Network (BEN) (NASDAQ: BNAI), an artificial intelligence (AI) company, aims to enhance support in this radically expanding industry. The company is an emerging provider of personalized patient engagement. It uses AI to power technology that can see, hear and understand the input it receives from a patient. Using human-like avatars as the interface, BEN says its HIPAA-compliant technology can support highly specific patient requests and can remember, analyze, speak and gesture in a similar way that a person would in a human-to-human interaction. The company’s AI assistants can provide insights about preventative medicine and healthcare options based on a patient’s insurance and health plan while also protecting sensitive medical information. These human-modeled AI assistants are also designed to help augment health and wellness coaching. BEN’s AI Assistants Are Filling Gaps In The Healthcare Industry In August 2024, the company entered an agreement with Members Only Health, a full-service concierge healthcare company. The members-only agreement sets up the development of an AI assistant to serve a number of patient needs. These may include the 24/7/365 availability of a personal concierge to navigate and coordinate the global network Members Only Health (MOH) maintains across providers, health plans and preventative medicine data. Now, MOH expects to have the ability to scale its business much faster and more efficiently by deploying AI assistants to support its growing client base. Nicholas Argento, CEO of Members Only Health says that patients who use healthcare concierge services benefit from professional care around the clock. He adds that AI technology like BEN’s can help ensure that patients “have access to up-to-date healthcare information and the most convenient options for treatment.” The concierge medicine market in the U.S. reached $6.7 billion in 2023. The market is expected to grow annually by nearly 10.4% through 2030. Not to mention, concierge services’ focus on accessibility will be even more important in the coming decades, as our population continues to age; by 2054, 84 million adults ages 65 and older will make up an estimated 23% of the population. BEN also entered into an agreement with INTERVENT International, a key player in the health coaching industry. The agreement with INTERVENT is intended to incorporate human-modeled AI assistants into INTERVENT’s scientifically proven health coaching programs. The goal is to scale a cost-effective, in-depth and conversational support system for both professional health coaches and patient participants. Led by physicians, INTERVENT is a high-tech/high-touch health management company. It delivers evidence-based behavior change and entity-wide or population-based health and wellness coaching. The agreement with BEN is aimed at helping INTERVENT train coaches faster and serve more program participants at a lower cost than would be possible with human interaction alone. INTERVENT’s CEO, Neil Gordon, MD, PhD, MPH, believes AI-driven technology will benefit healthcare providers and patients. He says that “AI will not replace appropriately trained health coaches, but appropriately trained health coaches who leverage purpose-built AI and other technologies are likely to replace those who do not.” How BEN Is Ensuring It Has A Strong Team To Herald In This New Age Of Healthcare And Technology “AI technology offers an incredible opportunity to vastly improve patient outcomes,” said Richard Isaacs, MD, FACS, Dean of the College of Medicine and Professor of otolaryngology at California Northstate University. Isaacs has an intimate understanding of the intersection of technology innovation and medicine and in 2021 was regarded by Modern Healthcare as one of the 100 Most Influential People in Healthcare. Isaacs is a recent addition to BEN’s Board of Directors. At the time of his appointment, he said that he has “always pursued the realization of what is possible in healthcare with new technologies” and that he looks “forward to helping guide BEN’s development of new applications … in the industry.” With the increasing adoption of AI technologies, BEN’s commitment to creating a team of innovators and experts can help set it apart from competitors. Issacs has a long history of embracing new technologies to benefit physicians and patients alike. While he was the chief physician at South Sacramento Medical Center, Issacs led the development and implementation of Kaiser Permanente’s electronic health record system. Under his direction, the facility first began using smartphone applications to help enhance personalized care and improve overall patient experiences. At the company’s core, it is interested in using its proprietary technology to advance industries that require support. It does not seem to be interested in the model of AI for the sake of AI, but rather in developing a robust AI product and connecting with partners to see how it can best assist in bringing evolution to industries in flux. “Improving patient experiences and healthcare outcomes starts with elevating the education and training of healthcare professionals, and enhancing access to healthcare,” said Paul Chang, CEO of BEN. “Supplementing training programs, health coaching (digital and otherwise), and patient engagement with AI technology helps to address significant resource and labor gaps in the healthcare industry while empowering professionals and patients to make informed decisions for optimal health.” Brand Engagement Network believes these agreements will help drive the development of healthcare AI assistants to augment and automate business processes ranging from professional health coaching to patient engagement. The collaborations are expected to help people access specialized healthcare, which may improve patient outcomes. To see more ways BEN is empowering the healthcare industry – as well as other important business sectors worldwide – visit the company’s website. Featured photo by Bermix Studio on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 19, 2024 08:35 AM Eastern Daylight Time

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The Risks And Rewards Of Betting Big On AI & Big Data

Benzinga

By Kyle Anthony, Benzinga The technological landscape is expanding, with artificial intelligence (AI) starting to play a seminal role in the next generation of computing. Many notable companies are establishing or integrating AI capabilities into their technological infrastructure. The proliferation of AI and its potential to bring about work efficiencies and newfound innovations is raising the expectations not only of consumers but also of investors who have exposure to companies within the AI ecosystem. Chips And Semiconductor Stocks Exceeding Software Stocks While much of the discussion about AI has centered on the Magnificent Seven – Apple (NASDAQ: AAPL), Amazon (NASDAQ: AMZN), Google (NASDAQ: GOOG), Meta (NASDAQ: META), Microsoft (NASDAQ: MSFT), Nvidia (NASDAQ: NVDA) and Tesla (NASDAQ: TSLA) – with a particular focus on Nvidia, the AI ecosystem is expansive and reflects differing stakeholders. Essential to AI development are semiconductors or chips; tiny electronic devices designed to enable functions such as processing, storing, sensing and moving data or signals. AI models employ different types of chips, including memory chips to store large amounts of data and logic chips to process the data. According to Gartner, revenues from AI semiconductors are forecast to be $137 billion by 2027, growing by a five-year compound annual growth rate of 26.5%. As reported by Market Watch, chips/semiconductor stocks outweighed software stocks in the S&P 500 for the first time in June and had the largest overall sector weighting. The changing of the guard reflects Wall Street’s expectations about the semiconductor sector’s ability to capitalize financially on AI. On a company level, Nvidia and Advanced Micro Devices, Inc. (NASDAQ: AMD) are chip designers leading innovation by continuing to push the limits of chip performance, enabling more complex and powerful AI applications. Conversely, end-user companies, such as Meta, are making material investments in their AI capabilities as they continue accelerating infrastructure investments to support their AI roadmap. In Q2 2024, Meta reported total revenues of $36.46 billion and a net income of $12.37 billion, increasing by 27% and 117%; respectively, compared to the same period in 2023. The firm anticipates full-year 2024 capital expenditures will be in the range of $35-40 billion, an increase from their prior range of $30-37 billion, due to their ongoing AI spending. Growing Concerns Of An AI Bubble While AI's potential is significant, growing concerns exist about firms' overinvestment and whether it will manifest as profit or be a cash pitfall. As noted by Forbes, there is a growing sentiment that for the millions that have been invested in AI, the returns thus far have been underwhelming – chatbots lacking a clear monetization strategy, cost-cutting approaches such as AI-driven coding and customer service and AI-powered search that occasionally generates inaccuracies. It would seem that the AI return on investment, thus far, isn’t living up to the large capital expenditures being made. Still, many leading big tech firms remain committed to investing in this space. On the regulatory side, the European Commission recently ratified the European Artificial Intelligence Act (AI Act), the world's first comprehensive regulation on AI. The AI Act aims to ensure that AI developed and used in the European Union (EU) is trustworthy and includes safeguards to protect fundamental rights. The regulation seeks to create a harmonized internal market for AI within the EU, fostering the adoption of this technology and creating a supportive environment for innovation and investment. Given the intense regulatory focus placed on big tech companies, including Alphabet, Amazon, Apple, ByteDance, Meta and Microsoft in Europe, the implications of the AI Act on their operations have yet to be determined. Still, they have the potential to be material in nature. Trading AI And Big Data With Direxion For traders looking to gain leveraged exposure to the fits and starts caused by the volatility of companies involved in the AI ecosystem, Direxion’s Daily AI and Big Data Bull (ARCA: AIBU) and Bear (ARCA: AIBD) 2X Shares offer enhanced, pure-play exposure to companies from the United States that have business operations in artificial intelligence applications and big data. Direxion’s Daily AI and Big Data Bull and Bear 2X Shares seek daily investment results, before fees and expenses, of 200%, or 200% of the opposite, respectively, of the performance of the Solactive US AI & Big Data Index*. They enable short-term traders to gain leveraged exposure to the index’s movements, on either side of the trade. For high-risk traders who are bullish or bearish on AI development, these ETFs present an opportunity to conveniently trade a group of seminal companies and meaningfully participate in their activity. These high-risk ETFs are best suited for those who can actively manage the inherent risks of leverage and are looking to capitalize on short-term trends occurring in the AI and big data industry. Featured photo by Steve Johnson on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. An investor should carefully consider a Fund's investment objective, risks, charges, and expenses before investing. A Fund's prospectus and summary prospectus contain this and other information about the Direxion Shares. To obtain a Fund's prospectus and summary prospectus call 866-476-7523 or visit our website at direxion.com. A Fundâs prospectus and summary prospectus should be read carefully before investing. An investor should carefully consider a Fund's investment objective, risks, charges, and expenses before investing. A Fundâs prospectus and summary prospectus contain this and other information about the Direxion Shares. To obtain a Fundâs prospectus and summary prospectus call 866-476-7523 or visit our website at direxion.com. A Fundâs prospectus and summary prospectus should be read carefully before investing. The Index is designed by Solactive AG to represent the securities of companies from the United States that have business operations in the field of artificial intelligence ("AI") applications and big data. Solactive AG is not a sponsor of, or in any way affiliated with, the Direxion Daily AI and Big Data Bull 2X Shares or Direxion Daily AI and Big Data Bear 2X Shares. Direxion Shares Risks - An investment in each Fund involves risk, including the possible loss of principal. Each Fund is non-diversified and includes risks associated with the Fundsâ concentrating their investments in a particular industry, sector, or geographic region which can result in increased volatility. The use of derivatives such as futures contracts and swaps are subject to market risks that may cause their price to fluctuate over time. Risks of each Fund include Effects of Compounding and Market Volatility Risk, Leverage Risk, Market Risk, Counterparty Risk, Rebalancing Risk, Intra-Day Investment Risk, Other Investment Companies (including ETFs) Risk, Cash Transaction Risk, Passive Investment and Index Performance Risk, and risks specific to the information technology sector and AI and big data companies. The value of stocks of information technology companies and companies that rely heavily on technology is particularly vulnerable to rapid changes in technology product cycles. Additional risks include, for the Direxion Daily AI and Big Data Bull 2X Shares, Daily Index Correlation Risk and for the Direxion Daily AI and Big Data Bear 2X Shares, Shorting or Inverse Risk and Daily Inverse Index Correlation Risk. Please see the summary and full prospectuses for a more complete description of these and other risks of each Fund. Distributor: ALPS Distributors, Inc. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 19, 2024 08:30 AM Eastern Daylight Time

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Industry Update: 3 Exciting Precision Oncology Players to Watch Following Summit’s Meteoric Rise: Silexion, Nuvectis, Scorpian

Global Markets News

Summit Therapeutics (NASDAQ: SMMT) recently captured headlines with the release of its Phase 3 data for ivonescimab, a targeted NSCLC therapy that has generated substantial buzz. The results from its trial conducted in China showed a dramatic 49% reduction in the risk of disease progression or death compared to Merck’s Keytruda, signaling a potentially disruptive force in NSCLC treatment. However, the news wasn’t without its concerns—since the trial data originates from China, there are questions about its applicability to broader, global populations. As noted by BMO Capital Markets’ Evan Seigerman: “Results may or may not be generalizable beyond the China-focused patient population initially assessed.” Despite this, Summit’s valuation has risen by over 100%, now approximating $19 billion. With such a high valuation, the company could see limited room for further significant gains, leading many in the industry to explore other emerging opportunities in precision oncology. Alongside Summit, there are quite a few other players in the field. Some if these companies have even already shown promising initial results and could see similar success in the future if they were to report positive results. These emerging players are worth watching for those interested in following precision oncology drug candidates and pipelines. Among them are precision oncology innovators such as Silexion Therapeutics, Nuvectis Pharma, and Scorpion Therapeutics, which we discuss below. Silexion Therapeutics: Disrupting the KRAS-Driven Cancer Space Silexion Therapeutics (NASDAQ: SLXN) is another under-the-radar player in the precision oncology space, with a focus on KRAS-driven cancers—a notoriously difficult target in oncology. While current small-molecule KRAS inhibitors are making progress, they are often limited to specific mutations, such as KRAS G12C, which accounts for a small percentage of cancers. Silexion’s RNA interference (RNAi) approach offers a broader solution, targeting a wider spectrum of KRAS mutations, particularly in pancreatic cancer, one of the deadliest and most treatment-resistant cancers. At the heart of Silexion’s approach is its LODER™ platform, which delivers siRNA directly to the tumor site, silencing KRAS mutations at the genetic level. This localized delivery not only increases efficacy by concentrating the treatment in the tumor, but it also reduces systemic side effects. Silexion’s next-generation candidate, SIL-204, is an optimized siRNA formulation designed to target pan-KRAS G12x mutations, positioning it to treat a broader range of KRAS-driven cancers beyond pancreatic cancer, such as lung and colorectal cancers. In Phase 2 trials for locally advanced pancreatic cancer, Silexion's LODER™ platform showed a 9.3-month improvement in overall survival when combined with standard chemotherapy. Additionally, the objective response rate (ORR) increased from 20% with chemotherapy alone to 55% with the combination, and in some cases, tumors that were initially non-resectable became operable after treatment with LODER™. These results are especially encouraging given the limited options available for pancreatic cancer patients. SIL-204, is expected to enter Phase 2/3 clinical trials in 2025-2026. What makes Silexion particularly intriguing is its current market valuation. Valued at aproximatly just ~$9 million following its SPAC merger, the company’s valuation could be perceived as low when compared to some of its peers, especially given its innovative technology and promising clinical achievements. Some have wondered whether this low valuation has more to do with dynamics post-SPAC companies. If Silexion can report positive results in its later-stage trials, the company’s outlook could dramatically improve, reflecting the potential of its RNAi-based platform. Like NXP900, SIL-204 could potentially have vast applications across multiple KRAS-driven cancer types, making Silexion a company to watch closely as it advances through clinical development. Nuvectis Pharma: Targeting NSCLC and Beyond by Inhibiting SRC/YES1 Kinases Nuvectis Pharma (NASDAQ: NVCT) has been quietly making strides in the precision oncology sector, developing innovative therapies aimed at overcoming treatment resistance in hard-to-treat cancers. Its lead candidate, NXP900, targets NSCLC by inhibiting the SRC/YES1 kinases, which play critical roles in cancer cell survival and resistance to current therapies. This approach positions NXP900 as a potential game-changer in the treatment of NSCLC, particularly in patients who have developed resistance to EGFR and ALK inhibitors, such as AstraZeneca’s Tagrisso and Novartis’ Alecensa. NXP900 is still in the early stages of clinical development, currently undergoing Phase 1 trials. However, preclinical studies have already shown that it has strong anti-tumor activity in resistant NSCLC models. Even more promising is its potential application beyond NSCLC. Like Summit's ivonescimab, NXP900 focuses on resistance, but it also has broader applications due to its ability to target multiple cancer types driven by SRC/YES1 pathways. This versatility makes it a promising asset not just for NSCLC but also for other difficult-to-treat cancers like squamous cell carcinomas. In addition to NXP900, Nuvectis is advancing NXP800, another precision oncology candidate that is further along in the clinical development process. NXP800 is currently in Phase 1b trials, targeting ARID1a-mutated cancers such as ovarian and endometrial cancers. The early clinical data for NXP800 is promising, showing positive responses in patients with platinum-resistant ovarian cancer. With two strong candidates in the pipeline, Nuvectis is positioning itself as a formidable player in the precision oncology landscape. As Summit’s ivonescimab continues to gain attention, Nuvectis’ earlier-stage NXP900, with its NSCLC focus and beyond, could see similar success in the future if clinical results continue to trend positively. Scorpion Therapeutics: Pioneering Mutant-Selective Therapies Scorpion Therapeutics is redefining the frontier of precision oncology with its focus on delivering highly selective small molecules targeting validated and previously undruggable cancer mutations. Its lead candidate, STX-478, is a mutant-selective, allosteric PI3Kα inhibitor currently in Phase 1/2 trials for advanced solid tumors. Early data presented at the ESMO Congress 2024 highlighted its potential, with STX-478 demonstrating a 23% overall response rate in breast cancer and a 21% response rate across all tumor types, positioning it as a potentially best-in-class PI3Kα inhibitor. STX-478 is notable for its ability to spare wild-type PI3Kα activity in normal tissues, avoiding the toxicities seen with previous PI3Kα inhibitors, such as hyperglycemia and rash. Tumor reductions were seen in 72% of patients treated with STX-478 as a monotherapy, with circulating tumor DNA levels dropping in 86% of patients. This mutant-selective precision could help overcome the limitations of existing PI3Kα inhibitors, which have struggled with dose-limiting toxicities. In July 2024, Scorpion raised $150 million in a Series C financing round, co-led by Frazier Life Sciences and Lightspeed Venture Partners. The additional funding will support the advancement of STX-478 and other pipeline assets, positioning Scorpion for further clinical success. Scorpion’s pipeline includes a broad range of wholly-owned compounds that target both validated and novel cancer targets, positioning the company for future expansion into larger patient populations. As STX-478 progresses through clinical development, Scorpion is poised to become a significant player in the precision oncology space, making it another company worth watching closely. Optimistic Outlook for Precision Oncology The precision oncology space is experiencing a golden era of innovation, with companies like Summit Therapeutics, Nuvectis Pharma, Silexion Therapeutics, and Scorpion Therapeutics leading the charge. As the focus shifts towards targeted therapies that address resistance mechanisms, the market is increasingly favoring companies with novel approaches and broad applications. Summit’s meteoric rise has shown that there is tremendous potential for companies that can demonstrate efficacy in overcoming cancer resistance. While Summit has already captured much of the current attention, companies like Nuvectis, Silexion, and Scorpion, with their earlier-stage pipelines, offer exciting opportunities for the industry to keep a close eye on. As these companies continue to report clinical data and advance through trials, the potential for breakthroughs in treating some of the most difficult cancers grows stronger. With targeted therapies offering the possibility of overcoming resistance without the need for chemotherapy, the future of cancer treatment looks brighter than ever. For those in the oncology space, keeping a close eye on emerging players like Nuvectis, Silexion, and Scorpion could lead to transformative developments as the field of precision oncology continues to evolve. * * * This update may include speculative forward looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. the BioTech and Pharma industries are volatile and risky and readers are advised to seek out preffesional advice in the relevent feilds from licensed profesionals. This update is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. [ https://justpaste.it/ch2qt/pdf ]. Global Markets News Network is a commercial digital brand compensated to provide coverage of news and developments related to innovative companies as detailed in the full documentation and it is thus subject to conflicts of interest. Contact Details News Coverage ronald@futuremarketsresearch.com

September 19, 2024 07:45 AM Eastern Daylight Time

HTX DAO x TRON TOKEN2049 Afterparty: Leading the Next Decade of Web3 Ecosystem

HTX

September 18, Singapore - Today, HTX DAO and TRON, in collaboration with Alethea AI, Tour Billion, BitWave, ChainGPT, Google Cloud, and The Block, hosted an afterparty following TOKEN2049, one of the world’s most influential Web3 events. This highly anticipated crypto night brought together over 1,100 Web3 pioneers to discuss the future of the Web3 ecosystem, with TRON founder and Global Advisor of HTX, Justin Sun, and several industry leaders delivering addresses. The afterparty attracted prominent projects, investment institutions, and KOLs from the crypto space. Notable media partners were in attendance to cover the event, including Odaily, BlockBeats, Foresight News, TechFlow, MarsBit, Cointime, DeThings, PANews, Jinse Finance, ChainCatcher, MetaEra, BroadChain, Bitcoin.com, BeInCrypto, Blockopedia, and Monsterblockhk. As the keynote speaker, Justin Sun highlighted the achievements of HTX and TRON while outlining a twin-engine strategy for future development in his video address titled "A New Decade: TRON x HTX Lead the Globe Web3 Ecosystem." He emphasized that blockchain technology, once a nascent concept, has now become a transformative force in reshaping industries worldwide and lauded TRON and HTX for playing pivotal roles in this evolution. "TRON's journey began with an attempt at an in-depth exploration of the limitless possibilities of blockchain technology. We remained committed to the core values of openness, transparency, and decentralization. Furthermore, HTX, one of the most important partners of TRON, has made remarkable contributions to the growth of the blockchain industry since its inception. This year marked the 11th anniversary of HTX, showing its longevity in this industry, and that is truly an achievement to be proud of. HTX has remained at the forefront of the industry, owing to its commitment to longtermism, proactive compliance to changing regulations, and its unwavering focus on security and user experience,” Sun added. Looking ahead to Web3's next decade, Sun believes blockchain technology and products need to focus on real-world applications, which requires enhanced interactivity, diversified use cases, AI-driven solutions, strengthened network systems, and broader acceptance. The upcoming decade will also witness closer collaborations between TRON and HTX. The most recent collaboration between the two industry giants took place in August with SunPump. This meme coin issuance platform, launched on the robust TRON network and supported by HTX’s market resources, became a phenomenal Web3 application in just one month of its debut. SunPump boosted on-chain transaction volume, creating a positive feedback loop that benefitted both TRON and HTX. "Our ultimate goal is to build an all-encompassing Web3 ecosystem that integrates payments, investments, and social interactions," said Justin Sun. "We will focus on driving the growth of the TRON ecosystem, drawing in more high-quality DApps and projects and enhancing the collaboration between TRON and HTX. Meanwhile, we will also tap into HTX's global influence and extensive resources. By integrating TRON’s cutting-edge technology with HTX's market strength, we can expand the global reach of our products and services with greater efficiency." In addition to Justin Sun, the event is also attended by several distinguished guests from prominent projects and media, including Arif Khan, founder and CEO of Alethea AI, an AI infrastructure provider; Victor Yap, Regional Marketing Director for Asia Pacific at Tour Billion, a GameFi launchpad; Leo, co-founder of BitWave, a Bitcoin layer-2 solution; Sharon Sciammas, CMO of ChainGPT, an AI tool provider; and Larry Cermak, CEO of The Block, a crypto media outlet. They each delivered speeches, sharing their insights and future perspectives on the crypto industry. Their discussions covered a range of trending topics, such as, AI, DePIN, BTCFi, and GameFi. It is worth mentioning that the event also captivated attendees with energetic performances and a variety of thrilling prize draws. The evening’s lucky winners took home a range of remarkable rewards, such as, 11 cold wallets, 2.2 billion $HTX, 5 $ETH, $2,000 in $MASA, and 2 Formula 1 tickets. At TOKEN2049 in 2023, HTX marked its 10th anniversary with a rebranding, representing the first milestone in its journey into the next decade. Over the last year, HTX has achieved substantial growth, consistently leading the industry in terms of trading volume and liquidity, while regularly introducing innovative products and high-quality assets. According to CoinGecko data, HTX became the second-ranked exchange globally in early August, making steady progress toward its goal of securing a spot in the top three exchanges. Furthermore, the establishment of HTX DAO represents another milestone in HTX's efforts to build a decentralized ecosystem. To date, with the support of HTX, the liquidity pledges received by HTX DAO and the amount of $HTX repurchased and burned have reached a total of $51.5 million, effectively driving the growth of the decentralized community. This year, participants from the HTX ecosystem remain active at TOKEN2049. In addition to the Afterparty hosted by TRON and co-hosted by HTX DAO, Edward, the Managing Partner of HTX Ventures, HTX’s global investment arm, will participate in a discussion hosted by Google Cloud on the theme “AI and Web3: Building a Trusted Digital Future.” HTX's global brand building has achieved initial success and is set to expand further. As a pioneer in the crypto space, HTX has consistently spearheaded industry innovation and led the way in setting new trends over its 11-year history. Looking forward, HTX will continue to pursue its vision of achieving financial freedom for 8 billion people on earth. As Justin Sun stated, “With the joint efforts of HTX and TRON, we are confident that we can create a truly practical, convenient, and thriving Web3 ecosystem for users worldwide within the next decade.” About HTX Founded in 2013, HTX has evolved from a virtual asset exchange into a comprehensive ecosystem of blockchain businesses that span digital asset trading, financial derivatives, research, investments, incubation, and other businesses. As a world-leading gateway to Web3, HTX harbors global capabilities that enable it to provide users with safe and reliable services. Adhering to the growth strategy of "Global Expansion, Thriving Ecosystem, Wealth Effect, Security & Compliance," HTX is dedicated to providing quality services and values to virtual asset enthusiasts worldwide. Contact Details Ruder Finn Asia htx@ruderfinn.com Company Website https://www.htx.com About HTX Founded in 2013, HTX has evolved over a decade from a simple cryptocurrency exchange to a comprehensive blockchain business ecosystem. This expansion covers a wide range of services including digital asset trading, financial derivatives, wallets, research, investments, incubation, and more. As a world-leading portal to Web 3.0, HTX is committed to a growth strategy focused on global expansion, ecological prosperity, wealth effect, and safety and compliance. This approach enables us to offer comprehensive, safe, and reliable services and value to virtual currency enthusiasts around the world, reinforcing our position as a global gateway to Web3. Contact Details Ruder Finn Asia htx@ruderfinn.com Company Website https://www.htx.com/

September 18, 2024 11:19 PM Eastern Daylight Time

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Reform of Africa's Criminal Justice Systems

Pinion Newswire

A well-functioning criminal justice system (CJS) is the bedrock of a safe and secure society. It protects our communities from exploitation and our citizens against false accusations. The CJS comprises government agencies mandated through legislation to work together to deter crimes against individuals, societies, and states. In a collaborated effort, they serve to punish offenders who cause physical or psychological harm against persons, are involved in damage or theft of property, and those who perform crimes against the state. Criminal justice systems involve multiple parts, each with a distinct role. The adversarial nature of most criminal justice systems requires functional independence between the judiciary and the agencies that present criminal cases to courts on behalf of the people. Criminal justice systems are inherently complex because of the independent functioning of agencies such as police investigation, prosecution, judiciaries, and prison authorities. They involve several independent functions: crime reporting, detection, prosecution, adjudication, sentencing, incarceration, rehabilitation, and reintroducing prisoners into society. While there is a requirement for independence, each component depends on one or more of the other components, without which it cannot function. Social Deprivation A large percentage of crimes in Africa can be directly attributed to social deprivation caused by poor housing and parenting, poverty, low levels of education, and unemployment. Socially deprived individuals are easily given over to more detestable behavior, such as substance abuse and gangsterism, where there is no respect for human life and freedom and no regard for the rule of law. African countries have also become havens for crimes such as fraud, corruption, extortion, kidnapping, human trafficking, and modern slavery. Unlike the modus of operandi in the age of colonial slavery, greedy people from within African countries who operate in concert with international syndicates have become the main actors. Criminal Justice Realities CJS agencies worldwide are poorly coordinated and function in silos. Petty crime cases take as long to finalize as complex cases because of a lack of case classification and appropriate diversion programs. Very few, if any, countries can claim that they have successfully integrated their criminal justice process and information flows. Blame will frequently be shifted to different areas of the system, with budget limitations often cited as the primary obstacle. However, most criminal justice systems are fraught with inefficiencies that lead to wastage and duplication, leading to a continuous cycle of increasing inefficiencies. Criminal justice systems almost everywhere in Africa suffer from a lack of end-to-end governance and the absence of politically accountable individuals who can influence strategic government expenditure and oversee the alignment and smooth functioning of the system as an integrated whole. Some African countries have taken promising steps toward integrating their criminal justice systems and have sound process and information integration plans. This has, however, been hampered by a lack of continuity of decision-makers and functional heads across CJS agencies. Changes at the ministerial level frequently trigger shifts in leadership across subordinate appointments, which in turn result in strategic and operational pauses for long periods and disruption of previous integrated planning and systems implementation. Appropriate Tools Budgets are mostly allocated to the different CJS components in an unscientific and uncoordinated way, creating unbalanced systems that result in blockages from start to finish. The process is characterized by multiple iterations between investigators and prosecutors and many fruitless court appearances that result in postponements before court adjudication. The result is a very high rate of cases that are closed by the police as “undetected” and an alarmingly low conviction rate. This translates into a criminal justice system that does not serve as a deterrent to crime. A cursory survey among crime detectives in Africa will almost always point to lacking basic but essential tools, such as vehicles to transport them to crime scenes, limiting available access to witnesses, prosecutors, and attending court hearings. They often must share mobile phones, which serve a dual purpose as recording and photographic devices. Forensic investigators face similar issues. Prison Overcrowding Most African prisons are overcrowded. The number of convicted prisoners almost always exceeds prison capacity. Prisons also have to accommodate high numbers of offenders who are awaiting trial. They should be kept separately from sentenced prisoners, but this is not always the case. The result is that young first-time offenders are often locked up in the same ultra-crowded spaces as individuals with extensive criminal records. Recommendations for Criminal Justice Reform The success of criminal justice systems depends on their ability to function seamlessly, with balanced and optimized resource utilization across the CJS entities and performance measured on an end-to-end basis. Successful CJS reform interventions have political and executive backing at the highest levels, ensuring they maintain a sustained involvement in the ongoing performance of the CJS. The critical factors are listed below: Focused and integrated governance and oversight structures backed by senior political sponsors and high-level officials. A single vision, mission, and overall CJS objectives at federal, provincial/state levels. Coordinated strategies, plans, and budgets, including cross-departmental resource models. A legislative reform program to replace inhibiting and outdated legislation, to enact legislation, and to publish diversion programs and alternative dispute resolution regulations, thereby allowing CJS role players to focus on serious crimes. Implementation of a permanent CJS structure to: Specialist career paths for investigators, prosecutors, and judiciary members who deal with complex commercial crime cases and other emerging crimes, including cybercrimes. Integrated and accessible CJS information technology system with shared criminal case information, criminal history, and biometric information of sentenced offenders. Outcomes The recommended actions will have strategic and operational benefits for society and criminal justice actors, with tangible and measurable outcomes that include: Successful investigations with fewer iterations between prosecution and investigation. Reduced number of court postponements, offender remands, and a decreased “awaiting trial” population. Shorter criminal case lapse time and increased cases with a final verdict. Significant elimination of duplication and wastage of public funds. Improved public confidence. Conclusion Effective criminal justice can only be served when all the role players are aligned through a joint mandate, common overall objectives, and coordinated and managed operating processes and procedures. This is contrasted by disjointed criminal justice systems that work in silos. This truth has evaded the attention of politicians, government agency heads, and CJS strategists for many decades. Insufficient attention to joint capacity planning, headcount balancing, skills requirements, skills matching, legislative alignment, and reform initiatives, results in delayed justice or no justice. A well-thought-through strategic approach to problem identification and solving, combined with the active involvement of the highest level of decision-makers, will result in actions that will automatically allow for short-term quick fixes, medium-term solutions, and longer-term interventions that ultimately must all be incorporated into a strategic Criminal Justice Reform Program. Contact Details StudeBaker Group Johann Marx +1 917-601-3863 johann@studebaker.group

September 18, 2024 04:41 PM Eastern Daylight Time

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Bluepeak Reaches Major Milestone of 100,000 Customers

Bluepeak

Bluepeak, a leading provider of high-speed fiber internet, has reached a significant milestone, surpassing 100,000 subscribers across the states of South Dakota, southwest Minnesota, Oklahoma, Wyoming and North Dakota. Bluepeak is dedicated to providing more high-speed, fiber internet choices to underserved areas, driven by principles of transparent pricing, honest communication, and local customer support. Since rebranding as Bluepeak in 2022, the company has rapidly expanded across the region, bringing high-speed fiber internet to areas that have long been overlooked. As part of its expansion efforts, early markets were chosen for their vibrant communities, strong partnerships, and a clear need for improved internet services. More than just numbers, this connectivity is creating new opportunities in education, healthcare, and business for residents. “We are incredibly proud to have reached this milestone. It reflects not just our growth, but the trust and support of our valued customers,” said Rich Fish, Bluepeak CEO. “This achievement underscores our commitment in providing a better choice in areas that have gone underserved for far too long. As we continue to expand and bring fiber to new markets, we remain steadfast in our mission to deliver exceptional services and enhanced connectivity.” Bluepeak’s dedication to delivering fast, reliable, and affordable fiber internet remains unwavering. Over the next year, the company plans to extend its reach to new communities, continuing to invest in market expansions with exciting announcements on the horizon, including new efforts in Texas. Residents across the Great Plains and Midwest interested in Bluepeak services can check for availability at mybluepeak.com. About Bluepeak Bluepeak is a new kind of internet provider bringing fast, reliable, affordable internet to places that have needed better options for too long. The company has roots serving Great Plains and Midwest communities going back more than 30 years. As the need for internet in the region has evolved, so has Bluepeak, upgrading and expanding service in South Dakota, southwest Minnesota, Oklahoma, Wyoming, North Dakota, and soon-to-be Texas, with the newest cutting-edge technology. These expansion efforts include multi-million-dollar infrastructure projects, community involvement and growth through local hires. Bluepeak is earning the trust of customers and businesses through simple, affordable offerings, responsive, reliable customer service and transparent pricing. The company’s unique approach to delivering internet service has earned Bluepeak accolades for customer satisfaction, network performance, workplace culture and meaningful community partnerships. Visit www.mybluepeak.com to learn more. Contact Details Parnomi PR, on behalf of Bluepeak Angie Knight +1 574-208-9090 media@parnomi.com Company Website https://www.mybluepeak.com

September 18, 2024 09:00 AM Mountain Daylight Time

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