In a strategic move to bolster its position in the optical network market, Finnish telecommunications behemoth Nokia has announced plans to acquire Infinera Corporation, a California-based optical networking equipment manufacturer. The deal, valued at $2.3 billion, marks a significant step in Nokia’s efforts to scale up its optical network capabilities and strengthen its foothold in North America.
The acquisition, announced on Thursday, sent ripples through the tech industry, with Infinera’s stock price surging by nearly 22% following the news. Under the terms of the agreement, Nokia will pay $6.65 per share for Infinera, representing a substantial 26.4% premium over the company’s closing price of $5.26 on the day of the announcement.
This move comes as telecommunications companies worldwide are racing to upgrade their network infrastructure to meet the growing demand for high-speed connectivity and data transmission. Optical networks, which use light to transmit data over fiber optic cables, are crucial for supporting the increasing bandwidth requirements of 5G networks, cloud computing, and emerging technologies like artificial intelligence and the Internet of Things.
Infinera, headquartered in San Jose, California, has built a reputation as a leading provider of optical semiconductors and networking equipment for both fixed-line and mobile telecommunications networks. The company’s expertise in this field is expected to complement Nokia’s existing portfolio and accelerate its growth in the optical networking sector.
The deal structure allows for flexibility in payment, with Nokia committing to pay at least 70% of the purchase price in cash. Infinera shareholders will have the option to receive up to 30% of the total consideration in the form of Nokia’s American Depositary Shares, providing an opportunity for investors to maintain a stake in the combined entity.
From a financial perspective, the acquisition is projected to be immediately accretive to Nokia’s comparable earnings per share in the first year after closing. Moreover, the Finnish company anticipates that the deal will contribute over 10% to its profits by 2027, underscoring the long-term strategic value of the acquisition.
The move is particularly significant for Nokia’s expansion plans in North America, a key market for telecommunications infrastructure. By integrating Infinera’s technology and customer base, Nokia aims to enhance its competitive edge against rivals in the region and capitalize on the ongoing investments in network upgrades and 5G rollouts.
Industry analysts view this acquisition as a clear signal of Nokia’s commitment to diversifying its product offerings and strengthening its position in critical growth areas. The optical networking market is expected to experience robust growth in the coming years, driven by the increasing demand for high-capacity data transmission in various sectors, including telecommunications, data centers, and enterprise networks.
As the telecommunications landscape continues to evolve rapidly, strategic acquisitions like this one are becoming increasingly common. Companies are seeking to consolidate their strengths, fill gaps in their technological capabilities, and expand their market reach through carefully planned mergers and acquisitions.
The Nokia-Infinera deal is subject to customary closing conditions, including regulatory approvals and shareholder consent. Both companies have expressed confidence in the transaction’s potential to create value for their respective stakeholders and contribute to the advancement of global telecommunications infrastructure.
As the industry awaits the completion of this significant acquisition, all eyes will be on Nokia to see how it leverages Infinera’s expertise to drive innovation and growth in the competitive optical networking market.
As we approach the midpoint of 2024, the U.S. economy continues to navigate choppy waters, displaying both signs of resilience and indications of a gradual slowdown. Recent economic data paints a picture of an economy in transition, with implications for investors across various sectors. The latest unemployment figures offer a nuanced view of the job market. While initial jobless claims dipped by 6,000 to 233,000 in the week ending June 22, the number of Americans receiving ongoing unemployment benefits climbed to 1.839 million – the highest level since November 2021. This uptick in continuing claims suggests that while layoffs remain relatively low, job seekers may be facing increased difficulty in finding new employment. The unemployment rate ticked up to 4.0% in May, marking its first increase since January 2022. However, economists caution against overinterpreting this rise, noting that the increase is concentrated among specific demographics and industries rather than indicating a broad-based weakening of the labor market.
The Commerce Department recently revised its estimate of first-quarter GDP growth upward to 1.4% annualized, a slight improvement from the previous 1.3% estimate but still significantly lower than the robust 3.4% growth seen in the fourth quarter of 2022. While a modest acceleration is expected in the second quarter, analysts project growth to remain below 2.0%. This slowdown in economic expansion reflects the cumulative impact of the Federal Reserve’s aggressive interest rate hikes, which have risen by 525 basis points since 2022 in an effort to combat inflation. The central bank has maintained its benchmark rate at 5.25%-5.50% since July 2023, but market expectations are now shifting towards potential rate cuts, with many anticipating the first reduction as soon as September 2024.
May’s economic data revealed some concerning trends in business spending and international trade. Orders for non-defense capital goods (excluding aircraft), a key indicator of business investment, fell by 0.6% in May. This decline suggests that higher borrowing costs and softening demand are beginning to impact companies’ willingness to invest in new equipment and technologies. On the trade front, the goods deficit widened by 2.7% to $100.6 billion in May, driven by a 2.7% drop in exports. This development could potentially act as a drag on second-quarter GDP growth, adding another layer of complexity to the economic outlook.
For investors, these economic indicators present a mixed bag of challenges and opportunities. The softening labor market and slowing economic growth may pressure consumer-focused sectors, while the potential for interest rate cuts later in the year could provide a boost to rate-sensitive industries such as real estate and utilities. The decline in business spending bears watching, particularly for those invested in industrial and technology sectors. Companies that provide essential equipment and services may face headwinds in the near term as businesses become more cautious with their capital expenditures. Meanwhile, the widening trade deficit could have implications for multinational corporations and currency markets. Investors may want to keep a close eye on companies with significant overseas exposure and consider the potential impacts of currency fluctuations on their portfolios.
As we move into the second half of 2024, the U.S. economy appears to be walking a tightrope between continued growth and potential contraction. While some economists believe we’re on track for a “soft landing,” investors should remain vigilant and diversified. The coming months will be crucial in determining whether the current slowdown stabilizes or accelerates. Key factors to watch include the Federal Reserve’s policy decisions, inflation trends, and global economic developments. As always, a well-informed and adaptable investment strategy will be essential in navigating these uncertain economic waters. The complex interplay of labor market dynamics, GDP growth, business investment, and international trade will continue to shape the economic landscape, offering both challenges and opportunities for astute investors in the months ahead.
10,000-participant randomized Phase 2b study will evaluate and compare GeoVax’s multi-antigen, vaccine
candidate (GEO-CM04S1) to an approved vaccine against COVID-19
Study is Funded by BARDA through Project NextGen, executed through its Clinical Studies Network
Atlanta, GA, June 27, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today that it will partner with Allucent, a global clinical research organization (CRO), to conduct a Phase 2b clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine.
GeoVax previously announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to evaluate the relative efficacy of GEO-CM04S1 compared to an approved/authorized COVID-19 vaccine to prevent symptomatic, PCR-confirmed SARS-CoV-2 infection. As part of BARDA’s Clinical Studies Network, Allucent will initiate and implement the BARDA-funded study. The combined value of the awards to GeoVax and Allucent toward the clinical evaluation of GEO-CM04S1 is approximately $367 million.
David Dodd, Chairman & CEO of GeoVax, stated, “The work supported by BARDA’s Project NextGen will significantly advance the collective efforts to combat COVID-19 and its variants, and we are proud that GEO-CM04S1 was selected to be part of those critically important initiatives. We are delighted to be collaborating with Allucent on this important study.”
Mark A. Goldberg, M.D., Chairman and CEO of Allucent, commented, “We are honored to have been previously chosen by BARDA to be part of its Clinical Studies Network for this critical initiative and pleased to be offered the opportunity to execute the Phase 2b trial of GEO-CM04S1 in collaboration with GeoVax. We are excited to leverage our clinical development expertise and resources to help develop next-generation booster vaccines that will enhance global immunity and save lives.”
About Project NextGen
Funding for this project is provided under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. GeoVax’s vaccine candidate provides many of the features identified, including broader protection among variants of concern (VOC) and a longer duration of protection.
GeoVax’s role in this project is being funded in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) 75A50123D00005.
Allucent’s role in this project is being funded in whole or in part with federal funds from the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract 75A50120D00016/75A50123F33005.
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.
GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:
As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data 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.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
As a booster vaccine for healthy adults who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466.
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®, which recently completed enrollment 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.
About Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of its biopharma and government clients. Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across various therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients. Visit Allucent.com for more information.
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.
CHATHAM, N.J., June 27, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of approximately 7,060,918 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu thereof). The closing of the public offering is expected to take place on or about June 28, 2024, subject to the satisfaction of customary closing conditions.
The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.
Dawson James Securities, Inc. is acting as the sole placement agent for the offering.
This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. 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 including those relating to the completion of the public offering, the satisfaction of customary closing conditions, the intended use of proceeds from the public offering and other statements that are predictive in nature. 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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.
New SmartAssist Solution to Enhance Emergency Response & Reduce Burden on 9-1-1 Call Handlers
CHANDLER, Ariz. – Jun. 27, 2024– Comtech (NASDAQ: CMTL) (“the Company”), a global technology leader, today announced the launch of SmartAssist™, an artificial intelligence (“AI”)-backed solution developed to answer low-priority non-emergency calls without engaging a telecommunicator.
SmartAssist is designed to help Emergency Communications Centers (“ECCs”) and Public Safety Answering Points (“PSAPs”) manage call and Internet of Things device volumes by using AI chatbots to answer and triage non-emergency calls. The first of many applications in SmartAssist relies on AI bots programmed using conversational design to understand the natural language of the caller and resolve the caller’s request without the need for human intervention for non-emergency calls.
“One of the most critical challenges ECCs face today is staffing shortages, which can cause delays in 9-1-1 call answering times,” said Jeff Robertson, President of Comtech’s Terrestrial & Wireless Networks Segment. “Our SmartAssist solution solves call volume challenges and staffing shortages by streamlining 9-1-1 workflows with new AI-backed capabilities that can effectively handle most non-emergency administrative calls without telecommunicator assistance. Built on Comtech’s industry-leading public safety solutions, SmartAssist further demonstrates our ability to deliver innovative first-to-market solutions that solve today’s most pressing public safety challenges.”
The SmartAssist solution provides robust AI-backed voice and chatbot capabilities that enable public safety customers to leverage customized response solutions for a broad spectrum of low-priority non-emergency caller inquiries, ranging from text messages and form creation to foreign language capacities and performance metrics.
SmartAssist Pilot Programs:
Comtech is partnering with multiple agencies and its Next Generation 911 customers across the United States in pre-market trials to integrate and deploy SmartAssist in PSAPs connected to the Company’s NG911 networks to enhance non-emergency 9-1-1 response rates, effectively prioritize mission-critical calls, improve situational awareness, and reduce staffing shortages.
SmartNG Portfolio:
SmartAssist is the first solution within Comtech’s SmartNG portfolio of services. The Company’s SmartNG portfolio of services will enable the convergence of Next Generation 911 and AI solutions to enhance and optimize ECC/PSAP workflows. As the first SmartNG service offered, SmartAssist will significantly enhance public safety call processing, reduce emergency response times, and alleviate the impacts of staffing shortages.
SmartAssist integrates with existing administrative phone lines without requiring changes to the Call Handling Equipment, allowing Comtech customers to immediately begin benefitting from this staff augmentation tool.
Comtech is continuing to build out its SmartNG portfolio, which will include other interoperable AI-backed capabilities that incorporate language identification, transcription, translation, and advanced analytics, among other services. Comtech’s SmartNG portfolio creates new comprehensive public safety solutions designed with the future in mind-enhancing emergency response and assisting with staffing challenges.
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.
Joe Gomes, CFA, 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.
Resolution. In a quick turnaround, The GEO Group and the State of Oklahoma Department of Corrections (ODOC) reached an agreement on a one-year contract to continue operating the Lawton Correctional and Rehabilitation Facility (LCRF) through June 2025. The Board of Correction approval allows the contract to move forward in the process to be approved by the Attorney General’s office and executed by ODOC.
Changes. As part of the agreement, ODOC will reduce the number of inmates housed at LCRF to 2,388 from a current 2,616. With the population reduction, GEO has pledged to actively work to reduce violence, provide more access to programs, and grant more out-of-cell time for the inmates.
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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).
Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.
Joe Gomes, CFA, 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.
New Contract. Comtech announced the Company has been awarded a contract from North Central Texas Emergency Communications District to provide NG911 services. The Company will be assisting in further modernizing the district’s infrastructure. The contract carries a five-year base award with three two-year option periods, and a maximum value of $30 million.
Continued Relationship. The district’s contract with Comtech continues an established relationship of over 10 years. Currently, the Company provides call routing and call handling technologies and serves over two million people in the state of Texas. With the contract, the district will have the ability to fully migrate to a new NG911 system, and the Company will also help in enhancing the region’s call routing capabilities.
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).
In a groundbreaking move, Simplify Healthcare has announced its acquisition of Virtical.ai, setting the stage for a dramatic transformation in health insurance technology. This strategic merger, revealed on June 24, 2024, combines Simplify Healthcare’s established SaaS platform with Virtical.ai’s advanced artificial intelligence capabilities, promising to revolutionize how health insurance providers operate in an increasingly complex market.
The timing of this acquisition is particularly significant as the healthcare industry grapples with mounting pressures to personalize services, streamline operations, and navigate intricate regulatory landscapes. By integrating Virtical.ai’s AI prowess into its Simplify Health Cloud™ platform, Simplify Healthcare aims to empower health insurance companies (Payers) with sophisticated tools to address these challenges effectively.
At the core of this acquisition lies the transformative potential of AI-driven solutions. Virtical.ai’s technology, which has been trained on an extensive database of health plan-specific documents, excels in data extraction and comparison. This capability enables Payers to offer highly personalized plans and benefits to both employer and individual segments, potentially revolutionizing the way health insurance is customized to meet individual needs.
Simplify Healthcare’s leadership team has expressed enthusiasm about the merger’s potential to reshape the industry. They emphasize the ability of AI models to process complex documents such as Statements of Benefits and Coverage (SBCs) and Machine Readable Files (MRFs), highlighting the potential for significant advancements in plan comparison, selection, and price transparency.
The acquisition also addresses critical challenges in network management. Virtical.ai’s platform can identify gaps in Payer networks by analyzing provider and member locations. This feature allows Payers to strategically promote their network coverage strengths and address deficiencies, ensuring members have access to suitable providers within their area. Moreover, the ability to benchmark negotiated provider rates against competitors offers Payers valuable insights for rate-setting and targeted marketing initiatives.
Virtical.ai’s leadership shares the excitement about the merger’s potential impact. They highlight how their AI models, built on decades of industry experience, are positioned to drive membership growth and revenue when integrated with Simplify Healthcare’s enterprise SaaS platform.
The integration of Virtical.ai’s technology is expected to enhance several of Simplify Healthcare’s existing solutions, including Benefits1™, Provider1™, Service1™, Claims1™, and Experience1™. These enhancements promise to provide Payers with more precise solutions to complex challenges in delivering products, benefits, and provider data.
Simplify Healthcare’s strategic team underscores the acquisition’s importance in the face of market disruptions. They believe that combining their industry-leading platform with Virtical.ai’s innovative AI solutions in Health Plan Sales and Network Management will empower Payers to achieve growth despite facing disruptive market and regulatory forces.
As the healthcare landscape continues to evolve, this acquisition positions Simplify Healthcare at the forefront of the AI revolution in health insurance technology. The promise of more personalized health plans, optimized network coverage, and data-driven decision-making tools could significantly impact not only Payers but also brokers and, ultimately, healthcare consumers.
With this bold move, Simplify Healthcare and Virtical.ai are poised to play a pivotal role in shaping the future of health insurance in an increasingly digital and personalized world. Their combined expertise and technological capabilities have the potential to drive innovation, enhance efficiency, and improve the overall experience for all stakeholders in the health insurance ecosystem.
CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.
Dawson James Securities, Inc. is the sole placement agent for the offering.
This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. 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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.
CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 26, 2024, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
**Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. 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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.
In a testament to the enduring strength and allure of the technology sector, e-commerce and cloud computing giant Amazon has reached a market capitalization of $2 trillion for the first time. This milestone, achieved on June 26, 2024, underscores the robust performance of tech stocks and reinforces the sector’s position as a cornerstone of modern investment strategies.
Amazon’s ascent to the $2 trillion club is not an isolated event but part of a broader trend in the tech industry. The company joins an elite group of tech behemoths, including Nvidia, Apple, Alphabet, and Microsoft, all of which have surpassed this remarkable valuation threshold. This collective success story highlights the tech sector’s resilience and its ability to generate substantial returns for investors.
The driving force behind this surge in tech valuations is multifaceted. Generative artificial intelligence has emerged as a particularly potent catalyst, igniting investor excitement and fueling unprecedented growth. Nvidia, a key player in AI hardware, exemplifies this trend, having seen its market value skyrocket from $2 trillion to $3 trillion in just over three months.
Amazon’s journey to $2 trillion has been propelled by several factors. The company’s cloud computing arm, Amazon Web Services (AWS), has shown strong recovery and growth potential, particularly in the realm of AI services. Additionally, CEO Andy Jassy’s cost-cutting initiatives have bolstered earnings, earning the approval of investors and analysts alike.
For investors, the tech sector continues to present compelling opportunities. The industry’s track record of innovation, adaptability, and growth makes it an attractive option for those seeking long-term value appreciation. From established giants like Amazon to emerging players in fields such as AI, cybersecurity, and clean tech, the sector offers a diverse range of investment prospects.
However, it’s crucial for investors to approach tech investments with a balanced perspective. While the sector has demonstrated remarkable growth, it also comes with its own set of risks, including regulatory challenges, intense competition, and the rapid pace of technological change. Diversification and thorough research remain key strategies for those looking to capitalize on the tech sector’s potential.
As we look to the future, the tech sector’s influence on the global economy shows no signs of waning. With ongoing advancements in AI, cloud computing, IoT, and other transformative technologies, the industry is poised to continue shaping our world and presenting new investment opportunities.
Amazon’s entry into the $2 trillion club is more than just a milestone for the company; it’s a reflection of the tech sector’s enduring strength and its potential to generate substantial returns. As technology continues to evolve and permeate every aspect of our lives, the sector remains a beacon for growth-oriented investors, offering the promise of innovation, disruption, and long-term value creation.
CHANDLER, Ariz. – June 26, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, today announced the North Central Texas Emergency Communications District (“NCT9-1-1”) awarded the Company a contract to deliver Next Generation 9-1-1 (“NG9-1-1”) services that will further modernize NCT9-1-1’s infrastructure. The NCT9-1-1 contract includes a five-year base award, as well as three additional two-year option periods, with a not to exceed value of approximately $30.0 million.
Comtech has partnered with NCT9-1-1 for over 10 years and the Company currently provides a wide range of call routing and call handling technologies serving over two million people in Texas. NCT9-1-1 is responsible for 40-plus Emergency Communications Centers in 13 counties and five municipalities surrounding the Dallas/Fort Worth Metroplex.
Through this new contract, Comtech’s comprehensive suite of public safety solutions will enable NCT9-1-1 to fully migrate to a new NG9-1-1 system. Comtech will also continue to enhance the region’s call routing capabilities by providing major NG9-1-1 sub-components, including Next Generation Core Services, Emergency Services Internet Protocol Network and Call Aggregation, among other services.
“As a longstanding partner, Comtech is working with NCT9-1-1 to bring forward new emergency response capabilities that ensure residents and visitors get the help they need when lives are on the line and seconds matter most,” said John Whitehead, General Manager of Comtech’s Safety and Security Technologies (“SST”) Division. “This contract further demonstrates the trust of our public safety partners in the United States, and we are honored to continue working with the NCT9-1-1 to deliver a purpose-built public safety architecture that meets the needs of communities and individuals in crisis.”
“Comtech is continuing to support the NCT9-1-1 by delivering critical NG9-1-1 capabilities that enhance emergency response services and protect our public,” said Christy Williams, Director of 9-1-1 at NCT9-1-1. “NCT9-1-1’s 10-plus year partnership with Comtech in the early adoption of NG9-1-1 services has taught us a lot. We are looking forward to continuous improvement with Comtech as we forge the future of emergency communications together.”
As one of the most trusted providers of public safety technologies, Comtech is continuing to expand its NG9-1-1 call routing and call handling solutions for governments and emergency response providers across the globe. The Company’s NG9-1-1 offerings are designed to adapt and continuously evolve over time to meet the needs of emerging use cases as well as future applications.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Side Effect Rates Were Low. Unicycive announced top-line results from its pivotal study to determine OLC (oxylanthanum carbonate) tolerability, safety, and dosing. The trial met its tolerability and safety endpoints with data that compares favorably with Fosrenol (lanthanum carbonate). Over 90% of the patients were able to lower their serum phosphate to target levels, with 70% reaching target at the lowest dose tested. An NDA filing is expected in 3Q24.
Low Discontinuation Rate Met The Primary Endpoint. Tolerability, the rate of discontinuations due to treatment related adverse events (TRAEs), was the primary endpoint. The Evaluable Population of 71 patients had only 1 TRAE discontinuation, a rate of 1.4%. In the Safety Population, a total of 3 patients out of 86 discontinued due to TRAEs, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.
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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.
