GXO Logistics’ $181 million acquisition of ecommerce fulfillment provider PFSweb signals the immense growth runway ahead for logistics providers as online retail continues rapid expansion.
The deal provides GXO greater exposure to high-growth ecommerce categories like health, beauty, luxury goods, apparel and more where PFSweb has cultivated specialized omnichannel capabilities. GXO also gains PFSweb’s proprietary order management systems, fraud protection, customer care services and distribution technologies that will strengthen its end-to-end fulfillment offerings.
PFSweb serves over 100 prominent consumer brands, including L’Oreal, Pandora, Kendra Scott and others through its facilities across North America, the UK and Belgium. This expands GXO’s relationships in categories experiencing online growth thanks to shifting consumer preferences.
The transformational rise of ecommerce is reshaping logistics networks and fueling acquisitions across fulfillment, last-mile delivery and automation. According to Statista, global ecommerce sales are projected to reach $5.4 trillion in 2023, highlighting the seismic shift to online shopping.
As volumes accelerate, logistics providers aim to capture demand through robust delivery solutions tailor-made for ecommerce. Fulfillment and last-mile acquisitions have increased as giants like GXO, XPO Logistics, UPS and FedEx move to capitalize on the boom in digital orders.
GXO is making sizable investments in automation, AI and optimizing warehouse flows to cement itself as the leader in orchestrating complex ecommerce fulfillment. The PFSweb deal aligns with its focus on allocating capital to high-growth, high-return logistics verticals.
For GXO, the acquisition deepens its competitive moat and brand relationships in strategically important retail categories. PFSweb’s expertise in direct-to-consumer support across the customer journey helps expand GXO’s proposition.
The blockbuster deal also gives GXO access to PFSweb’s 21-year track record successfully servicing and retaining top tier brands. PFSweb has developed a strong reputation for customized branded experiences and excellence in omnichannel execution.
GXO’s chief executive Malcolm Wilson emphasized how PFSweb complements GXO with brand relationships in rapidly expanding ecommerce verticals. The combination cross-sells more comprehensive logistics solutions to each company’s customer base.
For investors, GXO’s move spotlights the immense potential for logistics providers to capitalize on the secular shift online. Ecommerce has fundamentally transformed fulfillment, shipping and reverse logistics processes, with orders that are more variable, faster and customized compared to store replenishment.
Logistics companies essential to ecommerce are primed for significant growth as this trend accelerates. GXO, XPO, UPS, FedEx and other leaders stand to benefit from the structural shift given their networks, expertise and new technology investments.
Already PFSweb’s stock price has jumped nearly 50% following the acquisition news, underscoring Wall Street’s positive perspective. With ecommerce projected to continue double-digit expansion, the logistics sector remains firmly positioned to thrive into the future.
CALGARY, AB, Sept. 14, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces that our Board of Directors has declared a quarterly dividend of US$0.14 per common share, payable in cash on October 13, 2023, to shareholders of record at the close of business on September 29, 2023. This dividend is designated as an “eligible dividend” for Canadian income tax purposes.
Dividend payments to non-residents of Canada will be subject to withholding taxes at the Canadian statutory rate of 25%. Shareholders may be entitled to a reduced withholding tax rate under a tax treaty between their country of residence and Canada. For further information, see Alvopetro’s website at https://alvopetro.com/Dividends-Non-resident-Shareholders.
Alvopetro Energy Ltd.’svision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé and Murucututu natural gas fields and our strategic midstream infrastructure.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.
Forward-Looking Statements and Cautionary Language.This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the Company’s dividends, plans for dividends in the future, the timing and amount of such dividends and the expected tax treatment thereof. The forward‐looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of global pandemics and other significant worldwide events, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest in properties and the outcome of any redeterminations, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. In addition, the declaration, timing, amount and payment of future dividends remain at the discretion of the Board of Directors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR+ profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
CULVER CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail”), a leading, global independent developer and publisher of interactive digital entertainment, has launched Survivor Mercs, an early access game on Steam with an innovative Twitch Integration through its indie publishing sub-label Wandering Wizard.
Survivor Mercs, is a roguelite military styled action game that blends the Bullet Heaven and extraction shooter genre for a challenging single-player experience enhanced by a first of its kind social element through its Twitch Integration. The motivation behind Survivor Merc’s Twitch Integration was to revolutionize social interaction in single-player games within the genre and style of the game, creating a more engaging experience for streamers and players.
With the Twitch Integration, streamers are empowered to connect with their audience. They can now invite their fan base to actively participate by voting on upgrades, selecting mercenaries, and even making cameo appearances as in-game adversaries.
This forward-thinking development not only enhances gameplay but also opens up a world of opportunities for streamers and gamers to connect.
Jim Tsai, Chief Executive Officer of Snail, commented: “With the growth of streaming platforms we are looking forward to additional innovations involving community and live gaming. We hope with this small step we can be a leader in streamer friendly games that pushes the boundaries of what is possible for audience participation. Snail Games continues to push the boundaries of what’s possible in the gaming industry by providing a new perspective to the Bullet Heaven genre of gaming via the streaming service development.”
Play the Genetic Lottery! Commanders are generated with three random traits, offering thousands of unique combinations for each run, resulting in distinct challenges and synergies.
Build Your Dream Team! Assemble a squad of diverse mercenaries, each with their own abilities, weapons, and behavior. Explore individual skill trees and synergies to unleash devastation on your enemies.
Loot, loot… and more loot! Navigate procedurally generated maps, complete objectives, and gather valuable loot, but beware of the ticking clock as every minute spawns stronger enemies.
Interactive Twitch Integrations: Have fun with your viewers! Stream the game with Twitch integration and let your audience decide your fate!
Extraction or Confrontation: Choose between calling for extraction and leaving with all your valuable loot or facing a formidable final boss for even greater rewards. Survive to keep your loot and earn bonuses for your next mission.
Build up your Bunker HQ: Invest your loot to hire new mercenaries, research gear, unlock upgrades, and enhance your commanders with new traits.
No Run is the Same! Mercenaries and Commander combinations offer unique playstyles. Experiment with various gear, traits and mercenary combinations as you play through procedurally generated maps for endless variety.
Additional Features: Full controller and keyboard/mouse support, personal accessibility settings, and compatibility with SteamDeck for portable gaming.
About Snail, Inc.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.
Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Sale of battery recycling facility. Comstock’s LINICO subsidiary sold its battery recycling facility in the Tahoe Reno Industrial Center and associated assets to American Battery Technology Company (OTCQX: ABML) for $27 million comprised of cash and ABML shares. LINICO had leased the facility with an option to purchase for $15.25 million, of which $3.25 million was paid. Comstock made the remaining $12.0 million payment to Aqua Metals, Inc. (Nasdaq: AQMS) to purchase the facility prior to closing its transaction with ABML. American Battery Technology Company initiated a 1-for-15 reverse split of its common stock effective at 9:00 am ET on September 11, 2023.
Sale of American Battery Technology Company shares. Comstock recently sold its 9,076,923 ABML common shares for approximately $5.5 million. Related to the sale of the battery recycling business, Comstock has now generated total and net cash proceeds of $26.5 million and $14.5 million, respectively, representing a net gain on the sale of ~$7 million that will be reflected in the company’s third quarter financial statements. American Battery Technology Company will make a final payment of $0.5 million in cash during the fourth quarter of 2023.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Gaming company Snail, Inc. is shaking up single-player games with the launch of Survivor Mercs, featuring groundbreaking Twitch integration that allows streamers to actively engage viewers.
Survivor Mercs is a roguelite military action game for PC. But what makes it truly unique is the ability for streamers to let their audience influence gameplay through real-time voting on upgrades, mercenaries and enemies.
This pioneering social element empowers streamers to meaningfully interact with fans during solo play for the first time. It expands engagement beyond passive viewing, creating a more immersive community experience.
As streaming continues growing, innovative integrations like Snail’s can profoundly impact both streamers and game developers. The company is leading the way in exploring how to make single-player gaming more social and fun to watch.
For streamers, it unlocks new ways to creatively involve their community. For developers, it opens up opportunities to design streamer-friendly games tailored for live audiences.
Snail’s CEO called the integration a “small step” toward reimagining audience participation in live gaming. But it could be a giant leap for revolutionizing solo play for the streaming era.
Beyond the groundbreaking Twitch element, Survivor Mercs promises challenging roguelite action with thousands of character combinations and procedurally generated maps.
Snail is pioneering the future of streaming-based gameplay. The company’s innovative integration of Twitch with solo play in Survivor Mercs kicks open the door to deeper social interaction and engagement between streamers and their loyal fans.
The United Auto Workers (UAW) union is barreling towards a confrontation with Detroit automakers as contracts for 145,000 members expire Thursday night. With little progress made in negotiations so far, the UAW is planning targeted strikes to bring production to a halt.
The contracts cover union workers at Ford, General Motors and Stellantis, which operates the Chrysler, Dodge, Jeep and Ram brands. If new four-year agreements are not reached by the 11:59 pm deadline, the UAW will initiate selective walkouts aimed at crippling operations.
According to UAW President Shawn Fain, the union will announce which unspecified facilities will strike at 10 pm Thursday absent any last-minute deals. He confirmed the UAW does not plan to continue bargaining on Friday if it moves forward with work stoppages.
Experts say the UAW could paralyze North American auto output quickly by striking only one or two key plants per automaker. For example, halting production at a couple engine and transmission factories could idle up to three-quarters of assembly lines in less than a week.
This targeted approach allows the UAW to conserve its $825 million strike fund, which would drain rapidly if all 145,000 members walked out simultaneously. Members on strike receive $500 weekly from the fund.
Fain has demanded an immediate 20% raise in the first year of new contracts, plus 5% hikes in each subsequent year of the 4-year deal. But automakers have proposed more modest increases in the range of 17-20% over the life of the contract.
The UAW is also seeking to limit the use of temporary workers, who receive lower pay and fewer benefits compared to permanent employees. This has emerged as a major sticking point, especially with Stellantis.
All automakers stated they aim to reach agreements before midnight to avert walkouts. There remains a small chance of an eleventh-hour deal, though Fain insisted the deadline is firm and the UAW is prepared to strike.
The union could opt to reach separate contracts with one or two automakers while targeting the other(s) for strikes. Stellantis is seen as most prone to a walkout due its greater temporary workforce and past corruption scandals tying executives to union leaders.
Ford has not had a national strike since 1976, giving it leverage in negotiations. A short-term extension past Thursday is possible if talks are progressing, but Fain has repeatedly said 11:59 pm is the “deadline, not a reference point.”
Industry experts predict almost certain strikes at some Stellantis facilities. Potential targets include transmission plants in Indiana and Michigan. Shutting down a couple engine or transmission factories per automaker could rapidly idle assembly lines across North America.
In the event of a walkout, Fain instructed members not on strike to remain working under the expired contract rather than an extension. This could allow non-striking workers to collect state unemployment benefits and ease pressure on the UAW strike fund.
With the auto industry struggling with shortages and high inflation, a prolonged strike could have devastating consequences. But workers want a fair share of record profits, amid union concerns temporary employees erode hard-fought gains.
If negotiators walk away prior to midnight as talks deteriorate, last-ditch deals become unlikely. The two sides remain far apart on critical issues with hours left before contracts lapse. Against this backdrop, targeted strikes at U.S. auto plants seem imminent.
DevvStream Holdings, a leading developer of carbon offset projects and associated credit streams, has signed a definitive agreement to go public through a merger with special purpose acquisition company (SPAC) Focus Impact Acquisition Corp.
The combined company will be named DevvStream Corp. and is expected to list on the Nasdaq under ticker “DEVS”. The deal values DevvStream at an implied $212.8 million enterprise value.
Founded in 2021, Vancouver-based DevvStream partners with corporations and governments on sustainability initiatives. It brings projects generating carbon credits to market by co-investing or providing technical services in exchange for a share of long-term credit streams.
This capital-light model requires little upfront investment for participation in the fast-growing carbon markets. DevvStream estimates its current portfolio will generate $13 million in net revenue in 2024 and $55 million in 2025 as projects are expanded.
DevvStream participates in both regulated compliance markets and the rapidly expanding voluntary carbon credit market. The voluntary market hit $2 billion in 2022 but could reach up to $250 billion by 2030 according to estimates.
The merger will provide further expansion capital to DevvStream as it scales its portfolio of emissions-reducing projects. Focus Impact raised $172.5 million in its May 2021 IPO into a trust that will go to the combined company after redemptions.
According to DevvStream CEO Sunny Trinh, “Entering into a definitive agreement to merge with Focus Impact is a significant step towards accelerating the growth of our differentiated technology-based approach to carbon markets.”
He added that enhancing transparency and reliability in voluntary markets in particular can help drive participation and meaningful emissions reductions.
Focus Impact CEO Carl Stanton said the proposed merger “presents a significant opportunity to create substantial value for our shareholders.” He cited DevvStream’s systematic approach to carbon project development and blockchain-enabled tracking.
The transaction is expected to close in the first half of 2023, subject to shareholder approvals and other customary closing conditions. Upon completion, DevvStream will be listed on the Nasdaq under ticker “DEVS”.
With global momentum building around carbon markets and climate action, the merger comes at an opportune time. DevvStream is now poised to capitalize on surging demand as both corporations and governments seek to curb emissions.
ISG Announces 2023 ISG Paragon Awards™North America Winners
9/14/2023
Program recognizes innovative approaches to leveraging technology and new operating models for business success
STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, has announced the winners of the 2023 ISG Paragon Awards™ North America, which celebrate the ongoing transformation of sourcing industry partnerships through new approaches and technologies.
Winners in each category were selected by a panel of independent industry experts and announced at the ISG Sourcing Industry Awards Gala Dinner on Wednesday, September 13, at the Westin Dallas Stonebriar Golf Resort & Spa in Dallas.
The 2023 North America ISG Paragon Award winners are:
Excellence: Recognizing outstanding delivery by a technology or service provider
Infosys with Fortune Brands
Innovation: Recognizing the importance of imagination and entrepreneurial spirit in helping organizations future-proof their businesses and better serve clients
Material with Whataburger
Transformation: Recognizing the successful transformation of an organization or key business function
USTwith Harris Health
Workplace of the Future: Recognizing client and employee experience and productivity beyond technology
Unisys with California State University
Environmental Sustainability: Recognizing outstanding positive impacts in one or more environmental sustainability fields for clients, consumers, communities and/or employees
Mastek with Arizona Department of Forestry and Fire Management
Diversity: Recognizing diversity of thought and lived experience that enables changes to the status quo to deliver better client outcomes
Hexaware with IQVIA
“Congratulations to the winners of the 2023 ISG Paragon Awards North America for their innovative achievements in the technology services and sourcing industry,” said Todd Lavieri, partner and president, ISG Americas and Asia Pacific. “Providers and enterprises are continuously finding new ways to complement each other’s strengths and overcome business challenges together. ISG is honored to recognize these important and effective partnerships.”
The ISG Paragon Awards™ North America, produced by ISG Events, were awarded during ISG Sourcing Industry Week, which includes the ISG Sourcing Industry Conference and ISG SourceIT. Winners of the ISG Provider Lens™ Awards, recognizing outstanding performances by providers featured in ISG Provider Lens studies, were also honored at the September 13 gala.
ISG made a contribution in honor of ISG Sourcing Industry Week to Bridging Tech, a nonprofit public charity dedicated to providing educational opportunities and technology to K-12 students affected by homelessness.
Full details of the ISG Paragon Awards program are available on the award website.
About ISG
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.
CHATHAM, N.J., Sept. 14, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a poster presentation at the Seventh International Cancer Immunotherapy Conference 2023 (CICON23): Translating Science into Survival. The Conference is being held September 20-23, 2023, in Milan, Italy. A copy of the poster will be made available on the Tonix Pharmaceuticals website following the presentation at www.tonixpharma.com.
Poster Presentation Details
Title:
mTFF2-MSA (mTNX-1700) Suppresses Tumor Growth and Increases Survival in Anti-PD-1 Treated CT26.WT Subcutaneous and CT26-Luciferase Orthotopic Syngeneic Colorectal Cancer Models by Targeting MDSCs in BALB/C Mice
Authors:
Bruce L. Daugherty, Rebecca J. Boohaker, Rebecca Johnstone, Karr Stinson, Grace Zhao, Mingfa Zang, Jin Qian, Timothy C. Wan, Seth Lederman
Session Date:
September 21, 2023
Session Time:
12:30 p.m. – 2:00 p.m
Poster Number:
P220
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
BY THE COMTECH EDITORIAL TEAM – SEP 14, 2023 | 2 MIN READ
MELVILLE, N.Y. – September 14, 2023 — Comtech (NASDAQ: CMTL) announced today its Dynamic Cloud Platform (DCP) is now available for commercial and government satellite service providers in U.S. and international markets.
Comtech’s DCP will enable traditionally disparate satellite systems and ground station infrastructures to be easily integrated, creating a new path to introduce cloud-based applications, waveforms, and services. The company’s DCP is designed to be infrastructure, cloud, and application agnostic-allowing satellite customers to easily orchestrate, integrate, and manage a wide variety of applications, waveforms, and services across private, public, and hybrid cloud-based networks.
“We have proven and extensive experience integrating a variety of 5G technologies levering Comtech’s DCP for a number of terrestrial and wireless customers, including tier-1 mobile network operators,” said Ken Peterman, President and CEO, Comtech. “Now, our DCP is expanding into the satellite and space market-opening the door for commercial and government customers to integrate new network agnostic waveforms and applications that will help usher in a new era of ubiquitous, smart-enabled connectivity.”
Comtech is conducting trials and initial testing that will enable multiple satellite-based waveforms to be deployed using DCP across different cloud-based infrastructures. As part of the launch, Comtech’s DCP now offers a unique satellite-based software development kit to allow for the integration of virtualized ground stations and other applications across cloud networks. Comtech is also offering professional services to assist satellite customers with the integration of new applications on its DCP.
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.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
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.
Data Shows Clinically Meaningful Improvements. Ocugen provided an update to the Phase 1/2 clinical trial data for OCU400 in retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA), two rare diseases in which genetic mutations cause loss of vision and progress to blindness. We see these data as clinically meaningful for these indications as well as providing proof-of-concept for Ocugen’s method of targeting a “master control gene” that has downstream effects on other genes.
We See Proof-of-Concept For The “Master Control Gene” Approach. RP is a group of genetic disorders with over 100 possible genetic mutations that may be present and contributing to loss of vision. This makes the course of disease highly variable and difficult to target with a single therapy. Ocugen has been developing OCU400 to target the RHO and NR2E3 genes that control pathways and regulate other genes that act later in those pathways. The data show that OCU400 can affect several genetic pathways in eye, with improvements in three measures of vision.
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Calidi Biotherapeutics has completed its merger with special purpose acquisition company First Light Acquisition Group (FLAG), debuting as a publicly traded cancer immunotherapy company. The combined entity, now named Calidi Biotherapeutics, Inc., will commence trading on the NYSE American under ticker symbols “CLDI” and “CLDI WS” on September 13.
The merger provides Calidi with gross proceeds of approximately $28 million before expenses and debt repayments. This consists of $25 million raised in a concurrent private offering, $1 million in cash from FLAG’s trust, and $2 million in PIPE and non-redemption agreements.
Founded in 2014, Calidi is developing first-in-class immunotherapies using allogeneic stem cells to deliver targeted cancer treatments. The SPAC deal enables the company to continue advancing its pipeline as a publicly listed firm.
Calidi’s lead candidates CLD-101 and CLD-201 leverage proprietary platforms called NeuroNova and SuperNova. Both utilize allogeneic stem cells loaded with oncolytic viruses that directly infect and kill tumor cells.
CLD-101, which employs neural stem cells, is currently in a Phase 1 trial for recurrent high-grade glioma brain tumors. Interim data is expected in 2024. CLD-201 uses mesenchymal stem cells to treat advanced solid tumors, with a Phase 1/2 study slated for 2024.
According to Calidi CEO Allan Camaisa, the IPO “will allow us to push the boundaries of cell-based virotherapies and continue to research novel ways to eradicate cancer.”
SPACs have become an increasingly popular alternative to traditional IPOs in the biotech sector. Also known as “blank check companies”, SPACs raise capital through an IPO and then merge with a private entity to take it public. This allows the operating company to avoid some of the uncertainty associated with a traditional public debut.
First Light Acquisition Group, led by CEO Tom Vecchiolla, raised $172.5 million in its own IPO in May 2021. The team then sought a merger target that could benefit from the injection of public capital. They ultimately settled on clinical-stage Calidi and its novel immunotherapy approach.
In addition to the SPAC proceeds, Calidi has secured a $10 million forward purchase agreement from several institutional investors. It also intends to execute a $50 million purchase agreement with Lincoln Park Capital Fund.
Between its strengthened balance sheet and non-dilutive financing options, Calidi believes it now has the runway to advance its programs into 2025 without need for further equity funding.
According to Vecchiolla, “We are excited to see Calidi continue to grow as they transition into a public company and look forward to their clinical pursuit of new treatment options for patients everywhere in need.”
The merger completes Calidi’s transformation into a publicly traded company. With shares soon to start trading on the NYSE American under ticker “CLDI”, the company is poised to continue developing its promising immunotherapy candidates for cancer patients in need of new treatment options.
Rocket Pharmaceuticals (NASDAQ: RCKT) announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the design of a global pivotal Phase 2 trial for its gene therapy RP-A501 in Danon Disease. This marks an important milestone on the path to delivering a potentially transformative treatment for this devastating inherited cardiomyopathy.
Danon Disease is caused by genetic mutations in the LAMP2 gene leading to fatal heart failure. There are currently no approved therapies. The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe, taking the lives of most males by age 20 and females by 40. RP-A501 aims to be the first-ever therapy to change the course of Danon Disease.
The news sent Rocket’s stock price soaring 34% to $20.46 in after-hours trading on Tuesday, as investors welcomed the positive regulatory update.
The planned Phase 2 pivotal trial will be a global, single-arm, open label study enrolling 12 Danon Disease patients. This includes a pediatric safety lead-in of 2 patients. All participants will receive a dose of 6.7 x 1013 GC/kg of RP-A501 delivered through intravenous infusion.
To support potential accelerated approval by the FDA, the co-primary efficacy endpoints at 12 months are LAMP2 protein expression and reduction in left ventricular mass, a key measure of heart damage. Expression of LAMP2, which is deficient in Danon patients, and decreased cardiac hypertrophy would signal RP-A501 is restoring cardiac function at its root genetic cause.
Secondary trial endpoints consist of the biomarker troponin, heart failure questionnaires, functional classification, event-free survival, and safety. These could support eventual full approval. A concurrent global natural history study will provide an external control arm for comparison.
According to Rocket CEO Dr. Gaurav Shah, “RP-A501 has the potential to restore normal cardiac function and provide a lifetime of benefit to patients with Danon Disease who have no other viable treatment options.” The company believes this pivotal trial design sets the most rapid path to deliver RP-A501 to patients in dire need.
Rocket’s gene therapy approach involves using an engineered virus called AAV9 to deliver a functional LAMP2 gene into patients’ heart cells. The gene insert encodes LAMP2B, a key protein involved in the cellular recycling process called autophagy. Restoring LAMP2B in the heart could potentially halt the accumulation of cellular debris and improve cardiac structure and function.
The company has already manufactured sufficient high-quality RP-A501 drug product at its in-house cGMP facility to supply the full pivotal Phase 2 trial. Qualified potency assays are also in place to support quality control and regulatory compliance.
Looking ahead, Rocket plans to file a Clinical Trial Application in the EU in Q3 2023 to initiate study activities abroad. The company also recently secured an ICD-10 code from the Centers for Medicare and Medicaid Services for LAMP2 deficiency, which will support diagnostic efforts.
This alignment with the FDA represents a major achievement for both Rocket and the Danon Disease community. RP-A501 would be the first-ever approved treatment for this deadly cardiovascular condition. The gene therapy aims to be a one-time curative infusion that could provide transformative and lifelong benefits to affected patients.
Beyond Danon Disease, Rocket believes this program paves the way for developing genetic medicines against other inherited heart diseases. Cardiac gene therapy has long faced hurdles, but the company is forging a new path for treating genetic cardiovascular conditions at their root.
With the pivotal Phase 2 trial design now locked in, Rocket can move full speed ahead on enrolling patients and gathering data to support potential approval. The company expects to release initial results from the trial evaluating RP-A501 in 2024. This could lead to a approved treatment for Danon Disease in the not too distant future—bringing tremendous hope to patients and families affected by this devastating illness.
