Category:

Release – Great Lakes Announces Delivery of Their Multi Cats, The Cape Hatteras and The Cape Canaveral

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GLDD

Oct 10, 2023

PDF Version

HOUSTON, Oct. 10, 2023 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) (NASDAQ: GLDD), the largest provider of dredging services in the United States, announced today the delivery of the Cape Hatteras and the Cape Canaveral, the two Damen 3013 Multi Cats built by Conrad Shipyard in Morgan City, LA.

Chris Gunsten, Great Lakes’ Senior Vice President of Project Services and Fleet Engineering, commented on the improvements the Cape Hatteras and Cape Canaveral will represent, “This is a milestone for our Company and the U.S. dredging industry. The Multi Cat brings step change safety improvements to Great Lakes’ dredge pipeline operations, which was a prime driver for the investment. Pipe handling and connection work can now take place securely on deck, which will greatly reduce the risk of man overboards. These vessels will also enhance and improve Great Lakes’ pipe and anchor operations. Further, the Multi Cats’ two crane and multiple winch and wire tugger arrangements will significantly reduce manual work and the risk of soft tissues injuries. These vessels support our strong safety culture and gives us the ability to dredge with enhanced operating efficiencies needed to maintain our shorelines and waterways.”

The two identical vessels measure approximately 99 feet in length and are each powered by three EPA Tier III Caterpillar C32 TTA engines capable of meeting speeds of 10.2 knots and will have maximum bollard pull of approximately 32 short tons. Equipped with two large winches and two deck cranes they are ideal dredge support vessels with the ability to perform a wide range of tasks including handling submerged and floating pipelines as well as anchor handling and logistics supply. Efficiency is also greatly enhanced by eliminating the need for assorted floating support equipment such as derrick barges, towboats and anchor barges.

The two vessels are the first Damen Multi Cats to be built in the U.S. and are fully compliant with the U.S. Coast Guard and U.S. Army Corps of Engineers stability criteria.

The Company
Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 133-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking” statements as defined in Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), the Private Securities Litigation Reform Act of 1995 (the “PSLRA”) or in releases made by the Securities and Exchange Commission (the “SEC”), all as may be amended from time to time. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of Great Lakes and its subsidiaries, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements that are not historical fact are forward-looking statements. These cautionary statements are being made pursuant to the Exchange Act and the PSLRA with the intention of obtaining the benefits of the “safe harbor” provisions of such laws. Great Lakes cautions investors that any forward-looking statements made by Great Lakes are not guarantees or indicative of future events.

Although Great Lakes believes that its plans, intentions and expectations reflected in this press release are reasonable, actual events could differ materially. The forward-looking statements contained in this press release are made only as of the date hereof and Great Lakes does not have or undertake any obligation to update or revise any forward-looking statements whether as a result of new information, subsequent events or otherwise, unless otherwise required by law.

For further information contact:
Tina Baginskis
Director, Investor Relations
630-574-3024

Release – Defense Metals Updated Beneficiation Results Confirm the Production of a High Grade Flotation Concentrate at High Recovery

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DFMTF

VANCOUVER, BC, Oct. 10, 2023 /PRNewswire/ – Defense Metals Corp. (“Defense Metals” or the “Company“) (TSX-V:DEFN) (OTCQB:DFMTF) (FSE:35D) is extremely pleased to report the most recent results of the extensive comminution and beneficiation test work that has been conducted by SGS Canada Inc. in Lakefield, Ontario (“SGS“) on variability samples from the Wicheeda Rare Earth deposit.   

Figure 1: LCT-3 Flowsheet (CNW Group/Defense Metals Corp.)

Craig Taylor, CEO of Defense Metals, stated: “Our recent results shows that the Wicheeda feedstock can be crushed, ground and floated to produce a rare earth flotation product with similar or better recoveries and grades to the top producers globally. Our project has many favorable conditions for success: mineralogy, metallurgy, infrastructure, and community collaboration further supporting a path to production.”

Beneficiation Results

  • A total of 90 open-circuit flotation tests, using 1 or 2 kg of feed, were conducted on seventeen individual variability samples, various composites and blends.  Considering all open-circuit flotation tests, at a feed grade of 3% TREO (Total Rare Earth Oxide), the best fit line indicated 80% recovery to a 45% TREO concentrate. Closed circuit operations, as practised in flotation plants, can be expected to deliver higher recovery and grade.
  • In addition to the smaller-scale tests, 29 bulk flotation tests using 10 or 12 kg charges were completed to both further optimize parameters and generate 16 kg of 46% TREO content with a recovery of 78% for use as feed for hydrometallurgical tests. 
  • Very favourable results were obtained in a locked cycle test on a deposit composite giving a recovery rate of 85% of the rare earths at a concentrate grade of 50.7% TREO.    

The beneficiation tests were aimed at confirming the reagent suite and operating parameters developed in earlier testwork and in the 2020 flotation pilot plant operated on a 26t bulk sample.  The variability samples responded well to the flowsheet and the selected reagent suite and operating regimes (temperature, density). Details of the testwork are provided below.

Comminution Results

  • SMC and Bond comminution tests were complete on all variability samples. The recent work confirms, and significantly expands on, the data obtained during the 2020 pilot plant work.
  • The data indicate that grinding energy will be relatively low, in particular in the upper portions of the deposit when the softer dolomitic carbonatite (DC) material, with a Bond ball mill work index of 9 kWh/t, is the majority of the potential mill feed.
  • Autogenous or semi-autogenous grinding system followed by a ball mill will be very satisfactory for the Wicheeda comminution plant.

John Goode, Consulting Metallurgist to the Company, commented: “SGS has performed a very thorough investigation of the comminution and beneficiation characteristics of a wide variety of samples from the Wicheeda deposit. The new results are close to those reported earlier and used in previous studies.  Grinding energy requirements have been shown to be relatively low and flotation recovery and concentrate grades are high and very favourable.”

Methodology

The three key rare earth-bearing lithologies in the Wicheeda deposit are, (1) the higher-grade dolomite carbonatite (“DC“) which makes up 73% of the deposit, (2) the xenolithic carbonatite (“XE“) that represents 24% of the deposit, and (3) the syenite (“SYN“). Based on its near surface location,  the DC material is expected to comprise the majority of  the mill feed and the XE and SYN lithologies deeper in the deposit mined later. The primary rare earths minerals are monazite, bastnäsite and synchysite/parisite. 

The comminution and beneficiation tests were done at SGS by a team headed by Dr. Jing Liu, Senior Metallurgist. Test material comprised a 260 kg Master Composite and seventeen variability samples, each nominally 36 kg, prepared from drill core and representing the three main lithologies in the Wicheeda deposit.  The variability samples were selected to cover the three dominant lithologies, a range of grades (1.1% to 4.5% TREO), depths (7 m to 221 m down-hole), and locations in the deposit, (for additional results on different grades and lithologies please see news release dated October 11, 2022 and February 14, 2023).  Extensive mineralogy was completed on the samples and test products to better define the deposit and process results.

A total of 90 open-circuit flotation tests, using 1 or 2 kg of feed, were conducted on a DC composite, xenolithic and syenite composites, the individual variability samples, the Master Composite and various other composites and blends. At a feed grade of 3%, the best fit line indicates 80% recovery to a 45% TREO concentrate.  Closed circuit operations, as in a flotation plant, would deliver higher recovery and grade.  The lower-grade XE and SYN material that are expected to be encountered late in potential mine life delivered somewhat lower concentrate grades and recoveries.

Three locked-cycle tests were completed, with LCT-3 operated on 12 kg batches of a New Master Composite made up from all variability samples blended according to the lithology distribution. The flowsheet, illustrated in Figure 1, was operated over seven cycles and showed good stability. The feed grade to LCT-3 was 2.9% TREO and the concentrate assayed 50.7% TREO with a recovery of 85.4%.

Comminution test work was completed by SGS using standard Bond comminution tests and the SMC test which measures the competence of primary grinding mill feed.  The SMC results were provided to JKTech for interpretation.  The Bond ball mill work indices were 9, 11, and 13 kWh/t for the DC, XE, and SYN samples respectively.  The SMC report categorized the DC samples as being very soft and the XE samples as medium. 

Qualified Persons

The scientific and technical information contained in this news release, as it relates to the Wicheeda Rare Earth Element project, has been reviewed and approved by John Goode, P. Eng., and Kris Raffle, P.Geo., a director of the Company, both of whom are Qualified Persons as defined by National Instrument 43-101 and Mr. Goode has provided the technical information relating to metallurgy in this news release.

About the Wicheeda Rare Earth Element Project

Defense Metals 100% owned, 6,759-hectare (~16,702-acre) Wicheeda Project is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda deposit is readily accessible by all-weather gravel roads and is near infrastructure, including hydropower transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the deep-water port facilities at Prince Rupert, the closest major North American port to Asia.

About Defense Metals Corp.

Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned Wicheeda Rare Earth Element project located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB, and in Germany on the Frankfurt Exchange under “35D”.

Defense Metals is a proud member of Discovery Group. For more information please visit:
http://www.discoverygroup.ca/

For further information, please visit www.defensemetals.com or contact:

Todd Hanas, Bluesky Corporate Communications Ltd.
Vice President, Investor Relations
Tel: (778) 994 8072
Email: todd@blueskycorp.ca

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Cautionary Statement Regarding “Forward-Looking” Information

This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to completion of the PFS and the expected timelines, advancing the Wicheeda REE Project, the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR at www.sedarplus.ca. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical and engineering assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to, the effects of COVID-19 on the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–looking statements or forward–looking information, except as required by law.

SOURCE Defense Metals Corp.

Release – Kratos’ OpenSpace® Satellite Ground Platform Achieves MEF 3.0 Carrier Ethernet Certification

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

October 10, 2023 at 8:00 AM EDT

PDF Version

Industry First for a Satellite Ground System will Dramatically Enhance Satellite Communications Integration with Global Telecom Networks

SAN DIEGO, Oct. 10, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, announced today that its OpenSpace® Platform is the first commercially available, fully virtualized satellite ground system to achieve MEF 3.0 Carrier Ethernet certification. The OpenSpace Platform enables satellite operators to deliver and manage their services for applications including communications, MilSatcom, earth observation, remote sensing and more. Entirely software-defined and using the same industry standards adopted by global terrestrial and mobile network carriers, such as MEF’s Carrier Ethernet (CE) standard, OpenSpace makes satellite service networks interoperate seamlessly with terrestrial and cellular transport networks.

The convergence of satellite and telecom networks is predicted to lead to revenue gains of $35 billion by 2035 according to the GSMA, a global organization unifying the mobile ecosystem. Standards such as Carrier Ethernet play a critical role in this convergence by enabling satellite and telecommunications to integrate more easily. This convergence will benefit both industries: enabling terrestrial network providers to reach remote users who are inaccessible through fiber or cellular technologies while expanding the addressable market for satellite communications.

“Global communications carriers have traditionally viewed satellite as the ‘transport of last resort,’” according to Greg Quiggle, Senior Vice President of Product Management at Kratos. “The MEF 3.0 Carrier Ethernet certification validates that the OpenSpace Platform meets the highest telecom and cloud industry interconnectivity standards. With OpenSpace, satellite operators can mainstream their services for dynamic, performance-enhanced, orchestrated delivery through global telecom networks.”

MEF is a global industry association of network, cloud, security, and technology providers accelerating enterprise digital transformation. MEF 3.0 certifications offer a method for industry organizations to confirm compliance with industry-led MEF 3.0 standards for services, and the technology used to enable those services. OpenSpace is the first commercially available satellite communications ground system to be certified MEF 3.0 CE compliant.

Intelsat, one of the world’s largest commercial satellite operators, will employ the OpenSpace Platform as part of the advanced network being built to deliver services over their new family of software-defined satellites. According to Carmel Ortiz, Senior Vice President of Technology and Innovation at Intelsat, “Intelsat was the first GEO satellite operator to achieve MEF 3.0 Carrier Ethernet certification for our services, so we are very pleased to see OpenSpace meet the same standard, supporting our efforts toward end-to-end network interoperability. It also represents an important milestone for OpenSpace, demonstrating the ability to support interoperable service offerings in mobility and the eventual migration to 5G services.”

To receive MEF’s CE 3.0 certification for the OpenSpace Platform, Kratos passed a comprehensive set of test cases that ensure interoperability in a multi-vendor global network environment. The certification validates that the Platform supports the delivery of a broad range of MEF 3.0 portfolio of services including E-Line (point-to-point) and E-Tree (multipoint service) and operator services including Access E-Line (point-to-point).

According to Kevin Vachon, Chief Operating Officer, MEF, “Companies like Kratos understand the value that certification provides—simplified, pre-validated functionality for buyers and simplified, frictionless implementation and partnering. Achieving MEF 3.0 Carrier Ethernet certification is a step towards enabling the more seamless delivery of satellite services across global provider networks. Telecommunications operations require the service automation, scalability and end-to-end QoS and SLA visibility that Carrier Ethernet brings to network operations. We are delighted to see Kratos achieve MEF 3.0 certification.”

For more about OpenSpace dynamic ground visit: https://www.kratosdefense.com/Satcom.
For more information about telecom and satellite network integration, read NSR’s (an Analysys Mason company) white paper: https://www.kratosdefense.com/carrier-ethernet.

About Kratos OpenSpace
Kratos’ OpenSpace family of solutions enables the digital transformation of satellite ground systems to become a more dynamic and powerful part of the space network. The family consists of three product lines: OpenSpace SpectralNet for converting satellite RF signals to be used in digital environments; OpenSpace quantum products, which are virtual versions of traditional hardware components; and the OpenSpace Platform, the first commercially available, fully orchestrated, software-defined ground system. These three OpenSpace lines enable satellite operators and other service providers to implement digital operations at their own pace and in ways that meet their unique mission goals and business models. For more information about the OpenSpace family visit http://KratosDefense.com/OpenSpace.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology company that develops and fields transformative, affordable systems, products and solutions for United States National Security, allies and global commercial enterprises. At Kratos, affordability is a technology, and Kratos is changing the way breakthrough technology is rapidly brought to market – at a low cost – with products, systems and technologies rather than slide decks or renderings. Through proven commercial and venture capital backed approaches, including proactive, internally funded research and streamlined development processes, Kratos is focused on being first to market with our solutions, well in advance of competition. Kratos is the recognized technology disruptor in our core market areas, including Space and Satellite Communications, Cyber Security and Warfare, Unmanned Systems, Rocket and Hypersonic Systems, Next-Generation Jet Engines and Propulsion Systems, Microwave Electronics, C5ISR and Virtual and Augmented Reality Training Systems. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 25, 2022, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Ocugen Mucosal Vaccine Candidate Ocu500 Selected By NIH/NIAID Project Nextgen For Inclusion In Clinical Trials

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

October 10, 2023

PDF Version

  • NIAID is conducting early phase clinical trials on select next generation vaccine candidates with the intent to identify the most effective platforms and delivery routes
  • OCU500 will be tested as both inhaled and intranasal vaccine candidates
  • Clinical trials scheduled to start in early 2024

MALVERN, Pa., Oct. 10, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health, will conduct a trial comparing the administration of Ocugen’s mucosal vaccine candidate, OCU500, via two different mucosal routes, inhalation into the lungs and as a nasal spray.

Ocugen is developing a novel anti-viral mucosal vaccine platform initially targeting COVID-19 and influenza (flu). The intent is to provide protection against severe disease, increase durability and prevent transmission of viral threats. OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd) technology. Earlier clinical studies to prevent COVID-19 employing a similar vector administered via inhalation demonstrated increased mucosal antibodies, systemic antibodies, and durable immune response up to one year using one fifth (1/5) of the dose compared to the same vaccine given via intramuscular administration. Additionally, Ocugen believes that this vaccine can be rapidly scaled-up as new variants emerge.

“We believe our novel mucosal vaccine platform technology has the potential to prevent infection and spread of COVID-19, and improve durability for an annualized vaccine similar to flu,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This is the first vaccine candidate using our inhaled platform technology, which we hope to expand in order to address multiple respiratory threats, including flu. We have benefited from a strong collaborative relationship with NIAID and BARDA since the start of Project NextGen and we look forward to participating in this initiative.”

NIAID will be conducting clinical trials to evaluate several early stage vaccine candidates. The study involving Ocugen’s vaccine will be administered via both intranasal and inhaled routes and is designed to help answer an important question – does an inhaled COVID-19 vaccine provide greater immune response than the same vaccine administered through a nasal spray. Upon completion of the trial NIAID and Ocugen will assess the results and determine next steps for OCU500.

Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the clinical trials, including operations and related analysis. Ocugen will be responsible for providing clinical trial materials and upon completion will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.

The announced collaboration comes at a time when COVID-19 infection rates are rising with the emergence of new variants. Durability of existing vaccines continues to be of concern with antibody protection waning several months following vaccination while vaccine compliance rates have declined since the initial wave. According to a recent Harris poll, 66% of Americans would prefer to have more vaccine options. The poll also found that 52% of Americans would be more open to getting an intranasal or inhaled, versus injectable COVID-19 vaccine.

Ocugen looks forward to this important next step in the development of its novel mucosal vaccine platform and further supporting the Company’s commitment to advancing public health.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com 

Release – Finalists Named for 2023 ISG Paragon Awards™ EMEA

Posted on by aweinsoff@channelchek.com

Research News and Market Data on III

10/10/2023

Program recognizes innovative approaches to leveraging technology and new operating models for business success

LONDON–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced the finalists for the 2023 ISG Paragon Awards™ EMEA, which celebrate the ongoing transformation of sourcing industry partnerships through new approaches and technologies.

Winners in each category will be selected by a panel of independent industry experts and announced at the ISG Sourcing Industry Awards Gala Dinner on Wednesday, November 15, at the Park Plaza Victoria London.

Here are the EMEA finalists for the 2023 awards:

Excellence: Recognizing outstanding delivery by a technology or service provider

  • Genpact with a global power management company
  • Infosys BPM with a retail company
  • Microland with a major aviation and aerospace company
  • Tech Mahindra with a U.K. government agency
  • Unisys with a global consumer goods company

Innovation: Recognizing the importance of imagination and entrepreneurial spirit in helping organizations future-proof their businesses and better serve clients

  • Coforge with an insurance technology provider
  • IBM with an American telecommunications conglomerate
  • Infosys with an elevator and escalator manufacturer
  • WNS with a logistics and shipping company

Transformation: Recognizing the successful transformation of an organization or key business function

  • Colt Technology Services with a media company
  • Hexaware with a leading airline in the Middle East
  • Mphasis with a leading materials engineering company
  • Quinnox with a financial services organization
  • RIEDEL Networks with a document solution provider

Workplace of the Future: Recognizing client and employee experience and productivity beyond technology

  • Atos with a public sector organization in Scotland
  • Cognizant with the U.K.’s railway infrastructure manager
  • Hexaware with a global leader in workforce solutions
  • Teleperformance with a major tourism company
  • Unisys with a multinational chemical company

Environmental Sustainability: Recognizing outstanding positive impacts in one or more environmental sustainability fields for clients, consumers, communities and/or employees

  • Infosys with an automotive manufacturer
  • Telefónica Tech with a roofing manufacturer in Europe
  • Tech Mahindra with an Ethiopia utility company
  • GEP with a multinational pharmaceutical company
  • Infosys with a smart city initiative participating company

The ISG Paragon Awards™ EMEA, produced by ISG Events, recognize innovative ways of driving business success by leveraging digital technology and new operating models.

“This is an exciting time to be in the technology industry, as enterprises and providers work together to enable business growth,” said Steve Hall, partner and president, ISG EMEA. “Technology service providers continue to enable and deliver some of the most readily available pools of talent in both traditional and emerging technologies, geographies, markets and skill areas. Congratulations to the finalists for the 2023 ISG Paragon Awards EMEA for their innovation and productivity.”

The November 15 awards gala takes place during the ISG Sourcing Industry Conference for EMEA. In addition to the ISG Paragon Awards EMEA, ISG will announce the winners of the ISG Star of Excellence™ Awards, which recognize excellence in provider delivery based on enterprise client feedback, and the winners of the ISG Provider Lens™ Awards, recognizing providers named as Leaders in ISG Provider Lens™ studies.

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.

Source: Information Services Group, Inc.

IMF Economic Outlook: U.S. Growth Revised Up, Europe Down

Posted on by slightbourne@noblecapitalmarkets.com

The International Monetary Fund (IMF) recently released its updated World Economic Outlook report, providing insights into global economic projections. A key theme is diverging fortunes for major economies like the United States and Europe.

The IMF upgraded its 2023 GDP growth forecast for the U.S. to 2.1%, up 0.3 percentage points from its prior estimate. The upbeat revision reflects resilience in areas like business investment and consumer spending despite high inflation and interest rates. However, growth is still seen slowing in 2023 and 2024 as the impacts of tightening policy kick in.

Meanwhile, the IMF downgraded the euro zone 2023 outlook to 0.7% growth, 0.2 percentage points lower than previously expected. Slowing trade and higher rates are severely impacting Germany, while other euro economies face varied challenges. The IMF predicts gradual euro zone growth recovery to 1.2% in 2024, though still below pre-pandemic levels.

For the U.K., the IMF upgraded near-term growth slightly to 0.5% in 2023 but lowered its 2024 forecast on expectations of lingering damage from energy price shocks. The U.K. faces a difficult road ahead.

Overall, the IMF kept its global growth outlook unchanged at 3% for 2023. This sluggish pace reflects myriad headwinds including inflation, tight monetary policy, supply chain issues, and the war in Ukraine. IMF Chief Economist Gourinchas described the global economy as “limping along” below its pre-pandemic trend.

Positives like easing supply chain bottlenecks, lower Covid impacts, and stabilizing financial conditions will provide some uplift. But manufacturing and services slowdowns, synchronized central bank tightening, and China’s property crisis will constrain growth.

For investors, the IMF outlook sends mixed signals. U.S. economic resilience and continued consumer strength provide room for cautious optimism. But Europe’s downward revision and pervasive global headwinds like inflation suggest ongoing volatility and potential bumps ahead.

This outlook underscores the importance of defensive positioning and safe haven assets to balance riskier equities. Key takeaways for investors include:

  • Focus on U.S. sectors and stocks benefitting from higher business and consumer spending.
  • Tread carefully in Europe as weaker growth hits markets. Emphasize quality multinationals with less cyclical dependence.
  • Inflation and interest rates will remain challenges influencing markets and consumer behavior.
  • China’s faltering growth and property bubble pose threats worth monitoring.
  • Pay close attention to recession signals that could shift IMF forecasts and alter market psychology.

While the global economy is still expanding, momentum is slowing with many obstacles to navigate. Investors should build resilient portfolios capable of withstanding volatile conditions, while staying alert for any deterioration that could change the IMF’s cautious optimism.

Comtech Telecommunications (CMTL) – Major New Awards

Posted on by cpereira@noblefcm.com


Tuesday, October 10, 2023

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, 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.

U.S. Army Award. Yesterday, Comtech announced that it was recently awarded a U.S. Army contract with a maximum ceiling value of $544 million. The task order was awarded on Comtech’s existing contract with the U.S. Army, which leverages the ten-year, $5.1 billion Global Tactical Communications Systems II IDIQ contract vehicle.

Details. Under the contract, Comtech will provide onsite professional engineering services as well as supply and support the Company’s market leading satellite and terrestrial networking communications technologies for the Project Manager Tactical Network for the Global Field Service Representative (GFSR) support program. The GFSR program provides ongoing communications and IT infrastructure support for the Army, Air Force, Navy, Marine Corps, and NATO-enabling U.S. and coalition forces to maintain robust, resilient, and secure connectivity for global all-domain operations in all environments.


Get the Full Report

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. 

Defense Stocks in the Spotlight Amid Israel-Hamas Fighting

Posted on by slightbourne@noblecapitalmarkets.com

The recent flare-up of violence between Israel and Hamas has led to a rally in defense and aerospace stocks this week. Israel’s air strikes on Gaza, and rocket attacks into Israel, have prompted investors to bet on an escalation of military operations, boosting shares of defense contractors.

Raytheon Technologies, Northrop Grumman, Lockheed Martin, and General Dynamics all saw their share prices surge over 2% on Monday, as the conflict intensified. These major defense players have significant exposure to missile defense systems, aircraft, and other technologies used by the Israeli military.

With Israel ramping up airstrikes in response to Hamas rocket barrages, analysts expect missile stockpiles to be depleted at a faster pace. This could drive near-term orders for restocking and benefit Raytheon, a major supplier of guided missiles. Raytheon’s Patriot missile defense system is also likely seeing heightened utilization.

Meanwhile, Lockheed Martin produces F-16 fighter jets, Apache helicopters, and other aircraft central to Israeli offensive and defensive maneuvers. The company could see greater demand for maintenance, upgrades, and munitions as flight activity increases.

General Dynamics and Northrop Grumman also supply aircraft-related electronics and communications gear to the Israeli air force. Northrop’s AN/TPS-80 ground radar system provides surveillance capabilities relevant to the conflict.

Beyond immediate operations, the fighting may spur longer-term defense spending increases. With tensions high, Israel could expand investment in missile defense and strategic capabilities. Its domestic contractors, and major U.S. players, are poised to benefit.

Smaller defense firms could also get a lift. Israel frequently utilizes smaller contractors for specialized technology development catered to its unique needs. Small-cap companies like Kratos Defense and Ducommun, with niche Israeli defense exposure, may see expanded opportunities. Larger primes winning new contracts could also funnel work to smaller subcontractors.

However, analysts caution the rally may be short-lived without sustained escalation. While illustrating geopolitical risks, this week’s stock moves could reverse on a ceasefire. But major defense contractors remain well-positioned to support Israel’s defense requirements in an unpredictable region. Monitoring the situation is prudent for investors seeking defense exposure.

Haemonetics Expands Hospital Portfolio Through $253 Million Acquisition of OpSens

Posted on by slightbourne@noblecapitalmarkets.com

Medical technology firm Haemonetics Corporation recently announced a definitive agreement to acquire OpSens, Inc. in an all-cash deal valued at approximately $253 million. OpSens is a medical device company specializing in innovative fiber optic sensor technology for interventional cardiology applications. This strategic acquisition allows Haemonetics to expand its hospital business into the high-growth interventional cardiology market estimated at $1 billion.

Haemonetics, based in Boston, offers a suite of products for blood and plasma collection, the surgical suite, and hospital transfusion services. With the addition of OpSens’ sensor-guided guidewire and pressure guidewire products for transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI), Haemonetics bolsters its portfolio with clinically validated technology to improve patient outcomes.

OpSens’ core offerings include the SavvyWire, the first sensor-guided guidewire for TAVR procedures which enables shorter hospital stays, and the OptoWire, a pressure guidewire used to aid coronary artery disease diagnosis by measuring key parameters like fractional flow reserve (FFR). OpSens leverages proprietary optical technology across its sensor solutions for medical devices and critical industrial applications.

According to Stewart Strong, President of Global Hospital at Haemonetics, this acquisition expands Haemonetics’ leadership in interventional cardiology while providing a foundation for additional growth. By combining OpSens’ innovative technology with Haemonetics’ commercial infrastructure and hospital relationships, there is tremendous potential to increase adoption and improve patient care globally.

Strategically, Haemonetics gains several advantages from the purchase:

  • Access to a $1 billion total addressable market in interventional cardiology, a specialty area witnessing increasing procedure volume. OpSens’ competitive, clinically validated offerings are well-positioned for long-term growth.
  • The ability to accelerate OpSens product adoption leveraging Haemonetics’ existing commercial footprint and depth of penetration in U.S. hospitals for its VASCADE vascular closure portfolio.
  • Expanded product breadth and enhanced diversification into adjacent applications like industrial sensors. OpSens technology can be leveraged across Haemonetics’ hospital business and new markets.
  • Opportunities for continued R&D, clinical study efforts, and other business development activities to augment internal product development. Haemonetics aims to expand its hospital division via organic and inorganic investments.

Financially, Haemonetics expects the deal will be immediately accretive to revenue growth. On an adjusted basis, earnings per share is also expected to be accretive right away. Due to one-time integration costs, GAAP earnings per share may be slightly dilutive in the first full fiscal year before turning accretive.

Haemonetics will finance the transaction through existing cash balances and its revolving credit facility. This will result in a manageable rise in the company’s net debt to EBITDA ratio to around 2.1x. The purchase is anticipated to close by January 2024, subject to customary approvals.

In summary, the acquisition of OpSens for $253 million in cash strengthens Haemonetics’ position in the attractive interventional cardiology space while providing new technologies, commercial synergies, and earnings accretion over the long-term. It signals a bold move to supplement organic growth with value-enhancing strategic M&A, as Haemonetics looks to deliver innovation and drive better patient outcomes through continued expansion.

Take a look at more biotechnology companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage list.

Release – GeoVax Receives Notice of Allowance for Marburg Vaccine Patent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

ATLANTA, GA, October 9, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/584,231 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.

A recent presentation of data from nonhuman primate studies demonstrated that immunization with GeoVax’s vaccine candidate, GEO-MM01, conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected from viremia, weight loss and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. GeoVax is currently evaluating study designs to assess the potential for administering different dose levels of the vaccine and different routes of vaccine delivery to optimize utility and efficacy.

David Dodd, GeoVax President and CEO, commented, “While our focus and development priorities continue to be our next-generation COVID-19 vaccine and cancer immunotherapy programs, developing vaccines against lethal hemorrhagic fever viruses represents our commitment to addressing highly fatal endemic threats throughout the world. Our team is committed to supporting the successful advancement of such a vaccine, as we recognize the critically important medical and biodefense need, reflected by the inclusion of Marburg virus in the FDA Priority Review Voucher program. This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.”

About Marburg Virus

Marburg virus (MARV) is a hemorrhagic fever virus of the Filoviridae family, which also includes Ebola virus, and causes severe human disease with up to a 90% fatality rate. The Marburg virus is transmitted to people from fruit bats, and human-to-human transmission occurs through direct contact with bodily fluids, or contaminated surfaces and materials. MARV is rated by the World Health Organization (WHO) as a Risk Group 4 Pathogen. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks it as a Category A Priority Pathogen and the Centers for Disease Control and Prevention lists it as a Category A Bioterrorism Agent. MARV typically appears in sporadic outbreaks throughout Africa and the virus continues to pose potential public health and biodefense threats. There are currently no licensed vaccines or therapeutics against the diseases caused by MARV.

About the GV-MVA-VLPTM Platform

GeoVax’s GV-MVA-VLPTM vaccine platform utilizes modified vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact: Investor Relations Contact: Media Contact:
info@geovax.com    paige.kelly@sternir.com    sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929

Release – Comtech Receives U.S. Army Contract with $544 Million Ceiling to Provide Communications and Engineering Support Services

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CMTL

MELVILLE, N.Y. –
Oct. 9, 2023– Comtech (NASDAQ: CMTL) announced today that it was recently awarded a U.S. Army contract with a maximum ceiling value of $544 million.

Under the contract, Comtech will provide onsite professional engineering services, as well as supply and support the company’s market leading satellite and terrestrial networking communications technologies for the Project Manager (PM) Tactical Network (TN) for the Global Field Service Representative (GFSR) support program.

The GFSR program provides ongoing communications and IT infrastructure support for the Army, Air Force, Navy, Marine Corps, and NATO-enabling U.S. and coalition forces to maintain robust, resilient, and secure connectivity for global all-domain operations in all environments.

“This contract award further demonstrates the differentiated value of our networked communications technologies, as well as the unique, comprehensive domain expertise of our people providing professional engineering services for critical U.S. Department of Defense (DoD) missions across a comprehensive array of government programs,” said Ken Peterman, President and CEO, Comtech. “Comtech’s professional engineering services and our extensive portfolio of resilient, blended, smart-enabled networked communications technologies will help the DoD and coalition partners maintain an assured information advantage in an age of Combined Joint All Domain Command and Control (CJADC2) operations.”

This task order was awarded on Comtech’s existing contract with the U.S. Army, which leverages the ten-year, $5.1 billion Global Tactical Communications Systems (GTACS) II indefinite delivery / indefinite quantity (IDIQ) contract vehicle. Comtech was initially selected as one of multiple GTACS II IDIQ awardees in 2020. The GTACS II contract is designed to support of the Program Executive Office Command, Control and Communications-Tactical (PEO C3T), and PM TN. GTACS II provides the rapid acquisition of a wide range of C3T hardware, software, engineering services and logistics support services with an emphasis on tactical satellite communications.

Comtech’s portfolio of defense technologies and services, including those provided under this contract, are uniquely positioned to deliver capabilities that will enhance CJADC2 operations. The company has extensive experience developing and deploying customized, interoperable, robust, and resilient communications systems for all branches of the DoD and coalition forces. Comtech’s expansive portfolio of defense and security technologies is designed to continuously evolve over time to meet emerging Command, Control, Computers, Communications, Cyber, Intelligence, Surveillance and Reconnaissance (C5ISR) use cases and enhance mission effectiveness in future all-domain command and control operations.

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.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20231008650556/en/

Investor Relations

Robert Samuels

631-962-7102

robert.samuels@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Tonix Pharmaceuticals Provides Overview of TNX-2900 Program for the Treatment of Prader-Willi Syndrome at the Foundation for Prader-Willi Research Family Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 09, 2023 7:00am EDTDownload as PDF

CHATHAM, N.J., Oct. 09, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, provided an overview of Tonix’s TNX-2900 (potentiated intranasal oxytocin) program at the Foundation for Prader-Willi Research (FPWR) Family Conference in Denver, CO. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. Additional information can be found on the FPWR conference website here.

The presentation highlights preclinical data showing the enhancing effects of magnesium (Mg2+) on the activation of oxytocin receptors. The Mg2+ enhanced formulation of intranasal oxytocin is the basis for TNX-2900, in development to treat hyperphagia, or pathological over-eating, in children and adolescents with Prader-Willi syndrome (PWS). In preclinical studies, Mg2+ increases the potency of oxytocin, which is an anorexigenic hormone that reduces appetite and signals fullness, potentially improving receptor binding and resulting in improved therapeutic action.

TNX-2900 has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of PWS. Tonix plans to submit an investigational new drug (IND) application to the FDA in the fourth quarter of 2023. There is no treatment currently approved for hyperphagia in PWS.

Tonix licensed the technology to treat PWS from Inserm Transfert, the private subsidiary of Inserm (the French National Institute of Health and Medical Research).

About Prader-Willi Syndrome

Prader-Willi syndrome is recognized as the most common genetic cause of life-threatening childhood obesity1 and affects males and females with equal frequency and all races and ethnicities. The hallmarks of Prader-Willi syndrome are lack of suckling in infants and, in children, adolescents, and adults, severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. There is currently no approved treatment for either the suckling deficit in babies or the obesity and hyperphagia in older children associated with Prader-Willi syndrome.

1 Foundation for Prader-Willi Research (fpwr.org).

About TNX-2900 and Tonix’s Potentiated Oxytocin Platform

TNX-2900 is based on Tonix’s patented intranasal potentiated oxytocin formulation which is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin. Tonix is also developing a different intranasal formulation and device, designated TNX-1900, for prophylaxis of chronic migraine and for the treatment of insulin resistance and related conditions. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. It was originally approved by the U.S. Food and Drug Administration as Pitocin®*, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal form of oxytocin was marketed in the U.S. by Novartis to assist in the production of breast milk as Syntocinon®** (oxytocin nasal 40 units/ml), but the product was discontinued, and the New Drug Application was withdrawn.

*Pitocin® is a trademark of Par Pharmaceutical, Inc.

**Syntocinon® is a trademark of BGP Products Operations GmbH

About the Foundation for Prader-Willi Research (FPWR)

FPWR is a global nonprofit organization focused on funding research, advancing scientific understanding, and improving the lives of individuals with Prader-Willi syndrome. By supporting innovative research and forging strategic partnerships, FPWR seeks to find treatments and ultimately a cure for PWS. For more information please visit https://www.fpwr.org/. 

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 late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, 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 early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released October 9, 2023

Bristol Myers Squibb to Acquire Mirati Therapeutics for $4.8 Billion

Posted on by slightbourne@noblecapitalmarkets.com

Pharma giant Bristol Myers Squibb (BMY) announced today that it will acquire clinical-stage biotech Mirati Therapeutics (MRTX) for $58 per share in an all-cash deal totaling $4.8 billion. Mirati stockholders will also receive a contingent value right worth up to $12 per share, bringing the total potential deal value to $5.8 billion.

The acquisition will expand Bristol Myers Squibb’s oncology portfolio and pipeline. Mirati’s lead asset is KRAZATI (adagrasib), the first and only FDA-approved drug targeting the KRAS G12C mutation. KRAS mutations occur in about 13% of non-small cell lung cancers (NSCLC) and are linked to poor prognosis.

KRAZATI was granted accelerated approval in October 2022 as a second-line treatment for KRAS G12C-mutated NSCLC. It is also being tested in combination with a PD-1 inhibitor as a potential first-line NSCLC therapy. Beyond lung cancer, KRAZATI has shown promise in colorectal and pancreatic cancers.

“With multiple targeted oncology assets including KRAZATI, Mirati is another important step forward in our efforts to grow our diversified oncology portfolio,” said Bristol Myers CEO Giovanni Caforio. The company aims to leverage its global commercial infrastructure to maximize KRAZATI’s reach.

Mirati’s earlier-stage pipeline includes MRTX1719, an innovative PRMT5 inhibitor, as well as several KRAS-targeted agents. MRTX1719 could be the first targeted therapy for MTAP-deleted tumors, which represent about 10% of cancers.

“Bristol Myers Squibb’s global scale, resources and commitment to innovation will enable Mirati’s therapeutics to benefit more patients, faster,” said Mirati CEO Charles Baum.

Strategic Fit

Lung cancer is the most common cancer and leading cause of cancer death globally. The addition of KRAZATI establishes Bristol Myers as a leader in developing targeted lung cancer therapies. Mirati also expands Bristol Myers’ presence in colorectal and pancreatic cancers.

The acquisition builds on Bristol Myers’ recent deals for Turning Point Therapeutics and Eisai’s oncology business. As patents expire for the pharma giant’s top-selling cancer immunotherapy Opdivo, it aims to refill its oncology pipeline.

“With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction is aligned with our business development goals,” said Caforio.

Broader Biopharma Implications

The blockbuster Mirati acquisition also has significant implications for the broader biotech and biopharma sector. As large pharmas look to replenish pipelines, M&A activity has intensified. The deal shows that promising clinical-stage biotechs with innovative oncology pipelines continue to be attractive buyout targets.

Analysts note the 52% buyout premium Bristol Myers paid as a sign of their urgency to tap into Mirati’s next-gen oncology science. For startup biotechs pursuing novel approaches in high-value areas like oncology, it underscores the possibility of commanding large premium buyouts from “big pharma” acquirers.

However, smaller players also face the risk of being squeezed out as consolidation accelerates. The Mirati deal exemplifies the scaling up required to compete in cutting-edge areas like targeted cancer therapies. Smaller biotechs could find it increasingly difficult to independently develop and commercialize new drugs in the future.

That said, smaller biotechs may also benefit from big pharma’s growing appetite for M&A. The premiums being offered for innovative science and pipelines create lucrative exit opportunities for startups. And the influx of capital from buyouts can fund the next generation of biotech innovation.

Take a look at some emerging growth biotechnology companies by taking a look at Noble Capital Market’s Senior Research Analyst Robert LeBoyer’s coverage list.

Deal Terms

Under the definitive agreement, Bristol Myers will pay $58 per share for Mirati’s outstanding common stock. This represents a 52% premium over Mirati’s 30-day volume-weighted average price. Including Mirati’s $1.1 billion cash balance, the total equity value comes to $4.8 billion.

Each Mirati shareholder will also receive a CVR worth up to $12 per share. This contingent value right payment is triggered if Mirati’s MRTX1719 is approved within 7 years as a NSCLC therapy after two or fewer systemic treatments. The CVR adds up to $1 billion in potential additional value.

The transaction is expected to close in the first half of 2024, pending approval from regulators and Mirati shareholders. Bristol Myers anticipates the deal will be dilutive to its non-GAAP earnings through 2025 as it integrates Mirati. It plans to finance the acquisition through cash and debt offerings.

Caforio stated: “With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction is aligned with our business development goals.” The deal furthers Bristol Myers Squibb’s transformation into a leading oncology-focused biopharma.