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Gotta take the money and RUN!!!!
Running on sympathy with HOLO
Thank you Ghost and BTW I marked you because of your PM. Have a nice rest of the day
I just joined you monks. I am officially retired now! :)
Halted before the close! $18.64
Great call bro! Up 100%
Not showing you or anyone else! But I will show you a new runner for Monday if your interested
Agree. Little move love just poured in :)
Agree. Little move love just poured in :)
Then I'm sure you caught the $7.50 dipper!
$10.00 holy stock Gods!
I'm at retirement age, got married, and raised a family. Busted my ass for them for so many years! Now I always think back, was it worth it? I ponder on many things and feel most of us were brainwashed since biblical days. We got it all wrong
My mathematical skills are no longer needed to make decisions. This entire market is all BS now. But who gives a darn?
We're getting some pre-market love!
Fluff has turned into serious cabbage for me! :))
Berry Global and Glatfelter Announce Plans for Tax-Free Spin-Off and Merger of Berry’s Health, Hygiene and Specialties Global Nonwovens and Films Business with Glatfelter, Creating a Global Specialty Materials Leader
Combination creates a large-scale global franchise with an industry-leading solution set serving attractive, growing specialty materials markets
Establishes leading positions in the high value-added categories within the specialty materials industry, served by differentiated innovation capabilities
Transaction values the combined company at $3.6 billion on an enterprise value basis, with pro forma revenue of ~$3.6 billion and Adj. EBITDA (1) of ~$455 million
Berry and Glatfelter shareholders to own 90% and 10% of the combined company, respectively. Berry to receive an approximate net $1 billion cash distribution at closing
Enhances earnings power with secular rebound and expected cost synergies of at least $50 million by year three
Tax-efficient Reverse Morris Trust transaction allows for full shareholder participation in upside of combined company
Accelerates strategic repositioning of Berry to a pure-play provider of innovative, sustainable global packaging solutions
Improves Glatfelter’s leverage profile to increase shareholder value – transaction pro forma net leverage (2) of 4x
Meaningfully accelerates Glatfelter’s strategy to further optimize product portfolio and strengthen strategic innovation and sustainability offerings
Significant step in the optimization of Berry’s portfolio and the culmination of a comprehensive review to drive value creation for Berry shareholders
Berry and Glatfelter to Host Joint Investor Conference Call, Wednesday February 7, 2024 at 8:30 AM Eastern Daylight Time
EVANSVILLE, Ind. & CHARLOTTE, N.C.--(BUSINESS WIRE)-- Berry Global Group, Inc. (NYSE:BERY) and Glatfelter Corporation (NYSE:GLT) announced today they have entered into definitive agreements for Berry to spin-off and merge the majority of its Health, Hygiene and Specialties segment to include its Global Nonwovens and Films business (“HHNF”) with Glatfelter, to create a leading, publicly-traded company in the specialty materials industry. The Boards of Directors of Berry and Glatfelter have unanimously approved the transaction.
The new combined company (“NewCo”) will become a global leader in the growing specialty materials industry, serving the world’s largest brand owners across global end markets with favorable long-term growth dynamics. HHNF brings an extensive portfolio of proprietary technologies, with a strong focus on healthcare, hygiene, and specialty end markets, while Glatfelter provides a broad range of innovation capabilities and sustainability solutions. Together, the combined company will offer a highly complementary product suite, including both polymer-based and fiber-based solutions, supported by strong innovation capabilities, with significant geographic diversification and a presence in all major markets.
“This announcement is the culmination of a comprehensive review of strategic alternatives to determine the value-maximizing path forward for Berry shareholders,” said Kevin Kwilinski, Berry’s Chief Executive Officer. “We believe these two businesses, in combination, can drive significant value for shareholders with complementary portfolios, positioning each for greater success. Following completion of the transaction, Berry will become a pure-play provider of innovative, sustainable global packaging solutions, which we believe will deliver even more predictable earnings growth for Berry shareholders. Additionally, we believe HHNF in combination with Glatfelter will thrive as an independent company that is positioned to drive long-term growth with its global brand-owner customers.”
"The uniting of our organizations creates a premier nonwovens supplier and a global leader in specialty materials, with the talent, technologies, scale, and footprint to deliver commercial and operational excellence, and a wide range of solutions for our customers. Our combined company is scaled to accelerate innovation and leverage our intellectual property over a large worldwide commercial platform and is well positioned to deliver substantial shareholder value," said Thomas Fahnemann, Glatfelter's President and Chief Executive Officer.
Berry to Enhance its Focus on Consumer Packaging Leadership
In September, Berry announced a review of strategic alternatives for its Health, Hygiene & Specialties (‘HH&S’) segment. Today's announcement is the culmination of a comprehensive review of strategic alternatives to determine the value-maximizing path forward for Berry shareholders. The remaining HH&S businesses, including Berry’s tapes business, will be retained by Berry.
The proposed transaction marks an important milestone in Berry’s transition to becoming a streamlined and focused provider of consumer packaging. Post-separation, Berry will continue to offer industry-leading products, solutions, and material science to help customers achieve their commercial and sustainability goals. Pro forma for the separation transaction, Berry generated approximately $10.2 billion of revenue and $1.8 billion in Adjusted EBITDA for the last twelve months period end December 30, 2023. Furthermore, in conjunction with today’s announcement, Berry will change the name of its Engineered Materials segment to Flexibles to showcase the continued evolution of this segment towards high-value products and solutions.
Glatfelter to Deliver Significant Shareholder Value and Platform for Future Growth
For Glatfelter, the proposed transaction represents the next significant milestone in the Company’s time-tested strategy as a leading global supplier of specialty materials. The combination of Berry’s HHNF business and Glatfelter provides meaningful scale given the complementary technology and product portfolios, along with a platform for considerable growth in future periods. The transaction provides NewCo the opportunity to deliver significant value creation for Glatfelter shareholders by immediately deleveraging Glatfelter’s balance sheet and increasing the equity value of the overall enterprise, while also enhancing its credit profile with customers and suppliers. Glatfelter’s recent focus on optimizing its portfolio, managing the price/cost spread dynamic, and driving commercial and operational excellence, along with G&A cost discipline, provides the foundation to meaningfully contribute towards the overall success of NewCo.
Financial Highlights
Together, HHNF and Glatfelter generated pro forma revenue of approximately $3.6 billion and Adjusted EBITDA (1) of approximately $455 million based on combined results for the last twelve months (‘LTM’) period ended December 2023 for Berry and the LTM period ended September 2023 for Glatfelter, along with expected cost synergies of $50 million and combined pro forma adjustments of $25 million to be realized by year three.
(1)
Adjusted/Operating EBITDA are non-GAAP measures that refer to earnings before interest, taxes, depreciation, and amortization, pro forma, and as further described as Operating EBITDA for the LTM period ended December 2023 for Berry and Adjusted EBITDA for the LTM period ended September 2023 for Glatfelter, along with expected cost synergies of $50 million and combined pro forma adjustments to be realized by year three. A reconciliation to the nearest GAAP can be found in GLT’s September 10-Q for adjusted earnings and Berry numbers are a carveout of HH&S and unaudited.
(2)
Pro forma net leverage is a non-GAAP measure and refers to NewCo.’s net debt divided by adjusted EBITDA
Governance and Management
The new, publicly-traded company, which will be renamed and rebranded by transaction close, will be led by Curt Begle, Berry’s current President of HH&S, who will serve as CEO. Additional members of the combined company's senior management team will be announced at a later date.
“I am humbled and honored to be trusted as the leader of this new global enterprise and its 8,700 skilled and dedicated team members. This combination positions us to delight our customers, enhance the lives of our employees, and create value for our shareholders. Today’s announcement is the first step in creating a pure-play leader in nonwovens and specialty materials well-positioned in growing, global markets. We will increase the combined company’s relevance as a supplier of choice, through product innovation, superior service, and reliability. Our combined, well-invested platforms will provide value-added product offerings with leading sustainability-driven solutions for brand-owner customers globally,” stated Curt Begle, President of Berry’s Health, Hygiene & Specialties division.
The Board of Directors of the combined company will initially be comprised of nine total members, consisting of six designated by Berry and three designated by Glatfelter. The chairman will be designated by Glatfelter, and all directors will be named at a future date.
Strategic Rationale of the Combination
Creates a leading global competitor in the large and growing specialty materials industry
Broadens substrate, product and end market mix, combining highly complementary portfolios
Provides for significant geographic diversification with a presence in all major markets
Scales resources to drive innovation and leverage R&D across a large, global franchise
Combines extensive operational expertise, coupled with deep industry knowledge and technical know-how
Enables significant synergy potential; expected cost synergies $50 million composed of a combination of procurement, G&A and other operational improvement opportunities expected by the third year following closing
Transaction Details
The transaction is being structured as a Reverse Morris Trust transaction and is intended to be tax-free to Berry, Glatfelter and their respective shareholders for U.S. federal income tax purposes. Key details of the transaction include:
Ownership: Berry shareholders will own 90% of the combined company's common shares upon consummation of the transaction. Glatfelter shareholders will own the remaining 10% of the combined company.
Cash Proceeds: Berry is expected to receive net cash proceeds of approximately $1 billion at close and intends to use these proceeds to repay existing debt. Berry expects to maintain its existing capital allocation priorities following this transaction.
Financing: NewCo. has obtained committed financing from Citigroup and Wells Fargo Bank, N.A. and expects to raise permanent debt financing by transaction close, resulting in net leverage of approximately 4.0x, inclusive of Glatfelter’s $500 million 4.75% Senior Notes due 2029, which are anticipated to remain outstanding.
Closing: Closing of the transaction is expected to occur in the second half of calendar 2024, subject to various customary closing conditions, including regulatory approvals and Glatfelter shareholder approval. No vote of Berry’s shareholders is required for the transaction. Employee representation will be involved where applicable.
Pro Forma Impact to Berry: The transaction is expected to be leverage neutral to Berry.
Additionally, prior to closing of the transaction, Glatfelter will complete a reverse stock split of all of its issued and outstanding common stock. The reverse stock split ratio will be determined by Glatfelter and Berry, closer to the closing date of the transaction, and additional information will be provided prior to the effective time of the reverse stock split.
Conference Call Details
Berry and Glatfelter management will together discuss the transaction on a joint conference call/webcast scheduled for today at 8:30 a.m. ET. This call is expected to last approximately 30 minutes. A copy of this release along with the investor presentation can be found on Glatfelter’s investor website at www.glatfelter.com.
This will be followed by a separate conference call to discuss Berry’s fiscal first quarter 2024 financial results at 10:00 a.m. ET today. Both calls will be webcast live at the Company’s website at https://ir.berryglobal.com/financials. A new, simplified event registration and access provides two ways to access the call. A replay of the webcast will be available via the same link on our website approximately two hours after the completion of the call.
By Telephone
Participants may register for the transaction announcement call here now or any time up to and during the time of the call, and will immediately receive the dial-in number and a unique pin to access the call. While you may register at any time up to and during the time of the call, you are encouraged to join the call 10 minutes prior to the start of the event.
Via the Internet
The transaction-related conference call and accompanying webcast slides will also be broadcast live over the internet. To access the event, click on the following link: https://ir.berryglobal.com/financials. A replay of the webcast will be available via the same link on our website approximately two hours after the completion of the call.
Advisors
Citigroup Global Markets Inc. and Wells Fargo are serving as financial advisors to Berry, and Bryan Cave Leighton Paisner LLP is serving as legal advisor to Berry. J.P. Morgan Securities LLC is serving as financial advisor to Glatfelter, and King & Spalding LLP is serving as legal advisor.
Cautionary Statement Concerning Forward-Looking Statements
Statements in this release that are not historical, including statements relating the expected timing, completion and effects of the proposed transaction between Berry and Glatfelter, are considered “forward looking” within the meaning of the federal securities laws and are presented pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements because they contain words such as “believes,” “expects,” “may,” “will,” “should,” “would,” “could,” “seeks,” “approximately,” “intends,” “plans,” “estimates,” “projects,” “outlook,” “anticipates” or “looking forward,” or similar expressions that relate to strategy, plans, intentions, or expectations. All statements relating to estimates and statements about the expected timing and structure of the proposed transaction, the ability of the parties to complete the proposed transaction, benefits of the transaction, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions, and other statements that are not historical facts are forward-looking statements. In addition, senior management of Berry and Glatfelter, from time to time make forward-looking public statements concerning expected future operations and performance and other developments.
Actual results may differ materially from those that are expected due to a variety of factors, including without limitation: the occurrence of any event, change or other circumstances that could give rise to the termination of the proposed transaction; the risk that Glatfelter shareholders may not approve the transaction proposals; the risk that the necessary regulatory approvals may not be obtained or may be obtained subject to conditions that are not anticipated; risks that any of the other closing conditions to the proposed transaction may not be satisfied in a timely manner; risks that the anticipated tax treatment of the proposed transaction is not obtained; risks related to potential litigation brought in connection with the proposed transaction; uncertainties as to the timing of the consummation of the proposed transaction; unexpected costs, charges or expenses resulting from the proposed transaction; risks and costs related to the implementation of the separation of Berry’s HH&S global nonwovens and films business into a new entity (“Spinco”), including timing anticipated to complete the separation; any changes to the configuration of the businesses included in the separation if implemented; the risk that the integration of the combined companies is more difficult, time consuming or costly than expected; risks related to financial community and rating agency perceptions of each of Berry and Glatfelter and its business, operations, financial condition and the industry in which they operate; risks related to disruption of management time from ongoing business operations due to the proposed transaction; failure to realize the benefits expected from the proposed transaction; effects of the announcement, pendency or completion of the proposed transaction on the ability of the parties to retain customers and retain and hire key personnel and maintain relationships with their counterparties, and on their operating results and businesses generally; and other risk factors detailed from time to time in Glatfelter’s and Berry’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. These risks, as well as other risks associated with the proposed transaction, will be more fully discussed in the registration statements, proxy statement/prospectus and other documents that will be filed with the SEC in connection with the proposed transaction. The foregoing list of important factors may not contain all of the material factors that are important to you. New factors may emerge from time to time, and it is not possible to either predict new factors or assess the potential effect of any such new factors. Accordingly, readers should not place undue reliance on those statements. All forward-looking statements are based upon information available as of the date hereof. All forward-looking statements are made only as of the date hereof and neither Berry nor Glatfelter undertake any obligation to update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.
Additional Information and Where to Find It
This communication may be deemed to be solicitation material in respect of the proposed transaction between Be
MicroCloud Hologram Planned to Join the Communications Industry Association
BEIJING, Feb. 7, 2024 /PRNewswire/ -- MicroCloud Hologram Inc. (NASDAQ: HOLO) ("HOLO" or the "Company"), a Technology provider, today announced that it planned to join the Communications Industry Association.
The Communications Industry Association is a cross-sectoral, cross-regional and cross-ownership national industry organization and non-profit social and economic group. The Association constantly promotes technological innovation, technology export, and industry development in the communications industry, and contributes to the economic development of the communications field. The business unit in charge of the Association is the Ministry of Industry and Information Technology. Under the guidance of the Ministry of Industry and Information Technology, the Association carries out industry management, information exchange, business training, international cooperation, consulting services, etc., with the main objectives of promoting industry technological progress, improving product quality, strengthening economic and technological cooperation between enterprises and institutions, promoting unity, improving the quality of member units and economic benefits, and promoting communication products to meet the ever-increasing global demand and improve competitiveness in the international market.
The Association holds regular meetings to exchange with each other the experience of internal reforms and the situation of research, development, production and sales in each unit, to analyze the dynamics of foreign technological development, to study the development of the industry, to analyze the market, to discuss countermeasures together, and to reflect the problems and needs to the relevant departments. Over the past few years, many of the proposals put forward by the Association have received the attention and support of the relevant departments.
The Association has also carried out useful work and made certain achievements in coordinating institutional research and standard formulation for new technologies and products, and organizing product development by member units.
HOLO planned to join the Communications Industry Association in order to promote the development of the communications industry in the field of information technology innovation, in order to accelerate the development of a new generation of information technology and the integration of industry information technology innovation.
Partnership between COTEC and SunHydrogen will see the scale-up of green hydrogen panels SunHydrogen and COTEC have created an industrial partnership, in which they have decided to focus on scaling-up the production of 1m² green hydrogen panels.
COTEC is a South Korean-based company, who recently created a laboratory that is intended for SunHydrogen’s technology. The laboratory is suitable for the technology and so far, COTEC have been able to replicate the technology’s proprietary process on a laboratory scale, through the use of advanced industrial electroplating techniques.
This large development for this technology has been created due to the significance of it. The technology is said to be the only self-contained nanoparticle-based hydrogen generation device, which has the ability to split water molecules into high-purity green hydrogen. The solar panel SunHydrogen developed for the technology is made-up of multiple generators immersed in water. Each of these solar panels has billions of electroplated nanoparticles inside it.
The creation of this laboratory was completed for the scale-up of the technology, but also with the intention of accelerating the company’s progress to commercialisation. With its technology in the laboratory, SunHydrogen was able to gather a group of industrial partners and collaborators. These parties include the University of Iowa, the University of Michigan, Project NanoPEC, Geomatec, InRedox, MSC, COTEC, as well as consultants Professor Kazunari Domen, Dr Hiroshi Nishiyama and finally, Dr Taro Yamada from the University of Tokyo.
SunHydrogen’s CEO, Tim Young, expressed the company’s understanding that the scaling up to 1m² would come with, “inherent challenges.” However, alongside these challenges, the view that COTEC is the “ideal partner” who can help SunHydrogen reach their goals and address the challenges is a strong opinion upholding the partnership.
Young also commented, “I would like to thank COTEC for their dedication to our shared goals and our shareholders and supporters for their patience as we work to bring world-changing technology closer to commercialisation.”
https://www.hydrogen-expo.com/industry-news/partnership-between-cotec-sunhydrogen-see-scale-up-green-hydrogen-panels?utm_source=https%3a%2f%2fe.usa-hydrogenexpo.com%2fhydrogentechnologyusalz%2f&utm_medium=email&utm_campaign=HT+World+News+USA+-+General+Newsletter+-+06%2f02+Engaged&utm_term=Partnership+between+COTEC+and+SunHydrogen+will+see+the+scale-up+of+green+hydrogen+panels+&utm_content=84151&gator_td=n0X91M7r5oSCXLCypG2TePfeJfAO6FtugPJ7WTRlEIYVu40ljd81%2btqQPHFogyEcIIoWy6l5oqBDO7hEOJoMNf5U%2fYaf6YNVZpnf9potZ29eh7u496tFaaSCFijv3MsPDG25DxwkDDuLve%2fz66l%2fgvJGvGPOci%2f7tA51XByKNWGcQHaKmD3MEkywgcnDrqNY9vldiaZAPzS%2bzqSxfgejzg%3d%3d
Printing presses of new shares
As of November 3, 2023, the registrant had 708,247 shares of Class A common stock, $0.001 par value per share, outstanding.
Agrify Corporation Achieves Milestone with PX-30 Hydrocarbon Extraction System Installation in Michigan Facility
TROY, Mich, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Agrify Corporation (Nasdaq: AGFY) (“Agrify” or the “Company”), a leading provider of innovative cultivation and extraction solutions for the cannabis industry, today announced the successful installation of a PX-30 Hydrocarbon Extraction System at its customer’s Michigan facility.
The PX-30 Hydrocarbon Extraction System is the largest system of Agrify’s PX-Extraction series, and represents a cutting-edge advancement in hydrocarbon extraction technology, designed to enhance efficiency and precision in the extraction process. This installation marks a significant milestone for Agrify, reinforcing the company’s commitment to delivering state-of-the-art solutions to the cannabis and hemp industries as operators around the country continue to purchase and operate with Agrify’s latest technologies.
Lume Cannabis’ (“Lume Cannabis” or the “Customer”) Michigan facility had previously been operating with Agrify’s XMU Hydrocarbon Extraction System. As the Customer’s business grew and the operation required additional speed and throughput from the system, Lume Cannabis purchased the PX-30 system through the Company’s subsidiary Precision Extraction Solutions to elevate its extraction capabilities, meeting the increasing demand for premium extracts in the rapidly growing cannabis and hemp markets. “Having owned a Precision XMU for the past year and a half, the Precision PX-30 was the natural choice for Lume when we decided to expand our resin extraction capabilities. The Precision Extraction team has been great to work with and we appreciate their efforts to do anything in their power to ensure their customers have a smooth installation and startup experience,” said Stan Gourentchik, Lab Manager at Lume Cannabis.
Key features of the PX-30 hydrocarbon extraction system include:
High Extraction Efficiency: The PX-30 ensures optimal extraction yields, maximizing the production of high-quality extracts of up to 240+ lbs. per 8-hour shift.
Operational Design: Created with the operator in mind, the PX-30 offers ultra-low temperature operation with fast recovery times, with or without a compressor. All functions and features are easily accessible in a linear process flow with conveniently located controls and ergonomics designed for the operator.??
Safety/Compliance: Agrify prioritizes safety, and the PX-30 is built with state-of-the-art safety features to comply with 3A sanitary and cGMP standards.
"We are thrilled to announce the successful installation of another PX-30 hydrocarbon extraction system at one of our valued customers here in the state of Michigan," said Brian Towns, EVP & General Manager at Agrify. "This state-of-the-art technology aligns with our mission to provide our clients with the best tools for long-term success in an evolving industry. Agrify is committed to all of our customer’s success as their success is our success.”
As Agrify continues to innovate and invest in cutting-edge technologies, the Company remains at the forefront of the equipment and ancillary cannabis extraction market.
Helius Medical Technologies, Inc. Announces Alignment with FDA on Registrational Program for Treatment of Stroke Patients
-- Studies uses Portable Neuromodulation Stimulator (PoNS®) to evaluate cranial-nerve non-invasive neuromodulation for gait/balance deficits in stroke patients --
-- Interaction with FDA on clinical program feasibility streamlines cost and timeline and leverages trials with the Medical University of South Carolina and Brooks Rehabilitation --
-- Studies and real-world evidence results will be submitted for regulatory authorization under PoNS’s breakthrough designation for stroke --
-- Regulatory submission for stroke and marketing authorization expected in 2025 --
NEWTOWN, Pa., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced today that it has concluded its interaction with the U.S. Food and Drug Administration (“FDA”) on optimizing the development plan for its stroke program which aims to evaluate the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”) delivered using PoNS Therapy® on gait and dynamic balance in chronic stroke survivors. Helius’ registrational program includes two controlled studies. The clinical program will leverage a randomized, controlled, double blinded investigator-initiated trial (“IIT”), led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”) and a Company-sponsored study to enroll approximately 100 subjects. Dr. Kautz’s IIT began enrollment of 60 participants in September 2023 with the collaboration of Dr. Mark Bowden at Brooks Rehabilitation as a second site.
“Vetting the registrational program and design of our clinical studies with the FDA is an important milestone for Helius and meeting the agency’s expectations will give us the most efficient path to delivering PoNS Therapy to stroke patients,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer. “This development plan, which leverages early study results and real-world evidence from Canada, allows us to streamline the size, timeline, and cost of the registrational program and positions Helius on the best course toward potential FDA authorization under PoNS’s breakthrough designation for stroke.”
When evaluated in a real-world evidence (RWE) database analysis of Canadian stroke patients with gait or balance deficit, PoNS Therapy demonstrated a significant and clinically meaningful improvement in gait, averaging a 6.74-point improvement in the functional gait assessment (FGA) score over a 14-wk treatment period (95% CI: 4.85 to 8.63). Before starting PoNS Therapy, over 93% of patients were considered at risk of falling, as determined by an FGA<23 score at baseline. After a 14-week treatment regimen with PoNS, 28% of patients were no longer at fall risk, a considerable result given that, in routine clinical practice, rehabilitative physical therapy alone decreases the risk of falling in only 1-3% of patients. Across all stroke patients in the database, 69.2% of patients experienced at least a 5-point FGA improvement, which is larger than the 4.2-point minimal detectable change usually seen in stroke patients.
“One of our chief objectives is to optimize access to PoNS Therapy for stroke patients suffering from gait and balance deficit in North America. We recently announced collaborations with the University of Montreal and the Quebec Ministry of Health to evaluate the health economic benefits of PoNS Therapy in these patients and hope that our development approach will not only save several millions of dollars in healthcare burden cost but also lead us on the most expedited pathway toward authorization in the U.S., where an estimated 80% of the seven million stroke patients experience impaired walking,” stated Helius’ President and Chief Executive Officer, Dane Andreeff. “We are now targeting regulatory submission by early 2025 with the goal of receiving marketing authorization later in the same year.”
If authorized to treat stroke in the U.S., PoNS would be eligible for coverage under the proposed Transitional Coverage of Emerging Technologies (TCET) pathway, which would expedite Medicare coverage of certain breakthrough devices by allowing manufacturers the opportunity for increased premarket engagement with the Centers for Medicare & Medicaid Services (CMS). Under the new guidelines, qualifying breakthrough designations would have temporary coverage within six months after FDA market authorization. PoNS received breakthrough designations in both multiple sclerosis and stroke in the United States, potentially benefiting, with a new indication, an estimated 90% of stroke patients who are covered by Medicare.
About MUSC
Founded in 1824 in Charleston, South Carolina, MUSC is the state’s only comprehensive academic health system, with a unique mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates more than 3,200 students in six colleges – Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy – and trains more than 900 residents and fellows in its health system. MUSC brought in more than $298 million in research funds in fiscal year 2022, leading the state overall in research funding. MUSC also leads the state in federal and National Institutes of Health funding with more than $220 million. For information on academic programs, visit musc.edu.
As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest-quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. Patient care is provided at 16 hospitals (includes owned and affiliated), with approximately 2,700 beds and four additional hospital locations in development; more than 350 telehealth sites and connectivity to patients’ homes; and nearly 750 care locations situated in all regions of South Carolina. In 2022, for the eighth consecutive year, U.S. News & World Report named MUSC Health University Medical Center in Charleston the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.
MUSC has a total enterprise annual operating budget of $5.1 billion. The nearly 26,000 MUSC family members include world-class faculty, physicians, specialty providers, scientists, students, affiliates and care team members who deliver groundbreaking education, research, and patient care.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information visit www.heliusmedical.com.
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com.
Cautionary Disclaimer Statement
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s ability to receive authorization for stroke in the U.S., the success of the Company’s developmental, regulatory and commercialization efforts, the Company’s ability to be eligible for coverage under the proposed Transitional Coverage of Emerging Technologies (TCET) pathway, and the uses and effectiveness of PoNS and PoNS Therapy.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, disruptions in the banking system and financial markets, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, labor shortage and supply chain risks, our ability to maintain and enforce our intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, our operating costs and use of cash, and our ability to achieve significant revenues, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
Investor Relations Contact
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
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Source: Helius Medical Technologies, Inc.
© 2024 GlobeNewswire, Inc.
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Palantir Stock Jumps As 2024 Guidance Tops Estimates On Commercial Growth
https://www.investors.com/news/technology/pltr-stock-palantir-earnings-ai-news-q42023/
Exicure, Inc. and Bluejay Therapeutics Inc. Enter into a Patent License Agreement to Develop Cavrotolimod for the Treatment of Hepatitis
CHICAGO--(BUSINESS WIRE)-- Exicure, Inc., (NASDAQ:XCUR) a company that historically developed nucleic acid therapies, and Bluejay Therapeutics, Inc., a private clinical stage biopharmaceutical company focused on viral and liver diseases, announced today that Bluejay Therapeutics, Inc. ("Bluejay") and Exicure, Inc. ("Exicure") entered into a patent license agreement to develop cavrotolimod for potential treatment for hepatitis.
Under the terms of the agreement, Bluejay will receive an exclusive license in the field of hepatitis to all of Exicure’s relevant patents. Bluejay paid Exicure an initial small, one-time payment after the execution of this Agreement. Exicure will also be entitled to modest royalties on future net sales on all licensed technology by Bluejay during the term of the licensed patents. Exicure will be responsible for, and make all decisions concerning, the preparation, filing, prosecution, and maintenance for each patent and patent application included within the licensed patents.
"Our partnership with Bluejay continues the development of cavrotolimod," said Paul Kang, Chief Executive Officer of Exicure. "Exicure has spent considerable resources to discover and develop cavrotolimod. While historically, we focused on oncology, Bluejay’s commitment and expertise in developing cavrotolimod for potential treatment of hepatitis makes them an ideal partner to expand the use case of cavrotolimod," added Mr. Kang.
About Exicure
Exicure, Inc. has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. Following its recent restructuring and suspension of clinical and development activities, the Company is exploring strategic alternatives to maximize stockholder value, both with respect to its historical biotechnology assets and more broadly. For further information, see www.exicuretx.com.
Forward-Looking Statements
Nice find!
SunHydrogen and COTEC of South Korea Advance to Next Phase of Production for 1m² Green Hydrogen Panels
Press Release | 02/05/2024
CORALVILLE, IA, Feb. 05, 2024 (GLOBE NEWSWIRE) -- SunHydrogen, Inc. (OTCQB: HYSR), the developer of a breakthrough technology to produce renewable green hydrogen using sunlight and water, today announced that the Company has initiated the scale-up phase for production of 1m² green hydrogen panels with its industrial partner, COTEC.
SunHydrogen’s technology is currently the only self-contained nanoparticle-based hydrogen generation device capable of splitting water molecules into high-purity green hydrogen and oxygen using solely the sun’s energy. Just like a solar panel is comprised of multiple cells that generate electricity, the Company’s hydrogen panel encases multiple hydrogen generators immersed in water. Each hydrogen generator contains billions of electroplated nanoparticles, autonomously splitting water into hydrogen and oxygen.
Located in Changwon, South Korea, COTEC is a leader in industrial electroplating and electrochemical processes and holds expertise across the aerospace, automotive, defense, and nuclear industries.
In November, SunHydrogen’s CEO Tim Young visited COTEC’s facility to view firsthand the progress at their newly established laboratory dedicated to SunHydrogen’s technology. Since then, COTEC’s team has successfully replicated SunHydrogen’s proprietary process on a laboratory scale, employing advanced industrial electroplating techniques.
“With the successful completion of COTEC’s initial exploration phase, we're excited to announce the next phase of scaling SunHydrogen’s generators for 1m² green hydrogen panels,” said SunHydrogen’s Chief Scientific Officer Dr. Syed Mubeen.
“Given the breakthrough nature of our technology, our team is mindful of the fact that scaling to 1m² presents inherent challenges, and we believe COTEC is the ideal partner to help us address those challenges,” said SunHydrogen’s CEO Tim Young. “I would like to thank COTEC for their dedication to our shared goals and our shareholders and supporters for their patience as we work to bring world-changing technology closer to commercialization. Our team is delighted to begin 2024 with this work underway, and we look forward to sharing our ongoing progress with you.”
SunHydrogen has engaged a renowned group of industrial partners and collaborators around the world to accelerate the Company’s progress toward commercialization, including: University of Iowa; University of Michigan; Project NanoPEC; Geomatec; InRedox; MSC; COTEC; and consultants Prof. Kazunari Domen, Dr. Hiroshi Nishiyama, and Dr. Taro Yamada of the University of Tokyo.
Tritium Customers Win Largest Share of Round 1 Tennessee NEVI Program
Nearly 50% of the state’s first round of NEVI funding was awarded to Tritium customers for installation of Tritium fast charging stations
LEBANON, Tenn., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Tritium DCFC Limited (Tritium) (Nasdaq: DCFC), a global leader in direct current (DC) fast chargers for electric vehicles (EVs), today announced that the company was the top-awarded fast charger manufacturer for the first round of the State of Tennessee’s National Electric Vehicle Infrastructure (NEVI) Formula Program.
The Tennessee Department of Transportation (TDOT) and the Tennessee Department of Environment and Conservation (TDEC) awarded a total of over $21 million of federal funding. Over $10.5 million of the total federal award, accounting for nearly 50% of the state's initial NEVI funding round, was awarded to deploy 48 Tritium fast chargers across 12 new charging locations in the state. Tritium partners Universal EV LLC and PowerUp America were awarded funding for eight and four charging sites, respectively, with Lynkwell to provide the charging software for PowerUp America’s chargers.
“We are very proud to play a key role in the electrification of Tennessee's passenger and commercial vehicles and to contribute to the health and well-being of Tennesseans,” said Tritium CEO Jane Hunter. “This recognition underscores the deep roots Tritium is putting down in Tennessee with our plant in Lebanon, and NEVI wins like this will support local jobs and industry.”
Tritium's fast chargers will be manufactured at its state-of-the-art factory in Lebanon, Tennessee, which also exports chargers to Europe and the Asia Pacific region. With an expansion capacity to produce up to 30,000 units per year, Tritium’s fast charger factory is one of the largest in the world. The company believes that it is well-positioned to meet the Build America Buy America requirement that, by July of this year, at least 55% percent of the cost of all charger components be attributable to components manufactured in the United States.
About Tritium
Founded in 2001, Tritium (NASDAQ: DCFC) designs and manufactures proprietary hardware and software to create advanced and reliable DC fast chargers for electric vehicles. Tritium’s compact and robust chargers are designed to look great on Main Street and thrive in harsh conditions, through technology engineered to be easy to install, own, and use. Tritium is focused on continuous innovation in support of our customers around the world.
For more information, visit tritiumcharging.com.
My thinking is that volume came from a specific source.
I see that most of the volume happened during the 1st hour of trading.
2024 showing beautiful legs!
Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review
Newsfile Corp.
Newsfile Corp
If approved, afami-cel will be the first engineered T-cell therapy for solid tumors and the first effective treatment option for synovial sarcoma in more than a decade
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January 31, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: “The FDA’s acceptance of the BLA submission brings us one step closer to redefining treatment for people with synovial sarcoma. Our franchise has great potential and, if approved, we have the capabilities and the capital to launch afami-cel - the first engineered T-cell therapy on the market for a solid tumor cancer.”
Dennis Williams, PharmD, Senior VP of Late-Stage Development: "Historic outcomes are poor for advanced synovial sarcoma, with low objective response rates for second-line therapies and overall survival of less than 12 months for people who have received two or more prior lines of therapy. In clinical trials, afami-cel has demonstrated an impressive response rate of ~39% among heavily pre-treated patients with advanced synovial sarcoma and about a 17-month median survival. This regulatory milestone is a testament to our teams' relentless work to deliver a novel treatment option to more people diagnosed with synovial sarcoma."
This acceptance is supported by positive data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy. Data from the trial were presented at the Connective Tissue Oncology Society (CTOS) 2023 Annual Meeting.
She was beautiful. :) Dogs and Cats are unconditional love!
Kiora Pharmaceuticals Announces Private Placement of up to Approximately $45 Million
Newsfile Corp.
Newsfile Corp
$15 million in upfront financing with the potential to receive up to an additional approximately $30 million in potential warrant exercise proceeds for an aggregate of up to approximately $45 million in total gross proceeds
Encinitas, California--(Newsfile Corp. - January 31, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics to improve sight in patients with severe vision loss due to inherited or age-related orphan retinal diseases, today announced that it has entered into a securities purchase agreement with healthcare focused institutional investor(s) to raise up to approximately $45 million in gross proceeds, including initial upfront funding of $15 million and up to an additional approximately $30 million upon exercise of accompanying warrants at the election of the investors.
The financing includes participation from new healthcare-dedicated investors, including ADAR1 Capital Management, Nantahala Capital Management, Rosalind Advisors, Stonepine Capital Management, and Velan Capital, among others.
"This financing, combined with our agreement with Théa Open Innovation, demonstrates the confidence in our team and development pipeline from healthcare-focused institutional investors and corporate partners," said Brian M. Strem, Ph.D., President and Chief Executive Officer. "The significantly strengthened balance provides us with flexibility to fully-fund KIO-104 for the treatment of non-infectious uveitis and potentially other rare inflammatory indications in the back of the eye."
Maxim Group LLC is acting the sole placement agent for the private placement.
Pursuant to terms of the securities purchase agreement, Kiora will issue an aggregate of 27,154,237 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase up to an aggregate of 49,374,590 shares of its common stock at a combined purchase price of $0.5524 per share and accompanying warrants, in accordance with the "Minimum Price" requirement as defined in the Nasdaq rules. The exercise of the accompanying warrants (excluding the pre-funded warrants) are subject to shareholder approval and will consist of two tranches:
Tranche A warrants to purchase up to 24,687,295 shares of common stock at an exercise price of $0.6076 per share for an aggregate of up to approximately $15 million and will expire at the earlier of (i) 30 days following the announcement of full data (expected in Q2 2025) from the Company's Phase 2 clinical trial (ABACUS-2) of KIO-301 in patients with retinitis pigmentosa and the daily VWAP of the Company's common stock equaling or exceeding $1.1048 per share for 30 consecutive trading days following the announcement and (ii) five years from the date of shareholder approval of the warrants.
Tranche B warrants to purchase up to 24,687,295 shares of common stock at an exercise price of $0.6076 per share for an aggregate of up to approximately $15 million and will expire at the earlier of (i) 30 days following the announcement of topline data (expected in 2026) from the planned Phase 2 trial of KIO-104 in posterior non-infectious uveitis and the daily VWAP of the Company's common stock equaling or exceeding $1.3810 per share for 30 consecutive trading days following the announcement and (ii) five years from the date of shareholder approval of the warrants.
(ii) five years from the date of shareholder approval of the warrants.
In lieu of shares of common stock, certain investors are purchasing pre-funded warrants at a combined purchase price of $0.5523 per pre-funded warrant and accompanying warrants, which equals the purchase price per share of common stock and accompanying warrant, less the $0.0001 per share exercise price of each pre-funded warrant. The private placement is expected to close on or about February 5, 2024 subject to satisfaction of customary closing conditions.
Kiora intends to use the upfront net proceeds from the private placement to fund the Company's general business operations and ongoing activities related to expediting the development of KIO-104 for posterior non-infectious uveitis and other potential orphan inflammatory diseases. The aggregate net proceeds (assuming exercise of all accompanying warrants) are expected to be sufficient to fund subsequent, potentially pivotal, clinical trials and other work in the Company's ophthalmic programs.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock purchased in the private placement and shares of common stock underlying the warrants.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
About Kiora Pharmaceuticals
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of posterior non-infectious uveitis. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase. In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts.
Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to close the private placement and the timing thereof, any proceeds that may be received upon warrant exercises, the anticipated use of the net proceeds of the offering, the expected use of proceeds and the sufficiency of the proceeds from the private placement to fund specific programs, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104, KIO-201 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability
OMG! What a gorgeous kitty! Is that your cat buddy?
OMG! What a gorgeous kitty! Is that your cat buddy?
Surging! Any update on your end? TIA
How did you know that I'm a cat person? :)
Any time! You have gotta be happy with the nice gains today!
P&D POS!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
B RY you and I are like 2 peas in a pod! I love your post