Month: March 2024

Release – Nominations Open for 2024 ISG Women in Digital Awards

Posted on by aweinsoff@channelchek.com

Research News and Market Data on III

3/19/2024

Annual program recognizes women’s achievements in the digital world for the Americas, EMEA and Asia Pacific and India regions

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced that nominations are open for the third annual ISG Women in Digital Awards program, recognizing exceptional leadership among women in digital roles.

“ISG is delighted to open nominations for the 2024 ISG Women in Digital Awards program,” said Michael P. Connors, chairman and CEO, ISG. “We have been inspired by the women nominated for our 2022 and 2023 awards and excited by the levels of participation in every region. We look forward to recognizing another class of exceptional women in 2024.”

The awards program was launched in 2022 in the Americas, and expanded in 2023 to the Europe, Middle East and Africa (EMEA) and Asia Pacific and India regions. Last year, more than 330 exceptional women were nominated in all three regions and detailed in an ISG Women in Digital eBook.

An independent panel of judges for each region, drawn from the enterprise, provider and advisory communities, will evaluate nominations and select the 2024 winners in each region. Winners will be named in five categories:

  • Digital Innovator: for making a significant impact on an organization, business or client through creative use of digital solutions;
  • Rock Star Leader: for leading a major transformation with significant business impact and demonstrating exceptional leadership skills;
  • Women’s Advocate: for playing an active role guiding women to succeed in the digital world;
  • Rising Star: for demonstrating exceptional and continuous growth, with increasing levels of leadership, responsibility and sphere of impact, and
  • Digital Titan of the Year: recognizing the most outstanding “Woman in Digital” for 2024 in each region, chosen from all nominees.

In 2023, leaders with Johnson Controls, Kaiser Permanente, LTIMindtree, McKesson, the National Renewable Energy Laboratory, Amazon, Atos, Foundever, Kinseed, Unisys, ANZ Group Holdings, Australia Post, Silverlake Axis, Tech Mahindra and VicRoads were named ISG Women in Digital Award winners across the regions.

For 2024, the judging panel for the Americas will include Chris Putur, executive vice president, Technology and Operations, REI Co-Op (retired), and a member of the ISG Board of Directors; Kim Ewald Hurry, advisor relations leader, Kyndryl; Diane Schwarz, vice president and CIO, Johnson Controls, and Beth Thomas, partner, ISG Enterprise Change.

Pooja Arora, client partner, Tech Mahindra; Isabelle Roux-Chenu, corporate vice president, Capgemini (retired), and Lois Coatney, partner and president, ISG EMEA Sales and Consulting, will judge the EMEA awards.

Richa Vijayraj, PhD, director of ESG and Sustainability Transformation, Ramco Systems, and director, Impact HQ Australia, and Namratha Dharshan, chief business leader, ISG Provider Lens™, will be among the judges for the Asia Pacific and India awards.

Nominations may be submitted through the ISG Women in Digital Awards website through May 13. Winners will be announced during live virtual awards ceremonies on September 5 for the Americas; September 12 for EMEA, and September 19 for Asia Pacific and India.

“Women are making significant contributions in digital and technology roles,” said Kimberly Tobias, ISG director and program leader, ISG Women in Digital. “The ISG Women in Digital Awards celebrate their successes and the impact of their work, while aiming to encourage future generations to pursue careers in the digital world.”

The ISG Women in Digital Awards are part of the ISG Women in Digital community, established in 2018 to provide a platform to exchange practical advice and innovative ideas on diversity and advancement in the workplace. The community hosts a LinkedIn page, an ongoing ISG Digital Dish podcast series, and regular events for ISG employees and the greater IT and business services industry.

For more information about the ISG Women in Digital Awards, visit the program website or contact ISG.

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 AI and 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 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.

Release – Defense Metals Appoints HCF International Advisers for Strategic Funding Review of Wicheeda REE Project

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DFMTF

19 Mar, 2024, 03:01 ET

VANCOUVER, BC, March 19, 2024 /PRNewswire/ – Defense Metals Corp. (“Defense Metals” or the “Company“; (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce the appointment of HCF International Advisers Limited (“HCF“), a leading global independent corporate finance advisory boutique based in London, UK, to conduct a strategic funding review for the Company’s wholly-owned Wicheeda Rare Earth Element (REE) Project located in British Columbia, Canada.

HCF specializes in providing comprehensive financial advisory services with a primary focus on the metals and mining sector. The strategic funding review will, among other things, assist Defense Metals in thoroughly analyzing potential funding options and strategic partnerships for the development and advancement of the Wicheeda REE Project beyond the completion of its Preliminary Feasibility Study (PFS) expected in Q2 2024.

Craig Taylor, CEO of Defense Metals, commented:

“We are thrilled to collaborate with HCF International Advisers for a strategic funding review of our Wicheeda REE Project. Following our PFS, as we navigate the dynamic landscape of the metals and mining sector, having HCF’s expertise on board will be instrumental in evaluating and pursuing optimal funding and strategic partnership opportunities, especially in Europe.” 

About HCF International Advisers

HCF International Advisers is a leading independent corporate finance advisory boutique based in London, UK, specializing in providing strategic financial advice to companies in the metals and mining sector. With a commitment to excellence, HCF has a proven track record of assisting clients in navigating complex financial landscapes.

HCF is led by Guy de Sellier de Moranville, President and Co-founder, and Sean Gorman, CEO and Managing Director. HCF’s expertise in the financing of internationally recognized mining projects and, in particular, critical minerals, is evidenced by its involvement as financial adviser to projects in Canada, Africa and in particular to Arafura Rare Earths Limited on the financing of the Nolans NdPr Project (Northern Territory, Australia).

Guy de Selliers de Moranville – President and Co-founder of HCF

Guy is a seasoned finance professional with a distinguished career. He served as a Senior Advisor to the Atlantic Council’s Future Europe Initiative and played key roles in advising the European Commission and co-chairing a joint European/Russian task force for strategic energy projects. Mr de Selliers has held executive positions at Robert Fleming and Co Ltd, was a member of the senior executive team which created the European Bank for Reconstruction and Development (EBRD), and served as Senior Vice President at Lehman Brothers.

He has been a member of the board of directors of many influential organizations such as Solvay Group, Ageas Group, AG Insurance Belgium, Ivanhoe Mining, Pamplona, I Pulse, The Cranemere Group Ltd, Renewable Energy Foundation, and Drive Forward. Mr de Selliers, with a Master’s degree in engineering and a Master’s degree in economics from Louvain University in Belgium, is widely respected for his diverse expertise across various sectors, making him a valuable asset in the international business community. 

Sean Gorman – CEO & Managing Director of HCF

Sean has over 30 years of experience in the natural resources sector. As a Chartered Engineer, he led the design and construction of oil refineries and onshore gas plants around the world prior to moving into banking, where he worked in project finance and debt restructuring for the power sector. Subsequent to that he was Head of Business Development for a renewable energy company involved in equity investment prior to a successful sale of the company. As CEO of HCF Sean has worked on the financing for a wide range of projects across multiple jurisdictions and commodities though in recent years has had a strong focus on critical minerals and is leading the financing of the Arafura NdPr Project in Australia.

About Defense Metals Corp. and its Wicheeda Rare Earth Element Project

Defense Metals Corp. is focused on the development of its 100% owned, 8,301-hectare (~20,534-acre) Wicheeda REE Project that is located on the traditional territory of the McLeod Lake Indian Band in British Columbia, Canada.

The Wicheeda REE Project, approximately 80 kilometres (~50 miles) northeast of the city of Prince George, is readily accessible by a paved highway and all-weather gravel roads and is close to infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.

Defense Metals is a proud member of Discovery Group. For more information please visit:
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 the engagement of HCF, potential funding options and strategic partnerships, completion of a preliminary feasibility study on the Wicheeda REE Project, advancing the Wicheeda REE Project, the expectations and plans for 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+ (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 or obtain 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, engineering and pricing assumptions, decrease in the price of rare earth elements, the impact of viruses and diseases on the Company’s ability to operate, restriction on labour and international travel and supply chains, loss of key employees, consultants, officers 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.

Release – Tonix Pharmaceuticals Announces Transition to Fully Integrated Biopharmaceutical Company Expected on April 1, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 19, 2024 8:00am EDTDownload as PDF

Zembrace® SymTouch® and Tosymra® will be marketed by Tonix Medicines, Tonix’s wholly-owned commercial subsidiary

Commercial capabilities prepare Tonix for the potential launch in 2025 of Tonmya™ for the management of fibromyalgia, assuming FDA approval

CHATHAM, N.J., March 19, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will achieve its goal of transitioning to a fully integrated pharmaceutical company on April 1, 2024. Since the acquisition of Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg on June 30, 2023, Tonix Pharmaceuticals has been putting in place the personnel, systems and contracts required to support a commercial organization. Both products are indicated for the treatment of acute migraine with or without aura in adults.

“Tonix will become a fully integrated biopharmaceutical company with a mission of developing and marketing innovative, high-value therapeutics,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Tonix will assume responsibility for the distribution, selling and marketing of Zembrace SymTouch and Tosymra, as well as supply chain, regulatory and quality control of the two products.”

Dr. Lederman added, “The assumption of commercial activities by Tonix represents an important milestone in the evolution of Tonix as we continue to build and strengthen our commercial organization for the potential launch of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in 2025, assuming approval by the U.S. Food and Drug Administration (FDA).”   

About Zembrace® SymTouch® and Tosymra®

Zembrace SymTouch is the only actively promoted brand of sumatriptan autoinjector in the United States (other sumatriptan autoinjector products on the market are Imitrex® and generics to Imitrex®). It has a unique low dose and has demonstrated onset of migraine pain relief in as few as 10 minutes (17% of patients vs. 5% for placebo).1 Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230).1 Zembrace SymTouch currently has patent protection to 2036. Tosymra employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.2 Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).2 Tosymra currently has patent protection to 2031.

About Migraine

Nearly 40 million people in the United States suffer from migraine3 and it has been recognized as the second leading cause of disability in the world.4 Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).3

References:

  1. Zembrace SymTouch [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: February 2021.
  2. Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: Feb 2021.
  3. Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.
  4. GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976.

About Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 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

Zembrace® SymTouch® (sumatriptan Injection):   IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any ingredient in Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age. 

Source: Tonix Pharmaceuticals Holding Corp.

Released March 19, 2024

Release – Cocrystal Pharma Receives Pre-IND Responses from the FDA on Oral CC-42344 for Treating Influenza A

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

MARCH 19, 2024

Feedback provides greater clarity on regulatory requirements for planned Phase 2b trial

BOTHELL, Wash., March 19, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA) regarding CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. A Pre-IND review provides the opportunity to obtain FDA guidance and clarification on critical steps such as the proposed clinical trial design, as well as clinical drug manufacturing and nonclinical studies deemed necessary before filing the trial design. The feedback was provided in a written response to a Pre-IND package and questions submitted by the Company in January 2024.

“We value the FDA guidance as we prepare to file the IND for our Phase 2b trial and open enrollment of patients in the U.S.,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “This is an important milestone that provides greater clarity on the regulatory requirements and our planned oral CC-42344 clinical program.”

A Phase 2a challenge study of oral CC-42344 is underway in the United Kingdom to evaluate safety, and viral and clinical measures in healthy volunteers who are infected with the influenza A virus. The Company expects to report topline results from this study in the second half of this year.

In addition, preparations are underway to begin a Phase 1 study in Australia with the Company’s inhaled formulation of CC-42344 as a potential influenza A treatment and prophylaxis for those exposed to the virus. Recent preclinical data showed that inhaled CC-42344 exhibited highly effective delivery into the lung, superior lung exposure, efficacy in influenza-infected human lung epithelia, and a favorable safety profile.

CC-42344 Influenza A PB2 Inhibitor
CC-42344 is a novel, broad-spectrum, investigational antiviral candidate for the treatment of pandemic and seasonal influenza A. CC-42344 inhibits the first step in the viral replication process of influenza A by binding to a highly conserved PB2 site of the polymerase complex that is essential to replication. In vitro testing with CC-42344 showed excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety profiles. In addition, oral CC-42344 demonstrated favorable safety and tolerability results in a Phase 1 study in Australia. This antiviral candidate was discovered using the Company’s proprietary structure-based drug discovery platform technology.

About Seasonal Influenza
Each year there are approximately 1 billion cases of seasonal influenza worldwide, with 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected results of the Phase 2a trial for CC-42344 for the oral treatment of influenza A in the second half of 2024, efforts in preparation for an anticipated Phase 2b trial for oral treatment of influenza A following the Phase 2a trial, efforts to begin a Phase 1 study in Australia for an inhaled formulation of CC-42344 as a potential influenza A treatment and prophylaxis, and the potential efficacy and clinical benefits of, and market for, such product candidates. The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the studies including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies and our ability to obtain FDA approval to initiate the Phase 2b study. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. 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.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

# # #

Source: Cocrystal Pharma, Inc.

Released March 19, 2024

Comtech Telecommunications (CMTL) – Mixed Quarterly Results, Many Questions Remain

Posted on by cpereira@noblefcm.com


Tuesday, March 19, 2024

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.

Refi Overhang. The uncertainty created by the refinancing is impacting business results. For the first time in six quarters, sequential revenue declined with quarterly revenue barely exceeding year ago levels. Lower Space and Satellite segment revenue reflects order delays and supply chain constraints largely stemming from the refi overhang. Lower R&D expenses and One Comtech savings, along with a one-time gain, resulted in positive operating income for the third consecutive quarter.

2Q24 Results. Revenue was $134.2 million, flat y-o-y and below guidance of up 1% – 3% sequentially. We were at $154 million. Adjusted EBITDA totaled $15.1 million, versus $11.3 million in 2Q23. We were at $18.9 million. Comtech reported a net loss of $30.5 million, or a loss of $1.07/s, compared to a net loss of $6.5 million, or $0.23/s last year. Adjusted loss was $0.15/sh versus EPS of $0.09. We had forecast a net loss of $950,000, or a loss of $0.03 per share, and adjusted EPS of $0.28.


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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. 

Bit Digital (BTBT) – First Look at Fourth Quarter Results

Posted on by cpereira@noblefcm.com


Tuesday, March 19, 2024

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.

4Q Results. Fourth quarter revenue was $16.1 million, above last year’s revenue of $7.8 million and above our estimate of $13 million. The Company realized a gain of $8.6 million on its digital assets during the quarter. Net loss for the quarter was $2.0 million, or about $0.02 per share, versus last year’s net loss of $68.7 million, or $0.87 per share. The large improvement was due to a $50 million asset impairment the Company incurred last year that did not repeat. Adjusted EBITDA for the quarter was $11.9 million compared to a negative $8.0 million in the prior year.

Fiscal Year Results. Revenue for 2023 was $44.9 million, an increase of 39% from the previous year’s $32.3 million. Net loss for the year was $13.9 million, or $0.16 per share, an improvement of $91.4 million from the prior year’s loss of $105.3 million, or $1.34 per share. Adjusted EBITDA for the year was $12.4 million compared to a negative $26.9 million last year.


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. 

AstraZeneca Makes $2.4 Billion Bet on Next-Gen Cancer Radioconjugates

Posted on by slightbourne@noblecapitalmarkets.com

In a bold move to fortify its oncology pipeline, pharmaceutical giant AstraZeneca (NASDAQ: AZN) has agreed to acquire clinical-stage biotech Fusion Pharmaceuticals (NASDAQ: FUSN) for up to $2.4 billion. The deal gives AstraZeneca full access to Fusion’s pioneering radioconjugate (RC) therapies and expertise as it aims to transform cancer treatment and unseat traditional chemotherapy and radiation regimens.

Fusion specializes in developing a promising new class of precision oncology drugs called RCs, which dispense powerful, targeted radiation directly to cancer cells via targeting molecules like antibodies. By delivering potent radioisotope payloads to tumors in this manner, RCs may improve upon external beam radiation’s limitations and indiscriminately toxic effects.

Under the agreed terms, AstraZeneca will pay $21 per share in cash upfront to acquire all outstanding Fusion shares, valuing the biotech at approximately $2 billion. This headline price represents a staggering 97% premium over Fusion’s closing price prior to deal announcement. AstraZeneca has also committed up to $3 per share in additional contingent value rights tied to a future regulatory milestone, which could push the total deal value to $2.4 billion if achieved.

For AstraZeneca, the acquisition paves the way for a major expansion into promising RC therapeutics, which could revolutionize how cancers are treated in the future. The crown jewel of the deal is FPI-2265, Fusion’s lead RC candidate that uses the alpha particle-emitting isotope actinium-225 to target PSMA proteins in metastatic castration-resistant prostate cancer. FPI-2265 is already in Phase 2 clinical trials with early data expected in 2024.

Beyond this advanced asset, AstraZeneca gains control of Fusion’s broader pipeline of RC programs and candidates across multiple solid tumor types. Just as importantly, the transaction provides AstraZeneca with Fusion’s specialized R&D capabilities, manufacturing infrastructure, and actinium-225 supply chain specifically tailored for developing these next-wave radiotherapeutics.

This strategic acquisition doubles down on AstraZeneca’s burgeoning radio-isotope therapy initiatives. The pharma giant already has a collaboration with Fusion exploring lung cancer applications using one of its RC molecules. By bringing Fusion’s RC therapy capabilities fully in-house, AstraZeneca can now swiftly integrate and scale up this cutting-edge treatment modality across its industry-leading oncology portfolio.

For Fusion investors, the buyout represents a lucrative exit at a substantial premium, especially compared to the company’s $300 million market cap prior to deal reports. While always bittersweet to see a promising biotech get absorbed, Fusion’s technology and team are now set to be fueled by abundant AstraZeneca resources in pursuing RC breakthroughs.

The transaction, expected to close in Q2 2024 pending customary approvals, foreshadows a future where RCs could potentially supplant chemotherapy and radiotherapy as more precise, less toxic foundational cancer regimens. While still an emerging field, AstraZeneca’s bold multi-billion dollar investment signals its confidence in harnessing RCs’ unique advantages over traditional oncology treatments.

As AstraZeneca executes an ambitious pivot toward next-generation RC therapies, biotech and pharma investors would be wise to monitor this rapidly evolving space. The acquisition of Fusion continues to position the pharma titan at the vanguard of replacing archaic cancer protocols with targeted radioconjugate precision medicines.

WaveDancer’s Acquisition of AI Neuroscience Firm Firefly Poised to Shake Up Healthcare Tech

Posted on by slightbourne@noblecapitalmarkets.com

The financial markets are abuzz over WaveDancer, Inc.’s approved merger deal to acquire Firefly Neuroscience, an artificial intelligence company pioneering brain health diagnostics and analytics software. With stockholders from both companies green-lighting the transaction, the stage is set for a new player to emerge in the rapidly evolving neurological healthcare technology space.

WaveDancer (NASDAQ: WAVD), currently an IT services provider to government and commercial clients, is essentially acquiring the capabilities and pipeline of private AI neuroscience firm Firefly through a merger of one of its subsidiaries into the latter. Once the deal closes in Q2 2024, the combined entity will rebrand as Firefly Neuroscience, Inc. and trade under the new ticker AIFF on the Nasdaq Capital Market.

The new Firefly Neuroscience will be laser-focused on commercializing and advancing the development of Firefly’s innovative Brain Network Analytics (BNA) software platform, cleared by the U.S. Food and Drug Administration. Leveraging AI, machine learning, and a massive database of over 17,000 EEG brain scans, the BNA Platform aims to revolutionize the diagnosis and treatment of mental health conditions like depression and anxiety, as well as neurological disorders such as dementia, concussions, and ADHD.

“The WaveDancer favorable shareholder vote is an important step in consummating the merger and reinventing WaveDancer as an AI-enabled neurological health platform,” stated Jamie Benoit, Chairman and CEO of WaveDancer. The company plans to divest its legacy IT services operations to fully concentrate on scaling up Firefly’s neuroscience technology business post-merger.

Firefly’s unique AI platform has already garnered significant attention and investment from the medical community, with the company raising approximately $60 million to date to build out its EEG database, develop the software, secure patents, and attain FDA clearance. Now poised to transition into a publicly-traded commercial entity, Firefly Neuroscience could rapidly accelerate adoption of its solutions among pharmaceutical companies, clinical trials, and medical practitioners globally.

The combined firm will hit the ground running, with Firefly management slated to present at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on April 17-18, 2024. This high-profile investor forum will provide an ideal platform to lay out Firefly Neuroscience’s growth strategy and market opportunity to Wall Street.

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style…Read More

While the technology is highly specialized, analysts forecast significant potential upside for Firefly’s brain mapping and analytics capabilities across a range of healthcare markets struggling with neurological and mental health challenges. The company’s AI edge in these areas could position it to drive improved patient outcomes, lower costs through earlier interventions, and open new avenues for drug development and therapies.

For WaveDancer shareholders, the transaction marks a bold pivot into a cutting-edge industry riding powerful tailwinds of AI adoption in healthcare settings. Assuming a seamless merger and transition, the company could quickly morph into a promising pure-play on validated, scalable neurotechnology solutions backed by substantial technical assets and IP.

As the deal approaches the finish line, all eyes will be on Firefly Neuroscience’s market debut and ability to execute on the immense growth prospects its AI brain analytics platform presents. Healthcare investors would be wise to keep a close watch as this under-the-radar neuroscience firm prepares to seize a starring role on Wall Street.

Release – Bit Digital, Inc. Announces Fiscal Year 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTBT

NEW YORK, March 18, 2024 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (the “Company”), a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City, announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2023 with the U.S. Securities and Exchange Commission (“SEC”) on March 18, 2024.

Financial Highlights for Fiscal Year 2023

  • Total revenue for fiscal year 2023 was $44.9 million, a 39% increase compared to the prior year. The majority of revenue was earned from our bitcoin mining business.
  • The Company had cash, cash equivalents and restricted cash of $18.2 million, and total liquidity (defined as cash equivalents and restricted cash, USDC, and the fair market value of digital assets) of approximately $81.2 million1, as of December 31, 2023.
  • Total assets were $189.3 million and Shareholders’ Equity amounted to $152.7 million as of December 31, 2023.
  • Adjusted EBITDA2 was $12.4 million for the fiscal year 2023.
  • Adjusted earnings per share3 was $0.12 for fiscal year 2023.

Operational Highlights for Fiscal Year 2023

  • The Company earned 1,507.3 bitcoins during 2023, a 21% increase from the prior year. Growth was primarily driven by a higher active hash rate and partially offset by an increase in network difficulty.
  • The Company paid approximately $0.05 per kilowatt hour to its hosting partners for electricity consumed during fiscal year 2023.
  • The average fleet efficiency for the active fleet was approximately 28.8 J/TH as of December 31, 2023.
  • The Company earned 287.0 ETH in native staking and 81.9 ETH in liquid staking, respectively, during fiscal year 2023.
  • Treasury holdings of BTC and ETH were 642.6 and 15,108.0, with a fair market value of approximately $27.2 million and $34.5 million on December 31, 2023, respectively.
  • The BTC equivalent4 of our digital asset holdings as of December 31, 2023 (defined as if all ETH, LsETH, and USDC holdings were converted into BTC as of that date) was approximately 1,489.9 BTC, or approximately $63.0 million. This figure excludes approximately 2,701 ETH that transferred to an internally managed fund.
  • As of December 31, 2023, we had 46,548 miners owned or operating (in Iceland) for bitcoin mining with a total maximum hash rate of 3.9 EH/S.
  • The Company’s active hash rate of its bitcoin mining fleet was approximately 2.50 EH/s as of December 31, 2023.
  • The Company purchased approximately 10,900 bitcoin mining units during 2023.
  • For the year ended December 31, 2023, the Company wrote off 5,328 bitcoin miners and 730 ETH miners.
  • Approximately 93% of our fleet’s run-rate electricity consumption was generated from carbon-free energy sources as of December 31, 2023. These figures are based on data provided by our hosts, publicly available sources, and internal estimates, demonstrating our commitment to sustainable practices in the digital asset mining industry.
  • The Company had approximately 12,752 ETH actively staked in native and liquid staking protocols as of December 31, 2023. Approximately 12,352 were natively staked and 400 ETH were deployed in liquid staking protocols as of that date.
  • In October 2023, Bit Digital finalized an agreement with Soluna Computing, Inc (“Soluna”) for 4.4 megawatts of incremental hosting capacity in Kentucky to power its miners for an initial contract term of twelve months.
  • In October 2023, the Company announced the launch of Bit Digital AI, a new business line that provides specialized infrastructure to support generative artificial intelligence (“AI”) workstreams. The Company subsequently finalized a service agreement with a customer to provide the customer with computational power from 2,048 GPUs over a three-year period. To fulfil the contract, the Company purchased 256 servers manufactured by Super Micro Computer, Inc., an authorized Nvidia OEM, that were equipped with 2,048 Nvidia HGX H100 GPUs along with related equipment. To help finance this operation, the Company subsequently entered into a sale-leaseback agreement with a third party, selling 96 AI servers (equivalent to 768 GPUs) and leasing them back for three years. The GPUs are deployed at a third-party datacenter located in Iceland.
  • In November 2023, Bit Digital finalized an agreement with Dory Creek, a subsidiary of Bitdeer Technologies Group, for 17.5 MW of incremental hosting capacity to power its miners at a location in Texas. Additionally, Bit Digital will have the first right for up to an additional 17.5 MW of capacity that may be brought online by the operator.

Subsequent Events

  • On January 22, 2024, approximately 192 servers (1,536 GPUs) began generating revenue from the Company’s AI customer contact. Subsequently, approximately 64 additional servers (512 GPUs) commenced revenue generation on February 2, 2024.
  • On January 26, 2024, the Company finalized an agreement Coinmint for up to 6 MW of additional mining capacity at Coinmint’s hosting facility in Massena, New York. This new agreement brings the Company’s total contracted hosting capacity with Coinmint to approximately 46 MW. Bit Digital purchased approximately 2,340 S19k Pro mining units that have since been deployed at the facility as of the date of this report.

Strategic Priorities for Fiscal Year 2024

  • Expand the active bitcoin mining fleet to approximately 6.0 EH/s.
  • Diversify and grow Bit Digital AI with the goal of increasing annualized revenue to $100 million by year-end 2024.
  • Maintain a strong and flexible balance sheet
  • Increase our treasury holdings of staked ETH with retained earnings
  • Continued focus on sustainability

Management Commentary

“2023 was a foundational year for Bit Digital. The year began with the price of bitcoin near cyclical lows and ended on a trajectory that would propel the asset to new all-time highs in 2024. Despite the improvement in the price of bitcoin, our core mission remains unchanged; to build a company that can successfully endure all phases of the bitcoin price cycle.

We enacted numerous changes to our bitcoin mining hosting portfolio during 2023, ending the year with six hosting partners and seven operating sites across three countries. Notably, we expanded our operations into Iceland during 2023, providing Bit Digital with geographic diversification outside of North America and into a region with an abundance of clean energy and supportive government policies. We will continue to focus our expansion areas in areas that provide cost-effective, carbon-free energy sources. As we consider our growth targets for 2024, our focus is on improving our overall fleet efficiency and lowering our production cost.

Bit Digital enacted a growth strategy in 2023 which prioritized maintaining a formidable balance sheet ahead of the ‘halving’ which is expected to occur during April 2024. We ended 2023 with a strong liquidity position and zero debt, and our liquidity position has improved materially since year-end in sympathy with rising digital asset prices. We also managed to more than double our active hash rate compared to the end of 2022, leading to a 21% increase in total bitcoin production.

We announced the launch of a new business line, Bit Digital AI, during the fall of 2023. This business aims to provide AI-focused clients with digital infrastructure services, including GPU rental services. It was important to us that we didn’t merely announce an ambition, but a real business, and this business line has already begun to contribute meaningful revenue to Bit Digital (approximately $4 million during February 2024). This enterprise draws on our core competencies as a bitcoin miner, and we believe we are on a credible path to materially expanding the scope of this business line. We look forward to demonstrating the earnings power from this business as the year progresses.”

About Bit Digital

Bit Digital, Inc. is a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City. Our bitcoin mining operations are located in the US, Canada, and Iceland. The Company has also established a business line, Bit Digital AI, that offers infrastructure services for artificial intelligence applications. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com.

Investor Notice

Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 3.D of our Annual Report on Form 20-F for the fiscal year ended December 31, 2023. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors. See “Safe Harbor Statement” below.

Safe Harbor Statement

This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Footnotes:
1 This figure excludes approximately 2,701 ETH that were transferred to an internally managed fund.
2 Adjusted EBITDA refers to earnings before interest expense, income tax expense and depreciation and amortization expense (“EBITDA”) adjusted to eliminate the effects of certain non-cash and / or non-recurring items.
3 Adjusted EPS is a financial measure defined as our EBITDA divided by our diluted weighted-average shares outstanding, adjusted with the EPS impact related to the adjustments made to EBITDA to derive Adjusted EBITDA.
4 “BTC equivalent” is a hypothetical illustration of the value of our digital asset portfolio in bitcoin terms. BTC equivalent is defined as if all non-BTC digital assets, comprised of ETH, LsETH, and USDC, were converted into BTC as of December 31, 2023, and added to our existing BTC balance. Conversion values are found using the closing price on coinmarketcap.com.

Apple’s AI Ambitions Could Involve Major Partnerships

Posted on by slightbourne@noblecapitalmarkets.com

Apple is actively exploring partnerships with tech giants like Google and OpenAI as it accelerates its artificial intelligence efforts, according to a recent report from Bloomberg. The iPhone maker is said to be in “active negotiations” with Google to integrate the search giant’s Gemini generative AI into future Apple products and services.

The potential deal would give Apple access to Google’s advanced AI capabilities, allowing it to rapidly implement features like AI-powered text and image generation into offerings like iOS, Siri, and its productivity apps. Bloomberg reports that Apple has also considered integrating OpenAI’s viral ChatGPT model, highlighting the company’s willingness to leverage external AI expertise.

This openness to AI partnerships represents a strategic shift for the traditionally vertically integrated Apple. CEO Tim Cook confirmed earlier this year that the company is devoting “tremendous time and effort” to generative AI, with plans to release AI-powered features to consumers “later this year” with iOS 18. However, Apple’s in-house AI development efforts are reportedly lagging rivals.

While Apple employees have been testing an internal AI assistant called “Apple GPT,” the company’s generative AI tech is described as less capable than that of Microsoft, Google, and others. A partnership would allow Apple to utilize cutting-edge cloud AI while its own large language model, codenamed “Ajax,” continues development.

For Google, scoring an AI integration deal with its chief mobile rival would be a coup – expanding its AI’s reach to over 2 billion active iPhones globally. It could also strengthen Google’s position amid intensifying regulatory scrutiny over its lucrative deals making Google Search the default on Apple devices.

The two tech titans already have an $18 billion annual agreement in place for Google to be the preloaded search engine on iPhones and iPads. Adding AI services could make this partnership even more lucrative and harder for regulators to disentangle.

However, the deal risks being perceived as an admission from Apple that its AI capabilities lag behind Google’s, at least for now. Apple prides itself on cutting-edge silicon and integrated hardware/software experiences. Relying on Google’s AI could undermine its position as an innovation leader.

Apple may aim to provide on-device AI through its own models, while tapping Google’s cloud AI for more intensive generative tasks like text prompts or image creation. It’s already taken this hybrid approach with other services like Maps and web search.

Another complicating factor is Apple’s historical stance on privacy and protecting user data. Integrating Google’s AI could raise concerns about data sharing and usage policies that differ from Apple’s privacy-centric approach.

While the negotiations underscore Apple’s AI ambitions, many details remain unclear – including potential branding, business terms, technical implementation, or whether a deal will even be reached. Bloomberg reports any announcement is unlikely before Apple’s Worldwide Developers Conference in June.

As the AI Arms race intensifies, Apple is evidently willing to consider previously unorthodox partnerships and concessions to avoid falling behind rivals in this revolutionary technological domain. How it balances AI capabilities with its core principles and ultimately delivers its AI-powered user experiences will be crucial to maintaining its industry-leading device ecosystem.

Release – Kratos Receives $57.6 Million Contract for 70 BQM-177A Aerial Targets

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

March 18, 2024 at 8:00 AM EDT

PDF Version

SAN DIEGO, March 18, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets and industry-leading provider of high-performance, jet-powered unmanned aerial systems, announced today that its Unmanned Systems Division has received a $57,673,542 modification to a previously awarded firm-fixed-price contract. This modification exercises options to procure full rate production Lot Five of the BQM-177A Surface Launched Aerial Targets to provide for the production and delivery of 70 BQM-177A Surface Launched Aerial Targets and 70 Rocket-Assisted Takeoff attachment kits, as well as associated technical and administrative data in support of weapons system test, and evaluation and fleet training for the Navy.

Kratos BQM-177A Shipboard Launch

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d9916314-cd45-49cf-b0e0-d22296646070

Steve Fendley, President of Kratos Unmanned Systems Division, said, “It’s exciting to be a major part of this critically important capability for the U.S. Navy with our BQM-177A Sub-Sonic Aerial Target (SSAT) aircraft system (target). The 177A continues to push the envelope delivering leading edge realistic threat-representative capabilities to support today’s peer-level threat environment. We look forward to the increased production rate and continuing to evolve the system with our customer as the threats evolve.”

Greg Crewse, Program Manager for the Navy’s Aerial Targets program office (PMA-208), said, “In partnership with the Navy Aerial Targets program office, Kratos Defense and the BQM-177A Air Vehicle are true assets to the Navy and, together, we have the opportunity to engage in critical training exercises that will prepare our personnel to face a multitude of scenarios in a challenging, cost-effective test environment prior to engaging real-world threats, should the need arise. As recent real-world events have proven, these target presentations are growing ever more critical to prepare our warfighters to go into harm’s way – and prevail.”

About Kratos Defense & Security Solutions, Inc.
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high, and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. 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 31, 2023, 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 – ZyVersa Therapeutics Announces IRB Approval of Phase 2a Clinical Trial Protocol to Evaluate Cholesterol Efflux Mediator™ VAR 200 in Patients with Diabetic Kidney Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Mar 18, 2024

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  • Phase 2a trial is on track to begin in the first half of 2024.
  • Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.

WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces Institutional Review Board (IRB) approval of the Phase 2a clinical trial protocol to evaluate the efficacy and safety of Cholesterol Efflux Mediator VAR 200 in patients with diabetic kidney disease. The clinical trial is on track to begin in the first half of 2024.

Initiation of this clinical trial is a key milestone for ZyVersa. It is the first in human trial for VAR 200 intended to substantiate that the promising preclinical results demonstrated in three different animal models of kidney disease (diabetic kidney disease, focal segmental glomerulosclerosis, and Alport syndrome) translate to patients with kidney disease. The preclinical data demonstrated across all three kidney disease models that VAR 200:

  • Reduced cholesterol and lipid levels in the kidneys’ filtration system.
  • Protected against kidney injury and fibrosis.
  • Significantly reduced protein in the urine (proteinuria).

For more information about VAR 200, Click Here.

“A large body of evidence reinforces the importance of addressing kidney accumulation of cholesterol and lipids to help attenuate progression of chronic kidney disease, which affects over 35 million adults in the United States,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Currently, over 130,000 patients with kidney disease progress to renal failure each year, and more than 800,000 patients are living with renal failure requiring dialysis or transplant to sustain life. We are excited about the potential of Cholesterol Efflux MediatorTM VAR 200 to protect against kidney injury and reduce kidney disease progression.”

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

Release – Ocugen, Inc. Appoints Huma Qamar, MD, MPH As Chief Medical Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

March 18, 2024

MALVERN, Pa., March 18, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the appointment of Dr. Huma Qamar as Chief Medical Officer (CMO).

“I’m very pleased to name Dr. Qamar as the CMO at Ocugen,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This appointment recognizes her invaluable contributions to building a strong clinical team, overseeing a well-conducted Phase 1/2 gene therapy trial, and establishing relationships with leading medical and academic institutions and key opinion leaders.”

Dr. Qamar is a distinguished healthcare professional with a rich background in clinical research, having contributed her expertise to esteemed Ivy League institutions including Yale University, Harvard University, and University of Pennsylvania. Her expertise encompasses the development of Phase I-IV clinical protocols and execution of clinical studies, FDA inspections, and effective leadership of medical affairs teams.

“Having been a part of Ocugen’s mission and vision for more than three years now, it’s a pleasure to lead Ocugen’s clinical development at this pivotal time,” said Dr. Qamar. “I am committed to addressing patients’ unmet medical needs and bringing novel modifier gene therapy products to the market globally.”

Dr. Qamar has expertise in multiple therapeutic areas, including gene and cell therapy, vaccines, oncology (Heme-Onc, CAR-T, rare tumors, sarcoma, melanoma, women’s health, GU & GI, fetal oncology), rheumatology, dermatology, neurology, cardiology, hepatology, and infectious diseases.

“Dr. Qamar has a deep understanding of Ocugen’s ongoing clinical trials and a close working relationship with the clinical and regulatory teams, both of which are fundamentally important to the success of Ocugen’s programs,” said Dr. Prabhavathi Fernandes, Independent Lead Director, Ocugen board. “I’m confident that her determination and dedication will bring the Company’s first-in-class candidates through the upcoming clinical milestones to deliver on Ocugen’s long-term strategy.”

Prior to joining Ocugen, Dr. Qamar was Senior Vice President, Head of R&D at FSD Pharma—demonstrating her commitment to advancing scientific innovation and pharmaceutical development.

About Ocugen, Inc. 

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ 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 X and LinkedIn.

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