Category:

Release – Traws Pharma, Inc. Appoints Luba Greenwood to Board of Directors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TRAW

Sep 20, 2024

PDF Version

Experienced Life Sciences Executive Brings Strategic Expertise to Support Traws’ Further Transformation and Growth

Director James J Marino Also to Step Down from Traws Board After a Decade of Service

NEWTOWN, Pa., Sept. 20, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (Nasdaq: TRAW) (“Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer, today announced the appointment of Luba Greenwood as Director. In addition, Director James J. Marino is stepping down after nearly ten years of dedicated service, including four years as Chairman, due to other professional commitments.

“We are honored to welcome Luba Greenwood to the Traws Board,” said Iain Dukes, PhD, Executive Chairman of the Traws Board. “Luba brings a rich depth of experience as a Board Member, Investor, Strategic Advisor and Company Executive through her industry roles, including as a board member for public life science companies across a range of therapeutic areas, as Managing Partner of Binney Street Capital (BSC), and as Vice President of Global Business Development and M&A at Roche. As we begin the next phase of Traws’ development, including the advancement of our novel respiratory antiviral therapies through Phase 1 studies and the progression of our oncology strategy, we look forward to benefitting from Luba’s considerable expertise in strategy, corporate development and corporate governance.”

“I believe Traws is at a very important inflection point and I am excited to be part of the Company’s ongoing transformation,” said Luba Greenwood. “The Company has taken a very strategic approach to building and expanding its pipeline, starting with the April 2024 merger agreement with Trawsfynydd, one of the “Loch Companies” founded by the innovative i2020 Accelerator, supported by Torrey Pines Investments and Orbimed. Since April, the Company has delivered on its plan to advance the flu and COVID programs through Phase 1 dosing studies and initiate preparations to begin Phase 2 studies. In addition, it has progressed the development of its oncology strategy. I believe this is just the beginning for Traws and look forward to working with the Board and Management to create value for the Company’s investors and stakeholders.”

Dr. Dukes commented further, “On behalf of the Traws Board of Directors, I want to express our sincere gratitude to Jim for his dedicated and enduring service. As an active member of the biotech community, Jim has contributed valuable advice and leadership insight to the Company through the years, including four years as Chairman. We wish him all the best in his future endeavors.”

About Luba Greenwood
Luba Greenwood is an accomplished life science professional with substantial experience as an investor, board member, company executive, entrepreneur and industry leader. Ms. Greenwood founded and currently serves as the Managing Partner of the Dana Farber Cancer Institute Venture Fund, Binney Street Capital (BSC). In addition, Ms. Greenwood serves on the Board of Directors of several biopharmaceutical companies. Previously, Ms. Greenwood held roles as a senior executive or advisor for private and public biopharmaceutical companies, including Kojin Therapeutics, LUCA Biologics, Inc, and leading healthcare organizations including the Dana-Farber Cancer Institute. Prior to that, Ms. Greenwood held senior leadership and strategic business and corporate development roles for Verily Life Sciences LLC, F. Hoffmann-La Roche Ltd., and the Roche Diagnostics Innovation Center, East Coast. Ms. Greenwood received a B.A. in Biology from Brandeis University and a J.D. from Northeastern University Law School.

About Traws Pharma, Inc.

Traws Pharma is a clinical stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two potentially best-in-class oral small molecules in Phase 1 studies: tivoxavir marboxil, a novel oral antiviral drug candidate for influenza and avian flu, targeting the influenza cap-dependent endonuclease, and ratutrelvir, targeting Mpro (3CL protease) for COVID19.

In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance the oncology program which includes the novel proprietary multi-kinase CDK4-plus inhibitor, narazaciclib, and the multi-kinase inhibitor targeting cell cycle proteins including PLK-1, rigosertib.

Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections and cancer.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, merger integration, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Traws Pharma Contact:

Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com

Investor Contact:

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Three Mile Island’s Revival: Constellation Energy Taps Nuclear Power for AI Data Centers

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Constellation Energy will restart Three Mile Island’s Unit 1 reactor.
– Microsoft will purchase carbon-free power from the plant under a 20-year agreement.
– The energy demand from data centers and AI drives a growing interest in nuclear energy from tech companies.

In a groundbreaking development for clean energy, Constellation Energy has announced plans to restart the Unit 1 reactor at the Three Mile Island nuclear plant, selling the power to Microsoft to support its AI-driven data centers. This collaboration highlights the immense energy demand from tech companies as they scale AI infrastructure, while maintaining carbon-neutral goals. The restart, set for 2028, marks a significant shift in the role of nuclear power in supporting the energy needs of the tech industry, especially as the demand for data center electricity surges.

Three Mile Island’s Revival: Constellation Energy Taps Nuclear Power for AI Data Centers

In a strategic move signaling the resurgence of nuclear energy in the U.S., Constellation Energy has announced plans to restart the Unit 1 reactor at the Three Mile Island nuclear plant. The Pennsylvania-based reactor, inactive since 2019, will be powering Microsoft’s AI data centers under a 20-year power purchase agreement. This deal represents a significant partnership between the tech and energy sectors, underscoring the growing demand for reliable and sustainable energy sources to support the expansion of artificial intelligence (AI) and data infrastructure.

The deal between Constellation and Microsoft is the largest power purchase agreement for the nuclear plant operator and highlights a growing trend among tech giants looking to secure carbon-free energy sources for their operations. As the demand for AI and other energy-intensive technologies surges, companies are under pressure to balance the growing electricity needs with their climate goals. Nuclear energy, with its carbon-neutral output, offers an attractive solution.

Nuclear Energy’s Role in AI Development

With AI technology advancing at breakneck speed, the associated energy requirements are escalating. Data centers, which are central to AI processing, require vast amounts of electricity to power servers, storage systems, and cooling infrastructure. According to forecasts from Goldman Sachs, data centers will account for 8% of the U.S. electricity demand by 2030, up from 3% currently. This dramatic increase is pushing tech companies to seek reliable, scalable, and environmentally sustainable energy solutions.

In this context, the collaboration between Constellation and Microsoft is a powerful example of how nuclear energy can provide a stable and carbon-free energy source. The restart of Three Mile Island’s Unit 1 reactor, set for 2028, will help Microsoft meet the power needs of its AI data centers while adhering to its sustainability goals. The deal not only addresses Microsoft’s current needs but also aligns with broader energy trends, where nuclear energy is seen as a crucial player in the shift toward clean energy.

Investment and Future Prospects

Constellation Energy’s decision to restart the Three Mile Island Unit 1 reactor involves a substantial investment of $1.6 billion, with the company also planning to apply for an operational extension until 2054. The project represents the second time a nuclear plant has been restarted in U.S. history, with the Palisades nuclear plant in Michigan being the first, set to come online by 2025.

The move to revive Three Mile Island is part of a broader trend to bolster the nuclear energy sector in response to growing electricity demand, especially from high-growth sectors like AI, electric vehicles, and domestic manufacturing. Additionally, bipartisan support for nuclear energy is growing, with policymakers seeing it as an essential part of the nation’s clean energy future.

Tech and Energy Sectors Unite for a Sustainable Future

This partnership marks a key moment in the growing synergy between the tech and energy sectors. As tech companies like Microsoft and Amazon Web Services look to nuclear power to meet their increasing electricity demands, nuclear energy could play a central role in powering the digital future. In March 2024, Amazon Web Services struck a similar deal with Talen Energy to purchase power from the Susquehanna nuclear plant, and Oracle is currently designing a data center powered by small modular nuclear reactors.

In conclusion, Constellation Energy’s restart of the Three Mile Island reactor is a bold step that showcases nuclear power’s role in meeting the surging energy needs of the tech industry, particularly for AI applications. This development represents a pivotal moment for both the energy and tech sectors, as they collaborate to fuel innovation while staying true to sustainability commitments.

Fed’s “Recalibration” Explained: Shifting Monetary Policy for Economic Stability

Posted on by slightbourne@noblecapitalmarkets.com
Key Points
– Fed Chair Powell introduces the term “recalibration” to describe current monetary policy adjustments.
– The recalibration aims to maintain economic expansion and safeguard the labor market.
– The move reflects a shift from a rigid inflation focus to balancing economic growth.

Federal Reserve Chair Jerome Powell introduced a new term—“recalibration”—to describe a significant shift in the central bank’s monetary policy following its latest decision to cut interest rates. At a press conference after the recent Federal Open Market Committee (FOMC) meeting, Powell used the term to explain the Federal Reserve’s decision to reduce rates by 50 basis points without signs of major economic distress. The recalibration signals a transition from aggressive inflation-targeting measures toward a broader focus on maintaining economic expansion and securing a healthy labor market.

The half-point rate cut surprised markets and marked the first major rate cut beyond the typical 25 basis points in recent memory. Asset prices responded positively, with both the Dow Jones Industrial Average and the S&P 500 soaring to new highs. Investors took Powell’s recalibration narrative as a sign that the Fed is not panicking about the economy but instead taking preemptive measures to keep growth on track.

Economists, such as PGIM’s Tom Porcelli, pointed out that the recalibration allows the Fed to communicate that this easing cycle is about extending economic growth, not reacting to an imminent recession. This broader narrative shift gives the Fed more flexibility in its rate-cutting strategy, focusing on stabilizing the labor market while inflation moves closer to the 2% target.

Powell’s recalibration rhetoric also marks a clear distinction from previous buzzwords that haven’t always aged well. For instance, his infamous claim that inflation was “transitory” in 2021 eventually backfired as the Fed had to embark on an aggressive rate hike cycle. This new approach, however, aims to prevent any further economic slowdown, making adjustments in anticipation rather than reaction.

Some analysts, like JPMorgan’s Michael Feroli, still expect further rate cuts if the labor market continues to soften. Indeed, Powell emphasized that the recalibration is meant to “support the labor market” before any substantial downturn. While the economy remains relatively healthy, job creation has slowed recently, giving further justification for the recalibration.

Ultimately, Powell’s recalibration represents a shift in the Fed’s policy approach, focusing on broader economic health rather than just inflation control. Markets remain optimistic that this approach will provide stability and fuel further economic expansion.

Release – ACCO Brands Publishes 2023 Environmental, Social and Governance (ESG) Report

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on ACCO

LAKE ZURICH, Illinois, Sept. 19, 2024 — ACCO Brands Corporation (NYSE: ACCO) a leading global consumer, technology, and business branded products company, today published its 2023 Environmental, Social and Governance (ESG) Report.

“At ACCO Brands, we are committed to operating our business with the highest ethical standards and honoring our core value of acting responsibly in our global community,” said Tom Tedford, President and Chief Executive Officer.

“We also are transparent with our stakeholders about progress we are making under the pillars of People, Plant and Products. The ESG report is the primary way we highlight updates on our commitments to our employees, the environment, and the communities in which we live and work,” added Tedford.

ACCO Brands, with 46 brands sold in more than 100 countries, enables consumers, employees, and shareholders to achieve, create, collaborate and organize through essential brands, innovative products, smart investment and a winning team.

To access the Company’s 2023 ESG Report and learn more about the Company’s ESG efforts, click here Environmental, Social and Governance | ACCO Brands.

About ACCO Brands

ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn and play. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com

Release – Great Lakes Dredge and Dock to Present at Noble Capital Markets’ Basic Industries Emerging Growth Virtual Equity Conference on Wednesday, September 25, 2024

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GLDD

HOUSTON, Sept. 18, 2024 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) (NASDAQ: GLDD), the largest provider of dredging services in the United States, announced today that its Senior Vice President and Chief Financial Officer, Scott Kornblau, will present at Noble Capital Markets’ Basic Industries Emerging Growth Virtual Equity Conference on Wednesday, September 25, 2024, at 9:30 AM Eastern Standard Time. The broadcasted formal presentation will feature a fireside style Q&A. Scheduled 1×1 meetings on Thursday, September 26, 2024, with Scott Kornblau are also available for registered, qualified investor attendees.

Attendees interested in viewing the presentation can register for this event, at no cost, here: Virtual Equity Conference Registration.

A video webcast of the presentation will be available following the event on the Company’s website https://investor.gldd.com/investor-relations and as part of a complete catalog of presentations available on Channelchek  www.channelchek.com the investor portal created by Noble. The webcast will be archived on the company’s website and on Channelchek.com for 90 days following the event. 

The Company
Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 134-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

About Noble Capital Markets, Inc.
Noble Capital Markets (“Noble”) is a research driven investment bank that has supported small & microcap companies since 1984. As a FINRA and SEC licensed broker dealer Noble provides institutional-quality equity research, merchant and investment banking, and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the last two decades. Noble launched www.channelchek.com in 2018 – an investor community dedicated exclusively to public small and micro-cap companies and their industries. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 public emerging growth companies are listed on the site, with growing content including research, webcasts, podcasts, and balanced news. 

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

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

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

US Weekly Jobless Claims Drop to Four-Month Low Amid Economic Growth

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Jobless claims fell by 12,000 to 219,000 last week, signaling a strengthening labor market.
– Unemployment rolls also shrank, suggesting steady job growth and economic expansion.
– The Federal Reserve’s recent rate cuts aim to support the job market during economic cooling.

The U.S. labor market demonstrated its resilience as the number of Americans filing new applications for unemployment benefits dropped to a four-month low last week. According to the Labor Department’s report, jobless claims fell by 12,000 to a seasonally adjusted 219,000 for the week ending September 14. This decrease signals that the labor market remains strong, even as other economic indicators show signs of slowing.

These jobless claims, the most current data on the health of the labor market, reflect continued strength in employment. This comes on the heels of the Federal Reserve’s decision to cut interest rates by 50 basis points — a move aimed at sustaining the current low unemployment rate and stabilizing the economy amid fears of a potential recession.

Federal Reserve Chair Jerome Powell emphasized the Fed’s commitment to maintaining a strong labor market, noting that it’s crucial to act when the economy is still showing signs of growth. Economists have echoed this sentiment, stating that the current job market, though cooling, has not reached a point of concern that would signal an imminent recession.

Last week’s data also showed that continuing claims, a measure of those receiving benefits for more than a week, dropped by 14,000 to 1.829 million. This is the lowest level since early June, and it reflects an ongoing trend of low layoffs and strong consumer spending, which has helped to buoy the economy.

The latest numbers suggest that the economy grew at an estimated 3.0% annualized rate in the third quarter, following similar growth in the second quarter. Despite some signs of a labor market cooldown, such as lower job openings and reduced hiring, the low level of layoffs indicates that the overall economy remains on a steady course.

This decline in claims came at a critical time, as it coincided with the government’s survey of business establishments for September’s employment report. The nonfarm payrolls report for August showed a gain of 142,000 jobs, below the monthly average of 202,000 jobs over the past year, further confirming that the labor market is cooling but not in decline.

Despite the reduction in hiring, Powell remains optimistic, noting that the Fed is prepared to act if needed but is confident in the current trajectory of the labor market. The continuing stability of the job market, combined with the Fed’s recent actions, indicates that the central bank is navigating the economy towards a soft landing rather than a recession.

Overall, while challenges remain, the reduction in jobless claims points to steady economic expansion, backed by a resilient labor market and supportive monetary policy measures.

Release – Tonix Pharmaceuticals Announces Issuance of U.S. Patent by the United States Patent and Trademark Office Covering the Intranasal Delivery of FDA-Approved Tosymra® to Treat Migraines

Posted on by aweinsoff@channelchek.com

Research News and Market Data

September 19, 2024 7:00am EDT

New patent expected to expire in 2030

Tosymra® (sumatriptan nasal spray) 10mg is indicated and marketed for the acute treatment of migraine in adults

CHATHAM, N.J., Sept. 19, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the United States Patent and Trademark Office issued U.S. Patent No. 12,090,139 to the Company on September, 17, 2024. The patent, entitled “Formulations Comprising Triptan Compounds”, claims a pharmaceutical composition, a method of treating migraine via intranasal administration, and an intranasal delivery system for Tosymra®. This patent, excluding possible patent term extensions, is expected to expire in 2030.

“We believe this patent further solidifies Tosymra® in the market as a differentiated drug with a differentiated administration method,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This new patent targets specific delivery and composition. We are thrilled to have these additional issued patent claims, which add to the intellectual property protection existing for Tosymra®.”

About Migraine

Nearly 40 million people in the United States suffer from migraine1 and it has been recognized as the second leading cause of disability in the world2,3. 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)4.

1Law, H. Z., Chung, M. H., Nissan, G., Janis, J. E., & Amirlak, B. (2020). Hospital Burden of Migraine in United States Adults: A 15-year National Inpatient Sample Analysis. Plastic and reconstructive surgery. Global open, 8(4), e2790. https://doi.org/10.1097/GOX.0000000000002790

2GBD 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.

3Steiner, T.J., Stovner, L.J., Jensen, R. et al. Lifting the Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020).

4Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in October 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD, instrumental in progressing this development. 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

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 1-888-650-3789.

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.

Primary Logo

Source:

Released September 19, 2024

Comstock Inc. (LODE) – Comstock Fuels Executes its First International License Agreement

Posted on by cpereira@noblefcm.com


Thursday, September 19, 2024

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

International license agreement.Comstock Fuels executed a non-binding term sheet to grant SACL Pte. Limited, a Singapore-based renewable fuel project developer, an exclusive marketing agreement for Comstock Fuels’ advanced lignocellulosic biomass refining processes in Australia and New Zealand. The term sheet includes a master non-exclusive intellectual property license for the sole purpose of developing, financing, constructing, and managing renewable fuels production facilities. SACL has identified initial sites for the construction of three refineries in Australia. 

Terms of the agreement. Comstock Fuels will contribute site specific technology rights in exchange for a 20% equity stake in each refinery. Comstock will provide each producer with engineering support in exchange for 3% of each facilities’ capital and construction costs, increasing to 6% at and above a capacity of 250,000 metric tons per year (MTPY), including an upfront payment of $2.5 million payable upon execution of a site license agreement. Comstock Fuels will earn a royalty fee equal to 3% of the total sales of licensed products by each facility, increasing to 6% at and above a capacity of 250,000 metric tons per 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. 

Fed Lowers Interest Rates by Half Point in First Cut Since 2020

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– The Federal Reserve cuts interest rates by 50 basis points to a range of 4.75%-5.0%.
– Two additional rate cuts are expected later this year, with four more in 2025.
– The decision reflects concerns about a slowing labor market and confidence in inflation returning to target levels.

The Federal Reserve cut interest rates by half a percentage point on Wednesday, marking its first rate reduction since 2020. This shift signals the conclusion of the Fed’s most aggressive inflation-fighting campaign since the 1980s. With this cut, the central bank’s benchmark interest rate now stands at a new range of 4.75%-5.0%, ending the 23-year high range it held since July 2023. The decision was part of the Federal Open Market Committee’s (FOMC) two-day policy meeting.

This rate cut comes amid mounting concerns over the slowing U.S. labor market and the Fed’s renewed confidence in inflation trending downward. Employment data for the summer reflected weaker job growth, with only 118,000 jobs created in June, followed by 89,000 in July and 142,000 in August—well below the monthly average from the previous year. Fed Chair Jerome Powell emphasized the need to support a strong labor market while continuing to work toward stable prices.

Fed officials are now projecting two more 25-basis point cuts before the end of the year, followed by four more cuts in 2025, creating a path for a total of six additional cuts in the coming years. While the decision was not unanimous, with Fed Governor Michelle Bowman preferring a smaller 25-basis point cut, the majority consensus agreed on a more aggressive approach.

Inflation, which had surged following the pandemic, has shown signs of cooling in recent months. The Consumer Price Index (CPI) has consistently reported progress, with inflation now nearing the Fed’s long-term target of 2%. This, combined with the weaker labor market, has given the Fed confidence to make this significant cut.

Jerome Powell’s comments at Jackson Hole in August hinted at the possibility of such a move. He stressed that the Fed would do everything possible to support a strong labor market and indicated that the central bank had the flexibility to lower rates further if needed. Wednesday’s decision reflects the Fed’s focus on both inflation and employment as key factors influencing future monetary policy.

Despite the easing of inflation, the Fed has remained cautious, signaling that while they expect inflation to continue its downward trend, they are still closely monitoring economic data. Officials also updated projections, predicting an uptick in the unemployment rate to 4.4% and stable economic growth of 2% for the next two years.

As investors and businesses adjust to the new monetary landscape, the Fed’s rate cut is expected to influence borrowing costs, stock market activity, and broader economic behavior. The next steps, as outlined by the central bank, will depend heavily on incoming data related to inflation and employment.

MustGrow Biologics Corp. (MGROF) – A New Opportunity

Posted on by cpereira@noblefcm.com


Wednesday, September 18, 2024

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Funding. MustGrow announced yesterday that the Company is receiving funding from Agriculture and Agri-Food Canada (AAFC) to investigate its mustard-derived ingredient. The ingredient could potentially be used in human and animal health and food applications. The funding amount was not disclosed. The Company will continue to focus on its core business outside of the program, with the anticipation of more state approvals for TerraSante, in our view.

The Program. Under the program, the Company and AAFC will look at bioactive components in mustard seed and assess yellow mustard extracts for potential antibiotic and gut health applications in both humans and animals. They will also test the selected bioactive components for antifungal and antibacterial activities against food spoilage microbes and disease pathogens and for use as ingredients in functional foods and nutraceuticals for improved immunity and gut health in both humans and animals.


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. 

Fed Poised for First Rate Cut in Four Years as Market Speculates on Scale

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Investors expect the Fed to cut rates for the first time in four years.
– A 50 basis point cut is increasingly seen as possible, but a 25 basis point cut is more likely.
– The Fed will also provide guidance on future rate cuts and the economic outlook.

The Federal Reserve is set to cut interest rates for the first time in four years, marking a pivotal moment in its monetary policy approach. Investors and market analysts are divided on the expected size of the cut. Recent market moves suggest a growing possibility of a 50 basis point reduction, though a more conservative 25 basis point cut seems more likely, according to comments from several Federal Reserve officials.

The cut, which will bring the Federal Funds rate down to a range of 5.0% to 5.25%, represents a shift from the Fed’s aggressive inflation-fighting stance. The central bank has been steadily raising rates since 2022 to combat rising prices, but as inflation has started to slow, the Fed has turned its attention toward stabilizing the labor market and supporting economic growth.

According to Wilmington Trust bond trader Wilmer Stith, a 50 basis point cut, while a possibility, is still uncertain. He noted that a more moderate 25 basis point reduction might be the more palatable option for the Fed’s policy committee.

Recent economic data, including cooling inflation numbers, have spurred calls for a larger cut. However, the Fed remains cautious, emphasizing that it will continue to monitor the labor market and broader economic trends to determine the best course of action for future cuts.

Chief economist Michael Feroli from JPMorgan has called for a more aggressive 50 basis point cut, arguing that the shift in risks justifies a bolder move. He believes that the central bank needs to recalibrate its policy to maintain economic stability. Conversely, former Kansas City Fed president Esther George expects a more modest quarter-point cut, noting that the Fed might use this opportunity to signal the potential for deeper cuts later in the year.

Fed Chair Jerome Powell has emphasized the importance of sustaining a strong labor market, pledging to do everything possible to avoid further deterioration. He has expressed concern over economic weakening and stressed that the Fed has sufficient room to cut rates if needed to support the economy. However, Powell also acknowledged that inflationary pressures have started to ease, and that gives the central bank flexibility.

The Federal Open Market Committee (FOMC) will also release updated projections for unemployment, inflation, and economic growth alongside the rate decision. These forecasts, particularly the “dot plot” outlining future rate expectations, will provide important guidance on the central bank’s approach to monetary policy through the end of the year and into 2025.

Investors will be watching closely, with the potential for deeper cuts likely to influence market sentiment. Powell’s press conference following the rate decision is expected to shed light on the Fed’s next moves, offering insights into how aggressively the central bank will act to safeguard the economy from potential recession risks.

Trump Family Unveils Crypto Project Details: Who Can Buy World Liberty Financial Tokens?

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– 63% of World Liberty Financial tokens will be available to the public.
– The platform will offer decentralized finance services like lending and investing.
– Concerns arise over the project’s viability amid the Trump family’s limited crypto experience.

The Trump family has finally revealed key details about their latest venture in the digital currency space: World Liberty Financial, a crypto project designed to reshape how people interact with decentralized finance (DeFi). At an event held on X (formerly Twitter), the team behind the project disclosed who can buy the platform’s tokens and how those tokens will be allocated, offering greater transparency on a project that has generated significant interest over the past few weeks.

Token Distribution and Public Availability

According to founder Zak Folkman, 63% of the total tokens from World Liberty Financial (WLFI) will be made available for public purchase, while 20% will be reserved for the founding team, which includes members of the Trump family. An additional 17% will be set aside for user rewards, meant to incentivize active participation on the platform. Folkman assured listeners that there will be no pre-sales or early access for insiders, aiming to keep the token launch fair and accessible to all potential investors.

This announcement has garnered attention due to earlier leaked reports that suggested a 70% founder allocation, which raised concerns about the transparency and fairness of the project. The revised structure has slightly alleviated some of those concerns, although skepticism remains about whether the Trump family can successfully navigate the complex and volatile cryptocurrency market.

Trump’s Shift Toward Crypto

During the event, Donald Trump took center stage, offering insights into his evolving stance on cryptocurrency. Initially, the former president admitted he had little interest in digital currencies, but his involvement grew after witnessing the success of his own NFT collections. These collections, sold to supporters and collectors, were paid for using cryptocurrency, which he said helped change his perception of the digital finance world.

Trump remarked, “Crypto is something we have to do, whether we like it or not.” He also criticized the Securities and Exchange Commission (SEC) for what he perceives as an overly aggressive stance toward the industry. This sentiment reflects ongoing frustration among crypto entrepreneurs, many of whom feel that the SEC has stifled innovation through a regulatory approach focused on enforcement rather than clear guidelines.

Lofty Goals for World Liberty Financial

The Trump family and their business partner, Steve Witkoff, are aiming to create more than just a cryptocurrency token. They envision World Liberty Financial as a comprehensive DeFi platform, offering services that would allow users to borrow, lend, and invest in digital assets. Witkoff, who has traditionally worked in real estate, spoke about his excitement in helping to build a platform focused on “frictionless finance,” designed to provide opportunities for individuals who have limited access to traditional credit or banking services.

Despite these ambitious goals, the project has faced criticism and skepticism, with questions arising about the Trumps’ limited experience in the cryptocurrency sector. While the Trump brand brings name recognition, the complex nature of blockchain technology and DeFi operations may pose challenges for the team as they seek to gain credibility in the space.

Potential Risks and Challenges

Launching this crypto platform during a heated presidential campaign adds further intrigue. Trump’s increasing support for cryptocurrency on the campaign trail could appeal to a niche group of crypto-friendly voters, but it also raises the stakes for this project. Should World Liberty Financial stumble, it could tarnish Trump’s image among both supporters and investors.

Moreover, the cryptocurrency market is notoriously volatile, and new projects like World Liberty Financial often face significant obstacles to achieving long-term success. Investors and enthusiasts will be closely watching how this project unfolds, particularly given the Trumps’ high-profile involvement.

Moving Forward

The team behind World Liberty Financial has promised to release more updates on the project’s progress via official social media channels in the coming months. Meanwhile, potential investors have been urged to stay alert to possible scams, as the project has already attracted significant public interest.

As the Trump family forges ahead in the world of crypto, many remain curious—and cautious—about whether World Liberty Financial can live up to its promises or whether it will become another footnote in the rapidly evolving cryptocurrency landscape.

Organon to Acquire Dermavant, Expanding into U.S. Dermatology with VTAMA Cream

Posted on by slightbourne@noblecapitalmarkets.com

Organon, a global healthcare company focused on improving women’s health, announced a major acquisition of Dermavant Sciences Ltd., a subsidiary of Roivant. This acquisition includes Dermavant’s innovative dermatologic therapy, VTAMA® (tapinarof) cream, 1%, which is approved for treating plaque psoriasis and is currently under FDA review for atopic dermatitis.

The acquisition enhances Organon’s presence in the U.S. dermatology market, adding to their international portfolio. This move aligns with Organon’s mission to provide treatments for conditions that disproportionately affect women. The inclusion of VTAMA cream, which addresses psoriasis and potentially atopic dermatitis, fits into their strategic goal of expanding access to effective therapies. Dermavant’s established commercial team will integrate with Organon’s market capabilities, further extending the product’s reach.

Dermavant’s VTAMA cream has been a game changer in the dermatology space. Approved in May 2022, it provides a non-steroidal, once-daily treatment option for plaque psoriasis, a condition that impacts over 8 million Americans. Unlike traditional steroid treatments, VTAMA cream is free of safety warnings, making it an appealing option for long-term use. The product is also under review to extend its use to treat atopic dermatitis, a common inflammatory skin condition affecting over 16.5 million adults and 9.6 million children in the U.S.

Organon’s acquisition of Dermavant not only strengthens its foothold in the U.S. market but also provides a new channel for global growth. Organon CEO Kevin Ali emphasized that this acquisition is part of their commitment to improving women’s health and that integrating Dermavant’s operations would accelerate VTAMA’s availability to patients. With Organon’s commercial scale, they expect to significantly increase patient access to this novel therapy globally.

The acquisition is structured with an upfront payment of $175 million, a milestone payment of $75 million contingent upon FDA approval for atopic dermatitis, and additional payments of up to $950 million tied to commercial milestones. Dermavant shareholders will also receive tiered royalties on net sales. The deal, subject to regulatory approvals, is expected to close by the fourth quarter of 2024.

The acquisition complements Organon’s portfolio of women’s health solutions, biosimilars, and established medicines, bringing a much-needed dermatological therapy into its fold. VTAMA cream has been a success, becoming the top branded topical for plaque psoriasis within just two months of its launch. Organon expects that the therapy will continue to grow, especially as the FDA considers its use for atopic dermatitis.

For Dermavant, the deal provides an opportunity for continued growth, with the support and scale of Organon to take VTAMA to new markets and potentially reach millions of patients globally.

With this acquisition, Organon is well-positioned to further expand its impact in dermatology, providing innovative treatments for plaque psoriasis and potentially atopic dermatitis. The company continues to focus on improving the lives of patients, particularly women, by offering accessible and effective healthcare solutions.