Release – Travelzoo Q2 2024 Earnings Conference Call on July 25 at 11:00 AM ET

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Jul 18, 2024, 09:03 ET

NEW YORK, July 18, 2024 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):

WHAT:Travelzoo, the club for travel enthusiasts, will host a conference call to discuss the Company’s financial results for the second quarter ended June 30, 2024. Travelzoo will issue a press release reporting its results before the market opens on July 25, 2024.
WHEN:July 25, 2024 at 11:00 AM ET
HOW:A live webcast of Travelzoo’s Q2 2024 earnings conference call can be accessed at http://ir.travelzoo.com/events-presentations. The webcast will be archived within 2 hours of the end of the call and will be available through the same link.
CONTACT:Travelzoo Investor Relations
ir@travelzoo.com

About Travelzoo
We, Travelzoo®, are the club for travel enthusiasts. Our 30 million members receive exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give us access to irresistible deals.

SOURCE Travelzoo

Release – Cocrystal Pharma Reports Favorable Results from Single-Ascending Dose Cohorts of Phase 1 Study with CDI-988, its Oral Pan-Viral Norovirus/Coronavirus Protease Inhibitor

Research News and Market Data on COCP

JULY 18, 2024

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BOTHELL, Wash., July 18, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) today reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, pan-viral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. It is being developed as the first dual, broad-spectrum antiviral for the treatment of norovirus and coronaviruses.

“Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a strong candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. We are pleased with the encouraging safety and tolerability data from the CDI-988 Phase 1 study SAD cohorts,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are currently manufacturing drug product for the multiple-ascending dose (MAD) cohorts of this study, with subject enrollment planned to begin in the fourth quarter of this year.”

The single-center, randomized, double-blind Phase 1 study is evaluating the safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo in healthy adults and is being conducted in Australia. Study participants in the SAD cohorts received CDI-988 in doses ranging from 100 mg to 600 mg. All participants completed the study with no discontinuations. There were no serious adverse events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical exams or electrocardiograms.

About Norovirus
Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The NIH estimates the annual burden of noroviruses to the U.S. at $10.6 billion. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. To date, no antiviral treatment or vaccine is approved for norovirus infections.

Coronaviruses Including COVID-19 and Variants
Coronaviruses (CoV) are a family of viruses that historically have been associated with a wide range of symptoms, ranging from no symptoms at all to more severe disease that includes pneumonia, acute respiratory distress syndrome (ARDS), kidney failure and death. By targeting the viral replication enzymes and protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including SARS-CoV-2 and its variants, ARDS and Middle East Respiratory Syndrome (MERS). The ability of an asymptomatic individual to transmit infection heightened the public health challenge of COVID-19.

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 potential efficacy of CDI-988 against coronaviruses and noroviruses, the results of the CDI-988 Phase 1 trial for the antiviral treatment of coronaviruses and noroviruses, the expected timing of the CDI-988 MAD cohorts of the study, including estimated subject enrollment in the fourth quarter of fiscal year 2024, and the potential market for such product candidate. 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 obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers and procuring materials for the MAD cohorts CDI-988 Phase 1 study by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. 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, 2023. 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

# # #

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Source: Cocrystal Pharma, Inc.

Released July 18, 2024

Darden Restaurants Spices Up Portfolio with $605 Million Chuy’s Acquisition

In a new development that’s set to shake up the casual dining landscape, Darden Restaurants has announced its acquisition of Tex-Mex chain Chuy’s Holdings for approximately $605 million. This all-cash deal, revealed on Wednesday, July 17, 2024, marks Darden’s strategic entry into the vibrant Tex-Mex dining category and significantly expands its already impressive restaurant portfolio.

Under the terms of the agreement, Darden will acquire all outstanding shares of Chuy’s at $37.50 per share, representing a substantial premium over recent trading prices. The acquisition is expected to close during Darden’s fiscal second quarter, subject to customary closing conditions.

Darden, the powerhouse behind popular chains such as Olive Garden, LongHorn Steakhouse, and the recently acquired Ruth’s Chris Steak House, has long been a dominant force in the casual dining sector. With the addition of Chuy’s, Darden is poised to diversify its offerings and tap into the growing demand for authentic Tex-Mex cuisine.

Founded in Austin, Texas, in 1982, Chuy’s has built a loyal following with its made-from-scratch Tex-Mex dishes and quirky, eclectic restaurant atmospheres. The chain has expanded to 101 locations across 15 states, generating over $450 million in total revenues for the 12 months ended March 31, 2024. This impressive growth trajectory and strong brand identity caught the eye of Darden’s leadership.

Rick Cardenas, CEO of Darden Restaurants, expressed enthusiasm about the acquisition, stating, “Based on our criteria for adding a brand to the Darden portfolio, we believe Chuy’s is an excellent fit that supports our winning strategy.” Cardenas highlighted Chuy’s strong performance and growth potential as key factors in the decision.

The acquisition brings more than just a new cuisine to Darden’s table. It also adds 7,400 team members to the Darden family, further solidifying the company’s position as a major employer in the restaurant industry. This influx of talent and expertise in the Tex-Mex category could prove invaluable as Darden looks to expand Chuy’s reach.

For Chuy’s, the acquisition represents an opportunity to accelerate growth and reach new markets. Steven Hislop, CEO of Chuy’s, shared his excitement about the deal, saying, “Together we will accelerate our business goals and bring our authentic, made-from-scratch Tex-Mex to more guests and communities.”

The market’s reaction to the news was swift and significant. Chuy’s stock surged by 47.61% following the announcement, reflecting investor enthusiasm for the premium offered by Darden. Conversely, Darden’s stock saw a 3.37% dip, a common occurrence for acquiring companies as the market adjusts to the news of a major purchase.

This acquisition comes at a time when the restaurant industry is seeing increased consolidation as companies seek to diversify their portfolios and achieve economies of scale. Darden’s move to acquire Chuy’s is a prime example of this trend, as it allows the company to enter a new dining category without the need to build a brand from scratch.

As the dust settles on this major deal, all eyes will be on Darden to see how it integrates Chuy’s into its operations and leverages its resources to drive growth. For Chuy’s loyal customers, the hope is that the chain will maintain its unique character and quality while benefiting from Darden’s extensive industry experience and resources.

With this strategic acquisition, Darden Restaurants has not only added a flavorful new dimension to its portfolio but has also positioned itself to capitalize on the enduring popularity of Tex-Mex cuisine in the American dining landscape.

The Crucial Role of Quality Research in Small-Cap Investing

In the dynamic world of small-cap investing, distinguishing genuine opportunities from mere hype is paramount. Quality research serves as the cornerstone for informed decision-making, offering investors a comprehensive view of emerging growth companies. This article explores what constitutes quality research and why it’s indispensable for small-cap investors.

Quality research goes beyond surface-level information, providing a thorough examination of a company’s operations, market position, and financial health. Comprehensive research reports should offer detailed financial analysis, market trend assessments, competitive landscape overviews, and potential growth catalysts. For instance, when evaluating a small-cap tech company, quality research would not only present the latest earnings figures but also analyze the product pipeline, R&D efforts, and strategic partnerships. The goal is to make complex concepts accessible to all investors, regardless of their expertise level.

Effective research leverages visual tools to enhance understanding. Reports should incorporate charts and graphs illustrating financial trends, infographics depicting market share and competitive positioning, and timelines of key events and milestones. For example, a report on a biotech firm might include a flowchart of its drug development process, a bar graph comparing its market share to competitors, and a timeline of regulatory milestones. These visual elements make the research more engaging and easier to digest.

Maintaining objectivity is crucial in quality research. Investors should look for fact-based analysis, transparent disclosure of assumptions, and balanced presentation of strengths and risks. Analysts should clearly state the basis for their conclusions. For instance, if a company’s growth projections hinge on a new product launch, the research should detail assumptions about market adoption rates, pricing strategy, and anticipated competitive responses.

Quality research situates a company within its broader context. Reports should include industry analysis sections, exploration of relevant macroeconomic factors, and discussion of regulatory landscapes. For a renewable energy company, research might explore trends in government subsidies, advancements in solar technology, and shifts in consumer demand for green energy. This context helps investors appreciate external factors that could impact a company’s trajectory.

A rigorous and multi-faceted research process is essential. This typically involves primary research through interviews with company executives, in-depth analysis of regulatory filings and financial statements, industry expert consultations, and comprehensive review of competitor activities and market dynamics. Top-notch, licensed, and experienced financial analysts bring a wealth of expertise to their reports, ensuring that the research is of the highest caliber and provides investors with trustworthy and actionable insights.

Modern research benefits from advanced technological tools. Big data analysis for market trend identification, AI-driven insights for pattern recognition, sentiment analysis from social media and news sources, and predictive modeling for financial forecasting are all becoming standard in quality research. Experienced analysts leverage these tools to enhance their analysis, combining cutting-edge technology with their seasoned judgment to deliver superior research products.

When evaluating company-sponsored research, investors should be aware of potential biases. Look for clear disclosure of the relationship between the research provider and the featured companies. Quality research providers adhere to strict ethical guidelines, encourage readers to cross-reference findings with other sources, and maintain editorial independence in their analysis and recommendations.

Quality research should guide decision-making. Reports should conclude with clear, data-supported recommendations (buy, hold, or sell), a summary of key findings, potential risks and mitigating factors, and growth opportunities and catalysts. For example, a “buy” recommendation might be based on strong revenue growth, a robust balance sheet, and promising strategic initiatives, while also cautioning about potential regulatory hurdles.

To make the most of research reports, investors should check the credibility and track record of the research provider, look for clear disclosure of methodologies and potential conflicts of interest, pay attention to the depth of analysis and quality of sources cited, consider how well the report addresses potential risks and challenges, and compare the insights with other reputable sources.

In the fast-paced world of small-cap investing, quality research from experienced analysts is indispensable. It provides the depth, context, and objectivity needed to make informed investment decisions. By leveraging advanced technologies, adhering to strict ethical standards, and providing actionable insights from experienced financial analysts, quality research empowers investors to navigate the dynamic small-cap landscape effectively.

If you’re looking to enhance your small-cap investing strategy with access to quality research from experienced analysts, consider joining online communities dedicated to small-cap investing. These platforms often provide valuable insights, research reports, and opportunities to connect with other investors. By registering for free with reputable small-cap investing communities like Channelchek, you can take a significant step towards making more informed investment decisions.

Release – The United States Eventing Association Names Zomedica’s PulseVet(R) as the Official Shock Wave of the USEA

News Research and Market Data on ZOM

Zomedica will sponsor a variety of high-profile events within the USEA

ANN ARBOR, MI / ACCESSWIRE / July 17, 2024 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, is honored to announce that the United States Eventing Association, Inc. (USEA), a leading equestrian sports organization, has named PulseVet as the “Official Shock Wave of the USEA” for 2024. As part of its partnership with the USEA, PulseVet Shock Wave is also a “Gold Sponsor” of the USEA American Eventing Championships, “Bronze Sponsor” of the USEA Classic Series, and “Contributing Sponsor” of the USEA EA21 Program, the USEA Annual Meeting and Convention, and the USEA Adult Team Championships.

Zomedica’s PulseVet system is a world leader in veterinary electro-hydraulic shock wave technology for the treatment of a wide variety of conditions in equine, canine, and feline patients. The high-energy sound waves stimulate cells and release healing growth factors in the body that reduce inflammation, increase blood flow, and accelerate bone and soft tissue development. PulseVet’s technology is used in conditions including tendon and ligament healing, bone healing, osteoarthritis, chronic pain, and wound healing.

Zomedica CEO Larry Heaton commented, “We are excited to engage with USEA as the Official Shock Wave of their organization. Zomedica is committed to helping veterinarians provide the best possible care for horses at every level of training and competition, from rehabilitation to maintaining peak performance.”

“We are grateful to Zomedica for partnering with U.S. Eventing as its newest sponsor. Keeping our equine partners healthy and happy is a top priority, and we are thankful to have a brand committed to the same goals. Our event horses are a part of the family, and we are glad that the PulseVet shock wave device is focused on keeping them in top shape,” stated USEA CEO Rob Burk.

“As a long-time member, I am thrilled to partner with the USEA and help educate all those who enjoy the sport of eventing,” Zomedica’s Senior Product Manager of Therapeutics, Courtney Calnan, commented. “Eventing requires our equine teammates to be an ultimate athlete. I’m excited for the members of USEA to learn how the PulseVet system can help their partners feel their best.”

PulseVet’s electro-hydraulic shock wave technology has been clinically proven to treat tendon, ligament, and muscle injuries; osteoarthritis; degenerative joint disease; navicular syndrome; chronic back and neck pain; fractures; and wounds. Electro-hydraulic shock wave continues to be the most researched type of shock wave in the veterinary industry. The total addressable market for PulseVet devices in the US is estimated at $1 billion, with additional recurring revenue of $150 million annually for related consumables.

About the United States Eventing Association

The USEA is a non-profit 501(c)(3) educational organization committed to providing eventing enthusiasts with a competitive level suited to their individual skills. By assisting and educating competitors, event organizers, and officials; maintaining responsible safety standards; and registering qualified competitions and clinics, the USEA offers a strong and continuous training opportunity for an ever-expanding field of world-class competitors. Just as importantly, the USEA provides a means for all riders, regardless of age or ability, to experience the thrill of eventing. To learn more, visit www.useventing.com.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW™ digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $91 million in liquidity as of March 31, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Follow Zomedica

Cautionary Note Regarding Forward-Looking Statements

Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the expected market and Zomedica’s share of such market, continued growth of sales, the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work including the development of new cartridges; uncertainty as to the timing and results of verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, or other requirements for our products in the Middle East, Africa and India, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, particularly in the Middle East, Africa and India; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:
Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

Release – Tonix Pharmaceuticals, Set to File an NDA for Tonmya for the Management of Fibromyalgia, is Planning Expected Launch in 2H 2025

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July 17, 2024 8:00am EDTDownload as PDF

CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.

The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA – Tonix’s Tonmya and one from another U.S. company – there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.

Fibromyalgia Landscape

According to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix’s drug, Tonmya™, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States. Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. The last approved medication was approved in 2009, and two earlier ones were approved in 2008 and 2007.

Despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately $5 billion each. Both are now generic. A big difference about the fibromyalgia market today is that the condition is widely accepted. Before the heydays of the two blockbusters, many doctors doubted the existence of fibromyalgia due to the lack of visible physical signs and specific diagnostic tests. Many believe that fibromyalgia was overlooked because it affects mostly women.

Tonix will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a compound annual growth rate of 3.8% from 2024 to 2030.

Tonix Enters the Ring with Tonmya

Tonmya is a new therapeutic class and unlike the three currently approved fibromyalgia drugs, which are involved in the uptake of both serotonin and norepinephrine or are more specific for norepinephrine than serotonin. The other new drug candidate heading for FDA approval is very specific for norepinephrine and does not affect serotonin.

Tonmya (also known as TNX-102 SL) is a non-opioid, non-addictive sublingual tablet designed for bedtime use. Tonmya is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. Sleep quality is different than sleep quantity – or the amount of time spent asleep. By focusing on sleep quality, Tonmya is different from conventional sleep drugs. Traditional sleep aids like Ambien® fail to manage the type of sleep disturbances that exacerbate fibromyalgia symptoms.

In the latest Phase 3 trial, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that statistically significant results were also seen in improving sleep quality, reducing depression and fatigue and improving overall fibromyalgia symptoms and function. Tonmya was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.

Tonmya has been conditionally accepted by FDA as a trade name for the management of fibromyalgia. Tonix says it will file a new drug application (NDA) with the FDA in the second half of this year and has completed both manufacturing and multi-disciplinary-focused pre-NDA meetings with FDA.

As the anticipated NDA filing and FDA approval dates for Tonmya and a second new drug draw near, a battle in the fibromyalgia market heats up. Tonix Pharmaceuticals, with its innovative approach and promising clinical trial results, could be well positioned to disrupt a market long dominated by a few large players.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-2407/

*Tonmya is an investigational new drug and is not approved for any indication

Investor Contact

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

Important notice, please read: Certain statements in this document 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 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 17, 2024

Release – Unicycive Therapeutics Granted Patent On UNI-494 To Treat Acute Kidney Injury By The United States Patent And Trademark Office (USPTO)

Research News and Market Data on UNCY

July 17, 2024 7:03am EDT Download as PDF

ENSURES INTELLECTUAL PROPERTY PROTECTION UNTIL 2040

LOS ALTOS, Calif., July 17, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent No. 12,036,211 by the United States Patent and Trademark Office (USPTO) for UNI-494.

The patent, valid until 2040, secures protection of a method of treating a disease or a condition selected from acute kidney injury or contrast induced nephropathy by administering the UNI-494 compound. The UNI-494 compound covered in the method of use claims is not limited to a particular salt, dose or type of administration. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease.

“We are pleased to receive this patent from the USPTO, which ensures intellectual property protection for many years to come,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This Method of Use patent for UNI-494 is an important component of our strategy to become a leader in the development of drugs that target kidney disease. UNI-494 is currently in an ongoing Phase 1 clinical trial and recently received Orphan Drug Designation in Delayed Graft Function, a form of acute kidney injury. This patent helps protect our approach and expands our portfolio as we look to develop novel treatments for kidney diseases.”

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in the second half of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined on the basis of increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedInX, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released July 17, 2024

Release – V2X Secures $141 Million Award to Provide Assured Communications Capability to the Navy Fleet

Research News and Market Data on VVX

MCLEAN, Va., July 17, 2024 /PRNewswire/ — V2X Inc. (NYSE: VVX) proudly announces its award of a $141 million cost-plus-fixed-fee task order to continue providing comprehensive engineering support for Command, Control, Communications, Computer, and Intelligence (C4I) systems. This task order is part of the Navy’s Fleet Systems Engineering Team (FSET) program, which V2X has supported for 25 years, ensuring that no U.S. Navy Strike Group or Amphibious Ready Group deploys without V2X.

“V2X provides a full range of assured communications services that are integral to the readiness of U.S. Navy ships,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “Since 1999, we have delivered complex C4I support under FSET, showcasing our longstanding history of innovative solutions. We look forward to continuing this vital relationship with the Navy.”

With the task order, V2X will deliver end-to-end C4I systems engineering solutions to the U.S. Navy’s afloat force, including command ships, ballistic missile defense ships, strike groups, and specific shore facilities. Additionally, we will offer systems engineering and technical innovation for the swift integration of new capabilities to mitigate new threats to Navy networks. Our fleet systems engineers will play a crucial role in monitoring C4I system performance, providing essential feedback on computer network defense status, and ensuring Navy C4I systems are promptly protected in the event of a mission impacting event.

This win exemplifies of V2X’s expanding footprint with the Navy. The contract extends through July 2029, with an option to extend to 2030.

About V2X

V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

Media Contact

Angelica Spanos Deoudes
Director, Corporate Communications
Angelica.Deoudes@goV2X.com
571-338-5195

Investor Contact 
Mike Smith, CFA
Vice President, Treasury, Corporate Development and Investor Relations
IR@goV2X.com
719-637-5773

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-secures-141-million-award-to-provide-assured-communications-capability-to-the-navy-fleet-302199395.html

SOURCE V2X, Inc.

Release – The GEO Group Announces Extension of Exchange Offer

Research News and Market Data on GEO

BOCA RATON, Fla.–(BUSINESS WIRE)–Jul. 17, 2024– The GEO Group (NYSE: GEO) (“GEO” or the “Company”) announced today that it has extended its offers to exchange (the “Exchange Offer”) (i) up to $650.0 million aggregate principal amount of registered 8.625% Senior Secured Notes due 2029 (the “Secured Exchange Notes”) for any and all of its $650.0 million aggregate principal amount of unregistered 8.625% Senior Secured Notes due 2029 that were issued in a private placement on April 18, 2024 (the “Secured Original Notes”), and (ii) up to $625.0 million aggregate principal amount of registered 10.250% Senior Notes due 2031 (the “Unsecured Exchange Notes” and, together with the Secured Exchange Notes, the “Exchange Notes”) for any and all of its $625.0 million aggregate principal amount of unregistered 10.250% Senior Notes due 2031 that were issued in a private placement on April 18, 2024 (the “Unsecured Original Notes” and, together with the Secured Original Notes, the “Original Notes”).

The Exchange Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on July 16, 2024, will now expire at 5:00 p.m., New York City time, on July 23, 2024, unless earlier terminated or extended by the Company (such date and time, including any extension, the “Expiration Date”). Any Original Notes tendered may be withdrawn at any time prior to the Expiration Date, but not thereafter (the “Withdrawal Deadline”). Except for the extension of the Expiration Date and Withdrawal Deadline, all other terms of the Exchange Offer remain in full force and effect.

As of 5:00 p.m., New York City time, on July 16, 2024, which was the previous expiration date for the Exchange Offer, the aggregate principal amount of the Original Notes validly tendered and not validly withdrawn, as advised by D.F. King & Co., Inc., the Exchange Agent for the Exchange Offer, was as set forth in the table below:

The terms and conditions of the Exchange Offer are described in the Prospectus, dated June 14, 2024 and the Prospectus Supplement, dated June 27, 2024, which forms a part of the Registration Statement on Form S-4 filed with the Securities and Exchange Commission on May 31, 2024 and declared effective on June 13, 2024 (the “Registration Statement”). The Expiration Date for the Exchange Offer is being extended to provide time for remaining outstanding Original Notes to be tendered for exchange. The Exchange Offer is not conditioned upon any minimum amount of Original Notes being tendered. Subject to applicable law, the Company may waive certain other conditions applicable to the Exchange Offer or extend, terminate or otherwise amend the Exchange Offer in its sole discretion.

This news release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to participate in the Exchange Offer, nor shall there be any sale of the Exchange Notes or exchange of the Original Notes in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offer is being made solely pursuant to the Registration Statement. Copies of the Registration Statement and related prospectus can be obtained without charge by visiting the SEC website at www.sec.gov; by contacting D.F. King & Co., Inc., 48 Wall Street, 22nd Floor, New York, NY 10005; by calling toll-free at (800) 848-3405; or by e-mail at geo@dfking.com.

About The GEO Group

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of Forward-Looking Statements

This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Risks and uncertainties that could cause actual results to vary from current expectations and forward-looking statements contained in this press release include, but are not limited to, risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K, 10-Q, and 8-K reports. GEO disclaims any obligation to update or revise any forward-looking statements, except as required by law.

Pablo E. Paez (866) 301 4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Release – V2X to Announce Second Quarter 2024 Financial Results

Research News and Market Data on VVX

MCLEAN, Va., July 16, 2024 /PRNewswire/ — V2X, Inc., (NYSE: VVX), a leading provider of global mission solutions, will report second quarter 2024 financial results on Tuesday, August 6, 2024, before market open. Senior management will conduct a conference call at 8:00 a.m. ET that same day.

U.S.-based participants may dial in to the conference call at 877-506-6380, while international participants may dial 412-542-4198. A live webcast of the conference call as well as an accompanying slide presentation will be available at https://app.webinar.net/Aba2LPOkBXe and on the Investors section of the V2X website at https://gov2x.com/.

A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through August 20, 2024, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 10190283.

About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

Investor Contact
Mike Smith, CFA
Vice President, Treasury, Corporate Development and Investor Relations
IR@goV2X.com
719-637-5773

Media Contact
Angelica Spanos Deoudes
Director, Corporate Communications
Angelica.Deoudes@goV2X.com
571-338-5195

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-to-announce-second-quarter-2024-financial-results-302198671.html

SOURCE V2X, Inc.

Hemisphere Energy (HMENF) – Increasing Expectations for 2024 and 2025


Wednesday, July 17, 2024

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.

Updating estimates. We increased our 2024 adjusted funds flow (AFF) and earnings per share (EPS) estimates to C$44.3 million and C$0.34 from C$40.9 million and C$0.30. Our revisions are driven by higher crude oil price assumptions and a redistribution of quarterly production estimates. While we have assumed higher oil prices in the second and third quarters, our model assumes prices weaken in the fourth quarter. We increased our 2025 AFF and EPS estimates to C$41.1 million and C$0.30, respectively, from C$31.4 million and C$0.21 based on higher production volume and crude oil price assumptions. We think our 2025 estimates could be conservative if the company can increase annual production within its targeted range of 10% to 20%.

Normal course issuer bid (NCIB). Hemisphere renewed its NCIB to purchase up to 8,255,766 common shares, representing ~10% of the current public float, for cancellation. The NCIB commenced on July 14 and will terminate on July 13, 2025. Under its previous NCIB, which authorized the repurchase of 8,670,636 shares and terminated July on 13, the company purchased 4,074,400 shares on the open market at a weighted average price of C$1.425. Shares are generally purchased opportunistically during periods of weakness.


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Silicon Selloff: Tech Giants Tumble Amid US-China Chip War Concerns

In a significant market shift, tech and chip stocks experienced a sharp decline today, with industry giants like Nvidia, ASML, and Taiwan Semiconductor Manufacturing Company (TSM) leading the downturn. This sudden plunge comes amidst a perfect storm of geopolitical tensions, potential regulatory changes, and a broader rotation out of tech stocks.

The semiconductor industry, which has been riding high on the artificial intelligence (AI) boom, found itself at the center of multiple concerns. One of the primary factors contributing to the sell-off is the potential for tighter restrictions on exports of semiconductor technology to China. Bloomberg reported that the Biden administration is considering implementing more severe curbs on foreign-manufactured products that use even the smallest amount of American technology. This move could significantly impact U.S.-based companies’ ability to sell to China, a crucial market for many chip manufacturers.

ASML, the Netherlands-based chip equipment maker, saw its stock plummet by as much as 11%, marking the steepest decline among its peers. The company’s third-quarter guidance, which fell short of analyst expectations, added to the pressure on its stock. Despite beating second-quarter expectations, ASML’s revenue forecast for the current quarter and its projected gross margin range disappointed investors.

Nvidia, a darling of the AI boom, wasn’t spared from the sell-off. The company’s stock dropped more than 5% as investors recalibrated their expectations in light of potential export restrictions. Nvidia has already seen its sales to China decrease as a percentage of total data center revenue, from 19% in fiscal year 2023 to 14% in fiscal year 2024.

Adding fuel to the fire were comments from former U.S. President Donald Trump, who suggested that Taiwan should pay the United States for protection against potential Chinese aggression. Trump’s remarks, published in a Bloomberg Businessweek interview, sent shockwaves through the industry, particularly affecting TSM, which saw its shares fall more than 7%. Taiwan is a crucial hub for semiconductor manufacturing, with approximately 92% of the world’s most advanced chipmaking capacity.

The broader tech sector also felt the impact of this semiconductor slump. The tech-heavy Nasdaq 100 index was down more than 2%, underperforming the small-cap Russell 2000 index. This shift reflects a recent rotation out of big-cap tech names into small-cap stocks, a trend that began last week following the latest inflation data.

However, not all chip-related stocks suffered. U.S.-based companies like Intel and GlobalFoundries saw their shares rise, as they are perceived as potential beneficiaries of the Biden administration’s push to onshore chip production to the United States.

The semiconductor industry’s volatility highlights its sensitivity to geopolitical factors and regulatory changes. As the U.S. and China continue their technological rivalry, and as governments worldwide recognize the strategic importance of chip manufacturing, the sector may face ongoing uncertainty.

Investors and industry watchers are now closely monitoring how these developments will impact the long-term prospects of chip companies and the tech sector as a whole. The potential implementation of stricter export controls could reshape global supply chains and force companies to rethink their international strategies.

As the dust settles on this tumultuous trading day, it’s clear that the semiconductor industry stands at a crossroads. The interplay of technological advancement, geopolitical tensions, and regulatory pressures will likely continue to shape the sector’s trajectory in the coming months and years. For investors, navigating this landscape will require a keen understanding of both technological trends and geopolitical dynamics.

Wall Street’s New Obsession: Why Everyone’s Talking About Small Caps

In the ever-evolving world of finance, savvy investors are constantly on the lookout for the next big opportunity. As we navigate through 2024, a compelling narrative is unfolding in the realm of small cap and growth companies. These often-overlooked segments of the market are suddenly finding themselves in the spotlight, offering potentially lucrative prospects for those willing to look beyond the usual mega-cap darlings.

The recent surge in small cap stocks, as evidenced by the impressive performance of the Russell 2000 index, has caught the attention of both retail and institutional investors. This shift comes at a time when the market is reassessing its stance on interest rates, inflation, and the broader economic recovery. But what’s driving this renewed interest, and more importantly, what opportunities does it present?

First and foremost, the anticipation of interest rate cuts has breathed new life into small cap stocks. These companies, typically more sensitive to economic cycles, stand to benefit significantly from a more accommodative monetary policy. Lower interest rates can reduce borrowing costs, potentially boosting profitability and fueling growth initiatives. This environment could prove particularly advantageous for small cap growth companies, which often rely on access to capital to fund their expansion plans.

Moreover, as the economy continues to recover and diversify post-pandemic, small caps are well-positioned to capitalize on emerging trends and niche markets. Unlike their larger counterparts, these agile companies can quickly adapt to changing consumer preferences and technological advancements. From innovative healthcare solutions to cutting-edge clean energy technologies, small cap growth companies are often at the forefront of transformative industries.

The potential for outsize returns is another compelling factor drawing investors to this space. Historically, small caps have demonstrated the ability to generate significant returns, especially during periods of economic expansion. While past performance doesn’t guarantee future results, the current market conditions and economic indicators suggest a favorable environment for small cap outperformance.

However, it’s crucial to approach this opportunity with a discerning eye. Not all small caps are created equal, and thorough due diligence is essential. Investors should focus on companies with strong fundamentals, solid balance sheets, and clear paths to profitability. In the growth segment, particular attention should be paid to addressable market size, competitive advantages, and the quality of management teams.

Sector-specific opportunities also abound within the small cap and growth universe. For instance, the ongoing digital transformation across industries presents numerous opportunities in technology and software. Similarly, the push towards sustainable practices is opening doors for innovative companies in renewable energy, recycling, and eco-friendly consumer goods.

Another intriguing aspect is the potential for mergers and acquisitions activity. As larger companies look to innovate and expand, well-positioned small caps could become attractive takeover targets, potentially leading to premium valuations for shareholders.

It’s worth noting that investing in small caps and growth companies comes with its own set of risks. These stocks can be more volatile than their large-cap counterparts and may be less liquid. Additionally, company-specific risks are often more pronounced in smaller firms. Therefore, diversification and a long-term investment horizon are crucial when exploring this space.

For those looking to gain exposure to this exciting segment, various approaches are available. Direct investment in individual stocks offers the potential for significant returns but requires extensive research and risk management. Alternatively, exchange-traded funds (ETFs) and mutual funds focused on small cap and growth companies provide a more diversified approach, spreading risk across a basket of stocks.

As we look ahead, the renewed interest in small cap and growth companies appears to be more than just a fleeting trend. With favorable macroeconomic conditions, the potential for innovation-driven growth, and the possibility of sector-specific tailwinds, this segment of the market offers compelling opportunities for discerning investors.

In conclusion, while the allure of high-flying tech giants and blue-chip stalwarts remains strong, the current market dynamics suggest that it might be time to think small for potentially big returns. As always in investing, thorough research, careful consideration of risk tolerance, and a balanced approach are key to navigating this exciting but complex landscape.