Dexcom’s Stock Plummets: A Wake-Up Call for the Diabetes Management Giant

Key Points:
– Dexcom shares dropped over 40% in a single day, the worst in company history.
– Disappointing Q2 revenue and lowered full-year guidance shocked investors.
– Internal issues, not market changes, appear to be the primary cause of the downturn.

Dexcom, a leader in diabetes management technology, experienced a seismic shock on Friday, July 26, 2024, as its stock plunged more than 40% following a disappointing second-quarter earnings report. This dramatic fall, erasing approximately $18 billion in market capitalization, marks the company’s worst single-day performance since its 2005 IPO.

The catalyst for this financial tremor was Dexcom’s Q2 revenue report, which fell short of analyst expectations. Despite a 15% year-over-year increase to $1 billion, it missed the projected $1.04 billion target. More alarmingly, the company significantly lowered its full-year revenue guidance from $4.20-$4.35 billion to $4.00-$4.05 billion, a reduction that caught many investors off guard.

During the earnings call, CEO Kevin Sayer attributed the shortfall to several internal factors. A major restructuring of the sales team led to disruptions in customer relationships, particularly affecting the crucial durable medical equipment (DME) channel. The company also faced challenges with lower-than-expected new customer acquisition and reduced revenue per user, partly due to rebates offered for their new G7 continuous glucose monitor.

The magnitude of the guidance cut raised eyebrows among analysts. JPMorgan downgraded Dexcom’s stock, expressing shock at the level of disruption caused by internal reorganization. However, they and other analysts, including those from William Blair and Leerink, maintained that these issues are likely transient and should not significantly impact Dexcom’s long-term trajectory.

Interestingly, Dexcom’s woes do not appear to be linked to broader market trends, such as the rising popularity of GLP-1 weight loss treatments. Instead, the company’s stumbles seem largely self-inflicted, a fact that has both frustrated and perplexed market watchers.

Looking ahead, Dexcom is pinning hopes on its new over-the-counter continuous glucose monitor, Stelo, cleared by the FDA in March 2024 and set for an August launch. Designed for Type 2 diabetes patients who don’t use insulin, Stelo represents a significant expansion of Dexcom’s addressable market.

Despite the current turmoil, some analysts believe the market’s reaction may be overblown. Leerink analysts, in particular, argue that the magnitude of the sell-off is excessive given the likely temporary nature of Dexcom’s challenges.

Nevertheless, the incident serves as a stark reminder of the volatility inherent in the healthcare technology sector. It underscores the importance of effective execution, particularly in sales and customer relationship management, even for established market leaders.

As Dexcom works to right the ship, investors and industry observers will be watching closely. The company’s ability to overcome these short-term hurdles and leverage opportunities like the Stelo launch will be crucial in regaining market confidence.

While the road ahead may be bumpy, Dexcom’s strong market position and innovative product pipeline suggest that this may be a temporary setback rather than a long-term decline. However, the company will need to demonstrate improved execution and a clear path to recovery in the coming quarters to fully reassure investors and regain its market momentum.

Lineage’s $4.4 Billion IPO: A Cold Storage Giant’s Sizzling Market Debut

Key Points:
– Lineage, the world’s largest temperature-controlled warehouse REIT, goes public with a $4.4 billion IPO
– Shares rise up to 5% on first day of trading under ticker “LINE”
– Largest IPO since Arm’s $4.8 billion listing in September 2023
– Company’s success driven by aggressive acquisition strategy, with 116 acquisitions to date

In a landmark event for the 2024 stock market, Lineage, the global leader in temperature-controlled warehousing, made its public debut on the Nasdaq Stock Market. The company’s initial public offering (IPO) raised an impressive $4.4 billion, marking it as the largest public offering since chip designer Arm’s $4.8 billion listing in September 2023.

Lineage’s shares, trading under the ticker symbol “LINE,” saw an encouraging start, rising by as much as 5% during their first day of trading. The company priced 57 million shares at $78 each, near the top of its initial $70 to $82 target range. This pricing implies a valuation of over $18 billion for the cold storage giant.

The successful IPO is a testament to Lineage’s remarkable growth strategy and its critical role in the global food supply chain. Starting from a single warehouse, Lineage has expanded its operations through an aggressive acquisition approach, completing 116 acquisitions to date. This strategy has transformed Lineage into a global powerhouse with over 480 facilities across North America, Europe, and the Asia-Pacific region, boasting a total capacity of approximately 2.9 billion cubic feet.

Adam Forste, co-founder and co-executive chairman of Lineage, highlighted the company’s unique growth trajectory on CNBC’s “Squawk Box” just before trading began. “We started with one warehouse and we’ve done 116 acquisitions to turn Lineage into what it is today,” Forste explained. He also noted that many families who sold their companies to Lineage rolled their equity into the larger entity, creating a network of stakeholders celebrating the IPO together.

Lineage’s business model addresses a critical global issue: food waste in the supply chain. With an estimated $600 billion worth of food going to waste during or just after harvest, Lineage’s temperature-controlled storage facilities play a crucial role in reducing this waste and its associated environmental impact. Food waste currently accounts for about 11% of the world’s emissions, making it a significant contributor to climate change.

The company’s successful market debut comes at a time when IPOs have been relatively scarce, making Lineage’s offering particularly noteworthy. It’s more than twice the size of cruise operator Viking Holdings’ IPO in May, further emphasizing the scale of this public offering.

Lineage’s strong market reception also reflects investor confidence in the cold storage sector, which has seen increased demand due to changing consumer habits and the growth of online grocery shopping. The company’s global network of cold-storage facilities positions it well to capitalize on these trends and continue its expansion.

The IPO was underwritten by a group of major financial institutions, including Morgan Stanley, Goldman Sachs, Bank of America, J.P. Morgan, and Wells Fargo, further underscoring the significance of this offering.

As Lineage begins its journey as a public company, investors and industry observers will be watching closely to see how this cold storage giant navigates the challenges and opportunities of the public market. With its strong market position, proven growth strategy, and critical role in the global food supply chain, Lineage’s future looks promising as it embarks on this new chapter in its corporate history.

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Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Consumer, Communications, Media, and Technology Emerging Growth Virtual Equity Conference, taking place June 26th and 27th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the consumer, communications, media, and technology sectors..

Part of Noble’s Robust 2024 Events Calendar

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Release – Conduent Named “Best Place to Work for Disability Inclusion” for Third Consecutive Year

Research News and Market Data on CNDT

JULY 25, 2024

CORPORATE DIVERSITY

Conduent earned top scores in Disability Equality Index in U.S., Philippines and India

FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, today announced that it achieved top scores on the 2024 Disability Equality Index®, earning Conduent the distinction as one of the best places to work for disability inclusion by the American Association of People with Disabilities.

The 2024 designation is the third consecutive year Conduent was named a best place to work. Conduent earned top scores for the United States, India and the Philippines.

The Disability Equality Index is the world’s most comprehensive benchmarking tool for Fortune 1000 companies to measure disability workplace inclusion inside their organization and to assess performance across industry sectors.

“On the 10th anniversary of the Disability Equality Index, we’re extremely proud of the 542 national and international companies that are taking a proactive role in leading progress towards disability inclusion, setting a benchmark for others to follow. Their dedication to fostering inclusive workplaces not only attracts top talent but also drives innovation and creates sustainable performance in today’s global market,” said Jill Houghton, President and CEO of Disability:IN.

“It is an honor to receive top scores on the Disability Equality Index in recognition of Conduent’s commitment to disability inclusion. We will continue our efforts to create a welcoming, supportive, and accessible workplace for our associates of all abilities – one where everyone feels empowered to thrive. Through programs such as our Employee Impact Groups, accessibility awareness and education, mental health sessions, and flexible work, we continue to build a culture where everyone is valued, has a sense of belonging and can bring their authentic selves to work,” said Rob Houser, Global Head of Strategy and Executive Sponsor of Conduent’s Employee DisAbility Impact Group.

The 2024 Index measured: Culture & Leadership; Enterprise-Wide Access; Employment Practices (Benefits; Recruitment; Employment, Education, Retention & Advancement, Accommodations); Community Engagement; Supplier Diversity; and Responsible Procurement (Non-Weighted).

About Conduent

Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 59,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.

About the Disability Equality Index®

The Disability Equality Index has become the leading independent, third-party resource for the annual benchmarking of corporate disability inclusion policies and programs and is now trusted by more than 70% of the United States Fortune 100 and nearly half of the Fortune 500. Such companies must increasingly consider how emerging global reporting directives and stakeholder expectations surrounding social and corporate governance factors impact their operational, cultural, reputational and financial performance.

The Disability Equality Index is an objective, reflective, forward-thinking, and confidential disability rating tool designed to assist business in advancing inclusion practices. It is a comprehensive benchmark that helps companies build a roadmap of measurable, tangible actions across five scored categories: Culture & Leadership, Enterprise-Wide Access, Employment Practices, Community Engagement, and Supplier Diversity. Participating companies receive a score, on a scale of zero (0) to 100, with those scoring 80 or higher earning the distinction of “Best Places to Work for Disability Inclusion” for the benchmark year.

Findings from a two-year Global Disability Equality Index pilot informed the launch of a scored benchmark that opened in 2024 to seven new countries in addition to the United States. These include: Brazil, Canada, Germany, India, Japan, the Philippines, and the United Kingdom. Now in its 10th year, the Disability Equality Index has grown nearly 7x since 2015, expanding from 80 companies in its first year to 542 in 2024. Collectively, the 2024 edition received 753 submissions spanning the eight benchmarked countries.

About the American Association of People with Disabilities (AAPD)

AAPD is a convener, connector, and catalyst for change, increasing the political and economic power for people with disabilities. As a national cross-disability rights organization AAPD advocates for full civil rights for the 60+ million Americans with disabilities. Learn more at: www.aapd.com

About Disability:IN®

Disability:IN is a global organization driving disability inclusion and equality in business. More than 500 corporations partner with Disability:IN to create long-term business and social impact through the world’s most comprehensive disability inclusion benchmarking and reporting tool, the Disability Equality Index; best-in-class conferences and programs; expert counsel and engagement; and public policy leadership. Join us at disabilityin.org/AreYouIN #AreYouIN.

Note: To receive RSS news feeds, visit www.news.conduent.com. For open commentary, industry perspectives and views, visit http://twitter.com/Conduenthttp://www.linkedin.com/company/conduent or http://www.facebook.com/Conduent.

Trademarks

Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.

Media Contacts

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Release – GoHealth to Announce Second Quarter 2024 Results on August 8, 2024

Research News and Market Data on GOCO

Jul 25, 2024 at 8:00 AM EDT

CHICAGO, July 25, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that the company will release its second quarter 2024 financial results on the morning of August 8, 2024.

Chief Executive Officer, Vijay Kotte, and interim Chief Financial Officer, Katie O’Halloran, will host a conference call and live audio webcast on the day of the release at 8:00 a.m. (ET) to discuss the results.

A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Release – Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia

Research News and Market Data on TNXP

July 25, 2024 8:00am EDT

Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need

Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults

NDA submission on track for second half 2024

Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years

CHATHAM, N.J., July 25, 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 U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a non-opioid, centrally-acting analgesic drug under development for treating fibromyalgia, which is a common chronic pain condition affecting mostly women. The designation validates that fibromyalgia is a serious condition and that Tonmya has the potential to address this unmet medical need. Tonix previously announced alignment with the FDA regarding the content of its proposed NDA submission, following completion of the Company’s pre-NDA meetings. The Company reaffirms its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024.

“The FDA’s decision to grant Tonmya Fast Track designation supports our goal of bringing this well tolerated, non-opioid analgesic treatment option to the market in 2025,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options. If approved by the FDA, we expect Tonmya to become the first new pharmacotherapy for fibromyalgia in over 15 years. The NDA being prepared supports Tonmya’s potential position as a first line therapy for fibromyalgia, indicated for long-term daily use at bedtime.”

The FDA’s Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development. Tonix plans to request Priority Review designation, and if granted, FDA may accelerate the review of the NDA. For more information on Fast Track designation, please visit the FDA’s website at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

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

Tonmya is a centrally acting, non-opioid, analgesic investigational drug for bedtime use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function (all p≤0.001). RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally-related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Tonix has announced the results of two positive pre-NDA meetings and alignment with FDA on nonclinical, clinical pharmacology, clinical and CMC features of the NDA submission.

About Fibromyalgia

Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

Tonix Pharmaceuticals Holding Corp.**

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed 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 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 and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

**Tonix’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

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 25, 2024

Release – Harte Hanks to Report Second Quarter 2024 Financial Results on August 8, 2024

Research News and Market Data on HHS

Thursday, 25 July 2024 08:00 AM

CHELMSFORD, MA / ACCESSWIRE / July 25, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for over 100 years, announced today that the company will release financial results for the second quarter of 2024, the period ended June 30, 2024, on Thursday, August 8, 2024, after the close of the market.

The Company will host a conference call and live webcast to discuss these results at 4:30 p.m. EDT on the same day. Interested parties may access the webcast at https://www.webcaster4.com/Webcast/Page/2810/50867 or access the conference call by dialing 888-506-0062 in the United States or 973-528-0011 from outside the U.S. and using access code 821775.

A replay of the call can also be accessed via phone through August 22, 2024 by dialing (877) 481-4010 from the U.S., or (919) 882-2331 from outside the U.S. The conference call replay passcode is 50867.

About Harte Hanks:
Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

Investor Relations Contact:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

SOURCE: Harte Hanks, Inc.

Release – ZyVersa Therapeutics Selects Obesity and Related Metabolic Complications as Lead Indication for Inflammasome ASC Inhibitor IC 100

Research News and Market Data on ZVSA

Jul 25, 2024

PDF Version

WESTON, Fla., July 25, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100.

“Obesity, a well-established risk factor for an array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, and cancer, has reached pandemic proportions, affecting up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Published research demonstrating that inflammasome activation in fat tissue triggers cell death and systemic release of proinflammatory IL-1β, and ASC specks, which can perpetuate and spread inflammation leading to metabolic disturbances associated with obesity provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. We are excited about progressing our development program in this area of high unmet needs.”

Following is the rationale behind selection of obesity and related metabolic complications, and an overview of the development program.

Why Obesity and Related Metabolic Complications as an Indication?

  • Large Growing Market: The global obesity drug market reached nearly $24 billion in 2023, more than a sevenfold growth in just three years, and it is forecasted by IQVIA t to reach up to $131 Billion by 2028 (24 – 27% CAGR).
  • Significant Health and Economic Impact: Obesity, which now affects over 40% of Americans (CDC), is associated with multiple chronic medical conditions, including type 2 diabetes, heart disease, and some forms of cancer, at an annual cost and economic impact exceeding 1.4 trillion in the United States including healthcare expenditures, loss of productivity (Milken Institute).
  • Need for Alternative Mechanisms of Action to Complement GLP-1 agonists: While GLIP-1 drugs deliver meaningful weight loss, improve glucose control, and help to mitigate cardiovascular disease, they do not address the chronic tissue inflammation observed in adipose tissue, liver, muscle, and pancreatic islet cells that has emerged as a key feature of obesity. This chronic tissue inflammation, termed, “immunometabolism,” leads to insulin resistance, beta cell dysfunction, and development of type 2 diabetes and long-term inflammatory complications including microvascular disease (retinopathy, nephropathy, and neuropathy), macrovascular disease (stroke, myocardial infarction, and peripheral arterial disease), heart failure, and nonalcoholic fatty liver disease. As such, anti-inflammatory drugs have potential to provide additional benefits in obesity management (Immunity. 2022 Jan 11;55(1):31-55).

Rationale for Inflammasome Inhibitors as a Treatment for Obesity and Related Metabolic Complications

Inflammasomes, which are activated by nutrients, such as glucose and free fatty acids, trigger activation and stimulation of downstream inflammatory pathways, leading to chronic inflammation in obesity (Front Endocrinol (Lausanne). 2023 Aug 31;14:1232171).

  1. Nutrient overload triggers inflammasome-induced inflammation in the brain’s hypothalamus, causing increased appetite and food intake, increasing the number and size of fat cells associated with weight gain and obesity.
  2. The fat cells become hypoxic, resulting in cell death and macrophage recruitment. This leads to inflammasome activation, death of inflamed cells, and systemic release of proinflammatory cytokines, such as IL-1β, and ASC specks, spreading inflammation throughout the body. If unresolved, sustained inflammation leads to the metabolic complications of obesity.

Why Inflammasome ASC Inhibitor IC 100?

  • Multiple types of inflammasomes, not just NLRP3, are activated in obesity and related metabolic complications (NLRP1, NLRP3, NLRC4, and AIM2). Because IC 100 targets the inflammasome ASC component, it inhibits each of these inflammasomes, including NLRP3, with potential to better attenuate the damaging inflammation associated with obesity and its complications (Immunology. 2021 Aug;163(4):348-362).
  • Inflammation is spread and perpetuated by systemic release of proinflammatory IL-1β and ASC specks during death of inflamed cells, leading to obesity-related complications. IC 100 disrupts the structure and function of ASC specks, thereby attenuating spread and perpetuation of inflammation (Transl Res. 2022 Jul 3:S1931-5244(22)00150-5).

ZyVersa believes that inflammasome ASC Inhibitor IC 100 administered concurrently with GLIP-1 agonists will lead to incremental weight loss, and more importantly, attenuate the chronic tissue inflammation not addressed by GLIP-1 agonists to reduce the long-term micro- and macrovascular inflammatory complications.

Inflammasome ASC Inhibitor IC 100 Development Plans for Obesity and Related Complications

  • IC 100’s preclinical program is nearing completion, with a planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.
  • Preclinical scientific collaboration to assess IC 100 as a potential treatment for atherosclerosis, a common obesity-related metabolic complication, is expected to conclude H2-2024.
  • Preclinical scientific collaboration with University of Miami Miller School of Medicine to assess IC 100 as a potential treatment for obesity and metabolic syndrome is expected to begin H2-2024, with a second study looking at concomitant treatment with IC 100 and a GLIP-1 agonist to begin shortly thereafter.
  • ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board to guide clinical development plans for IC 100, which will be announced in the next few weeks.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

Release – Travelzoo Reports Second Quarter 2024 Results

Research News and Market Data on TZOO

NEW YORK, July 25, 2024 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):

  • Revenue of $21.1 million, consistent year-over-year
  • Consolidated operating profit of $4.0 million
  • Non-GAAP consolidated operating profit of $4.8 million
  • Cash flow from operations of $3.1 million
  • Earnings per share (EPS) of $0.23

Travelzoo, the club for travel enthusiasts, today announced financial results for the second quarter ended June 30, 2024. Consolidated revenue was $21.1 million, consistent year-over-year. In constant currencies, revenue was $21.2 million, up from $21.1 million year-over-year. Travelzoo’s reported revenue consists of advertising revenues and commissions, derived from and generated in connection with purchases made by Travelzoo members, and membership fees.

Net income attributable to Travelzoo was $2.9 million for Q2 2024, or $0.23 per share, compared with $0.17 in the prior-year period. Net income attributable to Travelzoo from continuing operations was $2.9 million for Q2 2024, or $0.23 per share, compared with $0.17 in the prior-year period.

Non-GAAP operating profit was $4.8 million. Non-GAAP operating profit excludes amortization of intangibles ($88,000), stock option expenses ($0.7 million) and severance-related expenses ($30,000). Please refer to “Non-GAAP Financial Measures” and the tabular reconciliation below.

“We will continue to leverage Travelzoo’s global reach, trusted brand, and strong relationships with top travel suppliers to negotiate more exclusive offers for members,” said Holger Bartel, Travelzoo’s Global CEO. “With more than 30 million members, 8 million mobile app users, and 4 million social media followers, Travelzoo is loved by travel enthusiasts who are affluent, active, and open to new experiences.”

Cash Position
As of June 30, 2024, consolidated cash, cash equivalents and restricted cash were $13.2 million. Net cash provided by operations was $3.1 million.

Travelzoo North America
North America business segment revenue remained consistent year-over-year at $14.1 million. Operating profit for Q2 2024 was $3.7 million, or 26% of revenue, compared to operating profit of $3.8 million in the prior-year period.

Travelzoo Europe
Europe business segment revenue increased 1% year-over-year to $6.0 million. In constant currencies, Europe business segment revenue increased 1% year-over-year. Operating profit for Q2 2024 was $512,000, or 9% of revenue, compared to operating loss of $239,000 in the prior-year period.

Jack’s Flight Club 
Jack’s Flight Club is a membership subscription service in which Travelzoo has a 60% ownership interest. Revenue from unaffiliated customers increased 9% year-over-year to $1.1 million. The number of premium subscribers increased 19% year-over-year. Jack’s Flight Club’s revenue from subscriptions is recognized ratably over the subscription period (quarterly, semi-annually, annually). Non-GAAP operating profit for Q2 2024 was $25,000. Non-GAAP operating profit excludes amortization of intangibles ($59,000) related to the acquisition of Travelzoo’s ownership interest in Jack’s Flight Club in 2020.

New Initiatives
New Initiatives business segment revenue, which includes Licensing and Travelzoo META, was $23,000. Operating loss for Q2 2024 was $184,000.

In June 2020, Travelzoo entered into a royalty-bearing licensing agreement with a local licensee in Japan for the exclusive use of Travelzoo’s brand, business model, and members in Japan. In August of 2020, Travelzoo entered into a royalty-bearing licensing agreement with a local licensee in Australia for the exclusive use of Travelzoo’s brand, business models, and members in Australia, New Zealand, and Singapore. Under these arrangements, Travelzoo’s existing members in Australia, Japan, New Zealand, and Singapore will continue to be owned by Travelzoo as the licensor. Travelzoo recorded $7,000 in licensing revenue from the licensee in Japan in Q2 2024. Travelzoo recorded $11,000 in licensing revenue from the licensee in Australia, New Zealand, and Singapore in Q2 2024. Licensing revenue is expected to increase going forward.

Members and Subscribers 
As of June 30, 2024, we had 30.8 million members worldwide, consistent with June 30, 2023. In North America, Travelzoo had 16.1 million unduplicated members as of June 30, 2024, down from 16.2 million as of June 30, 2023. In Europe, Travelzoo had 9.2 million unduplicated members as of June 30, 2024, consistent with June 30, 2023. Jack’s Flight Club had 2.2 million subscribers, including premium subscribers, as of June 30, 2024, consistent with June 30, 2023.

Discontinued Operations
In March 2020, Travelzoo decided to exit its Asia Pacific business and operate it as a licensing business going forward. Consequently, the Asia Pacific business has been classified as discontinued operations.

Income Taxes
A provision of $1.3 million for income taxes was recorded for Q2 2024, compared to an income tax expense of $1.1 million in the prior-year period. Travelzoo intends to utilize available net operating losses (NOLs) to largely offset its actual tax liability for Q2 2024.

Share Repurchase Program
During Q2 2024, the Company repurchased 800,000 of its outstanding common stock.

Looking Ahead 
For Q3 2024, we expect growth in revenue year-over-year, albeit at a smaller pace than in 2023. However, there could be unexpected fluctuations. We also expect for Q3 2024 higher profitability year-over-year. For 2025, we expect substantial growth in revenue as a result of additional revenue from membership fees.

In December 2023, we announced the introduction of a membership fee for Travelzoo beginning January 1, 2024. We recognize membership fee revenue ratably over the subscription period. Legacy Travelzoo members as of December 31, 2023, which represent more than 95% of members, are exempt from the fee during 2024. Therefore, we do not anticipate membership fee revenue from these members before 2025.

Non-GAAP Financial Measures
Management calculates non-GAAP operating income when evaluating the financial performance of the business. Travelzoo’s calculation of non-GAAP operating income, also called “non-GAAP operating profit” in this press release and today’s earnings conference call, excludes the following items: amortization of intangibles, stock option expenses and severance-related expenses. This press release includes a table which reconciles GAAP operating income to the calculation of non-GAAP operating income. Non-GAAP operating income is not required by, or presented in accordance with, generally accepted accounting principles in the United States of America (“GAAP”). This information should be considered as supplemental in nature and should not be considered in isolation or as a substitute for the financial information prepared in accordance with GAAP. In addition, these non-GAAP financial measures may not be the same as similarly titled measures reported by other companies.

Conference Call
Travelzoo will host a conference call to discuss second quarter 2024 results today at 11:00 a.m. ET. Please visit http://ir.travelzoo.com/events-presentations to

  • download the management presentation (PDF format) to be discussed in the conference call
  • access the webcast

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 Travelzoo members access to irresistible deals.

Certain statements contained in this press release that are not historical facts may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934. These forward-looking statements may include, but are not limited to, statements about our plans, objectives, expectations, prospects and intentions, markets in which we participate and other statements contained in this press release that are not historical facts. When used in this press release, the words “expect”, “predict”, “project”, “anticipate”, “believe”, “estimate”, “intend”, “plan”, “seek” and similar expressions are generally intended to identify forward-looking statements. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including changes in our plans, objectives, expectations, prospects and intentions and other factors discussed in our filings with the SEC. We cannot guarantee any future levels of activity, performance or achievements. Travelzoo undertakes no obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this press release.

View Full Release Here

Media Contact:
Investor Relations:
ir@travelzoo.com

SOURCE Travelzoo

Release – Ocugen, Inc. Announces Completion of Dosing In Subjects With Geographic Atrophy Secondary To dAMD In High-Dose Cohort Of Phase 1/2 ArMaDa Clinical Trial Of OCU410—A Novel Modifier Gene Therapy

Research News and Market Data on OCGN

July 25, 2024

PDF Version

• Initiated Phase 2 clinical trial

MALVERN, Pa., July 25, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a novel modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 1 million people in the United States.

“Currently, there are two FDA approved anti-complement therapies for GA, which targets only one pathway for a disease that has a multifactorial and complex etiology,” said Majda Hadziahmetovic, MD, Associate Professor of Ophthalmology, Vitreoretinal Diseases and Surgery, Duke University Eye Center, and the lead investigator for the OCU410 Phase 1/2 trial. “Though these treatments are a significant milestone, they provide limited benefits and involve a continuous regimen of multiple intravitreal injections over several years. This modifier gene therapy could potentially transform the landscape of GA treatment.”

Three subjects received a single subretinal administration of the highest dose (200 µL of 1.5×1011 vg/mL) being tested, which completed the dosing for the Phase 1 stage of the trial. The ArMaDa clinical trial for OCU410 is being performed at 14 leading retinal surgery centers across the United States.

“We are very encouraged about the potential of OCU410 as a one-time treatment option for GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen.

We have initiated a Phase 2 clinical trial that will assess the safety and efficacy of OCU410 in a larger group of patients who will be randomized into either of two treatment groups (medium- or high-dose) or a control group.

The Company will continue to provide clinical updates on a periodic basis.

About the Phase 1/2 ArMaDa clinical trial
The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with geographic atrophy and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-escalation study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

About dry age-related macular degeneration (dAMD) and geographic atrophy (GA)
Dry age-related macular degeneration (dAMD) affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 utilizes an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of geographic atrophy.

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

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

Release – Kelly Announces Second-Quarter 2024 Conference Call

Research News and Market Data on KELYA

TROY, Mich., July 25, 2024 (GLOBE NEWSWIRE) — Kelly, a leading global specialty talent solutions provider, will release its second-quarter earnings before the market opens on Thursday, August 8, 2024. In conjunction with its second-quarter earnings release, Kelly will publish a financial presentation on the Investor Relations page of its public website and will host a conference call at 9 a.m. ET.

The call may be accessed in one of the following ways:

Via the internet:
kellyservices.com

Via the telephone:
(877) 692-8955 (toll free) or (234) 720-6979 (caller paid)
Enter access code 5728672
After the prompt, please enter “#”

A recording of the conference call will be available after 1:30 p.m. ET on August 8, 2024, at (866) 207-1041 (toll-free) and (402) 970-0847 (caller-paid). The access code is 2784290#. The recording will also be available at kellyservices.com during this period.

About Kelly

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 500,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2023 was $4.8 billion. Learn more at kellyservices.com.

KLYA-FIN

Analyst & Media Contact:
Scott Thomas
(248) 251-7264
scott.thomas@kellyservices.com

Release – ACCO Brands Corporation Announces Second Quarter 2024 Earnings Webcast

Research News and Market Data on ACCO

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that it will release its second quarter 2024 earnings after the market close on August 1, 2024. The Company will host a conference call and webcast to discuss the results on August 2 at 8:30 a.m. EST. The webcast can be accessed through the Investor Relations section of www.accobrands.com and will be available for replay.

About ACCO Brands Corporation

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.

Christopher McGinnis
Investor Relations
(847) 796-4320

Kori Reed
Media Relations
(224) 501-0406Source: ACCO Brands Corporation