Release – Codere Online and Blip redefine online gaming in Mexico with innovative partnership

Research News and Market Data on CDRO

06/18/2024

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Mexico City, Mexico, June 18, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, is pleased to announce its groundbreaking collaboration with Blip, an AI-first conversational platform, to introduce an unparalleled gaming experience to its Mexican customers. This strategic alliance marks a significant milestone both in the global online gaming sector as well as in Mexico.

As the largest market by revenue for Codere Online, Mexico has been a focal point of growth and investment over the past several years. With a clear commitment to enhancing the gaming experience for its customers, Codere Online has consistently strived to introduce innovative solutions that cater to the evolving needs and preferences of its customers.

The latest venture with Blip underscores Codere Online’s dedication to pioneering advancements within the industry. The introduction of a conversational chatbot based on a leading communications platform, developed by Blip, will offer players new features and functionalities that will take their gaming experience to new heights.

This chatbot will enable Codere Online to launch exciting promotions and seamlessly service customers through an AI-powered, fully automated conversational chatbot integrated into one of the most widely used communications platforms. This cutting-edge technology, developed by Blip, will revolutionize the way players engage with Codere Online’s gaming platform, ensuring swift and personalized interactions.

Commenting on this transformative collaboration, Debbie Guivisdalsky, Codere Online’s Chief Operating Officer, stated: “we are thrilled to join forces with Blip to introduce this chatbot to the Mexican market. This strategic alliance exemplifies our commitment to innovation and customer satisfaction and will be a great tool to connect with our customers in an efficient way.

Mrs. Guivisdalsky further added: “the introduction of this state of the art chatbot represents another milestone in our path to delivering exceptional experiences to our players. Through this collaboration, we expect to provide superior experiences for our customers in Mexico while improving our ability to deploy highly targeted promotional campaigns”.

Jaime Navarro, Executive Director for EMEA & Latin America at Blip, asserted “Codere Online and Blip share a strong entrepreneurial spirit and are all about innovation and business transformation, which is why we could not think of a better fit. We are excited to work together to bring forward a cutting-edge conversational experience to the online gaming community in Mexico”.

About Codere Online
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.

About Blip
Blip is an AI-first platform that offers the best conversational intelligence solutions to help businesses connect with their customers through digital channels and leading messaging apps, such as WhatsApp, Messenger, RCS, Apple and Telegram.

Blip is present in more than 32 countries and has offices in Belo Horizonte and São Paulo in Brazil, Mexico City in Mexico, and Madrid in Spain. The brand has helped around 4,000 companies such as Dell, GM, Coca-Cola, Stellantis, Claro, and others to sell, engage and relate to consumers on digital channels.

About Codere Group
Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).

Contacts:

Investors and Media
Guillermo Lancha
Director, Investor Relations and Communications
Guillermo.Lancha@codere.com
(+34)-628-928-152

Primary Logo

Source: Codere Online Luxembourg, S.A.

Release – Tonix Pharmaceuticals Presented Data Comparing Real-World Treatment of Migraine with Industry Guidelines for Non-Oral Products at the Annual Scientific Meeting of the American Headache Society (AHS)

Research News and Market Data on TNXP

June 18, 2024 8:00am EDT

Gap in non-oral prescriptions relative to AHS guidelines represents an opportunity to increase awareness of Tonix’s two FDA-approved non-oral treatments for acute migraine

Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) are indicated for the treatment of acute migraine in adults

CHATHAM, N.J., June 18, 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, presented data from a poster presentation at the 66th Annual Scientific Meeting of the American Headache Society (AHS), held June 13-16, 2024. A copy of the Company’s poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the poster presentation titled, “American Headache Society Consensus Statement and Other Recommendations: How Many Practitioners Comply With the Recommendations?,” a retrospective review of real-world data compares real world usage of non-oral migraine products with the most recent AHS consensus statement. The data reaffirms several past recommendations from the AHS and stresses the need for customizing treatment of migraine headaches to the needs of patients, as well as using the most appropriate route of administration for any given acute attack based on the clinical presentation. So far, real world data show that compliance with the guidelines and the consensus statement have yet to be achieved but has the potential to be increased. Specifically, the data show the use of non-oral drugs for treating an acute migraine attack was only 7% in 2012 and has decreased to below 4% in 2023, when the potential need for such drugs is anticipated to be a significant percentage of patients based on epidemiological data.

“We believe personalizing therapy for migraine is the future and it is hoped that non-oral medicines will address some of the persistent dissatisfaction patients experience with their migraine treatments,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We hope that educating prescribers about the importance of customized treatments will lead to enhanced satisfaction and improve the quality of life of migraine patients. This represents an opportunity for growth in non-oral first-line therapeutics such Tonix’s Zembrace SymTouch and Tosymra.”

“Inconsistent and incomplete response to traditional or emerging oral acute migraine medications continue to be a burden for individuals living with migraines. We believe that both Zembrace SymTouch and Tosymra, due to their rapid-onset and route of administration are well suited to address this unmet need,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines.

Zembrace SymTouch is the only actively promoted brand of sumatriptan autoinjector in the U.S. (other sumatriptan autoinjector products on the market are Imitrex® and generics to Imitrex®). It has a unique low dose and has demonstrated onset of migraine pain relief in as few as 10 minutes (17% of patients vs. 5% for placebo)1. Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230)2. Tosymra employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.3,4, Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).1,4,5

About Migraine

Nearly 40 million people in the United States suffer from migraine6 and it has been recognized as the second leading cause of disability in the world7. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia)8.

1Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.

2Landy, S. et al. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 19, 69 (2018).

3Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Med Devices (Auckl). 2016;9:131-137.

4Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: Feb 2021.

5Wendt J, et al. A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517-526.

6IQVIA 2022 retail sales from the National Sales Perspectives (NSP) audit within the SMART database estimates Zembrace sales of ~$19.6 M and Tosymra sales of ~$3.5 M

7GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976.

8Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on 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 Tonmya1, 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 as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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

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

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

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

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

Do not use Zembrace if you have:

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

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

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

Zembrace may cause serious side effects including:

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

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

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

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.tonixpharma.com or call 1-888-650-3789.

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

INDICATION AND USAGE

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

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

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

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

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

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

Do not use Tosymra if you have:

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

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

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

Tosymra may cause serious side effects including:

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

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

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

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.tonixpharma.com or call 1-888-650-3789.

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

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

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

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 18, 2024

Release – GoHealth to Present at the Noble Capital Markets Consumer, Communications, Media, and Technology Emerging Growth Virtual Equity Conference

Research News and Market Data on GOCO

Jun 18, 2024 at 8:00 AM EDT

CHICAGO, June 18, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced the company will present at the Noble Capital Markets Consumer, Communications, Media, and Technology Emerging Growth Virtual Equity Conference on Wednesday, June 26, 2024, at 2:00 p.m. Eastern Time.

A live webcast of the presentation may be accessed through a link that will be posted on GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay will be available through the same link following the conference.

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 – Comtech Announces Third Quarter Fiscal 2024 Results and Entered into New $222.0 Million Credit Facility

Research News and Market Data on CMTL

CHANDLER, Ariz. – June 18, 2024 — Comtech (NASDAQ: CMTL) (“the Company”) today announced its third quarter fiscal 2024 financial results in a letter to shareholders which is now posted to the Investor Relations section of Comtech’s website. Investors are invited to access the third quarter fiscal 2024 shareholder letter at comtech.com/investors/. A copy of the letter will also be filed with the Securities and Exchange Commission in a Form 8-K.

Comtech also announced that on June 17, 2024, the Company entered into a $222.0 million credit facility with a new syndicate of lenders which is expected to be funded on or around June 18, 2024. The New Credit Facility matures on July 31, 2028, consists of a committed $162.0 million term loan facility and $60.0 million revolver loan facility and is expected to have outstanding borrowings at close of approximately $187.0 million, reflecting $25.0 million drawn on the revolver. A copy of the credit agreement will be filed with the Securities and Exchange Commission in a Form 8-K.

Comtech also intends to host an earnings conference call at 8:30AM ET today, Tuesday, June 18, 2024. Individuals can access the conference call by dialing (800) 267-6316 (domestic) or (203) 518-9783 (international) and using the conference I.D. of “Comtech.” A replay of the conference call will be available for two weeks by dialing (888) 566-0152 or (402) 220-9186. A live webcast of the call is also available at comtech.com/investors/.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

Investor Relations

Maria Ceriello

631-962-7102

investors@comtech.com

GeoVax Labs (GOVX) – GeoVax Receives BARDA Award For COVID Vaccine Trial


Tuesday, June 18, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Grant Provides Up To $367 Million Funding For The Phase 2b Trial. GeoVax announced that it has been selected to receive a Project NexGen grant to test CM04S1 in a Phase 2b study for prevention of COVID-19. The study will test CM04S1 against an approved vaccine in a randomized trial enrolling 10,000 volunteers. GeoVax will receive about $24.3 million for manufacturing, materials, and trial preparations, which can be increased to $45 million. About $343 million will be awarded to a CRO to conduct the trial.

Phase 2b Trial Will Have A Large Enrollment. The trial is designed as a Phase 2b double-blind study comparing GeoVax CM-04S1 to an approved mRNA COVID-19 vaccine. Enrollment will have an estimated 10,000 healthy volunteers to determine efficacy, safety, and immunogenicity of the vaccines. Previous trials with CM04S1 have shown both humoral and cellular immunity to multiple strains of the SARS-CoV-2 virus, with rapid and durable protection.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Boston Scientific Acquires Silk Road’s TCAR Platform for $1.16B

Boston Scientific Corporation has taken a major strategic step to strengthen its position in the vascular medical technology space by announcing a definitive agreement to acquire Silk Road Medical, Inc. for approximately $1.16 billion. This acquisition adds an innovative and clinically differentiated technology for stroke prevention to Boston Scientific’s already impressive portfolio of vascular solutions.

The target company, Silk Road Medical, is a pioneering medical device firm that has developed a revolutionary platform called TCAR (transcarotid artery revascularization) to treat carotid artery disease, a major cause of strokes. Carotid artery disease is responsible for one-third of all strokes and occurs when the carotid arteries in the neck become narrowed or blocked due to plaque buildup. Traditional treatment options include medical therapy management, stenting, or open surgery, all of which carry risks.

Silk Road’s TCAR procedure takes a minimally invasive approach by accessing the carotid artery through a small incision in the neck and temporarily reversing blood flow away from the brain during stenting. This prevents plaque from dislodging and causing a stroke, while a stent is placed to stabilize the blockage and prevent future strokes. Cat Jennings, President of Vascular Peripheral Interventions at Boston Scientific, praised the TCAR platform as “a notable advancement in the field of vascular medicine” that has “revolutionized stroke prevention and the treatment of carotid artery disease.”

The TCAR system gained U.S. Food and Drug Administration approval in 2015 and is supported by several clinical studies demonstrating a reduced risk of stroke and other complications associated with traditional open surgery. Notably, Silk Road Medical’s products are the only devices commercially available for use during the TCAR procedure, positioning the company as a leader in this fast-growing market segment.

Under the terms of the agreement, Boston Scientific will acquire all outstanding shares of Silk Road Medical for $27.50 per share in cash. Silk Road Medical is expected to generate net revenue of $194-198 million in 2024, reflecting 10-12% growth over the prior fiscal year. Boston Scientific anticipates the acquisition will be immaterial to its adjusted earnings per share in 2024 and 2025, and accretive thereafter.

For Boston Scientific, this strategic acquisition aligns perfectly with its core vascular business and strengthens its stroke solutions capabilities. By acquiring Silk Road Medical, Boston Scientific gains access to the innovative TCAR technology and can leverage its global commercial footprint and extensive physician relationships to drive further adoption of the platform. The combined entity can also explore potential synergies and opportunities to expand the applications of the TCAR technology beyond carotid artery disease.

The transaction is subject to customary closing conditions, including regulatory approvals, and Boston Scientific expects to complete the acquisition in the second half of 2024. While integrating Silk Road Medical’s operations, Boston Scientific plans to reinforce its commitment to providing meaningful innovation for physicians who treat patients with peripheral vascular disease.

This acquisition represents a strategic move by Boston Scientific to bolster its vascular offerings with a clinically differentiated and commercially successful stroke prevention technology. By integrating Silk Road Medical’s cutting-edge TCAR platform, Boston Scientific further solidifies its position as a leader in the vascular medical technology space and demonstrates its dedication to advancing solutions that improve patient outcomes and reduce the cost of healthcare.

Take a moment to take a look at more emerging growth biotechnology companies by looking at Noble Capital Markets Senior Research Analyst Robert LeBoyer’s coverage list.

Wall Street Euphoria Pushes S&P 500 to New Peaks

While each successive record tends to cement Wall Street’s unbridled bullishness, a growing chorus of skeptics warns the frenzied march higher is getting ahead of itself. Hedge funds have started dialing back their market exposure, with Goldman Sachs Prime Services reporting the biggest drop in leverage since early 2022 as the “smart money” takes a more defensive stance.

Yet for every doubting voice, there seems to be an emboldened stock market bull ready to revise their targets even higher. On Monday, Evercore’s Julian Emanuel raised his year-end S&P 500 forecast to 6,000 – the highest among major Wall Street strategists and implying over 10% further upside from current levels.

So what exactly is fueling the relentless melt-up at a time when economic growth shows signs of moderating? A convergence of factors led by receding inflation fears, the prospect of Fed rate cuts, and frothy speculation around disruptive themes like artificial intelligence.

The easing of price pressures has been a driving force. After peaking above 9% in 2023, economists project inflation will continue moderating towards the Fed’s 2% target amid cooling consumer demand. That’s allowing traders to bet the central bank will start reversing its aggressive rate hiking campaign as soon as September, providing a powerful tailwind for equities.

“Improving inflation trends would lead to a more constructive policy outlook, which should be a tailwind for equities and fixed income,” said researchers at Glenmede Investment Management. “A September rate cut is likely on the table.”

Of course, Fed officials have pushed back on expectations for steep rate cuts, reiterating that rates will likely remain restrictive for a while. But the Fed Fund futures market remains convinced of looser policy by year-end.

Fueling that enthusiasm is the burning zeal around cutting-edge themes like artificial intelligence and generative AI. The powerful rallies in mega-cap tech leaders have turbo-charged indexes like the Nasdaq-100, which is up nearly 35% year-to-date. Firms from Microsoft to Google parent Alphabet have soared amid optimism their AI investments will mint a new era of computing.

At the same time, shrinking bond yields have eased financial conditions, supporting equity valuations – especially in rate-sensitive growth sectors. The 10-year Treasury yield dipped back below 4.3% on Monday, extending a sizeable retreat from March’s highs above 4.6% amid rising hopes of a soft economic landing.

Underpinning the rally is the notion that some $6 trillion sitting in low-risk money market funds could get funneled back into stocks, emboldening dip-buyers to chase the market ever higher. While skeptics doubt the “great rotation” thesis, any whiff of outflows from cash could spark bouts of frenzied buying from investors piling in for fear of missing out on further gains.

To be sure, the sheer volume of record highs smashed in 2024 has become as much a sentiment indicator as a sign of genuine market strength. Measures of market breadth have steadily deteriorated, even as the large-cap indexes scale new peaks. That signals an increasingly narrow group of stocks doing the heavy lifting – a potential warning signal for traders watching for an impending reversal.

Still, with Wall Street’s biggest brains rapidly marking up their forecasts, Main Street investors have little incentive to fight the Fed-enabled melt-up. Whether the rally proves durable could ultimately hinge on earnings holding up and the central bank’s policy guidance around rates. For now, the path of least resistance appears to remain solidly higher.

Release – Codere maintains top 100 place in Brand Finance ranking of Spain’s most valuable brands

Research News and Market Data on CDRO

06/17/2024

Download(opens in new window)

Madrid, Spain, June 17, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), today announced that the Codere brand1 has been ranked 85th among the 100 most valuable brands in Brand Finance Spain’s 2024 ranking.

It marks the twelfth time since 2010 that the Codere brand has received this recognition in its home market, alongside global conglomerates such as Santander, Seat, and San Miguel. Most notably, it is the only company in the gaming industry to be included in the ranking.

The recognition is the latest milestone in a strong year for the Company, which has enjoyed strong financial results both across its Spanish and Mexican operations.

Alberto Telias, Chief Marketing Officer of Codere Online, stated: “We are extremely pleased to once again be named in the top 100 most valuable brands in Spain, in what is now the eighth consecutive year. Spain will always be our home market, and retaining our reputation as a key brand in this market despite our growing global footprint makes us very proud.”

Codere Online started operations in Spain in 2014. In the twelve months ended March 31, 2024, the Company generated nearly 80 million euros of net gaming revenue and over 28 million euros of Adj. EBITDA in Spain, further cementing a path to profitability that the Company is seeking to replicate across its high-growth Latin American markets.

***ENDS***

About Codere Online
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.

About Codere Group
Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).

Contacts:

Investors and Media
Guillermo Lancha
Director, Investor Relations and Communications
Guillermo.Lancha@codere.com
(+34) 628 928 152

1 Pursuant to the terms of a relationship and license agreement, Codere Group granted Codere Online a license to use certain “Codere” trademarks.

Primary Logo

Source: Codere Online Luxembourg, S.A.

Release – Office Depot OfficeMax Partners with Dormify, a Leader in Dorm Room Essentials, to Ease Back-To-School Shopping and Logistics Across 200 Markets

Research News and Market Data on ODP

From essential bed sheets and stylish accessories to sleek storage solutions and full room bundles — the Office Depot OfficeMax assortment of Dormify essentials will be accessible to students in stores and online, making it easier than ever to plan for move-in week.

BOCA RATON, Fla.–(BUSINESS WIRE)–Jun. 17, 2024– Office Depot is setting college students up for a successful 2024–2025 school year with its expanded collection of college dorm and school supplies in a new partnership with Dormify, a leader in dorm room decor and clever essentials. Students can shop an array of new stylish furniture and dorm room must-haves online at officedepot.com and in 200 stores.

“Our partnership with Dormify allows Office Depot OfficeMax to offer more college dorm supplies through our efficient and versatile shopping and shipping options,” said Kevin Moffitt, executive vice president of The ODP Corporation and president of Office Depot. “We’re passionate about enabling our customers’ educational goals, and providing students with the tools to be successful is an essential part of that mission. We are proud to empower students of all ages to thrive and positively impact the world.”

There are many ways to shop and ship beyond standard deliveries and in-store purchases. For those who plan ahead, Dormify products will be available in almost 200 stores throughout the summer with the option to ship to another store location for pickup in your college area during move-in. Students who buy online can take advantage of Office Depot’s free 20-minute in-store/curbside pickup or free delivery on orders over $35.

“The preparation for college move-in is rife with to-do lists, errands, and tasks. We’re committed to making the process as easy as possible by simplifying the logistics and have found a great partner in Office Depot,” says Amanda Zuckerman, co-founder of Dormify. “We’re thrilled that students and their families will have the opportunity to see, feel, and shop our products in-person at Office Depot in 200 markets that are around the corner from so many campuses. Students will also be able to place orders over the summer at a store near their hometown and have it ready for pickup at an Office Depot location near their school during move-in—a critical offering that we know our customers are requesting.”

The Dormify college dorm collection at Office Depot OfficeMax includes stylish storage and décor items that range from $15.99 to $309.99 such as best-sellers like eyelash fringe comforter and sham setvelvet flower-shaped pillow3-drawer cart with USB portstwin XL bedding bundle, and much more.

Office Depot is giving 10 people a chance to try the new collection themselves with a dorm makeover. Now through June 24, enter for your chance to win a $500 Office Depot OfficeMax merchandise card to put towards a fully outfitted dorm room for the upcoming school year. No purchase necessary. Visit officedepot.com/giveaways to enter.

To see and shop the full collection of college dorm furniture and décor, please visit: www.officedepot.com/l/school-supplies/college-supplies.

About Office Depot
Office Depot, LLC, an operating company of The ODP Corporation, is a leading specialty retailer providing innovative products and services delivered through a fully integrated omnichannel platform of Office Depot and OfficeMax retail stores and an award-winning online presence, OfficeDepot.com, to support the productivity and organization of its small business, home office and education clients. Office Depot is committed to enabling its clients’ success, strengthening local communities and providing equal opportunities for all. For more information, visit officedepot.com, download the Office Depot app on your iPhone or Android and follow @officedepot on Facebook, Twitter, Instagram and TikTok.

Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Any other product or company names mentioned herein are the trademarks of their respective owners.

About Dormify
Dormify is a college lifestyle and small-space decorating destination for the style-obsessed. Dormify simplifies the shopping experience for college students and post-grads by curating and creating exclusive products designed for small-space living without sacrificing style. Founded by Amanda Zuckerman and her mom, Karen, in 2011 when Amanda was in college, Dormify has become a trusted resource that makes outfitting your college dorm or apartment with everything you need (and want) stress-free and fun. Dormify has been highlighted by The New York Times, The Washington Post, Good Morning America, and The TODAY Show, and co-founder Amanda Zuckerman was named to Forbes “30 Under 30” list.

To learn more, visit dormify.com.

Jennifer Robins or Swati Joshi
Media Relations
mediarelations@officedepot.com

Source: Office Depot, LLC

Primo Water and BlueTriton Join Forces in $6.5B Healthy Hydration Mega-Merger

In a transformative move to build a dominant healthy hydration platform across North America, Primo Water Corporation and BlueTriton Brands have agreed to merge in an all-stock deal. The combination will create a new water industry juggernaut with over $6.5 billion in projected annual revenues from its diversified portfolio of bottled water, dispensers and delivery services.

The companies announced the definitive merger agreement on June 17th, under which Primo Water shareholders will own 43% of the new combined entity and BlueTriton shareholders will hold the remaining 57% stake. Upon closing, expected in the first half of 2025, the new company will boast significant scale and market presence as the leading pure-play healthy hydration business in North America.

Primo Water, based in Tampa, Florida, is a major provider of sustainable hydration solutions with a broad range of purified bottled waters sold through large format dispensers, watermakers and water refill stations. Its brand stable includes Primo Water, Crystal Springs, Mountain Valley and Sparkletts, among others.

BlueTriton, headquartered in Stamford, Connecticut, owns some of the most recognized regional spring water brands like Poland Spring, Deer Park, Ozarka, Ice Mountain, Zephyrhills and Arrowhead. Through its ReadyRefresh home and office delivery service, it also has a strong direct-to-consumer channel.

The combined company projects a staggering $1.5 billion in pro forma adjusted EBITDA for the 12 months ended March 2024, including an expected $200 million in annual cost synergies to be fully realized within three years post-close. Primo and BlueTriton anticipate over $565 million in adjusted free cash flow for that period.

The increased brand presence, diversified offerings across formats and price points, and enhanced distribution capabilities position the combined entity for sustained long-term growth in the healthy hydration space.

BlueTriton’s owner, private equity firm One Rock Capital Partners, sees the deal as creating an industry-leading healthy beverage platform with iconic American water brands that can capitalize on increasing consumer focus on health and wellness. The press release states it is “an important milestone” for the beverage category.

To help fund the integration, Primo Water plans to pay a special dividend of up to $133 million to its current shareholders prior to closing. The new entity intends to maintain Primo’s existing $0.36 per share annualized dividend policy initially.

The transaction, already approved by both companies’ boards, still requires regulatory approvals, a green light from Primo Water shareholders, and court approval of the legal arrangement. But if cleared as expected, the merged business projects a solid financial profile with forecasted leverage of 3.0x net debt to EBITDA at closing and a target to delever to 2.0-2.5x in the medium-term.

With beverage giants increasingly pushing into functional and better-for-you categories, the supercharged scale and brand diversity arising from the Primo-BlueTriton union could make for a powerful contender in capturing health-conscious consumer demand for enhanced, sustainable hydration options.

Learn about more emerging growth companies by attending Noble Capital Markets’ Consumer / TMT Virtual Equity Conference on June 26-27, 2024.

Release – Bitcoin Depot Targets Bitcoin Treasury Strategy

Research News and Market Data on BTM

June 17, 2024 8:00 AM EDT

Demonstrates the Company’s Confidence in the Future of Bitcoin by Strategically Allocating a Portion of Cash Reserves to BTC

ATLANTA, June 17, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced it plans to allocate a portion of its cash reserves to Bitcoin (BTC). Any future purchases will be opportunistic in nature and will not interfere with cash needs to support the company’s multiple growth opportunities.

This shift in BTM’s treasury strategy follows Accounting Standards Update (ASU) 2023-08, which, among other things, allows companies to record gains held on cryptocurrencies. The ASU will apply to all entities with fiscal years beginning after December 15, 2024.

“Adopting Bitcoin as part of our treasury strategy underscores our long-standing belief in Bitcoin as a significant financial asset and a store of value,” said Brandon Mintz, CEO of Bitcoin Depot. “We have always believed in providing easy access to Bitcoin for everyone, and this move reaffirms our confidence in Bitcoin’s potential for growth and stability. Given the recent accounting standards update, it also allows our shareholders to benefit from future BTC appreciation.”

Bitcoin, as an asset, has demonstrated remarkable resilience and growth since its inception, achieving a market capitalization of over $1 trillion at its peak. Institutional adoption has surged, with numerous companies and even countries recognizing Bitcoin’s value proposition. The introduction of Bitcoin ETFs has further legitimized its standing in traditional financial markets, making it more accessible to a wider range of investors. By including Bitcoin in its treasury strategy, Bitcoin Depot aligns itself with other forward-thinking institutions that see cryptocurrency as a hedge against inflation and a strategic asset for future growth.

This news also marks the latest show of momentum for Bitcoin Depot, which holds the largest market BTM share in North America, with over 7,400 Bitcoin ATM locations. The announcement follows several recent milestones and expansions for the company, including its first partnership with a major grocery chain as well as the advancement of its newly launched profit share program in April 2024.

The company also recently surpassed its goal of signing 8,000 BTM locations ahead of schedule to achieve the largest installed fleet of locations in its history and announced expansions into new markets, including Puerto Rico and Australia.

About Bitcoin Depot 
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America, with approximately 7,400 kiosk locations as of April 1, 2024. Learn more at www.bitcoindepot.com.

Cautionary Note Regarding Forward-Looking Statements
This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, the anticipated effects of the Amendment, and the closing of the Preferred Sale. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

Contacts: 

Investors
Cody Slach
Gateway Group, Inc.
949-574-3860
BTM@gateway-grp.com 

Media
Christina Lockwood, Brenlyn Motlagh, Ryan Deloney
Gateway Group, Inc. 
949-574-3860
BTM@gateway-grp.com

Primary Logo

Source: Bitcoin Depot Inc.

Released June 17, 2024

Release – Tonix Pharmaceuticals Presented Poster of Tonmya™ for the Management of Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2024

Research News and Market Data on TNXP

June 17, 2024 8:00am EDT

Treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) in Phase 3 RESILIENT study significantly reduced daily pain and demonstrated broad fibromyalgia symptom improvement, as demonstrated by significant improvement on the primary pain endpoint and on all six key secondary endpoints

RESILIENT was the second Phase 3 study to reach statistical significance on the primary endpoint

New Drug Application (NDA) submission to the FDA on track for the second half of 2024

CHATHAM, N.J., June 17, 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, presented data from a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024, held June 12-15, 2024 at the Messe Wien Congress Center in Vienna, Austria. A copy of the Company’s poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the poster presentation titled, “Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in RESILIENT, a Confirmatory Phase 3 Randomized Clinical Trial”, Tonyma met the pre-specified primary endpoint in the Phase 3 RESILIENT trial, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia while also demonstrating broad syndromal improvement. Tonmya demonstrated statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event (AE) profile comparable to prior studies and no new safety signals observed.

In pre-specified exploratory analyses, Tonmya treatment also improved depressive symptoms measured by the Beck Depression Inventory and improved female sexual function by the Changes in Sexual Function Questionnaire in the RESILIENT trial.

“People suffering with fibromyalgia tend to struggle with daily activities, have impaired quality of life and are frequently disabled, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe the activity of Tonmya on pain, sleep quality, fatigue cognitive dysfunction, and depression are indicative of the broad-spectrum activity of Tonmya, suggesting Tonmya treats fibromyalgia at a syndromal level. We are excited by the prospect of offering this patient population its potential first new therapy option in more than a decade.”

Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.

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 Tonmya1, 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 as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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 June 17, 2024

Aurania Resources (AUIAF) – Take-Aways from the Annual General Meeting


Monday, June 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.

Annual shareholder meeting. Shareholders approved all resolutions at the company’s annual meeting on June 13. These included approving the financial statements for the year-ended December 31, 2023, the report of the auditors, the appointment of auditors, election of directors, and the company’s incentive stock option plan for the upcoming year.

Corporate update. Dr. Keith Barron, CEO and Director, provided a corporate update highlighting key priorities in 2024 and 2025. These include: 1) exploration at the Lost Cities project in Ecuador, 2) advancing the company’s application for an exploration license in the Brittany Peninsula of northwestern France, 3) advancing joint venture and strategic partnership discussions, and 4) expanding community access agreements and community projects in Ecuador. At least one major mining company has been active in Aurania’s data room and in discussions with the company.


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