Author: aweinsoff@channelchek.com

Release – Tonix Pharmaceuticals Presented New Data on Tonmya™ Suggesting Activity for Improvement in Fibromyalgia-Associated Depression Severity in an Oral Presentation at ASCP Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 03, 2024 8:00am EDT

Tonmya treatment was associated with improvement in depressive symptoms as measured by the Beck Depression Inventory-II

In addition, post-hoc analyses showed improvement in depression, anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised

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

CHATHAM, N.J., June 03, 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 new data from the Phase 3 RESILIENT trial of Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 29, 2024 in Miami Beach, Fla. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the oral presentation titled, “Effects of Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) on Mood and Anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RESILIENT Trial,” Seth Lederman, MD, Chief Executive Officer, presented new data suggesting activity for improvement in depressive symptoms with Tonmya.

Depression was frequent among patients enrolled in the RESILIENT trial: ~47% reported experiencing depression within the past 6 months upon fibromyalgia diagnosis and ~25% of the intent-to-treat (ITT) population had experienced a lifetime major depressive episode (MDE). The effect of Tonmya on depressive symptoms was studied using the Beck Depression Inventory-II (BDI-II). Patients started with a baseline mean (standard deviation) for placebo of 10.0 (6.72) and Tonmya of 9.6 (6.32). The BDI-II score separated at Week 2 with a nominal p-value of <0.01. By Week 14, the total BDI-II score in the TNX-102 SL group improved over placebo with a nominal p-value of 0.005 and an effect size of 0.27.

Dr. Lederman said, “Although pain is the prototypic symptom in fibromyalgia and the validated FDA endpoint for the approval of a new drug, depression severity is also a prominent factor in the quality of life for fibromyalgia sufferers. In one study, depressive symptoms had a higher correlation with impaired quality of life than any other symptom, including pain frequency and intensity.2 The improvement in depression observed in the Phase 3 RESILIENT was particularly striking since the mean entry score of 10 reflects mild depression. Others have struggled to show benefits of traditional antidepressants in mild depression and consequently many antidepressants have been studied in moderate or severely depressed patients and the benefits of such drugs for patients with mild depression have been inferred.”

Dr. Lederman continued, “In addition to the BDI-II score, in post hoc analyses several individual items on the Fibromyalgia Impact Questionnaire-Revised (FIQR) also improved in the Tonmya-treated group, including : depression (p < 0.001), anxiety (p = 0.001), sensitivity (p = 0.020), memory problems (p = 0.001) and energy (p < 0.001), for which these p-values were not corrected for multiplicity. Together these findings indicate that Tonmya has broad-spectrum activity against fibromyalgia symptoms and may improve fibromyalgia at the syndromal level.”

In the RESILIENT trial, as previously reported, Tonmya improved overall daily pain (p=0.00005), the pre-specified primary endpoint, making it the second Phase 3 study of Tonmya in the management of fibromyalgia to reach statistical significance on the pre-specified primary endpoint. Tonmya also demonstrated statistically significant and clinically meaningful results 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.”

In the RESILIENT trial, there were no new safety signals, low rates of systemic adverse events, and a favorable tolerability profile.

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 and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.

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 Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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.

2Offenbaecher M, et al. Pain is not the major determinant of quality of life in fibromyalgia. Rheumatology International 2021; 41:1995–2006

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:

Released June 3, 2024

Release – Conduent Recognized as a Leader in 2024 NelsonHall Report on Multi-Process HR Transformation Services

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CNDT

MAY 31, 2024

FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, today announced that NelsonHall, a global analyst firm, has named the company a market leader in the 2024 NelsonHall Evaluation and Assessment Tool (NEAT) for Multi-Process HR Transformation Services for Large Enterprises. This year’s NelsonHall NEAT evaluates participants across a range of criteria and business situations in specific areas of capability, company focus, and geographic coverage.

“Conduent has proven capabilities and well-established HR operational expertise in the Large Enterprise market segment, where 80% of its business supports organizations with over 15,000 employees,” said Liz Rennie, HR Technology and Services Research Director at NelsonHall. “It delivers digital transformations with AI, automation, optimization, engagement, and accuracy, and brings ongoing operational refinements in areas such as employee experience and omni-channel digital solutions. Conduent’s partnership approach and delivery expertise are well-suited to supporting the transformation of complex and large organizations.”

For Large Enterprise Focus, this year’s NEAT report recognizes Conduent for:

  • The breadth of its Human Capital Solutions, including HR administration, global payroll data management services, benefits administration, and learning services;
  • Ability to drive global processes and support products such as HRO-in-a-Box, with more than 120 globally configurable and digitally enabled processes spanning the HR lifecycle (from recruitment to retirement);
  • Investment in front-end proprietary technology with a design approach that uses personas to drive personalization. Proprietary applications include Life@Work Connect, chat automation and real-time dashboards with program analytics and service levels;
  • Capability to serve clients on leading Cloud HCM platforms, including Oracle Cloud, SAP SuccessFactors, and Workday; and
  • CX approach to employee experience supported by an employee-centric delivery model.

“As NelsonHall noted, Conduent remains committed to providing our HR clients with solutions that are grounded in leading digital HR technology so that HR functions can perform better, while also increasing employee engagement and satisfaction,” said Jeff Weiner, Vice President and General Manager of Human Capital Solutions at Conduent. “NelsonHall’s recognition is a great affirmation that the work and investments we are putting into our offerings and delivering to our clients is positively impacting the employee’s experience and is a differentiator when HR teams need to select a partner.”

NelsonHall defines leaders as providers that exhibit a high capability relative to their peers to deliver both immediate benefit and future client requirements. In addition to Large Enterprise Focus, Conduent was also a “Leader” in Overall, Efficiency Focus, Europe Focus, Multi-Country Focus and North America Focus in this year’s NelsonHall NEAT Report. Earlier this year NelsonHall named Conduent a leader in HR Benefits Administration.

To read the custom report of Conduent’s evaluation in the 2024 NelsonHall NEAT Report, visit https://insights.conduent.com/reports/mphr-transformation-neat-report.

About NelsonHall

NelsonHall is the leading global analyst firm dedicated to helping organizations understand the ‘art of the possible’ in digital operations transformation. With analysts in the U.S., U.K., Continental Europe, and Asia, NelsonHall provides buy-side organizations with detailed, critical information on markets and vendors (including NEAT assessments) that helps them make fast and highly informed sourcing decisions. And for vendors, NelsonHall provides deep knowledge of market dynamics and user requirements to help them hone their go-to-market strategies. NelsonHall’s analysis is based on rigorous, all-original research, and is widely respected for the quality and depth of its insight.

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.

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

LISA PATTERSON

Conduent

lisa.patterson@conduent.com

+1-816-305-4421

GILES GOODBURN

Conduent

ir@conduent.com

+1-203-216-3546

Release – Data And Safety Monitoring Board Approves Simultaneous Enrollment In Cohort 3 And Phase 2 Initiation In OCU410 ArMaDa Study For Geographic Atrophy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 31, 2024

  • Established Medium Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial
  • DSMB Recommends Continuing with High-Dose Cohort Dosing with Concurrent Phase 2 Dosing

MALVERN, Pa., May 31, 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 a positive outcome of the Data and Safety Monitoring Board (DSMB) Review for its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV5-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 2-3 million people in the U.S. and Europe combined.

Six subjects with GA were dosed in the Phase 1/2 clinical trial to date—three subjects were dosed with the low dose and three subjects were dosed with the medium dose. An additional three patients will be dosed with the high dose of OCU410 in the dose-escalation phase.

“The DSMB has recommended to proceed with dosing subsequent GA subjects with the high dose of OCU410 in the dose-expansion phase of the study and concurrently initiate Phase 2 dosing,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial. “No serious adverse events (SAEs) related to OCU410 have been reported to date in both low- and medium-dose cohorts. I believe that this marks a critical next step towards determining the maximum tolerated dose for OCU410 and is an important milestone for its clinical development.”

“We are delighted to report a second positive DSMB recommendation for the treatment of GA, which significantly builds on the favorable safety and tolerability profile exhibited by OCU410,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 as a potential one-time treatment for GA with a single sub-retinal injection. The currently approved treatments for GA target only the complement pathway and require approximately 6-12 intravitreal injections annually. OCU410 addresses multiple pathways causing dAMD, including complement, lipid metabolism, inflammation, and oxidative stress, providing long-term benefit to patients.”

The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging 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 dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part 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 the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery 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 in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

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 patient’s 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.

Cautionary Note on 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 – Hemisphere Energy Announces Results from Annual General and Special Meeting of Shareholders

Posted on by aweinsoff@channelchek.com

Research News and Market Data on HMENF

May 30, 2024 2:35 PM EDT

Vancouver, British Columbia–(Newsfile Corp. – May 30, 2024) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) announces the results of its Annual General and Special Meeting of Shareholders that was held today.

Annual General and Special Meeting of Shareholders (“AGSM”)

A total of 46,475,140 common shares were voted, representing 47.45% of total shares issued and outstanding as at the April 11, 2024 record date of the AGSM.

Shareholders voted in favour of all items put forward by the Company’s Board of Directors and management, including:

  1. Fixed the number of directors of the Company at six (6);
  2. Elected the following directors of the Company for the ensuing year: Charles O’Sullivan, Don Simmons, Frank Borowicz, Bruce McIntyre, Gregg Vernon, and Richard Wyman;
  3. Appointed KPMG LLP as auditors of the Company for the ensuing year at a remuneration to be fixed by the Board of Directors; and
  4. Passed an ordinary resolution approving the renewal of the Company’s Stock Option Plan.

About Hemisphere Energy Corporation

Hemisphere is a dividend-paying Canadian oil company focused on maximizing value per share growth with the sustainable development of its high netback, low decline conventional heavy oil assets through polymer flood enhanced recovery methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.

For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:

Don Simmons, President & Chief Executive Officer
Telephone: (604) 685-9255
Email: info@hemisphereenergy.ca

Website: www.hemisphereenergy.ca

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

info

SOURCE: Hemisphere Energy Corporation

Release – Conduent Named to Newsweek’s Top 100 Global Most Loved Workplaces for 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CNDT

MAY 30, 2024

Inclusion on Newsweek’s Top 100 Global Most Loved Workplaces list for second straight year reflects commitment to a strong culture

Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, today announced being named a Newsweek’s Top 100 Global Most Loved Workplaces® for 2024.

The recognition is Conduent’s second consecutive appearance on Newsweek’s Top 100 Global Most Loved Workplaces®. The ranking is produced through collaboration with the research and analysis of Best Practice Institute (BPI), a leadership development and benchmark research company.

“Being included once again on Newsweek’s Top 100 Global Most Loved Workplaces is a reflection of our commitment to creating a workplace where our associates can be themselves, grow and gain skills and make a positive difference,” said Cliff Skelton, Conduent President and Chief Executive Officer. “This achievement is especially meaningful because it is based on how our associates feel about Conduent. The analysis also aligns with Conduent’s core values of teamwork, communication and inclusion as we deliver valuable outcomes for our clients.”

“As workplaces continue to shift, it’s clearer than ever that fostering collaboration, embracing a positive outlook, and aligning values are essential. The companies celebrated on the 2024 Global Most Loved Workplaces® list truly embody these principles. They show us that by championing respect and team-oriented outcomes, they’re not just building great workplaces, they’re shaping a brighter future for all,” said Nancy Cooper, Global Editor in Chief of Newsweek.

The results were determined after surveying more than 2 million employees from businesses with workforces varying in size from 30 to more than 10,000. The list recognizes companies that put respect, caring, and appreciation for their employees at the center of their business model and, in doing so, have earned the loyalty and respect of the people who work for them.

For the full Newsweek list of 2024’s Top 100 Global Most Loved Workplaces®, visit https://www.newsweek.com/rankings/global-most-loved-workplaces-2024.

Being named to Newsweek’s Top 100 Global Most Loved Workplaces® for 2024 is the third consecutive year earning a Newsweek Most Loved ranking for Conduent.

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 http://www.conduent.com.

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

SEAN COLLINS

Conduent

Sean.Collins2@conduent.com

+1-310-497-9205

GILES GOODBURN

Conduent

ir@conduent.com

+1-203-216-3546

Release – Tonix Pharmaceuticals Announces Two Poster Presentations of TNX-102 SL (Sublingual Cyclobenzaprine HCl) at the ASCP Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 30, 2024 8:00am EDTDownload as PDF

In the Phase 2 PREVAIL trial in fibromyalgia-type Long COVID, bedtime TNX-102 SL resulted in a signal in fatigue, sleep and cognitive function

Phase 2, investigator-initiated OASIS trial is designed to examine the safety and efficacy of TNX-102 SL in treating Acute Stress Disorder (ASD) after motor vehicle collision

First patient in OASIS expected to enroll in second quarter 2024

CHATHAM, N.J., May 30, 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 two poster presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 in Miami Beach, Fla. Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the poster presentation titled, “Effect of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) on Pain, Sleep, Fatigue, and Cognition in Fibromyalgia-Type Long COVID: Results of a Double-Blind Randomized Proof-of-Concept Phase 2 Study,” TNX-102 SL showed a robust effect size of 0.5 in improving fatigue and showed consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change, but did not meet the primary endpoint of multi-site pain reduction at Week 14. Prior to the trial, Tonix had pre-specified that any effect size greater than 0.2 would be considered of interest for further study and, even given a substantial placebo response in pain magnitude measurements, key endpoints such as sleep quality diary (ES = 0.23), PROMIS Sleep Disturbance (ES = 0.32), PROMIS Fatigue (ES = 0.50), PROMIS Cognitive Function (ES = 0.21), the Insomnia Severity Index (ES = 0.24) and the Sheehan Disability Scale (ES = 0.26) all matched the criterion for further evaluation. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.

“These results further support the growing evidence that for most Long COVID patients, symptoms are at least partly driven by central nervous system mechanisms rather than persistent exposure to the SARS-CoV-2 virus,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “While Tonix is preparing for submission of a New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia (branded “Tonmya”), we believe that these results demonstrate it may also be effective in managing pain and aiding in sleep quality for patients with fibromyalgia-type Long COVID, further indicating that for many patients Long COVID should be viewed in the context of a chronic overlapping pain condition like fibromyalgia or chronic fatigue syndrome/myalgic encephalomyelitis framework.”

In the poster presentation titled, “Optimizing Acute Stress Reaction (ASR) Interventions with TNX-102 SL* (Sublingual Cyclobenzaprine HCl) – The OASIS Trial: Sustaining Civilian Performance Post-Trauma by Reduction of ASR and Prevention of ASD/PTSD,” TNX-102 SL will be evaluated for the reduction in severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in civilians after a motor vehicle collision. To reduce the persistence of ASR symptoms and the rate and severity of ASD and PTSD, it may be critical to intervene in the immediate aftermath of trauma. Currently, there are no medications available at or near the point of care to treat patients suffering from acute trauma and support long-term health. Previous trials of TNX-102 SL showed that it reduced military PTSD symptoms in as early as two weeks with favorable tolerability. The first participant for the OASIS trial is expected to enroll in the second quarter of 2024.

“Previous trials of TNX-102 SL in PTSD suggested activity on sleep and stress related symptoms in the first several weeks of treatment,”1,2 said Dr. Lederman. “The study is motivated by the observation that the symptoms of ASR and PTSD are similar and by the hypothesis that TNX-102 SL’s effect on sleep quality may reduce ASR symptoms, possibly providing military personnel, veterans, and civilians with a new treatment option that, when administered in the early aftermath of a traumatic event, improves recovery, job performance, and quality of life.”

TNX-102 SL is a centrally acting, non-opioid medication, and, under the trade name Tonmya™, Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for the management of fibromyalgia. Tonix has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.

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 Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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.

  1. Sullivan GM, et al. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974.
  2. Parmenter ME, et al. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 (In Press). https://doi.org/10.1016/j.psychres.2024.115764

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 May 30, 2024

Release – QuoteMedia Powers Berkindale Analytics Market Data Platform

Posted on by aweinsoff@channelchek.com

Research News and Market Data on QMCI

PHOENIX, May 29, 2024 (GLOBE NEWSWIRE) — QuoteMedia, Inc. (OTCQB: QMCI), a leading provider of market data and financial applications, is pleased to introduce Berkindale Analytics, as a new Client and Partner for North American market data and information for their advanced data and analytics platform.

QuoteMedia’s real-time and historical market data feeds provide companies with access to fully consolidated feeds for a total picture of North American market activity which they can use in their advanced analytics platforms for the benefit of their users.

QuoteMedia is delivering a wide range of content, including consolidated enterprise data feeds for United States and Canadian exchanges, through low-latency REST APIs and End-of-Day Data Services. This provides Berkindale Analytics with the data required for their state-of-the-art deep analytics solution.

“Our partnership with QuoteMedia is a continuation of Berkindale’s ambition to deliver a cutting-edge data analytics platform that assists customers in modernizing and enhancing their market data strategies,” said Philippe Girard, Founder and CEO of Berkindale Analytics. “The quality and breadth of QuoteMedia’s data offerings, taken together with their unmatched dedication to ensuring we realize our vision, have made QuoteMedia the perfect choice for Berkindale.”

“We are very pleased to be partnering with Berkindale on their leading-edge research and analytics platform,” said Dave Shworan, CEO of QuoteMedia Ltd. “Berkindale takes genuine pride in providing their clients with the very best data solutions, and has earned a well deserved reputation for excellence. We are very proud to be partnering with them in meeting the needs of their diverse client base.”

About QuoteMedia

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, IEX Data Services LLC, U.S. Bank, Bank of Montreal (BMO), Broadridge Financial Systems, JPMorgan Chase, Scotiabank, CI Financial, Canaccord Genuity Corp., Hilltop Securities, Avantax, Zacks Investment Research, S&P Global Market Intelligence Inc., Business Wire, Cision (PR Newswire, CNW Group), The Goldman Sachs Group, TheStreet.com, Motley Fool, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Aviso Financial Inc., iA Private Wealth, Ally Invest, Inc., Leede Jones Gable, Firstrade Securities, Charles Schwab, Lightspeed Financial Services Group LLC, Equisolve, Stock-Trak and others. Quotestream®, QMod™ and Quotestream Connect™ are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com .

About Berkindale Analytics

Berkindale Analytics offers a sophisticated B2B cloud-based solution providing Level 2 granular market data, financial news, social media, and packaged analytics as distinct products to customers through direct download, API, and dashboards accessed from a web portal. The Berkindale platform uses machine learning technologies, data mining trends, and sentiment analysis with natural language processing which enables firms to maximize the value of the data and to deliver timely, actionable insights to our clients.

For additional information, please visit www.berkindale.com and stay in touch with us by signing up for our newsletter.

We invite you to speak with a representative for your data analytics needs.

QuoteMedia Investor Relations

Brendan Hopkins
Email: investors@quotemedia.com
Call: (407) 645-5295

Primary Logo

News Provided by GlobeNewswire via QuoteMedia

Release – Alliance Resource Partners, L.P. Announces Pricing of $400 Million Private Offering of Senior Notes

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

May 29, 2024

Download(opens in new window)

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP”) announced today that Alliance Resource Operating Partners, L.P. (“AROP”), the intermediate partnership of ARLP, and Alliance Resource Finance Corporation, AROP’s wholly owned subsidiary, priced the previously announced private placement of $400 million in aggregate principal amount of 8.625% senior unsecured notes due 2029 (the “New Notes”). The New Notes will be issued at par. The offering is expected to close on or about June 12, 2024, subject to customary closing conditions.

AROP expects to use a portion of the net proceeds from the offering of the New Notes to fund the redemption of its outstanding 7.5% Senior Notes due 2025 (the “2025 Notes”) and the remaining for general corporate purposes. On May 29, 2024, AROP delivered a conditional notice of redemption, subject to consummation of the offering of the New Notes, for all of the outstanding 2025 Notes. The redemption price for the 2025 Notes is 100% of the principal amount of the 2025 Notes outstanding, plus accrued and unpaid interest to the redemption date, which is expected to be June 28, 2024. This communication shall not constitute a notice of redemption under the indenture governing the 2025 Notes.

The New Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), or under the securities laws of any other jurisdiction. Thus, the New Notes may be offered only in transactions that are exempt from registration under the Securities Act and applicable state securities laws. The New Notes are offered only to qualified institutional buyers under Rule 144A and to persons outside the United States under Regulation S of the Securities Act. The New Notes will not be listed on any securities exchange or automated quotation system.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the New Notes, nor shall there be any sale of the New Notes in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

Cautionary Note Concerning Forward-Looking Statements

Certain statements and information in this news release constitute “forward-looking statements,” including statements regarding the intended use of proceeds. The words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could” or other similar expressions are intended to identify forward-looking statements, which are generally not historical in nature. These forward-looking statements represent ARLP’s expectations or beliefs concerning future events, and it is possible that the results described in this news release will not be achieved. These forward-looking statements are subject to risks, uncertainties and other factors, many of which are outside of ARLP’s control, which could cause actual results to differ materially from the results discussed in the forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as required by law, ARLP does not undertake any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. New factors emerge from time to time, and it is not possible for ARLP to predict all such factors. When considering these forward-looking statements, you should keep in mind the risk factors and other cautionary statements found in ARLP’s filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, ARLP’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The risk factors and other factors noted in ARLP’s SEC filings could cause actual results to differ materially from those contained in any forward-looking statement.

Investor Relations Contact:

Cary P. Marshall

Senior Vice President and Chief Financial Officer

918-295-7673

investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – QuantaSing to Report Third Fiscal Quarter Financial Results on June 6, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on QSG

May 29, 2024

PDF Version

BEIJING, May 29, 2024 (GLOBE NEWSWIRE) — QuantaSing Group Limited (NASDAQ: QSG) (“QuantaSing” or the “Company”), a leading online learning service provider in China, today announced that it plans to release its unaudited financial results for the quarter ended March 31, 2024, before the U.S. market opens on Thursday, June 6, 2024.

The Company’s management will hold an earnings conference call at 07:00 A.M. Eastern Time on Thursday, June 6, 2024 (07:00 P.M. Beijing Time on the same day) to discuss the financial results.

Listeners may access the call by dialing the following numbers:
International:
United States Toll Free:
Mainland China Toll Free: 
Hong Kong Toll Free:
Conference ID:		1-412-902-4272
1-888-346-8982
4001-201203
800-905945
QuantaSing Group Limited
  
The replay will be accessible through June 13, 2024 by dialing the following numbers:
International:
United States Toll Free:
Replay Access Code:		1-412-317-0088
1-877-344-7529
7529094
  

A live and archived webcast of the conference call will also be available at the Company’s investor relations website at https://ir.quantasing.com.

About QuantaSing Group Limited
QuantaSing is a leading online service provider in China dedicated to improving people’s quality of life and well-being by providing lifelong personal learning and development opportunities. The Company is the largest service provider in China’s online adult learning market and China’s adult personal interest learning market in terms of revenue, according to a report by Frost & Sullivan based on data from 2022. By leveraging its proprietary tools and technology, QuantaSing offers easy-to-understand, affordable, and accessible online courses to adult learners under a variety of brands, including QiNiu, JiangZhen, and QianChi, empowering users to pursue personal development. Leveraging its extensive experience in individual online learning services, the Company has also expanded its services to corporate clients including, among others, marketing services and enterprise talent management services.

For more information, please visit: https://ir.quantasing.com.

Contact
Investor Relations
Leah Guo
QuantaSing Group Limited
Email: ir@quantasing.com
Tel: +86 (10) 6493-7857

Robin Yang, Partner
ICR, LLC
Email: QuantaSing.IR@icrinc.com
Phone: +1 (212) 537-0429

Public Relations
Brad Burgess, Senior Vice President
ICR, LLC
Email: Brad.Burgess@icrinc.com

Release – Tonix Pharmaceuticals Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500 (Fc-modified humanized anti-CD40L mAb) at the American Transplant Congress 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 29, 2024 8:00am EDT

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

CHATHAM, N.J., May 29, 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 two oral presentations and a poster presentation at the American Transplant Congress 2024, being held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. Details on each presentation can be found below.

Copies of the Company’s poster presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the American Transplant Congress website here.

Oral Presentations Details
Presenter: Kohei Kinoshita, M.D., Center for Transplantation Sciences, Massachusetts General Hospital
Title: Combined Blockade of the CD154 and CD28 Co-Stimulation Pathways Attenuates Pathogenic Alloimmunity and Prolongs Survival in Cynomolgus Cardiac Allografts
Location: 109-AB‚ Level 1
Abstract: 860
Date/Time: Tuesday, June 4, 2024, 9:45 a.m. ET
   
Presenter: Ikechukwu Ileka, M.D., Massachusetts General Hospital and Harvard Medical School
Title: Extended Survival of 9- and 10-Gene-Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression
Location: 114 – Nutter Theater‚ Level 1
Abstract: 932
Date/Time: Tuesday, June 4, 2024, 10:15 a.m. ET
   
Poster Presentations Details
Presenter: Ikechukwu Ileka, M.D., Massachusetts General Hospital and Harvard Medical School
Title: Experience with a Novel Delayed Immune Tolerance Protocol in Nonhuman Primates Based on Anti-CD154, Anti-CD2, and Anti-CD28
Location: Poster Hall‚ Exhibit Hall A‚ Level 2
Abstract: C086
Date/Time: Monday, June 3, 2024, 9:15 a.m. ET
   

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 Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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:

Released May 29, 2024

Release – Alliance Resource Partners, L.P. Announces Private Offering of Senior Notes

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

May 29, 2024

Download(opens in new window)

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP”) announced today that Alliance Resource Operating Partners, L.P. (“AROP”), the intermediate partnership of ARLP, and AROP’s wholly owned subsidiary, Alliance Resource Finance Corporation, subject to market conditions, intend to offer $400 million in aggregate principal amount of senior unsecured notes due 2029 (the “New Notes”) in a private placement to eligible purchasers.

AROP expects to use a portion of the net proceeds from the offering of the New Notes to fund the redemption of its outstanding 7.5% Senior Notes due 2025 (the “2025 Notes”) and the remaining for general corporate purposes. On May 29, 2024, AROP delivered a conditional notice of redemption, subject to consummation of the offering of the New Notes, for all of the outstanding 2025 Notes. The redemption price for the 2025 Notes is 100% of the principal amount of the 2025 Notes outstanding, plus accrued and unpaid interest to the redemption date, which is expected to be June 28, 2024. This communication shall not constitute a notice of redemption under the indenture governing the 2025 Notes.

The New Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), or under the securities laws of any other jurisdiction. Thus, the New Notes may be offered only in transactions that are exempt from registration under the Securities Act and applicable state securities laws. The New Notes are offered only to qualified institutional buyers under Rule 144A and to persons outside the United States under Regulation S of the Securities Act. The New Notes will not be listed on any securities exchange or automated quotation system.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the New Notes, nor shall there be any sale of the New Notes in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

Cautionary Note Concerning Forward-Looking Statements

Certain statements and information in this news release constitute “forward-looking statements,” including statements regarding the intended use of proceeds. The words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could” or other similar expressions are intended to identify forward-looking statements, which are generally not historical in nature. These forward-looking statements represent ARLP’s expectations or beliefs concerning future events, and it is possible that the results described in this news release will not be achieved. These forward-looking statements are subject to risks, uncertainties and other factors, many of which are outside of ARLP’s control, which could cause actual results to differ materially from the results discussed in the forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as required by law, ARLP does not undertake any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. New factors emerge from time to time, and it is not possible for ARLP to predict all such factors. When considering these forward-looking statements, you should keep in mind the risk factors and other cautionary statements found in ARLP’s filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, ARLP’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The risk factors and other factors noted in ARLP’s SEC filings could cause actual results to differ materially from those contained in any forward-looking statement.

Investor Relations Contact:

Cary P. Marshall

Senior Vice President and Chief Financial Officer

918-295-7673

investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – YS Biopharma Announces Name Change to LakeShore Biopharma

Posted on by aweinsoff@channelchek.com

GAITHERSBURG, Md., May 24, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (Nasdaq: YS) (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced it is changing its legal name from “YS Biopharma Co., Ltd.” to “LakeShore Biopharma Co., Ltd”.

   

Dr. David Shao, Director, President, Co-Chief Executive Officer, and Chief Business Officer of the Company, commented, “We have decided to change our company name to LakeShore Biopharma to align with our global market positioning and international brand image. This change marks one of the first steps for us to expand our market reach, and we are eager to move forward and drive success under our new company name.”

The name change and trading symbol change will not affect any rights of shareholders or the Company’s operations and financial position. The Company’s ordinary shares and warrants will continue to be listed on the Nasdaq. Effective with the opening of the trading day on May 28, 2024, the ticker symbol of the Company’s ordinary shares and warrants will change from “YS” to “LSB” and from “YSBPW” to “LSBPW”, respectively. There is no action required by the Company’s current shareholders with respect to the company name or ticker symbol changes. The Company’s CUSIP will not change in connection with the name change.

About LakeShore Biopharma (formerly known as YS Biopharma)

LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.ysbiopharma.com.

Investor Relations Contact

Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-announces-name-change-to-lakeshore-biopharma-302155079.html

SOURCE 

Release – Traws Pharma’s ICAR Poster Highlights Potency Of COVID-19 Candidate

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TRAW

May 23, 2024

Differentiated resistance profile positions Traws’ program as a potential class leader

NEWTOWN, Pa., May 23, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced presentation of a poster at the annual International Conference on Antiviral Research (ICAR2024) which is being held from May 20th to May 24th in Gold Coast, Australia. The poster highlights positive results of preclinical experiments using patient isolates of COVID19 virus to define the resistance profile of ratutrelvir, formerly known as travatrelvir or TRX01, Traws’ ritonavir-free Mpro protease inhibitor for COVID19, currently in Phase 1 single and multiple ascending dose (SAD/MAD) escalation studies.

“We are very pleased to present the results of resistance studies for ratutrelvir at ICAR2024. Resistance studies are an important part of establishing a differentiation profile for an antiviral agent. Our initial data indicate that ratutrelvir has superior activity compared to nirmatrelvir against a range of omicron variants, based on a comparison of EC50. We believe the results presented at ICAR provide additional positive data to indicate that ratutrelvir has a differentiated resistance profile compared to nirmatrelvir,” said Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma.

Dr. Cautreels continued, “Some resistance mutations are common to both drugs but a large part of resistance to nirmatrelvir was not seen with ratutrelvir. Together, ratutrelvir’s differentiated resistance profile, promising pharmacokinetic effects, potential to be used without ritonavir and the accelerated pace of Phase 1 enrollment put the compound on track to advance to Phase 2 studies in H2 2024 and position ratutrelvir as a potential class-leading therapy for COVID- 19.”

C. David Pauza, Ph.D., Chief Scientific Officer, Virology at Traws Pharma said, “Understanding the patterns of resistance mutations gives us the ability to identify circulating viruses that may already be resistant to individual antiviral agents; selecting the right drug can be guided by this information. The resistance studies presented at ICAR compared ratutrelvir to nirmatrelvir, the only Mpro inhibitor approved in the U.S. Our data suggest that ratutrelvir exhibited greater activity compared to nirmatrelvir against wild type Mpro, and remained active against Mpro variants with specific mutations that are associated with nirmatrelvir resistance.”

Dr. Pauza added, “An important finding was that critical mutations accounting for much of the resistance to nirmatrelvir were not found using ratutrelvir, indicating important differences between the two compounds. These differences were most apparent when the nirmatrelvir-resistant mutants P252L or T304I were involved in drug resistance, as these mutations were not observed after ratutrelvir selection.

The data were reported in a poster entitled, “Travatrelvir, an inhibitor of SARS-CoV-2 Main Protease now in Phase 1 Clinical Trials: in vitro Drug Resistance Compared to Nirmatrelvir” (Abstract 356V) presented at ICAR by Bhargava Teja Sallapalli, Master of Veterinary Science, Department of Veterinary Medicine, Virginia-Maryland School of Veterinary Medicine, College Park Maryland et al. The poster can be found on the Scientific Presentations section of the Traws Investor Relations web page.

About Ratutrelvir, the Phase 1 Program and Planned Next Steps

Ratutrelvir (also previously known as 83-0060) was designed as an inhibitor of the SARS-CoV-2 Mpro (3CL protease). It has demonstrated in vitro activity against the original strain of the virus as well as the delta and omicron variants and is more active than nirmatrelvir (PAXLOVID®, Pfizer’s Mpro inhibitor) in preclinical studies. Also in preclinical studies, ratutrelvir did not require co-administration with a human cytochrome P450 (CYP) inhibitor, such as ritonavir, and so it is expected to avoid associated drug:drug interactions, potentially permitting wider patient use. The drug candidate’s pharmacokinetic (PK) profile may enable a once daily, treatment regimen and reduce the likelihood of viral rebound.

The Phase 1 study will evaluate single and multiple ascending doses of ratutrelvir in a double-blinded, placebo-controlled clinical trial to assess safety, tolerability, and pharmacokinetics. Subjects will be randomized 3:1 in five fasted and one fed single ascending dosing (SAD) cohorts and two multiple ascending dosing (MAD) cohorts. Topline data from the study, which is being conducted in Australia (NCT06402136), and the initiation of an international Phase 2 study in subjects with moderate to severe COVID19, are expected to take place in H2 2024.

About Traws Pharma, Inc.

Traws Pharma is a clinical stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes an oral inhibitor of the SARS-CoV-2 Mpro (3CL protease), ratutrelvir, and tivoxavir marboxil, a new oral antiviral drug candidate for influenza which targets the influenza cap-dependent endonuclease and has shown activity in cell-based assays against drug resistant viruses as well as against avian flu.

In the cancer program, Traws is developing the novel, proprietary multi-kinase CDK4-plus inhibitor narazaciclib for refractory endometrial cancer and potentially other cancers. Narazaciclib targets pathways involved in the development of resistance to CDK inhibitors.

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

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding preclinical studies to evaluate the resistance profile of ratutrelvir, the Phase 1 study of ratutrelvir in Australia and its design, timing and potential results and the timing of a planned Phase 2 study. Traws has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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

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