Author: aweinsoff@channelchek.com

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

Release – Bitcoin Depot Partners with New England-Based Convenience Retailer Nouria Energy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTM

May 23, 2024 8:00 AM EDTDownload as PDF

Company to Install 57 New Bitcoin ATM Kiosks Beginning in Q2 2024

ATLANTA, May 23, 2024 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced a new retail partnership with Nouria Energy Corporation (“Nouria”), a leading convenience store brand based in the northeastern U.S. with robust operations across 175 company owned c-stores and fuel retailers. Beginning in Q2 2024, Bitcoin Depot will deploy its kiosks into 57 Nouria locations across Massachusetts, Maine, and New Hampshire.

“We are thrilled to join forces with Nouria, a respected leader in convenience retail, as we continue our ambitious growth journey throughout 2024,” said Brandon Mintz, CEO of Bitcoin Depot. “At Bitcoin Depot, it is our singular mission to provide unparalleled convenience and pioneering solutions to enhance crypto accessibility for our customers. That objective is made possible through synergistic collaboration with our network of like-minded retail partners, and we look forward to our partnership with Nouria in the months ahead.”

“We are excited to partner with Bitcoin Depot to introduce BTM kiosks in Nouria stores, offering our guests exciting new opportunities to engage with cryptocurrency,” said Kristine Modugno, Director of Category Management at Nouria. “We continuously strive to elevate our suite of products and services for guests, and Bitcoin Depot’s products exemplify a customer-centric approach that perfectly aligns with our operational mentality.”

Bitcoin Depot’s products and services provide an intuitive, quick, and convenient process for converting cash into Bitcoin. This allows users to access the broader digital financial system, including using Bitcoin to make payments, transfers, remittances, online purchases, and investments.

The Company has successfully enacted a series of significant growth and expansion initiatives thus far in 2024, serving to reinforce its position as the market share leader in North America. In April 2024, Bitcoin Depot announced a partnership with its first major grocery chain and purchased an additional 2,300 kiosks to meet increased retailer demand. The Company’s momentum was reinforced further by recent expansion into Australia and Puerto Rico along with achieving the largest installed fleet of BTMs in its history by surpassing its goal of signing 8,000 BTM locations ahead of schedule.

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.   

About Nouria Energy Corporation
Nouria Energy Corporation, founded in 1989, is one of New England’s largest and most trusted family-owned and operated convenience stores and fuel retailers. With a robust C- Store operation of 175 company-owned locations and a vast dealer network, Nouria provides top-tier products, fresh food, and excellent customer service throughout the Northeast. Nouria also owns and operates over 60 independent car wash locations in New England under the Golden Nozzle brand.

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, Alex Kovtun  
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 

Source: Bitcoin Depot Inc.

Released May 23, 2024

Release – AdTheorent Named Best AdTech Platform in 2024 Digiday Media Awards

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ADTH

May 22, 2024

NEW YORK, May 22, 2024 /PRNewswire/ — AdTheorent Holding Company, Inc. (Nasdaq: ADTH), a machine learning pioneer using privacy-forward solutions to deliver measurable value for programmatic advertisers, today announced that it has been named “Best AdTech Platform” in the 2024 Digiday Media Awards. The Digiday Media Awards honor the companies that are modernizing digital media.

AdTheorent named “Best AdTech Platform” in the 2024 Digiday Media Awards.

   

AdTheorent is a digital media platform with transformational privacy-forward methods to execute high-performing programmatic digital advertising campaigns for brand and agency customers. Rather than focusing on targeting user IDs, AdTheorent uses advanced data science and machine learning to score ad impressions based on the statistical likelihood that serving ads on such impressions will yield desired campaign business goals. AdTheorent builds custom machine learning models for each campaign goal and deploys them to the platform for automated execution and optimization. In addition, AdTheorent’s groundbreaking algorithm-based and ID-independent audience targeting solution has re-conceptualized what a targetable digital audience can be, leveraging advanced algorithms – not user IDs – to focus campaign delivery within each advertiser’s desired target audience while driving performance. AdTheorent’s privacy-forward approach to digital advertising and its ability to drive superior performance for advertisers sets the company apart from others in the industry. 

“AdTheorent brings a foundationally different approach to programmatic advertising which drives business outcomes for advertisers in a privacy-forward and efficient manner. We remain committed to building and enhancing the most advanced and differentiated machine learning-powered advertising technology and solutions ever deployed in market,” said Jim Lawson, CEO of AdTheorent. “We are honored to win the Digiday Media Award for ‘Best AdTech Platform’ and thank the judges for this valuable recognition.”

The 2024 Digiday Media Awards recognize companies that are modernizing the digital media industry through technology, partnerships, and innovation. Digiday’s panel of industry-leading judges evaluated hundreds of entries to identify the companies or campaigns that clearly demonstrate success based on the following criteria: Innovation, Creativity, Consumer Value, Results and Overall. Digiday’s awards programs are some of the most influential in the industry.

For more information about AdTheorent’s approach, click here.

About AdTheorent
AdTheorent (Nasdaq: ADTH) uses advanced machine learning technology and privacy-forward solutions to deliver impactful advertising campaigns for marketers. AdTheorent’s machine learning-powered media buying platform powers its predictive targeting, predictive audiences, geo-intelligence, audience extension solutions and in-house creative capability, Studio A\T. Leveraging only non-sensitive data and focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals. 

AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for five consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada. For more information, visit adtheorent.com.

(PRNewsfoto/AdTheorent, Inc.)

   

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/adtheorent-named-best-adtech-platform-in-2024-digiday-media-awards-302152145.html

SOURCE AdTheorent

Melanie Berger, AdTheorent, melanie@adtheorent.com, 850-567-0082

Release – Tonix Pharmaceuticals to Deliver an Oral Presentation and Present Two Posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 22, 2024 8:00am EDT

Oral Presentation of Tonmya™ (TNX-102 SL) for Fibromyalgia; NDA preparation in progress

Posters Highlighting Other TNX-102 SL Programs In Clinical Development; Long COVID and Acute Stress Disorder

CHATHAM, N.J., May 22, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company will deliver an oral presentation and present two posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 at the Loews Miami Beach Hotel in Miami Beach, Fla.

The oral presentation will detail findings of studies of Tonmya (TNX-102 SL, sublingual cyclobenzaprine HCl) in fibromyalgia. One poster will describe the Phase 2 proof of concept study of TNX-102 SL in fibromyalgia-type Long COVID. The second poster will describe the upcoming investigator-initiated Phase 2 trial of TNX-102 SL in treating acute stress disorder and preventing posttraumatic stress disorder after motor vehicle collision, which will be conducted by the University of North Carolina, the sponsor of the study.

TNX-102 SL is a centrally acting, non-opioid medication, which is trade named Tonmya™ for the management of fibromyalgia. As previously announced, the second statistically significant Phase 3 study of Tonmya, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo in participants with fibromyalgia (p=0.00005). Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

Tonix plans to submit a New Drug Application (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.

Copies of the Company’s presentation and posters 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 ASCP website here.

Oral Presentation Details

Presenter:Seth Lederman, M.D., Chief Executive Officer
Title:Effects of Bedtime TNX-102 SL (Sublingual Cyclobenzaprine (CBP) HCl) on Mood and Anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RESILIENT Trial
Date/Time:May 29, 2024, 3:00 p.m. ET

Poster Presentation Details

Presenter:Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine
Title: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
Date/Time:May 30, 2024, 12:30 p.m. ET
Presenter:David Hsu, Ph.D., Senior Scientist
Title: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
Date/Time:May 30, 2024, 12:30 p.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: Tonix Pharmaceuticals Holding Corp.

Released May 22, 2024

Release – Tonix Pharmaceuticals Announces Key Findings from Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya™ for the Management of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

CHATHAM, N.J., May 21, 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, announced today that EVERSANA® Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TonmyaTM (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a potential new first line therapy for the management of fibromyalgia. Tonix previously announced that EVERSANA was selected to support the launch strategy and commercial planning of Tonmya. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market (GTM) strategy.

“The primary research and analysis conducted by EVERSANA provides valuable insights and informs the vision for the commercialization of Tonmya,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to refine our business strategy for the anticipated launch of Tonmya in 2025. It has been approximately fifteen years since patients suffering with fibromyalgia have been provided a new therapeutic option. The market research conducted by EVERSANA with physicians indicates a continued high unmet need, with the need ranked > 4.0 on a 5-point scale.”

Dr. Lederman continued, “We were surprised to learn that opioids dominate the fibromyalgia prescription market, despite the well-known risks of dependency. Opioids are prescribed to more patients following fibromyalgia diagnosis than all the FDA-approved fibromyalgia drugs combined. If approved, we believe that Tonmya can provide a non-opioid, centrally-acting solution for fibromyalgia patients. This is corroborated by EVERSANA’s primary market research in which physicians indicated median interest of 4.0 on a 5-point scale and intended use of Tomya in 40% of their fibromyalgia patients, upon approval.1 We look forward to submitting the NDA for Tonmya in the second half of this year and expect an FDA decision on approval in 2025.”

EVERSANA’s analysis of the market size was based on medical claims databases and epidemiological studies on prevalence and diagnosis2. Primary research with physicians was conducted to test the potential adoption of Tonmya based on its activity and tolerability.  

Key findings from claims data analyses2:

  • ~2.7 million adults in the U.S. currently diagnosed and treated for fibromyalgia.
    • ~90 percent of patients diagnosed with fibromyalgia are female.
  • Percentage of fibromyalgia patients who were prescribed certain drugs3:
    • FDA-approved fibromyalgia drug prescriptions:
      1. Duloxetine (generic Cymbalta®): 23%, pregabalin (generic Lyrica®): 13%, and Savella® (milnacipran): 1%
    • Off-label drug prescriptions:
      1. Gabapentin: 26%, hydroxycodone: 20%, cyclobenzaprine: 18%, oxycodone: 19%, tramadol: 13%, meloxicam: 12%, and amitriptyline: 6%
    • Off-label opioids prescriptions:
      1. Hydroxycodone: 20%, oxycodone: 19%, and tramadol: 13%
  • Targeted prescriber strategy for launch.
    • High prescribers are rheumatologists, pain medicine specialists, primary care physicians, neurologists, and psychiatrists.
  • ~50 percent of diagnosed fibromyalgia patients are covered by Medicare.
    • Medicare population stands to benefit from a decrease in out-of-pocket prescription drug liability to $2,000 per year when the changes from the Inflation Reduction Act are enacted in 2025.

Key findings from primary physician research4:

  • High level of dissatisfaction with currently prescribed drugs.
    • Physicians interviewed estimate that 85% of their patients fail first-line therapy due to efficacy and tolerability issues and 79% of their patients are on multiple therapies.
    • Prescribers indicate high unmet need in fibromyalgia, ranked >4.0 on a 5-point scale.
  • High level of interest in Tonmya from physicians interviewed as a potential new treatment option based on favorable activity and tolerability profile observed in Tonmya fibromyalgia clinical studies.
    • Median interest in Tonmya of 4 on a 5-point scale.
    • Physicians indicated intended use of Tonmya in 40% of their fibromyalgia patients.1

Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix’s second statistically significant Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

Tonix plans 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.

1 40% was the median preference share among physicians interviewed, assuming no market access barriers.
2 EVERSANA analysis of claims database, May 2024; commissioned by Tonix
3Note: the total number of patients is greater than 100% because of switching between medications and polypharmacy.
4 EVERSANA primary physician research, May 2024; commissioned by Tonix

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

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

*Tonmya™ 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.

About EVERSANA®

EVERSANA® is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive 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 with 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.

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 commercialize 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

Matt Braun
EVERSANA
Matt.braun@eversana.com

Source: Tonix Pharmaceuticals Holding Corp.

Released May 21, 2024

Release – GeoVax to Raise Approximately $1.3 Million of Gross Proceeds in Offering Priced At-the-Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Atlanta, GA, May 17, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into a definitive securities purchase agreement with a certain institutional investor for the purchase and sale of 802,844 shares of the Company’s common stock (or common stock equivalents) at a price of $1.68 per share in a registered direct offering priced at-the-market under Nasdaq rules.

In addition, in a concurrent private placement, the Company will issue to the investor warrants to purchase up to 1,605,688 shares of common stock. The warrants have an exercise price of $1.68 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $1.3 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about May 21, 2024, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a ‘shelf’ registration statement on Form S-3 (File No. 277585) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on March 13, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

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

About GeoVax

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®, which recently completed enrollment 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. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                   Investor Relations Contact:                  Media Contact:
info@geovax.com austin.murtagh@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8696 202-779-0929

Release – Traws Pharma Reports First Quarter 2024 Financial Results And Provides Business Update

Posted on by aweinsoff@channelchek.com

May 16, 2024

PDF Version

Completed acquisition of Trawsfynydd and concurrent $14 million Capital Raise

Excellent pipeline progress, led by candidates for COVID 19, influenza, and oncology programs

Poised to initiate Phase 2 studies in H2 2024 for our influenza candidate and
ritonavir-free COVID 19 protease inhibitor

NEWTOWN, Pa., May 16, 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 financial results for the first quarter of 2024, and provided a business update.

“2024 has already been a transformative year for Traws Pharma to advance our portfolio of novel treatments for serious respiratory infections and oncology programs. We completed the acquisition of Trawsfynydd and concluded a concurrent $14 million private placement financing. In addition, we initiated first-in-human dosing for our COVID 19 product candidate, including completion of the first cohort dosing group. Furthermore, we completed the last dose escalation cohort for our CDK4+ inhibitor, narazaciclib,” stated Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma. “We believe that we are poised to make even more meaningful progress in the second half of 2024, as we advance our influenza treatment and ritonavir-free protease inhibitor for COVID 19 into expanded Phase 1 dose escalation studies and begin Phase 2 development.”

“Based on the preclinical profile and early clinical data from our infectious disease candidates and narazaciclib, I am optimistic about the outlook for Traws’ portfolio and look forward to updating our investors with our progress through the year,” concluded Dr. Cautreels.

Traws Proprietary Portfolio Highlights:

TRX100 (tivoxavir marboxil): a cap-dependent endonuclease inhibitor for influenza: Phase 1

  • Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication including A and B strains
  • First Phase 1 study demonstrated safety and tolerability in healthy volunteers with pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose for treatment or prophylaxis
  • We plan to initiate Phase 1 dose extension to evaluate one additional, higher dose prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected in H1 2025

TRX01 (ratutrelvir): a ritonavir-free Mpro protease inhibitor for COVID19: Phase 1

  • Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), effective against the original, delta, and omicron variants of SARS-CoV-2, that does not require co-administration with ritonavir, reducing the risk of drug-drug interactions. Preclinical data support once-daily dosing for 10days which could overcome viral rebound seen with other agents.
  • We are in the process of conducting a Phase 1 first-in-human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers. The second dosing cohort is underway and topline data are expected H2 2024. A Phase 2 study is also planned to begin in H2 2024 in patients with moderate to severe COVID19. Topline data are expected H1 2025

Narazaciclib: CDK 4+ to treat solid tumors: Phase 1/2

  • Available preclinical and clinical data suggest that narazaciclib is active in numerous tumor types, inhibiting CDK 2/4/6, CSF1R and ARK 5/NUAK1. Preclinical studies also showed reduced neutropenia, as compared to palbociclib, and inhibition of palbociclib resistant cancer cells.
  • A dose escalation study to define the recommended Phase 2 dose (RP2D) recently enrolled the last cohort. A review of the clinical and PK/PD data is underway. We intend to utilize these data to define the clinical strategy, including selection of a lead indication and next steps in its development.

First Quarter 2024 Financial Results

Cash and cash equivalents as of March 31, 2024, were $16.4 million, compared with $20.8 million as of December 31, 2023.

In April 2024, the Company raised gross proceeds of $14 million from the sale of common and preferred stock to TPAV, LLC, an affiliate of Torrey Pines, and OrbiMed Private Investments VIII, LP, an affiliate of OrbiMed Advisors.

The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the fourth quarter of 2024.

Revenue was fifty-six thousand dollars for the first quarter of 2024, consistent with the same period in 2023.

General and administrative (G&A) expenses were $3.4 million for the first quarter of 2024, compared with $2.1 million for the same period in 2023. The increase in G&A expenses was caused by higher legal and professional fees related to the Trawsfynydd acquisition on April 1, 2024, partially offset by lower bonus accrual as well as lower insurance, meeting, and public company expenses.

Research and development (R&D) expenses were $1.9 million for the first quarter of 2024, compared with $4.1 million for the same period in 2023. The decrease was primarily caused by lower costs related to narazaciclib drug substance and drug product manufacturing, a reduction in clinical development and consulting costs and lower personnel expenses due to lower bonus accrual.

Net loss for the first quarter of 2024 was $5.0 million, or $0.24 per share on 20.8 million weighted average shares outstanding, compared with a net loss of $5.8 million, or $0.28 per share for the same period in 2023, based on 20.8 million weighted average shares outstanding.

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 potentially for refractory endometrial cancer and other solid tumor 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 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

Release – Xcel Brands To Host First Quarter 2024 Earnings Call On May 20

Posted on by aweinsoff@channelchek.com

Research News and Market Data on XELB

May 16, 2024 at 8:01 AM EDT

PDF Version

NEW YORK, May 16, 2024 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), today announced that it will report its first quarter 2024 financial results on May 20, 2024. The Company will hold a conference call with the investment community on May 20, 2024, at 5:00 p.m. ET.

A webcast of the conference call will be available live on the Investor Relations section of Xcel’s website at https://xcelbrands.co/pages/events-and-presentations or directly at https://edge.media-server.com/mmc/p/r52mtx59.

Interested parties unable to access the conference call via the webcast may dial 800-715-9871 or 646-307-1963 and use the Conference ID 3975904. A replay of the webcast will be available on Xcel’s website.

About Xcel Brands

Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, marketing, live streaming, social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as one thing. Xcel owns the Judith Ripka, Halston, LOGO by Lori Goldstein, and C. Wonder by Christian Siriano brands and a minority stake in the Isaac Mizrahi brand. It also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC and a 50% interest in a JV in TWRHLL (“Tower Hill”) by Christie Brinkley. Also Xcel owns a 30% interest in Orme, a short-form video market place. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customer’s shop. The company’s brands have generated in excess of $4 billion in retail sales via livestreaming in interactive television and digital channels alone. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.

For further information please contact:
Seth Burroughs
Xcel Brands
sburroughs@xcelbrands.com

Source:

Release – SEPTA Launches 3D Fare Gates Pilot Program with Conduent Transportation to Detect and Deter Fare Evasion

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CNDT  

MAY 16, 2024

TRANSPORTATION

SEPTA pilots Conduent’s solution with plans to expand the number of fare gates in the future

Conduent’s 3D Fare Gate Solution is designed to detect, deter and quantify fare evasion, benefiting both agencies and riders

FLORHAM PARK, N.J. — Conduent Transportation, a global provider of smart mobility technology solutions and business unit of Conduent Incorporated (Nasdaq: CNDT), today announced a pilot program by the Southeastern Pennsylvania Transportation Authority (SEPTA) using Conduent’s 3D Fare Gate Solution at a Philadelphia area transit station. The pilot aims to track and curb incidents of fare evasion, which costs SEPTA an estimated $30 million to $40 million annually.

“We’re excited to be part of this important pilot for SEPTA to help detect, deter and quantify fare evasion, while simultaneously offering both the agency and riders increased security and convenience”

SEPTA selected the 69th Street station in Upper Darby as its test location for riders traveling on the Market-Frankford and Norristown High Speed lines. The gates, each measuring 7 feet, 8 inches tall, began operating in April. Following the three-month pilot program, the agency plans to expand the fare gates’ availability to other stations, including those with high reported incidents of fare evasion.

“We’re excited to be part of this important pilot for SEPTA to help detect, deter and quantify fare evasion, while simultaneously offering both the agency and riders increased security and convenience,” said Adam Appleby, President, Transportation Solutions at Conduent. “As transit agencies across the country and around the world grapple with how to curb fare evasion, Conduent is poised and ready to deliver our solution, which has shown to deliver meaningful results and helps ensure riders pay their fares.”

Conduent’s 3D Fare Gate Solution uses innovative 3D detection optical sensors, allowing travelers fast and convenient access while detecting and deterring ticketing fraud. The gates also provide transit authorities quick access to reporting and analytics, aiding in enforcement decisions by identifying precisely when and where fare evasion occurs.

The gates, which were also implemented in Paris by Transilien SNCF in 2019, are designed to detect the most common types of fare evasion using advanced, sensor-based feedback mechanisms. The solution, which is ADA-compliant and adaptable to meet agency needs, improves equity in transportation by improving accessibility for all riders as well as helping to ensure passengers pay their share.

SEPTA is one of the largest transit systems in the country, serving five counties in the Greater Philadelphia area and connecting to Delaware and New Jersey transit systems. It operates across six transportation modes and has 2,800 vehicles in service, 285 subway and rail stations, plus 13,000 bus and trolley stops.

Conduent Transportation is a leading provider of streamlined, high-volume mobility services and solutions, spanning road usage charging and advanced transit systems, that enhance the services provided by transportation agencies to benefit the citizens who use them. For over 50 years, the company has helped clients advance transportation solutions in more than 20 countries.

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

NEIL FRANZ

Conduent

neil.franz@conduent.com

+1-240-687-0127

GILES GOODBURN

Conduent

ir@conduent.com

+1-203-216-3546