Category: Health

Release – Tonix Pharmaceuticals Reports Final Positive Pre-NDA Meeting with FDA for Tonmya™ for the Management of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 08, 2024 8:00am EDT

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia

Approximately 10 million adults in the U.S. are affected by fibromyalgia, predominantly women

NDA submission target confirmed for second half 2024, with potential for FDA approval in second half 2025

CHATHAM, N.J., July 08, 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 receipt of the formal minutes from a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. At the meeting, the Company and the FDA agreed that the proposed data package is sufficient to support the NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in the second half of 2025.

“We are delighted with the results of this critical milestone meeting with the FDA to discuss our NDA, and we are appreciative of the FDA’s guidance throughout this process. We believe Tonmya has the potential to greatly benefit fibromyalgia patients, many of whom remain dissatisfied with the current treatment options, and many of whom turn to addictive, detrimental opioids as off-label treatments,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The positive results from this pre-NDA meeting underscore the completeness of our data package in support of registration of Tonmya for the management of fibromyalgia.”

On June 20, 2024, Tonix announced receipt of formal minutes of a pre-NDA Type-B Chemistry, Manufacturing, and Controls (CMC) meeting confirming alignment with the FDA on key CMC topics to support the NDA submission. Today’s announcement confirms alignment with the nonclinical, clinical pharmacology and clinical features of the NDA submission, following completion of Tonix’s second and final pre-NDA meeting.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. According to the recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may also occur in the context of Long COVID.1

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

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

Tonix Pharmaceuticals Holding Corp.**

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction 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.

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

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

1U.S. National Academies of Sciences, Engineering, and Medicine. 2024. A Long COVID Definition: A chronic, systemic disease state with profound consequences. Washington, DC: The National Academies Press. https://doi.org/10.17226/27768. http://www.nationalacademies.org/long-covid-definition.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 8, 2024

Ligand Pharmaceuticals Expands Oncology Portfolio with $100 Million APEIRON Biologics Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its commercial-stage portfolio, Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced on July 8, 2024, its agreement to acquire APEIRON Biologics AG for $100 million in cash. This acquisition marks a significant expansion of Ligand’s oncology footprint, particularly in the realm of rare pediatric cancers.

The crown jewel of this acquisition is QARZIBA® (dinutuximab beta), a highly differentiated oncology drug used in the treatment of high-risk neuroblastoma in patients aged 12 months and above. QARZIBA, which received European Medicines Agency approval in 2017, is currently marketed in over 35 countries by global pharmaceutical company Recordati S.p.A.

Todd Davis, CEO of Ligand, emphasized the strategic importance of this acquisition, stating, “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors.”

The deal structure includes the initial $100 million cash payment, with the potential for up to an additional $28 million based on future commercial and regulatory milestones. Specifically, these additional payments are tied to QARZIBA royalties exceeding certain predetermined thresholds by either 2030 or 2034.

From a financial perspective, this acquisition is expected to make an immediate positive impact on Ligand’s bottom line. The company projects that the deal will be accretive to its earnings per share (EPS) by approximately $1.00 on an annualized basis, with a $0.50 impact expected for 2024 alone. In light of this, Ligand has increased its 2024 adjusted EPS guidance by 17% to a range of $5.00-$5.50.

The acquisition of APEIRON represents the sixth key asset added to Ligand’s commercial stage portfolio since the beginning of 2023, underscoring the company’s aggressive growth strategy. This diversification is expected to provide Ligand with a more stable and predictable revenue stream, a key consideration for investors in the volatile biotech sector.

QARZIBA’s unique position as the only immunotherapy for high-risk neuroblastoma marketed across Europe and other parts of the world makes it a particularly valuable addition to Ligand’s portfolio. Neuroblastoma, a rare cancer that primarily affects children, has limited treatment options, highlighting the potential impact of QARZIBA on patient outcomes.

In a parallel move, Ligand has also committed to investing up to $4 million in invIOs Holding AG, a privately held spin-off of APEIRON. This investment is aimed at financing the research and development of three innovative early-stage immuno-oncology assets, further expanding Ligand’s development stage portfolio.

Peter Llewellyn-Davies, CEO of APEIRON, expressed satisfaction with the deal, noting, “This transaction is an important milestone for our company and shareholders. We have spent more than 20 years translating academic research into therapeutic products for diseases with high unmet needs.”

The acquisition is expected to close in July 2024, subject to a 30-day shareholder objection period and other customary closing conditions. Upon completion, it will significantly reshape Ligand’s commercial portfolio and financial outlook.

As the biopharmaceutical industry continues to consolidate and seek ways to mitigate risk while maximizing potential returns, Ligand’s acquisition of APEIRON represents a strategic move to strengthen its position in the oncology market. By focusing on high-value, commercially available assets like QARZIBA, Ligand is positioning itself for sustained growth in the competitive and rapidly evolving pharmaceutical landscape.

Take a moment to take a look at emerging biotech companies by taking a look at Noble Capital Markets Research Analyst Robert LeBoyer’s coverage list.

Release – LakeShore Biopharma to Hold an Extraordinary General Meeting on July 25, 2024, Pursuant to Shareholders’ Requisition

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LSB

 Download this Press Release

GAITHERSBURG, Md., July 5, 2024 /PRNewswire/ — LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (“LakeShore 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 that the Company received a shareholders’ requisition dated June 14, 2024, issued by certain shareholders of the Company holding shares which carry in aggregate not less than 10% of all votes attaching to all issued and outstanding shares of the Company, including Yi Zhang, All Brilliance Investments Limited, Apex Pride Global Limited, Hopeful World Company Limited, and Acton Town International Limited (together, the “Requisitioning Shareholders”), requesting the directors of the Company to convene an extraordinary general meeting (the “EGM”) of the Company (the “Requisition”) to provide explanations to the shareholders of the Company on matters as described below:   

  1. The circumstances leading to the filing of the United States Securities and Exchange Commission Form 6-K Report, filed on June 10, 2024 (the “SEC Report”), including the reasons for the resignation of each of the former directors specified in the SEC Report.
  2. The justification for establishing new subsidiaries of the Company, including Lakeshore Tech Hong Kong Limited and Huan Yuanhang Technology (Beijing) Co., Ltd. The purpose of establishing these new subsidiaries, the related costs, the intended operations of each entity, and if any assets or personnel are intended to be transferred from the Company to any of the subsidiaries.
  3. The reasons leading to the conclusion that “[t]aking into account the financial resources available to the Company and Liaoning Yisheng, the Company does not expect the arbitration proceedings and related asset preservation order to have a material adverse impact on its business, financial condition and results of operations. The Company is in the course of evaluating its options to protect the legitimate interests of the Company and its shareholders through legal means” in the SEC Report.

The Board has reviewed the Requisition and decided to convene an EGM (the “Proposed EGM”) at 10:00 a.m. Hong Kong Time on July 25, 2024, virtually via a Zoom video conference call. The Proposed EGM will be held for the sole purpose of providing information as requested by the Requisitioning Shareholders. A copy of the notice of the Proposed EGM posted to the Company’s website will be attached as an exhibit to the Current Report on Form 6-K to be furnished by the Company with the United States Securities and Exchange Commission today.

The close of business on July 15, 2024 (Eastern Time) has been fixed as the record date of ordinary shares of the Company, par value $0.00002 per share for the EGM. Holders of record of the Company’s ordinary shares as of the record date shall be entitled to vote and have their votes counted at the EGM and any adjourned meeting thereof.

Instructions for accessing the video conference call are as follows:

Zoom dial-in details:

Meeting URL: https://us06web.zoom.us/j/6195900008?pwd=OTEvOGtnNFVpaUdBUkdRRlp4Y0txUT09

Meeting ID: 619 590 0008

Passcode: 666666

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 https://investor.lakeshorebio.com/.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “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. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of LakeShore Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, LakeShore Biopharma’s ability to source and retain talent, and the cash position of LakeShore Biopharma. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of LakeShore Biopharma’s management and are not predictions of actual performance.

LakeShore Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the Post-effective Amendment No. 2 to the Company’s Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that LakeShore Biopharma does not presently know or that LakeShore Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of LakeShore Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while LakeShore Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of LakeShore Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, LakeShore Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

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

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lakeshore-biopharma-to-hold-an-extraordinary-general-meeting-on-july-25-2024-pursuant-to-shareholders-requisition-302189967.html

SOURCE LakeShore Biopharma Co., Ltd

Release – Tonix Pharmaceuticals Awarded Up to $34 Million U.S. Department of Defense Contract for Accelerated Development of Broad-Spectrum Antiviral Program

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 01, 2024 8:00am EDT Download as PDF

Defense Threat Reduction Agency (DTRA) contract is expected to advance development of Tonix’s broad-spectrum oral antiviral program TNX-4200 for medical countermeasures

CHATHAM, N.J., July 01, 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 it has been awarded an Other Transaction Agreement (OTA) with a potential for up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments.

Tonix’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission and to fund a first-in-human Phase 1 clinical study.

“Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. Joint Forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President, and Chief Executive Officer of Tonix. “The DoD announced in December 2022 that they are moving beyond a ‘one bug, one drug’ approach and are seeking broad-spectrum drugs since one cannot predict which or how many viruses may be deployed.1 This funding provides important validation for our ongoing research and current in-house capabilities, and will enable Tonix to advance its antiviral discovery program.”

The $34 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.

Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.

1 “Approach for Research, Development, and Acquisition of Medical Countermeasure and Test Products.” 2022. Chemical and Biological Defense Program. U.S. Department of Defense. https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF (accessed March 5, 2024)

About Defense Threat Reduction Agency (DTRA)

The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD) is both a Defense Agency and Combat Support Agency with two distinct yet highly integrated roles countering Weapons of Mass Destruction (WMD) and emerging threats. Its origins stretch back to World War II and the Manhattan Project, but today the agency encompasses a wide variety of strategic and operational functions that deter, prevent, and ultimately prevail against these unique threats. DTRA enables the Department of Defense (DoD), the United States Government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats. DTRA provides cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to deter strategic attack against the United States and its allies; prevent, reduce, and counter WMD and emerging threats; and prevail against WMD-armed adversaries in crisis and conflict. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit www.dtra.mil.

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 July 1, 2024

Release – Unicycive Therapeutics Joins Russell Microcap® Index

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

July 01, 2024 7:03am EDT Download as PDF

LOS ALTOS, Calif., July 01, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced it was included in the Russell Microcap Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective at the open of US equity markets on Monday, July 1, 2024.

The annual Russell US Indexes reconstitution captures the 4,000 largest US stocks as of Tuesday, April 30th, ranking them by total market capitalization. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes.

“Inclusion in the Russell Microcap Index represents the latest milestone as a public company and validates the progress we have made over the last year,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Inclusion in the Index continues our strong momentum following our positive clinical trial results for oxylanthanum carbonate (OLC) announced last week. We believe our addition to this index will benefit our shareholders by increasing our visibility within the investment community.” 

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Russell’s US indexes serve as the benchmark for about $10.5 trillion in assets as of the close of December 2023. Russell indexes are part of FTSE Russell, a leading global index provider.

Fiona Bassett, CEO of FTSE Russell, An LSEG Business, comments, “Russell indexes–now in their 40th year–continue to evolve to reflect the dynamic US economy. Annual rebalancing plays a vital role in establishing accurate benchmarks, ensuring they correctly mirror their designated market segments and remain unbiased in terms of size and style.”

For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About FTSE Russell:

FTSE Russell is a leading global provider of benchmarking, analytics, and data solutions for investors, giving them a precise view of the market relevant to their investment process. A comprehensive range of reliable and accurate indexes provides investors worldwide with the tools they require to measure and benchmark markets across asset classes, styles, or strategies.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products, and index-based derivatives. ​​​​​​​

FTSE Russell is focused on applying the highest industry standards in index design and governance, employing transparent rules-based methodology informed by independent committees of leading market participants. FTSE Russell fully embraces the IOSCO Principles, and its Statement of Compliance has received independent assurance. Index innovation is driven by client needs and customer partnerships, allowing FTSE Russell to continually enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit https://www.lseg.com/en/ftse-russell.

About Unicycive Therapeutics

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

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released July 1, 2024

Schwazze (SHWZ) – Noble Consumer Virtual Conference

Posted on by cpereira@noblefcm.com


Monday, July 01, 2024

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Conference. We hosted Schwazze Chairman Justin Dye at the Noble Capital Emerging Growth Conference on June 27th. The entire presentation with Q&A can be found at https://www.channelchek.com/videos/schwazze-shwz-noble-capital-markets-virtual-consumer-tmt-conference-replay. The following are key highlights of the presentation.

Improving Outlook. Schwazze is seeing improvement in both Colorado and New Mexico from a competitive standpoint. In Colorado, pricing continues to stabilize, which will prove positive to both the top line and gross margin dollars. In New Mexico, enhanced enforcement of illegal operators and the illicit market is beginning to produce results, which will benefit Schwazze over the longer-term, in our view.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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

Release – Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 28, 2024 4:05pm EDTDownload as PDF

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance.

The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. acted as the sole placement agent for the offering.

Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

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 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 28, 2024

GeoVax Labs (GOVX) – CRO Partnership For Clinical Trial Allows Sponsored Phase 2b Trial To Move Forward

Posted on by cpereira@noblefcm.com


Friday, June 28, 2024

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

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

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

Partnership For BARDA-Funded Trial Announced. GeoVax announced a partnership with Allucent, a global clinical management organization (CRO), to conduct the Phase 2 clinical trial for CM04S1. The trial has been awarded approximately $357 million in funding through Project NextGen, with about $24.3 million going to GeoVax and the balance to fund the clinical trial costs. We see the partnership as an important step toward the start of the clinical trial, as well as another scientific validation for CM04S1 and the GeoVax manufacturing technologies.

The Partnership Allows The Trial To Begin As Expected. Under the grant, GeoVax is the trial sponsor with responsibility for manufacturing and providing vaccine supplies. The grant also requires a CRO to conduct the trial and manage its clinical operations. The announcement of the partnership with Allucent, a global CRO that can provide these services, allows the trial to move forward with a possible starting date during summer 2024.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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

Release – GeoVax Partners with Allucent to Conduct Phase 2b Clinical Study of Next-Generation COVID-19 Vaccine Candidate with Funding from BARDA

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

10,000-participant randomized Phase 2b study will evaluate and compare GeoVax’s multi-antigen, vaccine

candidate (GEO-CM04S1) to an approved vaccine against COVID-19

Study is Funded by BARDA through Project NextGen, executed through its Clinical Studies Network

Atlanta, GA, June 27, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today that it will partner with Allucent, a global clinical research organization (CRO), to conduct a Phase 2b clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine.

GeoVax previously announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to evaluate the relative efficacy of GEO-CM04S1 compared to an approved/authorized COVID-19 vaccine to prevent symptomatic, PCR-confirmed SARS-CoV-2 infection. As part of BARDA’s Clinical Studies Network, Allucent will initiate and implement the BARDA-funded study. The combined value of the awards to GeoVax and Allucent toward the clinical evaluation of GEO-CM04S1 is approximately $367 million.

David Dodd, Chairman & CEO of GeoVax, stated, “The work supported by BARDA’s Project NextGen will significantly advance the collective efforts to combat COVID-19 and its variants, and we are proud that GEO-CM04S1 was selected to be part of those critically important initiatives. We are delighted to be collaborating with Allucent on this important study.”

Mark A. Goldberg, M.D., Chairman and CEO of Allucent, commented, “We are honored to have been previously chosen by BARDA to be part of its Clinical Studies Network for this critical initiative and pleased to be offered the opportunity to execute the Phase 2b trial of GEO-CM04S1 in collaboration with GeoVax. We are excited to leverage our clinical development expertise and resources to help develop next-generation booster vaccines that will enhance global immunity and save lives.”

About Project NextGen

Funding for this project is provided under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. GeoVax’s vaccine candidate provides many of the features identified, including broader protection among variants of concern (VOC) and a longer duration of protection.

GeoVax’s role in this project is being funded in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) 75A50123D00005.

Allucent’s role in this project is being funded in whole or in part with federal funds from the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract 75A50120D00016/75A50123F33005.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T-cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:

  • As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T-cell responses.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
  • As a booster vaccine for healthy adults who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466.

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.

About Allucent

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of its biopharma and government clients. Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across various therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients. Visit Allucent.com for more information.

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@precisionaq.com sr@roberts-communications.com 
678-384-7220 212-698-8696 202-779-0929

Release – Tonix Pharmaceuticals Announces Pricing of Approximately $4.0 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 27, 2024 8:36am EDT

CHATHAM, N.J., June 27, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of approximately 7,060,918 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu thereof). The closing of the public offering is expected to take place on or about June 28, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

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 including those relating to the completion of the public offering, the satisfaction of customary closing conditions, the intended use of proceeds from the public offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 27, 2024

AI Revolution in Healthcare: Simplify Healthcare Acquires Virtical.ai

Posted on by slightbourne@noblecapitalmarkets.com

In a groundbreaking move, Simplify Healthcare has announced its acquisition of Virtical.ai, setting the stage for a dramatic transformation in health insurance technology. This strategic merger, revealed on June 24, 2024, combines Simplify Healthcare’s established SaaS platform with Virtical.ai’s advanced artificial intelligence capabilities, promising to revolutionize how health insurance providers operate in an increasingly complex market.

The timing of this acquisition is particularly significant as the healthcare industry grapples with mounting pressures to personalize services, streamline operations, and navigate intricate regulatory landscapes. By integrating Virtical.ai’s AI prowess into its Simplify Health Cloud™ platform, Simplify Healthcare aims to empower health insurance companies (Payers) with sophisticated tools to address these challenges effectively.

At the core of this acquisition lies the transformative potential of AI-driven solutions. Virtical.ai’s technology, which has been trained on an extensive database of health plan-specific documents, excels in data extraction and comparison. This capability enables Payers to offer highly personalized plans and benefits to both employer and individual segments, potentially revolutionizing the way health insurance is customized to meet individual needs.

Simplify Healthcare’s leadership team has expressed enthusiasm about the merger’s potential to reshape the industry. They emphasize the ability of AI models to process complex documents such as Statements of Benefits and Coverage (SBCs) and Machine Readable Files (MRFs), highlighting the potential for significant advancements in plan comparison, selection, and price transparency.

The acquisition also addresses critical challenges in network management. Virtical.ai’s platform can identify gaps in Payer networks by analyzing provider and member locations. This feature allows Payers to strategically promote their network coverage strengths and address deficiencies, ensuring members have access to suitable providers within their area. Moreover, the ability to benchmark negotiated provider rates against competitors offers Payers valuable insights for rate-setting and targeted marketing initiatives.

Virtical.ai’s leadership shares the excitement about the merger’s potential impact. They highlight how their AI models, built on decades of industry experience, are positioned to drive membership growth and revenue when integrated with Simplify Healthcare’s enterprise SaaS platform.

The integration of Virtical.ai’s technology is expected to enhance several of Simplify Healthcare’s existing solutions, including Benefits1™, Provider1™, Service1™, Claims1™, and Experience1™. These enhancements promise to provide Payers with more precise solutions to complex challenges in delivering products, benefits, and provider data.

Simplify Healthcare’s strategic team underscores the acquisition’s importance in the face of market disruptions. They believe that combining their industry-leading platform with Virtical.ai’s innovative AI solutions in Health Plan Sales and Network Management will empower Payers to achieve growth despite facing disruptive market and regulatory forces.

This merger also reflects a broader industry trend towards leveraging AI and machine learning to improve efficiency and personalization. By utilizing both generative AI and machine learning algorithms on unstructured document content and structured data, the combined entity aims to deliver cutting-edge solutions to Payers navigating the complexities of AI integration.

As the healthcare landscape continues to evolve, this acquisition positions Simplify Healthcare at the forefront of the AI revolution in health insurance technology. The promise of more personalized health plans, optimized network coverage, and data-driven decision-making tools could significantly impact not only Payers but also brokers and, ultimately, healthcare consumers.

With this bold move, Simplify Healthcare and Virtical.ai are poised to play a pivotal role in shaping the future of health insurance in an increasingly digital and personalized world. Their combined expertise and technological capabilities have the potential to drive innovation, enhance efficiency, and improve the overall experience for all stakeholders in the health insurance ecosystem.

Take a moment to take a look at GoHealth Inc. (GOCO), a health insurance marketplace that leverages modern machine-learning algorithms and helps individuals find the best health insurance plan for their specific needs.

Release – Tonix Pharmaceuticals Announces Proposed Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market data on TNXP

June 26, 2024 4:40pm EDT

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

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 June 26, 2024

Release – Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 26, 2024 3:13pm EDT

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 26, 2024, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction 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.

**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.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 26, 2024