TNXP Tonix Pharmaceuticals Holding Corp.

0.84
-0.06  -7%
Previous Close 0.9
Open 0.82
52 Week Low 0.3902
52 Week High 5
Market Cap $109,936,940
Shares 130,877,310
Float 127,422,687
Enterprise Value $56,808,678
Volume 8,105,455
Av. Daily Volume 13,640,066
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Upcoming Catalysts

Drug Stage Catalyst Date
TNX-102 SL (Tonmya)
Fibromyalgia
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
TNX-102 SL
Alcohol Use Disorder
Phase 2
Phase 2
Phase 2 trial planned. IND acceptance announced August 6, 2020.
Tonmya (TNX-102 SL)
Post-traumatic stress disorder (PTSD)
Phase 3
Phase 3
Phase 3 enrolment to be stopped due to futility - February 5, 2020. Top-line data has been delayed - June 19, 2020. No updated timeline.
TNX-601
PK trial
Phase 1
Phase 1
Efficacy trial to commence in 2020.
TNX-102 SL (Tonmya)
Post-traumatic stress disorder (PTSD)
Phase 3
Phase 3
Phase 3 trial halted due to insufficient efficacy - July 27, 2018.
TNX-1300 (RBP-8000)
Cocaine intoxication
Phase 2
Phase 2
In-licensed - noted May 23, 2019.
TNX-201
Episodic tension-type headache
Phase 2
Phase 2
Phase 2 data released February 2016 did not meet primary endpoint

Latest News

  1. Topline Results of Full Study Expected Fourth Quarter 2020

    RELIEF Study Protocol Was Formally Amended Mid-Study to Conform to FDA Guidance During COVID-19 Public Health Emergency

    Currently Enrolled 503 Participants Represents More than Original Target of 470

    Company is Currently Enrolling a Second Potential Pivotal Phase 3 Study (RALLY) of TNX-102 SL in Fibromyalgia, with Topline Data Expected Second Half of 2021

    CHATHAM, N.J., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today the outcome of the pre-planned interim analysis for the Phase 3 RELIEF study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the…

    Topline Results of Full Study Expected Fourth Quarter 2020

    RELIEF Study Protocol Was Formally Amended Mid-Study to Conform to FDA Guidance During COVID-19 Public Health Emergency

    Currently Enrolled 503 Participants Represents More than Original Target of 470

    Company is Currently Enrolling a Second Potential Pivotal Phase 3 Study (RALLY) of TNX-102 SL in Fibromyalgia, with Topline Data Expected Second Half of 2021

    CHATHAM, N.J., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today the outcome of the pre-planned interim analysis for the Phase 3 RELIEF study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. An independent statistical team conducted the unblinded interim analysis of the primary endpoint of the first 50 percent of randomized participants who entered the 14-week study. Based on the interim results and the prespecified sample size re-estimation, the independent data monitoring committee (IDMC) made the non-binding recommendation that the trial continue to completion with the addition of 210 participants to the original sample size of 470 participants, which is the maximum number of participants that could be added under the interim statistical analysis plan. Based on this information, the Company plans to complete the study with the 503 currently enrolled participants and to report topline results in the fourth quarter of 2020. The Company remains blinded to the interim analysis results.

    "We plan to complete the Phase 3 RELIEF study without adding new participants," commented Seth Lederman, M.D., President and Chief Executive Officer. "We started enrolling RELIEF in December 2019 and continued to enroll and study fibromyalgia sufferers through the onset and progression of the COVID-19 pandemic. We made changes to the protocol to conform to the U.S. Food and Drug Administration's (FDA's) guidance on research during the COVID-19 public health emergency. We need to consider the possibility that the onset of the COVID-19 pandemic affected both the reporting and variability of fibromyalgia symptoms in the interim analysis cohort, or first half, of the RELIEF participants in a way that was not anticipated prior to the pandemic. It is also possible that the second half of the RELIEF participants, enrolled after April 22, 2020, may have been affected by the ongoing nature of the pandemic, but differently than the first half which comprised the interim analysis cohort. The interim analysis plan did not contemplate any differences between the interim analysis cohort and subsequent cohort. The possibility that there are differences between the cohorts is the basis for our decision to complete the study without adding new participants, since the IDMC recommendation was based only on analysis of the interim analysis cohort. We believe that recruiting participants to the ongoing RALLY study is a more efficient use of resources than expanding the RELIEF study. Based on the prior Phase 2 and Phase 3 studies in fibromyalgia at a lower dose, we believe that TNX-102 SL has potential as a novel non-opioid, centrally-acting analgesic for the millions of U.S. adults suffering with fibromyalgia."

    Dr. Lederman continued, "Fibromyalgia is a significant treatment market in which the annual sales of approved drugs grew to more than $9 billion before Cymbalta® and Lyrica® went off patent. The dollar value of the fibromyalgia drug market has since decreased because of generic substitution, but the number of sufferers has not. We believe many are dissatisfied with available drug treatments. Poor tolerability is often a reason why patients give up taking the currently approved drugs. As many as one-third of fibromyalgia patients end up on chronic opiates. TNX-102 SL has the potential to provide relief from the pain and dysfunction of fibromyalgia with good tolerability and without addictive potential. We look forward to assessing top-line data from RELIEF in the fourth quarter of 2020."

    Tonix is currently enrolling into a second potentially pivotal Phase 3 trial, F306 or the RALLY study, to study TNX-102 SL for the management of fibromyalgia, with topline data expected in the second half of 2021. The trial design is very similar to the ongoing Phase 3 RELIEF study. The Company expects the FDA to require two positive registration-quality clinical studies to support marketing approval.

    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 6-12 million adults in the U.S., and physicians and patients report common dissatisfaction with currently marketed products. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled.

    About the Phase 3 RELIEF and RALLY Studies

    The RELIEF and RALLY studies are double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets). The two-arm trials each targeted enrolling 470 participants at approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

    Additional details about the RELIEF study are available at clinicaltrials.gov (NCT04172831).

    Additional details about the RALLY study are available at clinicaltrials.gov (NCT04508621).

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are Phase 2 ready, and the AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 980-9159

    Travis Kruse (media)

    Russo Partners



    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

    Primary Logo

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  2. Facility Addresses the Shortage of Vaccine Production Capacity in the U.S.

    When Fully Operational the ADC Is Expected to be Capable of Manufacturing Clinical Trial Quality Vaccines, Including Vaccines Under Development for COVID-19

    CHATHAM, N.J., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, completed the purchase a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines, including vaccines for COVID-19.

    Tonix expects the facility to be operational within 24 months with single-use bioreactors and purification suites with equipment for…

    Facility Addresses the Shortage of Vaccine Production Capacity in the U.S.

    When Fully Operational the ADC Is Expected to be Capable of Manufacturing Clinical Trial Quality Vaccines, Including Vaccines Under Development for COVID-19

    CHATHAM, N.J., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, completed the purchase a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines, including vaccines for COVID-19.

    Tonix expects the facility to be operational within 24 months with single-use bioreactors and purification suites with equipment for Good Manufacturing Practice production of vaccines for clinical trials, including when fully operational, the capability of producing sterile vaccines in glass bottles. In addition, research, development and supporting analytical capabilities are planned.

    Tonix currently is developing potential COVID-19 vaccines based on two live viral vector platforms: horsepox and bovine parainfluenza (BPI) virus. Four potential COVID-19 vaccines in development are based on the horsepox vector and two potential vaccines based on the BPI vector. Before year end the company expects to report results from an efficacy study of its lead COVID-19 candidate based on horsepox platform, TNX-1800, in which non-human primates are being challenged with SARS-CoV-2, the virus that causes COVID-19. The TNX-1800 vaccine is based on horsepox which is believed to be similar to the live attenuated single dose smallpox vaccine developed by Dr. Edward Jenner more than 200 years ago, which led to the eradication of smallpox. TNX-1800 is designed to express the SARS-CoV-2 spike protein and to elicit a predominately T cell response in order to provide long term immunity and prevent forward transmission.

    "We are excited to have taken the first step in vertically integrating more of our development activities, but, even more importantly, adding a manufacturing capability for clinical trial quality vaccines. We believe this provides Tonix with a competitive advantage, especially in the current COVID-19 environment in which more domestic development and manufacturing capacity is needed," commented Seth Lederman, M.D., Tonix's President and Chief Executive Officer. "As a nation, we have a mandate to reduce our reliance on off-shore resources and we hope our plans become a siren call for others to join in fulfilling this objective. We expect that the U.S. government will maintain a sustained interest in pandemic preparedness based on the devastating effect of COVID-19 on the health of the U.S. population, on education and on the economy."

    The facility is located in the New Bedford Business Park, but the facility is in a section of the park that is actually located in the Town of Dartmouth, Massachusetts. The two municipalities work together to accommodate businesses located in the Dartmouth portion of the park as the roads are inaccessible through Dartmouth and municipal services are provided by the City of New Bedford.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19 but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are Phase 2 ready, and the AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Elizabeth Isherwood (media)

    Moore & Isherwood Communications, Inc.



    (508) 996-3946

    Travis Kruse (media)

    Russo Partners



    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

     

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    • Presentation Times and Weblinks Released for Over 150 Presenting Companies
    • Day 1: Wednesday, September 23, 2020
    • ALL INSTITUTIONAL AND RETAIL INVESTORS ARE WELCOME

    NEW YORK, NY / ACCESSWIRE / September 22, 2020 / Sidoti & Company, LLC has released the presentation schedule, with weblink click-throughs, for Wednesday, September 23, 2020, the first day of its two-day Fall 2020 Virtual Investor Conference. The presentation schedule and related links for day two of the virtual event, Thursday, September 24, 2020, will be published shortly after the conclusion of Wednesday's session or can be found at www.sidoticonference.com/events (click Schedule).

    Virtual Agenda - Wednesday, September 23rd - All Times EDT

    Click on Company Name to Open Link to Zoom Meeting

    • Presentation Times and Weblinks Released for Over 150 Presenting Companies
    • Day 1: Wednesday, September 23, 2020
    • ALL INSTITUTIONAL AND RETAIL INVESTORS ARE WELCOME

    NEW YORK, NY / ACCESSWIRE / September 22, 2020 / Sidoti & Company, LLC has released the presentation schedule, with weblink click-throughs, for Wednesday, September 23, 2020, the first day of its two-day Fall 2020 Virtual Investor Conference. The presentation schedule and related links for day two of the virtual event, Thursday, September 24, 2020, will be published shortly after the conclusion of Wednesday's session or can be found at www.sidoticonference.com/events (click Schedule).

    Virtual Agenda - Wednesday, September 23rd - All Times EDT

    Click on Company Name to Open Link to Zoom Meeting

    8:30-9:00

    LICT Corporation (LICT)

    ****

    Tonix Pharmaceuticals Holding Corp. (TNXP)

    Acme United Corporation (ACU)

    ****

    The ODP Corporation [Office Depot] (ODP)

    Yatra Online Inc (YTRA)

    9:15-9:45

    Huron Consulting Group (HURN)

    Vishay Precision Group (VPG)

    ****

    Hooker Furniture Corporation (HOFT)

    ****

    Unifi (UFI)

    ****

    10:00-10:30

    AudioCodes (AUDC)

    Brady Corporation (BRC)

    ****

    ****

    Forrester (FORR)

    Neenah Inc (NP)

    Lincoln Educational Services (LINC)

    10:45-11:15

    A10 Networks (ATEN)

    CSW Industrials, Inc. (CSWI)

    LeMaitre Vascular (LMAT)

    ICF (ICFI)

    ****

    SWM Intl (SWM)

    ****

    11:30-12:00

    Benchmark Electronics, Inc. (BHE)

    Arcosa, Inc. (ACA)

    Winnebago Industries (WGO)

    Systemax Inc. (SYX)

    Carriage Services, Inc. (CSV)

    Quaker Houghton (KWR)

    LightPath Technologies, Inc. (LPTH)

    12:15-12:45

    G5 Entertainment AB (GENTF)

    Titan International, Inc. (TWI)

    RadNet, Inc. (RDNT)

    Tetra Tech, Inc. (TTEK)

    BBSI (BBSI)

    Minerals Technologies Inc. (MTX)

    Powell Industries, Inc. (POWL)

    1:00-1:30

    PC Connection, Inc. (CNXN)

    ExOne (XONE)

    Transcat, Inc. (TRNS)

    Universal Electronics (UEIC)

    Farmer Mac (AGM)

    Haynes International, Inc. (HAYN)

    AZZ Inc (AZZ)

    1:45-2:15

    Onto Innovation (ONTO)

    ****

    Dyadic International Inc (DYAI)

    Primoris Services Corporation (PRIM)

    Pitney Bowes (PBI)

    Heska Corporation (HSKA)

    Universal Technical Institute (UTI)

    2:30-3:00

    Immersion Corporation (IMMR)

    Mistras Group (MG)

    Hoth Therapeutics, Inc. (HOTH)

    TrueBlue (TBI)

    Viad Corp (VVI)

    Kadant Inc. (KAI)

    Balchem Corporation (BCPC)

    3:15-3:45

    Intelligent Systems (INS)

    CTS Corporation (CTS)

    Infusystem, Inc. (INFU)

    FAT Brands Inc. (FAT)

    Resources Connection (RGP)

    ABM Industries (ABM)

    Avista Corporation (AVA)

    4:00-4:30

    QAD (QADA)

    DMC Global Inc. (BOOM)

    Black Hills Corporation (BKH)

    The Alkaline Water Company (WTER)

    ServiceSource International, Inc. (SREV)

    Ranpak Holdings Corp (PACK)

    Alexander & Baldwin (ALEX)

    1x1s Only

    TTEC Holdings Inc. (TTEC)

    EnPro Industries (NPO)

    Modine Mfg. Company (MOD)

    La-Z-Boy Inc (LZB)

    Strategic Education, Inc. (STRA)

    Havertys (HVT)

    Perdoceo Education Corp. (PRDO)

    Federal Signal (FSS)

    Insteel Industries (IIIN)

    **Additional Companies Hosting 1x1s Both Days: EZCORP (EZPW) | Gorman-Rupp (GRC) | Heritage Insurance (HRTG) | Herman Miller (MLHR) | HNI Corp (HNI)**

    About Sidoti

    For over two decades, Sidoti has been a premier provider of independent securities research focused specifically on small- and micro-cap companies and the institutions that invest their securities, with most of our coverage in the $100 million - $3 billion market cap range. Our approach affords companies and institutional clients a combination of high-quality research, a small-and micro- cap focused nationwide sales effort, broad access to corporate management teams, and extensive trading support. We serve 500+ institutional clients in the U.S., Canada and the U.K., including many leading managers of portfolios with $200 million to $2 billion of AUM. Sidoti promotes meaningful interaction between issuers and investors in the small- and micro-cap space through our conferences www.sidoticonference.com and the hundreds of non-deal roadshows we host each year.

    Contact

    Sidoti Events Team
    212-453-7031

    SOURCE: Sidoti & Company, LLC



    View source version on accesswire.com:
    https://www.accesswire.com/607330/Sidoti-Virtual-Investor-Conference

    View Full Article Hide Full Article
  3. Webinar to be Moderated by Clive Cookson of the Financial Times on September 24, 2020

    Panelists Include Representatives from IAVI, Merck and Tonix Pharmaceuticals

    NEW YORK, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it will host a live webinar on Thursday, September 24, 2020 at 10:00 a.m. ET to discuss the concept of two types of immune responses – antibody vs. T Cell – as well as provide an overview of the challenges of developing an effective vaccine.

    Participating panelists for the event will be:

    • Swati Gupta, Vice President and Head of Emerging Infectious Diseases and Scientific Strategy, IAVI. Click HERE

    Webinar to be Moderated by Clive Cookson of the Financial Times on September 24, 2020

    Panelists Include Representatives from IAVI, Merck and Tonix Pharmaceuticals

    NEW YORK, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it will host a live webinar on Thursday, September 24, 2020 at 10:00 a.m. ET to discuss the concept of two types of immune responses – antibody vs. T Cell – as well as provide an overview of the challenges of developing an effective vaccine.

    Participating panelists for the event will be:

    • Swati Gupta, Vice President and Head of Emerging Infectious Diseases and Scientific Strategy, IAVI. Click HERE for full bio.
    • Seth Lederman, M.D., Co-Founder and CEO, Tonix Pharmaceuticals. Click HERE for full bio.  
    • Gokul Swaminathan, Associate Principal Scientist, Investigational Biology, Merck Research Laboratories. Click HERE for full bio.  

    The webinar will be held virtually and will include a Q&A session moderated by Clive Cookson, renowned Science Editor of The Financial Times.  Click HERE to register and access the Zoom link for this event.

    Details are as follows:

    Event:Antibody vs. T Cell Immunity: Is a Single Vaccine Enough to Stop COVID-19?
    Format:Virtual webinar followed by moderated Q&A session
    DateThursday, September 24, 2020
    Time10:00 a.m. – 11:30 a.m. ET

    A subsequent archived recording of the webinar and Q&A session will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating, attenuated vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based.  Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the fourth quarter of 2020.  Tonix is also currently enrolling patients in a second Phase 3 study for the management of fibromyalgia using TNX-102 SL, the results for which are expected in the second half of 2021. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the AUD program is also Phase 2 ready. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Olipriya Das (media)

    Russo Partners



    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

     

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  4. NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first patient was enrolled in the observational COV-LOGIC study (TNX-C001), a study of humoral (antibody) and cellular (T cell) immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19.  The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix's TNX-1800, which is a live replicating, attenuated virus vaccine designed to protect against COVID-19. 

    "This represents a significant milestone for the Company as the data…

    NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first patient was enrolled in the observational COV-LOGIC study (TNX-C001), a study of humoral (antibody) and cellular (T cell) immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19.  The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix's TNX-1800, which is a live replicating, attenuated virus vaccine designed to protect against COVID-19. 

    "This represents a significant milestone for the Company as the data we plan to collect from recovered and asymptomatic COVID-19 volunteers in this study will help inform vaccine development on how to safely provide the same immune responses that others got from recovering from actual SARS-CoV-2 infection," said Seth Lederman, M.D., President and CEO of Tonix.  "Our goal with TNX-1800 is to develop a vaccine that is well tolerated, produces strong, long-lasting immunity, and can be rapidly and broadly deployed.  The features of a protective immune response to SARS-CoV-2 remain unknown.  But since SARS-CoV-2 is a virus, we believe that T cell responses, in particular T Helper Type 1, or TH1 responses, will play an important, if not dominant, role in protecting against serious illness from COVID-19."

    About the COV-LOGIC Study (TNX-C001)

    The COV-LOGIC study is an observational multi-cohort sample collection study designed to collect the blood and nasopharyngeal (NP) swabs from individuals who have, and have not, been previously infected with SARS-CoV-2, or who have been intimately exposed to persons confirmed to have been infected with SARS-CoV-2, in order to analyze their antibody titers and T-cell responses to specific proteins of SARS-CoV-2 and to detect SARS-CoV-2 RNA which may be persistent in the nasopharynx at the time of sampling. For those individuals in whom viral RNA is detected during initial sampling, repeat blood and NP swab samples may be collected to examine temporal virus/immune response dynamics.  In addition, blood will be collected for DNA extraction and exome sequencing in order to assess whether host genetic factors might influence these humoral or cellular responses or viral persistence (if identified).

    About TNX-1800

    TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus that causes COVID-19 and to elicit a predominant T cell response.  Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor.  Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice1.  Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production.

    1Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

    About Southern Research

    Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit, scientific research organization with more than 400 scientists and engineers working across three divisions: Drug Discovery, Drug Development, and Engineering. SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospace firms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR has numerous ongoing drug discovery programs, which encompass 18 drug candidates to combat various forms of cancer, amyotrophic lateral sclerosis (ALS), Alzheimer's, schizophrenia, opioid use disorder, human immunodeficiency virus, diabetes, kidney disease, Parkinson's, tuberculosis, influenza, and others.  SR's strong history, which includes over 75 years of successful collaborations to solve complex problems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologies and market viability. SR is headquartered in Birmingham, Alabama with additional laboratories and offices in Frederick, Maryland.

    Further information about SR can be found at https://southernresearch.org/

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based.  Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the fourth quarter of 2020.  Tonix is also currently enrolling patients in a second Phase 3 study for the management of fibromyalgia using TNX-102 SL, the results for which are expected in the second half of 2021. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the AUD program is also Phase 2 ready. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Travis Kruse (media)

    Russo Partners



    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

    Primary Logo

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