Tonix Pharmaceuticals Holding Corp (TNXP)

[green maschine]

I still see this moving back up by EOW.

[Arnold25764]

Will definitely need to hold .40 rest of week.

[green maschine]

Is it Friday yet?

[Arnold25764]

Just keeps making new lows today.

[green maschine]

I can't see .30 at all, .40 maybe. We'll be alright by eow.

[Arnold25764]

I'm in but doesn't look like a bounce coming yet. Maybe see .30's by EOD.

[green maschine]

Bouncing from here. Are you in?

[Arnold25764]

By the next hour .30's coming?

[green maschine]

I think .433 was bottom.

[Arnold25764]

How low they going to take this today?

[DR. EVIL]

TIMBERRRRRR

[green maschine]

Besides the anti-SARS-CoV-2 monoclonal antibodies, "Tonix's lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023."

[Arnold25764]

Pretty good news. Hopefully see over a dollar here soon.

[green maschine]

Wait for the pullback I told myself right before jumping in today at .73. Ah well, it'll get to multi dollars soon. FOMO got me again.

[INFINITI]

Tomorrow this should be over $1 load up $$$$$

[Iron heart]

WOW huge NEWS! $TNXP

[INFINITI]

Dip and rip let’s goooo$$$

[Life is great]

Not for long. Will go crazy here.

[green maschine]

Agreed! I can't believe it's still in the sixty cent range.

[INFINITI]

This will run all week $$$$$

[green maschine]

I can't this up.

[INFINITI]

Looks good I’m in

[subslover]

Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Humanized anti-SARS-CoV-2 Monoclonal Antibodies from Curia Global, Inc.
December 12 2022 - 07:00AM
GlobeNewswire Inc.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has obtained an exclusive license from Curia Global, Inc., a leading contract research, development and manufacturing organization, for the development of three humanized murine monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection. SARS-CoV-2 is the cause of COVID-19.
“We believe that the licensing of these mAbs strengthens our pipeline of next-generation therapeutics to treat COVID-19,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes1. Although five monoclonal antibody products, containing seven distinct monoclonal antibodies, have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for either treatment or prophylaxis of COVID-19, only a single product, Evusheld®, is still recommended for use as a prophylaxis by the National Institutes of Health COVID-19 Treatment Guidelines Panel or FDA2,3. Moreover, concerns have been raised about the ongoing ability of Evusheld® to prophylax in the face of new variants4. We believe there is a need for second generation mAb treatments and prophylactics for COVID-195. To date, the EUA-approved products have been derived from the blood of COVID-convalescent patients or a humanized mouse6,7. The Company believes that humanized murine monoclonal antibodies discovered by Curia and licensed by Tonix represent a potential new approach to treating SARS-CoV-2 infection. The Company believes that murine monoclonal antibodies have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and may be harder for SARS-CoV-2 to evade as we face a ‘variant soup’ from both convergent and divergent evolution.”8

Brian Zabel, Ph.D., Senior Director at Curia said, “We are excited to work with Tonix because of their commitment to developing therapeutics to COVID-19. Murine monoclonal antibodies represent a different approach and one that has the potential to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein. Mice have a different repertoire of antibodies and the Curia technology for generating antibodies optimizes the selection of appropriate B cells by the timing of immunization, harvesting approach and screening platform.”

Seth Lederman added, “The potential therapeutic antibodies licensed leverage our expanding internal development and manufacturing capabilities for biologics. These murine monoclonal antibodies and their humanized counterparts build on a base of knowledge from the fully human monoclonal antibody platform, TNX-3600, which we are developing with Columbia University.”

1Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397
2https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ - accessed Nov 3, 2022
3FDA Updates on Bebtelovimab www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab- Accessed Nov 4, 2022
4Wu, K.J. October 29, 2022. The Atlantic. “The End of Evusheld: If you’re immunocompromised, this … isn’t great.” www.theatlantic.com/health/archive/2022/10/covid-variants-antibody-treatments-immunocompromised/671929/
5Madison Muller, M. November 16, 2022. Bloomberg. “Doctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates.” www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?
6Hansen J et al. Science. 2020 Aug 21;369(6506):1010-1014. Doi: 10.1126/science.abd0827
7 Asdaq, S.M.B. et al. A Patent Review on the Therapeutic Application of Monoclonal Antibodies in COVID-19. Int. J. Mol. Sci. 2021, 22, 11953. https://doi.org/10.3390/ijms222111953
8Callaway, E. Oct 28 2022. Nature (News). COVID ‘variant soup’ is making winter surges hard to predict: Descendants of Omicron are proliferating worldwide — and the same mutations are coming up again and again. www.nature.com/articles/d41586-022-03445-6

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes 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 and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*All of Tonix’s product candidates are investigational new drugs or biologics 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 the 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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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 the

[Value_Investor]

This Debt-FREE COVID-19 etc. Hot Bio-Tech NASDAQ stock has $4.1 a share Huge Book Value and $2.51 a share Huge Cash Value!

To match the Same performance with its NASDAQ peer (from $1.34 to $9.589 most recently), TNXP will bounce up to $2.5905!

To match the Same performance with its Bio-Tech peer (from $0.0005 to $0.0055), TNXP will hit $3.982!

So, TNXP is heading onto the Targets price area $3.982 ~ $2.5905 now...

Hyper Oversold --- from its most recent high $4.79 to the New Bottom $0.362!

Super Undervalued --- the Book Value is 11.33 Times of its Bottom and the Cash Value is 6.934 Times of its Bottom!

[stockmavin]

Dilution time. Received voting ballot to increase AS from 150 million to 1 billion.

[johnhancoque]

Get out before he craters to .10 cents
Seth has no limits unfortunately

[johnhancoque]

Seth dumped another round 60 million shares outstanding.
What a bloody crook. So much for buyback

[Value_Investor]

The Target $2.45 is based on the Same 5.2-Bagger bounce match between TNXP and its FIXED-Low-SS Bio-Tech peer (PBHG: from 0.0005 to 0.0026 most recently).

If TNXP matches another peer (TBLT: from $1.34 to $9.589) then it will hit $3.37!

[Value_Investor]

We should see $2.45 very soon since TNXP has already bottomed out at $0.4705!

Keep in mind that it has both Huge BV ($5.302) and Huge CV ($4.453)!

It is possible to see its most recent high $4.79 again with some hot news...

[Value_Investor]

Will TNXP surge the Same 5.2-Bagger to $2.704 from its New Bottom $0.52 like its OTC peer (PBHG: from previous Bottom 0.0005 to 0.0026) did most recently? Or TNXP will soar back to its most recent high $4.79 again since its Positive Huge Book Value is 10.689%-Higher than $4.79 while its Positive Huge Cash Value is only 7.035%-Lower than $4.79?

Super Undervalued now --- $5.302 Positive Huge Book Value and $4.453 Positive Huge Cash Value!

Hyper Oversold currently --- from $4.79 to $0.52 without any bad news at all!

Note, the Real Bottom was $0.5 which was created in the After-Hours on 09/26/2022 when TNXP hit previous Bottom $0.5215!

I believe that the majority of shareholders here need the price above $5 in order to make even or make gain!

[Value_Investor]

Will $0.865 be the New Bottom? Can we see its most recent high $4.79 again in the coming bounce?

Anyway if TNXP does the same 5.2-Bagger rally like its Bio-Medical peer (PBHG: from 0.0005 to 0.0026) then it will bounce up to $4.5!

Let's see if that is possible to see $4.79 ~ $4.5 again?

[Wild N Free]

Up and down up and down :) hopefully up again soon!

[PStockPickz]

Going afterhours

[doogdilinger]

Sky's the limit throughout the back half of the year;)

[subslover]

And another gorgeous day for Tonix. This one is paying the bills buddy.

[Pennyes]

Shorters or insiders, one of them!!..
this garbage is one of the Most shorted and tortured stock ever!!.. Management is a fked up one, worst management almost like that co called "Delcath Systems Inc (DCTH)", worst scamers on the universe!!! Lol!

[doogdilinger]

HUGE news thanks subs buddy!!!

[subslover]

Tonix Pharmaceuticals Receives Federal Grant from the National Institute on Drug Abuse (NIDA) to Advance Development of TNX-1300 as a Treatment for Cocaine Intoxication
August 02 2022 - 07:00AM
GlobeNewswire Inc.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of cocaine intoxication. TNX-1300 is a recombinant enzyme that efficiently degrades and metabolizes cocaine. Cocaine intoxication refers to a state in which cocaine has deleterious effects on several body systems, especially the cardiovascular system. TNX-1300 demonstrated activity on reversing the physiological effects of i.v. cocaine challenge in people who use cocaine in a prior Phase 2a randomized, double-blind, placebo-controlled clinical study.1
The grant is intended to support continued development of TNX-1300 as a treatment for life threatening cocaine intoxication. In 2021, more than 24,900 individuals in the U.S. died from drug overdose deaths involving cocaine2.

“This grant award underscores the unmet need for safe and effective treatments for cocaine intoxication and validates the progress we have achieved to date with TNX-1300,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Cocaine intoxication remains a serious issue in the U.S. where there is currently no specific pharmacotherapy indicated treatments. By targeting the cause rather than the symptoms of cocaine intoxication, we believe TNX-1300 may offer significant advantages to the current standard of care for cocaine intoxication.”

Tonix recently announced the design of a new single-blind, open-label, placebo-controlled, randomized Phase 2 clinical trial of TNX-1300 for the treatment of cocaine intoxication. The Phase 2 study, which has the potential to serve as a pivotal trial, is anticipated to start in the fourth quarter of 2022, pending U.S. Food and Drug Administration (FDA) agreement. TNX-1300 has been granted Breakthrough Therapy designation by the FDA. As a biologic and new molecular entity, TNX-1300 is eligible for 12 years of U.S. market exclusivity upon approval by the FDA, in addition to expected patent protection through 2029.

“The research Tonix is pursuing is a bright light in our shared goal of reducing overdose deaths and harm as we continue to battle the crisis in substance use disorders in New Jersey and across the country, which has only been compounded by the pandemic. This targeted treatment could bring down healthcare costs and, most importantly, loss of life due to cocaine overdose,” said Representative Mikie Sherrill (NJ-11). “With this federal grant, Tonix will be able to move one step closer to FDA authorization and getting this potentially life-saving treatment into the hands of emergency room doctors and nurses, as well as EMS and other first responders. I am proud to have Tonix’s headquarters based here in NJ-11.”

“Tonix has been an incredible partner and job creator in Maryland, and I commend their efforts in fighting against the substance use disorder crisis that our nation continues to face. With over 100,000 Americans killed by drug overdoses just last year, we need to work together to curb the loss and set our sights on prevention, harm reduction, treatment and recovery. That starts with medical innovation in our own communities and reliable investment in our country's brightest leaders. This funding from the National Institute on Drug Abuse will do just that,” said Representative David Trone (MD-06).

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number U01DA056245. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About TNX-1300

TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is being developed under an Investigational New Drug (IND) application for the treatment of cocaine intoxication. TNX-1300 is a recombinant protein enzyme produced through rDNA technology in a non-disease-producing strain of E. coli bacteria. Cocaine esterase (CocE) was identified in bacteria (Rhodococcus) that uses cocaine as its sole source of carbon and nitrogen and that grows in soil surrounding coca plants.3 The gene encoding CocE was identified and the protein was extensively characterized.3-6 CocE catalyzes the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid. Wild-type CocE is unstable at body temperature, so targeted mutations were introduced in the CocE gene and resulted in the T172R/G173Q double-mutant CocE, which is active for approximately 6 hours at body temperature.6 In a Phase 2 study, TNX-1300, at 100 mg or 200 mg i.v. doses, was well tolerated and rapidly reduced cocaine effects after a cocaine 50 mg i.v. challenge.1

About Cocaine Intoxication

Cocaine is an illegal recreational drug which is taken for its pleasurable effects and associated euphoria, as well as mental alertness, in some cases. Pharmacologically, cocaine blocks the reuptake of the neurotransmitter dopamine from central nervous system synapses, resulting in the accumulation of dopamine within the synapse and an amplification of dopamine signaling which reinforces the drug taking. With the continued use of cocaine, however, intense cocaine cravings can occur, resulting in a high potential for continued use and addiction, as well as the risk of cocaine intoxication. Cocaine intoxication refers to the deleterious effects of cocaine on several body systems, especially those involving the cardiovascular system. Common symptoms of cocaine intoxication include tachyarrhythmias and elevated blood pressure, either of which can be life-threatening. As a result, individuals with known or suspected cocaine intoxication are sent immediately to the emergency department, preferably by ambulance in case cardiac arrest o

[WHIP THE HORSE]

Somebody dropped 57,321 shares at bid, $1.86 in the last second? Shorters working hard...LOL!!!

[doogdilinger]

Boom-sha-ka-laka!

[doogdilinger]

Agreed subs! Final 5 months into EOY gonna be epic!

[subslover]

This Company has the $$$$$ to push the FDA for approvals!

[doogdilinger]

Let's keep banking brother! Friggin' lovin' every minute of it>>>$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

[subslover]

They got the $$$$$$$$$$$$$$$$$$$$$$$$ to burn and churn

[doogdilinger]

Another one for the winners circle choo-choo;)

[subslover]

Going BANG ZOOM!!!!

[subslover]

Going BANG ZOOM!!!!

[tw0122]

Nice Monday morning addition to Thursday news…* TONIX PHARMACEUTICALS ANNOUNCES COLLABORATION WITH KENYA MEDICAL RESEARCH INSTITUTE TO DEVELOP TNX-801 IN KENYA AS A VACCINE FOR THE PREVENTION OF MONKEYPOX AND SMALLPOX INFECTION

[subslover]

Tonix Pharma (TNXP) Announces Issuance of U.S. Patent Covering Potentiated Intranasal Oxytocin (TNX-1900) for the Treatment of Pain
https://www.streetinsider.com/Corporate+News/Tonix+Pharma+%28TNXP%29+Announces+Issuance+of+U.S.+Patent+Covering+Potentiated+Intranasal+Oxytocin+%28TNX-1900%29+for+the+Treatment+of+Pain/20392844.html

[tw0122]

52 week high $4.79 reachable

New York City declares monkeypox a public health emergency
BY FARIS TANYOS
UPDATED ON: JULY 30, 2022 / 8:05 PM / CBS NEWS


Just two days after New York state called monkeypox an "imminent threat," New York City followed suit Saturday, declaring the disease a "public health emergency."

The move was announced in a joint statement from New York City Mayor Eric Adams and city Health Commissioner Dr. Ashwin Vasan.

"New York City is currently the epicenter of the outbreak, and we estimate that approximately 150,000 New Yorkers may currently be at risk for monkeypox exposure," the statement read. "We will continue to work with our federal partners to secure more doses as soon as they become available.