Einstieg lohnenswert
Ein Börsenvolumen von 95 Millionen Aktien lässt nun auf ein steigendes Interesse schließen.
Für mich eine völlig unvermutete Reaktion, normalerweise fällt der Kurs unter die der Kapitalerhöhung, aber bei den Coronas scheint wohl alles anders zu sein und der Weg nach oben schein nun geöffnet zu sein.
Hab noch Geld übrig werde am Montag wieder einsteigen.
Etwa bei 72 Cent gelegen haben, also wurden die Kurse heute morgen in Europa gemacht. Vielleicht legen die Amis ja noch ne große Schippe drauf.
von daher passt das hier schon so.
Ob es dann zum US-Start so bleibt , alles Möglich ,
oder aber auch so richtig Zooom ...
und das schon seit 10 Uhr morgens im Pre ...
wäre ja mega , wenn wir hier auch Kurse 10/$+ sehen würden ...
Vor wenigen Monaten schon auf der Welle mitgeschwommen.
Da lief sie eigentlich ganz gut in der US Panik.
Denkt dran. Packt die Gewinne rechtzeitig ein.
Denn hier wird nur bzw. immer noch an Tierchen getestet. Die Marktreife für
einen impfstoff ist da vermutlich Lichtjahre entfernt.
Tonix Pharmaceuticals Holding Corp (TNXP)
HUGE NEWS!
Tonix Pharmaceuticals Announces Research Collaboration with Southern Research to Develop a Potential Vaccine to Protect Against New Coronavirus Disease 2019 (COVID-19) Based on Horsepox Virus (TNX-1800)
TNXP Announces Issuance of Patent in China for the Composition and Formulation of TNX-102 SL
Tonix Pharmaceuticals Announces Issuance of U.S. Patent for Crystalline Tianeptine Oxalate Salt, the Active Ingredient of TNX...
October 23 2019 - 07:00AM
GlobeNewswire Inc. Print
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 10,449,203 to the Company on October 22, 2019. This patent, “Tianeptine Oxalate Salts and Polymorphs,” includes claims directed to crystalline tianeptine oxalate salts, and disclosures directed to methods of using those crystalline forms and their compositions. This patent, excluding possible patent term extensions, is expected to provide Tonix with U.S. market exclusivity until December 28, 2037.
Tonix’s novel oral formulation of one of the claimed tianeptine oxalate salts, or TNX-601, is being developed as a potential treatment for posttraumatic stress disorder (PTSD) and also as a potential treatment for neurocognitive dysfunction associated with corticosteroid use. Tianeptine modulates the glutamatergic system indirectly and reverses the neuroplastic changes that are observed during periods of stress and corticosteroid use. Tianeptine is a weak mu-opioid receptor agonist, but does not have significant affinity for other known neurotransmitter receptors. Currently there is no tianeptine-containing product approved in the U.S., though tianeptine sodium (amorphous) has been available in Europe, Asia, and Latin America for the treatment of depression since 1987. TNX-601 is designed for daytime dosing and may provide improved stability, consistency, and manufacturability as compared to the amorphous sodium salt. TNX-601 is being developed under Section 505(b)(1) of the Federal Food, Drug and Cosmetic Act (FDCA).
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions. Tonix’s lead product candidate, TNX-102 SL*, is in development for posttraumatic stress disorder (PTSD), fibromyalgia, agitation in Alzheimer’s disease and alcohol use disorder (AUD). TNX-102 SL is in Phase 3 development as a bedtime treatment for PTSD (trade name Tonmya**) and fibromyalgia, with topline data in PTSD expected in the first half of 2020. The agitation in Alzheimer’s disease program is Phase 2 ready and the development for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix is advancing two other PTSD therapeutic programs in the pre-IND stage, with different mechanisms than TNX-102 SL and designed for daytime dosing: TNX-601 (tianeptine oxalate) and TNX-1600 (a triple reuptake inhibitor). TNX-601 is in clinical formulation testing outside of the U.S and is expected to be IND-ready in 2020. Tonix has two programs for treating addiction conditions: TNX-1300*** (double-mutant cocaine esterase) is in Phase 2 development for the treatment of cocaine intoxication and TNX-102 SL is in pre-IND development for AUD. Tonix’s preclinical pipeline includes 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. Finally, TNX-801 (live virus vaccine for percutaneous [scarification] administration) to potentially prevent smallpox and TNX-701 (undisclosed small molecule) to prevent radiation effects are being advanced as medical countermeasures to improve biodefense.
* TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.
** Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL for the treatment of PTSD.
***TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is an investigational new biologic and has 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; 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, 2018, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2019, and periodic reports on Form 10-Q filed with the SEC on or after the date thereof. Tonix does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contacts
Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(212) 980-9159
Scott Stachowiak (media)
Russo Partners
scott.stachowiak@russopartnersllc.com
(646) 942-5630
Peter Vozzo (investors)
Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Phase 3 development of new bedtime treatment for PTSD, including militaryrelated PTSD
• Major unmet need; ~12 million Americans annually
• Benefited from FDA 505(b)(2) NDA approval requirement
Complimentary day-time PTSD treatment in development
• Leverages development expertise in PTSD, i.e., regulatory, trial recruitment and execution
Fibromyalgia bedtime treatment in development
• New Phase 3 study design features discussed with FDA (April 2019 FDA Meeting Minutes)
• TNX-102 SL 5.6 mg (twice the dose previously studied in FM Phase 2/3 trials) will be studied in Phase 3 to support the indication
New indication in development for agitation in Alzheimer’s Disease
• Unmet medical need, no approved drug available
• Fast Track Phase 2/3 ready program
Innovative vaccine in development to prevent Smallpox
• Opportunity to supply stockpiling requirement; short development path
• Studies in mice suggest improved safety profile
Conclusion and Valuation
The U.S. military’s intense interest in identifying safe and effective PTSD treatments is important for Tonix, as the AtEase study is the only controlled clinical trial to show a benefit in treating military related PTSD. If those results can be duplicated in the HONOR study (and Tonmya® gets approved), the Department of Defense and the VA would likely be very interested in getting the treatment to military personnel and veterans who suffer from PTSD.
Our valuation for Tonix is derived from a probability adjusted discounted cash flow model that takes into account potential future revenues from the sale of TNX-102 SL in PTSD. Of the approximately 8.6 million individuals in the U.S. who suffer from PTSD, it’s estimated that approximately 20% seek treatment. With a peak market share of only 6%, we currently estimate that peak sales of $650 million are possible. Using a discount rate of 18% and a 50% probability of approval leads to a net present value for the PTSD program of $67 million. Combined with the company’s current cash position and dividing by a reasonable fully diluted share count of 8.1 million shares leads to a valuation of approximately $13 per share.
Insider & Institutional Ownership :
Rosalind Advisors, Inc. 553 908
Baker Bros. Advisors LP 510 922
B. Riley Capital Management LLC 378 138
Opaleye Management, Inc. 370 000
Empery Asset Management LP 315 000
The Vanguard Group, Inc. 184 377
Heights Capital Management, Inc. 89 713
Seth Lederman, MD 83 400
Ernest Mario, PhD 69 718
Kingdon Capital Management LLC 64 549
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IR Contact Information
Investor Relations
TONIX Pharmaceuticals
investor.relations@tonixpharma.com
! Aber wie immer gilt dass es keine Kaufempfehlung von mir und keinen Verkauf Empfehlung von mir jeder muss selbst ein bisschen lesen und dann auf den Knopf drücken
RE;
Tonix Pharmaceuticals Announces Research Collaboration with Southern Research to Develop a Potential Vaccine to Protect Against New Coronavirus Disease 2019 (COVID-19) Based on Horsepox Virus (TNX-1800)
https://ir.tonixpharma.com/press-releases/detail/...ollaboration-with