Tonix Pharmaceuticals Holding Corp.

TNXP

US8902608475

Pharmaceuticals

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07-09	Tonix Pharmaceuticals Prices $4 Million Public Offering; Shares Plunge	MT
07-09	Tonix Pharmaceuticals Holding Corp. announced that it expects to receive $30 million in funding	CI

TNX-4200: CD45 Targeted Broad Spectrum Antiviral

July 16, 2024 at 12:42 pm

Broad-spectrum Host- directed Therapeutics: CD45 Inhibitor as Antiviral

July 2024

NASDAQ: TNXP

Version P0576 July 15, 2024 (Doc 1476)

Tonix Awarded $34M Contract from DTRA/DoD

DTRA contract is expected to advance development of Tonix's broad-spectrum oral antiviral program (TNX-4200) for medical countermeasures

• Other Transaction Agreement (OTA) with a potential for up to $34 million over five years

Objective: Develop an orally available small molecule that reduces CD45 enzymatic activity, with broad-spectrum protection against a range of viral families through the completion of Phase 1 clinical evaluation

INFECTIOUS DISEASE PORTFOLIO

DoD Moves Beyond "One Drug, One Bug" Approach1,2

The US Department of Defense (DoD) is moving beyond the traditional "one drug, one bug" approach to antivirals, and embracing the "one drug, multiple bugs" approach to protect against viral illness in warfighters
The Defense Threat Reduction Agency (DTRA) is a division of the DoD that supports research to protect the warfighter
- DoD/DTRA collaborate with commercial partners to translate fundamental discoveries into products

INFECTIOUS DISEASE PORTFOLIO

1Vergun, D. DOD News. January 10, 2023. DoD aims to shield warfighters from novel biological agents. https://www.defense.gov/News/News-Stories/Article/Article/3261095/dod-aims-to-shield-warfighters-from-novel-biological-agents

2US Department of Defense, Chemical and Biological Defense Program, "Approach for Research, Development and Acquisition of Medical Countermeasure and Test Products, Dec. 2022.4https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF

Broad-spectrum Host Directed Antiviral Drug Development vs Virus-specific Approaches

Conventional Approach

Broad Spectrum Antivirals1

Single Virus Family		Broad Spectrum
Virus-Targeted2	Virus-Targeted	Host-Targeted

Drug	Virus	Drug	Virus	Drug	Virus

Biktarvy®	HIV	Veklury®	COVID	Intron-A®	Hep-C
tenofovir/		Remdesivir	SARS-CoV-2	Pegasys®
emtricitabine				interferon-alpha
Sovaldi®	Hep-C	Paxlovid®	COVID
Sofosbuvir		nirmatrelvir	SARS-CoV-2
		/ritonavir
Valtrex®	Herpes simplex	Ribavirin	Hep-C, RSV
Valacyclovir	and varicella
Arestvy®	Smallpox	Tembexa®	Smallpox
Tecovirimat		brincidofovir
Tamiflu®	Influenza
oseltamivir

Host-targetedbroad-spectrum antivirals is a new and emerging category

1Bekerman E, and Einav, S. Science. 2015 348(6232):282-3. doi: 10.1126/science.aaa3778.

2Examples: not a complete list

INFECTIOUS DISEASE PORTFOLIO

Enhancing Viral Immunity Has the Potential to Protect Against Viral Diseases

Too Little

Immune Suppression

Humira (adalimumab)

Enbrel (etanercept)

Rituxan (Rituximab)

Dupixent (dupilumab)

Keytruda (pembrolizumab)

Opdivo (nivolumab)

Intron A (interferon alpha -2a)

Pegasys (interferon alpha -2a)

Spectrum of Immunity

Therapeutic Zone

Tone down the	Rev up the
immune system	immune system
to treat:	to treat:
Autoimmunity examples:	Cancer examples:
Humira®	Keytruda®
Enbrel®	Opdivo®
Rituxan®	Viral disease examples:

Allergy examples:	Intron A®
Dupixent®	Pegasys®

Too Much

Autoimmunity

INFECTIOUS DISEASE PORTFOLIO

Enhancing Viral Immunity by Inhibiting CD45 Phosphatase

CD45 is a transmembrane protein tyrosine phosphatase (PTPase) expressed on most hematopoietic cells, including T lymphocytes
CD45 regulates receptor signaling pathways, particularly T cell activation
- It dephosphorylates the negative regulatory tyrosine kinases (e.g., lck and src)
Decreased levels of CD45 enhance antiviral1 and antibacterial immunity in animals2
Oral small-molecule inhibitors of CD45 have the potential to enhance antiviral immunity3-5

Goal: Develop an orally available small molecule that reduces

CD45 enzymatic activity

CD45 modulating host-directed antivirals would be an entirely new class of medicines

1Panchal RG, et al., Cell Host Microbe. 2009 6(2):162-73. doi: 10.1016/j.chom.2009.07.003. PMID: 19683682.

2Panchal RG, et al. J Biol Chem. 2009 284(19):12874-85. doi: 10.1074/jbc.M809633200

3Miski M, et al. Bioorg Med Chem Lett. 1995 5(14):1519-22. doi: 10.1016/0960-894X(95)00250-W.

4Hamaguchi T, et al. Bioorg Med Chem Lett. 2000 10(23):2657-60. doi: 10.1016/s0960-894x(00)00539-4. PMID: 11128645.

5Carr G, et al. Methods. 2014. 65(2):229-38, doi: 10.1016/j.ymeth.2013.09.007.

INFECTIOUS DISEASE PORTFOLIO

Kinases Enhance and Phosphatases Modulate Immune Responses

Kinasesenhance	CD45 phosphatase
immune responses	modulates
	immune responses

Kinasesadd phosphate "P" to	CD45 phosphatase
removes phosphate "P"
signaling molecules
From signaling molecules

Panchal RG, et al., .J Biol Chem. 2009 May 8;284(19):12874-85. doi: 10.1074/jbc.M809633200. Epub 2009 Mar 6.PMID: 19269962

INFECTIOUS DISEASE PORTFOLIO

Phosphatase Inhibitors Decrease Enzymatic Activity of CD45 and Potentially Enhance Viral Immunity

CD45 phosphatase

Kinasesenhance immune responses

INFECTIOUS DISEASE PORTFOLIO

TNX-4200: Orally Available CD45 Antagonists

Tonix is exploiting regenerative AI and computational biology to identify modulators of CD45 expression and inhibitors of CD45 function to develop candidate broad- spectrum antiviral drugs1

Goal: broad spectrum antivirals

CD45 modulating host-directed antivirals would be an entirely new class of medicines

Drugs that strengthen the body's immunity and protect against viral illness are called "host-directed" antivirals2,3

1Panchal RG, et al. J Biol Chem. 2009 284(19):12874-85. doi: 10.1074/jbc.M809633200

2Radoshitzky SR, et al., PLoS Pathog. 2016 Mar 31;12(3):e1005466. doi: 10.1371/journal.ppat.1005466. eCollection 2016 PMID: 27031835

3Loureiro ME, et al., PLoS Pathog. 2018 Jul 12;14(7):e1007125. doi: 10.1371/journal.ppat.1007125. eCollection 2018 Jul.PMID: 30001425

INFECTIOUS DISEASE PORTFOLIO

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Tonix Pharmaceuticals Holding Corp. published this content on 15 July 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 July 2024 16:41:05 UTC.

Latest news about Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Prices $4 Million Public Offering; Shares Plunge	07-09	MT
Tonix Pharmaceuticals Holding Corp. announced that it expects to receive $30 million in funding	07-08	CI
Tonix Pharmaceuticals Intends to Offer and Sell Shares of its Common Stock	07-08	CI
Tonix Pharmaceuticals Plans Stock Offering; Shares Fall After-Hours	07-08	MT
Tonix Pharmaceuticals Gets FDA Nod to Proceed With New Drug Application for Tonmya in Fibromyalgia	07-08	MT
Tonix Pharmaceuticals Reports Final Positive Pre-NDA Meeting with FDA for Tonmya? for the Management of Fibromyalgia	07-08	CI
Tonix Pharmaceuticals Receives Up to $34 Million U.S. Department of Defense Contract for Accelerated Development of Broad-Spectrum Antiviral Program	07-01	CI
Tonix Pharmaceuticals Closes $4 Million Offering	06-28	MT
Top Midday Decliners	06-27	MT
Wall Street Set to Open Marginally Lower Thursday as Investors Parse Bullish Economic Data	06-27	MT
US Futures Trend Lower Pre-Bell as Investors Await Slew of Economic Data	06-27	MT
Top Premarket Decliners	06-27	MT
Tonix Pharmaceuticals Regains Compliance With Nasdaq Minimum Bid Price Rule	06-26	MT
Tonix Pharmaceuticals Holding Corp. Presents Vaccine Platform Data in Keynote Talk At the Vaccine Congress 2024	06-25	CI
Tonix Pharmaceuticals Holding Corp. Announces Positive Pre-NDA CMC Meeting with FDA for Tonmya for the Management of Fibromyalgia	06-20	CI
Top Midday Decliners	06-12	MT
Wall Street Set to Open Higher Wednesday as Key Inflation Data Lower Than Expected	06-12	MT
US Futures Slightly Higher Ahead of Fed's Rate Decision, Key Inflation Data	06-12	MT
Top Premarket Decliners	06-12	MT
Tonix Pharmaceuticals Plans Common Stock Offering to Fund New Drug Application for Fibromyalgia; Shares Fall After Hours	06-11	MT
Tonix Pharmaceuticals to Implement 1-for-32 Reverse Stock Split -- Shares Fall	06-06	MT
Tonix Pharmaceuticals Holding Corp. Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500	06-06	CI
ToniTonix Pharmaceuticals Holding Corp. Presents New Data on Tonmya Suggesting Activity for Improvement in Fibromyalgia-Associated Depression Severity in an Oral Presentation at ASCP Annual Meeting	06-03	CI
Tranche Update on Tonix Pharmaceuticals Holding Corp.'s Equity Buyback Plan announced on January 25, 2023.	05-13	CI
Tonix Pharmaceuticals Holding Corp. Reports Earnings Results for the First Quarter Ended March 31, 2024	05-13	CI

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Company Profile

Tonix Pharmaceuticals Holding Corp. is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Its development portfolio is focused on central nervous system (CNS) disorders. Its product candidates include Tonmya (TNX-102 SL), TNX-102 SL, TNX-1300, TNX-2900, TNX-1900, TNX-1500, TNX-801 and TNX-1800. TNX-102 SL is for the management of fibromyalgia. Its CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has a therapy designation. Its 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 being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. It markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg.

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Pharmaceuticals

Calendar

2024-08-04 - Q2 2024 Earnings Release (Projected)

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Ratings for Tonix Pharmaceuticals Holding Corp.

Trading Rating

Investor Rating

ESG Refinitiv

C-

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Analysts' Consensus

Sell

Buy

Mean consensus

BUY

Number of Analysts

Last Close Price

0.5968 USD

Average target price

94.93 USD

Spread / Average Target

+15,807.06%

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Biopharmaceuticals

Tonix Pharmaceuticals Holding Corp.

Equities

TNXP

US8902608475

Pharmaceuticals

TNX-4200: CD45 Targeted Broad Spectrum Antiviral

EPS Revisions