Release – Lineage to Present at the NobleCon18 Investor Conference on April 20, 2022

 



Lineage to Present at the NobleCon18 Investor Conference on April 20, 2022

Research, News, and Market Data on Lineage Cell Therapeutics

CARLSBAD, Calif.–(BUSINESS WIRE)–Apr. 11, 2022–

Lineage Cell Therapeutics, Inc.

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at NobleCon18 – Noble Capital Markets’ Eighteenth Annual Investor Conference on
April 20th, 2022 at
4:30pm ET
in Seminole Ballroom A. NobleCon18 is taking place at the
Hard Rock Hotel & Casino in
Hollywood, Florida
,
April 19th – 21st, 2022.

An archived webcast of the corporate presentation will be available starting
April 21st, 2022 on the Events and Presentations page of the Lineage website, and as part of a complete catalog of presentations available on the conference website: www.nobleconference.com and on Channelchek www.channelchek.com, the investor portal created by
Noble Capital Markets. Additional videos are available on the Media page of the Lineage website.

About Lineage
Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include four allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and
Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Lineage Cell Therapeutics, Inc. IR Ioana C. Hone (
ir@lineagecell.com)
(442) 287-8963

Solebury
Trout IR
Mike Biega (
Mbiega@soleburytrout.com)

(617) 221-9660

Russo
Partners
– Media Relations
Nic Johnson or David Schull Nic.johnson@russopartnersllc.com

David.schull@russopartnersllc.com

(212) 845-4242

Source:
Lineage Cell Therapeutics, Inc.

New Tool Reveals How Immune Cells Find their Targets


Image credit: S. Pincus, E. Fischer, Austin Athman (NIH)


Improved Method to Identify B or T cells that Interact with Viral or Bacterial Proteins

 

Anne Trafton | MIT News Office

The human body has millions of unique B and T cells that roam the body, looking for microbial invaders. These immune cells’ ability to recognize harmful microbes is critical to successfully fighting off infection.

MIT biological engineers have now devised an experimental tool that allows them to precisely pick out interactions between a particular immune cell and its target antigen. The new technique, which uses engineered viruses to present many different antigens to huge populations of immune cells, could allow large-scale screens of such interactions.

“This technique leads the way to understand immunity much closer to how the immune system itself actually works, will help researchers make sense of complex immune recognition in a variety of diseases, and could accelerate the development of more effective vaccines and immunotherapies,” says Michael Birnbaum, an associate professor of biological engineering at MIT, a member of MIT’s Koch Institute for Integrative Cancer Research, and the senior author of the study.

Former MIT graduate student Connor Dobson is the lead author of the paper, which appears in Nature Methods.

A Simple Screen for a Complex System

Both B and T cells play critical roles in launching an immune response. When a T cell encounters its target, it starts proliferating to produce an army of identical cells that can attack infected cells. And B cells that encounter their target begin producing antibodies that help recruit other components of the immune system to clear the infection.

Scientists who study the immune system have several tools to help them identify specific antigen-immune cell interactions. However, these tools generally only allow for the study of a large pool of antigens exposed to one B or T cell, or a large pool of immune cells encountering a small number of antigens.

“In your body, you have millions of unique T cells, and they could recognize billions of possible antigens. All of the tools that have been developed to this point are really designed to look at one side of that diversity at a time,” Birnbaum says.

The MIT team set out to design a new tool that would let them screen huge libraries of both antigens and immune cells at the same time, allowing them to pick out any specific interactions within the vast realm of possibilities.

To create a simple way to screen so many possible interactions, the researchers engineered a specialized form of a lentivirus, a type of virus that scientists often use to deliver genes because it can integrate pieces of DNA into host cells. These viruses have an envelope protein called VSV-G that can bind to receptors on the surface of many types of human cells, including immune cells, and infect them.

For this study, the researchers modified the VSV-G protein so that it cannot infect a cell on its own, instead relying on an antigen of the researchers’ choosing. This modified version of VSV-G can only help the lentivirus get into a cell if the paired antigen binds to a human B or T-cell receptor that recognizes the antigen.

Once the virus enters, it integrates itself into the host cell’s genome. Therefore, by sequencing the genome of all the cells in the sample, the researchers can discover both the antigen expressed by the virus that infected the cell and the sequence of the T or B-cell receptor that allowed it to enter.

“In this way, we can use viral infection itself as a way to match up and then identify antigen-immune cell parings,” Birnbaum says.

Interactions Identified

To demonstrate the accuracy of their technique, the researchers created a pool of viruses with antigens from 100 different viruses, including influenza, cytomegalovirus, and Epstein-Barr virus. They screened these viruses against about 400,000 T cells and showed that the technique could correctly pick out antigen-T-cell receptor pairings that had been previously identified.

The researchers also screened two different B-cell receptors against 43 antigens, including antigens from HIV and the spike protein of SARS-CoV-2.

In future studies, Birnbaum hopes to screen thousands of antigens against B and T cell populations. “Our ideal would be to screen entire viruses or families of viruses, to be able to get a readout of your entire immune system in one experiment,” he says.

In one study that is now ongoing, Birnbaum’s lab is working with researchers at the Ragon Institute of MGH, MIT, and Harvard to study how different people’s immune systems respond to viruses such as HIV and SARS-CoV-2. Such studies could help to reveal why some people naturally fight off certain viruses better than others, and potentially lead to the development of more effective vaccines.

The researchers envision that this technology could also have other uses. Birnbaum’s lab is now working on adapting the same viruses to deliver engineered genes to target cells. In that case, the viruses would carry not only a targeting molecule but also a novel gene that would be incorporated exclusively into cells that have the right target. This could offer a way to selectively deliver genes that promote cell death into cancer cells, for example.

“We built this tool to look for antigens, but there’s nothing particularly special about antigens,” Birnbaum says. “You could potentially use it to go into specific cells in order to do gene modifications for cell and gene therapy.”

 

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Lineage Cell Therapeutics (LCTX) Scheduled to Present at NobleCon18 Investor Conference


Lineage Cell Therapeutics CEO Brian Culley provides a preview of their upcoming presentation at NobleCon18

NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events

Free Registration Available – More Info


Research News and Advanced Market Data on LCTX


NobleCon18 Presenting Companies

About Lineage Cell Therapeutics

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include four allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Release – PDS Biotechnology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)



PDS Biotechnology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Research, News, and Market Data on PDS Biotech

 

FLORHAM PARK, N.J., April 08, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, today announced that on April 6, 2022 PDS Biotech granted nonstatutory stock options to (a) Robert Imani, M.D., PhD, PDS Biotech’s Vice President Medical Director to purchase 70,000 shares of PDS Biotech common stock, and (b) Paul Ivany, PDS Biotech’s Senior Director Manufacturing Operations, to purchase 50,000 shares of PDS Biotech’s common stock, in each case, as a material inducement to their employment with PDS Biotech and in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended, which was adopted on June 17, 2019 and provides for the granting of equity awards to new employees of PDS Biotech.

Each stock option has an exercise price of $6.09, the closing price of PDS Biotech’s common stock on April 6, 2022. Each stock option vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date and the remaining shares vesting monthly over the 36-month period thereafter, subject to continued employment with the company through the applicable vesting dates.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Release – Avivagen Announces AGM Results and Update to Shareholders



Avivagen Announces AGM Results and Update to Shareholders

Research, News, and Market Data on Avivagen

 

Record Year of Progress for OxC-beta™ Adoption Worldwide

  • Supply agreement with AB Vista in United States, Brazil and Thailand compliments existing partnerships in Asia and Mexico

  • Continued positive animal trial results leading to orders, new customer wins and growing recognition from the scientific community

OTTAWA, Ontario, April 08, 2022–(BUSINESS WIRE)–Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Company”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, today announced the results of its annual general meeting of shareholders and highlighted the significant progress made in the Corporation’s efforts to drive further adoption of OxC-beta™ worldwide.

At the Company’s AGM held today, Avivagen’s Corporation’s shareholders voted to support all of the resolutions that came before the meeting. The resolutions included the election of directors and the reappointment of McGovern Hurley LLP as Avivagen’s auditor.

The voting results in respect of the election of directors are detailed below:

Nominee

% Of Votes Cast At The
Meeting

Which Were Cast For the
Election of Directors

% Of Votes Cast At
The Meeting
Which Were Withheld
From Voting

Kym Anthony

78.5%

21.5%

Graham Burton

86.1%

13.9%

Aubrey Dan

92.3%

7.7%

David Hankinson

94.0%

6.0%

Jeffrey Kraws

91.7%

8.3%

Paul Mesburis

93.5%

6.5%

“Like every business we’ve had to overcome the challenges that the extended Covid-19 pandemic brought over the past year, but our growth since early 2021 is a testament to the opportunities for OxC-beta™,” says Kym Anthony, Chief Executive Officer, Avivagen. “The past year has seen a series of important milestones, including growth throughout the countries we service in the Americas and Asia, new customer wins and distribution agreements, important leadership appointments and strong recognition from the scientific and investment communities. Avivagen is in its strongest position yet, and we’ve only scratched the surface of the potential for OxC-beta™ adoption.”

The past 12 months have seen a series of key milestones achieved in furthering adoption of OxC-beta™ in markets worldwide, including:

Distribution Agreements and Market Development Efforts

In October 2021, Avivagen struck an eight-year supply agreement with AB Vista, a leading global animal nutrition technology company. The agreement saw AB Vista become the exclusive distributor of OxC-beta™ for use with poultry, swine, ruminants and aquaculture in the United States, Brazil and Thailand, and also presents opportunities to collaborate on development efforts. It is believed that the agreement will drive greater adoption of OxC-beta™ in two of the world’s three largest feed production markets.

In July 2021 Avivagen retained the services of industry leader Lesley Nernberg as a technical sales and marketing consultant focused on accelerating adoption of OxC-beta™ in Asia. Avivagen also secured regulatory approval for use of the Corporation’s oxidized carotenoid-based feed additive product in Vietnam in February 2022, creating new market opportunities.

In February 2021, Avivagen signed an agreement with Meyenberg International Group to expand its OxC-beta™ sales efforts into five Central and South American markets. Meyenberg has been instrumental in securing new customer interest, driving trails of OxC-beta™ locally and finalizing new and recurring sales throughout Mexico, with continued progress in Central and South America.

Record Orders and Large Recurring Customers

In April 2021 Avivagen secured the largest OxC-beta™ order to date (4.4 metric tonnes) with long-standing customer UNAHCO in the Philippines. This was later followed up by another record 6.3 tonne order, as UNAHCO continues to gain market share despite current difficult economic conditions.

The Corporation has also secured and fulfilled first purchase orders with a number of landmark customers over the past year, including sales with a large integrated producer in Asia, and an initial order with a large, influential and industry-leading poultry producer in Mexico. Avivagen believes that the order size and volume of initial orders signals an opportunity for growth in OxC-beta™ adoption over the coming years.

Recognition from the Scientific Community and Trials

The growing interest and demand for new and innovative solutions for replacing AGP’s (Antibiotics as Growth Promoters) in feeds, has led to a number scientific papers from Avivagen being accepted and published in top-tier scientific publications over the past year. Of note, scientific papers written by Avivagen representatives have appeared recently in such esteemed publications as Poultry Science, the British Journal of Nutrition, Food and Chemical Toxicology, the Canadian Journal of Chemistry and the New Zealand Veterinary Journal.

The scientific community is now recognizing what distribution partners and customers have seen firsthand via trials of OxC-beta™ over the past several years – that the safety and utility of using OxC-beta™ in broilers, swine and cows is conclusive. Trials with several AB Vista customers in Brazil are currently underway which, if successful, could lead to a pipeline of new customer activity. Trials by two of Mexico’s most important and influential livestock fed and dairy production associations, Asociación Nacional de Fabricantes de Alimentos Para Consumo Animal. S.C (ANFACA) and Asociación Mexicana de Productores de Alimentos, A.C. (AMEPA), are also underway.

Results from a dairy trial in New Zealand showing positive outcomes for use against sub-clinical mastitis were published in the New Zealand Veterinary Journal and have played a key role in driving purchasing decisions for customers as far away as Mexico. Similar trials with large industry leaders have also returned positive results that are expected to lead to continued adoption over the coming years.

Positive Corporate Developments

Along with continued customer and market success for OxC-beta™, Avivagen has focused on strengthening its leadership and financials over the past year. The Corporation announced the appointment of James (Jamie) Nickerson, PhD as President of Avivagen in January 2022 after 15 years of success in roles supporting the Corporation’s business development and innovation efforts.

Avivagen also completed a bought deal financing of $7.5 million in February 2021, and a private placement of debentures and shares for gross proceeds of $5.678 million in March 2022. The proceeds from the debenture and share offering were used by Avivagen to retire principal and interest outstanding pursuant to existing debentures and for transaction expenses.

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of ?-carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture and OTCQB® Venture Market exchanges under the symbols VIV and VIVXF, and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Mexico, Philippines, Taiwan, New Zealand, Thailand, Australia and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions.

Statements set out in this news release relating to the market opportunities for the Company, the expectation that Avivagen’s current position positions it for future growth, expectation as to further adoption of or orders for the Company’s products, the possibility that trials underway could lead to additional orders in the future and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, unforeseen factors could limit the growth of the Company and the adoption of its products, customers are under no obligation to make additional orders and may not order increasing quantities of the Company’s products, partnerships may not be as successful as hoped, trials may not be successful or may not lead to additional adoption of the Company’s products, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds, all of which could occur due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Contacts

Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

Release – Tonix Pharmaceuticals Initiates Enrollment in the RESILIENT Study



Tonix Pharmaceuticals Initiates Enrollment in the RESILIENT Study, a Potentially Pivotal Phase 3 Study of TNX-102 SL for the Management of Fibromyalgia

Research, News, and Market Data on Tonix Pharmaceuticals

 

Results from Planned Interim Analysis Expected First Quarter 2023

A Positive Outcome in RESILIENT Together with Results from Previous Positive Phase 3 Study RELIEF May Support Submission of an NDA

CHATHAM, N.J., April 07, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 3 RESILIENT study of TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.

RESILIENT is the Company’s potentially pivotal Phase 3 study of TNX-102 SL, a proprietary sublingual tablet formulation of cyclobenzaprine HCl taken daily at bedtime for the management of fibromyalgia. An interim analysis by an Independent Data Monitoring Committee of the first 50% of enrolled patients for a potential sample size readjustment or early stop for futility is expected in the first quarter of 2023.

TNX-102 SL is in mid-Phase 3 development for the management of fibromyalgia. In December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg for the management of fibromyalgia (primary endpoint, p=0.010). Several secondary measures in RELIEF highlighted the broad effects of TNX-102 SL across several cardinal symptoms of fibromyalgia beyond pain. In March 2022, Tonix reported results of a subsequent Phase 3 study (RALLY) in which TNX-102 SL did not achieve statistical significance on the primary endpoint (p=0.115). Relative to the previous positive Phase 3 study (RELIEF), RALLY had an unexpected increase in study participant adverse event-related discontinuations in both the drug and placebo groups.

“Tonix remains dedicated to improving the lives of the millions suffering from fibromyalgia and we are pleased to have our confirmatory, potentially pivotal Phase 3 RESILIENT study getting underway,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Fibromyalgia is a complex syndrome in which many patients remain unsatisfied by existing treatment options. Based on the positive results from RELIEF study, together with our general understanding of TNX-102 SL tolerability, we are excited to initiate our new RESILIENT Phase 3 study for fibromyalgia.”

“Fibromyalgia is a pain disorder characterized by chronic widespread pain, non-restorative sleep, fatigue, and impaired cognition,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Approximately one-fourth of people with fibromyalgia resort to prescription opioids for analgesia2. TNX-102 SL is a centrally acting analgesic that has the potential to be a new non-addictive, non-opioid bedtime medication for the management of fibromyalgia with broad spectrum symptom coverage. Symptoms of fibromyalgia overlap with those of other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’3,4 This type of pain syndrome is increasingly recognized as ‘nociplastic pain’,5 and the underlying mechanism is termed ‘central sensitization.’6 Opiates are generally not recommended for fibromyalgia or other nociplastic pain syndromes.”

1TNX-102 SL is an investigational new drug and has not been approved for any indication.
2Sarmento, CVM, et al. (2019) “Opioid prescription patterns among patients with fibromyalgia.” J Opioid Manag. 15(6):469-477. doi: 10.5055/jom.2019.0537. PMID: 31850508
3Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
4Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
5Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
6Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1

About the Phase 3 RESILIENT Study

The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial is expected to enroll approximately 470 participants in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation. An interim analysis by an Independent Data Monitoring Committee will be conducted on the primary endpoint based on the first 50% of enrolled participants for a potential sample size readjustment or early stop for futility.

For more information, see ClinicalTrials.gov Identifier: NCT05273749.

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., approximately 90% of whom are women. 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. Physicians and patients report common dissatisfaction with currently marketed products.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, ?1-adrenergic, H1-histamine, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, PTSD, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study now launched in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-1300 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 the development of TNX-102 SL; 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 thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Giving Old Drugs New Purpose to Meet Unmet Needs


Image credit: Michael Chen (Flickr)


Repurposing Generic Drugs Can Reduce Time and Cost to Develop New Treatments – But Low Profitability Remains a Barrier

 

Discovering new ways to use existing drugs can come about intentionally or by chance.

Sometimes physicians or patients notice an unanticipated beneficial effect from a drug. One example is sildenafil, a drug originally developed to treat severe chest pain from coronary artery disease. While sildenafil failed clinical trials, researchers noticed that one of its side effects was induced erections. This led to its successful rebranding as the erectile dysfunction drug Viagra.

Most of the time when drugs are repurposed for diseases or conditions they were not originally intended for, it’s done deliberately. As scientists raced to develop treatments for COVID-19, drug repurposing came into the spotlight for reasons good and bad.

As a researcher focused on drug discovery and development, I have seen the potential of repurposing and the challenges it faces. While finding new uses for drugs that have already been tested for safety and approved by the FDA can substantially reduce the time and cost of development, financial and logistical barriers can make it difficult to get to market.

The Success of Thalidomide

When repurposing is successful, a drug that is ineffective or harmful for one condition can be lifesaving for others.

One such drug is thalidomide, first approved as a morning sickness treatment. It gained notoriety in the late 1950s when it caused birth defects in an estimated 10,000 infants worldwide, resulting in changes in drug regulation and development that included increased developmental toxicity testing. Thalidomide was globally banned by the end of the 1960s.

In the 1990s, however, researchers discovered that thalidomide inhibits angiogenesis, or the growth of new blood vessels that deliver nutrients and oxygen to tumors. Its new use as a treatment for a blood cancer called multiple myeloma ultimately saw clinical and commercial success. This led to the development of improved versions of the drug that treat cancer with reduced side effects.

Scientists have continued to find other therapeutic uses for thalidomide.

When researchers discovered that thalidomide targets a molecule in the body that marks other proteins for destruction, they leveraged this function into an emerging technology called PROTACs. Many drugs work in the body by inhibiting a particular target that produces an unwanted effect, typically in a way that is reversible and temporary. PROTACs, on the other hand, are a type of drug that can destroy the target altogether. This potentially increases the effectiveness of the drug and reduces the chance of drug resistance.

An example is bavdegalutamide, a PROTAC that combines thalidomide with an inhibitor typically used to treat prostate cancer. This inhibitor works by blocking a target that supplies the tumor with hormones that help it grow. An ongoing phase 2 clinical trial on bavdegalutamide hinges on the idea that destroying the target would cut off hormone supply to tumors and stop their growth more effectively than conventional inhibitors.

Researchers are currently churning out PROTACS often by repurposing existing drugs. With ongoing promising results, 2021 saw the launch of a flurry of clinical trials testing PROTACs as a treatment for a number of different cancers.

 

Repurposing for COVID-19

Reearchers have used a myriad of drug repurposing approaches during the COVID-19 pandemic, ranging from educated guesses to large-scale drug screening and data mining from millions of electronic health records. Irrespective of how researchers decide which drugs to repurpose, all candidates must demonstrate strong clinical benefit in people before they can be authorized or approved for a new proposed use by the FDA.

My research team and I tested 1,425 FDA-approved drugs in human cells infected with COVID-19 and found 17 repurposing candidates for further examination. Several of the leads we identified have since entered preliminary clinical trials, including drugs originally intended to treat leprosy and prostate cancer, as well as a supplement derived from milk.

Researchers initiated hundreds of clinical studies early in the pandemic to test drug repurposing candidates for COVID-19. There have been a few notable successes including the generic antidepressant fluvoxamine, which reduced the risk of hospitalization by 32% in one clinical study. One meta-analysis on fluvoxamine and two other antiviral COVID-19 drugs, molnupiravir and Paxlovid, found that they all offered protective benefits against COVID-19 with comparable safety profiles.

Unlike these new COVID-19 antivirals, however, fluvoxamine has a 40-year track record of safely treating depression and obsessive-compulsive disorder. Despite this, fluvoxamine has not been authorized for emergency use by the FDA, and the National Institutes of Health states that there is insufficient evidence for its use against COVID-19.

Drug Discovery Challenges

Successful drug repurposing highlights the difficulty of predicting off-target effects of new treatments.

Eflornithine, for example, is a drug found to be ineffective against cancer – but it does turn out to inhibit facial hair growth in women and cure a parasitic infection called trypanosomiasis, or sleeping sickness. It’s often not immediately obvious why one drug would effectively treat two seemingly different health issues like these.

There are approximately 2,500 FDA-approved drugs, and an average of 46 new drugs are approved each year. However, over 90% of drugs that enter clinical trials fail. This increases to 97% for cancer drugs. While many shots on goal are required to produce a viable drug, each failed drug is a candidate for repurposing. Researchers like me have been collecting these “failed” compounds for further testing, trawling through research papers, patents and clinical trial databases to find repurposing candidates. Some labs have used artificial intelligence to automate this process.

But it can be difficult to ascertain what drugs are available to repurpose. While one drug development database proposes that there are 47,000 previously tested compounds ready for repurposing, there is no central repository for this information.

Parsing through the thousands of drugs for repurposing candidates can be difficult without knowing all the available options.

Commercialization Landscape

Drug repurposing faces an intellectual property barrier. Repurposing is most accessible with generic drugs that don’t have patents restricting their use for other conditions. But there is less opportunity for profit with generics than with new drugs.

Patents allow drug suppliers to have a monopoly over sales for a span of time. Repurposed drugs are typically granted “use patents” that protect the use of an existing drug for a new particular disease. But companies consider this type of protection less valuable than a “composition of matter” patent that restricts drug sales just to patent owners. An FDA analysis found a drug with two drug suppliers resulted in an average 39% price reduction, and six or more suppliers resulted in a 95% reduction. With less patent protection on a drug, more competitors can enter the market and manufacturers make less money.

Because of this perceived lack of commercial potential, drug repurposing is typically left to academic institutions that don’t have the resources to get either new or retooled drugs through the costly approval process.

It’s possible that if fluvoxamine were a new drug in development with patent protection within a Big Pharma company, it might have already gained FDA approval to treat COVID-19. But as it stands, fluvoxamine is a widely available generic that any doctor can prescribe “off-label” to treat conditions that have not been approved by the FDA, like COVID-19.

This leads to a tragedy of the commons whereby no company will invest in the clinical trials needed to bring a repurposed drug to the marketplace because the resulting benefits would be immediately shared with all competitors.

Bringing a new drug to market is a lengthy and costly process with a high failure rate. When the pharmaceutical industry can’t justify developing a new drug because of a low return on investment, drug repurposing can fill the gap. Federal support could make repurposing more appealing from a business standpoint, giving companies the incentive to enter the marketplace and boost this cost-effective way to address unmet medical needs.

 

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Tonix Pharmaceuticals Initiates Enrollment in the RESILIENT Study, a Potentially Pivotal Phase 3 Study of TNX-102 SL for the Management of Fibromyalgia



Tonix Pharmaceuticals Initiates Enrollment in the RESILIENT Study, a Potentially Pivotal Phase 3 Study of TNX-102 SL for the Management of Fibromyalgia

Research, News, and Market Data on Tonix Pharmaceuticals

 

Results from Planned Interim Analysis Expected First Quarter 2023

A Positive Outcome in RESILIENT Together with Results from Previous Positive Phase 3 Study RELIEF May Support Submission of an NDA

CHATHAM, N.J., April 07, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 3 RESILIENT study of TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.

RESILIENT is the Company’s potentially pivotal Phase 3 study of TNX-102 SL, a proprietary sublingual tablet formulation of cyclobenzaprine HCl taken daily at bedtime for the management of fibromyalgia. An interim analysis by an Independent Data Monitoring Committee of the first 50% of enrolled patients for a potential sample size readjustment or early stop for futility is expected in the first quarter of 2023.

TNX-102 SL is in mid-Phase 3 development for the management of fibromyalgia. In December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg for the management of fibromyalgia (primary endpoint, p=0.010). Several secondary measures in RELIEF highlighted the broad effects of TNX-102 SL across several cardinal symptoms of fibromyalgia beyond pain. In March 2022, Tonix reported results of a subsequent Phase 3 study (RALLY) in which TNX-102 SL did not achieve statistical significance on the primary endpoint (p=0.115). Relative to the previous positive Phase 3 study (RELIEF), RALLY had an unexpected increase in study participant adverse event-related discontinuations in both the drug and placebo groups.

“Tonix remains dedicated to improving the lives of the millions suffering from fibromyalgia and we are pleased to have our confirmatory, potentially pivotal Phase 3 RESILIENT study getting underway,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Fibromyalgia is a complex syndrome in which many patients remain unsatisfied by existing treatment options. Based on the positive results from RELIEF study, together with our general understanding of TNX-102 SL tolerability, we are excited to initiate our new RESILIENT Phase 3 study for fibromyalgia.”

“Fibromyalgia is a pain disorder characterized by chronic widespread pain, non-restorative sleep, fatigue, and impaired cognition,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Approximately one-fourth of people with fibromyalgia resort to prescription opioids for analgesia2. TNX-102 SL is a centrally acting analgesic that has the potential to be a new non-addictive, non-opioid bedtime medication for the management of fibromyalgia with broad spectrum symptom coverage. Symptoms of fibromyalgia overlap with those of other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’3,4 This type of pain syndrome is increasingly recognized as ‘nociplastic pain’,5 and the underlying mechanism is termed ‘central sensitization.’6 Opiates are generally not recommended for fibromyalgia or other nociplastic pain syndromes.”

1TNX-102 SL is an investigational new drug and has not been approved for any indication.
2Sarmento, CVM, et al. (2019) “Opioid prescription patterns among patients with fibromyalgia.” J Opioid Manag. 15(6):469-477. doi: 10.5055/jom.2019.0537. PMID: 31850508
3Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
4Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
5Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
6Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1

About the Phase 3 RESILIENT Study

The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial is expected to enroll approximately 470 participants in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation. An interim analysis by an Independent Data Monitoring Committee will be conducted on the primary endpoint based on the first 50% of enrolled participants for a potential sample size readjustment or early stop for futility.

For more information, see ClinicalTrials.gov Identifier: NCT05273749.

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., approximately 90% of whom are women. 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. Physicians and patients report common dissatisfaction with currently marketed products.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, ?1-adrenergic, H1-histamine, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, PTSD, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study now launched in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-1300 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 the development of TNX-102 SL; 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 thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

HMNC Brain Health Scheduled to Present at NobleCon18 Investor Conference


HMNC Brain Health CFO Nir Naor provides a preview of their upcoming presentation at NobleCon18

NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events

Free Registration Available – More Info


Learn more about HMNC


NobleCon18 Presenting Companies

About HMNC Brain Health

HMNC Brain Health is a disruptive clinical stage biopharma company pioneering Precision Psychiatry, powered by its AI Platform, and focusing on Treatment-Resistant Depression (TRD) and Major Depressive Disorder (MDD). HMNC Brain Health uses its AI Platform, combining Psychiatry, Genomics, and Analytics, to develop innovative therapies for mental health disorders.

Release – Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University



Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19

Research, News, and Market Data on Tonix Pharmaceuticals

 

TNX-2300, a Live Virus Vaccine Based on a Bovine Parainfluenza Virus Vector, in Development to Protect Against COVID-19

Co-Expression of the CD40-Ligand Will be Tested to Direct Immune Response

CHATHAM, N.J., April 05, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a new preclinical research agreement with Kansas State University (K-State) to extend the research being performed under its original agreement. Tonix and K-State are working together to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform, bovine parainfluenza virus, and also to test the effect of co-expression of the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.

“Vaccines based on live replicating viruses trigger the immune system by direct stimulation of T cells, with the potential to elicit strong, long-lasting and durable immunity,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are currently well over 300 potential COVID-19 vaccines in various stages of development1, but relatively very few utilize live replicating viral platforms. TNX-2300* is a live replicating virus vaccine designed to elicit T cell immunity.”

Dr. Lederman continued, “Modern live virus vaccines in development for COVID-19 use a vector system to present SARS-CoV-2 protein antigens. K-State is studying bovine parainfluenza virus as the vector. A traditional live virus vaccine approach would use a weakened version of SARS-CoV-2, but SARS-CoV-2 contains genes that weaken the immune response by thwarting innate immunity. In the first completed phase of the research project, K-State showed that vaccinating hamsters with bovine parainfluenza virus expressing SARS-CoV-2 spike protein elicited antibody responses to the SARS-CoV-2 spike protein. Our goal in utilizing bovine parainfluenza virus as a live virus vaccine vector is to develop a COVID-19 vaccine that is well tolerated, produces durable immunity, prevents forward transmission and can be rapidly and broadly deployed.”

Under the extended research agreement, K-State will continue to advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza virus and also to test the effect of co-expression of the CD40-ligand.

Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans2-7. Notably and most importantly, following extensive testing in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children3,6. The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally. The technology also includes a molecular stimulant called CD40-ligand, which triggers strong immunity, including T cell responses. TNX-2300 is designed to potentially stimulate immunity against the SARS-CoV-2 spike protein. The research is being directed by Dr. Waithaka Mwangi, Kansas State University, Department of Diagnostic Medicine/Pathobiology, who is the inventor of the new technology. In addition, K-State has granted Tonix an option for an exclusive license for the clinical and commercial use of K-State’s intellectual property associated with coronavirus vaccines under this relationship.

*TNX-2300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

1World Health Organizationhttps://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccinesCOVID-19 – Landscape of novel coronavirus candidate vaccine development worldwide, March 2022.
2Liang, B., et al., J. Virol. 2016. 90:10022.
3Karron, R. A., et al., Vaccine. 2012. 30:3975.
4Haller, A. A., et al., J. Gen Virol. 2003. 84:2153.
5Schmidt, A. C., et al., J. Virol. 2001. 75:4594.
6Karron, R. A., et al., J. Infec. Diseases. 1995. 171:1107.
7Haller, A. A., et al., J. Virol. 2000. 74:11626.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the first half of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022.

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-102 SL is an investigational new drug and has not been approved for any indication.
7TNX-1300 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 the development of TNX-2300; 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 thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Release – Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL



Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)

Research, News, and Market Data on Tonix Pharmaceuticals

 

Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Expected to Start Second Quarter 2022

Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

CHATHAM, N.J., April 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is now known officially as Post-Acute Sequelae of COVID-19 (PASC2).

“We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Over 30% of people who recover from COVID-19 continue to experience a constellation of symptoms long past the time that they have recovered from acute COVID-19 illness3-4. The symptoms of Long COVID, which can include fatigue, multi-site pain, sleep disturbances, fevers, shortness of breath, cognitive impairment, gastrointestinal symptoms, anxiety, and depression, can persist for many months and can range from mild to incapacitating5. Our study will focus on testing TNX-102 SL in the treatment of patients with multi-site pain associated with Long COVID. This group of patients have symptoms that overlap with other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’6,7 This type of pain syndrome is increasingly recognized as nociplastic pain,8 and the underlying mechanism as ‘central sensitization.’9 Fibromyalgia is considered one of the chronic overlapping pain conditions and our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia.”

About the Phase 2 Study

This Phase 2 study will be a double-blind randomized, placebo-controlled 14-week trial to evaluate the safety and efficacy of sublingual TNX-102 SL 5.6 mg daily at bedtime in the treatment of patients with multi-site pain associated with Long COVID. The trial will be conducted at approximately 30 sites to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be Change from Baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.10-13 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.14 While the vaccines available in the U.S. through either FDA approval or under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

1 TNX-102 SL is an investigational new drug and has not been approved for any indication.
2 Feb. 24, 2021 – White House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from the World Health Organization on long COVID.
3 Logue JK, et al. (2021) “Sequelae in Adults at 6 Months After COVID-19 Infection”. JAMA Netw Open. ;4(2):e210830. doi:10.1001/jamanetworkopen.2021.0830
4 Carfì, A et al.. (2020) “Persistent symptoms in patients after acute COVID-19.” JAMA 324.6: 603-605.
5 Nalbandian, Ani, et al. (2021) “Post-acute COVID-19 syndrome.” Nature Medicine27(4): 601-615.
6 Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
7 Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
8 Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
9 Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1
10 Briggs, A, and Vassall, A. (2021) “Count the cost of disability caused by COVID-19.” Nature 593(7860): 502-505.
11 Nittas V, et al. (2022) “Long COVID Through a Public Health Lens: An Umbrella Review.” Public Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501
12 Davis, HE., et al. (2021) “Characterizing long COVID in an international cohort: 7 months of symptoms and their impact.” EClinicalMedicine 38: 101019.
13 Martin C, et al. (2021) “A model framework for projecting the prevalence and impact of Long-COVID in the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec 2. doi:10.1371/journal.pone.0260843
14 The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID that overlaps with fibromyalgia, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1 TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2 TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3 TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4 TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5 TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6 TNX-1300 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 the development of TNX-102 SL, 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 thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)



Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)

Research, News, and Market Data on Tonix Pharmaceuticals

 

Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Expected to Start Second Quarter 2022

Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

CHATHAM, N.J., April 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is now known officially as Post-Acute Sequelae of COVID-19 (PASC2).

“We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Over 30% of people who recover from COVID-19 continue to experience a constellation of symptoms long past the time that they have recovered from acute COVID-19 illness3-4. The symptoms of Long COVID, which can include fatigue, multi-site pain, sleep disturbances, fevers, shortness of breath, cognitive impairment, gastrointestinal symptoms, anxiety, and depression, can persist for many months and can range from mild to incapacitating5. Our study will focus on testing TNX-102 SL in the treatment of patients with multi-site pain associated with Long COVID. This group of patients have symptoms that overlap with other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’6,7 This type of pain syndrome is increasingly recognized as nociplastic pain,8 and the underlying mechanism as ‘central sensitization.’9 Fibromyalgia is considered one of the chronic overlapping pain conditions and our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia.”

About the Phase 2 Study

This Phase 2 study will be a double-blind randomized, placebo-controlled 14-week trial to evaluate the safety and efficacy of sublingual TNX-102 SL 5.6 mg daily at bedtime in the treatment of patients with multi-site pain associated with Long COVID. The trial will be conducted at approximately 30 sites to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be Change from Baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.10-13 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.14 While the vaccines available in the U.S. through either FDA approval or under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

1 TNX-102 SL is an investigational new drug and has not been approved for any indication.
2 Feb. 24, 2021 – White House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from the World Health Organization on long COVID.
3 Logue JK, et al. (2021) “Sequelae in Adults at 6 Months After COVID-19 Infection”. JAMA Netw Open. ;4(2):e210830. doi:10.1001/jamanetworkopen.2021.0830
4 Carfì, A et al.. (2020) “Persistent symptoms in patients after acute COVID-19.” JAMA 324.6: 603-605.
5 Nalbandian, Ani, et al. (2021) “Post-acute COVID-19 syndrome.” Nature Medicine27(4): 601-615.
6 Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
7 Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
8 Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
9 Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1
10 Briggs, A, and Vassall, A. (2021) “Count the cost of disability caused by COVID-19.” Nature 593(7860): 502-505.
11 Nittas V, et al. (2022) “Long COVID Through a Public Health Lens: An Umbrella Review.” Public Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501
12 Davis, HE., et al. (2021) “Characterizing long COVID in an international cohort: 7 months of symptoms and their impact.” EClinicalMedicine 38: 101019.
13 Martin C, et al. (2021) “A model framework for projecting the prevalence and impact of Long-COVID in the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec 2. doi:10.1371/journal.pone.0260843
14 The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID that overlaps with fibromyalgia, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1 TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2 TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3 TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4 TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5 TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6 TNX-1300 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 the development of TNX-102 SL, 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 thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19



Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19

Research, News, and Market Data on Tonix Pharmaceuticals

 

TNX-2300, a Live Virus Vaccine Based on a Bovine Parainfluenza Virus Vector, in Development to Protect Against COVID-19

Co-Expression of the CD40-Ligand Will be Tested to Direct Immune Response

CHATHAM, N.J., April 05, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a new preclinical research agreement with Kansas State University (K-State) to extend the research being performed under its original agreement. Tonix and K-State are working together to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform, bovine parainfluenza virus, and also to test the effect of co-expression of the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.

“Vaccines based on live replicating viruses trigger the immune system by direct stimulation of T cells, with the potential to elicit strong, long-lasting and durable immunity,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are currently well over 300 potential COVID-19 vaccines in various stages of development1, but relatively very few utilize live replicating viral platforms. TNX-2300* is a live replicating virus vaccine designed to elicit T cell immunity.”

Dr. Lederman continued, “Modern live virus vaccines in development for COVID-19 use a vector system to present SARS-CoV-2 protein antigens. K-State is studying bovine parainfluenza virus as the vector. A traditional live virus vaccine approach would use a weakened version of SARS-CoV-2, but SARS-CoV-2 contains genes that weaken the immune response by thwarting innate immunity. In the first completed phase of the research project, K-State showed that vaccinating hamsters with bovine parainfluenza virus expressing SARS-CoV-2 spike protein elicited antibody responses to the SARS-CoV-2 spike protein. Our goal in utilizing bovine parainfluenza virus as a live virus vaccine vector is to develop a COVID-19 vaccine that is well tolerated, produces durable immunity, prevents forward transmission and can be rapidly and broadly deployed.”

Under the extended research agreement, K-State will continue to advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza virus and also to test the effect of co-expression of the CD40-ligand.

Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans2-7. Notably and most importantly, following extensive testing in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children3,6. The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally. The technology also includes a molecular stimulant called CD40-ligand, which triggers strong immunity, including T cell responses. TNX-2300 is designed to potentially stimulate immunity against the SARS-CoV-2 spike protein. The research is being directed by Dr. Waithaka Mwangi, Kansas State University, Department of Diagnostic Medicine/Pathobiology, who is the inventor of the new technology. In addition, K-State has granted Tonix an option for an exclusive license for the clinical and commercial use of K-State’s intellectual property associated with coronavirus vaccines under this relationship.

*TNX-2300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

1World Health Organizationhttps://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccinesCOVID-19 – Landscape of novel coronavirus candidate vaccine development worldwide, March 2022.
2Liang, B., et al., J. Virol. 2016. 90:10022.
3Karron, R. A., et al., Vaccine. 2012. 30:3975.
4Haller, A. A., et al., J. Gen Virol. 2003. 84:2153.
5Schmidt, A. C., et al., J. Virol. 2001. 75:4594.
6Karron, R. A., et al., J. Infec. Diseases. 1995. 171:1107.
7Haller, A. A., et al., J. Virol. 2000. 74:11626.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the first half of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022.

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-102 SL is an investigational new drug and has not been approved for any indication.
7TNX-1300 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 the development of TNX-2300; 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 thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.