Category: Health

Release – Item 9 Labs Closes Out 2022 as a Top 10 Cannabis Brand in Arizona

Posted on by aweinsoff@channelchek.com

Research News and Market Data on INLB

– Awarded Multiple First Place Podium Finishes in Arizona’s Largest Cannabis Competitions
– Named No. 1 Cannabis Brand in Arizona by MJ Brand Insights For Creative Brand Engagement

PHOENIX , Jan. 12, 2023 /PRNewswire/ — Item 9 Labs —the award-winning, premium cannabis brand from Item 9 Labs Corp. (OTCQX: INLB)—kicks off 2023 after a year of budding growth and achievements embedded in product innovation and increased consumer engagement.

The Arizona marijuana market has experienced one of the most rapid developments in consumer participation and retail expansion of any market over the past year, according to cannabis data research firm BDSA. With the legalization of adult-use marijuana in early 2021, Arizona has seen noticeable popularity across the pre-roll, flower and concentrate categories with the market predicted to exceed $1 billion by year end.

BDSA recognized Item 9 Labs as one of the top 10 cannabis brands in the state overall, along with top five placements across multiple vape categories.

“Wrapping up 2022 as a top 10 brand is a true testament to our team of extraction and cultivation experts and their deep commitment to delivering masterfully crafted cannabis products,” said Item 9 Labs Corp. Chief Executive Officer, Mike Weinberger . “In the year ahead, we are optimistic that our Item 9 Labs brand will continue building on this positive momentum while driving forward brand recognition and loyalty.”

In August 2022 , Item 9 Labs was recognized as the No. 1 cannabis brand in Arizona by MJ Brand Insights (MJBI) , the official publication of MJ Unpacked , for its creative brand engagement. Using a proprietary, comparison-based scoring system by Pioneer Intelligence, the technology leverages data to benchmark marketing performance of consumer-facing cannabis brands.

This past June, the brand launched a new permanent mainstay to its product lineup— 1-gram concentrate infused pre-rolls —recognizing the trending triple-digit growth of this category. Item 9 Labs infused pre-rolls are crafted with award-winning flower and live resin sugar, live resin badder or crumble concentrates, which are grown and extracted in-house. With products in 65 percent of Arizona’s dispensaries, the brand sold more than 13,000 units of its pre-rolls within the first two months and they have been flying off the shelves ever since.

Item 9 Labs consistently bolsters and strengthens its existing extensive product lineup. As the brand entered 2022, it introduced its best-selling proprietary vape technology Orion 710 Live Resin Pod and Battery System with a half-gram pod (500 mg) due to the popularity of its 1-gram (1000 mg) pod. Since hitting the market, Item 9 Labs sold nearly 64,000 units across the state, creating buzz amongst local consumers and generating a go-to vape option for the market.

“Last year was the first year we witnessed the true impact of legal cannabis sales and saw how consumer dynamics evolved alongside it,” said Item 9 Labs Corp. Chief Operating Officer, Chris Wolven . He added, “We put an emphasis on the art of innovation and fueled our go-to-market strategy to meet the increasing demand, and it shows in the awards we took home for product excellence.”

Item 9 Labs’ dedication to perfecting its cannabis products this past year did not go unnoticed. The brand earned multiple top podium finishes in Arizona’s largest and longest-running annual cannabis festivals and awards events. At the Spring Errl Cup and Fall Errl Cup this year, the brand was awarded:

  • First place for “Best Cannabis Vape Pen – Indica”
  • First place for “Best Cannabis Vape Pen – Sativa”
  • Second place for “Best Cannabis Flower – Sativa”
  • Second place for “Best Cannabis Vape Pen – Indica”
  • Second place for “Best Concentrate – Hybrid”
  • Third place for “Best Hand-Crafted Cannabis Product”
  • Third place for “Best Cannabis Vape Pen – Sativa”
  • Third place for “Best Derivative”

For more information on Item 9 Labs, the brand’s wide range of premium cannabis products and its awards, visit item9labs.com or Item 9 Labs’ Instagram .

ABOUT ITEM 9 LABS
Item 9 Labs cultivates the highest quality cannabis products while providing transparency, consistency and well-being for an enhanced cannabis experience. With more than 30 podium finishes in Arizona marijuana competitions, Item 9 Labs is a trusted source for premium cannabis products. Starting with intentionally grown flower, the Item 9 Labs product catalog spans across five core categories, including several active cannabis strains, cannabis vape products, premium concentrates and Orion vape technology. For additional information, visit item9labs. com .

ABOUT ITEM 9 LABS CORP.
Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States . The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency and well-being. Headquartered in Arizona, the company is currently expanding its operations space up to 640,000-plus square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit item9labscorp. com .

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties, including, but not limited to, risks and effects of legal and administrative proceedings and governmental regulation, especially in a foreign country, future financial and operational results, competition, general economic conditions, proposed transactions that are not legally binding obligations of the company and the ability to manage and continue growth. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual outcomes may vary materially from those indicated. Important factors that could cause actual results to differ materially from the forward-looking statements we make in this news release include the introduction of new technology, market conditions and those set forth in reports or documents we file from time to time with the SEC. We undertake no obligation to revise or update such statements to reflect current events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Media Contact:
Lisa Sass
Serendipit Consulting
lsass@serendipitconsulting.com
602-283-5209

Investor Contact:
Item 9 Labs Corp.
investors@item9labscorp.com
800-403-1140

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/item-9-labs-closes-out-2022-as-a-top-10-cannabis-brand-in-arizona-301720085.html

SOURCE Item 9 Labs

Release – Multi-State Cannabis Operator, Schwazze Announces Key Executive Leadership Additions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

January 11, 2023

NEO: SHWZ
OTCQX: SHWZ

DENVER, Jan. 11, 2023 /CNW/ – Medicine Man Technologies operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announces changes to its executive leadership team in preparation for its growth initiatives in Colorado and New Mexico.

   

Todd Williams, who has been acting as a Senior Advisor & Consultant for Mergers & Acquisitions and Real Estate, will become EVP, M&A and Real Estate. Williams has been a key member of the Schwazze Executive Leadership Team in an advisory capacity for the past three years and joins the Schwazze team as a full-time employee to continue his focus on M&A and real estate. Williams joins Schwazze in a period of significant organic and new acquisition growth for the Company. He is a seasoned veteran with more than 25 years’ experience in business development, mergers and acquisitions, and asset valuation. Previously, Williams was Vice President of Corporate Development at Albertsons, Inc., where he managed the acquisition of more than 1,600 operating grocery stores with more than $40 billion in sales and $10 billion in transaction value, as well as divesting 168 stores with over $3 billion in sales.

Steve Pear is moving from head of the New Mexico division to become President, Wholesale Division, responsible for leading the Company’s wholesale sales and marketing efforts. As a newly created role within the Company’s Executive Leadership Team, Pear’s focus will shift to optimizing our commercial footprint on a national scale while driving our core brands to the next level. He has been instrumental in leading the New Mexico team since the R.Greenleaf acquisition was completed in February of 2022. While Pear is stepping away from his role in New Mexico, he has positioned the team for continued success as Schwazze expands further in the New Mexico market. Reporting directly to Pear in his new role will be Jeremy Bullock (VP, Commercial Sales) and Julie Suntrup (VP, Corporate Marketing & Brands).

Replacing Pear in New Mexico is Ken Diehl as President, New Mexico Division. Diehl is a highly accomplished retail industry operations, merchandising and marketing professional with 30 years’ experience overseeing billions in annual revenue, leading retail teams, improving spending, and increasing profitability. He has an impressive history of growing Fortune 500 companies’ sales as well as profits. Diehl brings to Schwazze grocery retail experience with Kroger, Albertsons, Jewel Osco, A&P, and Strack & Van Til, holding the roles as Chief Executive Officer, Chief Merchant, Chief Operator and Chief Marketer. Most recently, Diehl was Chief Merchant for Leslie’s Pool Supplies while also helping to project lead an IPO in specialty retail. Diehl studied at Arizona State University as well as Cornell University, before leaving to joining the military where he earned Top Secret clearance as an honored veteran of the United States Navy.

“We are excited to add key, seasoned individuals to our Executive Leadership team as the Company positions itself for growth in 2023 and beyond. Ken Diehl’s retail leadership will be key as we grow our New Mexico retail footprint to meet the needs of our customers, and Steve Pear’s transition to Schwazze’s wholesale division demonstrates our intent to grow our in-house brands’ sales across both states. In addition, I’m happy Todd Williams has chosen to come on board in a full-time capacity to fuel our M&A and organic growth efforts.” said Nirup Krishnamurthy, President of Schwazze.

Since April 2020, Schwazze has acquired, opened or announced the planned acquisition of 41 cannabis retail dispensaries (Star Buds, Emerald Fields and R,Greenleaf) as well as seven cultivation facilities and two manufacturing plants in Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division, and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (OTCQX: SHWZ; NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit www.Schwazze.com.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/multi-state-cannabis-operator-schwazze-announces-key-executive-leadership-additions-301718562.html

SOURCE Schwazze

Using Stem Cells to Treat Cancer

Posted on by phoffman@channelchek.com
Image Source: NIH (Flickr)

Triggering Cancer Cells to Become Normal Cells – How Stem Cell Therapies Can Provide New Ways to Stop Tumors from Spreading or Growing Back

How cells become cancerous is a process researchers are still trying to fully understand. Generally, normal cells grow and multiply through controlled cell division, where old and damaged cells are replaced after they die by new cells. Sometimes this process stops working, leading cells to start growing uncontrollably and develop into a tumor.

Traditionally, cancer treatments like chemotherapy, immunotherapy, radiation and surgery focus on killing cancer cells. Another type of treatment using stem cells called differentiation therapy, however, focuses on persuading cancer cells to become normal cells.

Two economists discussed that and more in a recent wide-ranging and exclusive interview for The Conversation. Brian Blank is a finance professor at Mississippi State University who specializes in the study of corporations and how they respond to economic downturns, Huanhuan Joyce Chen, Assistant Professor of Molecular Engineering, University of Chicago Pritzker School of Molecular Engineering and Abhimanyu Thakur,Postdoctoral Scholar in Molecular Engineering, University of Chicago Pritzker School of Molecular Engineering.

We are researchers who study how stem cells, or immature cells that can develop into different types of cells, behave in states of health and disease. We believe that stem cells can provide potential treatments for cancer of all types in many different ways.

How Do Stem Cells Contribute to Cancer?

Stem cells are unspecialized cells, meaning they can eventually become any one of the various types of cells that make up different parts of the body. They can replenish cells in the skin, bone, blood and other organs during development and regenerate and repair tissues when they’re damaged.

There are different types of stem cells. Embryonic stem cells are the first cells that initially form after a sperm fertilizes an egg and can give rise to all other cell types in the human body. Adult stem cells are more mature, meaning they can replace damaged cells only in one type of organ and have a limited ability to multiply. Researchers can reprogram adult stem cells, or differentiated cells, in the lab to act like embryonic stem cells.

Because stem cells can survive longer than regular cells, they have a much higher probability of accumulating genetic mutations that can result in loss of control over their growth and ability to regenerate. This is why many tumors harbor a small subpopulation of cells that function like stem cells. These so-called cancer stem cells are thought to be responsible at least in part for cancer initiation, progression, metastasis, recurrence and treatment resistance.

What is Differentiation Therapy?

Accumulating evidence is also showing that cancer stem cells can differentiate into multiple cell types, including noncancerous cells. Researchers are taking advantage of this fact through a type of treatment called differentiation therapy.

The concept of differentiation therapy originated from scientists observing that hormones and cytokines, which are proteins that play a key role in cell communication, can stimulate stem cells to mature and lose their ability to regenerate. It followed that forcing cancer stem cells to differentiate into more mature cells could subsequently stop them from multiplying uncontrollably, making them become normal cells.

Differentiation therapy has been successful in treating acute promyelocytic leukemia, an aggressive blood cancer. In this case, retinoic acid and arsenic are used to block a protein that stops myeloid cells, a type of blood cell derived from the bone marrow, from fully maturing. By allowing these cells to fully mature, they lose their cancerous qualities.

Furthermore, because differentiation therapy doesn’t focus on killing cancer cells and doesn’t surround healthy cells in the body with harmful chemicals, it can be less toxic than traditional treatments.

Using Stem Cells to Treat Cancer

There are many other potential ways to use stem cells to treat cancer. For example, cancer stem cells can be directly targeted to stop their growth, or turned into “Trojan horses” that attack other tumor cells.

Quiescent cancer stem cells, which don’t divide but are still alive, are another potential drug target. These cells typically play a big role in treatment resistance for various cancer types because they are able to regenerate and avoid death even better than regular cancer stem cells. Their quiescent quality can persist for decades and lead to a cancer relapse. They are also challenging to distinguish from regular cancer stem cells, making them difficult to study.

Researchers can also genetically engineer stem cells to express a protein that binds to a desired target in a cancer cell, increasing the efficacy of treatments by releasing drugs right at the tumor. For example, mesenchymal stem cells derived from bone marrow naturally migrate toward and stick to tumors, and can be used to deliver cancer drugs directly to cancer cells.

Stem cells can also be used to make organoid models, or miniature versions of organs, to screen potential cancer drugs and study the underlying mechanisms that lead to cancer.

Challenges in Stem Cell Therapy

Although, stem cells hold numerous advantages in their use in cancer therapy, they also face various challenges. For example, many current stem cell therapies that aren’t used in combination with other drugs are unable to completely eliminate tumors. There are also concerns about stem cell therapies potentially promoting tumor growth.

Despite these challenges, we believe that stem cell technologies have the potential to open new avenues for cancer therapy. Integrating genetic engineering with stem cells can overcome the major drawbacks of chemotherapeutics, such as toxicity to healthy cells. With further research, cancer stem cell therapies may one day become part of the standard of care for many types of cancer.

Release – BioSig Executes Agreement with Bellin Health for the Acquisition of its PURE EP™ Technology

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BSGM

January 10, 2023

Westport, CT, Jan. 10, 2023 (GLOBE NEWSWIRE) —

  • Leading Midwest healthcare system reports significant cost savings and noise reduction following evaluation of the PURE EP™ System
  • Medical center signs agreement to acquire the Company’s digital signal processing technology for arrhythmia care

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that Bellin Health System in Green Bay, Wisconsin has signed an agreement to acquire the Company’s PURE EP™ System.

The agreement follows a 60-day formal evaluation of the PURE EP™ System at Bellin Health. The hospital reported that the PURE EP™ demonstrated a significant cost savings per case as well as a substantial reduction in noise and signal interference compared to the use of conventional systems only.

The agreement grants Bellin Health full autonomy with respect to its operation of the PURE EP™ System, and BioSig will not be required to provide an on-site clinical account manager following the new system install.

The PURE EP™ System is a combination of hardware and software that enables the real-time acquisition of raw signal data—absent of unnecessary noise or interference—allowing physicians to make informed clinical decisions based on clear and precise data. With the heightened visualization of active signals, the PURE EP™ System is facilitating personalized patient care and innovations in the field of electrophysiology.

“Bellin has observed, first-hand, that clear cardiac signals provide more information that can impact procedural efficiency without driving up procedural costs,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies. “The terms of this agreement represent a new milestone for the PURE EP™ System—expanding the accessibility and automaticity of our novel digital signal processing technology.”

Bellin Health recently announced plans to combine operations with Gundersen Health System, a physician-led, nonprofit, integrated healthcare network headquartered in La Crosse, Wisconsin. The hospital serves 22 counties in western Wisconsin, southeastern Minnesota, and northeast Iowa. The merger allows the health systems to offer access to more resources and a broader network of top-tier clinical services, shared provider expertise, state-of-the-art technology and digital healthcare tools that bring virtual care options into homes and workplaces.1

About Bellin Health
Bellin Health’s Heart and Vascular Team brings more than 50 years of experience in all facets of cardiac care, making the medical center the most experienced program in the region. The physicians at Bellin are board-certified specialists with experience in all areas of cardiovascular care including echocardiography, nuclear cardiology, interventional cardiology, electrophysiology, and endovascular medicine. As the largest group of cardiovascular specialists in Green Bay, Bellin Health is renowned for its comprehensive cardiovascular care centers across the Midwest and its surrounding regions. (www.bellin.org).

About BioSig Technologies 
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives. 

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. 

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating. 

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.2

  


Forward-looking Statements 
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds; (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed; (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

1 https://www.gundersenhealth.org/news/gundersen-bellin-anticipate-merger-closing-nov-30-start-of-operations-dec-1

2Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

Organs-On-A-Chip Minimize Late-Stage Drug Development Failures

Posted on by phoffman@channelchek.com
Image: Lung-on-a-Chip,  National Center for Advancing Translational Sciences (Flickr)

Organ-On-A-Chip Models Allow Researchers to Conduct Studies Closer to Real-Life Conditions – and Possibly Grease the Drug Development Pipeline

Bringing a new drug to market costs billions of dollars and can take over a decade. These high monetary and time investments are both strong contributors to today’s skyrocketing health care costs and significant obstacles to delivering new therapies to patients. One big reason behind these barriers is the lab models researchers use to develop drugs in the first place.

Preclinical trials, or studies that test a drug’s efficacy and toxicity before it enters clinical trials in people, are mainly conducted on cell cultures and animals. Both are limited by their poor ability to mimic the conditions of the human body. Cell cultures in a petri dish are unable to replicate every aspect of tissue function, such as how cells interact in the body or the dynamics of living organs. And animals are not humans – even small genetic differences between species can be amplified to major physiological differences.

Fewer than 8% of successful animal studies for cancer therapies make it to human clinical trials. Because animal models often fail to predict drug effects in human clinical trials, these late-stage failures can significantly drive up both costs and patient health risks.

To address this translation problem, researchers have been developing a promising model that can more closely mimic the human body – organ-on-a-chip.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Chengpeng Chen, Assistant Professor of Chemistry and Biochemistry, University of Maryland, Baltimore County

As an analytical chemist, I have been working to develop organ and tissue models that avoid the simplicity of common cell cultures and the discrepancies of animal models. I believe that, with further development, organs-on-chips can help researchers study diseases and test drugs in conditions that are closer to real life.

What are Organs-On-Chips?

In the late 1990s, researchers figured out a way to layer elastic polymers to control and examine fluids at a microscopic level. This launched the field of microfluidics, which for the biomedical sciences involves the use of devices that can mimic the dynamic flow of fluids in the body, such as blood.

Advances in microfluidics have provided researchers a platform to culture cells that function more closely to how they would in the human body, specifically with organs-on-chips. The “chip” refers to the microfluidic device that encases the cells. They’re commonly made using the same technology as computer chips.

Not only do organs-on-chips mimic blood flow in the body, these platforms have microchambers that allow researchers to integrate multiple types of cells to mimic the diverse range of cell types normally present in an organ. The fluid flow connects these multiple cell types, allowing researchers to study how they interact with each other.

This technology can overcome the limitations of both static cell cultures and animal studies in several ways. First, the presence of fluid flowing in the model allows it to mimic both what a cell experiences in the body, such as how it receives nutrients and removes wastes, and how a drug will move in the blood and interact with multiple types of cells. The ability to control fluid flow also enables researchers to fine-tune the optimal dosing for a particular drug.

The lung-on-a-chip model, for instance, is able to integrate both the mechanical and physical qualities of a living human lung. It’s able to mimic the dilation and contraction, or inhalation and exhalation, of the lung and simulate the interface between the lung and air. The ability to replicate these qualities allows researchers to better study lung impairment across different factors.

Bringing Organs-On-Chips to Scale

While organ-on-a-chip pushes the boundaries of early-stage pharmaceutical research, the technology has not been widely integrated into drug development pipelines. I believe that a core obstacle for wide adoption of such chips is its high complexity and low practicality.

Current organ-on-a-chip models are difficult for the average scientist to use. Also, because most models are single-use and allow only one input, which limits what researchers can study at a given time, they are both expensive and time- and labor-intensive to implement. The high investments required to use these models might dampen enthusiasm to adopt them. After all, researchers often use the least complex models available for preclinical studies to reduce time and cost.

This chip mimics the blood-brain barrier. The blue dye marks where brain cells would go, and the red dye marks the route of blood flow. Vanderbilt University/Flickr

Lowering the technical bar to make and use organs-on-chips is critical to allowing the entire research community to take full advantage of their benefits. But this does not necessarily require simplifying the models. My lab, for example, has designed various “plug-and-play” tissue chips that are standardized and modular, allowing researchers to readily assemble premade parts to run their experiments.

The advent of 3D printing has also significantly facilitated the development of organ-on-a-chip, allowing researchers to directly manufacture entire tissue and organ models on chips. 3D printing is ideal for fast prototyping and design-sharing between users and also makes it easy for mass production of standardized materials.

I believe that organs-on-chips hold the potential to enable breakthroughs in drug discovery and allow researchers to better understand how organs function in health and disease. Increasing this technology’s accessibility could help take the model out of development in the lab and let it make its mark on the biomedical industry.

Release – Ocugen Announces Positive Top-Line Data For Covid-19 Vaccine Candidate Covaxin™ (Bbv152) In Phase 2/3 Immuno-Bridging And Broadening Study: Both Co-Primary Endpoints Met

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

January 9, 2023

  • Study met both co-primary endpoints with robust immune responses
  • COVAXIN™ was found to be well-tolerated in vaccine-naïve individuals and in individuals previously vaccinated with mRNA vaccines in the United States (U.S.), with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis
  • These data add to the body of evidence that COVAXIN™, an adjuvated whole SARS-CoV-2 virus inactivated vaccine, has been demonstrated to be well-tolerated and effective against COVID-19 disease

MALVERN, Pa., Jan. 09, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen) (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced positive results from the Phase 2/3, observer-blind, immuno-bridging and broadening study of its COVID-19 vaccine candidate, COVAXIN™ (BBV152; Clinicaltrials.gov, NCT05258669), a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades. COVAXIN™, an inactivated virus vaccine adjuvanted with TLR7/8 agonist, has been demonstrated in clinical trials to generate a broader immune response against the whole virus covering important antigens such as S-protein, RBD, and N-protein; whereas currently approved vaccines in the U.S. target only S-protein antigen. Additionally, in contrast to other inactivated vaccines, clinical trials have demonstrated that TLR7/8 agonist adjuvant in COVAXIN™ generates a Th1-biased immune response that induces robust long-term memory B- and T-cell responses.

“The successful completion of this study represents an important milestone to the ongoing management of COVID-19,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Given that a portion of the public remains hesitant to receive mRNA vaccines, this investigational COVID-19 vaccine candidate, which relies on a well-established approach to vaccine development and manufacturing, may provide an important additional vaccine option.”

This study enrolled 419 U.S. adult participants that were randomized 1:1 to receive two doses of COVAXIN™ or placebo, 28 days apart. Blinded safety results and preliminary unblinded immunogenicity results are available through Day 56, one month following the second vaccination. Immunogenicity results from COVAXIN™-vaccinated participants in the U.S. were compared with results in COVAXIN™-vaccinated participants in the Bharat Biotech International Limited (Bharat Biotech)-sponsored Phase 3 study in India (Clinicaltrials.gov NCT04641481). Approximately 24% of tested participants in the U.S. were vaccine-naïve while all participants in the Bharat Biotech Phase 3 study were vaccine-naïve. Immune responses were adjusted for differences between the U.S. and Indian cohorts in baseline neutralizing antibody, body mass index, gender, and age. Both co-primary immunogenicity endpoints were met, with the 95% confidence interval (CI) for the propensity score-adjusted geometric mean titer ratio (U.S./India) well above the non-inferiority limit of 0.667 and the 95% CI for the propensity score-adjusted difference in seroconversion rates well above the non-inferiority limit of -10%.

Blinded safety data are also available for one month following vaccination. There were no deaths, related potential immune mediated medical conditions (PIMMCs), or related adverse events of special interest (AESIs). There were also no cases of myocarditis, pericarditis, thrombotic events, or Guillain-Barré syndrome. Thirty medically attended adverse events in 18 subjects and two serious adverse events (SAE) in one subject were reported, and all were considered unrelated to vaccination.

“These positive data represent an important step in the management of the ever-evolving COVID-19 pandemic,” said Dr. Eric Feigl-Ding, epidemiologist and health economist, Chief of COVID Task Force at the New England Complex Systems Institute, Co-Founder of the World Health Network, and the Chief Health Economist for Microclinic International. “The need for different vaccine approaches to COVID-19 has become critically apparent with the continued emergence of variants to the SARS-CoV-2 virus.”

The top-line data from the immuno-bridging and broadening study will be critical to support Ocugen’s future plans for the development of COVAXIN™ in the U.S.

About COVAXIN™ (BBV152)
COVAXIN™ is an investigational vaccine candidate product in North America. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

COVAXIN™ is currently approved for adults in India and authorized under emergency use in 25 countries, with more than 350 million doses administered to adults outside the United States to date. COVAXIN™ is listed by the World Health Organization (WHO) as authorized for emergency use. Applications for emergency use authorization are pending in more than 60 other countries. Additionally, as many as 85 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™.

About the OCU-002 Study
OCU-002 is a randomized, observer-blind, placebo-controlled, immune-bridging, and broadening study conducted in 8 sites in the United States (Clinicaltrials.gov, NCT05258669). 419 U.S. participants were randomized to received two doses of vaccine 1:1 to COVAXIN™ or placebo, 28 days apart. Blinded safety results and unblinded immunogenicity results are available through Day 56, one month following the second vaccination.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

About Bharat Biotech
Bharat Biotech International Limited has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 19 vaccines, four bio-therapeutics, registrations in more than 125 countries, and the World Health Organization (WHO) Prequalification. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, BBIL has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 5 billion doses of vaccines worldwide, BBIL continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (JENVAC®), Rabies, Chikungunya, Zika, Cholera, and the world’s first tetanus toxoid conjugated vaccine for Typhoid. BBIL’s commitment to global social innovation programs and the public-private partnership resulted in introducing path-breaking WHO pre-qualified vaccines such as BIOPOLIO®, ROTAVAC®, ROTAVAC® 5D, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. Novel vaccines against malaria and tuberculosis are under development through global partnerships. The acquisition of Chiron Behring Vaccines has positioned BBIL as the world’s largest rabies vaccine manufacturer with Chirorab® and Indirab®. Bharat Biotech’s COVAXIN®, India’s indigenous COVID-19 vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Ocugen Contact: 
Tiffany Hamilton
Head of Communications
IR@ocugen.com

Biotech is Getting Investor’s Attention in a Big Way

Posted on by phoffman@channelchek.com
Image Credit: Patrick Foto(Flickr)

Well-Chosen Biotech Stocks Could Payoff Big for Investors

The Biotech sector has been flatlined since September but is now suddenly showing significant signs of life already in 2023. It’s only the second week of the new year, and already three US-based public small-cap companies are to be acquired by cash-rich drugmakers looking to expand their portfolios. The stocks of biotechs Albireo (ALBO), Amryt (AMYT), and CinCor (CINC) are all up between 93% and 140% after the announcements. A case can easily be made that the beaten-down biotech sector and the cash-rich pharmaceutical giants, with aging patents on their current drug portfolios, are going to find they are stronger together – this could be a huge win for investors.

Details of Recent Announcements

Ipsen (IPN), a French drug company, agreed to buy liver drug maker Albireo Pharma for at least $952 million, or $42 per share, plus another $10 per share if the FDA approves its Bylvay drug.

Italy’s Chisi Farmaceutici agree to pay up to $1.5 billion for Amryt Pharma. Amryt makes drugs for rare diseases. The agreement requires at least $14.50 per share, plus another $2.50 depending on milestones for its Filsuvez product, which treats a skin disease.

AstraZeneca, an Anglo-Swedish pharmaceutical company, said it’s paying up to $1.8 billion for CinCor Pharma, a maker of a blood pressure medication. The deal calls for $26 per share in cash, plus as much as another $10 per share if it’s able to make a Food and Drug Administration submission for a product based on baxdrostat drug in development for hypertension and chronic kidney disease.

The one thing in common between all three deals is an incentive for management to meet milestones which could include getting approval of late-stage drugs. Presumably, with the additional resources, these goals could become much easier for the companies that are allowing themselves to be acquired.

Will Other Acquisitions Follow?

Investors have learned all too well about investment bubbles, a situation where so much money flows into a sector that it becomes substantially overvalued. Then, when money isn’t flowing so freely, prices fall apart. But, the inverse of a bubble can also occur. A sector can be ignored for so long that investors don’t see value; when activity begins to perk up, many recognize value all at once and suddenly the sector is on fire. This inverse bubble may be at the earliest stages in small-cap biotech.

Source: Koyfin

“Smart Money” Investors Chasing Biotechs

In a story unrelated to the publicly traded companies being acquired, Reuters is reporting that private equity firms that had stayed uninvolved in what the firms believed to be the risk in the drug development business are now showing strong interest. “These firms are seeking to capitalize on the growing gap between the supply of capital for clinical research and the number of drugs competing for it, eight buyout executives and investors interviewed by Reuters said.”

The Reuters article highlights Blackstone (BX.N) as one company they explain is “leading the charge.” Carlyle is another investment group that, according to Reuters, is “now preparing to raise a dedicated life sciences fund,” the article explained the fund “could amass several billions of dollars, according to people familiar with the fundraising plans.” Reuters quoted Carlyle’s Global Head of healthcare as saying, “We are big believers in what we’ve called the biopharma revolution and in the explosion of discovery and science.”

These investment groups are not taking ownership in the companies they invest in, but rather a stake in clinical trials which stand a much greater chance with the injection of this new capital. The payoff arrangements are different for each deal.

What Should Self-Directed Investors Watch?

If there is a continued resurgence of activity among big pharma firms buying up publicly traded biotech firms, then small investors can expect to see more huge winners and, of course, others that never get off the ground. That is to say, while a few firms become the overnight 100% winners, many more languish and trade up and down without going any place. Increasing your chances of having at least one big winner among your holdings involves understanding the market, the companies, and the dynamics surrounding life sciences investments.

If you have already signed-up to have access to research and company information on Channelchek, then you have access to small-cap biotech stocks, and the research provided by the Senior Life Sciences Research Analyst at Noble Capital Markets. If you haven’t signed up, do this now by clicking here, and review the library of videos with interviews of management of biotechs and dig into the companies to learn where each is at in development and research.

Paul Hoffman

Managing Editor, Channelchek

Schwazze (SHWZ) – Continuing to Expand the Dispensary Base

Posted on by cpereira@noblefcm.com


Thursday, January 05, 2023

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Make It Six. On Tuesday, Schwazze announced the opening of another R.Greenleaf New Mexico dispensary, the sixth such opening since Schwazze’s February 2022 acquisition. The new R. Greenleaf store is located in Alamogordo. R. Greenleaf now has 16 locations throughout the state.

Alamogordo. A town of just over 31,000 people, Alamogordo is the seat of Otero County, located in southern New Mexico. Alamogordo is primarily a service and retail economy, driven by tourism, a large nearby military installation-Holloman Air Force Base-and a concentration of military retirees. There appears to be three other dispensaries in the town, according to Leafly. Notably, Alamogordo is less than 90 miles from El Paso.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Tonix Pharmaceuticals Appoints Zeil Rosenberg, M.D., M.P.H., as Executive Vice President, Medical for Infectious Disease Programs

Posted on by cpatches

Research News and Market Data on TNXP

Dr. Rosenberg Will Lead Clinical Development of Tonix’s Vaccine and Antiviral Programs

CHATHAM, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its new Executive Vice President, Medical. In this role, Dr. Rosenberg will be responsible for leading Tonix’s clinical development efforts for vaccines and antivirals. Dr. Rosenberg will be based in the Company’s Chatham, N.J. headquarters, and as part of his role will oversee the clinical development of Tonix’s vaccine for smallpox and monkeypox, TNX-801, the vaccine for COVID-19, TNX-1850, and the antiviral anti-SARS-CoV-2 spike protein monoclonal antibodies, TNX-3600 and TNX-3800, to protect immunocompromised individuals from severe COVID-19.

“We are pleased to welcome Dr. Rosenberg to Tonix’s clinical team to lead the development of our infectious disease programs at a time when Tonix continues to make meaningful progress in the clinical development of multiple programs within its robust pipeline,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

“Dr. Rosenberg brings to our team expertise as an infectious disease drug developer and we are fortunate to have someone with Dr. Rosenberg’s skills, vision and operational expertise join at a pivotal time in the evolution of our infectious disease product portfolio, with our vaccine candidate for monkeypox, TNX-801, expected to enter clinical testing in 2023, and TNX-3600 and TNX-3800 moving ahead in pre-clinical development to address the need for anti-SARS-CoV-2 monoclonal antibodies for immune-compromised individuals,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “At Becton, Dickinson and Company (BD), Dr. Rosenberg worked on the development of the BD Bifurcated Needle, a safety-engineered improved bifurcated needle device for the percutaneous administration of live virus vaccinia vaccines, as well as BD VaxiNet™, a data monitoring system to improve patient safety in smallpox vaccine mass immunization efforts, which we believe have direct relevance to our recombinant poxvirus (RPV) platform.”

“I am thrilled to join Tonix’s executive management team and lead the clinical development of its infectious disease portfolio,” said Dr. Rosenberg. “I look forward to working together with the talented Tonix team to advance the Company’s portfolio of promising vaccines and antiviral therapies and help bring them to as many appropriate patients as possible.”

Dr. Rosenberg was most recently at PPD, part of Thermo Fisher Scientific, serving as Executive Director, Biotech and as Therapeutic Area Head for Vaccines at its Accelerated Enrollment Solutions Group, where he provided leadership on multiple successful COVID-19 vaccine clinical trials. At BD he was Worldwide Business Leader and Medical Director for Immunization, and was Vice President for Medical Affairs at Admera Health, a medical diagnostics company focused on precision medicine. He was key to the launch of a global public private partnership, including UNICEF and WHO, to help eliminate maternal and neonatal tetanus through immunization, resulting in the significant reduction of neonatal mortality. He served as National Immunization Advisor to the Indonesian Ministry of Health in Jakarta, sponsored by the U.S. Agency for International Development (USAID), and as Chief Technical Officer for Immunization at USAID, Washington, D.C.

Dr. Rosenberg received his B.A. with Honors and Distinction at Stanford University, earned his M.D. at the University of California, San Francisco and completed his internship and residency at Mount Sinai and Cornell University Medical College, respectively. He holds a Masters of Public Health from Columbia University. Dr. Rosenberg is an elected Fellow of both the American College of Preventive Medicine and the New York Academy of Medicine, and Specialty Fellow of the American Academy of Pediatrics. He has served as AAS Science, Engineering and Diplomacy Fellow.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

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 – Genprex Announces Selection of Preclinical Data for Oral Presentation at 16th International Conference on Advanced Technologies & Treatments for Diabetes

Posted on by cpatches

Research News and Market Data on GNPX

Exciting Data from University of Pittsburgh Researchers in Non Human Primates that Underpins Genprex’s Gene Therapy Program in Diabetes to be Showcased

AUSTIN, Texas — (January 4, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators at the University of Pittsburgh will present preclinical data highlighting the therapeutic potential of Genprex’s gene therapy for Type 1 diabetes at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) being held February 22-25 in Berlin, Germany and online.

“ATTD 2023 presents an ideal opportunity for the results of this important study to be presented to the diabetes community. The data further support the potential of Genprex’s novel gene therapy being developed for the treatment of Type 1 diabetes to change the trajectory of this devastating disease,” said Mark Berger, MD, Genprex’s Chief Medical Officer. “Using the expression of Pdx1 and MafA transcription factors, this approach has been shown first in mice and then in non human primate studies to lead to the creation of new beta-like cells that produce insulin and may provide long-term replacement of beta-cells.”

The diabetes gene therapy approach is comprised of a novel infusion process that uses endoscopic delivery of an adeno-associated virus (AAV) vector to bring therapeutic genes directly to the pancreas. In models of Type 1 diabetes, these genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, where autoimmunity is not at play, it is believed that using a similar approach the exhausted beta cells will be rejuvenated and replenished. 

Presentation Details:

Abstract Number: 203

Abstract Title: Pancreatic Intraductal Infusion of Adeno-Associated Virus To Treat Non-Human Primates in a Toxin-Induced Diabetes Model

Format: Oral Presentation

Presenter: Ranjeet Kalsi, DO, representing the laboratory of  George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery, University of Pittsburgh School of Medicine

Time/Date: 1:45 pm Central European Standard Time on Saturday, February 25, 2023

The abstract will be made available on the ATTD conference website at https://attd.kenes.com. 

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The Company’s lead product candidate, REQORSA® (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In a similar approach used in Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are rejuvenated and replenished.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K for the year ended December 31, 2021.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships, including those with its third party manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex’s intellectual property and licenses. 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

GNPX Investor Relations

investors@genprex.com

GNPX Media Contact

Kalyn Dabbs

media@genprex.com

PDS Biotechnology Corp. (PDSB) – PDS Licenses Merck’s IL-12 Used In Its Combination Studies

Posted on by cpereira@noblefcm.com


Wednesday, January 04, 2023

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.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

License Gives Exclusive Rights To M9241. PDS Bio announced a licensing agreement with Merck KGaA covering M9241, the proprietary IL-12 tumor-targeting cytokine used in its Phase 2 Triple Therapy combination study. As discussed in our Research Note on December 29, most recent results have shown significant improvement in outcomes for these patients. Since PDS did not have commercial rights to M9241 before the licensing agreement, we believe this is a highly positive development.

Licensing Terms Are Favorable For Both Companies. The license agreement gives PDS exclusive worldwide rights to M9241. PDS will take over all development, manufacturing, and commercialization, while Merck continues to supply the drug during the transition. PDS will pay Merck a licensing fee of $5 million in cash and $5 million in its common stock, consisting of 378,787 shares or about 1.3% of the shares outstanding. Merck will receive development and regulatory milestones of up to $11 million for the first two indications, as well as commercial milestones of up to $105 million plus 10% royalties on initial sales.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – PDS Biotech Announces Exclusive Global License Agreement for Investigational IL-12 Tumor-Targeted Cytokine from Merck KGaA, Darmstadt, Germany

Posted on by cpatches

Research News and Market Data on PDSB

PDS Biotech bolsters immuno-oncology portfolio with a clinical-stage product synergistic with its Versamune® platform

PDS Biotech to host conference call and webcast on Tuesday, January 3, 2023, at 8:00 AM EST

FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor. The combination of Versamune® and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241. PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions. Merck KGaA will receive 378,787 shares of PDS Biotech’s common stock having a value of $5 million, based on the closing price of PDS Biotech’s common stock on December 30, 2022.

“We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy,” said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy. I’d like to thank the Merck KGaA, Darmstadt, Germany team for their support of PDS Biotech’s mission to potentially offer more cancer patients improved treatment options.”

M9241 was studied in a novel triple combination at the National Cancer Institute in a Phase 2 trial (NCT04287868) in combination with PDS0101, a Versamune® based HPV16-targeted immunotherapy, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β). The triple combination was studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Data highlights for patients who had failed prior treatments including CPIs:

  • Median overall survival for treated patients is 21 months in 29 CPI refractory patients. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • 63% (5/8) of treated patients with the optimal dose combination had significant tumor shrinkage of over 30% (objective response). With the standard of care, the reported percentage of patients having an objective response is less than 10%.
  • 79% (11/14) of treated patients demonstrated a greater than two-fold increase in HPV16-targeted T cells.

Results for patients who had failed prior treatments but were CPI-naïve also continue to appear to be encouraging:

  • 88% (7/8) of CPI naïve patients had an objective response.
  • 38% (3/8) of responders had a complete response.
  • In CPI naïve subjects, 75% (6/8) remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech has a scheduled meeting with the Food and Drug Administration (FDA) to discuss a registrational trial for investigating the triple combination of M9241, PDS0101 and a checkpoint inhibitor in recurrent/metastatic HPV-positive cancers.

Dr. Lauren V. Wood, Chief Medical Officer at PDS Biotech, commented, “M9241 seems to be unique in its ability to target the tumor’s microenvironment and appears to further promote proliferation of Versamune®-induced T cells in the tumors while also potentially enhancing the killing potency of the T cells. With the addition of M9241 to our Versamune®-based pipeline products, our goal is to develop and achieve checkpoint inhibitor-agnostic and independent combinations in advanced cancers. We look forward to expanding clinical development of our novel investigational combination products.”

Conference Call and Webcast
PDS Biotech will host a conference call and webcast on Tuesday, January 3, 2023, beginning at 8:00 AM EST. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13734890. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also 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 in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0301
PDS0301 is a tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor. Together with Versamune® based immunotherapies, PDS0301 works to promote a targeted T cell attack against cancers and also overcome tumor-induced immune suppression. Clinical data suggest this combination may demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis. A National Cancer Institute-supported Phase 2 clinical study of PDS0301 in a triple combination therapy is being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers.

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 or preliminary 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; the success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; 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 Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

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

Media Contacts:
Bill Borden
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620
Email: bborden@tiberend.com

Dave Schemelia
Tiberend Strategic Advisors, Inc.
Phone: +1 (609) 468-9325
Email: dschemelia@tiberend.com

Release – Tonix Pharmaceuticals to Present at Biotech Showcase 2023

Posted on by cpatches

Research News and Market Data on TNXP

CHATHAM, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at Biotech Showcase 2023 being held January 9-11, 2023, at the Hilton San Francisco Union Square.

Details of the Tonix presentation are as follows:

Event:Biotech Showcase 2023
Date:Tuesday, January 10, 2023
Time:3:00 p.m. PT (6:00 p.m. ET)
Location:Hilton San Francisco Union Square
Track:Yosemite C (Ballroom Level)

A live webcast and subsequent archived recording of the Company presentation will be available under the IR Events tab of the Investors section of the Tonix Pharmaceuticals website at www.tonixpharma.com or can be found here. Investors interested in arranging a meeting with the Company’s management during the conference should contact Brandon.Weiner@Westwicke.com.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com 
(862) 904-8182

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.

Released January 3, 2023