Release – Tonix Pharmaceuticals Announces Research Agreement with University of Maryland, Baltimore, to Study TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Heart Xenograft Transplantation in Animals

Research News and Market Data on TNXP

February 01, 2023 7:00am EST

Research Study to Assess the Role of TNX-1500 in the Prevention of Heart Xenograft Rejection

Preclinical Xenotransplantation Studies are Expected to Support Regulatory Filings for TNX-1500

CHATHAM, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has entered into a sponsored research agreement with the University of Maryland, Baltimore (UMB), for the prevention of rejection in heart xenograft transplantation in animals utilizing TNX-15001, an Fc-modified humanized monoclonal antibody directed against CD40-ligand. UMB’s preclinical studies will utilize genetically-modified porcine hearts supplied by Revivicor, Inc., a subsidiary of United Therapeutics Corporation. The principal investigator is Muhammad M. Mohiuddin, M.D., MBBS, Professor of Surgery, and Director, Cardiac Xenotransplantation Program, University of Maryland School of Medicine.

“We are excited to collaborate with the University of Maryland and Dr. Mohiuddin on the development of TNX-1500 for the prevention of rejection in xenograft transplantation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a third generation anti-CD40L monoclonal antibody that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. Previous preclinical studies in non-human primates demonstrated that TNX-1500 showed activity in preventing allograft and xenograft organ rejection and was well tolerated. A positive result from this study would potentially help support an Investigational New Drug (IND) application and human clinical studies.”

“Despite exciting advancements in the field of xenotransplantation, better therapeutics are needed to prevent xenograft organ rejection,” said Dr. Mohiuddin. “Several lines of research indicate that anti-CD40L is required for long term xenograft acceptance. We are excited to collaborate in support of developing an effective immunosuppression regimen for patients requiring xenograft transplantation.”

The primary objective of the preclinical research study is to study the activity of TNX-1500 in preventing cardiac xenograft rejection in animals to support an IND application for human studies.

About TNX-1500

TNX-1500 (Fc-modified anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases and for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. In June 2022, Tonix announced data from three oral presentations at the 2022 American Transplant Congress of animal studies found that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. In those studies, blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human primate models of cardiac and kidney allograft transplantation without clinical thrombosis. Copies of the presentations are available under Scientific Presentations on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

1TNX-1500 is a biologic at the pre-IND stage of development and has not been approved for any indication

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. 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 second 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 second quarter 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

Cultivating a Microbiome that Reduces the Incidence of Cancer

Image Credit: NIH (Flickr)

Microbes in Your Food Can Help or Hinder Your Body’s Defenses Against Cancer – How Diet Influences the Conflict Between Cell ‘Cooperators’ and ‘Cheaters’

The microbes living in your food can affect your risk of cancer. While some help your body fight cancer, others help tumors evolve and grow.

Gut microbes can influence your cancer risk by changing how your cells behave. Many cancer-protective microbes support normal, cooperative behavior of cells. Meanwhile, cancer-inducing microbes undermine cellular cooperation and increase your risk of cancer in the process.

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 Gissel Marquez Alcaraz, Ph.D. Student in Evolutionary Biology, Arizona State University and Athena Aktipis, Associate Professor of Psychology, Center for Evolution and Medicine, Arizona State University.

We are evolutionary biologists who study how cooperation and conflict occur inside the human body, including the ways cancer can evolve to exploit the body. Our systematic review examines how diet and the microbiome affect the ways the cells in your body interact with each other and either increase or decrease your risk of cancer.

Cancer is a Breakdown of Cell Cooperation

Every human body is a symphony of multicellular cooperation. Thirty trillion cells cooperate and coordinate with each other to make us viable multicellular organisms.

For multicellular cooperation to work, cells must engage in behaviors that serve the collective. These include controlled cell division, proper cell death, resource sharing, division of labor and protection of the extracellular environment. Multicellular cooperation is what allows the body to function effectively. If genetic mutations interfere with these proper behaviors, they can lead to the breakdown of cellular cooperation and the emergence of cancer.

Cancer cells can be thought of as cellular cheaters because they do not follow the rules of cooperative behavior. They mutate uncontrollably, evade cell death and take up excessive resources at the expense of the other cells. As these cheater cells replicate, cancer in the body begins to grow.

Cancer is fundamentally a problem of having multiple cells living together in one organism. As such, it has been around since the origins of multicellular life. This means that cancer suppression mechanisms have been evolving for hundreds of millions of years to help keep would-be cancer cells in check. Cells monitor themselves for mutations and induce cell death, also known as apoptosis, when necessary. Cells also monitor their neighbors for evidence of abnormal behavior, sending signals to aberrant cells to induce apoptosis. In addition, the body’s immune system monitors tissues for cancer cells to destroy them.

Cells that are able to evade detection, avoid apoptosis and replicate quickly have an evolutionary advantage within the body over cells that behave normally. This process within the body, called somatic evolution, is what leads cancer cells to grow and make people sick.

Microbes Can Help or Hinder Cell Cooperation

Microbes can affect cancer risk through changing the ways that the cells of the body interact with one another.

Some microbes can protect against cancer by helping maintain a healthy environment in the gut, reducing inflammation and DNA damage, and even by directly limiting tumor growth. Cancer-protective microbes like Lactobacillus pentosus, Lactobacillus gasseri and Bifidobacterium bifidum are found in the environment and different foods, and can live in the gut. These microbes promote cooperation among cells and limit the function of cheating cells by strengthening the body’s cancer defenses. Lactobacillus acidophilus, for example, increases the production of a protein called IL-12 that stimulates immune cells to act against tumors and suppress their growth.

Other microbes can promote cancer by inducing mutations in healthy cells that make it more likely for cellular cheaters to emerge and outcompete cooperative cells. Cancer-inducing microbes such as Enterococcus faecalis, Helicobacter pylori and Papillomavirus are associated with increased tumor burden and cancer progression. They can release toxins that damage DNA, change gene expression and increase the proliferation of tumor cells. Helicobacter pylori, for example, can induce cancer by secreting a protein called Tipα that can penetrate cells, alter their gene expression and drive gastric cancer.

Healthy Diet with Cancer-Protective Microbes

Because what you eat determines the amount of cancer-inducing and cancer-preventing microbes inside your body, we believe that the microbes we consume and cultivate are an important component of a healthy diet.

Beneficial microbes are typically found in fermented and plant-based diets, which include foods like vegetables, fruits, yogurt and whole grains. These foods have high nutritional value and contain microbes that increase the immune system’s ability to fight cancer and lower overall inflammation. High-fiber foods are prebiotic in the sense that they provide resources that help beneficial microbes thrive and subsequently provide benefits for their hosts. Many cancer-fighting microbes are abundantly present in fermented and high-fiber foods.

In contrast, harmful microbes can be found in highly-processed and meat-based diets. The Western diet, for example, contains an abundance of red and processed meats, fried food and high-sugar foods. It has been long known that meat-based diets are linked to higher cancer prevalence, and that red meat is a carcinogen. Studies have shown that meat-based diets are associated with cancer-inducing microbes including Fusobacteria and Peptostreptococcus in both humans and other species.

Microbes can enhance or interfere with how the body’s cells cooperate to prevent cancer. We believe that purposefully cultivating a microbiome that promotes cooperation among our cells can help reduce cancer risk.

Release – Ocugen, Inc. to Present At 2023 BIO CEO & Investor Conference

Research News and Market Data on OCGN

January 31, 2023

MALVERN, Pa., Jan. 31, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen will present at the BIO CEO & Investor Conference being held February 6-9, 2023, at the Marriott Marquis in New York City.

Dr. Musunuri and members of Ocugen’s executive team will conduct one-on-one meetings with registered investors and pharmaceutical companies, showcasing the Company’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.

Details of the presentation are as follows:

Event: BIO CEO & Investor Conference
Date: Monday, February 6, 2023
Presentation Time: 11:00 a.m. ET
Location: Winter Garden Room, 6th Floor, Marriott Marquis, New York City
Registration: https://www.bio.org/events/bio-ceo-investor-conference

Conference attendees that would like to schedule a meeting with the Ocugen leadership team are encouraged to register through the BIO CEO attendee portal.

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.

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. 

Contact: 

Tiffany Hamilton 
Head of Communications 
IR@ocugen.com  

Release – Tonix Pharmaceuticals Announces Presentation of Clinical and Non-Clinical TNX-1900 Data at the Annual Headache Cooperative of the Pacific (HCOP) Winter Conference

Research News and Market Data on TNXP

January 31, 2023 7:00am EST

Preliminary Results from Human PET Study Show that Intranasal Application of a Radioisotope of Magnesium-Potentiated Oxytocin is Delivered to the Trigeminal Ganglia

Preliminary Results on Human Cadaveric Trigeminal Ganglia Show Co-expression of Oxytocin Receptors and CGRP

Preliminary Results Show Sex Differences in Oxytocin Potency in an Animal Model

CHATHAM, N.J., Jan. 31, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that David C. Yeomans, Ph.D., presented data from clinical and nonclinical studies in an oral presentation at the 16th Annual Headache Cooperative of the Pacific (HCOP) Winter Conference on January 27, 2023. The oral presentation titled, “Primary vs Secondary Sex Hormones and Migraine,” includes research sponsored by and licensed to Tonix Pharmaceuticals. Professor Yeomans was a founder of Trigemina, which Tonix acquired, and he remains a consultant to Tonix. A copy of the presentation is available under the Scientific Presentations tab of the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

“In addition to data showing that magnesium (Mg++) potentiates the analgesic effects of oxytocin, the presentation includes new preliminary data from a Positron Emission Tomography (PET) study in human volunteers dosed with a proprietary nitrogen-13 (13N) radioisotope of oxytocin formulated with Mg++,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “A signal was observed in the trigeminal ganglia, indicating that intranasal oxytocin plus Mg++ delivers oxytocin to the trigeminal ganglia which have known roles in migraine headache. These studies were a collaboration with Aarhus University and the principal investigator, Michael Winterdahl, PhD.”

In addition to the PET study, the presentation includes data collected from isolated human trigeminal ganglia neurons in vitro which show oxytocin receptor co-expressed with calcitonin gene-related peptide (CGRP). The results of these studies, which were performed by postdoctoral fellow Vimala Bharadwaj, PhD, are believed to represent the first observation of oxytocin receptors in human tissue rather than in an animal model. Previously, it has been shown that oxytocin receptors and CGRP co-localize in rat trigeminal ganglia neurons. The cytokine IL-6 functionally upregulated expression of human trigeminal oxytocin receptors in vitro, similar to what has been shown previously in rats, in which oxytocin has been shown to functionally inhibit electrically evoked activity of trigeminal neurons.

Finally, the presentation highlights data which suggest a sex difference in oxytocin potency. “The results indicate that oxytocin is more potent in inhibiting trigeminal ganglion neuronal excitability in female rats compared to males,” said Professor David C. Yeomans. “Moreover, treating male rats with estrogen for four days increased the responsiveness of their isolated trigeminal ganglia to oxytocin in vitro such that they show a similar level of responsiveness to oxytocin as female trigeminal ganglia. The Company believes that together, these findings have potential dosing implications in humans who suffer from chronic migraine.”

In late 2021, Tonix received Investigational New Drug clearance from the U.S. Food and Drug Administration to support the initiation of a Phase 2 study of TNX-1900 (intranasal magnesium potentiated oxytocin) for the prevention of migraine headache in chronic migraineurs. The Company expects to begin enrollment in the Phase 2 study during the first quarter of 2023.

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 31, 2023

Release – Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

Research News and Market Data on TNXP

January 30, 2023 7:00am EST

CHATHAM, N.J., Jan. 30, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On January 27, 2023, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.

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 30, 2023

How Does the Moderna Cancer Vaccine Work?

Moderna is testing an mRNA vaccine in combination with pembrolizumab to treat melanoma (The Conversation)

Moderna’s Experimental Cancer Vaccine Treats But Doesn’t Prevent Melanoma – a Biochemist Explains How it Works

Media outlets have reported the encouraging findings of clinical trials for a new experimental vaccine developed by the biotech company Moderna to treat an aggressive type of skin cancer called melanoma.

Although this is potentially very good news, it occurred to me that the headlines may be unintentionally misleading. The vaccines most people are familiar with prevent disease, whereas this experimental new skin cancer vaccine treats only patients who are already sick. Why is it called a vaccine if it does not prevent cancer?

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 Mark R. O’Brian, Professor and Chair of Biochemistry, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo.

I am a biochemist and molecular biologist studying the roles that microbes play in health and disease. I also teach cancer genetics to medical students and am interested in how the public understands science. While preventive and therapeutic vaccines are administered for different health care goals, they both train the immune system to recognize and fight off a specific disease agent that causes illness.

Melanoma is an aggressive form of skin cancer

How Do Preventive Vaccines Work?

Most vaccines are administered to healthy people before they get sick to prevent illnesses caused by viruses or bacteria. These include vaccines that prevent polio, measles, COVID-19 and many other diseases. Researchers have also developed vaccines to prevent some types of cancers that are caused by such viruses as the human papillomaviruses and Epstein-Barr virus.

Your immune system recognizes objects such as certain microbes and allergens that do not belong in your body and initiates a series of cellular events to attack and destroy them. Thus, a virus or bacterium that enters the body is recognized as something foreign and triggers an immune response to fight off the microbial invader. This results in a cellular memory that will elicit an even faster immune response the next time the same microbe intrudes.

The problem is that sometimes the initial infection causes serious illness before the immune system can mount a response against it. While you may be better protected against a second infection, you have suffered the potentially damaging consequences of the first one.

This is where preventive vaccines come in. By introducing a harmless version or a portion of the microbe to the immune system, the body can learn to mount an effective response against it without causing the disease.

For example, the Gardasil-9 vaccine protects against the human papillomavirus, or HPV, which causes cervical cancer. It contains protein components found in the virus that cannot cause disease but do elicit an immune response that protects against future HPV infection, thereby preventing cervical cancer.

How Does the Moderna Cancer Vaccine Work?

Unlike cervical cancer, skin melanoma isn’t caused by a viral infection, according the latest evidence. Nor does Moderna’s experimental vaccine prevent cancer as Gardasil-9 does.

The Moderna vaccine trains the immune system to fight off an invader in the same way preventive vaccines most people are familiar with do. However, in this case the invader is a tumor, a rogue version of normal cells that harbors abnormal proteins that the immune system can recognize as foreign and attack.

What are these abnormal proteins and where do they come from?

All cells are made up of proteins and other biological molecules such as carbohydrates, lipids and nucleic acids. Cancer is caused by mutations in regions of genetic material, or DNA, that encode instructions on what proteins to make. Mutated genes result in abnormal proteins called neoantigens that the body recognizes as foreign. That can trigger an immune response to fight off a nascent tumor. However, sometimes the immune response fails to subdue the cancer cells, either because the immune system is unable to mount a strong enough response or the cancer cells have found a way to circumvent the immune system’s defenses.

Moderna’s experimental melanoma vaccine contains genetic information that encodes for portions of the neoantigens in the tumor. This genetic information is in the form of mRNA, which is the same form used in the Moderna and Pfizer-BioNtech COVID-19 vaccines. Importantly, the vaccine cannot cause cancer, because it encodes for only small, nonfunctional parts of the protein. When the genetic information is translated into those protein pieces in the body, they trigger the immune system to mount an attack against the tumor. Ideally, this immune response will cause the tumor to shrink and disappear.

Notably, the Moderna melanoma vaccine is tailor-made for each patient. Each tumor is unique, and so the vaccine needs to be unique as well. To customize vaccines, researchers first biopsy the patient’s tumor to determine what neoantigens are present. The vaccine manufacturer then designs specific mRNA molecules that encode those neoantigens. When this custom mRNA vaccine is administered, the body translates the genetic material into proteins specific to the patient’s tumor, resulting in an immune response against the tumor.

Combining Vaccination with Immunotherapy

Vaccines are a form of immunotherapy, because they treat diseases by harnessing the immune system. However, other immunotherapy cancer drugs are not vaccines because, while they also stimulate the immune system, they do not target specific neoantigens.

In fact, the Moderna vaccine is co-administered with the immunotherapy drug pembrolizumab, which is marketed as Keytruda. Why are two drugs needed?

Certain immune cells called T-cells have molecular accelerator and brake components that serve as checkpoints to ensure they are revved up only in the presence of a foreign invader such as a tumor. However, sometimes tumor cells find a way to keep the T-cell brakes on and suppress the immune response. In these cases, the Moderna vaccine correctly identifies the tumor, but T-cells cannot respond to it.

Pembrolizumab, however, can bind directly to a brake component on the T-cell, inactivating the brake system and allowing the immune cells to attack the tumor.

Not a Preventive Cancer Vaccine

So why can’t the Moderna vaccine be administered to healthy people to prevent melanoma before it arises?

Cancers are highly variable from person to person. Each melanoma harbors a different neoantigen profile that cannot be predicted in advance. Therefore, a vaccine cannot be developed in advance of the illness.

The experimental mRNA melanoma vaccine, currently still in early-phase clinical trials, is an example of the new frontier of personalized medicine. By understanding the molecular basis of diseases, researchers can explore how their underlying causes vary among people, and offer personalized therapeutic options against those diseases.

Release – Tonix Pharmaceuticals Announces Presentation of Licensed Antiviral Drug Technology at the 2nd Wnt & β-catenin Targeted Drug Development Conference

Research News and Market Data on TNXP

January 26, 2023 4:15pm ESTDownload as PDF

Oral Presentation Describes Activity of Wnt/β-catenin Signaling Pathway Inhibitors Against SARS-CoV-2 in Cell Culture and in an Animal Model

CHATHAM, N.J., Jan. 26, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Tom Hobman, Ph.D., Professor of Cell Biology, University of Alberta, presented data from his laboratory at The University of Alberta during a presentation at the 2nd Wnt & β-catenin Targeted Drug Development Conference held in Boston, Mass., on January 26, 2023. The oral presentation titled, “Targeting the Wnt/β -catenin pathway as a broad-spectrum antiviral strategy,” includes research sponsored by Tonix Pharmaceuticals focused on the development and testing of Wnt/β-catenin signaling pathway inhibitors as broad-spectrum antivirals against SARS-CoV-2 and other emerging viruses. Tonix has previously announced that it exercised an option to license the antiviral technology platform. A copy of the presentation is available on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

“Antiviral therapeutics are needed to mitigate the effects of SARS-CoV-2 and future coronavirus outbreaks, and Professor Hobman’s work is designed to facilitate the identification and testing of novel broad-spectrum antiviral drugs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Professor Hobman presented data showing that inhibition of Wnt/β-catenin pathway induces peroxisomes and enhances interferon response during viral infection, significantly reducing SARS-CoV-2 replication in vitro and in vivo.”

“For future pandemics, the scientific community must be ready with an arsenal of easily self-administered drugs that can be tested in rapid, efficient clinical trials immediately after the causative viral agent is identified,” said Professor Tom Hobman. “The research collaboration between Tonix and The University of Alberta is focused on the development and testing of Wnt/β-catenin signaling pathway inhibitors as broad-spectrum antivirals against SARS-CoV-2 and other emerging viruses.”

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 26, 2023

Item 9 Labs (INLB) – Reports 4Q and Full Year 2022 Results


Thursday, January 26, 2023

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 by 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 https://investors.item9labscorp.com/.

Joe Gomes, Managing Director – Generalist 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.

4Q22 Results. Item 9 Labs filed its 10K last week for the fiscal year ending September 30, 2022. While the Company did not press release the results, we backed into the 4Q22 results which shows revenue of $4 million and a $15 million operating loss, driven by a $409,000 impairment charge and a $9.5 million loss on assets held for sale. Item 9 Labs recorded a net loss for the quarter of $18.4 million, or a loss of $0.19 per share. We had forecast revenue of $5.5 million, a $2.2 million operating loss, and a net loss of $3.9 million, or a loss of $0.04 per share.

Still Winning Awards. Item 9 Labs continues to pile up awards for its products, which we believe will not only help the Company through the current challenging market but also positions the Company for above average growth as the cannabis market rebounds. BDSA recognized Item 9 Labs as one of the top 10 cannabis brands in Arizona overall, along with top five placements across multiple vape categories.


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 Participation in the Channelchek Takeaway Series

Research News and Market Data on PDSB

FLORHAM PARK, N.J., Jan. 26, 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 its participation in the Channelchek Takeaway Series from the J.P. Morgan Healthcare Conference to be broadcast Thursday, January 26, starting at 10:00 a.m., EST. The event will include an overview of PDS Biotech’s business and clinical development strategy from Frank K. Bedu-Addo, Ph.D., President and CEO, followed by a question and answer session with Noble Capital Markets’ Senior Analyst Robert LeBoyer.

Details regarding the event are as follows:

Event:Channelchek Takeaway Series
Date:January 26, 2023
Time:10:00 a.m., EST
Registration:https://us02web.zoom.us/webinar/register/WN_8AW1yjzKSIeqE1satmhSrQ

The J.P. Morgan Healthcare Conference is considered to be the most important healthcare investment symposium in the industry, connecting global industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. Noble Capital Markets’ equity analysts and investment bankers attended the conference and sat down with various c-suite executives. For the Channelchek Takeaway Series, Noble’s analysts are unpacking what they learned at the conference and talking to a selection of c-suite executives in the healthcare space.

The event will be broadcast starting at 10:00 a.m., EST on Thursday, January 26. Investors can attend the Channelchek Takeaway Series virtually at no cost. Registration details are available on Channelchek.

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®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune® and PDS0301 based candidates have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated 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.

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

Bill Borden 
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – Onconova Therapeutics Announces Participation in The Channelchek Takeaway Series

Research News and Market Data on ONTX

NEWTOWN, Pa., Jan. 26, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced their participation in the Channelchek Takeaway Series from the J.P.Morgan Healthcare Conference, to be broadcast Thursday, January 26, starting at 10:00 EST.

The J.P. Morgan Healthcare Conference is considered to be the most important healthcare investment symposium in the industry, connecting global industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. Noble Capital Markets’ equity analysts and investment bankers attended the conference and sat down with various c-suite executives. For the Channelchek Takeaway Series, Noble’s analysts are unpacking what they learned at the conference and talking to a selection of c-suite executives in the healthcare space.

Steven M. Fruchtman, MD, President and Chief Executive Officer of Onconova, provides a corporate overview, then takes questions from Noble’s Senior Analyst Robert LeBoyer.

The event will be broadcast starting at 10:00 am EST on Thursday, January 26. Investors can attend the Channelchek Takeaway Series virtually at no cost. Registration details are available on Channelchek.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

For more information, please visit www.onconova.com.

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email: contact@noblecapitalmarkets.com

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email: contact@channelchek.com

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Cocrystal Pharma Announces Participation in Virtual Investor Events

JANUARY 26, 2023

BOTHELL, Wash., Jan. 26, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the participation of James Martin, co-CEO and CFO, in the following virtual investment community events:

  • Noble Capital Markets’ J.P. Morgan Healthcare Conference Takeaways hosted by ChannelChek featuring an interview with Noble Capital Market’s managing director and senior biotechnology analyst Robert LeBoyer discussing management’s perspective on the market environment for biotechnology companies and Cocrystal’s opportunity. The Takeaways event is available beginning today, January 26, at 11:00 a.m. Eastern time. Register here for the event.
  • Noble Capital Markets C-Suite Interview Series hosted by ChannelChek featuring an interview with Mr. LeBoyer with an update on Cocrystal’s influenza and COVID-19 antiviral programs and upcoming clinical and regulatory milestones. The interview will be available by February 1 on the ChannelChek platform by registering here.
  • Sequire’s Virtual Biotechnology Conference featuring a company presentation on Thursday, February 2 at 11:30 a.m. Eastern time Eastern time. Register here for the presentation.

About ChannelChek
Channelchek.com is a comprehensive investor-centric portal featuring more than 6,000 emerging growth companies that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. More information is available at www.channelchek.com.

About Sequire
Sequire is a premier investor intelligence and communications platform where companies can track their investors’ behaviors and trends and use those insights to engage current and potential investors across marketing channels. More information is available at srax.com and mysequire.com.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

# # #

Source: Cocrystal Pharma, Inc.

Released January 26, 2023

Baudax Bio (BXRX) – Baudax Bio Announces Positive Interim Analysis Of BX1000 Phase II Trial


Wednesday, January 25, 2023

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Phase II Trial For Patients Undergoing Elective Surgery.  The BX1000 neuromuscular blocker is an intermediate-duration agent (~45 minutes) enrolling 80 patients in a Phase II trial. The randomized, double-blind, active-controlled IV-administered clinical trial compares three different doses of BX1000 (0.15 mg/kg IV, 0.25 mg/kg IV, 0.35 mg/kg IV) to a standard dose (0.6 mg/kg IV) of rocuronium, a standard of care blocking agent. (ClinicalTrials.gov Identifier: NCT05687253)

Primary Endpoints And Secondary Endpoints.  The primary endpoints assess the time frame needed to reach intubation conditions (time frame is within 2 minutes of administration) and also assess, using a standardized scale (Poor, Good, Excellent), the proportion of patients meeting Good or Excellent conditions. Secondary endpoints assess the safety and tolerability profile of BX1000.


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. 

Axcella Therapeutics (AXLA) – Long COVID Phase 2b/3 Trial Changes The AXA1125 Outlook


Wednesday, January 25, 2023

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

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.

Regulators Agree With Axcella’s Plan For A Phase 2b/3 Clinical Trial. Axcella Heath announced that US and UK regulators have agreed to a plan for a global Phase 2b/3 study of AXA1125 in Long COVID-19 patients. An IND has been submitted to the FDA for trials in the US, and agreement from the UK regulators has been received.  The Phase 2b/3 trial will include other countries to support worldwide approvals.  We see this as an important milestone for AXA1125 and the future of the company.

The Trial Announcement Reduces Uncertainty Around AXA1125.  As discussed in our Research Note on August 3, results from the Phase 2a trial in Long COVID showed a significant improvement in the physical fatigue, mental fatigue, and the 6-minute walk test. In December 2022, the company restructured to preserve cash, raising uncertainty about further development for the drug. The announcement of the Phase 2b/3 IND submission provides a development plan, allowing investors to assess timeframes and progress toward the market.


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.