Category: Health

Item 9 Labs (INLB) – A Management Change

Posted on by cpereira@noblefcm.com


Thursday, December 01, 2022

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, 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.

New CEO. Yesterday, Item 9 Labs announced Mike Weinberger, the Company’s Chief Franchise Officer, has assumed the CEO mantle, replacing Andrew Bowden. Given the upcoming transformational acquisition of Sessions Cannabis, we view the change in leadership as a positive for the Company.

Franchise Experience. As Item 9 Labs goes full bore in cannabis franchising, Mr. Weinberger’s long background in the franchising industry will become even more valuable, in our opinion. A 20-plus year franchise industry veteran, Mr. Weinberger launched Item 9 Labs Corp.’s dispensary franchise, Unity Rd., in 2018 and grew the brand to more than 20 entrepreneurial groups driving development across 10 states before the sale of Unity Rd. to Item 9 Labs. Mr. Weinberger also led 500 unit Maui Wowi, a global coffee and smoothie franchise.


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*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. 

Baudax Bio (BXRX) – Curing the Deficiency: Reverse Stock Split

Posted on by cpereira@noblefcm.com


Thursday, December 01, 2022

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.

Stock split approved at November 3, 2022 shareholder meeting. Shareholders of record September 29, 2022, approved the 1-for-40 stock split. The stock split will become effective for December 1, 2022, Nasdaq trading. The Company’s common stock will also commence trading under a new CUSIP number (07160F404).

Curing the deficiency.  Baudax Bio received Nasdaq notice that the minimum $1.00 bid price requirement was not being met and had until January 2, 2023, to cure the issue, unless they sought to obtain an additional 180 days to regain compliance.  The reverse split should bring the Company into listing compliance.


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. 

In the Womb a Genetic Battle Sometimes Rages

Posted on by aweinsoff@channelchek.com
Rotterdams Ballonenbed (Flickr)

Pregnancy is a Genetic Battlefield – How Conflicts of Interest Pit Mom’s and Dad’s Genes Against Each Other

Baby showers. Babymoons. Baby-arrival parties. There are many opportunities to celebrate the 40-week transition to parenthood. Often, these celebrations implicitly assume that pregnancy is cooperative and mutually beneficial to both the parent and the fetus. But this belief obscures a more interesting truth about pregnancy – the mother and the fetus may not be peacefully coexisting in the same body at all.

At the most fundamental level, there is a conflict between the interests of the parent and fetus. While this may sound like the beginning of a thriller, this genetic conflict is a normal part of pregnancy, leading to typical growth and development both during pregnancy and across an individual’s lifetime – something my research focuses on.

However, even though genetic conflict is normal during pregnancy, it can play a role in pregnancy complications and developmental disorders when left unchecked.

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, Jessica D. Ayers, Assistant Professor of Psychological Science, Boise State University.

What is Genetic Conflict?

Pregnancy is generally thought of as a period when a new individual is created from a unified blend of genes from their parents. But this is not quite right.

The genes a fetus gets from each parent carry slightly different instructions for development. This means there are contrasting and sometimes conflicting blueprints for how to build the new individual. Conflict over which blueprint to follow for fetal growth and development is the essence of the genetic conflict that occurs during pregnancy.

Moms have to use their bodies to help the fetus grow during pregnancy while dads don’t. This means that the genes the fetus inherits from mom have to not only provide for the current fetus, but also try to keep mom alive and healthy and make sure there are resources left over for a potential future pregnancy. These reserves include both biological resources like glucose, protein, iron and calcium, as well as the time and energy needed to help her children after birth as they grow and develop.

Dad’s genes don’t have this same pressure because they don’t use their bodies to help the fetus grow during pregnancy. A dad’s genes, then, don’t need to ensure that anyone other than the current fetus thrives.

To better understand this situation, pretend that all of the resources a mom can give her children come in the form of a milkshake. Once the milkshake runs out, mom has nothing left to give her children. Maternal genes, therefore, want each child to drink only as much as they need to grow and develop. This ensures that the milkshake can be “shared” across all current and future children.

Paternal genes, on the other hand, have no such guarantee of representation in this mother’s other children – the father of the current child may not be the father of the mother’s potential future children. This lack of guaranteed genetic representation means there is no pressure on the father to “share” the milkshake. The best strategy when it comes to paternal genes, then, is for the fetus to drink as much of the milkshake as they can.

These two strategies play a figurative game of tug of war throughout pregnancy. Both sides are trying to pull fetal development slightly more toward their side. Paternal genes encourage the fetus to grow and develop quickly and take more resources, while maternal genes encourage the fetus to grow and use only what’s necessary for proper development. Conflict over how deeply the embryo implants in the uterus and how quickly the placenta and fetus grow are just a few areas where researchers have documented this tug of war during pregnancy.

The milkshake problem helps researchers determine where to look for genetic conflict by simplifying where trade-offs may take place during pregnancy. Because fetal growth is at the heart of genetic conflict, researchers have focused on processes where conflict over resource transfers from mother to fetus can be observed. These investigations have found that the placenta, a fetal organ responsible for all resource transfers during pregnancy, is dominated by paternally-expressed genes. It releases paternally-derived insulin-like growth factors that make mom less sensitive to her own insulin and hormones that increase maternal blood pressure, both of which ultimately increase the amount of resources the fetus can use to grow during pregnancy but have the potential to harm the mother’s health.

Genetic Conflict and Pregnancy Complications

If genetic conflict goes uncontrolled, it can cause pregnancy complications for the mother and developmental disorders for the child. In fact, there is a growing consensus among researchers that some of the most well-known pregnancy complications like preeclampsia, gestational diabetes, miscarriages and preterm births may best be explained by unchecked genetic conflict.

Despite the potential role that genetic conflict plays in pregnancy complications, current medical treatments are reactive rather than proactive. A pregnant person must show signs of experiencing complications before medical interventions and treatments can take place.

Knowing how unchecked genetic conflict contributes to pregnancy complications could provide researchers another way to develop treatments that are proactive and, ideally, preventive. However, there are currently no treatments for pregnancy complications that consider genetic conflict. Though gestational diabetes can be attributed to underlying genetic conflict, a pregnant person must present with elevated blood sugar levels before doctors can treat underlying conflict over insulin production and blood sugar.

Pregnancy During the COVID-19 Pandemic has Been Challenging for Many

The experiences of pregnant people during the COVID-19 pandemic provide an example of why more research on genetic conflict is needed. During the pandemic, doctors saw both a dramatic decrease in the number of preterm births as well as an increase in the number of stillbirths and miscarriages. Both types of complications are influenced by genetic conflict, but the reasons behind these opposing trends are unclear.

As a woman who was pregnant early in the pandemic, my pregnancy was scary and stressful, spent at home away from the pressures of “normal” life. More research on the complex process of pregnancy and genetic conflict’s role in complications could help researchers better understand how the changes brought by the pandemic produced such wildly different pregnancy outcomes.

The Success Rate of Noninvasive Transcranial Magnetic Stimulation for Depression

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

Patients Suffering with Hard-to-Treat Depression May Get Relief from Noninvasive Magnetic Brain Stimulation

Not only is depression a debilitating disease, but it is also widespread. Approximately 20 million adult Americans experience at least one episode of depression per year.

Millions of them take medication to treat their depression. But for many, the medications don’t work: Either they have minimal or no effect, or the side effects are intolerable. These patients have what is called treatment-resistant depression.

One promising treatment for such patients is a type of brain stimulation therapy called transcranial magnetic stimulation.

This treatment is not new; it has been around since 1995. The U.S. Food and Drug Administration cleared transcranial magnetic stimulation in 2008 for adults with “non-psychotic treatment-resistant depression,” which is typically defined as a failure to respond to two or more antidepressant medications. More recently, in 2018, the FDA cleared it for some patients with obsessive-compulsive disorder and smoking cessation.

Insurance generally covers these treatments. Both the psychiatrist and the equipment operator must be certified. While the treatment has been available for years, the equipment to perform the procedure remains expensive enough that few private psychiatry practices can afford it. But with the growing recognition of the potential of transcranial magnetic stimulation, the price will likely eventually come down and access will be greatly expanded.

Does it Work?

Transcranial magnetic stimulation is a noninvasive, pain-free procedure that has minimal to no side effects, and it often works. Research shows that 58% of once treatment-resistant patients experience a significant reduction in depression following four to six rounds of the therapy. More than 40 independent clinical trials – with more than 2,000 patients worldwide – have demonstrated that repetitive transcranial magnetic stimulation is an effective therapy for the treatment of resistant major depression.

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 Patricia Junquera, Associate Professor and Vice Chair of Clinical Services, Florida International University.

As a professor and psychiatrist who has used transcranial magnetic stimulation to treat some of my patients, I have seen depression symptoms decrease even within the first two weeks of treatment. What’s more, the effects continue after the treatment has ended, typically for six months to a year. After that, the patient has the option of maintenance treatment.

About the Procedure

For the patient, the procedure is easy and simple. One sits in a comfortable chair with a snug pillow that holds their head in place, puts on earplugs and can then relax, check their phone, watch TV or read a book.

A treatment coil, which looks like a figure 8, is placed on the patient’s head. A nearby stimulator sends an electrical current to the coil, which transforms the current into a magnetic field.

The field, which is highly concentrated, turns on and off rapidly while targeting a portion of the prefrontal cortex – the area of the brain responsible for mood regulation.

Researchers know that people suffering from depression have reduced blood flow and less activity in that part of the brain. Transcranial magnetic stimulation causes increases in both blood flow and in the levels of dopamine and glutamate – two neurotransmitters that are responsible for brain functions like concentration, memory and sleep. It’s the repeated stimulation of this area – the “depression circuit” of the brain – that brings the antidepressant effect.

It is Not ‘Electroshock’ or Deep Brain Stimulation

Some people confuse transcranial magnetic stimulation with electroconvulsive therapy, a procedure used for patients with severe depression or catatonia. With electroshock therapy, the anesthetized patient receives a direct electrical current, which causes a seizure. Typically, people who undergo this procedure experience some memory loss after treatment.

Transcranial magnetic stimulation is very different. It doesn’t require anesthesia, and it doesn’t affect memory. The patient can resume daily activities right after each treatment. Dormant brain connections are reignited without causing a seizure.

It should also not be confused with deep brain stimulation, which is a surgical procedure used to treat obsessive-compulsive disorder, tremors, epilepsy and Parkinson’s disease.

Side Effects and Access

Transcranial magnetic stimulation patients undergo a total of 36 treatments, at 19 minutes each, for three to six weeks. Research has concluded that this is the best protocol for treatment. Some patients report that it feels like someone is tapping on their head. Others don’t feel anything.

Some very minor side effects may occur. The most common is facial twitching and scalp discomfort during treatment, sensations that go away after the session ends. Some patients report a mild headache or discomfort at the application site. Depending on how effective the therapy was, some patients return for follow-ups every few weeks or months. It can be used in addition to medications, or with no medication at all.

Not everyone with depression can undergo this type of brain stimulation therapy. Those with epilepsy or a history of head injury may not qualify. People with metallic fillings in their teeth are OK for treatment, but others with implanted, nonremovable metallic devices in or around the head are not. Those with pacemakers, defibrillators and vagus nerve stimulators may also not qualify, because the magnetic force of the treatment coil may dislodge these devices and cause severe pain or injury.

But for those who are able to use the therapy, the results can be remarkable. For me, it is amazing to see these patients smile again – and come out on the other side feeling hopeful.

Release – Tonix Pharmaceuticals Announced Data from its Fully Human anti-SARS-CoV-2 Monoclonal Antibody Platform in an Oral Presentation at the World Antiviral Congress

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on TNXP

November 30, 2022 7:00am EST

Research Being Conducted in Collaboration with Scientists at Columbia University

SARS-CoV-2 Variants have Evaded Antibody Therapeutics Previously Granted FDA Emergency Use Authorization, but which are No Longer Recommended for Use by the NIH COVID-19 Guidelines Panel

Immunocompromised Individuals, Including Organ Transplant Recipients, are at Increased Risk of Severe COVID-19 and Poor Outcomes

Therapeutic Antibody Platform Leverages Tonix’s Expanding Internal Development and Manufacturing Capabilities for Biologics

CHATHAM, N.J., Nov. 30, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced data from its fully human anti-SARS-CoV-2 monoclonal antibody platform in an oral presentation delivered by Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, at the World Antiviral Congress 2022 in San Diego, Calif. The project is part of a broader research collaboration and option agreement with scientists at Columbia University designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The presentation titled, “Platform for Generating Fully Human anti-SARS-CoV-2 Spike Therapeutic Monoclonal Antibodies” highlights the need for a broad array of monoclonal antibodies (mAbs) which can be scaled up quickly and potentially combined with other mAbs to treat or prevent COVID-19.

“We believe that the development of these fully human mAbs strengthens our pipeline of next-generation therapeutics to treat Covid-19,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and bad outcomes1. Although five mAb products, containing 7 distinct mAbs, have received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for either treatment or prophylaxis of COVID-19, only a single product, Evushield® is still recommended for use as a prophylaxis by the NIH COVID Guidelines panel or FDA2,3. Moreover, concerns have been raised about the ongoing ability of Evushield to serve as a prophylaxis against COVID-19 in the face of new variants4. For these reasons, we believe there is a need for second generation mAb treatments and prophylactics for COVID-195. Generating fully human mAbs starting from recovered patient blood samples has the potential to reduce the time required to create novel therapeutics in response to newly identified COVID-19 variants.”

Ilya Trakht, Ph.D., Associate Research Scientist at Columbia and principal investigator of the sponsored research agreement said, “We are excited to work with Tonix because of their commitment to developing therapeutics to COVID-19. As new variants emerge, anti-spike mAbs that were highly effective against older variants of SARS-CoV-2, may quickly lose their place in the treatment landscape. To protect immunocompromised people, we are committed to assembling a diverse inventory of monoclonal antibodies to keep pace with circulating mix of SARS-CoV-2 variants. Our proprietary technology is based on CD40-ligand promoted B-cell expansion and the MFP-2S human hybridoma system”

Seth Lederman added, “This potential therapeutic antibody platform leverages our expanding internal development and manufacturing capabilities for biologics.”

1Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397

2https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ – accessed Nov 3, 2022

3“FDA Updates on Bebtelovimab” – “This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.” – www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab– Accessed Nov 4, 2022

4Wu, K.J. October 29, 2022. The Atlantic. “The End of Evusheld: If you’re immunocompromised, this … isn’t great. www.theatlantic.com/health/archive/2022/10/covid-variants-antibody-treatments-immunocompromised/671929/

5Madison Muller, M. November 16, 2022 Bloomberg. “Doctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates.” www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?

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 second 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 fourth quarter of 2022. 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 consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. 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 first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*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 November 30, 2022

Release – Lineage To Present at BTIG Ophthalmology Day and The Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on LCTX

November 29, 2022 at 8:00 AM EST

PDF Version

  • Fireside Chat with BTIG Research Scheduled for November 29, 2022 at 12:00pm Eastern
  • Panel Hosted by Cantor Research Scheduled for December 8, 2022 at 1:45pm Eastern

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 29, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the BTIG Virtual Ophthalmology Day, on November 29, 2022 at 12:00pm Eastern Time, in a fireside chat hosted by Yun Zhong, Ph.D., Director, Biotech Equity Research at BTIG. Mr. Culley will also be presenting at Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference on December 8, 2022 at 1:45pm Eastern as part of the “Ophthalmology Panel, Vision For The Future: Dry AMD, Other Greenfield Opportunities, and Late-Stage Stories To Shake Things Up”. The panel will be hosted by Jennifer Kim, Vice President, Equity Research at Cantor Fitzgerald, and the conference is taking place at the Fontainebleau Miami Beach hotel, December 7-8, 2022.

“I look forward to the opportunity to discuss the evolving landscape in dry AMD, a disease for which there are currently no FDA-approved therapies and which has attracted significant investor attention as of late,” stated Brian M. Culley, Lineage CEO. “Atrophic AMD is a progressive disease that if left untreated can ultimately rob a person of their vision. It is increasingly positive for patients that new potential therapies for dry AMD are attracting mainstream interest, and I am excited at how a cell transplant approach can be more prominently featured in such conversations.”

BTIG’s Virtual Ophthalmology Day 2022 is exploring emerging innovation in ophthalmology and is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research, and related brokerage services. BTIG’s Corporate Access program hosts client events across the consumer, digital assets, energy and infrastructure, financials, healthcare, real estate and technology sectors. To join the conference, please email info@btig.com.

The Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech conference will feature one-on-ones with leading companies in the Medical & Aesthetic Dermatology, Ophthalmology & MedTech industries, as well as key opinion leaders in the dermatology and ophthalmology space. To join the conference and for more information, please contact your Cantor representative.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: investor attention in the dry AMD landscape or mainstream interest in potential dry AMD therapies, and the impacts these may have on patients with, or potential therapies for, dry AMD and the role that cell transplant therapies may have in the treatment of dry AMD moving forward; and the potential benefits of treatment with OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential treatments for dry AMD, including OpRegen, may not prove to be successful in clinical trials be and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005145/en/

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

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Schwazze (SHWZ) – CEO Dye Adding Shares

Posted on by cpereira@noblefcm.com


Tuesday, November 29, 2022

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.

Insider Buying. In a series of Form 4 filings, between November 14th and November 23rd Schwazze CEO Justin Dye purchased 1,325,852 SHWZ shares at a cost of $2.36 million, or a per share average of $1.78. According to the most recent Form 4 filed on November 25th, Mr. Dye directly currently owns 1,368,062 SHWZ common shares and indirectly owns 9,287,500 SHWZ common shares through Dye Capital & Company.

Details. Through three Form 4 filings, Mr. Dye reported transactions from November 14th through November 23rd. The largest daily purchase of 509,700 shares occurred on November 23rd, which also included the highest average price at $2.00 per share. The recent transactions occurred at prices ranging from $1.13 to $2.10 per share.  


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*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 – Onconova Therapeutics To Present At The Upcoming RHK Capital Disruptive Growth Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on ONTX

Nov 28, 2022

PDF Version

NEWTOWN, Pa., Nov. 28, 2022 (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 that it will participate in the RHK Capital Disruptive Growth Conference being held in the offices of Reed Smith in New York, NY on December 5-6, 2022. Mark Guerin, Chief Operating Officer & Chief Financial Officer, will present a corporate overview at the conference on Tuesday, December 6th at 11:20 a.m. ET.

To learn more or submit a registration request for the conference, visit http://disruptnyc.com/.

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.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.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 – Lineage Announces Launch of Phase 2a Study By Genentech Of Rg6501 (Opregen®) In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on LCTX

November 28, 2022 at 8:00 AM EST

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 28, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that its partner Genentech, a member of the Roche Group, has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy. The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy (GA) secondary to age-related macular degeneration. The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging, within 3 months following surgery. RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech.

“In our Phase 1/2a clinical trial, RG6501 (OpRegen) demonstrated the potential to slow, stop, or reverse the progression of GA in patients with GA. These results can be maintained beyond one year following a one-time, approximately 30-minute outpatient procedure,” stated Brian M. Culley, Lineage CEO. “We are excited that Roche and Genentech are advancing the OpRegen program in a larger clinical study and will seek not only to optimize and potentially improve its delivery, but also confirm safety and activity of OpRegen in this patient population. We expect the findings from this Phase 2a study will be highly informative and may increase the probability of success in any future larger, comparative trials.”

“We are excited for the launch of this Phase 2a study, where one of the key objectives is to optimize the delivery of OpRegen to achieve the best outcomes,” stated Seppi Lin, Vice President of OMNI Early Clinical Development at Genentech. “This study will provide key insights for the future development of the OpRegen program. Geographic Atrophy (GA) secondary to AMD is a disease area of high unmet need with no approved therapies, and we are committed to developing effective and innovative medicines for patients with serious eye diseases.”

About the Phase 2a Study

The planned Phase 2a clinical study is a multicenter, open-label, single arm study to optimize subretinal surgical delivery and to evaluate the safety and activity of OpRegen in patients with GA secondary to AMD. Approximately 30 and up to 60 patients may be enrolled across multiple sites and will receive OpRegen administered as a single subretinal injection to one eye with impaired vision. Study treatment will consist of a single subretinal injection of OpRegen at a dose of up to approximately 200,000 cells delivered to target areas of GA in the study eye.

The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by SD-OCT imaging within 3 months following surgery.

About Geographic Atrophy

Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with GA.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our collaboration and license agreement with Roche and Genentech and the timing of anticipated FDA interactions; the potential of RG6501 (OpRegen) to be a safe, effective and durable, one-time treatment for geographic atrophy secondary to age related macular degeneration; the significance of this Phase 2a study, including the potential that it will be informative or increase the potential of success in future larger, comparative trials; and preclinical activities, clinical trials, and clinical data updates related to our programs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005217/en/

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

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Release – Ocugen To Present At 3rd Annual Dry AMD Therapeutics Summit

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

November 28, 2022

MALVERN, Pa., Nov. 28, 2022 (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 the Company’s Chief Scientific Officer, Arun Upadhyay, Ph.D., will participate in the 3rd Annual Dry AMD Therapeutics Summit at the Revere Hotel in Boston, Mass. from November 30-December 2, 2022.

“I am very pleased that Dr. Upadhyay will share more about our Modifier Gene Therapy platform—a novel approach to treating retinal diseases—during the Dry AMD Summit,” said Dr. Shankar Musunuri, Chairman, CEO & Co-Founder of Ocugen. “Our candidate, OCU410, is being developed to utilize the nuclear hormone receptor gene RORA for the treatment of dry AMD and we plan to file an IND application to initiate Phase 1/2 clinical trials in Q2 2023. We are enthusiastic about the potential for OCU410 to address unmet medical need in this category.”

Panel Discussion: Reviewing the Current State of Dry AMD Preclinical Models & What the Future Looks Like
Date: Wednesday, November 30, 2022
Time: 12:45 p.m. ET

Presentation: A Modifier Gene Therapy Approach for Treatment of Dry AMD
Date: Thursday, December 1, 2022
Time: 11:45 a.m. ET

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 patient’s 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

PDS Biotechnology Corp (PDSB) – Raising Price Target to $19 Based On Clinical Progress

Posted on by cpereira@noblefcm.com


Monday, November 28, 2022

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.

Raising Our Price Target to $19 Per Share. Data presentations from clinical trials for PDS0101 have driven PDSB within 10% of our previous price target. We continue to see PDS0101 as a highly promising treatment for HPV-positive cancers and see several important milestones to drive the stock higher in the coming year.

Price Target Is Based On PDS010 Sales Potential.  Our new price target is based on discounted sales estimates for PDS010 sales in HPV-positive cancer. Following an End-of-Phase 2 meeting with the FDA following the June 2022 VERSATILE-002 data presentation, the company announced that it was accelerating its timetable for the pivotal trial for PDS0101. We expect this trial to begin in 2023 and project product launch in 2026.


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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 – Filament Health Announces Psilocybin Supply Agreement With The Centre For Addiction And Mental Health

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FLHLF

CAMH to use Filament’s natural psilocybin drug candidate for a clinical trial studying treatment-resistant depression

Vancouver, British Columbia, November 17, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament”or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced an agreement with the Centre forAddiction and Mental Health (CAMH), Canada’s largest mental health teaching hospital and one of the world’s leading research centres in the field. Filament will supply CAMH with its natural psilocybin drug candidate for a proposed clinical trial studying the effects of psilocybin for treatment-resistant depression (TRD). The trial will be funded by the first ever Canadian federal grant to study psilocybin.

“Treatment-resistant depression affects millions of people and is a leading cause of disability worldwide, and current treatments are limited by either poor efficacy or tolerability,” said Dr. Ishrat Husain, the CAMH trial’s lead investigator. “Existing clinical data suggests that psilocybin shows promise for treating treatment-resistant depression; our intention is to expand on this research by examining whether psychedelic effects are necessary to achieve an antidepressant response. The trial design relies upon a supply of safe, high quality psilocybin so Filament Health’s support is crucial to our success.”

Treatment-resistant depression (TRD)affects up to a third of all depressed individuals, and results in substantial functional decline and high mortality rates.Current treatment options for TRD, can have either inadequate efficacy, adverse effects, or are difficult to access. With this trial, CAMH intends to determine whether psychedelic-assisted psychotherapy with psilocybin is a viable alternative treatment, and whether psychedelic effects are necessary for efficacy.

“CAMH is one of the world’s most well-regarded mental health research institutions,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “We’re proud to donate our natural psilocybin drug candidate to support this vital research.It’s another important step in our mission of getting safe, natural psychedelics into the hands of everyone who needs them, as soon as possible.

The clinical trial application is under review by Health Canada with approval anticipated by January 2023.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF)(NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn.

MEDIA RELATIONS

Anna Cordon, Director of Communications778.245.9067

anna@filament.health‍

INVESTOR RELATIONS

ir@filament.health

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward‐looking statements” and “forward‐looking information,” respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, “expect”,“anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”,“intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements.Forward‐looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including status of patent applications and the ability to secure patents.There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐ looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws.

Release – Tonix Pharmaceuticals to Participate in the A.G.P. Biotech Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on TNXP

November 23, 2022 7:00am EST

CHATHAM, N.J., Nov. 23, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate virtually in the A.G.P. Biotech Conference and host investor meetings. The conference is being held Wednesday, November 30, 2022 – Thursday, December 1, 2022.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the conference coordinator or Ian Frost at ian.frost@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 second 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 fourth quarter of 2022. 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 consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. 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 first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*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 November 23, 2022