Month: September 2023

Release – Tonix Pharmaceuticals Announces Commitment to Supply Tosymra® (sumatriptan Nasal Spray) 10 mg for Treatment of Acute Migraine to Meet Potential Increased Demand Following GSK’s Planned Discontinuation of Imitrex® (sumatriptan) Nasal Spray After January 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

September 06, 2023 7:00am EDTDownload as PDF

Tosymra Nasal Spray 10 mg is a Proprietary Acute Migraine Treatment Approved Under the 505(b)2 Pathway Based on Bioequivalence to Imitrex (sumatriptan) Injection 4 mg

GlaxoSmithKline Recently Notified FDA that it will Discontinue Imitrex Nasal Spray 5 mg and 20 mg Products after January 2024

CHATHAM, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it is committed to meeting potential increased demand for Tosymra® (sumatriptan) nasal spray 10 mg after GlaxoSmithKline’s (GSK) planned discontinuation of Imitrex (sumatriptan) nasal spray 5 mg and 20 mg products after January, 2024.

On August 8, 2023, GSK informed the U.S. Food and Drug Administration (FDA) of its plan to discontinue Imitrex nasal spray 5 mg and 20 mg doses after January 31, 2024. The notification is posted on the FDA Drug Shortages website.1 Tonix is preparing for potential increased demand for Tosymra (sumatriptan nasal spray) 10 mg to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis of bioequivalence to Imitrex injection 4 mg.

Drug shortages have presented an ongoing challenge for the U.S. healthcare system, reaching near-record levels2 in recent months, causing treatment delays and rationing. Tonix is ready to step in to alleviate potential shortages in sumatriptan, a widely used treatment option for acute migraine.

“In response to FDA outreach, we have confirmed our commitment to meet potential increased demand for sumatriptan nasal spray from patients who suffer from migraines,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “While Tosymra nasal spray and Imitrex nasal spray are not substitutable at the pharmacy, we plan to alert providers to the possibility of prescribing Tosymra for patients who may benefit from a nasal spray formulation of sumatriptan.”

The American Headache Society Consensus Statement on migraine treatments recommends that “a non-oral formulation should be used in patients whose attacks are associated with severe nausea or vomiting, who do not respond well to traditional oral treatments, or who have trouble swallowing orally administered medications.”3 Approximately 73% of migraine patients have been reported to experience nausea with or without vomiting during their attacks.4

“Intranasal sumatriptan is an important therapy for those who suffer from migraines. We believe Tosymra is differentiated from other intranasal formulations of sumatriptan, which are generic equivalents to Imitrex nasal spray because of its proprietary Intravail® absorption enhancer technology,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines. “Intravail technology helps the medication absorb into the bloodstream so it can work quickly, providing migraine pain relief in as little as 10 minutes for some patients.”5,6,7

About Migraine

Nearly 40 million people in the United States suffer from migraine8 and it has been recognized as the second leading cause of disability in the world.9 Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 third quarter of 2023. Tonix’s rare disease development 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 development 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 rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

1FDA Drug Shortage, accessed Aug 24, 2023 – https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sumatriptan+Nasal+Spray&st=d&tab=tabs-2
2CNN, accessed September 1, 2023 – https://www.cnn.com/2023/08/10/health/drug-shortage-pharmacist-survey/index.html
3Ailani J, et al. Headache. 2021. 61: 1021–1039
4Newman LC. Headache. 2013. 53 Suppl 1:11-6
5Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: 2021
6Mathew NT, et al. Arch Neurol. 1992. 49(12):1271-6
7Wendt J, et al. Clinical Therapeutics. 2006. 28(4):517-526
8Burch RC, et al. Neurol Clin. 2019. 37(4):631-649
9Steiner TJ, et al. J Headache Pain. 2020. 21(1): 137

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any ingredient in Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.

Zembrace® SymTouch® (sumatriptan Injection):   IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Source: Tonix Pharmaceuticals Holding Corp.

Released September 6, 2023

Release – MustGrow and Janssen PMP, a division of Janssen Pharmaceutica NV, Announce Significant Project Expansion

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

  • Exclusive agreement with Janssen PMP to now include postharvest potatoes and bananas globally, a significant strengthening of existing partnership.
  • Janssen PMP postharvest research, development, and commercialization capabilities have driven expansion.
  • Janssen PMP will continue to fund and complete all application testing and development work.

SASKATOON, Saskatchewan, Canada, Sep. 6, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”), and Janssen PMP, a division of Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (“Janssen PMP”) are pleased to announce a significant expansion to their existing Exclusive Evaluation and Option Agreement (the “Agreement“) to test and develop MustGrow’s biological mustard plant-based technologies for certain postharvest food preservation storage applications globally. The Agreement will now also include postharvest potatoes and bananas globally.

Under the Agreement, the initial evaluation work excluded postharvest potatoes and bananas. However, with 15 months of postharvest evaluation work completed utilizing MustGrow’s technology, Janssen PMP and MustGrow have produced very encouraging and efficacious results, supporting the decision to add postharvest potatoes and bananas to Janssen PMP’s exclusive evaluation work. 

“The postharvest banana market is one of our historical markets where the need for natural fungicides is growing. Also, developing a natural technology acting as an anti-sprouting and as a fungicide for stored potatoes is a major opportunity for Janssen PMP and for the industry.” says Geoffroy de Chabot-Tramecourt, Director R&D and Business Development at Janssen PMP.

“Food storage and preservation continues to be a critical global issue. Our current partnership with Janssen PMP on the postharvest food preservation side has produced positive results with our natural technology that continues to open up new market areas and opportunities”, adds MustGrow COO Colin Bletsky.  “Janssen PMP brings more than 50 years of relevant postharvest development and market experience, and it is expected that adding these two key storage applications will help accelerate the commercialization pathway by levering the knowledge generated from testing other fruits and vegetables as well.” 

Janssen PMP is a world leader in postharvest product development and has proven aptitude in pace of work, knowledge, and market scope. This additional postharvest market area to Janssen PMP is expected to accelerate MustGrow’s development timeline, levering the current project work and technical/marketing expertise of Janssen PMP’s postharvest professionals.

Janssen PMP will continue to fund and drive all application testing and development work.

Postharvest Protection for Global Food Security

Potatoes, the world’s fourth most important food crop in terms of human consumption after maize, wheat and rice,(1) is a US$4 billion industry in the US, with as much as 33% of yield lost per year due to postharvest issues – approximately US$1.3 billion in lost revenue.(2) The Food and Agriculture Organization (FAO) has strongly endorsed potatoes as a food security crop.  Potatoes require up to nine months of storage and become waste without proper sprout suppression management, making postharvest sprout suppression a key element of potato storage.

The environment within storage and during particular stages of storage are most conducive to the spread of diseases. Controlling diseases in storage is difficult since the majority of chemical treatments have been either banned or are ineffective. For example, the leading agrochemical product for sprout suppression, CIPC, was banned by the European Union on Oct. 8, 2020.  For over 60 years, CIPC had long been the major global sprout suppressant, widely applied to stored potatoes.  With this ban in effect, potato growers must now refrigerate produce, with the additional capital expenditure and refrigeration energy consumption making this temporary approach unsustainable.  Although the ban was anticipated, no effective treatment alternatives have emerged – creating a major problem for existing potato storage sites.

Fruit and vegetable crops play a critical role in global food nutrition. More than one-third of produce (worth approximately US$1 trillion in value) is lost or wasted in postharvest operations,(3) which includes loss attributed to fungal and bacterial diseases. Fresh vegetables are highly perishable living tissues that are particularly susceptible. Postharvest fungal and bacterial diseases can cause annual vegetable crop losses of 40–60%.(4) Reducing postharvest losses could increase food availability, reducing pressure on the mounting food supply shortage and global inflationary pressures with respect to food prices. In addition, food production could be more environmentally sustainable with less waste.

Sources:

(1) https://www.intechopen.com/chapters/78618
(2) https://vegetablegrowersnews.com/news/help-to-reduce-huge-losses-in-potato-industry-seen-in-biochemistry/
(3) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5296677/
(4) https://www.intechopen.com/online-first/79995

About JANSSEN PMP

Janssen PMP (https://www.janssenpmp.com/) is a division of Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

Janssen PMP is a long-established world leader in the development and formulation of new and highly effective active substances and end-use products for the protection of materials and food, especially fruits and vegetables. With more than 50 years’ experience in Post-Harvest treatments and Plant Protection, Janssen PMP has developed strong technical and commercial expertise. Through protection of our surroundings, we aim to protect the health and well-being of the people in the environment in which our products are being used.

ON BEHALF OF JANSSEN PMP

Geoffroy de Chabot-Tramecourt
Director R&D and Business Development
Turnhoutseweg 30, 2340 Beerse, Belgium
Tel: +32 14 60 28 57
Mobile: +32 471 80 82 09
Email: gdchabot@its.jnj.com

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world.  MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals.  Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertility markets.  Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements.  Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features.  Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility.  MustGrow has approximately 49.7 million basic common shares issued and outstanding and 55.6 million shares fully diluted.  For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”.  Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: (i) the timing and results of any evaluation work on postharvest potatoes and bananas by Janssen PMP; (ii) the potential acceleration of MustGrow’s development timeline by transferring the additional postharvest market area to Janssen PMP;  (iii) the potential of MustGrow technology to extend shelf life of fruits and vegetables; (iv) the ability of the Company’s technology as a postharvest treatment to help secure a safe, environmentally sustainable food supply, with less waste; and (v) the ability to increase food availability and reduce pressure on the food supply shortage and global inflationary pressures with respect to food prices, by reducing postharvest losses.  

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow.  Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) the preferences and choices of agricultural regulators with respect to product approval timelines; (ii) the ability of MustGrow’s partners to meet obligations under their respective agreements; and (iii) other risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2021 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com.  Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2023 MustGrow Biologics Corp. All rights reserved.

Tonix Pharmaceuticals (TNXP) – Long COVID Study Did Not Meet Primary Endpoint But Provides Important Data

Posted on by cpereira@noblefcm.com


Wednesday, September 06, 2023

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Phase 2 PREVAIL Study Announces Mixed Results. Tonix announced that the Phase 2 PREVAIL study testing TNX-102 SL in Long COVID did not meet its primary endpoint of multi-site pain reduction at week 14. The study was able to improve several important symptoms of Long COVID that could become acceptable endpoints in a Phase 3 trial.

Several Measures Showed Benefits In The Trial. PREVAIL was a blinded placebo-controlled study with an enrollment of  63 patients. Several secondary endpoints showed consistent benefits over the course of the study. These include fatigue, sleep quality, cognitive function, disability, and the Patient Global Impression of Change (PGIC). We believe these data show the drug can reduce several important symptoms of Long COVID.


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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. 

Defense Metals Corp. (DFMTF) – New Exploration Targets Underscore the Potential to Expand the Wicheeda REE Deposit

Posted on by cpereira@noblefcm.com


Wednesday, September 06, 2023

Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power market, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Property located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Geophysical survey reveals two new exploration targets. Defense Metals completed a ground radiometric geophysical survey over the Wicheeda rare earth element (REE) deposit and identified new anomalies that may represent rare earth element mineralized carbonatite within the current mineral resource pit shells defined in the 2021 preliminary economic assessment (PEA). Two previously unknown anomalies were identified, each approximately 40 meters in width and extending approximately 250 meters northwest from the main body of the Wicheeda REE deposit. The survey further defined the surface extent of outcropping REE mineralization. 

New targets offer resource expansion potential. The two anomalies are under cover and have a similar geophysical expression to known drilled and outcropping rare earth mineralization. Recall Hole WI21-39 intersected relatively higher-grade carbonatite at depth returning 2.91% total rare earth oxide (TREO) over 45 meters from a depth of 69 meters downhole that is believed to represent the downdip projection of the eastern anomaly.


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. 

Bit Digital, Inc. (BTBT) – Increasing Hash Rate Means Increasing Production

Posted on by cpereira@noblefcm.com


Wednesday, September 06, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

August Production. Bit Digital produced 139.9 BTC, a 5% increase compared to the prior month’s 133.0 BTC. The increase was due to a higher average active hash rate, partially offset by an increase in network difficulty. The active hash rate was approximately 2.03 EH/s as of August 31, 2023 compared to 1.78 EH/s last month.

Staking. Bit Digital had approximately 13,188 ETH actively staked in native and liquid staking protocols as of August 31, 2023, up from 12,708 last month. Approximately 10,784 were natively staked and 2,404 ETH were deployed in liquid staking protocols as of that date, with 416 ETH deposited but in queue to be activated on the Ethereum staking network, which are estimated to come online by the end of September 2023. The blended APY the Company earned was 4.4% on its staked ETH position for the month of August 2023.


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. 

Saudi-Russian Oil Alliance Stokes Prices and Tensions

Posted on by slightbourne@noblecapitalmarkets.com

Saudi Arabia and Russia have extended their joint oil production cuts by 1.3 million barrels per day until the year’s end. This move caused oil prices to spike, with benchmark Brent crude exceeding $90 per barrel, a level unseen since November.

While this decision may lead to higher inflation and fuel costs, it also strains Saudi Arabia’s relations with the U.S., as President Biden had previously warned of “consequences” for Saudi-Russian cooperation due to Russia’s Ukraine conflict involvement.

Saudi Arabia plans to monitor market conditions closely and take further action if needed, aligning with OPEC+ efforts to stabilize oil markets. Russia will continue its daily 300,000-barrel cut.

Brent crude had traded between $75 and $85 per barrel since November before these announcements.

No immediate U.S. reaction, but past criticism of OPEC, Saudi Arabia, and Russia by U.S. lawmakers persists. Analysts predict these cuts may create global oil imbalances and push prices above $90 per barrel if there isn’t a significant economic downturn.

U.S. gasoline prices average $3.81 per gallon, slightly below the 2012 Labor Day high of $3.83, but the impact remains uncertain. Higher gasoline prices can raise transportation costs and contribute to inflation.

Take a moment to learn about InPlay Oil, a junior oil and gas exploration and production company with operations in Alberta focused on light oil production.

Click here for company information, including equity research from Noble Capital Markets.

Saudi Arabia’s production cut, initiated in July, aligns with other OPEC+ countries extending cuts into the following year, yet previous cuts failed to significantly raise oil prices due to weak demand and tighter monetary policies. International travel’s revival is expected to boost oil demand.

Saudi Arabia aims to boost oil prices to fund its Vision 2030 initiative, diversifying its economy and creating jobs, including the $500 billion Neom city project.
Balancing these goals, Saudi Arabia must manage its U.S. relationship, complicated by past tensions over Jamal Khashoggi’s killing. Recent negotiations include nuclear cooperation, raising nonproliferation concerns.

Higher oil prices from these cuts also aid Russia in funding the Ukraine conflict, as Western sanctions reduce Moscow’s revenues, leading to discounted oil sales.

These dynamics add complexity to the global geopolitical landscape surrounding oil production.

US Dollar Soars: China and Japan’s Defensive Moves Amidst Inflation Concerns

Posted on by slightbourne@noblecapitalmarkets.com

China and Japan are actively defending their currencies against the rising US dollar, sparking inflation concerns. Both the yen and yuan have depreciated significantly due to market expectations of prolonged higher interest rates by the US Federal Reserve.

In response, China’s central bank is providing robust guidance through its daily yuan reference rate to prevent excessive weakening. Japan has issued a stern warning against rapid yen depreciation, signaling readiness for intervention.

Despite these efforts, doubts linger about their effectiveness, especially if the Federal Reserve maintains a hawkish stance or China’s economic recovery remains sluggish. The strong US dollar also affects European currencies, with the euro and pound hitting their lowest levels since June, raising concerns of quicker rate cuts by eurozone and UK central banks to counter rising borrowing costs. Investors globally watch closely as central banks and the Federal Reserve navigate these currency dynamics, with potential implications for inflation and future monetary policies.

AMETEK Snaps Up UEI to Grow in Aerospace and Defense Testing

Posted on by slightbourne@noblecapitalmarkets.com

Pennsylvania instrumentation company AMETEK (NYSE: AME) is expanding its testing and measurement capabilities with the acquisition of United Electronic Industries.

Massachusetts-based UEI is a leader in data acquisition and control solutions for aerospace, defense, energy and semiconductor sectors. Its products enable customers to build robust systems for simulation, monitoring and automated testing.

AMETEK CEO David Zapico expressed excitement about bringing UEI’s innovative solutions into the company’s Power Systems and Instruments division. He said the $35 million deal broadens AMETEK’s presence in attractive markets that complement existing strengths.

UEI will join AMETEK’s Electronic Instruments Group, known for analytical, calibration and display instruments. The acquisition aligns with AMETEK’s growth strategy of targeting niche segments and making strategic buys.

Headquartered near Philadelphia, AMETEK has annual sales over $6 billion globally. The 90-year-old firm focuses on cash flow and capital deployment to drive double-digit earnings growth.

Take a moment to learn about Kratos Defense & Security Solutions, a company that specializes in satellite communications, missile defense, and hypersonic systems.

Click here for company information, including equity research from Noble Capital Markets.

Western Midstream Expands in Powder River Basin with Meritage Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Western Midstream Partners, LP (NYSE: WES) is set to expand its footprint in the Powder River Basin through the acquisition of Meritage Midstream Services II, LLC (Meritage). This all-cash transaction comes with a price tag of $885 million and is expected to close in the fourth quarter of 2023, subject to regulatory approvals.

Meritage, headquartered in Denver, Colorado, operates a substantial natural gas gathering and processing business in Wyoming’s Powder River Basin. The acquisition will significantly increase WES’s natural gas processing capacity, taking it to 440 MMcf/d. Additionally, it will diversify WES’s customer base with long-term contracts and acreage dedications from reputable counterparties.

The Powder River Basin has attracted considerable investment due to its multi-stacked pay horizon potential, making it an appealing prospect for energy companies. As part of this acquisition, WES aims to enhance its position in the basin and pursue additional acreage dedications and business development opportunities.

Upon completing the transaction, WES anticipates recommending a Base Distribution increase of $0.0125 per unit, providing a potential boost for its investors.

This strategic move represents a significant step for WES in expanding its presence in a region with promising energy prospects.

Take a look at Alvopetro Energy, a company that engages in the acquisition, exploration, development and production of natural gas.

Deadline Extended: Trump’s Truth Social and Digital World Acquisition Gain More Time

Posted on by slightbourne@noblecapitalmarkets.com

Shareholders of Digital World Acquisition (DWAC), the investment partner of former President Donald Trump’s media venture, have granted an extension to the company’s merger deadline. This extension allows the special purpose acquisition company (SPAC) more time to complete its long-pending merger with Truth Social, a social network with pro-Trump leanings.

The extension comes after a concerted effort to secure shareholder approval, arriving just three days before the liquidation deadline of Truth Social on September 8. A failure to secure shareholder approval would have compelled the SPAC to dissolve, resulting in the return of $300 million to shareholders, depriving Trump Media & Technology Group of the funds associated with the deal.

However, the merger still faces challenges, including meeting closing conditions and resolving issues raised by the Securities and Exchange Commission (SEC). In July, the SEC alleged that Digital World had misled investors in its official merger documents. Correcting these inaccuracies and resubmitting the filings is necessary before the merger process can proceed. Additionally, required quarterly financial statements covering operations in the first half of 2023 have not been filed with the SEC.

Digital World Acquisition had initially anticipated a year for the merger process when it went public in September 2021 but has encountered several hurdles necessitating deadline extensions, including a previous one in September 2022.

Following the news of the extension, Digital World’s shares experienced a rise to over $18 before settling at $16.80 per share at 11 a.m. The stock had reached its peak at approximately $175 per share in 2021.

Explore other SPAC Mergers via SPACtrac reports from Noble Capital Markets

FG Merger Corp. (FGMC) -Asymmetric Return Profile Acquisition To Unlock iCoreConnect SaaS Potential

Heritage Distilling Co.: Liquor With A Kicker

SoftBank’s Arm Aims for $52 Billion Valuation in Landmark US IPO

Posted on by slightbourne@noblecapitalmarkets.com

SoftBank Group’s Arm is gearing up for its highly-anticipated initial public offering (IPO), with ambitions to secure a valuation exceeding $52 billion. In an announcement made on Tuesday, the renowned chip designer unveiled plans to issue 95.5 million American depository shares, priced between $47 and $51 each, with a target of raising up to $4.87 billion at the upper end of this range.

While this valuation marks a decline from the $64 billion that SoftBank paid last month to acquire the remaining 25% stake in Arm from its $100 billion Vision Fund, it still surpasses the abandoned $40 billion sale of Arm to Nvidia Corp, which fell through last year due to opposition from antitrust regulators.

Arm, headquartered in Cambridge, England, holds a dominant position in the global technology landscape, powering over 99% of the world’s smartphones. Its innovative designs are also integral to a wide array of devices, spanning from tablets and laptops to servers and automobiles. Notably, Arm maintains a substantial presence in the United States.

Expected to be the largest IPO in the United States this year, Arm’s public offering carries significant weight as a litmus test for an IPO market grappling with challenges such as rising interest rates and geopolitical tensions stemming from the Ukraine conflict.

Despite these obstacles, investors are likely to welcome Arm’s IPO with open arms. The company boasts profitability and a remarkable history of technological innovation. Furthermore, Arm’s designs play a pivotal role in advancing emerging technologies like artificial intelligence and the metaverse.

For SoftBank, this IPO represents a major triumph. The Japanese conglomerate has been under pressure to enhance its investment returns, and while the sale of Arm would have been a monumental windfall, the IPO is a noteworthy achievement in its own right.

The success of Arm’s IPO hinges on several key factors:

1. IPO Market Conditions: The strength of the overall IPO market will play a vital role in determining Arm’s success.

2. Investor Appetite for Tech Stocks: As a technology company, Arm’s fate will be closely tied to investor sentiment towards tech stocks.

3. Valuation of Arm: The company’s valuation must be attractive to prospective investors.

4. Demand for Arm’s Shares: The level of demand for Arm’s shares will significantly impact the outcome.

If Arm’s IPO prevails, it could usher in a new era for the IPO market, potentially inspiring other startups to pursue public offerings. This success story would also bolster SoftBank’s financial standing and burnish its reputation as a savvy investor. Moreover, the technology industry would reap the rewards of heightened visibility and liquidity associated with Arm’s shares.

However, should Arm’s IPO falter, it could stymie the company’s growth prospects due to a lack of capital infusion. SoftBank would bear the financial brunt, and its reputation as an investor might suffer. Additionally, the technology sector would miss out on the potential benefits of Arm’s IPO.

In conclusion, Arm’s IPO is a watershed moment poised to leave an indelible mark on the company, SoftBank, and the technology sector at large. Its success will pivot on a complex interplay of factors, but if it prospers, it promises significant advantages for all stakeholders involved.

Timken Strengthens Industrial Motion Portfolio Through Des-Case Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

The Timken Company (NYSE: TKR), a global leader in engineered bearings and industrial motion products, has announced its acquisition of Des-Case Corp., a Nashville-based manufacturer specializing in filtration products for industrial lubricants. Founded in 1983, Des-Case serves various industrial sectors, and it is expected to generate approximately $40 million in revenue in 2023.

Des-Case is recognized for its innovative filtration solutions that complement Timken’s automatic lubrication systems. This acquisition opens up opportunities for synergy, such as cross-selling and international expansion. Des-Case’s product range includes breathers, filter elements, condition monitoring, lubrication storage, and filter systems, all of which play a crucial role in improving equipment reliability, reducing downtime, and extending the lifespan of customer systems.

Des-Case employs around 120 individuals and operates manufacturing facilities in both Tennessee and the Netherlands. The acquisition was funded through a combination of cash reserves and Timken’s existing revolving credit facility.

Timken, with over a century of experience and innovation, designs and manufactures engineered bearings and industrial motion products. In 2022, the company achieved $4.5 billion in sales and has a global workforce of more than 19,000 employees across 46 countries. Timken has received recognition as one of America’s Most Responsible Companies, World’s Most Ethical Companies, America’s Most Innovative Companies, and America’s Best Large Employers by various prestigious organizations.

Take a look at other companies in the metals space by exploring Mark Reichman’s coverage list.

Release – Fazoli’s Brings Back Fan Favorite Pizza Baked Pasta!

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

SEPTEMBER 05, 2023

Limited Time Menu Reintroduces Italian Chain’s Most Popular Mashup

LOS ANGELES, Sept. 05, 2023 (GLOBE NEWSWIRE) — Fazoli’s, America’s favorite fast and fresh Italian chain, today announces the return of the beloved Pizza Baked Pasta to its menu for a limited time. Beginning Sept. 5, the classic dish will be available to order in three irresistible variations: Pizza Baked Pasta, Meaty Pizza Baked Pasta and Supreme Pizza Baked Pasta. Also included in the limited-time offering is Pumpkin Cheesecake made by The Cheesecake Factory Bakery®, a welcome addition to the dessert menu just in time for fall.

The classic Pizza Baked Pasta is back better than before, this time featuring a penne pasta smothered in the chain’s signature zesty Pizza Bake Sauce, loaded with mozzarella and pepperoni, and then baked to sizzling perfection. Guests can elevate the dish by opting for the Meaty Pizza Baked Pasta, which includes the classic ingredients plus Italian sausage and bacon, or the brand-new Supreme Pizza Baked Pasta, made with the classic ingredients, Italian sausage, bacon, red and green peppers, onions, and mushrooms. All three renditions of the dish are available through the end of the year – giving customers plenty of time to try all three at restaurants systemwide!

“At Fazoli’s, we’re dedicated to crafting innovative Italian dishes,” said Tisha Bartlett, Vice President of Marketing at Fazoli’s. “The return of our Pizza Baked Pastas is a celebration of that commitment, and we’re eager for our devoted fans to once again enjoy a quintessential Fazoli’s classic.”

As part of the limited-time menu, guests will also get a taste of fall with Pumpkin Cheesecake made by The Cheesecake Factory Bakery® available through Oct. 30. Made with a secret blend of spices, garnished with a rosette of whipped cream, and drizzled with Ghirardelli Salted Caramel Sauce, The Cheesecake Factory’s legendary Pumpkin Cheesecake is a delightful sweet and spiced treat that will have each forkful tasting like sweater weather.

Founded in 1988, Fazoli’s prides itself in serving quality Italian pastas, sub sandwiches, salads, pizza, and dessert. For more information on Fazoli’s, visit Fazolis.com.

About FAT (Fresh. Authentic. Tasty.) Brands
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About Fazoli’s: Fast. Fresh. Italian.
Founded in 1988 in Lexington, Ky., Fazoli’s owns and operates nearly 220 restaurants in 27 states, making it the largest QSR Italian chain in America. Fazoli’s prides itself on serving quality Italian food, fast, fresh and friendly. Menu offerings include freshly prepared pasta entrees, Submarinos® sandwiches, salads, pizza and desserts – along with its unlimited signature breadsticks. Fazoli’s is a winner of FastCasual and Steritech’s 2020 Excellence in Food Safety Award and ranked number seven on FastCasual’s “Top 100 Movers and Shakers” list in 2022. Additionally, it was named to Technomic’s “Top 500 Chain Restaurant Report” in 2022, selected as one of the “Top 50 Global Fast Casual Innovators in 2021” by Foodable, a “Top 200 Franchises in 2021” by Franchise Business Review, and an Entrepreneur 2018 “Franchise 500.” Fazoli’s was a recipient of the 2021 American Business Awards Gold Stevie Awards in Food & Beverage for Company of the Year.

Media Contact:
Ali Lloyd
FAT Brands
alloyd@fatbrands.com

Source: FAT Brands Inc.

Fazoli’s Brings Back Fan Favorite Pizza Baked Pasta!

SEPTEMBER 05, 2023

 DOWNLOAD PDFPDF FORMAT (OPENS IN NEW WINDOW)

Limited Time Menu Reintroduces Italian Chain’s Most Popular Mashup

LOS ANGELES, Sept. 05, 2023 (GLOBE NEWSWIRE) — Fazoli’s, America’s favorite fast and fresh Italian chain, today announces the return of the beloved Pizza Baked Pasta to its menu for a limited time. Beginning Sept. 5, the classic dish will be available to order in three irresistible variations: Pizza Baked Pasta, Meaty Pizza Baked Pasta and Supreme Pizza Baked Pasta. Also included in the limited-time offering is Pumpkin Cheesecake made by The Cheesecake Factory Bakery®, a welcome addition to the dessert menu just in time for fall.

The classic Pizza Baked Pasta is back better than before, this time featuring a penne pasta smothered in the chain’s signature zesty Pizza Bake Sauce, loaded with mozzarella and pepperoni, and then baked to sizzling perfection. Guests can elevate the dish by opting for the Meaty Pizza Baked Pasta, which includes the classic ingredients plus Italian sausage and bacon, or the brand-new Supreme Pizza Baked Pasta, made with the classic ingredients, Italian sausage, bacon, red and green peppers, onions, and mushrooms. All three renditions of the dish are available through the end of the year – giving customers plenty of time to try all three at restaurants systemwide!

“At Fazoli’s, we’re dedicated to crafting innovative Italian dishes,” said Tisha Bartlett, Vice President of Marketing at Fazoli’s. “The return of our Pizza Baked Pastas is a celebration of that commitment, and we’re eager for our devoted fans to once again enjoy a quintessential Fazoli’s classic.”

As part of the limited-time menu, guests will also get a taste of fall with Pumpkin Cheesecake made by The Cheesecake Factory Bakery® available through Oct. 30. Made with a secret blend of spices, garnished with a rosette of whipped cream, and drizzled with Ghirardelli Salted Caramel Sauce, The Cheesecake Factory’s legendary Pumpkin Cheesecake is a delightful sweet and spiced treat that will have each forkful tasting like sweater weather.

Founded in 1988, Fazoli’s prides itself in serving quality Italian pastas, sub sandwiches, salads, pizza, and dessert. For more information on Fazoli’s, visit Fazolis.com.

About FAT (Fresh. Authentic. Tasty.) Brands
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About Fazoli’s: Fast. Fresh. Italian.
Founded in 1988 in Lexington, Ky., Fazoli’s owns and operates nearly 220 restaurants in 27 states, making it the largest QSR Italian chain in America. Fazoli’s prides itself on serving quality Italian food, fast, fresh and friendly. Menu offerings include freshly prepared pasta entrees, Submarinos® sandwiches, salads, pizza and desserts – along with its unlimited signature breadsticks. Fazoli’s is a winner of FastCasual and Steritech’s 2020 Excellence in Food Safety Award and ranked number seven on FastCasual’s “Top 100 Movers and Shakers” list in 2022. Additionally, it was named to Technomic’s “Top 500 Chain Restaurant Report” in 2022, selected as one of the “Top 50 Global Fast Casual Innovators in 2021” by Foodable, a “Top 200 Franchises in 2021” by Franchise Business Review, and an Entrepreneur 2018 “Franchise 500.” Fazoli’s was a recipient of the 2021 American Business Awards Gold Stevie Awards in Food & Beverage for Company of the Year.

Media Contact:
Ali Lloyd
FAT Brands
alloyd@fatbrands.com

Source: FAT Brands Inc.