Author: aweinsoff@channelchek.com

Release – ZyVersa Therapeutics, Inc. Announces Pricing of $2.1 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 24, 2023

WESTON, Fla., July 24, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa” or “the Company”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases with high unmet needs, announced today the pricing of a “reasonable best efforts” public offering of 12,727,273 shares of common stock (or pre-funded warrants in lieu thereof) and common warrants to purchase up to 12,727,273 shares of common stock, at a combined public offering price of $0.165 per share (or pre-funded warrant in lieu thereof) and common warrant for aggregate gross proceeds of approximately $2.1 million, before deducting placement agent fees and other offering expenses. The warrants will have an exercise price of $0.165 per share, will be exercisable immediately, and will expire five years from the initial issuance date. The pre-funded warrants and accompanying common warrants are identical, except that each pre-funded warrant is immediately exercisable for one share of common stock at an exercise price of $0.0001, the purchase price for a pre-funded warrant and accompanying common warrants is the public offering price minus $0.0001 and the pre-funded warrants do not expire until exercised.

The closing of the offering is expected to occur on or about July 26, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds of this offering for working capital and other general corporate purposes and may use a portion of the net proceeds to redeem the remaining outstanding shares of its Series A preferred stock.  

A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-272657) previously filed with the Securities and Exchange Commission (SEC) which became effective on July 18, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. An electronic copy of the final prospectus will be filed with the SEC and may be obtained, when available, on the SEC’s website located at http://www.sec.gov and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.

In connection with the offering, the Company agreed to amend, effective upon the closing of this offering, the terms of the April 2023 common stock purchase warrants held by a purchaser in the offering to reduce the exercise price thereof to the initial exercise price of the common warrants being sold in the offering and to extend the expiration date of such April 2023 warrants consistent with the expiration date of the common warrants. All of the other terms of the April 2023 warrants will remain unchanged.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About ZyVersa Therapeutics

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including market and other conditions, ZyVersa’s ability to satisfy all conditions precedent to the closing of the offering; ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – Tonix Pharmaceuticals Announces Data Supporting the Memory- and Cognition-Enhancing Effects of Racemic Tianeptine and (S)-Tianeptine, but not (R)-Tianeptine, in the In Vivo Rat Novel Object Recognition (NOR) Test

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 24, 2023 7:00am EDT

New Findings Support Development of Racemic Tianeptine and (S)-Tianeptine (Estianeptine) as First-in-Class Oral Therapies in Alzheimer’s Disease and Other Psychiatric and Neurodegenerative Conditions with Memory Deficits

(S)-Tianeptine Effects on Novel Object Recognition are Consistent with a Role for PPAR-β/δ Activation in Improving Memory and Cognition

Topline Results Expected First Quarter 2024 from the Currently Enrolling Potentially Pivotal Phase 2 UPLIFT Study of TNX-601 ER (Racemic Tianeptine) in Major Depressive Disorder

CHATHAM, N.J., July 24, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced data supporting the memory- and cognition-enhancing effects of two Tonix drug candidates, TNX-601 ER (tianeptine hemioxalate extended release) and TNX-4300 (estianeptine), the single (S)-isomer of tianeptine. TNX-601 ER is being tested in the potentially pivotal Phase 2 UPLIFT1 trial for the treatment of major depressive disorder (MDD), with topline results expected in the first quarter of 2024. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease.* The findings reported today show that tianeptine and estianeptine improve memory and cognition as measured in the rat Novel Object Recognition (NOR) test. The finding that estianeptine is responsible for improving memory and cognition suggests a role for PPAR-β/δ activation in memory.

Tianeptine is an antidepressant that has been marketed outside the U.S. for more than 30 years. Tianeptine is also a racemic drug composed of a 1:1 mixture of two mirror-image isomers. Tonix recently reported that the (S)-isomer (estianeptine) is responsible for its positive effects on neuroplasticity in cell culture, while the (R)-isomer is responsible for racemic tianeptine’s off-target activity on the µ-opioid receptor.2,3 Tonix also recently reported that estianeptine activates peroxisome proliferator-activated receptors PPAR-β/δ and PPAR-γ. These activities on molecular targets in neurons and glia in the brain are believed to relate to tianeptine’s ability to restore connectivity between neurons that atrophy in conditions of stress or depression in animal models.4 Tianeptine’s mechanism is distinct from traditional antidepressants that alter the level or activity of serotonin, norepinephrine, and dopamine neurotransmitters, which are believed to indirectly induce neurons to make new connections.5

“The memory- and cognition-enhancing effects of racemic tianeptine and estianeptine seen in the NOR test are consistent with human clinical studies in which racemic tianeptine treatment improved cognition and memory in patients with Alzheimer’s disease and depression6 and in patients with bipolar disorder,7” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We recently reported that estianeptine induces neuroplasticity in cell culture.2 The new findings indicate that estianeptine also improves memory and cognition in the in vivo rat NOR test. We believe that together these findings support the development of tianeptine and estianeptine in psychiatric and neurodegenerative diseases. Tianeptine’s ability to restore atrophied neuronal connections in animals2 suggests the potential to achieve durable outcomes.”

“The rat NOR test is an experimental tool to assess drug effects on memory and evaluate their potential as treatments for neurodegenerative conditions like Alzheimer’s disease,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Since the main initial clinical feature in Alzheimer’s disease is impairment in newly learned facts or memories, improving learning and memory are important properties of potential new therapeutics. The specific type of learning and recognition memory measured by the NOR is believed to be relevant to the neurocircuitry impaired in Alzheimer’s disease.”

Dr. Sullivan continued, “Our ongoing clinical studies in major depression on TNX-601 ER, which contains racemic tianeptine, are expected to inform and potentially accelerate the development of TNX-4300 which contains the single isomer, estianeptine. We believe that estianeptine bypasses the synapse and activates intracellular PPAR-β/δ and PPAR-γ targets. The finding that estianeptine is responsible for tianeptine’s ability to improve memory and cognition in the NOR test implicates PPAR-β/δ activation specifically as a molecular target. This finding is consistent with the impaired memory of mice lacking the PPAR-β/δ gene.”8

In depression, estianeptine is believed to act on PPAR-β/δ and PPAR-γ targets in the nucleus to enhance genetic transactivation involved in restoring hippocampal neuroplasticity and neurogenesis. These findings also have applicability to neurodegenerative diseases in which neuronal connections are atrophied.2 The reported PPAR mechanism has potential relevance to why tianeptine is not associated with sexual dysfunction, weight gain or several other treatment-limiting toxicities associated with the antidepressants currently marketed in the U.S. for long-term use. However, tianeptine has other potential side effects that are described in its labeling outside the U.S. where it is marketed as a prescription drug.

Tonix owns worldwide rights to the novel salt, racemic tianeptine hemioxalate and to the proprietary extended-release formulation employed in TNX-601 ER that allows once daily dosing. TNX-601 ER is currently being studied in the Phase 2 UPLIFT trial, which is targeting enrollment of approximately 300 patients at about 30 U.S. clinical sites. Tonix has also filed patents claiming single (S)-isomer estianeptine, the active ingredient in TNX-4300, which is devoid of activity on the µ-opioid receptor. TNX-4300 is currently in preclinical development for depression, bipolar disorder, Alzheimer’s disease, and Parkinson’s disease.

Key experiments were performed by scientists at Tonix’s Research and Development Center (RDC) in Frederick, Maryland.

*TNX-601 ER and TNX-4300 are investigational new drugs and are not approved for any indication. TNX-601 ER is being developed under an IND. TNX-4300 is at the pre-IND stage of development.

About Tianeptine

Racemic tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established tolerability profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release once-daily tianeptine product is approved in any jurisdiction. In animal models, tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.4 Tianeptine’s enhancement of neuroplasticity in animal models of stress is believed to be mediated by activation of PPAR isoforms PPAR-β/δ and PPAR-γ, which is mechanistically distinct from traditional monoaminergic antidepressants marketed in the U.S. and contributes to its potential for clinical indications beyond depression and stress disorders. Tianeptine and its MC5 metabolite are also weak µ-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities.3,9 In cases where tianeptine has been abused, the dose has been approximately 8-80 times the therapeutic dose in depression on a daily basis.9 In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated9 suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks11-15, 3-months,16 or 12-months17 of treatment. Estianeptine is believed to mimic naturally occurring polyunsaturated fatty acid ligands in low affinity interactions with PPAR-β/δ and PPAR-γ. Estianeptine’s activation of nuclear PPAR-β/δ and PPAR-γ receptors appears to be a more direct mechanism to achieve the goal of restoring neuronal connectivity than the active ingredients of current pharmacologic therapies for depression. Tianeptine’s proposed mechanism as a plastogen is consistent with its clinical effects in promoting cognition in depressed patients with Alzheimer’s disease5 and in patients with bipolar disorder.6 The PPAR-β/δ target is validated by prior work on agonists treating animal models of neurodegenerative and autoimmune diseases of the central nervous system.18 Alzheimer’s disease has been proposed to be a form of diabetes that affects the CNS, sometimes termed “type-III diabetes.”19 The PPAR superfamily plays key roles in metabolic processes, and activation of PPAR-β/δ in brain by tianeptine shows promise to prevent the cognitive dysfunction associated with CNS insulin resistance. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest other potential uses including as a treatment for posttraumatic stress disorder (PTSD), as well as for preventing neurocognitive dysfunction associated with corticosteroid use.

About the Novel Object Recognition Test (NOR)

NOR is one of several cognitive tests that engage working memory and is considered a model for testing therapeutics or co-factors for Alzheimer’s disease.20 The NOR task depends on the accurate comparison of novel information with recently stored memories. Among animal behavioral models for assessing cognitive functioning, the NOR test measures a specific form of recognition memory without assumptions about drug mechanism. The NOR is based on the spontaneous behavior of rodents without the need for external motivation, reward, or punishment. Impairments of NOR are seen in many animal models, including mice that overexpress the amyloid protein associated with Alzheimer’s disease.21 The NOR tests on tianeptine and estianeptine were performed by a third-party contract research organization. In the NOR test, rats were assessed for cognitive ability in a test apparatus comprising an open-field arena and were scored by an observer blind to treatments. The positive control for a drug effect was the acetylcholinesterase inhibitor medication galantamine, which is the active ingredient of Razadyne®, approved by the U.S. Food and Drug administration as a treatment for Alzheimer’s disease. On Days 1 and 2, rats were allowed to freely explore the empty arena for a 10-minute habituation period. On Day 3, rats were administered saline, galantamine or test article (racemic tianeptine or estianeptine) and following the pretreatment time of 60 min, rats were then placed into the test arena in the presence of two identical objects. The time spent actively exploring the objects during a 3-minute training (T1) session was recorded. Each rat was returned to its home cage following training. After 48 hours, the rats were administered saline, galantamine or test article again, and, after 60 min, they were placed into the test arena in the presence of two objects: one familiar and one novel. The times spent exploring each object were recorded for 5 minutes in the testing session (T2). The outcome measure known as the Recognition Index was employed in these studies, defined as the ratio of the time spent exploring the novel object over the total time spent exploring both objects. These results are being prepared for presentation at a scientific meeting and for publication.

References

  1. Clinical Trials.gov I.D. NCT05686408
  2. Sullivan, GM et al. June 1, 2023. Poster presentation at the American Society of Clinical Psychopharmacology, Miami, FL. https://www.tonixpharma.com/wp-content/uploads/2023/06/ASCP-Poster-2023-A-Randomized-Placebo-Controlled-Multicenter-Trial-of-Monotherapy-with-TNX-601-ER.pdf
  3. Samuels et al., Neuropsychopharmacology. 2017, 42(10):2052-2063
  4. McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249
  5. Duman RS, et al. Nat Med. 2016 22(3):238-49.
  6. García-Alberca JM, et al. J Alzheimer’s Dis 2022, 88 (2), 707-720.
  7. Kauer-Sant’Anna M, et al. J Psychopharmacol 2019, 33 (4), 502-510.
  8. Barroso et al., Biochim Biophys Acta. 2013. 1832:1241–1248
  9. Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53.
  10. Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.
  11. Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
  12. Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
  13. Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
  14. Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
  15. Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
  16. Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
  17. Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, 15, 61–65.
  18. Kahremany S et al. Br J Pharmacol 2015, 172(3):754-70
  19. Nguyen et al., Int J Mol Sci. 2010, 21(9):3165
  20. Bengoetxea X, et al. Front Biosci (Schol Ed). 2015, 7(1):10-29.
  21. Romberg C, et al., Brain. 2012, 135(Pt 7):2103-14.

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 markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. 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 CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the first quarter of 2024. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with topline results expected in the first quarter of 2024. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth 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 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 is expected to be 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, 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.

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 the 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

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.

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.

Source: Tonix Pharmaceuticals Holding Corp.

Released July 24, 2023

Release – Travelzoo Q2 2023 Earnings Conference Call on July 27 at 11:00 AM ET

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TZOO

07/21/2023

NEW YORK, July 21, 2023 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):

WHAT:Travelzoo, a global Internet media company that provides exclusive offers and experiences for members, will host a conference call to discuss the Company’s financial results for the second quarter ended June 30, 2023. Travelzoo will issue a press release reporting its results before the market opens on July 27, 2023.
WHEN:July 27, 2023 at 11:00 AM ET
HOW:A live webcast of Travelzoo’s Q2 2023 earnings conference call can be accessed athttp://ir.travelzoo.com/events-presentations. The webcast will be archived within 2 hours of the end of the call and will be available through the same link.
CONTACT:Travelzoo Investor Relations
ir@travelzoo.com

About Travelzoo

Travelzoo® provides its 30 million members with exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give Travelzoo members access to irresistible deals.

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SOURCE Travelzoo

Release – GeoVax Announces Initiation of Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia

Posted on by aweinsoff@channelchek.com

Research news and Market Data on GOVX

 

  • Last updated: 20 July 2023 13:05
  • Created: 20 July 2023 17:39
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Seeking Improved Immune Response vs mRNA Vaccine

ATLANTA, GA, July 20, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the start of an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355), titled “Randomized observer-blinded phase 2 trial of COVID-19 booster with GEO-CM04S1 or Pfizer-BioNTech Bivalent vaccine in patients with chronic lymphocytic leukemia,” at City of Hope National Medical Center, led by Alexey Danilov, M.D., PhD as principal investigator. GEO-CM04S1, a multi-antigenic SARS-CoV-2 vaccine that targets the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2, is actively under clinical study by GeoVax in severely immunocompromised individuals, as well as in healthy adults for use as a universal heterologous booster.

Despite a high vaccination rate, chronic lymphocytic leukemia (CLL) patients may be at high risk for lethal COVID-19 infection due to poor immune response to COVID-19 infections or vaccination. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. Targeting both the spike and nucleocapsid protein antigens broaden the specificity of the immune responses and protects against the loss of efficacy associated with the significant sequence variation observed with the spike antigen.

The study will examine the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be 56 days following the first booster injection. Up to 40 participants will be treated in each arm, with immune responses evaluated at the interim and final analyses in each arm.

Brian Koffman, M.D.C.M., FCFP DABFP (retired) MS Ed, Executive Vice President and Chief Medical Officer of the CLL Society, a nonprofit dedicated to the unmet needs of those diagnosed with CLL/small lymphocytic lymphoma (SLL), commented, “Despite the current authorized COVID-19 vaccines providing protective immunity among the majority of patient populations, individuals with CLL/SLL, regardless of their treatment status, have had less predictable and often insufficient immune responses to the currently authorized vaccines. Within the CLL/SLL patient population, more robust and durable protective immunity is needed, especially next-generation vaccines that could induce stronger T cell and antibody responses. This trial leverages past success with a similar type of vaccine used for protection against a different viral infection in the immunocompromised to develop a vaccine intended to provide enhanced and more durable protection against COVID-19 infections in the high-risk CLL/SLL population. The CLL Society and the CLL/SLL community welcome this study and look forward to the results.”

Kelly McKee, M.D., GeoVax Chief Medical Officer, commented, “Unpublished clinical data recently presented at several medical conferences confirmed our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants, and by extension, to immunocompromised patients. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines. We expect the CLL trial will further confirm the potential benefit of CM04S1 in another population of immunocompromised individuals.”

David Dodd, GeoVax President, and CEO, added, “We are excited to begin this third important study for CM04S1 and look forward to sharing progress reports as we advance. We believe the CM04S1 vaccine, containing the two antigens, S and N, along with the recognized antibody and cellular immune responses resulting from the MVA approach, has the potential to offer greater booster protection than that from the current vaccines in use, as well as provide a greater degree of protection within immunocompromised patients.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment) indicates that CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. CM04S1 also continues to advance in another Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently, in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

Media Contact:

Susan Roberts

sr@roberts-communications.com

202-779-0929

Release – Kelly Announces Strategic Restructuring Actions to Accelerate Profitable Growth

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KELYA

July 20, 2023

  • Strategic restructuring follows comprehensive review of company’s growth and efficiency objectives as part of ongoing transformation
  • Aggressive action builds on strategic progress to monetize non-core assets, reinvest capital in organic and inorganic growth initiatives, and shift to higher-margin, higher-growth business mix
  • Actions expected to result in meaningful, sustainable EBITDA margin expansion beginning immediately, and substantial improvement in the second half of 2023 and beyond

TROY, Mich., July 20, 2023 /PRNewswire/ — Kelly (Nasdaq: KELYA, KELYB), a leading global specialty talent solutions provider, today announced strategic restructuring actions that will further optimize the company’s operating model to enhance organizational efficiency and effectiveness. These actions are part of the comprehensive transformation initiative the company announced in May to drive EBITDA margin improvement and accelerate long-term profitable growth.

The strategic restructuring actions realign business-critical resources to Kelly’s business units, streamline corporate resources, reduce redundant organizational layers, and optimize work processes. These structural changes simplify the company’s operations and unlock additional resources to invest in growth. As a result of these actions, the company has implemented a workforce reduction plan and notified affected employees in accordance with applicable employment laws and regulations. Employees whose roles were included in the workforce reduction are eligible for applicable severance, benefits, and outplacement services.

“Today marks a difficult but necessary step forward on Kelly’s journey to accelerate profitable growth,” said Peter Quigley, president and chief executive officer. “These actions follow an exhaustive review of the company’s business and functional operations to determine how we can work more efficiently to improve profitability over the long term. I am confident the structural improvements we have made to Kelly’s operating model position the company to pursue new avenues of growth that will enable it to deliver greater value for customers, talent, and shareholders.”

As a result of the strategic restructuring actions, Kelly expects to see meaningful expansion of its EBITDA margin beginning immediately with substantial improvement in the second half of 2023 and beyond. The company expects to incur a restructuring charge from these actions in the range of $7.5-$8.5 million in the third quarter of 2023. Mr. Quigley and Olivier Thirot, executive vice president and chief financial officer, will provide additional details about the strategic restructuring as it relates to the company’s ongoing transformation, including expectations for EBITDA margin improvement, during its upcoming second-quarter earnings conference call on August 10, 2023.

About Kelly®

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 450,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2022 was $5.0 billion. Learn more at kellyservices.com.

Forward-Looking Statements

This release contains statements that are forward looking in nature and, accordingly, are subject to risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about Kelly’s financial expectations, are forward-looking statements. Factors that could cause actual results to differ materially from those contained in this release include, but are not limited to, (i) changing market and economic conditions, (ii) disruption in the labor market and weakened demand for human capital resulting from technological advances, loss of large corporate customers and government contractor requirements, (iii) the impact of laws and regulations (including federal, state and international tax laws), (iv) unexpected changes in claim trends on workers’ compensation, unemployment, disability and medical benefit plans, (v) litigation and other legal liabilities (including tax liabilities) in excess of our estimates, (vi) our ability to achieve our business’s anticipated growth strategies, (vi) our future business development, results of operations and financial condition, (vii) damage to our brands, (viii) dependency on third parties for the execution of critical functions, (ix) conducting business in foreign countries, including foreign currency fluctuations, (x) availability of temporary workers with appropriate skills required by customers, (xi) cyberattacks or other breaches of network or information technology security, and (xii) other risks, uncertainties and factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release and we undertake no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.

KLYA-FIN

MEDIA CONTACT:ANALYST CONTACT:
Jane StehneyJames Polehna
(248) 765-6864(248) 244-4586
stehnja@kellyservices.comjames.polehna@kellyservices.com

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SOURCE Kelly Services, Inc.

Release – Travelzoo is the Top Choice for Travel Enthusiasts in Germany

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TZOO

07/20/2023

BERLIN, July 20, 2023 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO), a global Internet media company that provides exclusive offers and experiences for members, has won the top spot in the category of “Best Travel Deals Provider” in a nationwide consumer survey in Germany. The win has particular significance given Germany is the third-largest travel market in the world.

The survey was conducted by renowned research institute ServiceValue GmbH in partnership with Die Welt, one of the country’s most influential national newspapers.

Casting over 900,000 votes, consumers ranked 2,513 companies across 187 categories, making this one of the most comprehensive consumer-voted surveys in Germany. When asked which brand exhibits the highest quality for travel deals, consumers cast the largest number of votes for Travelzoo, naming it “Product Champion”.  

Winners in other categories included companies such as Mercedes-Benz, Lufthansa, Rolex, and Amazon.

Travelzoo was also recognized for “high customer value” in a second national survey this month, commissioned by popular broadsheet BILD Zeitung. Consumers cast over 500,000 votes, evaluating 2,198 companies in 138 categories.

Find out why Travelzoo is the choice of judges, industry experts, and more than 30 million members around the world. Become a Travelzoo member today: https://travelzoo.com/signup.

About Travelzoo

Travelzoo® provides its 30 million members with exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give Travelzoo members access to irresistible deals.

Travelzoo is a registered trademark of Travelzoo. All other names are trademarks and/or registered trademarks of their respective owners.

Media Contacts:    

Regina Schneider – Berlin
+49 160 7498 691
rschneider@travelzoo.com

Cat Jordan – London
+44 77 7678 1525
cjordan@travelzoo.com

Paige Cram – Los Angeles
+1 609 668 0645
pcram@travelzoo.com

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Release – Largo Reports Improvements to Production in Q2 2023 and Begins Commissioning of its Ilmenite Concentration Plant; Francesco D’Alessio Appointed as President of Largo Clean Energy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LGO

July 19, 2023

Q2 2023 and Other Highlights

  • V2O5 production of 2,639 tonnes (5.8 million lbs1) in Q2 2023 vs. 3,084 tonnes produced in Q2 2022 and 25% above production in Q1 2023
  • V2O5 production of 676 tonnes in April, 945 tonnes in May and 1,018 tonnes in June
  • The Company achieved normalized production levels in June after completing the following actions in Q2 2023: the completion of its infill drilling campaign for 2023 resulting in a further refinement of the Company’s short-term mining model, the completion of upgrades to its crushing process as well as an improvement in its mining performance over levels seen in Q1 2023
  • The Company completed all planned upgrades to its crushing process in Q2 2023, including the installation of a new dry magnetic separator and updates to its crushing circuit, which is expected to reduce operational maintenance costs and provide more flexibility in the blending of different ores to stabilize V2O5 production going forward
  • Global V2O5 recovery rate3 of 81.0% in Q2 2023 vs. 81.8% in Q2 2022
  • The Company completed construction of its ilmenite concentration plant in June and subsequently began commissioning of the facility shortly thereafter; The Company expects to complete the commissioning phase in Q3 2023 and start a gradual ramp-up of ilmenite production in Q4 2023
  • V2O5 equivalent sales of 2,557 tonnes in Q2 2023 vs. 3,291 tonnes sold in Q2 2022 due to lower available inventory
  • During Q2 2023, the average benchmark price per lb of V2O5 in Europe was $8.46, a 24% decrease from the average of $11.08 seen in Q2 2022 following softer spot market demand during the quarter, primarily due to adverse conditions in the Chinese and European steel sectors
  • Francesco D’Alessio was appointed as President of Largo Clean Energy (“LCE”)
  • Cold commissioning of LCE’s Enel Green Power España (“EGPE”) vanadium redox flow battery (“VRFB”) was completed in Q2 2023; Hot commissioning and provisional acceptance by EGPE is expected in Q3 2023
  • 2023 production, sales, cost and capital expenditures guidance remain unchanged

TORONTO–(BUSINESS WIRE)– Largo Inc. (“Largo” or the “Company“) (TSX: LGO) (NASDAQ: LGO) today announces quarterly production of 2,639 tonnes (5.8 million lbs1) and sales of 2,557 tonnes of vanadium pentoxide (“V2O5”) equivalent, respectively, in Q2 2023.

Daniel Tellechea, Interim CEO and Director of Largo, stated: “We are pleased to report that key operational actions taken in Q2 2023 have resulted in improved production rates exiting the quarter, particularly in June with over 1,000 tonnes of V2O5 produced. He continued: “In Q2 2023, construction of the Company’s ilmenite concentration plant was completed, followed by the start of commissioning, marking a significant milestone for the Company. As we look forward to completing commissioning and ramp-up processes in the following quarters, we anticipate having sufficient stocks of produced ilmenite concentrate for sale by the start of 2024.”

Francesco D‘Alessio, President of LCE commented: “With this new role, I am fully committed to leading LCE with the immediate objective of evaluating all strategic options for this business in order to fully maximize its unique value proposition in the energy storage sector. This includes but is not limited to the potential strengthening and formalization of existing industry relationships, developing additional collaborative partnerships, evaluating alternative deployment strategies, and performing a comprehensive review of cost reduction measures. Going forward, I anticipate providing updates as this process continues to evolve.”

Maracás Menchen Mine Operational and Sales Results

Q2 2023Q1 2023Q2 2022
    
Total Ore Mined (tonnes)489,892341,967378,273
Ore Grade Mined – Effective Grade (%) 20.860.811.18
Total Mined – Dry Basis (tonnes)3,671,8423,523,6562,503,696
    
Concentrate Produced (tonnes)99,08378,695124,317
Grade of Concentrate (%)3.342.993.28
Global Recovery (%) 381.083.081.8
    
V2O5 produced (Flake + Powder) (tonnes)2,6392,1113,084
High purity V2O5 equivalent produced (%)35.847.818.7
V2O5 produced (equivalent pounds) 15,817,9924,653,9536,799,048
Total V2O5 equivalent sold (tonnes)2,5572,8493,291
Produced V2O5 equivalent sold (tonnes)2,2682,6042,783
Purchased V2O5 equivalent sold (tonnes)289245508
      

Q2 2023 Additional Highlights

  • Normalized Production Levels in June: V2O5 production from the Maracás Menchen Mine was 676 tonnes in April, 945 tonnes in May and 1,018 tonnes in June for a total of 2,639 tonnes produced in Q2 2023. In addition to certain mining performance and crushing process improvements made during the quarter, the Company also completed its 2023 infill drilling campaign in Q2 2023, resulting in a further refinement of the Company’s short-term mining model. In Q2 2023, global recoveries3 averaged 81.0%, largely in line with 81.8% averaged in Q2 2022. The Company mined 489,892 tonnes of ore with an effective V2O5 grade2 of 0.86% in Q2 2023 compared to 378,273 tonnes with an effective V2O5 grade2 of 1.18% in Q2 2022 and 341,967 tonnes with an effective V2O5 grade2 of 0.81% in Q1 2023, demonstrating a significant improvement in total ore mined over the prior quarter and prior comparative quarter. The increase in total ore mined as well as increased crushed and milled ore is a direct result of the Company’s strategy to successfully recover delays caused by the previously announced mine contractor transition in September 2022 and heavy rains experienced in December 2022.

  • Mine Site Cost Reduction Measures: The Company continues to focus on identifying and implementing various cost reduction measures at its Maracás Menchen Mine during the current period of sustained inflationary pressures. In addition to upgrading its crushing process to reduce operational maintenance costs, the Company has identified several other areas for cost reduction and is in the process of implementing the following initiatives: a reduction in sodium carbonate and other raw materials expenditures, a reduction of mining costs, with a primary focus on reducing rehandling activities and implementing an optimization of haulage distance and a reduction of equipment rental expenditures. The Company expects to begin realizing the benefits of these cost reduction measures in Q3 2023.

  • 2023 and 2024 Infill Drilling Campaigns: The Company has completed its 2023 infill drilling campaign and has completed approximately 90% of its 2024 infill drilling campaign. Data generated from infill drilling is expected to create greater accuracy and reliability of the short-and mid-term mining plan for the Maracás Menchen Mine. Going forward, the Company plans to conduct infill drilling on a bi-annual basis to create greater certainty and efficiency in its planning process. Largo expects that a consistent infill drilling campaign should assist the Company in improving the reliability and accuracy of its production guidance on a go forward basis.

  • Q2 2023 Sales In Line with Quarterly Target – Focus on High Purity Vanadium Demand: In Q2 2023, V2O5 equivalent sales of 2,557 tonnes (which includes 289 tonnes of purchase material sold) were in line with expectations for the quarter but represented a 22% decrease in tonnes sold over Q2 2022. In Q2 2023, the Company continued to experience strong aerospace demand for its products and focused on selling its high purity vanadium units to this market. The Company produced approximately 36% of its quarterly production as high purity in Q2 2023.

  • Cold Commissioning of Enel Green Power España VRFB Completed: During Q2 2023, LCE finalized the pumping of electrolyte for EGPE’s VCHARGE VRFB deployment and completed cold commissioning of the system in June. The battery system was also successfully interconnected with the grid and the system inverter was successfully utilized to form the chemistry in Q2 2023. The battery is currently performing charge-discharge cycles as part of the ongoing hot commissioning phase, which is anticipated to be completed in Q3 2023, along with provisional acceptance of the system by EGPE.

  • Appointment of Francesco D’Alessio as President of LCE: Mr. D’Alessio has over 15 years of experience in metals sales and trading, including overseeing sales and shipment of vanadium, as well as more recent experience in clean energy storage sales. Over the last three years, he has been actively involved in the overall sales strategy at Largo, contributing to the Company’s ongoing initiatives in the energy storage sector. Mr. D’Alessio began his tenure at Largo in 2019 as Head of Sales, Americas, and was subsequently promoted to the position of Commercial Director in 2022.

About Largo

Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURETM and VPURE+TM products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company is in the process of implementing a ilmenite concentrate plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business to support a low carbon future.

Largo’s common shares trade on the Nasdaq Stock Market and on the Toronto Stock Exchange under the symbol “LGO”. For more information on the Company, please visit www.largoinc.com.

Cautionary Statement Regarding Forward-looking Information:

This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. Forward‐looking information in this press release includes, but is not limited to, statements with respect to the timing and amount of estimated future production and sales; the future price of commodities, ; costs of future activities and operations, including, without limitation, the effect of inflation and exchange rates; the timing and success of the commissioning and ramp up of the ilmenite plant,; the ability to sell ilmenite on a profitable basis, the successful vertical integration of the Company; the effect of unforeseen equipment maintenance or repairs on production; the ability to sufficiently reduce the cost of production through cost reduction measures;; the extent to which infill drilling data will create greater accuracy and reliability in the short-term mining plan and production guidance, the extent of capital and operating expenditures; the impact of globalprice increases on the Company’s global supply chain and future sales of vanadium products. Forward‐looking information in this press release also includes, but is not limited to, statements with respect to our ability to build, finance and operate a VRFB business, our ability to protect and develop our technology, our ability to maintain our IP, the competitiveness of our product in an evolving market, our ability to market, sell and deliver our VCHARGE batteries on specification and at a competitive price, our ability to secure the required production resources to build and deploy our VCHARGE batteries, our ability to attract partners, collaborators and/or investors to build the VRFB business on terms attractive to the Company, and the adoption of VRFB technology generally in the market. Forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “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” or “will be taken”, “occur” or “be achieved”. All information contained in this news release, other than statements of current and historical fact, is forward looking information. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Largo or Largo Clean Energy to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks described in the annual information form of Largo and in its public documents filed on www.sedar.com and available on www.sec.gov from time to time. Forward-looking statements are based on the opinions and estimates of management as of the date such statements are made. Although management of Largo has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. 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. Largo does not undertake to update any forward-looking statements, except in accordance with applicable securities laws. Readers should also review the risks and uncertainties sections of Largo’s annual and interim MD&As which also apply.

Trademarks are owned by Largo Inc.

1 Conversion of tonnes to pounds, 1 tonne = 2,204.62 pounds or lbs.
2 Effective grade represents the percentage of magnetic material mined multiplied by the percentage of V2O5 in the magnetic concentrate.
3 Global recovery is the product of crushing recovery, milling recovery, kiln recovery, leaching recovery and chemical plant recovery.

For further information:
Investor Relations
Alex Guthrie
Senior Manager, External Relations
+1.416.861.9778
aguthrie@largoinc.com

Source: Largo Inc.

Release – CoreCivic Announces 2023 Second Quarter Earnings Release and Conference Call Dates

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CXW

July 19, 2023

BRENTWOOD, Tenn., July 19, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today that it will release its 2023 second quarter financial results after the market closes on Monday, August 7, 2023. A live broadcast of CoreCivic’s conference call will begin at 10:00 a.m. central time (11:00 a.m. eastern time) on Tuesday, August 8, 2023.

To participate via telephone and join the call live, please register in advance here https://register.vevent.com/register/BI245ce05fd4c64a6ead7845124358177d. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode.

Participants may access the audio-only webcast of the conference call from the Company’s website at www.corecivic.com under the “Events & Presentations” section of the “Investors” page. A replay of the webcast will be available for seven days.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Contact:Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024
Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – Salem Media Announces Management Changes

Posted on by aweinsoff@channelchek.com

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July 19, 2023 5:00am EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today some changes to the management structure of the company in a limited number of markets. These changes provide some cost savings and will allow Salem’s most seasoned leaders to expand their impact on the performance of the company.

  • Terry Fahy, Regional VP/GM for Los Angeles, will now also oversee Oxnard.
  • Steve Brodsky, GM for San Diego, will also manage Honolulu.
  • Dennis Hayes, GM for Portland, will now oversee Seattle as well.
  • Kevin Isaacs, GM for Cleveland, will now also manage Pittsburgh.
  • Mark Durkin, Regional VP/GM for Sacramento, will also manage Phoenix.

Earlier this year, Salem made similar changes with:

  • Carolyn Cassidy managing both Tampa and Columbus.
  • John Gallagher managing both Chicago and Little Rock.

In some cases, the former GM will stay on in a sales/sales management role.

Salem CEO, David Santrella, said “These changes were made to allow Salem to continue to innovate and invest in our business and to allow the very best leaders to oversee our radio stations.”

Some other changes were made as well. Salem is combining the sales efforts of Salem Media Reps and the Salem Web Network with the combined sales team reporting to Mike Reed and Mike DeAmicis at Salem Media Reps.

David Evans, Salem COO said, “This unified sales team will now have easier access to all digital assets within our company to more fully grow into a ‘One-World’ company that offers ministries, advertisers, and our audiences’ multiple platforms with which to consume content and reach communities.”

ABOUT SALEM MEDIA GROUP:

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230714305565/en/

Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group

Released July 19, 2023

Release – Snail, Inc. Announces Updates for Expedition Agartha and DEDsafío Event Success Featuring ARK: Survival Evolved

Posted on by aweinsoff@channelchek.com

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July 19, 2023 at 7:52 AM EDT

CULVER CITY, Calif., July 19, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail”), a leading, global independent developer and publisher of interactive digital entertainment, today announced the upcoming major updates for the first-person looter survival game, Expedition Agartha, and the highlight of the recent DEDsafío event featuring ARK: Survival Evolved.

Snail’s indie gaming subsidiary, Wandering Wizard, in collaboration with Matrioshka Games, has scheduled the release of the Skill Tree update and Server Wipe for Expedition Agartha on August 1. Until this date, the game’s PTR server will remain active, encouraging players to provide additional feedback or suggestions.

Furthermore, the DEDsafío event, held on July 12, drew participation from 75 streamers, expanding the reach of Snail’s well-received game, ARK: Survival Evolved. During the DEDsafío event, ARK: Survival Evolved achieved a prominent viewership status worldwide on YouTube Gaming Live, garnering around 61,000 viewers at its peak. ARK: Survival Evolved also ranked in the top 10 games on Twitch in Latin America and received noteworthy visibility on KICK’s live channels, a new streaming platform. Westcol, a streamer who participated in the DEDsafío event, attracted over 18,000 viewers while live streaming his gameplay of ARK: Survival Evolved on KICK. These developments highlight Snail’s commitment to providing engaging and quality content for the global gaming community and its promotion across diverse platforms.

“Snail continues to prioritize the enhancement of our gaming portfolio and active engagement with our player community,” said Jim Tsai, Chief Executive Officer of Snail. “The forthcoming Expedition Agartha updates and the well-attended DEDsafío event are indicative of our dedication to enhance the visibility and success of our games. We anticipate a continuation of strong player engagement and growth in our diverse game portfolio in the future.”

About Snail, Inc.

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.

Contacts:

Investors:

investors@snail.com

Release – Salem Media Announces the Passing of its Co-founder Stuart Epperson Sr.

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SALM

July 17, 2023 4:56pm EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) with a heavy heart, announced today the passing of co-founder, Stuart Epperson. He was 86. Stuart, along with his brother-in-law, Edward Atsinger, founded Salem Communications (now Salem Media Group) in 1986 and expanded Salem’s influence with Christian and politically conservative News Talk formatted radio stations and media assets nationwide. Mr. Epperson was a longtime leader in Christian radio as a former member of the board of directors of the National Religious Broadcasters Association. In 2005, Time Magazine named him one of the 25 most influential evangelicals in America. Stuart was involved in several other conservative organizations dedicated to preserving Judeo Christian values in our culture through public policy. He was a member and the past president of the conservative Council for National Policy (“CNP”). In 1984 and 1986, Epperson was the Republican nominee for the fifth Congressional district of North Carolina.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230717970556/en/

Stuart Epperson Sr. (Photo: Business Wire)

Epperson attended Bob Jones University in Greenville, South Carolina, where he received a bachelor’s degree in radio/television broadcasting and a master’s degree in communications. Epperson is survived by his wife, Nancy, his four children, daughters Kristy, Karen, and Kathy, and son Stuart Jr. and by 21 grandchildren, 1 great grandchild and 2 more on the way, as well as a sister, Mary Lee King.

Salem Media Group Executive Chairman Ed Atsinger commented: “Stuart will be greatly missed by many. I will miss him, but I take comfort in realizing that he is already receiving his reward for a life well-lived. A life that personifies the words of the Apostle Paul in 2 Timothy 4:7-8: ‘I have fought the good fight. I have finished the race. Now there Is in store for me the crown of righteousness, which the Lord, the righteous Judge, will award to me on that day and not only to me, but also to all who have longed for his appearing.’”

ABOUT SALEM MEDIA GROUP:

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230717970556/en/

Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.

Released July 17, 2023

Release – ZyVersa Therapeutics Announces Publication in the Journal, Hepatology, Highlighting the Role of NLRP3 Inflammasome-Mediated IL-18 in Development of Liver Fibrosis

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 17, 2023

  • Liver fibrosis is a progressive form of chronic liver injury mediated by persistent NLRP3 inflammasome activation in liver cells called hepatic stellate cells (“HSCs”), which leads to the development of cirrhosis and liver cancer
  • Inflammasome NLRP3 activation leads to production of the proinflammatory cytokines, IL-1β and IL-18, and IL-18 activates HSCs resulting in liver fibrosis
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation through ongoing production of IL-1β and IL-18

WESTON, Fla., July 17, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Hepatology, demonstrating the role of NLRP3 inflammasome-mediated IL-18 in the development of liver fibrosis.

In the paper titled, “Interleukin‐18 signaling promotes activation of hepatic stellate cells in mouse liver fibrosis,” the authors evaluated serum levels of IL-18 in patients diagnosed with liver fibrosis/cirrhosis, and they conducted studies in three different mouse models of liver fibrosis. Following are key findings reported in the paper:

  • Levels of circulating IL‐18 and IL‐18 binding protein were elevated in patients with liver fibrosis/cirrhosis in comparison to healthy controls
  • Data in liver fibrosis mouse models provided strong evidence that IL-18 signaling and its downstream effects have a pivotal role in the development of liver fibrosis (fibrogenesis)
  • The pivotal role of IL-18 signaling in liver fibrosis was confirmed in IL-18 deficient mice, which showed protection from fibrotic liver changes

The authors stated, “Our results highlight the pivotal role of IL-18 signaling in liver fibrogenesis through the activation of HSCs in vitro and in vivo in three different mouse models.” To read the article, Click Here.

“The research published in the Hepatology demonstrated that NLRP3 inflammasome-mediated activation of IL-18 has a pivotal role in liver fibrosis, providing support for inflammasome inhibition as a promising treatment. Unlike NLRP3 inhibitors, which only inhibit formation of the NLRP3 inflammasome to block initiation of the inflammatory cascade, Inflammasome ASC inhibitor IC 100 inhibits formation of multiple types of inflammasomes, and it uniquely inhibits ASC specks to block perpetuation of damaging inflammation,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641       

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – Century Lithium Appoints New Director

Posted on by aweinsoff@channelchek.com

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July 17, 2023 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to announce the appointment of Dr. Corby G. Anderson to its Board of Directors, effective July 14, 2023.

Dr. Anderson is a Licensed Professional Chemical Engineer with over 40 years of global experience in engineering, design, industrial plant operations, corporate level management, education, research, and professional service. He holds degrees of BSc in Chemical Engineering from Montana State University, an MSc in Metallurgical Engineering from Montana Tech, and a PhD in Mining Engineering and Metallurgy from the University of Idaho. He most recently assisted Century Lithium as its Technical Advisor, Metallurgy.

“We are pleased to welcome Dr. Anderson to the Company’s Board of Directors” said Bryan Disher, Chair of Century Lithium. “As Technical Advisor, Dr. Anderson has been instrumental in the advancement of our Clayton Valley Lithium Project, and we look forward to his continued contribution to the Company in his new role on the Board of Directors”.

About Century Lithium Corp.

Century Lithium Corp. (formerly Cypress Development Corp.) is an advanced stage lithium company, focused on developing its 100%-owned Clayton Valley Lithium Project in west-central Nevada, USA. Century Lithium is currently in the pilot stage of testing on material from its lithium-bearing claystone deposit at its Lithium Extraction Facility in Amargosa Valley, Nevada and progressing towards completing a Feasibility Study and permitting, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

ON BEHALF OF CENTURY LITHIUM CORP.
WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com 
centurylithium.com  

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release includes certain statements that may be deemed to be “forward-looking statements”. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” “scheduled,” and other similar words. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration, and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.