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Release – Tonix Pharmaceuticals Announces Topline Results from Phase 2 PREVAIL Proof-of-Concept Study of TNX-102 SL for the Management of Fibromyalgia-Type Long COVID

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

September 05, 2023 7:00am EDTDownload as PDF

TNX-102 SL showed a robust effect size of 0.5 in improving fatigue and showed consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change, but did not meet the primary endpoint of multi-site pain reduction at week 14

Findings fulfill the objectives of this proof-of-concept study, supporting the decision to advance the program based on a proposed primary endpoint using the PROMIS Fatigue scale

Tonix plans to meet with FDA to discuss a path to registration; fatigue is the signature symptom of Long COVID and the principal symptom overlapping with CFS/ME and fibromyalgia syndromes

CHATHAM, N.J., Sept. 05, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced topline results from the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL 5.6 mg for the management of fibromyalgia-type Long COVID. TNX-102 SL treatment showed a robust effect size (ES) in improving fatigue and showed consistent activity trending to improvements across the secondary endpoints of sleep quality, cognitive function, disability and patient global impression of change (PGIC). TNX-102 SL trended towards improvement but did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at Week 14. The proposed mechanism of TNX-102 SL is improving sleep quality, which NIH recently announced is a target of future RECOVER clinical trials in Long COVID, a National Institute of Health (NIH) research program designed to understand, treat, and prevent long COVID.1,2 There is currently no approved drug for the treatment of Long COVID.

PREVAIL was a randomized, double-blind, placebo-controlled, multi-site proof-of-concept study of 63 patients with laboratory-documented COVID-19 illness preceding Long COVID. PREVAIL was designed and conducted to guide the design of registrational studies of TNX-102 SL in fibromyalgia-type Long COVID. TNX-102 SL was generally well tolerated with an adverse event (AE) profile comparable to prior studies with TNX-102 SL. AE-related discontinuations were similar in drug and placebo arms. No new safety signals were observed.

“The robust activity of TNX-102 SL on the PROMIS Fatigue scale3-5 (ES=0.5, Figure 4) is important because patients and experts view fatigue as the signature symptom of Long COVID and it has been identified as the dominant symptom contributing to disability,”6 said Dr. Seth Lederman, President and CEO of Tonix Pharmaceuticals. “In addition, TNX-102 SL showed consistent trends toward improvement in sleep quality, cognitive function, disability and the PGIC responder rate for TNX-102 SL compared to placebo (Figure 5) at week 14 (34.4% vs. 16.1%, difference=18.2%). Together, these findings fulfill the objectives of this proof-of-concept study in supporting the decision to advance the program based on a proposed primary endpoint using the PROMIS Fatigue scale.”

The Company intends to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale. The meeting is expected to take place in the first quarter of 2024. Fatigue is the symptom of Long COVID that principally overlaps with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and fibromyalgia. In the NIH funded RECOVER study analysis, fatigue was the top featured symptom and is common in each of the four clusters.7

“The data from PREVAIL reinforce our belief in TNX-102 SL as a potential bedtime medicine for the management of fibromyalgia-type Long COVID,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “We believe the PREVAIL trial results will help guide the next phase of development for TNX-102 SL, supporting the design of a potential registrational trial for fibromyalgia-type Long COVID based on PROMIS fatigue as a primary endpoint, pending review and feedback from the FDA. In both of our prior Phase 3 studies of TNX-102 SL 5.6 mg in fibromyalgia, we observed numerical improvement in the PROMIS fatigue score (in RELIEF p=0.007 MMRM8 and in RALLY p=0.007 MMRM9).”

Dr. Sullivan continued, “Although the validity of PROMIS Fatigue is not yet established in Long COVID, we believe the results of PREVAIL, together with extensive data from studies in other chronic conditions3-5 – including Tonix’s studies in fibromyalgia – make PROMIS Fatigue a solid candidate for the primary endpoint of future Long COVID registrational studies. We look forward to an anticipated End-of-Phase 2 meeting with the FDA to discuss these data and expect to present full data from PREVAIL in a peer-reviewed format and at upcoming medical conferences. Together, we believe these findings support the recognition of fibromyalgia-type Long COVID as a clinically meaningful subgroup of Long COVID patients and underscore the potential of TNX-102 SL as a once daily, oral therapy for this debilitating condition. We are grateful to the patients and their families and supporters, who participated in this study.”

Key Phase 2 PREVAIL Study Results

In the study, 63 subjects were enrolled and randomized 1:1 across approximately 30 U.S. sites to receive either TNX-102 SL or placebo daily at bedtime for 14 weeks. Subjects started with TNX-102 SL 2.8 mg tablet or one placebo tablet for the first 2 weeks and then increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks of the treatment period. The percentage of subjects completing the study was 81.3% in the TNX-102 SL group and 80.6% in the placebo group. Demographics and baseline characteristics are shown in Table 1.

Table 1: Demographics and Baseline Characteristics  
    
VariablePlaceboTNX-102 SLTotal
 N=31N=32N=63
 Age, mean years (SD)51.4 (10.01)48.6 (8.80)50.0 (9.45)
 Female, number (%)25 (80.6%)21 (65.6%)46 (73.0%)
 Male, number (%)6 (19.4%)11 (34.4%)17 (27.0%)
 Ethnicity   
Hispanic or Latino3 (9.7%)2 (6.3%)5 (7.9%)
Not Hispanic or Latino28 (80.6%)30 (93.8%)58 (92.1%)
 Race   
American Indian or AN, number (%)1 (3.2%)0 (0.0%)1 (1.6%)
Asian, number (%)0 (0.0%)1 (3.1%)1 (1.6%)
Black or African American, number (%)5 (16.1%)7 (21.9%)12 (19.0%)
Native Hawaiian or PI, number (%)0 (0.0%)0 (0.0%)0 (0.0%)
White or Caucasian, number (%)24 (77.4%)21 (65.6%)45 (71.4%)
Multiple Races, number (%)1 (3.2%)3 (9.4%)4 (6.3%)
BMI, mean kg/m2 (SD)29.5 (4.44)29.8 (4.07)29.6 (4.22)
 Employed, number (%)26 (83.9%)25 (78.1%)51 (81.0%)
    
Abbreviations: AN, Alaskan Native; BMI, body mass index; PI, Pacific Islander; SD, standard deviation

Primary endpoint

  • Given the lack of Long COVID treatments and the size of the current proof-of-concept study, an ES ≥ 0.2 was the pre-specified threshold for declaring the primary endpoint positive. The study trended towards a benefit but did not achieve statistical significance on the primary efficacy endpoint of change from baseline in the diary numerical rating scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores for TNX-102 SL at the Week 14 endpoint versus placebo (effect size (ES) = 0.08, Figure 1.)

Secondary endpoints

  • The change from baseline to the Week 14 endpoint for the daily sleep quality diary, PROMIS Sleep Disturbance, PROMIS Fatigue, PROMIS Cognitive function, the Insomnia Severity Index (ISI) and Sheehan Disability Scale showed numerical improvements (MMRM, ES ≥ 0.2): sleep diary (MMRM, ES =0.23, Figure 2.), PROMIS sleep Disturbance (MMRM, ES=0.32, Figure 3.), PROMIS fatigue (MMRM, ES=0.50, Figure 4.), PROMIS Cognitive Function – Abilities, (MMRM, ES=0.21), the ISI (ANCOVA, ES=0.24) and the Sheehan Disability Scale (ANCOVA, ES=0.26). Moreover, robust activity was observed in the PGIC responder (very much improved or much improved) rate for TNX-102 SL compared to placebo (Figure 5): week 6 (31.3% vs. 9.7%, difference=21.6%), week 10 (28.1% vs. 12.9%, difference=15.2%), week 14 (34.4% vs. 16.1%, difference=18.2%).

Safety profile

TNX-102 SL demonstrated a favorable safety and tolerability profile over 14 weeks of treatment with no new safety signals. The most common adverse events are shown in Table 2. Participants with at least one treatment-emergent adverse event (TEAE) were at a rate of 56.3% on TNX-102 SL and 38.7% on placebo. In the TNX-102 SL group, 6.3% discontinued due to TEAE compared to 9.7% on placebo. Only one TEAE in the study was rated as severe, gastritis in a participant in the TNX-102 SL group. There were no serious adverse events (SAEs) in the study.

 Table 2: Adverse Events Occurring in ≥ 2 Participants in Either Treatment Group
     
  PlaceboTNX-102 SLTotal
  N=31N=32N=63
Administration Site Reactions   
 Hypoaesthesia oral066
 Product taste abnormal033
 Glossodynia022
 Oral pain022
 Paraesthesia oral022
Systemic Adverse Events   
 Influenza like illness202
     

Abbreviations: LS, least squares; SE, standard error

Abbreviations: LS, least squares; SE, standard error

Abbreviations: LS, least squares; SE, standard error; SD, sleep disturbance

Abbreviations: LS, least squares; SE, standard error

*p=0.034, #p=0.096

About the Phase 2 PREVAIL Study
The Phase 2 PREVAIL proof-of-concept study was a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with laboratory-documented post-acute sequelae of SARS-CoV-2 infection (PASC). The trial was conducted at approximately 30 sites in the U.S. The primary efficacy endpoint is the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue, and cognitive function.

For more information, see ClinicalTrials.gov Identifier: NCT05472090.

About Long COVID or Post-Acute Sequelae of COVID-19 (PASC)

Post-acute sequelae of COVID-19, or PASC is the formal name for a condition now widely known as Long COVID. The U.S. Department of Health and Human Services (HHS) recently estimated that 7.7 million to 23 million Americans have developed Long COVID and announced the formation of the “Office of Long COVID Research and Practice” to lead the Long COVID response and coordinate efforts across the federal government. 10 Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops a chronic syndrome called Long COVID.11 These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. According to the Centers for Disease Control and Prevention (CDC), 1 in 13 adults in the U.S. (7.5%) have Long COVID symptoms.11 Long COVID is typically associated with moderate or severe COVID-19 but can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. More than 40% of adults in the United States reported having COVID-19 in the past, and nearly one in five of those (19%) are currently still having symptoms of Long COVID.11 Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.12-15 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.16 The U.S. Department of Health and Human Services National Research Action Plan on Long COVID17, released in August 2022, addresses the overlap of Long COVID with CFS/ME, which, like fibromyalgia, is one of the overlapping chronic pain syndromes with central and peripheral sensitization.18 A published survey19 found comparable pain, fatigue, and functional impairment between Long COVID, fibromyalgia, and CFS/ME. This symptom overlap between these conditions has suggested that altered neurologic function is one of the leading hypotheses to explain them.20 While the vaccines available in the U.S., through either FDA approval or under Emergency Use Authorization, have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

About Fibromyalgia-Type Long COVID

Common symptoms of Long COVID, including multi-site pain, fatigue, unrefreshing sleep, and cognitive dysfunction, or ‘brain fog,’ are hallmarks of conditions like fibromyalgia and CFS/ME. Defining subgroups of Long COVID patients that overlap with fibromyalgia and CFS/ME is expected to facilitate the development of new treatments.20 We are studying TNX-102 SL in the subgroup of Long COVID patients whose symptoms overlap with fibromyalgia, which we have termed ‘Fibromyalgia-type Long COVID.’ TNX-102 SL is in phase 3 development for the management of fibromyalgia.8,21 Fibromyalgia has been recognized by the U.S. Food and Drug Administration (FDA) with three approved medicines. The recent identification of Long COVID subgroups in the National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored RECOVER study7 was an important step. In their recent publication7 cluster analysis of the symptom frequencies in the RECOVER study (Researching COVID to Enhance Recovery (RECOVER) research program) identified four subgroups of Long COVID patients. Cluster #4 represented approximately one quarter of the population (28%) and reported the highest frequencies of pain (back pain (58%), joint pain (64%) or muscle pain (60%)), high frequencies of fatigue (94%) and ’Brain Fog,’ (94%) and a high level of impairment of Quality of Life. We believe Cluster #4 is a subgroup of Long COVID that overlaps with fibromyalgia. We also believe that Cluster #3, representing another approximately 29% of the RECOVER cohort, includes many patients with Fibromyalgia-type Long COVID because 100% of that group suffer from ‘Brain Fog’, 94% experience fatigue and approximately one third experience pain (back pain (32%), joint pain (36%) or muscle pain (34%)). Fibromyalgia can result from a variety of different stressors, in addition to infectious illnesses, including hormonal, metabolic, and psychological stressors.23,24 It can be challenging to distinguish fibromyalgia and CFS/ME clinically, given the high level of symptom overlap between them. Each of these conditions is defined by a constellation of symptoms, and there is no widely recognized diagnostic laboratory test that distinguishes them. We presented an analysis of a Fibromyalgia-type Long COVID subgroup from the TriNetX claims database at the BIO-sponsored Long COVID meeting in February 2023.21 That study provided real-world evidence that the majority of Long COVID patients present with a constellation of symptoms that overlap with fibromyalgia and CFS/ME. These symptoms include fatigue, cognitive symptoms, and multi-site pain. Fibromyalgia-type Long COVID, like fibromyalgia and CFS/ME, appears to be both a subgroup of Long COVID and one of several chronic overlapping pain conditions that have in common the neurological process called central and peripheral sensitization, which is increasingly known by the term nociplastic pain.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

*TNX-102 SL is an investigational new drug and is not approved for any indication

Citation:

  1. NIH News Release. July 31, 2023. “NIH launches long COVID clinical trials through the RECOVER Initiative, opening enrollment.” https://www.nih.gov/news-events/news-releases/nih-launches-long-covid-clinical-trials-through-recover-initiative-opening-enrollment (accessed September 4, 2023).
  2. Johnson, M and Goldstein A. Washington Post. July 31, 2023. “NIH announces long covid treatment studies with hundreds of patients” www.washingtonpost.com/health/2023/07/31/long-covid-treatment-studies-nih/
  3. Cook, K.F., et al. 2016Journal of Clinical Epidemiology, 73, 89- 102
  4. Cella, D., et al. 2016Journal of Clinical Epidemiology, 73, 128–134
  5. Lai, J.S., et al. 2011Archives of Physical Medicine and Rehabilitation, 92(10 Supplement), S20-S27.
  6. Walker S, et al. BMJ Open 2023;13:e069217. doi:10.1136/ bmjopen-2022-069217
  7. Thaweethai T, et al. JAMA. 2023. 329(22):1934-1946
  8. Lederman S, et al. Arthritis Care Res. 2023 https://doi.org/10.1002/acr.25142
  9. Sullivan, G et al. Tonix data on file, 2023
  10. NIH Press Release. July 31, 2023. “HHS Announces the Formation of the Office of Long COVID Research and Practice and Launch of Long COVID Clinical Trials Through the RECOVER Initiative” www.hhs.gov/about/news/2023/07/31/hhs-announces-formation-office-long-covid-research-practice-launch-long-covid-clinical-trials-through-recover-initiative.html (accessed September 4, 2023).
  11. NIH News Release. June 22, 2022. “Nearly One in Five American Adults Who Have Had COVID-19 Still Have ‘Long COVID’” https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220622.htm (accessed September 4, 2023).
  12. Briggs, A, and Vassall, A. Nature. 2021. 593(7860): 502-505
  13. Nittas V, et al. Public Health Rev. 2022. 43:1604501
  14. Davis, HE., et al. EClinicalMedicine. 2021. 38:101019
  15. Martin C, et al. PLoS One. 2021. 16(12):e0260843
  16. The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.
  17. Department of Health and Human Services, Office of the Assistant Secretary for Health. 2022. National Research Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC 20201. www.covid.gov/assets/files/National-Research-Action-Plan-on-Long-COVID-08012022.pdf
  18. Maixner W, et al. J Pain. 2016. 17(9 Suppl):T93-T107
  19. Haider S, et al. Pain. 2023. 164(2):385-401
  20. Sutherland, S. Scientific American. 2023
  21. Tonix Pharmaceuticals Press Release. Feb 22, 2023. https://ir.tonixpharma.com/news-events/press-releases/detail/1369/tonix-pharmaceuticals-describes-emerging-research-on-the
  22. Moldofsky H, et al. J Rheumatol. 2011. 38(12):2653-63
  23. Clauw DJ, and Calabrese L. Ann Rheum Dis. 2023
  24. Clauw DJ, et al. Pain. 2020. 161(8):1694-1697

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Topline results from a proof-of-concept Phase 2 study were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

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

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

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

Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/07482efe-4b16-4cb5-a5d8-1608e1e5412c

https://www.globenewswire.com/NewsRoom/AttachmentNg/e16dda0e-ab4a-44aa-aeb5-919ce14afb84

https://www.globenewswire.com/NewsRoom/AttachmentNg/bbe66a9f-1154-4117-a045-4d07e061660d

https://www.globenewswire.com/NewsRoom/AttachmentNg/18539d75-14de-4e41-800a-5d2ff547f9d3

https://www.globenewswire.com/NewsRoom/AttachmentNg/de06c2b0-02b7-4efa-9f67-ea4ef1429b63

Source: Tonix Pharmaceuticals Holding Corp.

Released September 5, 2023

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Release – Entravision and Match Media Group Partner Across Africa

Posted on by aweinsoff@channelchek.com

Research News and Market Data on EVC

Entravision and Match Media Group Partner Across Africa

September 1, 2023

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SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, announced today that its African based digital business unit has become the exclusive sales partner in Africa of Match Media Group, the group that powers advertising for brands including Tinder, OkCupid and Match.

(Graphic: Business Wire)

Match Group is on a mission to spark meaningful connections for every single person in the world. Founded 25 years ago, Match pioneered the concept of online dating and continues to foster innovation in the online dating industry. With more than 20 offices around the world, the company operates several iconic brands under its portfolio including Match, OkCupid, Tinder, and The League. Today, hundreds of millions of singles have found a meaningful connection using Match Group services.

“This partnership with Match Media Group reinforces our commitment to advertisers to connect brands to consumers through local strategic support, creative expertise and a suite of innovative advertising opportunities on the platform,” said Julian Jordaan, President of Entravision Africa. “Globally, we’re seeing a dating renaissance, with online dating now being the most common way that singles are making new connections. We’re thrilled to be partnered with Match Media Group in Africa to connect consumers to brands in an authentic and relevant way.”

As the exclusive sales partner to Match Media Group across the African continent, Entravision has created a dedicated local team of experts based in South Africa to provide businesses with the tools crucial to sales growth, while also assisting customers in deploying their advertising investments more efficiently across their digital technologies.

About Entravision

Entravision (NYSE: EVC) is a global advertising solutions, media and technology company. Over the past three decades, we have strategically evolved into a digital powerhouse, expertly connecting brands to consumers in the U.S., Latin America, Europe, Asia and Africa. Our digital segment, the company’s largest by revenue, offers a full suite of end-to-end advertising services in 40 countries. We have commercial partnerships with Meta, X Corp. (formerly known as Twitter), TikTok, and Spotify, and marketers can use our Smadex and other platforms to deliver targeted advertising to audiences around the globe. In the U.S., we maintain a diversified portfolio of television and radio stations that target Hispanic audiences and complement our global digital services. Entravision remains the largest affiliate group of the Univision and UniMás television networks. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.

About Match Group

Match Group (NASDAQ: MTCH), through its portfolio companies, is a leading provider of digital technologies designed to help people make meaningful connections. Our global portfolio of brands includes Tinder®, Hinge®, Match®, Meetic®, OkCupid®, Pairs™, PlentyOfFish®, Azar®, Hakuna™, and more, each built to increase our users’ likelihood of connecting with others. Through our trusted brands, we provide tailored services to meet the varying preferences of our users. Our services are available in over 40 languages to our users all over the world.

Forward-Looking Statements

This press release contains certain forward-looking statements. These forward-looking statements, which are included in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, may involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results and performance in future periods to be materially different from any future results or performance suggested by the forward-looking statements in this press release. Although the Company believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that actual results will not differ materially from these expectations, and the Company disclaims any duty to update any forward-looking statements made by the Company. From time to time, these risks, uncertainties and other factors are discussed in the Company’s filings with the Securities and Exchange Commission.

Entravision in Africa
Matthew Banner
matthew.banner@entravision.com
www.entravisionafrica.com

Investors:
Kimberly Orlando
ADDO Investor Relations
310-829-5400
evc@addo.com

Source: Entravision

Release – MustGrow Announces Grant of RSUs and DSUs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

SASKATOON, Saskatchewan, Canada, September 1, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”), today announced that the board of directors of the Company  authorized and approved the grant of a total of 612,757 deferred share units (“DSUs”) and 177,035 restricted share units (“RSUs”) to certain directors, officers, and consultants of the Company, effective August 31, 2023. This grant of DSUs and RSUs is made pursuant to the Company’s Omnibus Equity Incentive Plan (the “Plan”).

The RSUs will vest on March 28, 2024. Once vested, each RSU will entitle the recipient to receive one common share in the capital of the Company or a cash payment equivalent thereof at the discretion of the Company. The DSUs will vest in accordance with the terms of the Plan immediately upon grant. Settlement of the DSUs will occur when a holder ceases to be a director, officer or employee of the Company or any of its affiliates, as applicable. On settlement, each DSU will entitle the recipient to receive one common share in the capital of the Company or a cash payment equivalent thereof at the discretion of the Company.

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 56.3 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson

Director & CEO

Phone: +1-306-668-2652

info@mustgrow.ca

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

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

© 2023 MustGrow Biologics Corp. All rights reserved.

Eskay Mining Corp. (ESKYF) – Drilling Program Yields Early Successes

Posted on by cpereira@noblefcm.com


Friday, September 01, 2023

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

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

Consolidated Eskay Gold Project. Eskay Mining is focused on the exploration and development of precious metal volcanogenic massive sulfide (VMS) targets along the Eskay rift in a region of northwest British Columbia known as the Golden Triangle. The company’s 100%-controlled Eskay Gold Project encompasses 52,600 hectares, or 26 square kilometers, of highly prospective property within proximity to several world class gold deposits, including the adjacent past-producing Eskay Creek Mine.

Drilling program is focused on seven targets. Eskay has drilled approximately 4,300 meters of its planned 6,500-meter diamond drill program. This year’s program is focused on seven targets, including: 1) Tarn Lake, 2) Maroon Cliffs, 3) Hexagon-Mercury, 4) Storie Creek, 5) Cumberland, 6) Scarlet Knob-Bruce Glacier, and 7) TV South.


Get the Full Report

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

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

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

Codere Online (CDRO) – Race to Profitability Still on Track

Posted on by cpereira@noblefcm.com


Friday, September 01, 2023

Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile application. Codere currently operates in its core markets of Spain, Italy, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence in the region.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

Strong Q2 results. The company reported better-than-expected revenue and adj. EBITDA. Q2 revenue was €39.1 million and adj. EBITDA was a loss of €4.5 million, compared with our estimates of €36.0 million and a loss of €6.8 million, respectively.

Key markets performing well. In Mexico and Spain, the company reported another quarter of robust year-over-year revenue growth. In Mexico, revenue grew 51% to €18.0 million while, in Spain, revenue grew 24% to €17.5 million. Notably, this was the first quarter in which revenue from Mexico eclipsed the revenue in Spain.  


Get the Full Report

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

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

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

1·800·Flowers.com, Inc. (FLWS) – Gross Margins Surprise On The Upside

Posted on by cpereira@noblefcm.com


Friday, September 01, 2023

For more than 45 years, 1-800-Flowers.com has offered truly original floral arrangements, plants and unique gifts to celebrate birthdays, anniversaries, everyday occasions, and seasonal holidays, and to deliver comfort during times of grief. Backed by a caring team obsessed with service, 1-800-Flowers.com provides customers thoughtful ways to express themselves and connect with the most important people in their lives. 1-800-Flowers.com is part of the 1-800-FLOWERS.COM, Inc. family of brands. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Exceeds EBITDA estimate. The company’s fiscal Q4 results were mixed with a “miss” in revenues, but nicely beating our adj. EBITDA estimate. Revenues declined 17.9% to $398.8 million, versus our estimate of $414.2 million. Gross margins substantially improved leading to a beat in adj. EBITDA of a seasonal loss of $6.6 million versus our loss estimate of $10.1 million. 

Favorable margin outlook. We believe that a combination of lower ocean freight costs, moderating commodity prices, lower inventory write-offs, and a shift toward higher priced, higher margin products, all should allow the company to move gross margins from 37.5% in 2023 to 39.3% in fiscal 2024 and then to 39.6% in 2025. Our gross margin assumptions are conservatively below the pre-pandemic levels of 42.1% in 2019 and offer positive upside surprise potential. 


Get the Full Report

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

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

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

A Huge Turnaround for Marijuana Stocks This Week

Posted on by phoffman@channelchek.com

Recapping the Cannabis Rally

In the U.S., Marijuana stocks have reawakened and have been enjoying investor attention. The last week in August has been one of their best since March 2020. The driver behind the surge in investor interest is the prospect of a significant shift in the regulatory landscape resulting from a potential reclassification of cannabis by the U.S. Drug Enforcement Administration (DEA). This development has provided optimism throughout the industry, causing notable gains in various cannabis stocks.

High Week for Marijuana Investors

The M.J. PurePlay 100 Index soared by as much as 4.6% at the open on September 1, extending its weekly gain to an impressive 29%. This performance marks the best stretch for the index since March 2020. Similarly a benchmark Cannabis ETF, known by its ticker WEED, enjoyed an extraordinary surge, reaching an all-time high with gains of 45% for the week.

Source: Market Screener

A Shifting Regulatory Landscape

The week brought unexpected excitement as the industry had begun to feel forgotten about. Then, surprisingly, Assistant Secretary for Health Rachel Levine made a groundbreaking recommendation that cannabis be reclassified as a Schedule III drug under the Controlled Substances Act. This strong support immediately drove up the industrys’ stocks as investors look to capitalize on the potential implications.

It then got even better for investors. A more pronounced turning point started when the DEA confirmed its intention to review the current classification of cannabis. This has been anticipated for years, and has not occurred.

For years, the classification of marijuana as a Schedule I drug, placing it alongside substances like heroin and LSD, has posed a significant challenge to the cannabis industry. This categorization has created hurdles for cannabis companies, particularly in their ability to access essential financial services due to conflicting federal laws.

Possible Investor Benefits

Reduced Regulatory Risk: If cannabis is reclassified as a Schedule III drug, it could significantly lower the regulatory risk associated with the industry. This shift would alleviate some of the financial obstacles that cannabis companies face under current federal law.

Take a moment to learn more about Schwazze, a leading vertically integrated cannabis holding company with a portfolio consisting of top-tier licensed brands spanning cultivation, extraction, infused-product manufacturing, dispensary operations, consulting, and a nutrient line.

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

Banking Services: The reclassification could incentivize more banks and financial institutions to offer traditional banking services to cannabis companies, reducing their reliance on cash transactions and enhancing financial stability.

Research Opportunities: A Schedule III rating would facilitate more comprehensive research on cannabis, potentially leading to its removal from the controlled-substance category in the future. This could open doors to groundbreaking discoveries and innovations within the cannabis sector.

Tax Benefits: A change in classification may lead to the removal of certain tax credit and deduction bans for marijuana businesses, providing financial relief and potentially boosting profitability for the industry.

However, it’s important to note that despite these positives, the cannabis industry may still require additional regulatory clarity. The SAFE Banking Act, aims to address some marijuana stumbling blocks and issues by providing legitamate cannabis businesses with access to banking services. To ensure a smooth transition, further guidance may be necessary to ensure compliance with federal anti-money laundering statutes and other applicable laws.

Take Away

The reawakening of marijuana stocks this week reflects the industry’s growing optimism surrounding the potential reclassification of cannabis by the DEA. This transformative development could have far-reaching implications, ranging from reduced regulatory risks and tax benefits to improved access to banking services and expanded research opportunities. However, investors should stay up to date and informed as the regulatory landscape evolves, keeping a close eye on legislative developments and industry trends to make informed investment decisions. Part of that vigilance could include updates from Channelchek in your email each day by obtaining a free subscription here.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.marketscreener.com/quote/index/MJ-PUREPLAY-100-INDEX-GRO-56414425/

iCoreConnect (ICCT) Trending Following Merger

Posted on by cpatches

iCoreConnect, Inc. (Nasdaq: ICCT) recently underwent a business merger with FG Merger Corp. (Nasdaq: FGMC) and has since exhibited stability in the stock market. A notable event was a temporary halt in trading on Nasdaq due to a technical issue with the conversion of shares. However, trading resumed on August 30, 2023, after the issue was addressed.  iCoreConnect is currently trending on various financial social media platforms and websites, reflecting heightened investor interest. Their stock price is up 206% since the start of the week as trading opened Friday.


iCoreConnect’s primary objective is to improve workflow productivity and practice profitability via its cloud-based software and technology solutions. Currently, the company has a portfolio of 16 SaaS enterprise solutions. Additionally, they’ve secured endorsements from over 100 state or regional healthcare associations in the U.S. Based on their recent statements, iCoreConnect has projected its revenue and annualized recurring revenue for 2023 and expressed interest in expanding into the ePrescription and insurance verification sectors.


To understand more about iCoreConnect’s activities, developments, and potential in the healthcare technology and enterprise solutions industry, a recent report from Noble Capital Markets Analyst Gergory Aurand provides a detailed analysis and overview.

Learn more about iCoreConnect and read Noble’s report here

FTC Approves Horizon Therapeutics Acquisition

Posted on by cpatches

After months of scrutiny, including a lawsuit filed by the Federal Trade Commission, the FTC has given drug giant Amgen the go-ahead to proceed with their planned acquisition of Horizon Therapeutics, a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people affected by rare, autoimmune and severe inflammatory diseases.

The planned acquisition was originally announced late in 2022 but has been held up due to concerns that the deal may stifle competition in the pharmaceutical industry. One key point resolved in an agreement announced Friday stipulates that Amgen is prohibited from “bundling” two of Horizon’s key drugs. A “bundling” tactic could involve rebates or promotions to insurers for recommending or favoring those Horizon products.

Horizon Therapeutics is up slightly in early market trading on Friday following the announcement. The company currently has a market cap of $26.4bn. The merger, valued at $27.8bn, is expected to be completed in Q4 of 2023.

Explore Noble Capital Markets’ Biotechnology Analyst Robert LeBoyer’s coverage list for detailed analysis on other biotech stocks.

August Jobs Report Delivers Mixed Results

Posted on by cpatches

U.S. Jobs Up. Unemployment Also Up.

Today’s Report

The U.S. jobs report for August is out, with 187,000 jobs added to the economy in August. This is slightly higher than the 170,000 economists had expected. On the other side, unemployment is up slightly, at 3.8%. This is 0.3% higher than economists had predicted. Wages increased slightly, up 0.2% month-over-month, and remain up more than 4% over last year.

About the U.S. Jobs Report

The U.S. jobs report, specifically the nonfarm payroll report, is a critical economic indicator that holds immense significance for both financial markets and policymakers. This report, typically released on the first Friday of each month by the U.S. Bureau of Labor Statistics, provides crucial insights into the health of the labor market in the United States.

The report serves as a barometer of economic health. It offers valuable data on the number of jobs created or lost in the previous month, the unemployment rate, and wage growth. This information helps economists and investors gauge the overall economic performance and can influence their outlook on future economic conditions. If job creation exceeds expectations, it can signal a robust economy, potentially leading to higher consumer spending and business investments.

This report also has a significant impact on financial markets. Stock, bond, and currency markets can experience substantial volatility on the day of the report’s release. Positive job growth can boost investor confidence and lead to stock market gains, while weaker-than-expected data can trigger market sell-offs. Additionally, the Federal Reserve closely monitors the jobs report when making decisions about interest rates and monetary policy, making it a key factor in shaping the direction of these markets in the medium to long term.

In summary, the U.S. jobs report is a vital economic indicator that provides insights into the labor market’s health and has a profound impact on financial markets, influencing investor sentiment, asset prices, and even central bank decisions. It is closely watched by economists, investors, and policymakers alike for its role in shaping economic outlooks and investment strategies.

Release – Eskay Mining Drills VMS Mineralization at Four New Targets at its Consolidated Eskay Project, Golden Triangle, BC

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ESKYF

August 31, 2023

Toronto, August 31, 2023 – Eskay Mining Corp. (“Eskay” or the “Company”) (TSX-V:ESK) (OTCQX: ESKYF) (Frankfurt:KN7)(WKN:A0YDPM) is pleased to announce it has recently drilled significant intervals of stockwork and/or massive sulfide mineralization at four new targets as part of its 2023 diamond drill campaign at its 100% controlled Consolidated Eskay Gold Project in the Golden Triangle of British Columbia. Precious metal-rich volcanogenic massive sulfide (“VMS”) deposits are the focus of Eskay’s exploration.

As of this news release, Eskay Mining has drilled approximately 4,300m of its planned 6,500m 2023 diamond drill campaign. In Company news releases dated May 18 and July 27, 2023, seven new targets were discussed as subjects of this year’s exploration campaign: Tarn Lake, Maroon Cliffs, Hexagon-Mercury, Storie Creek, Cumberland, Scarlet Knob-Bruce Glacier and TV South (Figure 1). Drilling at Tarn Lake, Scarlet Knob-Bruce Glacier, Hexagon-Mercury and Cumberland have yielded significant intercepts of stockwork and/or massive sulfide mineralization. Results are summarized below:

Cumberland: This target is situated approximately five km south of the TV deposit, subject of substantial drilling over the past three seasons. No appreciable work has been conducted in this area for at least twenty years. A current total of five drill holes have been completed by Eskay Mining this season, each intercepting seafloor-proximal stockwork and massive sulfide mineralization (Figures 3 and 4) over core lengths of approximately 25 to 85 meters. Spot XRF analyses indicates these intercepts are highly elevated in silver, copper, lead, zinc, arsenic, antimony and tellurium. Gold analysis by XRF is unreliable. This VMS deposit appears to strike NNW and dips moderately steeply to the east. Its stratigraphic position is believed to be in the Upper Hazelton Group at a level similar to the Eskay Creek deposit located approximately 20 km north. Like TV, Cumberland is situated on the eastern limb of the Eskay Anticline. The Company has one additional hole planned at Cumberland to follow up on this exciting new discovery.

Scarlet Knob-Bruce Glacier: This target is situated along the eastern side of the toe of Bruce Glacier in an area where spot rock chip sampling returned several Au- and Ag-bearing assays, including one with 56 gpt Au last season. To date, four drill holes have probed the westward dipping succession of volcanic rocks in search of the paleo-sea floor exhalative position of the VMS system. All four holes have encountered significant intervals of 20-50m of intense stockwork mineralization followed by mudstone thought to represent the overlapping paleo-sea floor strata (Figure 5). Like Cumberland, spot XRF analyses indicates this stockwork mineralization is highly elevated in silver, copper, lead, zinc, arsenic, and antimony. Mineralization is believed to be hosted in the lower part of the Hazelton Formation. Further drilling will be conducted in an area approximately 200 m north of holes drilled to date near a newly discovered outcrop of base-metal-rich VMS mineralization (Figure 6). This exciting newly discovered massive sulfide mineralization is thought to be at or very close to the paleo-sea floor position.

Tarn Lake: The Tarn-Lake target is situated on the west side of Bruce Glacier and saw limited drilling in 2022 that yielded encouraging precious metal results. Three holes completed to date have encountered sulfide stockwork mineralization ranging from 30-130m in length, much longer than recorded in drilling in 2022. Spot XRF analyses indicates this stockwork mineralization is highly elevated in silver, copper, lead, zinc, arsenic, and antimony. Mineralization is thought to be hosted by rocks in the lower part of the Hazelton Formation near a paleo-sea floor position much like Scarlet-Knob-Bruce Glacier to the east. One additional hole is being drilled at this exciting discovery this year.

Hexagon-Mercury: Targeting at Hexagon-Mercury, situated on the western flank of the Eskay Anticline approximately 9 km south of Eskay Creek mine, has been driven by geophysical anomalies interpreted by Riaz Mirza of Simcoe Geoscience. The first of two drill holes completed to date yielded an intercept of over 100m of appreciable stockwork sulfide mineralization hosted by volcanic rock thought to be part of the lower Hazelton Group. Spot XRF analyses indicate this stockwork is moderately to strongly anomalous in arsenic and other pathfinder elements. Eskay Mining is contemplating following up this discovery with further drilling this season.

The last target to be drill tested this season is Storie Creek, an as yet undrilled area situated just 3.5 km SSE of the Eskay Creek mine (Figure 2). Recent geologic interpretation by Eskay Mining’s team discussed in a Company news release dated July 27, 2023 indicates that uppermost Hazelton Group strata including the Contact Mudstone sub-crops underneath the NE-trending Storie Creek drainage and dips gently northwestward underneath a veneer of post-mineral Bowser Lake Formation sedimentary rocks. Extensive gossanous outcrops of Upper Hazelton Formation rocks were discovered along the eastern side of Storie Creek over a strike length of at least 4 km. Gossan forms from weathering of sulfides that may be associated with mineralization. Upon review of historic soil data dating back to the early 1990’s, Eskay’s geologic team has identified two areas where high silver-in-soil values occur, an indication that the Storie Creek gossanous outcrops are likely associated with mineralization. Two drill holes are planned at Storie Creek beginning in a few days.

One hole completed at TV South failed to encounter significant mineralization, however favorable volcanic host-rocks and VMS-related alteration were observed in drill core. Subsequent field discoveries of sulfide rich outcrops in areas nearby suggest this hole was drilled in an unfavorable orientation and that further exploration work is warranted at TV South. Two drill holes completed at the Maroon Cliffs target failed to encounter appreciable mineralization.

Drilling at the Consolidated Eskay Project is expected to finish by mid-September. Assays from the first holes of the 2023 program are expected back late September.

Dr. Quinton Hennigh, P. Geo., a Director of the Company and its technical adviser, a qualified person as defined by National Instrument 43-101, has reviewed and approved the technical contents of this news release.

About Eskay Mining Corp:

Eskay Mining Corp (TSX-V:ESK) is a TSX Venture Exchange listed company, headquartered in Toronto, Ontario. Eskay is an exploration company focused on the exploration and development of precious and base metals along the Eskay rift in a highly prolific region of northwest British Columbia known as the “Golden Triangle,” 70km northwest of Stewart, BC. The Company currently holds mineral tenures in this area comprised of 177 claims (52,600 hectares).

All material information on the Company may be found on its website at www.eskaymining.com and on SEDAR at www.sedar.com.

For further information, please contact:

Mac Balkam
President & Chief Executive Officer		T: 416 907 4020
E: Mac@eskaymining.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements: This Press Release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements.

(Figure 1. Plan view of Eskay Mining’s land holdings at Consolidate Eskay Gold Project. The blue line indicates the position of the cross section in Figure 2.)

(Figure 2. Cross-sectional interpretation of the geology of the corridor extending from Eskay Creek mine in the northwest to Scarlet Knob in the southeast. See Figure 1 for location. View is to the northeast and field of view is approximately 8 km. At Eskay Creek, mineralization occurs in and around three horizons, all at one time sea floor positions, the Contact Mudstone, Lower Mudstone and Even Lower Mudstone, belonging to the Hazelton Group. Storie Creek and the region extending approximately 2 km to the northwest has strong potential to host these same three stratigraphic horizons making this a uniquely prospective target. At Tarn Lake, Bruce Glacier and Scarlet Knob, the lowest sea floor position is the focus of exploration.)

(Figure 3. Seafloor-proximal sulfide mineralization in drill hole CBL23-28. Stockwork sulfide mineralization infills the host pillow andesite breccia, and transitions to semi-massive replacement-style mineralization just below the paleoseafloor position. Seafloor-hosted sulfide mineralization is massive, and is associated with barite breccia. This style of mineralization and alteration is consistent with a seafloor position. All styles of sulfide mineralization intercepted at Cumberland are highly polymetallic with abundant pyrite, sphalerite, galena, chalcopyrite, arsenopyrite and Ag-sulfosalt minerals. The Au pathfinder elements mercury and tellurium are highly enriched at Cumberland as determined by handheld XRF analyses.)

(Figure 4. Seafloor-proximal sulfide mineralization in drill hole CBL23-29. Stockwork mineralization was intercepted as deep as 120 m in this hole, and transitions to semi-massive replacement-style mineralization hosted by pillow andesite and associated with barite alteration. Immediately overlying the pillow andesite is massive sulfide infilling barite breccia. This style of mineralization and alteration is consistent with a seafloor position. All styles of sulfide mineralization intercepted at Cumberland are highly polymetallic with abundant pyrite, sphalerite, galena, chalcopyrite, arsenopyrite and Ag-sulfosalt minerals. The Au pathfinder elements mercury and tellurium are highly enriched at Cumberland as determined by handheld XRF analyses.)

(Figure 5. The paleoseafloor position at Scarlet Knob intercepted by drill hole SKN23-01 is characterized by intensely silicified rhyolite that hosts sulfide stockwork mineralization. Immediately overlying the rhyolite is an unaltered mudstone that contains large blobs of Ag-bearing sulfide minerals. The asymmetric alteration between the rhyolite and the mudstone is a key indicator of the seafloor position in VMS systems. Identification of the seafloor horizon in drill core enabled our team to locate the same stratigraphic position along strike approximately 200 m to the north of SKN23-01.)

(Figure 6. The gossan outlined in green in the top image delineates the zone of semi-massive to massive sulfide identified by our field team (note the two geologists for scale). The image at bottom shows one of several samples of massive polymetallic sulfide collected along the trend of mineralization. Galena, pyrite, and chalcopyrite are the dominant sulfide minerals along this trend.)

Release – GeoVax to Present at the H.C. Wainwright 25th Annual Global Investment Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 31 August 2023 13:05
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Company to Provide Updates on Multiple Phase 2 Clinical Trials

for GEO-CM04S1 and Gedeptin®

ATLANTA, GA, August 31, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it will present a company overview and host investor meetings during the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 in New York City.

Presentation Details:

Presenter:                          David Dodd, Chairman & CEO

Date/Time:                        2:30pm ET, September 11, 2023

Location:                            Lotte New York Palace Hotel, New York, NY

Conference Website:      https://hcwevents.com/annualconference/

Webcast:                            A webcast of the presentation will be available here:

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 three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a 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.

Contact:

 

  • Last updated: 31 August 2023 13:05
  • Created: 31 August 2023 14:20
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Company to Provide Updates on Multiple Phase 2 Clinical Trials

for GEO-CM04S1 and Gedeptin®

ATLANTA, GA, August 31, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it will present a company overview and host investor meetings during the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 in New York City.

Presentation Details:

Presenter:                          David Dodd, Chairman & CEO

Date/Time:                        2:30pm ET, September 11, 2023

Location:                            Lotte New York Palace Hotel, New York, NY

Conference Website:      https://hcwevents.com/annualconference/

Webcast:                            A webcast of the presentation will be available here:

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 three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a 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.

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

investor@geovax.com

678-384-7220