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About Beasley

Beasley Media Group (BMG), LLC, a subsidiary of Beasley Broadcast Group, Inc., is a multiplatform media company providing advertising and digital marketing solutions across the United States. BMG owns 62 radio properties located in large and medium markets across the country, as well as offers capabilities in audio technology, esports, podcasting, ecommerce and events. Founded in 1961, nearly 41% of Beasley radio properties are located in the nation’s top 50 markets such as Philadelphia, Boston, Detroit, Las Vegas, New Jersey, West Palm Beach, Boston and Atlanta. The remaining stations are primarily in vibrant regional centers like Central North Carolina, Northeast Georgia and Southeast Florida.

Release – Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University



Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19

Research, News, and Market Data on Tonix Pharmaceuticals

 

TNX-2300, a Live Virus Vaccine Based on a Bovine Parainfluenza Virus Vector, in Development to Protect Against COVID-19

Co-Expression of the CD40-Ligand Will be Tested to Direct Immune Response

CHATHAM, N.J., April 05, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a new preclinical research agreement with Kansas State University (K-State) to extend the research being performed under its original agreement. Tonix and K-State are working together to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform, bovine parainfluenza virus, and also to test the effect of co-expression of the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.

“Vaccines based on live replicating viruses trigger the immune system by direct stimulation of T cells, with the potential to elicit strong, long-lasting and durable immunity,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are currently well over 300 potential COVID-19 vaccines in various stages of development1, but relatively very few utilize live replicating viral platforms. TNX-2300* is a live replicating virus vaccine designed to elicit T cell immunity.”

Dr. Lederman continued, “Modern live virus vaccines in development for COVID-19 use a vector system to present SARS-CoV-2 protein antigens. K-State is studying bovine parainfluenza virus as the vector. A traditional live virus vaccine approach would use a weakened version of SARS-CoV-2, but SARS-CoV-2 contains genes that weaken the immune response by thwarting innate immunity. In the first completed phase of the research project, K-State showed that vaccinating hamsters with bovine parainfluenza virus expressing SARS-CoV-2 spike protein elicited antibody responses to the SARS-CoV-2 spike protein. Our goal in utilizing bovine parainfluenza virus as a live virus vaccine vector is to develop a COVID-19 vaccine that is well tolerated, produces durable immunity, prevents forward transmission and can be rapidly and broadly deployed.”

Under the extended research agreement, K-State will continue to advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza virus and also to test the effect of co-expression of the CD40-ligand.

Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans2-7. Notably and most importantly, following extensive testing in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children3,6. The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally. The technology also includes a molecular stimulant called CD40-ligand, which triggers strong immunity, including T cell responses. TNX-2300 is designed to potentially stimulate immunity against the SARS-CoV-2 spike protein. The research is being directed by Dr. Waithaka Mwangi, Kansas State University, Department of Diagnostic Medicine/Pathobiology, who is the inventor of the new technology. In addition, K-State has granted Tonix an option for an exclusive license for the clinical and commercial use of K-State’s intellectual property associated with coronavirus vaccines under this relationship.

*TNX-2300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

1World Health Organizationhttps://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccinesCOVID-19 – Landscape of novel coronavirus candidate vaccine development worldwide, March 2022.
2Liang, B., et al., J. Virol. 2016. 90:10022.
3Karron, R. A., et al., Vaccine. 2012. 30:3975.
4Haller, A. A., et al., J. Gen Virol. 2003. 84:2153.
5Schmidt, A. C., et al., J. Virol. 2001. 75:4594.
6Karron, R. A., et al., J. Infec. Diseases. 1995. 171:1107.
7Haller, A. A., et al., J. Virol. 2000. 74:11626.

About Tonix Pharmaceuticals Holding Corp.

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

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-102 SL is an investigational new drug and has not been approved for any indication.
7TNX-1300 is an investigational new biologic and has not been approved for any indication.

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

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-2300; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Release – Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL



Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)

Research, News, and Market Data on Tonix Pharmaceuticals

 

Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Expected to Start Second Quarter 2022

Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

CHATHAM, N.J., April 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is now known officially as Post-Acute Sequelae of COVID-19 (PASC2).

“We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Over 30% of people who recover from COVID-19 continue to experience a constellation of symptoms long past the time that they have recovered from acute COVID-19 illness3-4. The symptoms of Long COVID, which can include fatigue, multi-site pain, sleep disturbances, fevers, shortness of breath, cognitive impairment, gastrointestinal symptoms, anxiety, and depression, can persist for many months and can range from mild to incapacitating5. Our study will focus on testing TNX-102 SL in the treatment of patients with multi-site pain associated with Long COVID. This group of patients have symptoms that overlap with other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’6,7 This type of pain syndrome is increasingly recognized as nociplastic pain,8 and the underlying mechanism as ‘central sensitization.’9 Fibromyalgia is considered one of the chronic overlapping pain conditions and our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia.”

About the Phase 2 Study

This Phase 2 study will be a double-blind randomized, placebo-controlled 14-week trial to evaluate the safety and efficacy of sublingual TNX-102 SL 5.6 mg daily at bedtime in the treatment of patients with multi-site pain associated with Long COVID. The trial will be conducted at approximately 30 sites to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be Change from Baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. 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. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.10-13 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 2020.14 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.

1 TNX-102 SL is an investigational new drug and has not been approved for any indication.
2 Feb. 24, 2021 – White House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from the World Health Organization on long COVID.
3 Logue JK, et al. (2021) “Sequelae in Adults at 6 Months After COVID-19 Infection”. JAMA Netw Open. ;4(2):e210830. doi:10.1001/jamanetworkopen.2021.0830
4 Carfì, A et al.. (2020) “Persistent symptoms in patients after acute COVID-19.” JAMA 324.6: 603-605.
5 Nalbandian, Ani, et al. (2021) “Post-acute COVID-19 syndrome.” Nature Medicine27(4): 601-615.
6 Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
7 Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
8 Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
9 Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1
10 Briggs, A, and Vassall, A. (2021) “Count the cost of disability caused by COVID-19.” Nature 593(7860): 502-505.
11 Nittas V, et al. (2022) “Long COVID Through a Public Health Lens: An Umbrella Review.” Public Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501
12 Davis, HE., et al. (2021) “Characterizing long COVID in an international cohort: 7 months of symptoms and their impact.” EClinicalMedicine 38: 101019.
13 Martin C, et al. (2021) “A model framework for projecting the prevalence and impact of Long-COVID in the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec 2. doi:10.1371/journal.pone.0260843
14 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.

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 serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has 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 these patents 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.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID that overlaps with fibromyalgia, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1 TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2 TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3 TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4 TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5 TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6 TNX-1300 is an investigational new biologic and has not been approved for any indication.

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

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-102 SL, failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)



Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)

Research, News, and Market Data on Tonix Pharmaceuticals

 

Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Expected to Start Second Quarter 2022

Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

CHATHAM, N.J., April 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is now known officially as Post-Acute Sequelae of COVID-19 (PASC2).

“We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Over 30% of people who recover from COVID-19 continue to experience a constellation of symptoms long past the time that they have recovered from acute COVID-19 illness3-4. The symptoms of Long COVID, which can include fatigue, multi-site pain, sleep disturbances, fevers, shortness of breath, cognitive impairment, gastrointestinal symptoms, anxiety, and depression, can persist for many months and can range from mild to incapacitating5. Our study will focus on testing TNX-102 SL in the treatment of patients with multi-site pain associated with Long COVID. This group of patients have symptoms that overlap with other chronic pain conditions, which as a group have been termed, ‘chronic overlapping pain conditions.’6,7 This type of pain syndrome is increasingly recognized as nociplastic pain,8 and the underlying mechanism as ‘central sensitization.’9 Fibromyalgia is considered one of the chronic overlapping pain conditions and our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia.”

About the Phase 2 Study

This Phase 2 study will be a double-blind randomized, placebo-controlled 14-week trial to evaluate the safety and efficacy of sublingual TNX-102 SL 5.6 mg daily at bedtime in the treatment of patients with multi-site pain associated with Long COVID. The trial will be conducted at approximately 30 sites to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be Change from Baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. 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. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.10-13 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 2020.14 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.

1 TNX-102 SL is an investigational new drug and has not been approved for any indication.
2 Feb. 24, 2021 – White House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from the World Health Organization on long COVID.
3 Logue JK, et al. (2021) “Sequelae in Adults at 6 Months After COVID-19 Infection”. JAMA Netw Open. ;4(2):e210830. doi:10.1001/jamanetworkopen.2021.0830
4 Carfì, A et al.. (2020) “Persistent symptoms in patients after acute COVID-19.” JAMA 324.6: 603-605.
5 Nalbandian, Ani, et al. (2021) “Post-acute COVID-19 syndrome.” Nature Medicine27(4): 601-615.
6 Maixner W, et al.. (2016) “Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification”. J Pain. 17(9 Suppl):T93-T107.
7 Veasley C, et al. (2015): Impact of chronic overlapping pain conditions on public health and the urgent need for safe and effective treatment: 2015 analysis and policy recommendations. Chronic Pain Research Alliance. http://www.chronicpainresearch. org/public/CPRA_WhitePaper_2015-FINAL-Digital.pdf. Accessed July 26, 2021.
8 Trouvin AP, Perrot S. (2019) “New concepts of pain”. Best Pract Res Clin Rheumatol. 33(3):101415.
9 Nijs J, George SZ, Clauw DJ, et al. (2021) “Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine”. The Lancet Rheumatology. 3(5):e383-e392. doi:10.1016/s2665-9913(21)00032-1
10 Briggs, A, and Vassall, A. (2021) “Count the cost of disability caused by COVID-19.” Nature 593(7860): 502-505.
11 Nittas V, et al. (2022) “Long COVID Through a Public Health Lens: An Umbrella Review.” Public Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501
12 Davis, HE., et al. (2021) “Characterizing long COVID in an international cohort: 7 months of symptoms and their impact.” EClinicalMedicine 38: 101019.
13 Martin C, et al. (2021) “A model framework for projecting the prevalence and impact of Long-COVID in the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec 2. doi:10.1371/journal.pone.0260843
14 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.

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 serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has 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 these patents 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.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID that overlaps with fibromyalgia, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the second quarter of 2022. Finally, TNX-13006 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

1 TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2 TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3 TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4 TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5 TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6 TNX-1300 is an investigational new biologic and has not been approved for any indication.

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

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-102 SL, failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Bitcoin Energy Use Could be Slashed Significantly


Image Credit: Rich (Flickr)


Could a Code Change Slash Cryptocurrency Energy Use?

 

Fewer and fewer people are using bitcoin for digital payments. Nevertheless, bitcoin transactions are consuming more energy than ever before – the same amount as the whole of Thailand. With a carbon footprint equivalent to the Czech Republic’s (around 114 million tonnes per year), bitcoin is cancelling out other climate wins.

The global take-up of electric vehicles, for example, is estimated to have prevented 50 million tonnes of CO2 so far. That’s less than half of bitcoin’s emissions for a single year. And the problem’s getting worse. The growth of bitcoin “mining” powered by fossil fuels is outpacing greener alternatives, causing bitcoin’s carbon footprint to swell five-fold in just two years.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It was written by and represents the research-based opinions of Peter Howson, Senior Lecturer in International Development, Northumbria University, Newcastle.

 

But, according to campaign groups Greenpeace and the Environmental Working Group, all this can be easily fixed with a simple update to bitcoin’s software. Their campaign, called Change the Code Not the Climate, launched recently and calls on bitcoin software developers to switch the network from its currently wasteful system for verifying transactions to a more climate-friendly alternative.

The switch, they claim, would reduce bitcoin’s carbon footprint by 99.9%. But it’s unlikely to happen soon – and here’s why.

 

Proof of Waste to Proof of Stake?

Bitcoiners don’t trust bankers, taxmen and other meddling middlemen. Because there are no banks with bitcoin, the job of keeping the books straight is given to a global network of specialist computers. The owners of these computers compete for bookkeeping tasks in return for the transaction fees paid by network users. They also get a few newly minted bitcoins as a thank you.

This competition is known as Proof of Work (PoW) mining. It works like an ever-expanding game of hungry hippos. The more players that join the contest, the more work each hippo needs to do in order to win anything. If a new hippo with green intentions joins the game, everyone at the table has to work harder. Players powered by coal in Kazakhstan, or fossil gas in Texas, then belch out extra smog.

The higher the bitcoin price, the more the dirty hippos are prepared to waste on coal and gas until their costs for doing so are equal to their reward. And so, Proof of Work is proof of waste. And this is waste by design: Bitcoiners call this inefficiency “the feature, not the bug”.

Greenpeace hopes the bitcoin community could learn to love Proof of Stake (PoS) instead. With the network running on PoS, bitcoin’s bookkeepers would need to stake a prescribed minimum number of bitcoins as a security deposit. If they validate fraudulent transactions, they lose their stake. This disincentive keeps the network secure.

A number of blockchains, including Cardano, EOS, and TRON already use a PoS system, where token holders vote for the most qualified block producers. While bitcoin currently uses millions of mining computers, these PoS networks usually maintain an assembly of around 20 machines using a comparably minuscule amount of energy, taking turns to receive bookkeeping rights.

 

Code Blockers

For bitcoin, coding these changes would be straightforward. Greenpeace claims that only 30 people – the largest mining outfits, exchanges like Coinbase and Binance, and code developers – would need to agree the switch to PoS.

But this ignores the fact that everyone would need to run the upgraded software. On average, to successfully mine bitcoin once per week requires shelling out around US$1.8 million (£1.4 million) on hardware. Most miners are protective of these investments and conservative when it comes to amending the software code that underwrites their winnings.

For this reason, Chris Bendiksen, a commentator at the cryptocurrency website CoinShares, puts the chance of Bitcoin ever moving to PoS at 0%. “There is no appetite among Bitcoiners to destroy the security of the protocol by making such a move”, he says.

Bitcoin is no stranger to coding stalemates. An amendment to fix intermittent congestion issues and stabilize transaction fees was proposed in 2016. Despite being a relatively simple fix, the change split the bitcoin community, with the vast majority continuing to support the slower, more expensive status quo.

Even if some users were prepared to ditch PoW, the original bitcoin network would continue in some form. This PoW version would keep the name, branding, super-rich disciples, and polluting PoW miners. The PoS offshoot could end up as just another disappointing experiment.

Another PoW heavyweight network, Ethereum, has been promising a shift to PoS since birth. But this migration has remained just around the corner for several years.

Starting a PoS network from scratch is another option. But there is already a BitcoinPoS cryptocurrency. Aside from an early flurry of interest, it’s attracted few supporters.

 

Tackling Crypto Greenwashing

Many Bitcoiners scoffed at the Greenpeace campaign. After all, much of the funding for this marketing mission comes from billionaire venture capitalist Chris Larsen, co-founder of rival cryptocurrency Ripple.

Larsen’s Ripple was also an original member of the UN-backed Crypto Climate Accord, an organization convened in April 2021 to promote more sustainable cryptocurrency trading. In response, prominent bitcoin advocates established the Bitcoin Mining Council – a public relations group aiming to “defend bitcoin against uninformed and hostile energy critics,” like Larsen.

Some argue governments in Europe and North America should follow China’s lead and ban PoW mining.

Retaliatory campaigns from bitcoin advocates are ramping up, and their greenwashing appears to be winning. The European Parliament recently rejected a bill to ban PoW mining across the EU. The UK government also fears an exodus of crypto trading talent to other financial centers. Research I have led suggests that effective regulation of bitcoin will not come from charity appeals. A globally coordinated ban, led by governments, is likely to prove the most effective solution.

 

Suggested Reading



Crypto Mining Gives Mothballed Fossil Fuel Plants New Life



Small-Cap Names in a Big Crypto Market





The Advantages of Microcap Equities for Investors



Why the Metaverse is Attracting Traditional Professions

 

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Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19



Tonix Pharmaceuticals Announces Extension of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19

Research, News, and Market Data on Tonix Pharmaceuticals

 

TNX-2300, a Live Virus Vaccine Based on a Bovine Parainfluenza Virus Vector, in Development to Protect Against COVID-19

Co-Expression of the CD40-Ligand Will be Tested to Direct Immune Response

CHATHAM, N.J., April 05, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a new preclinical research agreement with Kansas State University (K-State) to extend the research being performed under its original agreement. Tonix and K-State are working together to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform, bovine parainfluenza virus, and also to test the effect of co-expression of the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.

“Vaccines based on live replicating viruses trigger the immune system by direct stimulation of T cells, with the potential to elicit strong, long-lasting and durable immunity,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are currently well over 300 potential COVID-19 vaccines in various stages of development1, but relatively very few utilize live replicating viral platforms. TNX-2300* is a live replicating virus vaccine designed to elicit T cell immunity.”

Dr. Lederman continued, “Modern live virus vaccines in development for COVID-19 use a vector system to present SARS-CoV-2 protein antigens. K-State is studying bovine parainfluenza virus as the vector. A traditional live virus vaccine approach would use a weakened version of SARS-CoV-2, but SARS-CoV-2 contains genes that weaken the immune response by thwarting innate immunity. In the first completed phase of the research project, K-State showed that vaccinating hamsters with bovine parainfluenza virus expressing SARS-CoV-2 spike protein elicited antibody responses to the SARS-CoV-2 spike protein. Our goal in utilizing bovine parainfluenza virus as a live virus vaccine vector is to develop a COVID-19 vaccine that is well tolerated, produces durable immunity, prevents forward transmission and can be rapidly and broadly deployed.”

Under the extended research agreement, K-State will continue to advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza virus and also to test the effect of co-expression of the CD40-ligand.

Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans2-7. Notably and most importantly, following extensive testing in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children3,6. The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally. The technology also includes a molecular stimulant called CD40-ligand, which triggers strong immunity, including T cell responses. TNX-2300 is designed to potentially stimulate immunity against the SARS-CoV-2 spike protein. The research is being directed by Dr. Waithaka Mwangi, Kansas State University, Department of Diagnostic Medicine/Pathobiology, who is the inventor of the new technology. In addition, K-State has granted Tonix an option for an exclusive license for the clinical and commercial use of K-State’s intellectual property associated with coronavirus vaccines under this relationship.

*TNX-2300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

1World Health Organizationhttps://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccinesCOVID-19 – Landscape of novel coronavirus candidate vaccine development worldwide, March 2022.
2Liang, B., et al., J. Virol. 2016. 90:10022.
3Karron, R. A., et al., Vaccine. 2012. 30:3975.
4Haller, A. A., et al., J. Gen Virol. 2003. 84:2153.
5Schmidt, A. C., et al., J. Virol. 2001. 75:4594.
6Karron, R. A., et al., J. Infec. Diseases. 1995. 171:1107.
7Haller, A. A., et al., J. Virol. 2000. 74:11626.

About Tonix Pharmaceuticals Holding Corp.

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

1TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-102 SL is an investigational new drug and has not been approved for any indication.
7TNX-1300 is an investigational new biologic and has not been approved for any indication.

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

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of TNX-2300; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
olipriya.das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Musk Refiles with SEC Changing Status to Active Investor in Twitter



Twitter Gets a New Board Member Who Instantly Causes Stock to Rocket

 

Elon Musk, known to be one of the most innovative CEOs of this generation, has been causing the SEC to become more innovative just to keep him from violating
disclosure rules
and other regulations. Some of his more public SEC problems are with what he
posts on Twitter
as the CEO of Tesla. On Monday, he filed the wrong regulatory paperwork, and filed it late. The report disclosed a huge stake in Twitter. On Tuesday, he refiled.

 

Background

On Monday (March 4), Elon Musk disclosed that he bought a 9.2% stake in the social media platform Twitter. This made him the company’s largest shareholder and set off a rally in its shares of more than 27%. US securities law requires that within ten days of acquiring 5% or more of a company, a report must be filed reporting the event. The filing said that March 14, 2022, is the date of the event that required the disclosure. Under this timeline, March 24 would have been the day the ownership report should have been filed. The penalty for this is determined per violation and could amount to $207,183, according to Urska Velikonja, a law professor at Georgetown University Law Center.

Based on the 27% increase in Twitter’s stock price, on $3 billion invested, the civil penalty wouldn’t be felt at all. But there is concern the SEC could look into market manipulation allegations regarding the Twitter stock purchase, and seek harsher sanctions in a previous and ongoing SEC problem regarding a sale he made in Tesla (TSLA) stock to raise money to pay
$11 billion in taxes
.

Edit Button on SEC Reports

Do-over. Elon Musk has taken the step to refile his disclosure, placing himself in the category of an active investor. The old filing (form 13G classified him as a passive investor). The new disclosure (form 13D) categorizes Musk as an active investor. It shows he had been acquiring Twitter shares almost daily between January 31 and April 1. The price range was $32.80 to $40.30. Twitter closed Tuesday at $50.98.

Board Seat

Elon Musk has been involved in such diverse companies as Paypal (PYPL), SpaceX, Tesla (TSLA), The Boring Company, and even the Dogecoin
Foundation.
No doubt, he recognizes the power of social media or micro-blogging. He is also, in his own words a, “free speech absolutist.” So, for Musk to be in the position of being the largest shareholder and have a seat in the boardroom as the company decides the best road to take for its shareholders, is considered a positive for Twitter. The company has lost significant share price this year as users have become disheartened with management’s policies regarding Tweet rules and behind the scene elevation of some discussions over others.

Take-Away

On March 25, Musk tweeted a poll: “Free speech is essential to a functioning democracy. Do you believe Twitter rigorously adheres to this principle?” The next day he Tweeted he was giving “serious thought” to building a new social media platform.  This week he moved in that direction.

His public concern is that Twitter is not an open forum. The serial entrepreneur is likely to put his mark on the company as a board member and as a significant shareholder. Investors have reacted positively to the news.

 

Suggested Reading



Elon Reminds Jeff Bezos that He’s Pulling Away



Elon Musk Weighs in on Unrealized Capital Gains Tax Idea





Musk Boosts DOGE Once Again



Dogecoin Group Works to Give Currency Greater Purpose

 

Sources

https://www.nasdaq.com/articles/analysis-teslas-musk-may-add-to-sec-ire-with-late-report-about-twitter-stake

www.finance.yahoo.com/news/musk-refiles-disclosure-show-221958940.html

 

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Tokens.com (SMURF) – Building Momentum for 2022 and Beyond

Wednesday, April 06, 2022

Tokens.com (SMURF)
Building Momentum for 2022 and Beyond

Tokens.com Corp is a Proof-of-Stake technology company that provides investors with a secure way to gain exposure to staking rewards and cryptocurrencies. It provides investors with exposure to the digital assets that power Decentralized Finance and Non-Fungible Tokens, without the burden of buying, managing, and securing digital assets themselves. The company creates value for its investors through earning Staking yields and the appreciation of its digital asset inventory, all achieved through environmentally friendly technology.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

    4Q21 Results. Tokens.com reported 4Q21 revenue of $326,185, a sequential decline from the third quarter’s $448,976, due to a decline in the value of the crypto assets. We had estimated revenue of $640,000. Higher one-time operating expenses drove an operating loss of $3.0 million in the quarter, with a net loss for the quarter of $3.7 million, or a loss of $0.04 per share. We had projected net income of $25,000, or breakeven per share.

    Poised for 2022.  Today, Tokens.com has three Web 3.0 verticals: purchase and staking, through PoS technology, of tokens; the Metaverse Group, which is focused on building a virtually integrated digital real estate business; and Hulk Labs, which is focused on holding NFT assets and investing in crypto based games that have a token return attached to them …


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. 

 

Cypress Development (CYDVF)(CYP) – Clayton Valley Project to Source Lithium from Nevada Claystone

Wednesday, April 06, 2022

Cypress Development (CYDVF)(CYP)
Clayton Valley Project to Source Lithium from Nevada Claystone

Cypress Development Corp is a Canadian exploration company. It is principally engaged in the acquisition, exploration, and evaluation of resource properties. The company holds an interest in Clayton Valley Lithium Project and Gunman Zinc / Silver Project which are located in Nevada. The company operates through the single segment being The Acquisition and exploration of mineral properties.

Mark Reichman, Senior Research Analyst of Natural Resources, Noble Capital Markets, Inc.

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

    Initiating coverage. Cypress Development Corp. is advancing its 100%-owned Clayton Valley Lithium Project encompassing 6,500 acres in Esmeralda County near Silver Peak, Nevada. Cypress intends to mine Nevada claystone, produce a high-grade lithium concentrate solution and apply a licensed lithium extraction process based on ion-exchange to produce lithium carbonate or hydroxide. Clayton Valley offers several competitive advantages, including a large land package in a mining friendly state, an existing lithium carbonate equivalent resource base, well-developed infrastructure, direct lithium extraction technology, a leased facility permitted for pilot testing, and secured water rights.

    Significant existing mineral resource.  A preliminary feasibility study, amended in March 2021, highlighted 1.304 billion tonnes of indicated resources, averaging 905 parts per million (ppm) lithium, including probable reserves of 213 million tonnes of probable reserves averaging 1,129 parts per million (ppm) lithium, or 1.28 million tonnes of lithium carbonate equivalent (LCE). The study affirmed …


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. 

 

CoreCivic, Inc. (CXW) – What Can End of Title 42 Mean

Tuesday, April 05, 2022

CoreCivic, Inc. (CXW)
What Can End of Title 42 Mean?

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 corrections and detention management, a growing network of residential reentry centers to help address America’s recidivism crisis, and government real estate solutions. We are a publicly traded real estate investment trust and the nation’s largest owner of partnership correctional, detention and residential reentry facilities. We also believe we are the largest private owner of real estate used by U.S. government agencies. The Company has been a flexible and dependable partner for government for more than 35 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.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

    Title 42 to End? The Biden Administration has stated the enforcement of Title 42 to expel immigrants will end May 23rd. First authorized in March 2020 during the COVID crisis, Title 42 continued to be enforced by the Biden Administration over the past year as a key tool to stop the spread of the virus in border facilities, but with the decline in COVID cases, the Administration will end the use of Title 42.

    Poised for a Surge? In the first five months of the government fiscal year, monthly Southwest border encounters are averaging nearly 170,000 and are on pace to top two million for the year.  Some reports suggest the number of people crossing once the restriction is lifted could triple to 18,000 per day, or more than double the current monthly encounter amount …


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. 

 

The GEO Group Inc. (GEO) – What Can End of Title 42 Mean

Tuesday, April 05, 2022

The GEO Group, Inc. (GEO)
What Can End of Title 42 Mean?

With over 94,000 beds owned, leased or managed across its business lines and serving over 260,000 people daily, GEO is a leading provider of mission critical real estate to its governmental partners. The Company is the first fully integrated equity REIT specializing in the design, financing, development, and operation of secure facilities, processing centers, and community reentry centers in the U.S., Australia, South Africa, and the U.K.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

    Title 42 to End? The Biden Administration has stated the enforcement of Title 42 to expel immigrants will end May 23rd. First authorized in March 2020 during the COVID crisis, Title 42 continued to be enforced by the Biden Administration over the past year as a key tool to stop the spread of the virus in border facilities, but with the decline in COVID cases, the Administration will end the use of Title 42.

    Poised for a Surge? In the first five months of the government fiscal year, monthly Southwest border encounters are averaging nearly 170,000 and are on pace to top two million for the year.  Some reports suggest the number of people crossing once the restriction is lifted could triple to 18,000 per day, or more than double the current monthly encounter amount …


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

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

 

Release – Defense Metals Closes Private Placement Financing



Defense Metals Closes Private Placement Financing

News, and Market Data on Defense Metals

 

News Release – Vancouver, British Columbia – April 5, 2022:Defense Metals Corp. (“Defense Metals” or the “Company”) (TSX-V:DEFN / OTCQB:DFMTF / FSE:35D) is pleased to announce that it has closed a non-brokered private placement (the “Private Placement”) for gross proceeds of $4,558,049.57, consisting of 6,340,057 flow-through common shares of the Company (each, a “FT Share”) at a price of $0.35 per FT Share and 8,996,267 units of the Company (each, a “Unit”) at a price of $0.26 per Unit.  

Each FT Share is a “flow-through share” within the meaning of the Income Tax Act (Canada) (the “Act”). Each Unit consists of one common share of the Company and one common share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to purchase one common share of the Company at a price of $0.40 for a period of 24 months from the date of issuance, provided that if after four months from the date of issue and prior to the expiry of the Warrants, the closing price of the common shares of the Company is equal to or greater than $0.60 for a period of 15 consecutive trading days, the Company will have the right to accelerate the expiry of the Warrants by giving notice to the holders that the Warrants will expire 15 days from the date of notice.  

The proceeds of the Private Placement will be used for the exploration and development of the Company’s Wicheeda Rare Earth Element Project located near Prince George, British Columbia and for general working capital purposes.

In connection with the Private Placement, the Company paid aggregate cash finder’s fees of $162,152.92 and issued 487,087 non-transferable finder warrants to Leede Jones Gable Inc., Qwest Investment Fund Management Ltd., Accilent Capital Management Inc., iA Private Wealth Inc., Haywood Securities Inc., Canaccord Genuity Corp., Research Capital Corporation and Glores Securities Inc. The finder warrants are exercisable for a period of 24 months from issuance at a price of $0.35 per share.

An insider-director of the Company subscribed for 60,000 Units, which participation constituted a “related party transaction” within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). Such participation is exempt from the formal valuation and minority shareholder approval requirements under MI 61-101 pursuant to subsections 5.5(b) and 5.7(1)(a) as the Company’s common shares are not listed on a specified market and the fair market value of the securities acquired do not exceed 25% of the Company’s market capitalization. 

All securities issued under the Private Placement are subject to a four month hold period in accordance with applicable securities laws.

About the Wicheeda REE Project

The 100% owned 2,008-hectare Wicheeda REE Property, located approximately 80 km northeast of the city of Prince George, British Columbia, is readily accessible by all-weather gravel roads and is near infrastructure, including power transmission lines, the CN railway, and major highways.

The Wicheeda REE Project yielded a robust 2021 PEA that demonstrated an after-tax net present value (NPV@8%) of $517 million, and 18% IRR[1]. A unique advantage of the Wicheeda REE Project is the production of a saleable high-grade flotation-concentrate. The PEA contemplates a 1.8 Mtpa (million tonnes per year) mill throughput open pit mining operation with 1.75:1 (waste:mill feed) strip ratio over a 19 year mine (project) life producing and average of 25,423 tonnes REO annually. A Phase 1 initial pit strip ratio of 0.63:1 (waste:mill feed) would yield rapid access to higher grade surface mineralization in year 1 and payback of $440 million initial capital within 5 years.

Qualified Person

The scientific and technical information contained in this news release as it relates to the Wicheeda REE Project has been reviewed and approved by Kristopher J. Raffle, P.Geo. (BC) Principal and Consultant of APEX Geoscience Ltd. of Edmonton, AB, a director of Defense Metals and a “Qualified Person” as defined in NI 43-101.

About the Company

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

Contact Information – For more information, please contact:

Todd Hanas, Bluesky Corporate Communications Ltd.

Vice President, Investor Relations

Tel: (778) 994 8072

Email: todd@blueskycorp.ca

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 news release.

This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful, including any of the securities in the United States of America. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “1933 Act”) or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.

Forward-Looking Information

This news release contains “forward?looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements that address the Private Placement, use of proceeds, other statements relating to the technical, financial, and business prospects of the Company, its projects, and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company 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 may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of metals, anticipated costs and the ability to achieve goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms, and that third party contractors, equipment and supplies and governmental and other approvals required to conduct the Company’s planned exploration activities will be available on reasonable terms and in a timely manner. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration results, risks related to the inherent uncertainty of exploration and cost estimates and the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR at www.sedar.com. There is a possibility that future exploration, development or mining results will not be consistent with the Company’s expectations. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, failure to secure personnel and equipment for work programs, adverse weather and climate conditions, failure to maintain all necessary government permits, approvals and authorizations, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, the price of metals and commodity price fluctuations, failure to maintain community acceptance (including First Nations), increase in costs, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–looking statements or forward–looking information, except as required by law.


[1] Independent Preliminary Economic Assessment for the Wicheeda Rare Earth Element Project, British Columbia, Canada, dated January 6, 2022, with an effective date of November 7, 2021, and prepared by SRK Consulting (Canada) Inc. is filed under Defense Metals Corp.’s Issuer Profile on SEDAR (www.sedar.com).

Release – Maple Gold Reports Fall 2021 Drill Results at Douay



Maple Gold Reports Fall 2021 Drill Results at Douay, Including 4.63 g/t Gold over 6.7 Metres Within 1.54 g/t Gold over 32.2 Metres at the 531 Zone, and Makes Equity Incentive Plan Grants

Research, News, and Market Data on Maple Gold Mines

 

Vancouver, British Columbia–(Newsfile Corp. – April 5, 2022) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to report final assay results from the Fall 2021 drill program at the Company’s Douay Gold Project (“Douay” or the “Project”) in Quebec, Canada, which is held by a 50/50 joint venture (the “JV”) between the Company and Agnico Eagle Mines Limited. The JV completed a total of seven (7) holes and roughly 3,420 metres (“m”) under the Fall 2021 drill program, with every hole intersecting multiple intervals of >1 gram per tonne gold (“g/t Au”).

Highlights:

  • Drill hole DO-21-316 at the 531 Zone intersected 1.54 g/t Au over 32.2 m (from 430.0 m downhole), including 4.63 g/t Au over 6.7 m within 2.13 g/t Au over 18.9 m.
  • DO-21-316 intercepts are located approximately 135 m down-plunge from the best intercept drilled to-date at the 531 Zone (DO-21-310; see news from September 9, 2021) and below the SLR 2022 NI43-101 Mineral Resource Estimate (“SLR 2022”) conceptual pit limits, indicating down-plunge continuity of high-grade mineralized trends and resource expansion potential at depth in the 531 Zone.
  • Drill hole DO-21-317 intersected three discrete gold zones: 5.58 g/t Au over 3.0 m (from 258.0 m downhole); 1.62 g/t Au over 16.0 m (from 284.0 m downhole); and 3.42 g/t Au over 8.0 m (from 369.0 m downhole).
  • DO-21-317 intercepts are located up-plunge relative to the DO-21-310 intercept and within a different stratigraphic horizon relative to DO-21-316 that is also favourable for gold mineralization, indicating multiple stacked gold zones that remain open.

“Our exploration team has delivered significant drill intercepts every year at the 531 Zone since 2019 when our targeting became supported by 3D modelling,” stated Fred Speidel, VP Exploration of Maple Gold. “These new intercepts further support our belief that there are multiple stacked gold zones with apparent cross-plunges that appear to be structurally controlled. Demonstrated gold mineralization combined with a general lack of drilling has our team excited about the potential for the 531 Zone to deliver additional pit-constrained and underground resources as we continue with larger step-out and deeper drilling in 2022.”

Fall 2021 Drill Program Interpretation and Summary of Results

The JV’s Fall 2021 drill program included drilling in three separate areas (see Figure 1 for drill hole locations) outlined below with corresponding objectives:

  1. 531 Zone (3 holes): Targeting further up-plunge and down-plunge along one of the two main interpreted mineralized trends (see Figure 2).
  2. Central Zone (2 holes): Located 450 m and 650 m east of the SLR 2022 Central Zone conceptual pit and designed to test the eastern continuity of sediment-hosted gold mineralization and support further drilling along a 700 m drilling gap (see Figure 1).
  3. Nika Zone / Porphyry Zone Gap Area (2 holes): The Porphyry Zone and Nika Zone are geologically similar and these two drill holes were drilled in the gap area between these two zones and their respective SLR 2022 conceptual pits.



Figure 1: Douay plan view map highlighting Fall 2021 drill hole locations

The 531 Zone has several geological similarities to the Douay West Zone; however, the former has seen significantly less drilling to-date (see Figure 1) and represents an opportunity to expand resources with mineralization remaining open in multiple directions.

Figure 2: North-looking 531 Zone section (50 m total width) with SLR 2022 resource blocks and drill hole locations.

Figure 2 shows gold mineralization extending down-plunge over 300 m from D-93-08 through DO-21-317 to beyond DO-21-316 and then to 70531 (the original 531 Zone discovery hole). Mineralization remains open along both trends (blue and red arrows) at the 531 Zone. Apart from historical drillholes D-92-41 (2.0 g/t Au over 22.9 m) and D-93-08 (1.52 g/t Au over 13.7m), there is no drilling up-plunge to test at shallower depths on this section (see Figure 2 above) leaving mineralization open toward surface. DO-21-319 (2.12 g/t Au over 2.20 m, including 3.56 g/t Au over 1.5 m and 1.44 g/t Au over 5 m, including 2.47 g/t Au over 2.0 m) was an approximately 160 m step-out drill hole (mostly off section in Figure 2) that appears to have just intersected the lower edge of westerly-plunging mineralization in this area, which warrants follow-up drilling.

A second, roughly perpendicular trend or “cross-plunge”, currently less defined but consistent with the typical easterly-plunging mineralization at Douay, is supported by current geological interpretations and the distribution of SLR 2022 resource blocks. This trend is also open to depth with very little drilling (red arrow), but does include DO-20-262X, one of the most significant holes drilled at 531 Zone (see news releases from June 5, 2019 and March 16, 2020).

The DO-21-316 intercept (1.54 g/t Au over 32.2 m, including 2.13 g/t Au over 18.9 m and 4.63 g/t Au over 6.70 m) is hosted in bleached, massive, and relatively homogenous brecciated mafic intrusive that is geologically similar to the previously reported DO-21-310 intercept (8.8 g/t Au over 28 m) located approximately 135 m up-plunge. The DO-21-317 intercepts (5.58 g/t Au over 3.0 m; 1.62 g/t Au over 16.0 m; and 3.42 g/t Au over 8.0 m) are hosted in altered and mineralized fenitized basalts or interflow sediments, also favourable for gold, and are interpreted as additional stacked gold zones.

The altered mafic (and to a lesser degree sedimentary) host rocks, as observed in drill core, point to the possibility of an additional alkaline intrusive complex beneath the 531 Zone. The JV’s ongoing and planned drilling in 2022 includes larger step-out and deeper drilling to target areas with significant resource expansion potential. Drill testing the 531 Zone at greater depths continues to rank high on the JV’s priority list.

Central Zone drilling intersected multiple narrow zones of mostly sediment-hosted gold mineralization, including multi-gram intercepts in both drill holes. DO-21-318 intersected 2.53 g/t Au over 4.0 m (from 286.0 m downhole); DO-21-315 intersected 1.25 g/t Au over 4.0m (from 260.0 m downhole) and 4.24 g/t Au over 1.0 m (from 362.0 m downhole). Collectively, these two holes confirm that gold mineralization continues well to the east of the current SLR 2022 Central Zone conceptual pit and support drilling still further to the east along a 700 m drilling gap.

Drilling in the Nika Zone intersected multiple broad intervals of lower-grade mineralization in a gap area with very limited drilling between the Nika and Porphyry Zones (see Figure 1 and Table 1). This gap area has a similar magnetic signature as the centre of the Nika Zone (some 500 m to the northwest) where hole DO-21-282X intersected 1.58 g/t Au over 132 m (see news release from May 26, 2021). Given the general lack of drilling within this gap area, and particularly the presence of near-surface gold mineralization starting at top of bedrock, the results will be further interpreted with the aim of vectoring in towards larger near-surface concentrations of >1 g/t Au mineralization.

Complete Fall 2021 drill program results at Douay are included in Table 1 below.




Table 1 – Summary of Fall 2021 Drill Program Results at Douay

Notes: All intervals are downhole core lengths. True widths estimated to be approximately 70-90% of core lengths.

Annual Equity Incentive Plan Grants

Pursuant to its Equity Incentive Plan (the “Plan”) dated December 17, 2020 and the policies of the TSX Venture Exchange, the Company has granted stock options (“Options”), Restricted Share Units (“RSUs”) and Deferred Share Units (“DSUs”) to certain employees, officers and directors of the Company.

Options to purchase an aggregate of 3,500,000 common shares of the Company (each, a “Common Share”) were granted, with an exercise price of $0.42 per Common Share. Each Option grant vests one-third on the date of the grant, one-third 12 months from the date of the grant and one-third 24 months from the date of the grant. Once vested, each Option is exercisable into one Common Share for a period of five years from the date of the grant.

The Company also granted a total of 3,530,000 RSUs and 900,000 DSUs. Each RSU grant vests one-third on April 30, 2022, one-third 12 months from the date of the grant and one-third 24 months from the date of the grant. Once vested, each RSU and DSU entitles the holder thereof to receive either one Common Share, the cash equivalent of one Common Share or a combination of cash and Common Shares, as determined by the Company, net of applicable withholdings.

Further details regarding the Plan are set out in the Management Information Circular of the Company filed on May 19, 2021, which is available on SEDAR.

Qualified Person

The scientific and technical data contained in this press release was reviewed and prepared under the supervision of Fred Speidel, M. Sc., P. Geo., Vice-President Exploration of Maple Gold. Mr. Speidel is a Qualified Person under National Instrument 43-101 Standards of Disclosure for Mineral Projects. Mr. Speidel has verified the data related to the exploration information disclosed in this press release through his direct participation in the work.

Quality Assurance (QA) and Quality Control (QC)

The JV implements strict Quality Assurance (“QA”) and Quality Control (“QC”) protocols at Douay covering the planning and placing of drill holes in the field; drilling and retrieving the NQ-sized drill core; drillhole surveying; core transport to the Douay Camp; core logging by qualified personnel; sampling and bagging of core for analysis; transport of core from site to ALS laboratories in Val-d’Or, QC; sample preparation for assaying; and analysis, recording and final statistical vetting of results. For a complete description of protocols, please visit the Company’s QA/QC webpage at www.maplegoldmines.com.

About Maple Gold

Maple Gold Mines Ltd. is a Canadian advanced exploration company in a 50/50 joint venture with Agnico Eagle Mines Limited to jointly advance the district-scale Douay and Joutel gold projects located in Quebec’s prolific Abitibi Greenstone Gold Belt. The projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold resource at Douay (SLR 2022) that holds significant expansion potential as well as the past-producing Eagle, Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property.

The district-scale property package also hosts a significant number of regional exploration targets along a 55 km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the project ripe for new gold and polymetallic discoveries. The Company is well capitalized and is currently focused on carrying out exploration and drill programs to grow resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.

ON BEHALF OF MAPLE GOLD MINES LTD.

“Matthew Hornor”

B. Matthew Hornor, President & CEO

For Further Information Please Contact:

Mr. Joness Lang
Executive Vice-President
Cell: 778.686.6836
Email: jlang@maplegoldmines.com

Mr. Kiran Patankar
SVP, Growth Strategy
Cell: 604.935.9577
Email: kpatankar@maplegoldmines.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 PRESS RELEASE.

Forward Looking Statements:

This press release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada, including statements about exploration work and results from current and future work programs. Forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events. Actual events or results could differ materially from the Company’s expectations and projections. Investors are cautioned that forward-looking statements involve risks and uncertainties. Accordingly, readers should not place undue reliance on forward-looking statements. For a more detailed discussion of such risks and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, refer to Maple Gold Mines Ltd.’s filings with Canadian securities regulators available on www.sedar.com or the Company’s website at www.maplegoldmines.comThe Company does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.