Market Newsdesk

MIAMI, April 16, 2021 (GLOBE NEWSWIRE) — Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics for the psychedelic and mental health sectors, announced today plans to launch brain mapping ketamine clinical trials using Brain Scientific technology later this year. The clinical trial will establish the statistical correlation between the ketamine treatment and patient improvement from the disorders.

The trial, which is designed to enroll 35 patients, is expected to start in the second half of 2021. Ehave is currently completing the necessary preclinical studies necessary to begin enrolling patients in the trial. The average drop out ratio of clinical trials is around 15 % and Ehave will need at least 25-30 patients’ egg data to establish statistical significance of the efficacy of the ketamine over the indication, such as PTSD and Major Refractory Depression. Ehave will partner with Brain Scientific Inc. to leverage both data and AI to correlate biomarkers for the Identification of Chronic pain, Depression (major and persistent), PTSD, Bipolar disorder, General anxiety, ADHD and Schizophrenia. The two companies will collaborate to exploit graph based AI, linked data protocols with respect to such AI and leverage such data and AI to develop neural net algorithms.

Ketamine has been used in the past to reduce the amount of potentially addictive pain medication required after certain medical procedures, but it is now being studied as a treatment for major depression, though it has not yet been approved by the FDA to treat depression. In March 2019 the U.S. Food and Drug Administration approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers and was approved by the FDA in 1970. The FDA granted the approval of Spravato to Janssen Pharmaceuticals, Inc., a pharmaceutical company headquartered in Beerse, Belgium and owned by Johnson & Johnson. Ketamine clinks to treat depression are becoming common in many cities in the U. S. and Canada. Ehave intends to provide Ketamine clinics and medical practitioners with software, staffing, protocols, and equipment as part of the KetaDASH platform.

Dr. Manideep Gopishetty, Medical Advisor and Chief Medical Officer of Ehave said, “The brain mapping of the patients to measure the efficacy of the ketamine treatment would help us to identify the biomarkers of the brain which shows the changes in neuroplasticity of the brain areas impacted by the treatment and could pave pathway to new forms of treatment using the drug and would also help companies to bring ketamine treatment to fore front to address chronic mental health disorders based on the outcomes of the study.”

The study’s primary goal is to assess the candidate therapy’s safety and tolerability. Both Ehave and Brain Scientific have expressed a commitment to provide regular progress updates regarding the clinical trial process, activities related to the study’s launch, and any expected timelines. Depression is a common mental disorder affecting more than 264 million people worldwide. Mental health experts find a strong link between loneliness and depression and drug overdoses. According to national drug abuse data, drug overdoses have increased 42% since Covid-19 reared its ugly head. As a result, mental health disorders are on the rise in every country and could cost the global economy up to $16 trillion annually by 2030.

Alfred Farrington II, CIO of Ehave, Inc. said, “Ehave’s goal is to help practitioners make more informed decision about mental health care. We believe the data from this clinical trial will provide longitudinal insights that can link brain analysis and psychedelics. This clinical trial in conjunction with Brain Scientific has the potential to revolutionize mental health by digitizing and analyzing data in order to give the health industry the opportunity to learn from it and help mental health researchers make informed decisions for better outcomes.”

Ben Kaplan, CEO of Ehave said, “We are very grateful to all families who volunteer to take part in research and drug development efforts. We look forward to continuing our remarkable partnership with Brain Scientific as we advance towards a treatment for major depression.”

Additional Ehave Inc. Information

We are truly grateful for the support of EHVVF shareholders! Please join the conversation on our Ehave supporter’s telegram group at https://t.me/EhaveInc.

The company posts important information and updates through weekly videos from the official company YouTube channel https://www.youtube.com/channel/UCnyW1mgMd0qmYkEMq3O6FWA.

Please follow Ehave on Twitter @Ehaveinc1

About Ehave, Inc.

Ehave, Inc. (EHVVF) is a leader of digital therapeutics delivering evidence-based therapeutic interventions to patients. Our primary focus is on improving the standard care in therapeutics to prevent or treat brain disorders or diseases through the use of digital therapeutics, independently or together, with medications, devices, and other therapies to optimize patient care and health outcomes. Our main product is the Ehave Telemetry Portal, which is a mental health informatics platform that allows clinicians to make objective and intelligent decisions through data insights. The Ehave Infinity Portal offers a powerful machine learning and artificial intelligence platform with a growing set of advanced tools and applications developed by Ehave and its leading partners. This empowers patients, healthcare providers, and payers to address a wide range of conditions through high quality, safe, and effective data-driven involvement with intelligent and accessible tools. Additional information on Ehave can be found on the Company’s website at: www.ehave.com.

About Brain Scientific:

Brain Scientific is a commercial-stage healthcare company with two FDA-cleared products, providing next-gen solutions to the neurology market. The Company’s smart diagnostic devices and sensors simplify administration, shorten scan time and cut costs, allowing clinicians to make rapid decisions remotely and bridge the widening gap in access to neurological care. To learn more about our corporate strategy, devices or for investor relations please visit: www.brainscientific.com or email us at [email protected].

Forward-Looking Statement Disclaimer

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading “Risk Factors” in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC’s website, http://www.sec.gov.

Contact: Ehave Inc

Media Inquiries: Gabe Rodriguez

[email protected]

Investor Relations:

Email: [email protected]

Phone: (623) 261-9046

• New findings from MS PATHS show that treatment with TYSABRI
  
  ^®
  
   (natalizumab) can lead to meaningful improvements in mental and social health compared to Ocrevus
  
  ^®
  
  (ocrelizumab)
  
• Real-world data from VUMERITY
  
  ^®
  
  (diroximel fumarate) reinforce the treatment’s positive gastrointestinal tolerability profile
• Biogen advances leading research to help inform future patient management including new information on the clinical profile of extended interval dosing with natalizumab
  

CAMBRIDGE, Mass., April 16, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies to be presented at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting, April 17-22. The presentations include data on quality of life benefits and analyses of extended interval dosing (EID) with TYSABRI^® (natalizumab) as well as new real-world experience data from VUMERITY^® (diroximel fumarate). The research adds to the vast clinical knowledge Biogen continues to advance as part of its commitment to the care of people living with MS.

“With chronic conditions like MS, where every patient has a different experience with the disease, it is critically important to understand how treatment impacts their daily living and quality of life,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “These data show that the benefits TYSABRI provides in terms of a patient’s quality of life are substantial and that the positive gastrointestinal tolerability profile of VUMERITY can help people with relapsing MS continue with treatment, which is essential to delay its progression.”

Analyses Demonstrate Improved Quality of Life Outcomes with TYSABRI
and Further Evaluate Extended Interval Dosing

To better understand clinically meaningful quality of life benefits following treatment with TYSABRI, MS PATHS (Partners Advancing Technology and Health Solutions) researchers analyzed patient reported data on 12 different domains on the Neuro-QoL (Quality of Life in Neurological Disorders) questionnaire such as sleep disturbance, anxiety, fatigue, depression and participation in daily activities. Results included:

• In people treated with TYSABRI or Ocrevus^® (ocrelizumab) with baseline impairment, statistically significant improvements were seen in 10 of 12 and 8 of 12 Neuro-QoL domains, respectively. In 11 of 12 domains on the Neuro-QoL questionnaire, the adjusted annualized rate of improvement was greater with TYSABRI as compared to Ocrevus.
• The difference between the two therapies was statistically significant in favor of TYSABRI in three of the domains: satisfaction with social roles and activities (p=0.02), participation in social roles and activities (p=0.0001) and emotional and behavioral dyscontrol (p=0.01).

Neuro-QoL is an independently validated set of patient-reported outcome measurements that assess the physical, mental and social effects of people living with neurological conditions such as MS. Biogen established the MS PATHS network to foster collaboration between leading MS centers in Europe and the U.S. to help transform patient care by generating standardized data from a diverse, real-world patient population.

Additionally, results from two new analyses investigating EID with natalizumab may help further inform the drug’s benefit-risk profile. Biogen continues to evaluate the efficacy, safety and tolerability of natalizumab EID through the prospective NOVA trial (NCT03689972) with initial results expected in 2021.

• From an analysis of data in MS PATHS, natalizumab patients receiving either EID or Standard Interval Dosing (SID) had comparable real-world effectiveness on quantitative magnetic resonance imaging (MRI) outcomes (p>0.05 for all MRI outcomes).
• An updated analysis of data from the TOUCH Prescribing Program demonstrated in the primary analysis that EID is associated with a significant (P<0.0001) 88% reduction in the risk of progressive multifocal leukoencephalopathy (PML) in comparison to the approved every four-week dose. The data, which included more patients followed for a longer period and with slightly greater exposures, reinforces results from earlier analyses of EID.

Data Confirm Positive Gastrointestinal Tolerability Profile With VUMERITY in Real-World Setting

New findings on the use of VUMERITY in a real-world setting reinforce the benefits of improved gastrointestinal (GI) tolerability and confirm that the experience in clinical trials is consistent with clinical practice. In a retrospective analysis of data from December 2019 to August 2020 of 160 patients with relapsing MS, the treatment discontinuation rate due to GI side effects was low (3.8%) with 88.6% estimated to still be on therapy at the end of analysis and a high rate of adherence (91.4%). In a subgroup of patients who switched from TECFIDERA^® (dimethyl fumarate) to VUMERITY, the majority of patients switched as a result of gastrointestinal tolerability with most remaining on therapy (92.3%).

Biogen Continues Leading Research in MS

The presentations at AAN are part of Biogen’s ongoing commitment to the MS community, improving the understanding of the disease and advancing treatment through innovation. The company recently launched a subcutaneous injection of TYSABRI in Europe and an intramuscular administration of PLEGRIDY^® (peginterferon beta-1a) in the United States and Europe. Biogen currently has more than 25 MS clinical trials underway including research on considerations around COVID-19 vaccination for people with MS.

Data Presentations Featured at AAN:

• Impact of Natalizumab on Quality of Life in a Real-World Cohort of Patients with Multiple Sclerosis: Results from MS Partners Advancing Technology and Health Solutions (MS PATHS) – P15.023
• No Difference in Radiologic Outcomes for Natalizumab Patients on Extended Interval Dosing Compared with Standard Interval Dosing in MS PATHS – P15.210
• Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-week (Q4W) Dosing: Updated Analysis of the TOUCH^® Prescribing Program Database – P15.201
• Multiple Sclerosis Patients Treated with Diroximel Fumarate in the Real-world Setting have High Rates of Persistence and Adherence – P15.227

About TYSABRI

^®

(natalizumab)

TYSABRI is a well-established relapsing multiple sclerosis (RMS) treatment indicated for relapsing forms of MS in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. TYSABRI is approved in 80 countries, and over 220,000 people worldwide have been treated with TYSABRI, with over 880,000 patient-years of experience, based on clinical trials and prescription data.¹

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the presence of anti-JC virus antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.

TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis), a decrease in lymphocyte counts and infections, including opportunistic and other atypical infections.

Please click here for Important Safety Information, including Boxed Warning, and full Prescribing Information, including Medication Guide for TYSABRI in the U.S., or visit your respective country’s product website.

About VUMERITY

^®

 (diroximel fumarate)

VUMERITY is an oral fumarate with a distinct chemical structure from TECFIDERA^® (dimethyl fumarate), approved in the U.S. for the treatment of relapsing forms of multiple sclerosis in adults, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once in the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate.

VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, dimethyl fumarate or to any of the excipients of VUMERITY; and in patients taking dimethyl fumarate. Serious side effects for VUMERITY are based on data from dimethyl fumarate (which has the same active metabolite as VUMERITY) and include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, which is a rare opportunistic viral infection of the brain that has been associated with death or severe disability, a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. The most common adverse events, obtained using data from dimethyl fumarate (which has the same active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea.

Please click here for Important Safety Information and full Prescribing Information, including Patient Information for VUMERITY in the U.S.

About TECFIDERA

^®

 (dimethyl fumarate) 

TECFIDERA, a treatment for relapsing forms of multiple sclerosis (MS) in adults, is the most prescribed oral medication for relapsing MS in the world and has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing forms of MS. TECFIDERA is approved in 69 countries, and more than 500,000 patients have been treated with it, representing more than 950,000 patient-years of exposure across clinical trial use and patients prescribed TECFIDERA. Of these, 6,335 patients (14,241 patient-years) were from clinical trials.²

TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Serious side effects include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, a rare opportunistic viral infection of the brain which has been associated with death or severe disability, have been seen with TECFIDERA patients in the setting of prolonged lymphopenia although the role of lymphopenia in these cases is uncertain. Other serious side effects include a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. In clinical trials, the most common adverse events associated with TECFIDERA were flushing, abdominal pain, diarrhea and nausea.

Please click here for Important Safety Information and full Prescribing Information, including Patient Information for TECFIDERA in the U.S., or visit your respective country’s product website.

About PLEGRIDY

^®

 (peginterferon beta-1a)

PLEGRIDY is a pegylated interferon dosed once every two weeks for relapsing forms of multiple sclerosis (MS) in adults, the most common form of MS. PLEGRIDY is currently approved in over 60 countries including the U.S., Canada, Australia and Switzerland and across the European Union. Over 61,000 people worldwide have been treated with PLEGRIDY, with over 120,000 patient-years of experience, based on prescription data.³ Biogen continues to work toward making PLEGRIDY available in additional countries across the globe.

The efficacy and safety of PLEGRIDY are supported by one of the largest pivotal studies with interferons conducted in people living with relapsing-remitting MS. In clinical studies, PLEGRIDY has been proven to significantly reduce the rate of MS relapses, slow the progression of disability and reduce the number of MS brain lesions while demonstrating a well-characterized safety profile for patients with relapsing forms of MS. Side effects reported include liver problems, including liver failure and increases in liver enzymes; depression or suicidal thoughts; serious allergic reactions; injection site reactions, cardiac problems, including congestive heart failure; blood problems, such as decreases in white blood cell or platelet counts; autoimmune disorders; and seizures. In clinical trials, the most common adverse events associated with PLEGRIDY were injection site reactions and flu-like symptoms. A list of adverse events can be found in the full PLEGRIDY product labeling for each country where it is approved. PLEGRIDY can be considered for use in relapsing MS patients throughout the full course of pregnancy and during breast-feeding, if clinically needed.

Please click here for Important Safety Information and full Prescribing Information, including Medication Guide for PLEGRIDY in the U.S., or visit your respective country’s product website.

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media Twitter, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of TYSABRI and VUMERITY; the results of certain real-world data; clinical trials and data readouts and presentations; the identification and treatment of MS; our research and development program for the treatment of MS; and the potential of our commercial business, including TYSABRI and VUMERITY. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; risks of unexpected costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

References:

1. Combined post-marketing data based on prescriptions and clinical trials exposure to TYSABRI as of January 31, 2021.
2. Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of December 31, 2020.
3. Combined post-marketing data based on prescriptions for PLEGRIDY as of September 30, 2020.

MEDIA CONTACT: David Caouette + 1 617 679 4945 [email protected]

INVESTOR CONTACT: Mike Hencke +1 781 464 2442 [email protected]

Ublituximab demonstrated superiority versus teriflunomide in reducing annualized relapse rates and MRI brain lesions

Ublituximab was generally well tolerated, with no unexpected safety signals

BLA submission targeted in Q3 2021

Webcast to be held today, Friday, April 16, 2021 at 8:30 AM ET

NEW YORK, April 16, 2021 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced positive results from two global, active-controlled, Phase 3 studies, called ULTIMATE I & II, evaluating ublituximab, the Company’s investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide, in patients with relapsing forms of multiple sclerosis (RMS). Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Key secondary MRI endpoints were also met.

These data will be previewed on a call today and presented at the American Academy of Neurology (AAN) 73^rd Annual Meeting, tomorrow April 17, 2021. Details of each event are included below.

Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and Global Study Chair for the ULTIMATE I & II studies commented, “The results of the ULTIMATE I & II studies show that not only did ublituximab effectively reduce relapses in patients with RMS, but had a profound effect on suppressing inflammatory activity, evident by the reduction in both T1 Gd enhancing lesions as well as T2 lesions. Taken together, historically low ARRs, marked reductions in brain lesions and very low rates of confirmed disability progressions resulted in nearly half of the patients treated with ublituximab achieving no evidence of disease activity, a goal we strive for when treating our patients with RMS, which continues to be a challenge to achieve.” Dr. Steinman continued, “Today represents an exciting day for RMS patients who continue to need efficacious and convenient treatment options.”

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “We are extremely pleased with the results from the ULTIMATE I & II Phase 3 trials. We believe these data showcase ublituximab to be a highly efficacious treatment option with a generally well tolerated safety profile. If approved, ublituximab will be the only CD20 offered in a convenient one-hour infusion every six months, following the first dose. We look forward to sharing these results during our webcast and at AAN and are targeting a BLA submission for ublituximab to treat patients with RMS in the third quarter of this year.”

The ULTIMATE I & II studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the Day 1 infusion (150mg over four hours). The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Additionally, data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in the third quarter of 2021.

Data highlights from the ULTIMATE I & II Phase III studies in patients with RMS include:

Primary Endpoint: Annualized Relapse Rate (ARR) Results

• In ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.076 compared to 0.188 for teriflunomide, representing a relative reduction of approximately 60% (p<0.0001).
• In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.091 compared to 0.178 for teriflunomide, representing a relative reduction of approximately 50% (p=0.0022).

MRI Results

• Total number of T1 Gadolinium (Gd) enhancing lesions were reduced as a result of ublituximab treatment by 97% and 96% relative to treatment with teriflunomide in ULTIMATE I & II, respectively (p<0.0001).
• New or enlarging T2 lesions were reduced as a result of ublituximab treatment by 92% and 90% relative to treatment with teriflunomide in ULTIMATE I & II, respectively (p<0.0001).

No Evidence of Disease Activity (NEDA) Results

• In ULTIMATE I, 44.6% of ublituximab treated patients achieved NEDA representing a 198% improvement over teriflunomide (p <0.0001).
• In ULTIMATE II, 43% of ublituximab treated patients achieved NEDA representing a 277% improvement over teriflunomide (p<0.0001).

Prespecified Pooled Disability Results

• A very low rate of disability progression was observed across all treatment groups. Only 5.2% of ublituximab treated patients showed a 12-week Confirmed Disability Progression (CDP), compared to 5.9% with teriflunomide, and only 3.3% of ublituximab treated patients showed a 24-week CDP, compared to 4.8% with teriflunomide; neither was statistically different.
• Ublituximab treatment increased the proportion of patients with 12-week Confirmed Disability Improvement (CDI) and 24-week CDI, demonstrating a 100% improvement in 12-week CDI (12% v. 6%; p=0.0003), and an 88% improvement in 24-week CDI (9.6% v. 5.1%; p=0.0026) compared to teriflunomide.

Ublituximab was generally well tolerated with no unexpected safety signals. Overall, the proportion of patients in the ublituximab group with adverse events was similar to the teriflunomide group in a pooled analysis of both studies (approximately 88% in each treatment group); the most common adverse event associated with ublituximab was infusion related reactions (47.7% of patients who received ublituximab experienced at least one infusion-related reaction vs. 12.2 percent for the teriflunomide group).

ULTIMATE I & II PHASE 3 INVESTOR & ANALYST WEBCAST DETAILS

• Date & Time: Friday April 16, 2021 at 8:30 AM ET
• Key Opinion Leader Participants:
  • Lawrence Steinman, MD, of Stanford University and the Global Study Chair for the ULTIMATE I & II Phase 3 trials
  • Edward J. Fox, MD, PhD, of Central Texas Neurology Consultants and Chair for the ublituximab Phase 2 trial
  • Enrique Alvarez, MD, PhD, of University of Colorado Medicine
• Live Webcast: http://ir.tgtherapeutics.com/events (also archived for future review)

AAN ANNUAL MEETING POSTER PRESENTATION DETAILS

Title: Efficacy and safety of ublituximab versus teriflunomide in relapsing multiple sclerosis: Results of the Phase 3 ULTIMATE I and II trials

• Date & Time: Available for viewing beginning Saturday April 17, 2021 at 8:00 AM ET
• Abstract Number: 4494
• Lead Author: Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University

ABOUT THE ULTIMATE I & II TRIALS

ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Both studies have met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide. Key secondary MRI endpoints have also been met. Data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted Q3 2021. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

ABOUT UBLITUXIMAB

Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

ABOUT MULTIPLE SCLEROSIS

Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.^1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.¹

ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ™ (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has two programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.

UKONIQ™ is a trademark of TG Therapeutics, Inc.

Cautionary Statement

This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II studies and the Company’s plans and timelines for submission of a Biologics License Application (BLA) for ublituximab for the treatment of relapsing forms of Multiple Sclerosis (RMS).

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II trials that we announce or publish may change, or the perceived product profile may be impacted, as more data or additional endpoints (including efficacy and safety) are analyzed; the risk that safety issues will emerge despite our belief that there were no unexpected safety signals identified in the ULTIMATE I & II trials; our ability to complete the BLA submission for ublituximab in RMS within the timeline projected and the risk that FDA will not accept the submission; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS for efficacy, safety or other issues or, if approved, that we will not receive regulatory approval within the timeline projected; the risk that if approved, ublituximab will not be commercially successful; our ability to expand our commercial infrastructure, and successfully launch, market and sell ublituximab in RMS if approved; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including ublituximab; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:

Investor Relations

Email: [email protected]
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations:

Email: [email protected]
Telephone: 1.877.575.TGTX (8489), Option 6

_________________________________________________________

<sup>1.

 MS Prevalence. National Multiple Sclerosis Society website. 

https://www.nationalmssociety.org/About-the-Society/MS-Prevalence

. Accessed October 26, 2020.

 2.

 Multiple Sclerosis International Federation, 2013 via
Datamonitor
p. 236.</sup>

MINNEAPOLIS, MN, US, April 16, 2021 (GLOBE NEWSWIRE) — PetVivo Holdings, Inc. (OTCQB: PETV) (the “Company”) an emerging biomedical device company focused on the commercialization of innovative medical therapeutics for pets is pleased to announce that Robert J. Folkes has accepted a position with the Company as its new Chief Financial Officer.

“We are incredibly excited to have Bob join the PetVivo management team and provide his well-recognized expertise to further the overall mission of PetVivo.” said John Lai, Chief Executive Officer of PetVivo Holdings, Inc. “Mr. Folkes brings a wealth of experience to our team, not only as expert in leading the operations and finances of medical device companies, but also as an expert and leader of management teams in publicly traded companies.”

Mr. Folkes, 58, served as the Chief Operating Officer from February 2015 until September, 2020 and as the Chief Financial Officer from 2005 until April 2016 of Tactile Systems Technology, Inc.; Mr. Folkes was instrumental in the successful completion of Tactile System’s initial public offering in July, 2016. Tactile System is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. Prior to joining Tactile Systems in 2004, Mr. Folkes was the Chief Financial Officer for Advanced Respiratory, a medical device company, from 1997 until its sale in 2003. Prior to joining Advanced Respiratory, Mr. Folkes was an Audit Senior Manager for Ernst & Young LLP. He served as Ernst & Young’s Senior Manager of the Entrepreneurial Services Group, and was involved with numerous SEC registrations, mergers and acquisitions. Mr. Folkes is a Certified Public Accountant and earned a B.A. in Accounting from the University of Minnesota – Carlson School of Management.

“I am thrilled to join PetVivo, a company whose technology could truly enhance the lives of companion animals,” said Mr. Folkes. “PetVivo has unique strengths, a strong business model and an innovative technology; I look forward to working with the team to execute on the company’s priorities, accelerate growth and enhance value for shareholders and all stakeholders.”

About PetVivo Holdings, Inc.

PetVivo Holdings Inc. (OTCQB: PETV) is an emerging biomedical device company currently focused on the manufacturing, commercialization and licensing of innovative medical devices and therapeutics for companion animals. The Company’s strategy is to leverage human therapies for the treatment of companion animals in a capital and time efficient way. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market much earlier than more stringently regulated pharmaceuticals and biologics.

PetVivo has a pipeline of seventeen products for the treatment of animals and people. A portfolio of eighteen patents protects the Company’s biomaterials, products, production processes and methods of use. The Company’s lead product Kush, a veterinarian-administered, intraarticular injection for the treatment of osteoarthritis in dogs and horses, is scheduled for expanded commercial sale later this year.

CONTACT:

John Lai, CEO
PetVivo Holdings, Inc.
Email: [email protected]
(952) 405-6216

Forward-Looking commercial Statements:

The foregoing material may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the potential listing of the Company’s common stock on Nasdaq, are based on information currently available the Company and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning the Company’s business are described in detail in the Company’s Annual Report on Form 10-K for the year ended March 31, 2020 and other periodic and current reports filed with the Securities and Exchange Commission. The Company is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Attachment

• PETVIVO HOLDINGS, INC

 • ICICI Securities, Axis Capital, SBI Capital & Edelweiss Financial Services are Lead Managers to the Proposed IPO

NOIDA, India and JOHNS CREEK, Ga., April 16, 2021 (GLOBE NEWSWIRE) — Ebix, Inc. (NASDAQ: EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance, financial, healthcare and e-learning industries today announced that its EbixCash Indian subsidiary has decided to commence work with immediate effect, leading to the proposed IPO of EbixCash. The Company made that decision after a meeting of all the four investment bankers with the Company a few days back. ICICI Securities, Axis Capital, SBI Capital & Edelweiss Financial Services are Lead Managers to the proposed EbixCash IPO.

Accordingly, the Company has decided to engage two statutory auditors in a dual auditor role (a named national auditor and a named international auditor) for the IPO, to commence the 3-year audit exercise leading to filing of the draft red herring prospectus (DRHP), with the Securities and Exchange Board of India. DHRP is the preliminary registration document prepared by the investment bankers for the prospective IPO. The Company is targeting the filing of the DHRP by the fourth quarter of 2021 with a targeted IPO in the first quarter of 2022.

EbixCash also announced earlier that it has already engaged the domestic and international legal firms for this exercise. The Company has also selected a BIG4 accounting firm for the market and product analysis sections of the DHRP. Over the next few months, the Company will be engaging a few other firms for various elements of the DHRP.

A few weeks back, the Company had announced the addition of SBI Capital Markets as the fourth Lead Manager for the EbixCash IPO, besides ICICI Securities, Axis Capital & Edelweiss Financial Services who were appointed Book Running Lead Managers for the IPO earlier. ICICI Securities serves as the Left Banker for the IPO.

SBICAP, ICICI, Axis and Edelweiss are considered amongst the top investment bankers in India in terms of reach, number of issues handled, money raised and overall performance. Each of them appears in most of the top 5 rankings of investment banks in India. All of these firms plan to initiate equity research coverage of EbixCash after the IPO.

EbixCash today is one of India’s top on-demand financial and insurance exchanges, with a “Phygital” strategy that combines 320,000 physical distribution outlets in many Southeast Asian Nations (“ASEAN”) countries, to an Omni-channel online digital platform. The Company’s EbixCash Financial exchange portfolio encompasses leadership in areas of domestic & international money remittance, foreign exchange (Forex), travel, pre-paid & gift cards, utility payments, lending, wealth management etc. in India and other markets.

About EbixCash and Ebix, Inc.

With a “Phygital” strategy that combines 320,000 physical distribution outlets in many Southeast Asian Nations (“ASEAN”) countries, to an Omni-channel online digital platform, the Company’s EbixCash Financial exchange portfolio encompasses leadership in areas of domestic & international money remittance, foreign exchange (Forex), travel, pre-paid & gift cards, utility payments, lending, wealth management etc. in India and other markets. EbixCash’s Forex operations have emerged as a leader in India’s airport Foreign Exchange business with operations in 32 international airports including Delhi, Mumbai, Bangalore, Hyderabad, Chennai and Kolkata, conducting over $4.8 billion in gross transaction value per year. EbixCash’s inward remittance business in India conducts approx. $6.5 billion gross annual remittance business, confirming its undisputed leadership position in India. EbixCash, through its travel portfolio of Via and Mercury, is also one of Southeast Asia’s leading travel exchanges with over 2,200+ employees, 212,450+ agent network, 25 branches and over 9,800 corporate clients; processing an estimated $2.5 billion in gross merchandise value per year. EbixCash’s Financial Technology solutions are today deployed across prestigious financial institutions and Banks in 44 countries. For more information, visit the Company’s website at www.ebixcash.com

With 50+ offices across 6 continents, Ebix, Inc., (NASDAQ: EBIX) endeavors to provide On-Demand software and E-commerce services to the insurance, financial, healthcare and e-learning industries. In the Insurance sector, Ebix’s main focus is to develop and deploy a wide variety of insurance and reinsurance exchanges on an on-demand basis, while also, providing Software-as-a-Service (“SaaS”) enterprise solutions in the area of CRM, front-end & back-end systems, outsourced administration and risk compliance services, around the world. For more information, visit the Company’s website at www.ebix.com

CONTACT:

Darren Joseph
[email protected] or 678 281 2027

David Collins or Chris Eddy
Catalyst Global – 212-924-9800 or[email protected]

MONTREAL, April 16, 2021 (GLOBE NEWSWIRE) — Dynacor Gold Mines Inc. (TSX-DNG) (Dynacor or the “Corporation”), an international gold ore industrial corporation servicing ASMs (artisanal and small-scale miners), today announced (unaudited) first-quarter sales of US$40.9 million (C$51.8 million)¹, compared to US$30.9 million (C$41.3 million) in the first quarter of 2020, a 32.4% increase.

In March 2021, the Corporation had sales of US$12.9 million (C$16.2 million) compared to US$9.0 million (C$12.5 million) in March 2020, a 43.3% increase.

The average selling price of gold in March 2021 was US$1,725 per oz. The average selling price for the first-quarter 2021 was US$ 1,785 per oz.

The first-quarter 2021 sales of US$40.9 million represents Dynacor’s best first-quarter of sales ever and places the Corporation ahead of its 2021 sales guidance of US$150.0 million, based on $US1,850 per oz gold price.

The 2021 and comparative 2020 quarterly sales and average selling prices were as follows:
https://www.globenewswire.com/NewsRoom/AttachmentNg/82fd1cd7-abac-478e-8fcb-f0dfe92342a1

During the first quarter of 2021, the Veta-Dorada Plant processed an all-time quarterly best of 29,327 tonnes of ore compared to 22,901 tonnes in the first quarter 2020, an increase of 28.1%.

The Corporation recently announced a 43% nameplate capacity increase at its Veta Dorada plant which is underway with a completion target date set for June 2021. (refer to March 24,2021 press release).

ABOUT
DYNACOR

Dynacor is a dividend-paying industrial gold ore processor headquartered in Montreal, Canada. The corporation is engaged in gold production through the processing of ore purchased from the ASM (artisanal and small-scale mining) industry. At present, Dynacor operates in Peru, where its management and processing teams have decades of experience working with ASM miners. It also owns a gold exploration property (Tumipampa) in the Apurimac department.

The corporation intends to expand its processing operations in other jurisdictions as well.

Dynacor produces environmental and socially responsible gold through its PX IMPACT® gold program. A growing number of supportive firms from the fine luxury jewelry, watchmakers and investment sectors pay a small premium to our customer and strategic
partner for this PX IMPACT® gold. The premium provides direct investment to develop health and education projects for our artisanal and small-scale miner’s communities.

Dynacor is listed on the Toronto Stock Exchange (DNG) and the OTC in the United States under the symbol (DNGDF). Dynacor is listed on the Toronto Stock Exchange (DNG).

FORWARD-LOOKING
INFORMATION

Certain statements in the preceding may constitute forward-looking statements, which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Dynacor, or industry results, to be materially different from any future result, performance or achievement expressed or implied by such forward-looking statements. These statements reflect management’s current expectations regarding future events and operating performance as of the date of this news release.

Toronto Stock Exchange (TSX): DNG OTC (United States): DNGDF
Shares Outstanding: 38,740,059

Website: http://www.dynacor.com
Twitter: http://twitter.com/DynacorGold

¹
sales are converted using the monthly average exchange rate

PDF available: http://ml.globenewswire.com/Resource/Download/a480508f-541c-411b-8985-b231d23f492e

CONTACT: For more information, please contact:

Director, Shareholder Relations Dale Nejmeldeen
Dynacor Gold Mines Inc. 
T: 514-393-9000 #230
E: [email protected]

SUWANEE, GA, April 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — SANUWAVE Health, Inc. (OTCQB: SNWV), a leading provider of next-generation wound care products, announced today that the Company will be participating in a number of leading wound care industry conferences – both virtual and in-person – where it will highlight the clinical merits of its “Energy First” protocols and showcase how its end-to-end portfolio of non-invasive and biologic-response therapeutic solutions address the entire wound care continuum.

SANUWAVE is currently scheduled to participate in the following industry events:

SuperBones SuperWounds East 2021	Virtual	April 17-18
Advanced Wound Care Conference (AWCC)	New Orleans, LA	May 7
SAWC Spring Virtual Wound Care Week	Virtual	May 10-14
LSI 2021 Emerging MedTech Summit	Dana Point, CA	May 11-13
Wound Care Business Meetings 2021	Philadelphia, PA	June 11
Midwest Podiatry Conference	Virtual	June 17-20
Wound Care Business Meetings 2021	Atlanta, GA	June 25

“We are excited to share SANUWAVE’s new brands with the country’s leading wound care specialists at upcoming industry conferences, starting with the SuperBones event on April 18th, where we will discuss the coding, billing and reimbursement for our ‘Energy First’ products,” stated Kevin A. Richardson, II, Chairman and Chief Executive Officer of SANUWAVE Health.  

“SANUWAVE will continue to educate the industry on the clinical merits of our ‘Energy First’ products and how they improve clinical outcomes for those patients with chronic, non-healing wounds. We invite everyone to visit us at our booths at these conferences—whether virtual or in-person—and learn what the new SANUWAVE suite of solutions has to offer.”  

About SANUWAVE 

SANUWAVE Health, Inc. (OTCQB: SNWV) is focused on the research, development, and commercialization of its patented, non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.  

SANUWAVE’s end-to-end wound care portfolio of regenerative medical products and product candidates help restore the body’s normal healing processes.  SANUWAVE applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, plastic/cosmetic, and cardiac/endovascular conditions. For more information, please visit. www.SANUWAVE.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief, or current expectations of the company, its directors, or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions, and factors that may affect operating results, performance, and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

Media CONTACT: 

Jane Byram

SCORR Marketing

512.626.2758

[email protected]