Lineage Cell Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 11, 2022

Research, News, and Market Data on Lineage Cell Therapeutics

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 4, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its second quarter 2022 financial and operating results on Thursday, August 11, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 11, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005025/en/

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(
ir@lineagecell.com)
(442) 287-8963

Russo Partners – Media Relations
Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Onconova Therapeutics to Provide Corporate Update and Announce Second Quarter Financial Results on August 11, 2022

News and Market Data on Onconova Therapeutics

Company to host conference call and webcast at 4:30 p.m. Eastern Time on Thursday, August 11, 2022

NEWTOWN, Pa., Aug. 04, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its second quarter 2022 financial results on Thursday, August 11, 2022. Management plans to host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.

Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing (800) 289-0571 for domestic and (856) 344-9290 for international callers and using conference ID 3600715.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit 
www.onconova.com.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680

ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200

bmackle@lifesciadvisors.com

 

Avivagen Announces Significant Order of OxC-beta™ in Brazil

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ August 3, 2022 /– Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce it has secured a significant order for OxC-beta™ from AB Vista. The 1.2 tonne order of OxC-beta™ will be shipped for use in Brazil, where AB Vista is running ongoing trials with several large poultry and cattle producers. “We are excited to be making further inroads into one of the world’s largest feed production markets. The large size of this order is a testament to the growing demand for safe and effective alternatives to antibiotics, and the market opportunity for our products,” says Kym Anthony, Chief Executive Officer, Avivagen. “We expect this important relationship with AB Vista will continue to play a significant role in the increased adoption and use of OxC-beta™ to promote animal health and growth in livestock throughout the Americas.” Brazil was ranked as the number three feed-producing country in the world in the 2022 Alltech Agri-Food Outlook, producing 80.1mmt in 2021. AB Vista is the exclusive distribution partner for OxC-beta™ in the United States, Brazil and Thailand. About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release. About OxC-beta™ Technology and OxC-beta™ Livestock Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia. Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics. Forward Looking Statements This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to the future growth and prospects for Avivagen and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. For more information: Avivagen Inc. Drew Basek Director of Investor Relations 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733 E-mail: d.basek@avivagen.com Kym Anthony Chief Executive Officer 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164 Website: www.avivagen.com Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

 

Wednesday, August 03, 2022

Axcella Therapeutics (AXLA)
Phase 2a Data In Long COVID-19 Shows Improvements In Fatigue and Function

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Phase 2a Trial In Long COVID-19 Shows Benefits.  Accella announced preliminary results from its Phase 2a trial testing AXA1125 in Long Covid-19.  After previous AXA1125 data had shown effects on mitochondrial function, inflammation, and bioenergetics, the Phase 2a trial was designed to test AXA1125 in treating symptoms of fatigue and mental fatigue that follow COVID-19 infection.

Patients had improvements in their fatigue scores.  The trial was a double-blind, placebo-controlled trial that enrolled 41 patients with Long COVID-19.  Patients were randomized to receive either 67.8 grams per day of AXA1125 (n=21) or placebo (n=20) for 28 days.  Trial endpoints included validated clinical fatigue measurements such as the Chalder Fatigue Questionnaire (CHQ-11), 6-minute walk test (6MWT), and other biomarkers….

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. 

Axcella Announces Highly Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID

Research, News, and Market Data on Axcella Therapeutics

Subjects with Long COVID receiving AXA1125 experienced a
clinically and statistically significant improvement in mental (p=0.0097) and
physical (p=0.0097) fatigue scores compared to placebo subjects

Responders to AXA1125 demonstrated significantly improved scores
during a 6 minute walk test

No emergent adverse events (AEs) or serious adverse events
(SAEs) occurred

Regulatory meetings are planned to discuss a path to
registration trial

Axcella to host a conference call today at 8:00 a.m. ET; To
register, click here

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 2, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today reported topline results from the Phase 2a randomized, double-blind, placebo-controlled investigation to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.

Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide with fatigue as the most common symptom reported. The recent Congressional subcommittee on Long COVID stated that one million Americans have been pushed out of work due to Long COVID. Additionally, it was stated that Long COVID contributed to approximately $1 trillion in lost earnings and $529 billion in increased medical spending.

We believe effective treatment of this complex and often debilitating disease requires addressing the underlying dysregulation of multiple biological pathways. Given the lack of therapeutic options for Long COVID patients and based on our understanding of AXA1125’s positive impact on mitochondrial function, bioenergetics, and inflammation, Axcella conducted a placebo-controlled interventional study in collaboration with clinical researchers at University of Oxford as an exploratory trial to test the hypothesis that administration of AXA1125 could ameliorate fatigue symptoms of Long COVID. Bill Hinshaw, CEO of Axcella, remarked, “At Axcella, once we understood we had a potential Long COVID intervention we acted rapidly to test the hypothesis that we could address the high and growing need that exists for patients living with debilitating Long COVID fatigue. We are delighted to report that we have meaningful clinical results as well as an increased understanding on the best endpoints for future, potentially registrational studies and look forward to engaging with the regulatory authorities around the next steps in clinical development.”

Since established endpoints for Long COVID do not exist, the study incorporated multiple endpoints for prioritization, selection, and use in a future registration trial to assess the effects of AXA1125 compared to placebo in subjects with moderate to severe fatigue. Safety and tolerability were also studied.

In the study, 41 subjects were enrolled and randomized to receive either 67.8 grams per day of AXA1125 (N=21) or a matched placebo (N=20) in two divided doses for 28 days, with a one-week safety follow-up period. All 41 subjects who started the study remained in the study to completion. Endpoints included phosphocreatine recovery time (PCr_?) following moderate exercise as assessed by 31P-magnetic resonance spectroscopy (MRS), which was included to assess mitochondrial function, and most importantly, clinically relevant endpoints including self-reported mental and physical fatigue as assessed by the Chalder Fatigue Questionnaire (CFQ-11), 6 minute walk test (6MWT) as well as serum lactate levels. The CFQ-11 is a validated patient reported outcome measure of fatigue that has been used in measuring patient impact in fatigue states such as chronic fatigue syndrome.

Subjects who received AXA1125 had improvements in measures of mental and physical fatigue that were both highly statistically significant and clinically relevant compared to those who received placebo. Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30 (p=0.0039), -2.94 (p=0.0097) and -1.32 (p=0.0097), respectively. Clinically meaningful shifts in the severity of physical and mental fatigue were also noted in subjects who received AXA1125 compared to those who received placebo. There was a statistically significant correlation of improvement in fatigue score and greater distance achieved in the 6MWT (p=0.0027), an objective measure of physical ability, only observed in subjects who received AXA1125.

Baseline PCr_? among all subjects was significantly higher and had a higher degree of inter-subject variability (92.46 Seconds + 35.3 Seconds) than previously reported in the literature. These findings support the hypothesis that there is significant mitochondrial dysfunction in these patients but limits the utility of this parameter in a clinical trial. There was no significant difference on the primary outcome measure of PCr_? following moderate exercise between subjects receiving AXA1125 and placebo. There was a notable trend toward significant improvement in serum lactate levels after a 6MWT in AXA1125 subjects (p=0.0730). AXA1125 was safe and well tolerated with no significant adverse events reported by study subjects.

“The statistically significant improvement in reported mental and physical fatigue among study participants receiving AXA1125 is a very encouraging finding for Long COVID patients, who often experience extreme and constant fatigue throughout their day,” said study leader, Dr. Betty Raman, Associate Professor of Cardiovascular Medicine at the Radcliffe Department of Medicine, University of Oxford.

Karim Azer PhD, Axcella’s VP, Platform and Discovery stated, “The results of this trial encourage us to further evaluate the multi-targeted effects of AXA1125 on mitochondrial and related biomarkers to advance our understanding of the benefits AXA1125 delivers to Long COVID patients. Preliminary analysis including mitochondrial, inflammatory, and endothelial environment biomarker work provides additional data strengthening the core rationale for AXA-1125’s compelling clinical benefits.”

Dr. Jason Maley, Director of Beth Israel Deaconess Medical Center Critical Illness and COVID-19 Survivorship Program, remarked that, “This is the first pharmaceutical agent to demonstrate improved outcomes for patients with Long COVID in a randomized controlled trial and suggests that AXA1125 may play an important part in the long-term treatment of these patients as they seek to return to the life they had before the infection. On behalf of the innumerable patients urgently seeking therapies for the debilitating symptoms of Long COVID, I am excited to see the continued development of AXA1125.”

Conference Call
Information
Register for the call by clicking here.
A live webcast of the call, as well as a replay, will be available on the Events and Presentations section on the Company’s website: https://ir.axcellatx.com/events-and-presentations.

Internet Posting of
Information
Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella
Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH). The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Forward-Looking
Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding interest that may ensue in the Company’s product candidates or securities following announcement of the Company’s recent clinical trial results and the timing of the Company’s clinical trial data readouts and next steps for its clinical programs, including a potential registration trial of AXA1125 for the treatment of Long COVID. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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, including, without limitation, those related to the belief that mitochondrial dysfunction is a key driver of Long COVID induced fatigue, potential impact of COVID-19 on the Company’s ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the Company is able to collect in its clinical trials of AXA1125, other potential impacts of COVID-19 on the Company’s business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the Company’s clinical trial plans and timing, clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its therapeutic potential, whether and when, if at all, the Company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the Company’s target indications, and other risks identified in the company’s SEC filings, including Axcella’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements.

Dr. Maley receives compensation as a consultant for the Company.

View source version on 
businesswire.com: https://www.businesswire.com/news/home/20220802005461/en/

Company
Ashley Robinson
arr@lifesciadvisors.com
(617) 430-7577

Source: Axcella Therapeutics

Tonix Pharmaceuticals Receives Federal Grant from the National Institute on Drug Abuse (NIDA) to Advance Development of TNX-1300 as a Treatment for Cocaine Intoxication

Research, News, and Market Data on Tonix Pharmaceuticals

There is No
FDA-Approved Product for Cocaine Intoxication

TNX-1300 Has Been Granted
Breakthrough Therapy Designation by the FDA

Phase 2 Single-Blind,
Placebo-Controlled, Potential Pivotal Study Expected to Start in Fourth Quarter
2022, Pending FDA Agreement

CHATHAM, N.J., Aug. 02, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of cocaine intoxication. TNX-1300 is a recombinant enzyme that efficiently degrades and metabolizes cocaine. Cocaine intoxication refers to a state in which cocaine has deleterious effects on several body systems, especially the cardiovascular system. TNX-1300 demonstrated activity on reversing the physiological effects of i.v. cocaine challenge in people who use cocaine in a prior Phase 2a randomized, double-blind, placebo-controlled clinical study.¹

The grant is intended to support continued development of TNX-1300 as a treatment for life threatening cocaine intoxication. In 2021, more than 24,900 individuals in the U.S. died from drug overdose deaths involving cocaine².

“This grant award underscores the unmet need for safe and effective treatments for cocaine intoxication and validates the progress we have achieved to date with TNX-1300,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Cocaine intoxication remains a serious issue in the U.S. where there is currently no specific pharmacotherapy indicated treatments. By targeting the cause rather than the symptoms of cocaine intoxication, we believe TNX-1300 may offer significant advantages to the current standard of care for cocaine intoxication.”

Tonix recently announced the design of a new single-blind, open-label, placebo-controlled, randomized Phase 2 clinical trial of TNX-1300 for the treatment of cocaine intoxication. The Phase 2 study, which has the potential to serve as a pivotal trial, is anticipated to start in the fourth quarter of 2022, pending U.S. Food and Drug Administration (FDA) agreement. TNX-1300 has been granted Breakthrough Therapy designation by the FDA. As a biologic and new molecular entity, TNX-1300 is eligible for 12 years of U.S. market exclusivity upon approval by the FDA, in addition to expected patent protection through 2029.

“The research Tonix is pursuing is a bright light in our shared goal of reducing overdose deaths and harm as we continue to battle the crisis in substance use disorders in New Jersey and across the country, which has only been compounded by the pandemic. This targeted treatment could bring down healthcare costs and, most importantly, loss of life due to cocaine overdose,” said Representative Mikie Sherrill (NJ-11). “With this federal grant, Tonix will be able to move one step closer to FDA authorization and getting this potentially life-saving treatment into the hands of emergency room doctors and nurses, as well as EMS and other first responders. I am proud to have Tonix’s headquarters based here in NJ-11.”

“Tonix has been an incredible partner and job creator in Maryland, and I commend their efforts in fighting against the substance use disorder crisis that our nation continues to face. With over 100,000 Americans killed by drug overdoses just last year, we need to work together to curb the loss and set our sights on prevention, harm reduction, treatment and recovery. That starts with medical innovation in our own communities and reliable investment in our country’s brightest leaders. This funding from the National Institute on Drug Abuse will do just that,” said Representative David Trone (MD-06).

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number U01DA056245. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About TNX-1300

TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is being developed under an Investigational New Drug (IND) application for the treatment of cocaine intoxication. TNX-1300 is a recombinant protein enzyme produced through rDNA technology in a non-disease-producing strain of E. coli bacteria. Cocaine esterase (CocE) was identified in bacteria (Rhodococcus) that uses cocaine as its sole source of carbon and nitrogen and that grows in soil surrounding coca plants.
³ The gene encoding CocE was identified and the protein was extensively characterized.^3-6 CocE catalyzes the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid. Wild-type CocE is unstable at body temperature, so targeted mutations were introduced in the CocE gene and resulted in the T172R/G173Q double-mutant CocE, which is active for approximately 6 hours at body temperature.⁶ In a Phase 2 study, TNX-1300, at 100 mg or 200 mg i.v. doses, was well tolerated and rapidly reduced cocaine effects after a cocaine 50 mg i.v. challenge.¹

About Cocaine
Intoxication

Cocaine is an illegal recreational drug which is taken for its pleasurable effects and associated euphoria, as well as mental alertness, in some cases. Pharmacologically, cocaine blocks the reuptake of the neurotransmitter dopamine from central nervous system synapses, resulting in the accumulation of dopamine within the synapse and an amplification of dopamine signaling which reinforces the drug taking. With the continued use of cocaine, however, intense cocaine cravings can occur, resulting in a high potential for continued use and addiction, as well as the risk of cocaine intoxication. Cocaine intoxication refers to the deleterious effects of cocaine on several body systems, especially those involving the cardiovascular system. Common symptoms of cocaine intoxication include tachyarrhythmias and elevated blood pressure, either of which can be life-threatening. As a result, individuals with known or suspected cocaine intoxication are sent immediately to the emergency department, preferably by ambulance in case cardiac arrest occurs during transit. According to the U.S. Centers for Disease Control and Prevention (CDC), in 2021 the number of overdose death involving cocaine reached 24,900 individuals.² Also according to a recent report by the CDC, among all 2020 U.S. drug overdose deaths, approximately nearly 1 in 5 involved cocaine.⁷ In 2020, Black Americans experienced the highest death rate for overdoses involving cocaine, at 14 per 100,000.⁷

References

¹ Nasser AF, Fudala PJ, Zheng B, Liu Y, Heidbreder C. A randomized, double-blind,
placebo-controlled trial of RBP-8000 in cocaine abusers: pharmacokinetic
profile of rbp-8000 and cocaine and effects of RBP-8000 on cocaine-induced
physiological effects. J Addict Dis. 2014;33(4):289-302.

² Centers
for Disease Control and Prevention (CDC) – https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

³ Bresler MM, Rosser SJ, Basran A, Bruce NC. Gene cloning and nucleotide sequencing
and properties of a cocaine esterase from Rhodococcus sp. strain MB1. Appl Environ Microbiol. 2000. 66(3):904-8.

⁴ Larsen NA, Turner JM, Stevens J, Rosser SJ, Basran A, Lerner RA, Bruce NC, Wilson IA. Crystal structure of a bacterial
cocaine esterase. Nat Struct Biol. 2002. 9(1):17-21.

⁵ Turner JM, Larsen NA, Basran A, Barbas CF 3rd, Bruce NC, Wilson IA, Lerner RA. Biochemical characterization and
structural analysis of a highly proficient cocaine esterase. Biochemistry. 2002. 41(41):12297-307.

⁶ Gao D, Narasimhan DL, Macdonald J, Brim R, Ko MC, Landry DW, Woods JH, Sunahara RK, Zhan CG. Thermostable variants of cocaine
esterase for long-time protection against cocaine toxicity. Mol Pharmacol. 2009. 75(2):318-23.

⁷ National
Institute on Drug Abuse https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates#:~:text=Overall%2C%20drug%20overdose%20deaths%20rose,overdose%20deaths%20reported%20in%202020

About Tonix
Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’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 (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is mid-Phase 2 with a new potentially pivotal Phase 2 study expected to be initiated in the fourth quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the second half of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

^*All of Tonix’s product candidates are investigational
new drugs or biologics and have 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 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

 

Wednesday, July 27, 2022

Ayala Pharmaceuticals (AYLA)
Stock Rises As Data Milestone Approaches and Public Offering Cancelled

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

AYLA Traded Higher On Unusual Volume.  On July 25, Ayala filed a request to withdraw its S-1 Registration statement for the public offering it filed on July 18.  The stock closed at $0.87 per share, then traded as high as $2.42 per share (up 178%) before closing at $1.69 per share on July 26.  Daily volume was 101.6 million, compared with its 3-month average volume of 78.5 thousand shares per day.

Part B of The RINGSIDE Trial Could Be Driving The Stock.  The Phase 2/3 RINGSIDE trial is a two-part trial testing AL102, Ayala’s gamma secretase inhibitor that blocks activation of the NOTCH signaling pathway.  Tumors with mutations in the NOTCH pathway are associated with a more aggressive course of disease and poor outcomes. RINGSIDE is testing AL102 in desmoid tumors, a rare cancer of the connective tissue….

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. 

Tonix Pharmaceuticals Announces Appointment of Sina Bavari, Ph.D. as Executive Vice President, Infectious Disease Research and Development

Research, News, and Market Data on Tonix Pharmaceuticals

CHATHAM, N.J., July 25, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Sina Bavari, Ph.D. as its new Executive Vice President, Infectious Disease Research and Development. In this role, Dr. Bavari will be responsible for leading Tonix’s development of its growing infectious disease pipeline and will serve as a key member of the Company’s executive leadership team. Dr. Bavari will be based in Frederick, Md. and, as part of his role, will oversee scientific development at Tonix’s Infectious Disease R&D Center located there.

“We are delighted that Dr. Bavari has joined our team to lead our infectious disease research and development efforts,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Dr. Bavari has a proven track record of innovation and of developing scientific strategies as well as leading programs at all stages of discovery and development.”

“I am excited to join Tonix and to lead the Company’s efforts in infectious disease research and development programs, including vaccines in development for monkeypox, smallpox and COVID-19,” said Dr. Bavari. “The Frederick, Md. Research and Development Center, or RDC, is a state-of-the-art facility with exceptional capabilities. The facility is up and running and is staffed by an outstanding team of scientists. I look forward to leveraging my years of experience in industry and government to expedite this important work with the goal of ultimately solving health problems on a global basis.”

Dr. Bavari has a record of achievement utilizing new and complex technologies and in guiding programs through clinical decision points into advanced development. He is an inventor of approximately 30 patents, published over 300 peer-reviewed manuscripts and contributed to 15 development candidates, as well as numerous Investigational New Drug candidate filings. Most recently, he served as Chief Scientific Officer / Scientific Director at the U.S. Army Research Institute of Infectious Diseases (USAMRIID) and has held numerous leadership roles at USAMRIID, including Chief, Molecular and Translational Sciences Division and Therapeutic Discovery Center; Chief, Target Discovery & Experimental Microbiology, Integrated Toxicology Division; and Chief, Immunology, Target Identification, and Translational Research, Bacteriology Division. Dr. Bavari earned his Ph.D. in Immunotoxicology and Pharmaceutical Science at the University of Nebraska Medical Center in Omaha, Neb., and his M.S. in Nuclear Physics and Nuclear Pharmacy at the University of Southern California, Los Angeles.

Tonix Pharmaceuticals
Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’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 (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is mid-Phase 2 and has been granted Breakthrough Therapy Designation by the FDA. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the second half of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. TNX-601 ER (tianeptine hemioxalate extended-release tablet) is being developed as an antidepressant in the U.S., with a Phase 2 study expected to be initiated in first quarter of 2023 pending IND clearance. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

*All of Tonix’s product
candidates are investigational new drugs or biologics and have 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 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) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners
Olipriya.Das@russopartnersllc.com 
(646) 942-5588

Peter Vozzo (investors)
Westwicke/ICR

peter.vozzo@westwicke.com 
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released
July 25, 2022

 

Friday, July 22, 2022

BioSig Technologies (BSGM)
BioSig Announces Real World PURE EP Physician-Initiated Research

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com). The Company’s first product, PURE EP(TM) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Announced study tests real-world AF patients.  BioSig announced yesterday a physician-initiated study. The research will study 30 patients with de novo paroxysmal atrial fibrillation (AF)  undergoing pulmonary vein isolation (PVI), with 6 month and 12 month follow-up. While the PURE EP 2.0 trial assessed PURE EP signal quality vs. current technology, this is the first real world study of patient outcomes. To date there have been few human trials that test the durability of PVI AF procedures. The study is officially registered at clincaltrials.gov NCT05464537 .

Kansas City Heart Rhythm Research Foundation is conducting the study.  Recall that Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center recently purchased the PURE EP System. Dhanunjaya DJ Lakkireddy, MD, Medical Director for the Kansas City Heart Rhythm Institute, is initiating this research protocol analyzing the signals acquired by the PURE EP System during RF ablation.  Long lasting, contiguous and deep enough ablation lesions have been and are a clinical challenge due to thickness of atrial tissue in different regions, as well as factors like the power and contact force of the ablation catheter.  AF ablation procedures might need to be repeated if the ablated tissue does not prevent recurrence of AF.  PURE EP signal processing will be reviewed for helping produce more durable, quicker and cost-effective outcomes….

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. 

BioSig Announces Physician-Initiated Research Protocol at The Kansas City Heart Rhythm Institute

News and Market Data on BioSig Technologies

Led by Dhanunjaya DJ Lakkireddy, MD., the study will investigate expanded applications for the signals acquired by BioSig’s PURE EP(T.M.) System

Westport, CT, July 21, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that Dhanunjaya DJ Lakkireddy, MD, Medical Director for the Kansas City Heart Rhythm Institute, will initiate a research protocol analyzing the signals acquired by the PURE EP(T.M.) System during Radiofrequency (RF) ablation.

The single center study at Overland Park Regional Medical Center and officially registered with clinicaltrials.gov [NCT05464537], will include 30 participants with paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI). The study aims to build on previous research that claims the loss of the negative component of the unipole during PVI can serve as a tool for achieving durability with overall lesser procedure time and no significant increase in adverse events.  AF recurrence will be examined at 6 and 12-months post-procedure.

“Positive results from this study could substantially emphasize the value of the PURE EP System in the EP lab by decreasing procedural cost specific to both time and product spend,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

Dr. Lakkireddy is a board-certified, fellowship-trained cardiologist specializing in electrophysiology. With more than 15 years of experience, he has specialized interest in complex arrhythmia management for all types of arrhythmias conditions. The Company recently announced that Overland Park Regional Medical Center (OPRMC) has signed an agreement to purchase the Pure EP(T.M.) System under the terms of the Company’s new leasing program. This represents BioSig’s first national purchasing agreement since announcing The Company’s new commercial structure and clinical support teams.

About The Kansas City
Heart Rhythm Institute
The Kansas City Heart Rhythm Institute brings the highest quality clinical care, research and arrhythmia education to Kansas City and the surrounding area. With eight practicing Electrophysiologists, the Kansas City Heart Rhythm Institute has three Electrophysiology clinics in the greater Kansas City area as well as outreach locations in four major hospitals.

About Overland Park
Regional Medical Center
Overland Park Regional Medical Center is a licensed 343-bed facility offering acute medical care services to patients. Cardiovascular programs at OPRMC have received certification from The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). OPRMC’s clinician and physician experts excel in a wide range of interventional cardiology practices and complex electrophysiology procedures, including Complex Arrhythmia Management (AF, VTACH, PVC, SVT), Convergent AF Ablation (with C.T. surgeon and E.P.), Leadless Pacemakers & Internal Cardiac Defibrillators, and Left Atrial Appendage Closure.

About BioSig
Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP(T.M.) System, is a novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP(T.M.) was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights.

The Company is in a national commercial launch of the PURE EP(T.M.) System. The technology is in regular use in some of the country’s leading centers of excellence, including 
Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St.
David’s Medical Center.

Clinical data acquired by the PURE EP(T.M.) System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the 
Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(T.M.) signals over conventional sources.

Forward-looking
Statements
This press release contains “forward-looking statements.” 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 not guarantees of future performance, 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. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Source: BioSig Technologies, Inc.

Released July 21, 2022

 

Image Credit: National Human Genome (Flickr)

Cells Become Zombies When the Ends of their Chromosomes are Damaged – a Tactic Both Helpful and Harmful for Health

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 Patricia Opresko, Professor of Environmental and Occupational Health, University of Pittsburgh Health Sciences and Ryan Barnes, Postdoctoral Researcher in Environmental and Occupational Health, University of Pittsburgh Health Sciences.

Damage to the ends of your chromosomes can create “zombie cells” that are still alive but can’t function, according to our recently published study in Nature Structural and Molecular Biology.

When cells prepare to divide, their DNA is tightly wound around proteins to form chromosomes that provide structure and support for genetic material. At the ends of these chromosomes are repetitive stretches of DNA called telomeres that form a protective cap to prevent damage to the genetic material. However, telomeres shorten each time a cell divides. This means that as cells divide more and more as you age, your telomeres become increasingly shorter and more likely to lose their ability to protect your DNA.

Telomeres serve as protective caps at the ends of each chromosome.

Damage to genetic material can lead to mutations that cause cells to divide uncontrollably, resulting in cancer. Cells avoid becoming cancerous when their telomeres become too short after dividing too many times and potentially accruing damage along the way, however, they do this by entering a zombielike state that stops cells from dividing through a process called cellular senescence.

Because they are resistant to death, senescent – or “zombie” – cells accumulate with age. They can be beneficial to health by promoting senescence in nearby cells at risk of becoming cancerous and attracting immune cells to clear out cancer cells. But they can also contribute to disease by impairing tissue healing and immune function, and by secreting chemicals that promote inflammation and tumor growth.

We wanted to know if direct damage to telomeres can be sufficient to trigger senescence and make zombie cells. In order to figure this out, we needed to confine damage just to the telomeres. So we attached a protein to the telomeres of human cells grown in the lab. Then we added a dye to the protein that makes it sensitive to light. Shining a far-red light (or light with a wavelength slightly shorter than infrared light) on the cells induces the protein to produce oxygen free radicals – highly reactive molecules that can damage DNA – right at the telomeres, sparing the rest of the chromosome and the cell.

We found that direct damage to the telomeres was sufficient to turn cells into zombies, even when these protective caps weren’t shortened. The reason for this, we discovered, was likely a result of disrupted DNA replication at the telomeres that leaves chromosomes even more susceptible to damage or mutations.

The telomeres (green) at the tips of chromosomes (blue) damaged by free radicals become fragile (green arrows) and trigger senescence. Ryan Barnes/Opresko Lab

Why it Matters

Telomeres naturally shorten with age. They limit how many times a cell can divide by signaling cells to become zombies when they reach a certain length. But an excess of free radicals produced from both normal bodily processes as well as exposure to harmful chemicals like air pollution and tobacco smoke can lead to a condition called oxidative stress that can accelerate telomere shortening. This can prematurely trigger senescence and contribute to age-related diseases, including immunodeficiency, cardiovascular disease, metabolic disease and cancer.

Our study reveals that telomeres not only serve as alarm clocks that indicate a cell divided too many times, but also as warning bells for harmful levels of oxidative stress. Age-related shortening of telomeres isn’t the only thing that triggers senescence; telomere damage is also sufficient to turn a cell into a zombie.

 

What Other Research is Being Done

Researchers are studying treatments and interventions that can protect telomeres from damage and prevent zombie cell accumulation. A number of studies in mice have found that removing zombie cells can promote healthy aging by improving cognitive function, muscle mass and function and recovery from viral infections.

Researchers are also developing drugs called senolytics that can either kill zombie cells or prevent them from developing in the first place.

 

What’s Next

This study focuses on the consequences of telomere damage in actively dividing cells, like kidney and skin cells. We’re now looking at how this damage will play out in cells that don’t divide, like neurons or heart muscle cells. While researchers have shown that the telomeres of nondividing cells and tissues become more dysfunctional with age, it’s unclear why this happens when these telomeres should not be shortening in the first place.

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Why are Drug Names So Long and Complicated? A Pharmacist Explains the Logic Behind the Nomenclature

At some point in your life, you’ll likely find yourself with a prescription from your doctor to fill. While it’s important to keep track of all the medications you’re taking, that can be hard to do when the names of so many of these drugs are difficult to pronounce and even harder to remember.

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 Jasmine Cutler, Assistant Professor of Pharmacotherapeutics, University of South Florida

In my role as a pharmacist, I’ve helped countless patients figure out exactly which medication they were taking for what ailment. Some wonder why they were prescribed the medication in the first place, or need help differentiating between drugs with names that seem like complete gibberish.

But there is a rhyme and a reason to drug names. All prescribed medications follow a standard nomenclature that describes what the drug is made of and how it functions.

Who Names Drugs?

Drugs get both a brand, or proprietary, name and a generic name that is nonproprietary. Each is assigned in a slightly different process.

As long as a drug compound isn’t trademarked, drug companies decide on a proprietary brand name for the medications they sell. Usually the brand name relates to the conditions the drug is intended to treat and is easy for both providers and patients to remember but doesn’t follow a standardized naming guideline. For example, the drug Lopressor helps lower blood pressure.

On the other hand, generic drug names all follow a standard nomenclature that helps medical providers and researchers more easily recognize and classify the drug. Lopressor, for example, has a generic name of metoprolol tartrate. The U.S. Adopted Names Council, composed of representatives from the Food and Drug Administration, American Medical Association, U.S. Pharmacopeia and American Pharmacists Association, works with the World Health Organization to assign international nonproprietary names, or INNs, to drug compounds. Similar organizations exist internationally.

A globally recognized naming process makes an otherwise confusing name game more manageable. It helps the medical community easily learn and categorize newly approved medications and reduce prescribing errors by providing a unique, standard name that reflects each active ingredient in the drug.

For example, several Type 2 diabetes medications fall under one class called glucagon-like peptide-1 (GLP-1) receptor agonists. Although all medications in this class have different brand names, each of the generic versions ends in the suffix “-tide.” This helps health providers identify all the drugs that belong to this medication class. A few examples include Byetta (exenatide), Trulicity (dulaglutide) and Victoza (liraglutide).

 

How are Generic Drug Names Assigned?

The naming process starts when a drug company submits an application to the U.S. Adopted Names Council with a proposed generic name. USAN considers a number of factors when evaluating a name, such as whether it relates to how the drug works, how translatable it is to other languages and whether it is easy to say. In general, the name should be simple – fewer than four syllables long – and should not be easily confused with other existing generic drugs.

Once a name is agreed upon by USAN and the drug company, it is then proposed to the INN Expert Group. Sponsored by the World Health Organization, the INN Expert Group is composed of global specialists who represent the pharmaceutical, chemical, pharmacological and biochemical sciences. They may either accept the proposed name or suggest an alternative. Once the drug company, USAN and the INN Expert Group come to an agreement about a name, it is placed in the WHO Drug Information journal for four months for public comments or objections before final adoption.

 

What’s in a Generic Drug Name?

Generic names follow a prefix-infix-stem system. The prefix helps distinguish a drug from other drugs in the same class. The infix, used more occasionally, further subclassifies the drug. The stem at the very end of the name indicates the drug’s function and marks its place within the name game.

Stems are composed of one or two syllables that describe a drug’s biological effects as well as its physical and chemical qualities and structure. Drugs with the same stem share features like the conditions they treat and how they work in the body. The WHO publishes a regularly updated stem book to keep everything in line.

For example, the stem “-prazole” indicates that the drug is chemically related to a class of compounds called benzimidazoles that have similar functions. As a result, drugs such as lansoprazole (Prevacid), esomeprazole (Nexium) and omeprazole (Prilosec) all treat acid reflux, ulcers and heartburn. The “e” prefix of esomeprazole differentiates it from omeprazole, which has a slightly different chemical structure.

Another common example is drugs that use the stem “stat,” which means enzyme inhibitors. Atorvastatin (Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor) all belong to the same class of inhibitors that block a key enzyme in the body’s cholesterol production process. As a result, these cholesterol-reducing “statins” are used to prevent cardiovascular conditions like heart attack and stroke.

 

Are There Exceptions to the Name Game?

Although generic names stay consistent, there have been multiple changes to brand names over the past couple of decades after increases in prescribing and dispensing errors. Some examples include the acid reflux and stomach ulcer drug omeprazole, which was rebranded from Losec to Prilosec because it was frequently confused with the diuretic Lasix. Another example is when the antidepressant Brintellix was changed to Trintellix because it was commonly confused with the blood thinner Brilinta.

Some generic medications may work at multiple targets in the body and be used for multiple conditions. For example, drugs with the stem “-afil,” such as tadalafil (Cialis), sidenafil (Viagra) and vardenafil (Levitra), belong to a class of drugs that relax smooth muscle and widen the blood vessels. Although commonly prescribed for erectile dysfunction, they can also be used to treat pulmonary arterial hypertension, a specific type of elevated blood pressure that affects the arteries in the heart and lungs.

In addition, nomenclature guidelines
aren’t set in stone, and the U.S. Adopted Names Council anticipates that they
will continue to change as newer, more complex substances are discovered, developed
and marketed.

For example, a rise in the number of drugs developed with different salts and esters has led to the use of a modified naming process to incorporate the inactive parts of the compound.

As you can guess, it takes health care providers countless months and years to learn and understand this naming process. We are taught the science behind each chemical structure and how it works, which makes it easier to know the rules of the name game. But for those without a background in chemistry and biology, it can be like reading a foreign language.

There are several resources that can help you navigate the drug name game, however. Ask your health care provider or pharmacist if you have questions about how your medication works or what it is used for. They are generally a phone call or visit away.

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NexusBioAg and MustGrow Biologics Announce Exclusive Marketing and Distribution Agreement in Canada

Research, News, and Market Data on MustGrow Biologics

Collaboration expands
innovative, sustainable and regenerative farming solutions for Canadian growers

Downers Grove, ILL. & SASKATOON, SASK. — July 20, 2022 — Univar Solutions Inc. (NYSE: UNVR) (“Univar
Solutions“),  a leading global solutions provider to users of specialty ingredients and chemicals, announced today that NexusBioAg, a division of Univar Solutions, and MustGrow Biologics Corp. (CSE: MGRO) (OTC: MGROF) (FRA: 0C0) (“MustGrow“), an agricultural biotechnology company focused on providing science-based biological solutions for high-value crops, have reached an exclusive marketing and distribution agreement in the Canadian canola and pulse market for TerraMG™, a mustard-derived soil biopesticide technology. The addition of this plant-based technology further diversifies and expands NexusBioAg’s extensive portfolio of inoculants, micronutrients, nitrogen stabilizers and foliars for the Canadian agricultural market.

In 2021, NexusBioAg and MustGrow initiated a field research program to develop MustGrow’s sustainable farming technology in Canadian canola and pulse crops. This technology has the potential to address the agronomic challenges of ClubRoot and Aphanomyces diseases which impact these crops. Building on the past data, the companies now are moving forward to the next stage of the development process. Through this exclusive marketing and distribution agreement, NexusBioAg customers have access to the latest in agronomic innovation, which is yet to be registered with Canada’s Pest Management Regulatory Agency.

“TerraMG complements the NexusBioAg portfolio and we are excited to add this technology to our growing product offering. As the sole distributor of TerraMG in Canada for use in canola and pulse crops, this agreement further reinforces NexusBioAg’s commitment to collaborating with leading manufacturers to launch innovative, sustainable and cutting-edge solutions that provide value to the Canadian agricultural industry and benefit its growers,” said Matthew Ottaway, senior vice president, global consumer solutions for Univar Solutions.

NexusBioAg is committed to launching innovative, cutting-edge products, with a focus on sustainability and regenerative agriculture, which benefit the Canadian agricultural industry and growers. MustGrow specializes in the research and development of organic biopesticides, harnessing the mustard seed’s natural defense mechanism with a technology that has the potential to control diseases, pests and weeds. Combining the proficiencies of both companies in the agriculture market will help Canadian growers benefit from innovative and sustainable farming solutions.

“We are very pleased to partner with an organization like NexusBioAg. Their team’s technical and commercial expertise is unparalleled and will be advantageous in accelerating the development and growth of TerraMG for use in Canadian canola and pulse crops. The NexusBioAg team has tremendous knowledge of the Canadian agriculture market as well as sustainable farming solutions. We look forward to commercializing this biopesticide technology in the Canadian market together,” remarked MustGrow COO Colin Bletsky.

For more information about NexusBioAg’s crop nutrition solutions, please visit nexusbioag.com. To learn more about TerraMG™, visit mustgrow.ca.

About Univar Solutions
Univar Solutions (NYSE: UNVR) is a leading global chemical and ingredient distributor representing a premier portfolio from the world’s leading producers. With the industry’s largest private transportation fleet and technical sales force, unparalleled logistics know-how, deep market and regulatory knowledge, formulation and recipe development, and leading digital tools, Univar Solutions is well-positioned to offer tailored solutions and value-added services to a wide range of markets, industries, and applications. While fulfilling its purpose to help keep communities healthy, fed, clean and safe, Univar Solutions is committed to helping customers and suppliers innovate and focus on Growing Together. Learn more at univarsolutions.com.

About NexusBioAg
Univar Solutions’ NexusBioAg provides an expanded portfolio of crop nutrition solutions, including industry-leading inoculants, micronutrients, nitrogen stabilizers, and foliar products. With a diverse collection of inventory and logistics experts, procurement, customer service, agronomists, and sales and marketing experts, NexusBioAg strives to help meet increasingly unique agricultural businesses’ needs. Through these best-in-class capabilities, a collaborative team-oriented approach, and a commitment to agricultural integrity, NexusBioAg is helping customers innovate and grow. Learn more at NexusBioAg.com.

About MustGrow
MustGrow is an agriculture biotech company developing organic biopesticides and bioherbicides by harnessing the natural defense mechanism of the mustard plant to protect the global food supply from diseases, insect pests, and weeds. MustGrow and its leading global partners — Janssen (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Over 100 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation. MustGrow has approximately 49.2 million basic common shares issued and outstanding and 55.1 million shares fully diluted. For further details please visit mustgrow.ca.  

Univar Forward-Looking Statements
This press release includes certain statements relating to future events and Univar Solutions’ intentions, beliefs, expectations, and predictions for the future, which are “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, as amended. Forward-looking statements are subject to known and unknown risks and uncertainties, many of which may be beyond Univar Solutions’ control. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the expectations and assumptions. A detailed discussion of these factors and uncertainties is contained in Univar Solutions’ filings with the Securities and Exchange Commission. Potential factors that could affect such forward-looking statements include, among others: the ultimate geographic spread of the COVID-19 pandemic; the duration and severity of the COVID-19 pandemic; actions that may be taken by governmental authorities to address or otherwise mitigate the impact of the COVID-19 pandemic; the potential negative impacts of COVID-19 on the global economy and Univar Solutions’ customers and suppliers; the overall impact of the COVID-19 pandemic on Univar Solutions’ business, results of operations and financial condition; other fluctuations in general economic conditions, particularly in industrial production and the demands of Univar Solutions’ customers; significant changes in the business strategies of producers or in the operations of Univar Solutions’ customers; increased competitive pressures, including as a result of competitor consolidation; significant changes in the pricing, demand and availability of chemicals; Univar Solutions’ levels of indebtedness, the restrictions imposed by Univar Solutions’ debt instruments, and Univar Solutions’ ability to obtain additional financing when needed; the broad spectrum of laws and regulations that we are subject to, including extensive environmental, health and safety laws and regulations; an inability to integrate the business and systems of companies we acquire, including of Nexeo Solutions, Inc., or to realize the anticipated benefits of such acquisitions; potential business disruptions and security breaches, including cybersecurity incidents; an inability to generate sufficient working capital; increases in transportation and fuel costs and changes in Univar Solutions’ relationship with third party providers; accidents, safety failures, environmental damage, product quality and liability issues and recalls; major or systemic delivery failures involving Univar Solutions’ distribution network or the products we carry; operational risks for which we may not be adequately insured; ongoing litigation and other legal and regulatory risks; challenges associated with international operations; exposure to interest rate and currency fluctuations; potential impairment of goodwill; liabilities associated with acquisitions, ventures and strategic investments; negative developments affecting Univar Solutions’ pension plans and multi-employer pensions; labor disruptions associated with the unionized portion of Univar Solutions’ workforce; and the other factors described in Univar Solutions’ filings with the Securities and Exchange Commission. We caution you that the forward-looking information presented in this press release is not a guarantee of future events or results and that actual events or results may differ materially from those made in or suggested by the forward-looking information contained in this press release. In addition, forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “plan,” “seek,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe” or “continue” or the negative thereof or variations thereon or similar terminology. Any forward-looking information presented herein is made only as of the date of this press release, and Univar Solutions does not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise, except as required by law.

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

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: (i) potential product approvals; (ii) anticipated actions by partners to drive field development work including dose rates, application frequency, application methods, and the regulatory work necessary for commercialization; (iii) expected product efficacy of MustGrow’s mustard-based technologies; and (iv) expected outcomes from collaborations with commercial partners.

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

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

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

© 2022 MustGrow Biologics Corp. All rights reserved.