Baudax Bio receives notice of allowance for U.S. Patent Application covering use of ANJESO® for the treatment of moderate to severe pain

Research, News, and Market Data on Baudax Bio

August 22, 2022 8:00am EDT

MALVERN, Pa., Aug. 22, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, announced today that the United States Patent and Trademark Office (“USPTO”) has provided a Notice of Allowance for patent application No. 16/297,095, titled “Methods of administering intravenous meloxicam in a bolus dose”, which includes claims covering the use of multiple doses of ANJESO^® for the treatment of moderate to severe pain resulting in a reduction in summed pain intensity difference and also a reduction in the use of rescue analgesia 48 hours following the first dose. (the “’095 Application”). A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months. Once issued, the ‘095 Application will be eligible for listing in the United States Food and Drug
Administration’s (FDA) Orange Book: Approved Drug Products with Therapeutic
Equivalence Evaluations as it relates to ANJESO^®.

Once issued, the ‘095 Application will be the second ANJESO^® patent to be listed in the Orange Book with an expiry date of March 2039. Upon issuance, the ‘095 application will join seven other patents listed in the Orange Book, amongst others owned or licensed by Baudax that currently provide exclusivity to the ANJESO
^® franchise. The ‘095 Application emphasizes ANJESO’s
^® potential to treat moderate to severe pain while potentially reducing the use of rescue analgesics.

“We are pleased by the progress we have made in the United States Patent and Trademark Office and the continued recognition of the inventive nature of our ANJESO^® franchise,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “The ‘095 Application is expected to provide a significant barrier for generic entry and are expected to be joined by other patents currently pending in the USPTO.”

About ANJESO^®

ANJESO^® (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO^® is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. As a non-opioid, Baudax Bio believes ANJESO^® has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO
^® was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO^®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO^®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Forward-Looking
Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including statements relating to Baudax Bio’s patent portfolio, and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:

Investor Relations
Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

Source: Baudax Bio, Inc.

Released August 22, 2022

Tonix Pharmaceuticals Initiates Enrollment in Phase 2 PREVAIL Study of TNX-102 SL for the Treatment of Long COVID

Research, News, and Market Data on Tonix Pharmaceuticals

August 22, 2022 7:00am EDT

Results from Planned Interim Analysis Expected
First Half 2023

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

Concerning Rate of Opioid Use Observed in Long
COVID Patients with Multi-Site Pain

CHATHAM, N.J., Aug. 22, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 2 PREVAIL study of TNX-102 SL¹ as a potential treatment for a subset of patients with Long COVID syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is known officially as Post-Acute Sequelae of COVID-19 (PASC)².

“We are pleased to be starting a Phase 2 clinical study in this indication which is a growing problem and for which no drug is currently approved. We believe Long COVID, characterized by multi-site pain, fatigue and sleep disturbance, has features of central sensitization syndromes similar to fibromyalgia. Fibromyalgia is considered one of the clusters of chronic overlapping pain conditions that have much in common with Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Findings from our retrospective observational database study in over 50,000 Long COVID patients showed that more than 40% of Long COVID patients in the sample have fibromyalgia-like multi-site pain symptoms, suggesting that we should be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition. Our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia. We recognize the need to better understand and develop treatment for Long COVID.”

“This retrospective observational database study also revealed the rate of opioid use in Long COVID patients,” said Greg Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Opioid use was noted in 36% of Long COVID patients with multi-site pain symptoms relative to 19% of Long COVID patients without multi-site pain. In those with multi-site pain, opioid use increased to 39% of patients when fatigue was present, and 50% when insomnia was present. We look forward to continuing to progress this study with the goal of developing a non-addictive, centrally acting analgesic which potentially treats not only pain but also the sleep disturbance and fatigue that are common in Long COVID.”

About the Phase 2 PREVAIL
Study

The Phase 2 PREVAIL study is 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with post-acute sequelae of SARS-COV-2 infection (PASC). The trial is being conducted at approximately 30 sites in the U.S. and is expected to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be changed from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue and cognitive function. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation or to stop the study early for efficacy, currently anticipated in the first half of 2023.

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

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

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.^3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.^4-7 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.⁸ While the vaccines available in the U.S. through either FDA approval or under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

¹TNX-102 SL is an
investigational new drug and has not been approved for any indication.

²Feb. 24, 2021 – White
House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from
the World Health Organization on long COVID.

³Harris, H, et
al. Tonix data on file. 2022

⁴Briggs, A, and Vassall,
A. (2021) “Count the cost of disability caused by COVID-19.” Nature
593(7860): 502-505.

⁵Nittas V, et al. (2022)
“Long COVID Through a Public Health Lens: An Umbrella Review.” Public
Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501

⁶Davis, HE., et al. (2021)
“Characterizing long COVID in an international cohort: 7 months of
symptoms and their impact.” EClinicalMedicine 38: 101019.

⁷Martin C, et al. (2021)
“A model framework for projecting the prevalence and impact of Long-COVID in
the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec
2. doi:10.1371/journal.pone.0260843

⁸The NIH provision of
Title III Health and Human Services, Division M–Coronavirus Response and
Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated
Appropriations Act of 2021. The bill was enacted into law on 27 December 2020,
becoming Public Law 116-260.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

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 initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2022. 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 first half of 2023. 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 (CD40L or CD154) 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) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners
Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com

(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released
August 22, 2022

Image Credit: The Focal Project (Flickr)

Sixteen Years After the Human Genome Project Completion, Regenerative Medicine May Hit its Stride

Bluebird Bio’s performance this past week shows what the power of FDA approval can do when a biotech company gets the green light. Not only did investors enjoy a 51.7% increase in the gene therapy company’s stock price, but patients can now overcome a severe genetic disease. Gene therapies and regenerative medicine are now beginning to blossom, 16 years after the last human chromosome was mapped, completing the human genome project. Quite a few specialized biotech companies have been started within the past 16 years, and many have a product pipeline in various stages of FDA approval. Below is information on Bluebird and two other public companies involved in genetic medicine that you may want to pay attention to.

Source: Koyfin

Bluebird Bio (BLUE)

Bluebird Bio’s blood disorder gene therapy was approved a few days earlier than anticipated. The approval of Zynteglo is exciting for those whose lives will be changed by the gene therapy, investors that have had confidence in the surrounding science, and of course, everyone working at Bluebird bio. Congratulations.

A downside to the FDA approval is that the therapy for betibeglogene autotemcel (beti-cel), will initially cost $2.8 million for those receiving it. More positively, the pediatric and adult patients that will benefit have been requiring ongoing red blood cell transfusions. Zynteglo is a one-time gene therapy, so those afflicted can receive transfusion independence.

Lineage Cell Therapeutics (LCTX)

Lineage Cell Therapeutics is a clinical-stage biotech company developing new cellular therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and helping the body fight cancer. At the company’s core are two proprietary technology platforms: cell replacement and cell and drug delivery. Its cell replacement platform creates new cells and tissues with its pluripotent and progenitor cell technologies. The company’s cell and drug delivery programs are based upon its proprietary HyStem cell and drug delivery matrix technology.

There is no better way for any investor to develop an understanding of a biotech company in the regenerative medicine or gene therapy space than to have its products and pipeline explained to them by the CEO. Channelchek and Noble Capital Markets have arranged for an online interactive roadshow (bring your questions) for interested investors to attend. This will be held on Tuesday (August 23). More information is available here.

Miromatrix (MIRO)

Miromatrix is a company that may one day eliminate waitlists for organ transplants. The company claims to lead the development of bioengineered organs for transplantation with over 118 issued patents worldwide. The technology is able to be applied across many of needs. Specifically, they are currently focused on creating transplantable kidneys (MiroKidney) and livers (MiroLiver) with expectations to also bioengineer other critical organs like lungs, pancreas, and heart.

The decellularization technology is supported through pre-clinical and animal studies that the FDA cleared in previously commercialized matrix products. The company’s bioengineered organs have the potential to eliminate ongoing therapies and prolong life. They also are expected to reduce costs across many areas of the healthcare system. 

Take Away

The FDA approval of Zynteglo for Bluebird Bio and the stock performance was a reminder this week of the potential for companies in the regenerative medicine space to make a difference. It has been 16 years since the human genome project was completed. Many of these companies were started shortly after; perhaps their research and development are about to pay off.

Explore more companies like BLUE, LCTX, and MIRO by registering for Channelchek and exploring under the “COMPANY Data” tab.

Paul Hoffman

Managing Editor, Channelchek

Virtual Roadshow – August 23 Lineage Cell Therapeutics – Brian M. Culley, CEO Join Lineage Cell Therapeutics CEO Brian M. Culley for this exclusive corporate presentation, followed by a Q & A session moderated by Robert LeBoyer, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level Register Now

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Source

https://en.wikipedia.org/wiki/Human_Genome_Project#History

https://www.zynteglo.com/

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Avivagen Announces New Dairy Customer in Mexico

Research, News, and Market Data on Avivagen

• Family-owned dairy business with established reputation for high-quality products turning to OxC-beta^TM to support quality of milk
• Order procured through Meyenberg International, Avivagen’s Mexican distribution partner

Ottawa, ON /Business Wire/ August 19, 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 promising new customer in the Mexican dairy industry.  The agreement will see the customer order 220 kg/month of OxC-beta^TM over a three-month period, beginning in September 2022.

“This new agreement represents the continued expansion of OxC-beta™ use within the dairy industry, a key growth market for Avivagen due to its size and positive economics,” said Kym Anthony, Chief Executive Officer, Avivagen Inc. “Mexico remains an important geographic region for us. We are excited about the potential for this first dairy order in the country to lead to others in this vital industry.”

The new customer, based in the Jalisco State region of Mexico, is a thirty-year old, family-owned business with a history of supplying high quality dairy products. The order follows a thorough assessment by the customer of numerous trials previously conducted in Mexico with OxC-beta™, resulting in higher quality milk and yields across a range of important metrics.

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, the potential for additional orders for
Avivagen’s products, future shipments 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.  Orders may be cancelled for many
reasons 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.

Friday, August 19, 2022

MustGrow Biologics Corp. (MGROF)
Extending an Agreement

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

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

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

Sumitomo Extension. MustGrow announced Wednesday that the Company has extended the option with Sumitomo for exclusive testing with MustGrow’s technology on potatoes and bananas in North, Central, and South America. The Company did not disclose the length of the extension.

Positive Results. During Sumitomo’s use of MustGrow’s mustard-based products for preplant soil fumigation, bioherbicide, and postharvest and food preservation, Sumitomo’s efforts have shown positive levels of efficacy in comparison to certain synthetic chemical standards. With the extension, Sumitomo will to continue to drive all field development, along with regulatory and market assessment work for commercialization. We believe this to be a testament to the safeness and efficacy of MustGrow’s technology and believe this to be a step forward towards seeing top-line revenue….

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. 

Image Credit: Pexels (Kampus Productions)

Covid-19 Vaccine and Healthcare Responsibility to Begin Falling on the Patient

The Department of Health and Human Services (HHS) is scheduled to hold a planning session on Aug. 30 that will include representatives of stakeholders involved with Covid-19 prevention and treatment. This includes pharmaceutical companies, state health departments, health insurers, and pharmacies. Under the direction of the Biden administration, the HHS plans to end the practice of taxpayer-funded Covid-19 vaccines and Covid-19 therapies.

Objectives

The goal of the planning session is to shift more control of pricing and coverage to the healthcare industry. This could increase costs for consumers and generate sales for companies.

Since the start of the pandemic-related programs, the expectation has been that the costs associated with Covid-19 shots and therapies would shift to individuals choosing them and away from the federal government. With funding for the pandemic response disappearing, along with the global outbreak itself, officials are now mapping out the transition of care to fall on the users.

Businesses Affected

The earnings and market implications to certain companies could be significant, depending on the outcome of the planning sessions.  As of February 2022, pharmaceutical companies, including Pfizer (PFE) and Moderna (MRNA) reported at least $79 billion in combined global sales of Covid-19 vaccines and therapies for 2021. Pfizer also reported $8.1 billion in global sales during the second quarter for its Covid-19 treatment, Paxlovid.

As of mid-February, no money was left in HHS’s public-health and social-services emergency fund for healthcare providers. This month (August), the administration stopped supplying monoclonal antibody treatments. Eli Lilly & Co. (LLY) now focuses on sales of its Covid-19 monoclonal antibody treatment to states, hospitals, and other healthcare providers. As far as vaccines, the Biden administration has already signed purchase agreements for updated doses for the fall.

The impact of shifting vaccine procurement to businesses means that each insurer and pharmacy benefit manager may be negotiating with drug manufacturers. The impact on prices is they would likely be higher than what the federal government has paid, and health insurance premiums could come under upward pressure as well.

Timeframe

Shifting payments for Covid-19 drugs and vaccines to the commercial market is expected to take months. During the upcoming August meeting, officials and company representatives are expected to discuss regulatory issues and access to vaccines and treatment, along with reimbursement and coverage, for the uninsured.

The change presents challenges, including what, if anything, to do with roughly 30 million people without health insurance. Currently, the federal government has been purchasing Covid-19 vaccines and treatments and making them available at no user cost during the pandemic. Medicaid and Medicare don’t cover antivirals; they were approved under an emergency-use authorization. This will all have to be addressed.

Take Away

The use of government funding during the pandemic was a boon to many companies. These companies may now be asked to embrace something closer to the “old normal” which could be a more difficult road. The timeline toward transitioning is long and there are many considerations for each stakeholder affected.

Paul Hoffman

Managing Editor, Channelchek

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Image Credit: NIAID (Flickr)

Monkeypox Treatments and Vaccines are Creating Investor Opportunities

Investors are joining healthcare providers and public officials as they all gear up for what is now being called a public health emergency. Monkeypox was a rare disease that has been infecting humans since 1970. The latest global monkeypox outbreak, while significant, has demonstrated the known disease is less of a concern than the novel coronavirus, which made its way to the U.S. in 2020. However, the U.S. President, the WHO, and other global authorities have declared monkeypox an emergency. They have begun stockpiling pills, patches, and vaccines in anticipation of a full-scale effort to prevent the spread.

As authorities declare their intentions, investors are working toward understanding the disease and the likely treatments. From this, they forecast which they expect will be most supported, effectively “the winners.” This list is likely to include everything from antiseptic manufacturers, to contact tracing products, condom manufacturers, and of course, preventatives and treatments. It is the medical side of preventing and treating the diseases that is already getting support from deep-pocket governments.

The virus continues to spread. There were 12,688 confirmed monkeypox cases in the U.S. on Tuesday (August 16), according to the CDC. This is an increase from 9,492 the previous Tuesday. The U.S. has more confirmed cases than any other country. Outside the U.S.,  Brazil, France, Germany, Spain, and the U.K. each also have thousands of monkeypox cases.

Investor’s Attention

Bavarian Nordic (BAVA.CO), a Copenhagen-listed company, is a Danish biotech vaccine manufacturer. The company manufactures the only authorized vaccine against monkeypox in the world. Bavarian Nordic has received an onslaught of requests for supplies of the shot. While they have a monopoly on an approved vaccine, they told Bloomberg today (August 17), “Demand keeps rising, and it’s no longer certain that we can continue to meet the demand we’re facing even with the upgrade of our existing manufacturing site in Denmark.” This could provide investors with additional opportunity if they choose to outsource manufacturing of their Jynneos monkeypox vaccine.

BAVA is up 164% since May 1.

Siga Technologies (SIGA), is a U.S.-based Nasdaq listed company. Siga manufactures a therapy for smallpox that is not yet approved in the U.S. for monkeypox called Tpoxx. Tpoxx has been approved for use for monkeypox in the UK and other affected countries outside the U.S.

SIGA is up 266% since May 1. 

Tonix Pharmaceuticals (TNXP), is a U.S.-based Nasdaq listed company that is developing a live form of the horsepox virus to be used as a preventative for monkeypox and smallpox infections. In January 2020, the company announced the results of test studies in non-human primates that were challenged with monkeypox. In that study, the safety of TNX-801 was exhibited by stable body weights and body temperatures for all treated animals.  

Read the most recent TNXP research
report by Noble Capital Markets.

Take Away

Just a short time ago, investors were made aware of how profitable a declared healthcare crisis can be for companies and their investors. Obviously, those medically impacted benefit as well. While the growing monkeypox outbreak does not pose as large a threat as Covid-19, it provides an interesting opportunity as it is already declared a health threat. The emergency status means there will be significant financial support to curtail and eliminate the outbreak. Learning early where that will be could be profitable

Investors can research small and microcap biotech and pharmaceutical companies on Channelchek by signing-up to have access to the complete website.

Paul Hoffman

Managing Editor, Channelchek

Suggested Content

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Capitalism versus Coronavirus (May 2020)

Tonix Pharmaceuticals (TNXP) NobleCon18 Presentation Replay

Sources

https://www.whitehouse.gov/briefing-room/press-briefings/2022/08/11/press-briefing-by-white-house-monkeypox-response-team-and-public-health-officials/

https://www.hpnonline.com/infection-prevention/article/21277723/mayo-clinic-expertise-on-monkeypox

https://www.cdc.gov/poxvirus/monkeypox/about.html

https://www.npr.org/sections/health-shots/2022/08/04/1115676160/white-house-declares-monkeypox-a-public-health-emergency

https://www.cdc.gov/poxvirus/monkeypox/sexualhealth/index.html

https://www.pinknews.co.uk/2022/07/16/monkeypox-sexually-transmitted-semen-condom-sex/

https://www.barrons.com/articles/monkeypox-vaccine-supply-bavarian-nordic-51660735711

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BioSig’s Cardiac Signal Processing Technology To Be Featured at Kansas City Heart Rhythm Symposium 2022

News and Market Data on BioSig Technologies

August 17, 2022

Leading Medical Center of Excellence Physician will discuss
integrating the PURE EP™ System into their practice and procedural workflow

Westport, CT, Aug. 17, 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  its participation in the Kansas City Heart Rhythm Symposium, being held on August 20-21, 2022. The Company’s PURE EP ™ System,  a non-invasive device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology, will be highlighted in a physician presentation during the symposium.

The presentation, titled, “Going Back to Old School –
Leveraging EGMs to Improve Efficacy, Safety of Ablation” will be conducted during a symposium session beginning at 12:30 PM ET on Sunday, August 21, 2022. Hicham El Masry. M.D., a Cardiac Electrophysiologist at Mayo Clinic’s Arizona Campus, will discuss the clinical advantages of the PURE EP™ System and the impact the technology has made on his electrophysiology (EP) practice and procedural workflow.  

During the event, the Company’s clinical and commercial teams will host product demonstrations that will showcase the latest advancements and software features of its PURE EP ™ System. The Company will also provide an update on developments in its clinical pipeline. 

“We are looking forward to returning to KCHRS, with the latest advancements of the PURE EP™ System that have been demonstrated and featured by one of our earliest adopters,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. “We would like to thank Dr. Lakkireddy for allowing us to be a part of such an important meeting and Dr. El Masry for representing our technology at the symposium.”

To
register for the event, please click here.

BioSig recently announced the commencement of a physician-initiated research protocol that will analyze the signals acquired by its PURE EP™ System during Radiofrequency (RF) ablation. Led by Dhanunjaya DJ Lakkireddy, MD, Medical Director for the Kansas City Heart Rhythm Institute, the single center study underway at Overland Park Regional Medical Center, is officially registered with clinicaltrials.gov [NCT05464537], and includes 30 participants with paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI).

About
KCHRS 2022
The Kansas City Heart Rhythm Symposium is an EP-focused medical education event for the neighboring four state regions. A variety of topics will provide specialists and generalists an update on the evolution of disease processes, diagnostic tools, therapeutic strategies and ethical issues in the advancement of patient care. To learn more visit, www.kchrs.com.

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™ 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™ 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™ 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™ 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.

Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

55 Greens Farms Road

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

MustGrow Biologics and Sumitomo Corporation Announce Extension of Exclusive Agreement and Program Advancement

Research, News, and Market Data on MustGrow Biologics

• Sumitomo Corporation has extended the option for exclusive testing with MustGrow’s technology for preplant soil fumigation, bioherbicide, postharvest and food preservation for potatoes, and bananas in North, Central, and South America.
• Sumitomo Corporation continues to demonstrate positive levels of efficacy utilizing MustGrow’s technology in comparison to synthetic chemical standards.
• Sumitomo Corporation to continue driving all field development, including regulatory and market assessment work necessary for commercialization.

TOKYO,
JAPAN & SASKATOON, SK, CANADA – August 17, 2022 – Sumitomo Corporation
(TYO: 8053) (OTC: SSUMY) and MustGrow Biologics Corp. (CSE: MGRO) (OTC: MGROF)
(FRA: 0C0) (“MustGrow”) have signed an extension to their Exclusive Evaluation and Option Agreement (the “Extension
Agreement”) to continue developing MustGrow’s mustard-based technology across the Americas.

Pursuant to the Extension Agreement, MustGrow has granted Sumitomo Corporation the exclusive right to continue developing MustGrow’s mustard-based technologies for preplant soil fumigation, bioherbicide, and postharvest and food preservation for potatoes and bananas in North, Central, and South America for an additional option period (the “Extension
Period”). Over the span of the initial option period, Sumitomo Corporation’s evaluation efforts demonstrated positive levels of efficacy utilizing MustGrow’s technology in comparison to certain synthetic chemical standards. These positive tests, conducted across the Americas, resulted in the parties’ desire to extend the term of the Exclusive Evaluation and Option Agreement. During the Extension Period, Sumitomo Corporation plans to continue to drive all field development, regulatory and market assessment work necessary for commercialization.

The global crop protection chemicals market size was valued at USD 63.7 billion in 2020, and is projected to reach a value of USD 74.1 billion by 2025.⁽¹⁾ The growth of this market is attributed to the increasing need for food security of the growing global population. A large growth market is biopesticides, which are pesticides produced naturally, with minimum usage of chemicals. Due to rising environmental concerns and awareness of the pollution potential and health hazards of many synthetic conventional pesticides, the demand for biopesticides has been rising steadily in all parts of the world.

SUMITOMO CORPORATION COMMENT

“We are convinced that BioSolutions combined with AgTech are the future of agriculture and fundamental pillars where we are focusing our investment in the development of new solutions. After evaluating and verifying the effectiveness of the MustGrow technology in different crops with different application techniques, we are very glad to take a step forward in the collaboration with MustGrow.”

“We expect to strengthen this collaboration to accelerate the development to make this safe and effective tool available to farmers as soon as possible for a more sustainable agriculture,” said Marcos Mares, Head of Global Business Development in Sumitomo Corporation AgriScience Department.

MUSTGROW COMMENT

“We are very excited to have Sumitomo Corporation commit to the next stage of our agreement. Considering that close to 45% of the global food is produced in North, Central and South America, it is critical to continue to innovate and develop technologies like ours,” said Corey Giasson, MustGrow’s President & CEO. “Having an organization like Sumitomo Corporation demonstrate the benefits in field and commit to move forward with our technologies is a great step to providing a sustainable solution for farmers globally.”

Source 1 – https://www.marketsandmarkets.com/Market-Reports/crop-protection-380.html

About
Sumitomo Corporation

 Sumitomo Corporation (“SC”) is a leading Fortune 500 global trading and business investment company with 131 locations (Japan: 20, Overseas: 111) in 66 countries and regions. The entire SC group consists of more than 900 companies. SC conducts commodity transactions in all industries utilizing worldwide networks, provides customers with financing, serves as an organizer and a coordinator for various projects, and invests in companies to promote greater growth potential. SC’s core business areas include six business units: Metal Products; Transportation & Construction Systems; Infrastructure; Media & Digital; Living Related & Real Estate; and Mineral Resources, Energy, Chemical & Electronics, and one initiative: Energy Innovation.

SC began exporting business of crop protection products in the 1970s, and has expanded its business realm to importing and wholesaling in 37 countries with 40 companies. Leveraging these broad networks and its long experience in the industry, SC has further expanded its activities to make a multifaceted contribution to global agriculture, such as the direct sales of agricultural inputs to farmers and the utilization of cutting-edge agricultural technologies.

For more information, please visit: https://www.sumitomocorp.com/en/jp.

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 www.mustgrow.ca.

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. 

Wednesday, August 17, 2022

Ayala Pharmaceuticals (AYLA)
RINGSIDE Data Presentation Announced With 2Q Results

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.

Financial Loss Was Less Than Expected.  Ayala reported 2Q22 loss of $ 8.2 million or $(0.54) per share, compared with our estimated loss of $10.9 million or $(0.71) per share.  The difference was largely due research and development spending of $5.6 million coming in lower than our estimate of $8.2 million.  Cash on hand at the end of the quarter was $20.1 million.

Phase 2/3 RINGSIDE Trial Data Presentation Planned At ESMO.  In July, Ayala announced preliminary findings from the Phase 2/3 RINGSIDE trial testing AL102 in desmoid tumors.  As discussed in our note from July 6, the company reported encouraging results although no data was released.  It stated that the trial had shown sufficient tumor activity, safety, and reiterated plans to initiate Phase B later in the year. The data presentation is now planned for the meeting of the European Society for Medical Oncology (ESMO) to be held September 9-13 in Paris, France. …

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 Sees Positive Momentum from Sales Pipeline Growth

News and Market Data on BioSig Technologies

August 16, 2022

Westport, CT, Aug. 16, 2022 (GLOBE NEWSWIRE) —

• Company sees increase in
  medical centers entering into 60-day evaluation agreements

• Existing customers
  seeing positive results from PURE EP™ System expected to increase
  number of units purchased

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 it is seeing positive momentum from the growth of its sales pipeline, and expects to see an increase in enterprise adoption of its PURE EP™ System  in the coming months.

Since BioSig’s national commercial launch of its PURE EP™ System on July 1st, 2022, the Company’s commercial pipeline has experienced a steady increase in advanced leads and technology adoption across several key regions and centers of excellence. Under the terms of its new leasing program, the Company recently signed a purchase agreement with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center. In addition, the Company inked its first master services agreement with one of the largest U.S. healthcare systems.

Among several key regions, BioSig’s PURE EP™ System continues to gain interest in hospitals across the Midwest, including new evaluation agreements with the Cleveland Clinic, a leading Medical Center of Excellence, and an additional installation at a leading medical center in Springfield, IL.

“The demand for minimally invasive catheter-based ablation procedures continues to grow. We believe that market demand is high, and expect to see an acceleration of commercial activity in our quarterly results going forward,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

BioSig’s commercial momentum is supported by its recent decision to streamline the PURE EP™ System evaluation period from 180-360 days to 60-days. The Company has also implemented a new leasing program to help expedite the acquisition of Pure EP’s superior signal processing capabilities and shortens the sales cycle.  Consistent with its stated commercial strategy, BioSig is prioritizing the growth of its robust sales team, including the recent appointment of a new sales leader who will cover the COLT states (Colorado, Oklahoma, Louisiana, and Texas).

“By shortening our evaluation period and providing flexible paths to purchase, we are meeting the demands of physicians and supply chain management, ensuring that superior signal processing technology is within reach. We’re pleased to be exploring opportunities for repeat business and additional unit placement with many of our existing accounts,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

Looking further ahead, the Company will be participating in several key industry conferences and events, including the 2022 Kansas City
Heart Rhythm Symposium, taking place at the end of the month and the Cleveland Clinic
Global EP Summit 2022 in September, where BioSig will serve as sponsor at the annual global summit.

The Company is also expanding its clinical research pipeline, including the recent commencement of a physician-initiated research protocol that will analyze the signals acquired by its PURE EP™ System during Radiofrequency (RF) ablation. Led by Dhanunjaya DJ Lakkireddy, MD, Medical Director for the Kansas City Heart Rhythm Institute, the single center study underway at Overland Park Regional Medical Center, is officially registered with clinicaltrials.gov [NCT05464537], and includes 30 participants with paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI).

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™ 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™ 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™ 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™ 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.

Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

55 Greens Farms Road

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

Source: BioSig Technologies, Inc.

Released
August 16, 2022

Tuesday, August 16, 2022

Genprex (GNPX)
REQORSA Approved For Dose Escalation In Phase 1/2 Trial

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.

Sufficient Safety Shown In First Cohort.  Genprex announced that the first cohort from its Phase 1/2 Acclaim-1 trial in non-small cell lung cancer (NSCLC) has shown sufficient safety to allow treatment of a second cohort at a higher dose. This approval from the Safety Review Committee (SRC) after it analyzed patient data in the first cohort. Genprex expects all three cohorts in the Phase 1 portion to be completed by YE22.

Mechanism Of Action Could Improve Patient Survival.  The Acclaim-1 study is Phase 1/2 trial testing the combination of REQORSA with Tagrisso (osimertinib) in non-small cell lung cancer (NSCLC).  This combines Tagrisso’s action as an EGF inhibitor with Requorsa’s delivery of the TUSC2 cancer suppressor gene.  REQORSA adds the inhibition of several pathways leading to tumor growth and proliferation, and restores pathways that defend against cancer.  The REQORSA combination has received Fast-Track designation for NSCLC from the FDA….

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. 

Tuesday, August 16, 2022

Cocrystal Pharma (COCP)
2Q Reported With Influenza and COVID-19 Product Updates

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.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.

2Q Included One-Time Charges.  Cocrystal reported a loss of $24.4 million or $(0.25) per share, including a write-off of goodwill for $19.1 million and a legal settlement expense of $1.6 million.  Operating expenses excluding these charges were $3.7 million, compared with our estimated operating expenses of $3.8 million.  The company ended the quarter with $51.0 million in cash.

Influenza Program Reported First Data With More Expected Later in 2022.  The company reported that data from CC-42344, its oral PB2 inhibitor that blocks a polymerase enzyme needed for viral replication.  Data from a single-ascending dose study supporting the once-daily dosing schedule.  Additional results from the Phase 1 study enrolling healthy volunteers in Australia are expected to be announced later this year.   …

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.