PaxMedica Inc. (NASDAQ: PXMD)

The QualityStocks Daily Newsletter would like to spotlight PaxMedica Inc. (NASDAQ: PXMD).

PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, is reporting that its phase 2 study research exploring the potential of low-dose suramin intravenous infusions as an autism spectrum disorder ("ASD") treatment has been published. According to the announcement, the findings from the study were published in the "Annals of General Psychiatry." The company noted that the research had been led by PaxMedica CMO Dr. David Hough, who worked with a team of renowned ASD specialists. The research was based on a comprehensive, 14-week randomized, double-blind, placebo-controlled study with 52 participants diagnosed with moderate to severe ASD; the participants were boys aged 4 to 15 years of age. The main focus of the study was to evaluate the efficacy and safety of suramin intravenous infusions, with the 10 mg/kg suramin arm demonstrating promising results in the improvement of core symptoms. According to the company, the study revealed statistically significant improvements in the Clinical Global Impressions-Improvement ("CGI-I") scale among the 10 mg/kg arm compared to the placebo group. "We are highly encouraged by the findings of our study, which provide significant insights into the potential of suramin as a safe and effective treatment for the core symptoms of ASD," said PaxMedica chief medical officer Dr. David Hough in the press release.

To view the full research article, visit https://ibn.fm/tHy16

To view the full press release, visit https://ibn.fm/AZK36

New research has found that children with disorders on the autism spectrum have lower physical activity levels and worse sleep in comparison to their peers. One of the study's coauthors, Xiao Liang, stated that the study was driven by results from earlier research as well as his experience as an inclusive education teacher in Hong Kong. Liang, who is a research assistant professor in the rehabilitation sciences department at Hong Kong Polytechnic University, added that he discovered that students with autism spectrum disorders (ASD) had low levels of physical activity during class as well as recess and lunch break. For his previous research, he carried out a systematic review to summarize accelerometer-measured levels of physical activity in adolescents and children with ASD. He determined that only 47% of adolescents and children with ASD met the WHO-recommended guidelines on physical activity guidelines and noted that age-related reductions in physical activity were evident in adolescents and children around the globe. A number of companies such as PaxMedica Inc. (NASDAQ: PXMD) are working to develop novel treatments for various neurologic conditions, including autism spectrum disorder. The success of these efforts will benefit plenty of affected people around the world.

PaxMedica Inc. (NASDAQ: PXMD) is a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic therapies (APTs) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms.

The company’s lead programs are focused on ASD, for which there are currently no approved pharmacologic treatments that target its cause and symptoms. Currently used treatments only address the symptoms of the condition, rather than targeting the pathophysiology itself.

PaxMedica is on a promising path to address these unmet medical needs, bringing hope to millions. Anti-purinergic therapies target the excess production of purines in cells. An overexpression of purines can offset homeostasis and result in an overproduction of cellular adenosine triphosphate, the main energy molecule in all living cells.

The company is headquartered in Tarrytown, New York.

Product Pipeline

PaxMedica is building a robust pipeline of products targeting ASD and related neurodevelopmental conditions. The company’s lead product in development may help eliminate, reduce or modulate some of the more troublesome aspects of ASD. That would open the potential for people with autism to integrate their behavior with others more successfully and improve their lives.

PaxMedica’s lead programs, PAX-101 and PAX-102, utilize the company’s proprietary source of suramin sodium, a broadly acting anti-purinergic therapy that has been known for over 100 years. Its current pipeline includes:

• PAX-101 (IV Suramin) for ASD – PAX-101 completed a Phase 2B study for ASD in 2021. Suramin is a broadly acting APT and has reported positive results from a dose range study. The results of PaxMedica’s Phase 2B study, which targeted 52 subjects across six sites in South Africa, were presented to AACAP in October 2021.
• PAX-102 (Intranasal Suramin) – PaxMedica has developed a proprietary intranasal formulation of suramin that is currently being evaluated in ASD and other neurodevelopmental conditions.
• PAX-101 for HAT – Given suramin’s historical use as a treatment for Human African Trypanosomiasis (HAT), or African Sleeping Sickness, the company is also developing PAX-101 as a treatment for HAT. PaxMedica’s most advanced program is the pursuit of PAX-101 for early-stage East African HAT.
• Selective APTs – PaxMedica has conducted several preclinical studies to evaluate other APTs that are more selective to specific purinergic receptors and may offer additional benefits over suramin.

Market Opportunity

According to a report by Fortune Business Insights, a leading global market research company, the global ASD therapeutics market was estimated at $1.93 billion in 2022 and is projected to grow from $2.01 billion in 2023 to $3.42 billion by 2030, a CAGR of 7.9% over the forecast period. As there is no current treatment for the core symptoms of autism, PaxMedica believes the addressable market for PAX-101, if approved, could greatly exceed these forecasts.

Autistic disorder, Asperger’s Syndrome and Pervasive Development Disorder are the three main types of ASD, affecting millions of people globally. A 2020 report by the U.S. Centers for Disease Control & Prevention estimated that one in 36 children in the U.S. have been diagnosed with autism disorder.

Several factors are expected to contribute to market growth prospects. A growing prevalence of the condition globally and rising awareness coupled with available treatment options are key factors expected to drive ASD therapeutics market growth during the forecast period. Growing investment in R&D to find effective treatments is also expected to fuel global market growth.

Management Team

Howard Weisman is Chairman and CEO of PaxMedica. He has been a founder and CEO of several specialty pharma and medical device companies. Most recently, he was executive chairman and co-founder of Sofregen, a biotech company. He also served as CEO and president of Seventh Sense Biosystems, a medical device development company. He also was founder, chairman and CEO of EKR Therapeutics, a specialty pharmaceutical company, and founder and COO of ESP Pharma, a company focused on cardio and neurovascular products. He has a bachelor’s degree in chemistry from Rutgers University.

David Hough, M.D., is Chief Medical Officer at PaxMedica. He is a neuroscience clinical development consultant who previously served as vice president at Janssen Research and Development and in various leadership roles over 17 years. Most recently, he was the compound development team leader for SPRAVATO® for treatment-resistant depression. Prior to that, he was the schizophrenia disease area leader. He played a pivotal role in the development programs for oral INVEGA®, INVEGA SUSTENNA® and XEPLION® for schizophrenia. He is a graduate of West Point and is board certified in psychiatry.

Stephen Sheldon is COO and CFO at PaxMedica. He has served as CEO of Thailand-based specialty healthcare company Indochina Healthcare Co. Ltd. since 2015. Previously, he was a consultant for PricewaterhouseCoopers Healthcare Advisory in the Chicago office. He was responsible for developing specialty pharmacy patient programs, strategy development for specialty products and compliance programs. He has an MBA from Thunderbird School of Global Management and a bachelor’s degree in computer science and visual arts from Bowdoin College.

PaxMedica Inc. (NASDAQ: PXMD), closed Tuesday's trading session at $4.5, up 47.541%, on 35,202,542 volume. The average volume for the last 3 months is 56,804 and the stock's 52-week low/high is $2.50/$69.19.

Recent News

• PaxMedica Inc. (NASDAQ: PXMD) - Study Finds Autism Compromises Sleep Quality, Physical Activity in Kids
• InvestorNewsBreaks - PaxMedica Inc. (NASDAQ: PXMD) Phase 2 Study Results Published in Peer-Reviewed Journal
• PaxMedica Inc. (NASDAQ: PXMD) PRV Sale Prospects Strengthened by Recent Industry Developments

HeartBeam Inc. (NASDAQ: BEAT)

The QualityStocks Daily Newsletter would like to spotlight HeartBeam Inc. (NASDAQ: BEAT) .

HeartBeam (NASDAQ: BEAT), a cardiac technology company that has developed the first and only credit card-size 3D-vector electrocardiogram ("VECG") platform for patient use at home, today announced that the United States Patent and Trademark Office has granted a new patent on its VECG platform. Patent number 11,793,444, "Electrocardiogram Patch Devices and Methods," describes methods and systems for remote detection and/or diagnosis of acute myocardial infarction ("AMI" or heart attack) through handheld and adhesive devices. This is HeartBeam's third issued U.S. patent on its on-demand 12-lead ("12L") wearable cardiac monitor, strengthening its position in the large global electrocardiogram ("ECG") patch market that is estimated to reach $4.8 billion by 2030. "This patent represents an integral part of the company's strategy to ensure HeartBeam's disruptive technology is well protected," said Branislav Vajdic, Ph.D., CEO and founder of HeartBeam. "We believe our 12-lead ECG technology has the potential to become the standard of care and are actively pursuing options to bring the 12-lead extended wear patch to market."

To view the full press release, visit https://ibn.fm/XT3U4

HeartBeam Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector 12-lead electrocardiogram (ECG) platform for heart attack detection anytime, anywhere. The company’s proprietary ECG telehealth technology aims to redefine the way high risk cardiovascular patients are diagnosed in ambulatory and acute care settings. HeartBeam’s initial focus is on providing diagnostic data to help physicians with care management of patients with cardiovascular disease.

In August 2022, HeartBeam announced that it submitted its HeartBeam AIMI™ software for approval from the U.S. Food and Drug Administration (FDA). HeartBeam AIMI is a platform technology to improve the speed and accuracy of heart attack detection in acute care settings. The company expects FDA approval by the end of 2022, and a full commercial roll-out of HeartBeam AIMI is targeted for Q1 2023.

HeartBeam sees submission of its first product based on its platform technology as an important milestone toward commercialization, which underscores the company’s continued progress toward making the HeartBeam AIMI platform widely available to help emergency department physicians quickly and accurately identify a heart attack.

While the FDA conducts its regulatory review, HeartBeam will focus on executing key components of its commercialization plan and subscription revenue model. It will also continue to engage in discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize HeartBeam products.

The company is based in Santa Clara, California.

Products

HeartBeam’s development portfolio includes two products:

• HeartBeam AIMI is software that provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack in acute care settings and, as noted above, has been submitted for FDA approval; and
• HeartBeam AIMIGo™, the first and only credit card-sized 12-lead output ECG device coupled with a smartphone app and cloud-based diagnostic software system for remote heart attack detection.

HeartBeam is developing AIMIGo, a medical-grade detection and monitoring technology for use in remote heart attack detection, thereby allowing physicians to diagnose a patient’s heart attack as it occurs, even if the patient is not at a medical facility. The company’s system, once approved by the FDA, can be used by patients at home or almost anywhere and anytime to help their physicians assess whether chest pain is the result of a heart attack or another cause. While approximately 82% of chest pain ED visits are unnecessary, patients delay approximately 3 to 4 hours after symptoms begin, increasing mortality rates by 40%. The company’s goal is to shorten the time to treatment outside of the medical facility to improve patients’ well-being.

HeartBeam’s AIMIGo is a powerful, portable and easy-to-use prescription-based product. It comprises a smartphone app, a credit card-sized ECG device placed on a patient’s chest, the HeartBeam cloud platform, and a digital portal for the physician to view ECG results and direct patient action. For the first time outside of a medical setting, HeartBeam AIMIGo enables patients and their clinicians to determine if symptoms are due to a heart attack, quickly and easily, so care can be expedited, if needed.

Pending FDA clearance, AIMIGo is initially intended to be available by prescription, and is reimbursable under existing remote patient monitoring codes (RPM codes). This provides a new revenue stream to physicians who before did not have a way to monitor these high-risk patients. The RPM codes provide a monthly reoccurring revenue stream to the company, as well. On average, at current reimbursement rates, the practice will receive $1,300+ per year per patient they monitor, and the company will receive $600 per year per patient from this RPM reimbursement.

Market Overview

Adoption rates of telehealth services increased dramatically in recent years, with the COVID-19 pandemic serving as a major driver of growth. Among the areas seeing the greatest expansion are cardiology, radiology, behavioral health and online consultation.

Encouraging this growth, governments are actively developing new policies and reimbursement guidelines to promote the use of digital health platforms. The U.S. Centers for Medicare & Medicaid Services (CMS), for example, has recently expanded reimbursement for telehealth services. U.S. market growth is also being driven by the rising prevalence of chronic conditions and the growing geriatric population.

Remote heart attack detection is a previously unsolved problem with a massive and underserved market that is several times larger than the $2 billion total addressable market (TAM) in the U.S. for ECG cardiac arrhythmia monitoring.

Approximately 8 million Americans have suffered at least one heart attack, and a total of 18 million have been diagnosed with coronary artery disease (CAD). Based on these figures, HeartBeam projects a total addressable U.S. market TAM valued at $10 billion annually for its AIMIGo solution for remote heart attack monitoring of CAD.

Management Team

Branislav Vajdic, Ph.D., Chief Executive Officer and Founder of HeartBeam, Inc, combines over 30 years of experience in technology development and senior management positions. Dr. Vajdic has been deeply involved with the development of HeartBeam’s technology to fit his vision for the company. Prior to HeartBeam, from 2007 to 2010, Dr. Vajdic was CEO and Founder of NewCardio, a publicly traded company in the cardiovascular devices space. From 1984 to 2007, Dr. Vajdic was at Intel, where he held various senior management position. At Intel, Dr. Vajdic was the designer of first Flash memory and two key inventions that enabled Flash as a product and led engineering groups responsible for Pentium 1 through Pentium 4 designs. Dr. Vajdic was awarded two Intel Achievement Awards, the highest level of award for outstanding contributions to Intel. Dr. Vajdic is author of numerous patents and publications in the fields of cardiovascular devices, as well as chip design. Dr. Vajdic holds a Ph.D. in Electrical Engineering from the University of Minnesota.

Jon Hunt, Ph.D., has over 35 years’ experience in the medical/medical device industry with extensive domestic and international experience in general management, clinical/regulatory, sales and marketing. He also has diverse experience in Fortune 500 companies, as well as start-up environments. Dr. Hunt was the Vice President of Clinical Science and Technology, Medical Device Innovation Consortium, from July 2019 to July 2021, and Vice President of Clinical and Regulatory Affairs, Cryterion Medical from January 2018 to June 2019 (acquired by Boston Scientific Corporation in July 2018 for $202M). Dr. Hunt was the Founding President and CEO of Bardy Diagnostics, Inc. from October 2013 to November 2017 (acquired by Hill-Rom Holdings, Inc.). Prior to joining Bardy Diagnostics, Dr. Hunt spent the previous 11 years as the Vice President of Clinical & Regulatory Affairs with Cameron Health, Inc. (acquired by Boston Scientific Corporation). Dr. Hunt spent the previous 10 years with Cardiac Pacemakers, Inc., St. Jude Medical and Cardiac Pathways Corporation. Dr. Hunt began his career with Cardiac Pacemakers, Inc. (now Boston Scientific Corporation) as the Director of Clinical Programs. He subsequently held positions at St. Jude Medical in Clinical Affairs and as the Business Unit Director for the Cardiac Rhythm Management division for Europe, the Middle East and Africa. At Cardiac Pathways Corporation, Dr. Hunt held various executive positions as Vice President of International Sales and Marketing and Vice President of Worldwide Sales and Marketing (acquired by Boston Scientific Corporation). Dr. Hunt received his Ph.D. in Motor Control from The Pennsylvania State University, his Master’s from California State University, Long Beach and his undergraduate degree from Keele University in the United Kingdom.

Rick Brounstein, HeartBeam’s Chief Financial Officer, combines over 30 years of experience in health technology senior management. Since 2017, Mr. Brounstein has been and is currently a partner of Hardesty, LLC, a financial services firm, and Mr. Brounstein is currently a managing director of CTRLCFO, LLC, a firm Mr. Brounstein founded in 2016 to support funded start-ups in life science and technology. From 2008 to 2011, Mr. Brounstein was Chief Financial Officer of NewCardio, Inc., a microcap public company in the cardiology space, and, over his career, he has been with nine other companies in life science or technology, holding positions including Chief Financial Officer, Chief Operating Officer, Treasurer and Accounting Manager. From June 2001 through November 2007, Mr. Brounstein held several positions at Calypte Biomedical Corporation, a publicly traded medical device company, including Chief Financial Officer and Executive Vice President. In January 2007, Mr. Brounstein was appointed as the National Member Representative for the 2007 COSO Monitoring Project, which published new guidelines for monitoring internal financial controls in February 2009; Mr. Brounstein subsequently was a member of the FEI task force that issued the updated COSO Internal Control Framework in 2013. In March 2005, Mr. Brounstein was appointed to the SEC Advisory Committee on Smaller Public Companies. Mr. Brounstein earned his Certified Public Accountant (CPA) certification while working at Arthur Andersen LLP, formerly a public accounting firm. Mr. Brounstein holds a B.A. in accounting and an M.B.A. in finance, both from Michigan State University.

Ken Persen, HeartBeam’s Chief Technology Officer, combines over 28 years of experience in the medical device and digital health industries in engineering and senior management positions. Mr. Persen has been involved in several companies in Cardiac Rhythm Management, holding positions including Chief Executive Officer, Chief Technology Officer, Executive Vice President and Director of Engineering. Since 2016 and prior to joining HeartBeam, Mr. Persen was the Chief Technology Officer at LIVMOR, Inc., a digital health company. In addition, from 2016 through November 2021, he was also Chief Executive Officer of LIVMOR. Prior roles included Director of Engineering at Cameron Health (acquired by Boston Scientific), a late-stage medical device start up, and engineering and management positions at Guidant Corp. (acquired by Boston Scientific), a large medical device manufacturer. He has an undergraduate degree from University of Minnesota, Duluth, with a BA in Computer Science.

HeartBeam Inc. (NASDAQ: BEAT), closed Tuesday's trading session at $1.35, up 2.2727%, on 434,849 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $69.19/$.

Recent News

• HeartBeam Inc. (NASDAQ: BEAT) - InvestorNewsBreaks - HeartBeam Inc. (NASDAQ: BEAT) Granted 3rd US Patent on Novel VECG Platform
• InvestorNewsBreaks - HeartBeam Inc. (NASDAQ: BEAT) to Host Third Quarter 2023 Results Conference Call
• Implicity Expands Senior Leadership Team with New U.S. Chief Commercial Officer

Clene Inc. (NASDAQ: CLNN)

The QualityStocks Daily Newsletter would like to spotlight Clene Inc. (NASDAQ: CLNN).

D-Wave's new open-source demonstration highlights how its Advantage(TM) quantum computing system can be used to tackle challenges in wireless channel decoding, a growing worldwide problem given the dramatic global growth in wireless connections

Demonstration shows quantum computing's ability to tackle challenges of this magnitude relative to classical computation

Quantum and quantum-hybrid technologies offer value in helping network providers solve a variety of telco-related optimization problems

D-Wave Quantum (NYSE: QBTS), a leader in quantum computing systems, software and services, and the world's first commercial supplier of quantum computers, recently announced the launch of a new open-source demonstration that highlights how its Advantage(TM) annealing quantum computing system can be used to tackle wireless channel decoding problems. The demo, available through the company's Leap(TM) real-time quantum cloud service, identifies solutions for increasing transmission capacity for wireless and cellular networks using coordinated multipoint decoding.

Clene Inc. (NASDAQ: CLNN) is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).

Its lead drug candidate is CNM-Au8®, an oral suspension developed to restore neuronal health and function by increasing energy production and utilization by driving critical cellular energy producing reactions that enable neuroprotection and remyelination to increase neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is being studied in various clinical trials, including the Harvard/MGH Healey ALS Platform clinical trial for patients with ALS; RESCUE-ALS, a completed proof-of-concept clinical trial in patients with early symptomatic ALS; the REPAIR trials, completed target engagement clinical trials showing brain energy metabolite change with CNM-Au8; and a completed MS clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing MS. The company also has a nanotherapeutic platform of drug discovery.

CNM-Au8

CNM-Au8, Clene’s lead asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Multiple pathogenic insults contribute to neuronal death. Mitochondrial dysfunction and NAD+ decline is a common final pathway in neurodegeneration, with NAD+ as a critical determinant of cell survival and function. CNM-Au8’s catalytic mechanisms target the energetic deficits, oxidative stress and accumulation of misfolded proteins that are common to many neurodegenerative diseases.

The unique catalytic mechanism of action of CNM-Au8 is hypothesized to act as a neuroprotective and remyelinating therapy in neurodegenerative disease states in order to: (1) drive, support and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed and/or damaged cells, (2) directly catalyze the reduction of harmful, reactive oxygen species (“ROS”) and (3) promote protein homeostasis via activation of the heat shock factor-1 pathway, recognized to dampen the cytotoxicity caused by misfolded and denatured proteins, which are known to occur ubiquitously in neurodegenerative diseases.

CNM-Au8 is used in combination with other agents, has no known drug-drug interactions, and is designed to improve function and survival. The clinical effects of both function and survival were seen in its clinical ALS trials, as earlier announced.

More than 500 estimated years of collective exposure across ALS, MS, and Parkinson’s disease participants in CNM-Au8 clinical trials and Expanded Access Protocol (compassionate use) programs have been recorded without any observed safety signals.

CNM-Au8 is a federally registered trademark of Clene Inc. Clene, based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland, began in 2013.

Market Opportunity

ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide, with a life expectancy of typically three to five years. Clene estimates that global ALS treatment sales will be greater than $1 billion annually within the coming few years. Additional treatments affecting daily function and survival remain the market need.

Additionally, there are more than 2 million MS patients globally, and Clene estimates the market size to be worth more than $23 billion annually. While the MS community has been successful at limiting relapses, non-relapsing MS patients continue to clinically deteriorate even while receiving effective immunomodulatory disease-modifying therapies (“DMTs”). A critical unmet medical need remains for therapeutic interventions that protect neuronal function and myelin health independent of immunomodulation to address progression independent of relapse activity.

Management Team

Robert Etherington is President, Director and CEO of Clene. He has more than 30 years of sales, marketing and leadership experience in the pharmaceutical industry. Prior to joining Clene, he worked at Actelion Pharmaceuticals, the largest biopharma company in the European Union prior to its acquisition by Johnson & Johnson in 2017, where he led that company’s U.S. commercial operations. He began his pharmaceutical sales and marketing career at Parke-Davis, a division of Pfizer, where he rose to the position of Team Leader overseeing the drug Lipitor.

Mark Mortenson is Chief Science Officer at Clene. He is co-inventor of the technology platform developed to produce the company’s therapeutics. He is the inventor or co-inventor on 32 other U.S. patents and hundreds of corresponding international patents. He is a former chief patent counsel responsible for 5,500 U.S. and international patents and patent applications. He holds bachelor’s degrees in physics and ceramic engineering from Alfred University, a master’s degree in materials science from Penn State University and a J.D. from George Washington University.

Benjamin Greenberg, M.D., MHS, FAAN, is Head of Medical at Clene. He is an internationally recognized expert in disorders of the central nervous system. He is currently professor of neurology and Vice Chair of Clinical and Translational Research in the department of Neurology at University of Texas Southwestern Medical Center in Dallas. He holds a bachelor’s degree from Johns Hopkins, a master’s degree in molecular microbiology and immunology from the Johns Hopkins School of Public Health and graduated from Baylor College of Medicine. He served residency in neurology at The Johns Hopkins Hospital.

Morgan R. Brown is CFO at Clene. He has more than 30 years of finance and accounting experience, with 23 years at biotech, pharmaceutical and medical device companies. He has served in similar roles at Lipocine Inc., Innovus Pharmaceuticals, World Heart Corp., Lifetree Clinical Research and NPS Pharmaceuticals Inc. He previously worked at accounting firm KPMG. He is a CPA with a bachelor’s degree in accounting from Utah State University and an M.S. in business administration from the University of Utah.

Clene Inc. (NASDAQ: CLNN), closed Tuesday's trading session at $0.7872, up 0.562085%, on 914,080 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.3962/$3.20.

Recent News

• Clene Inc. (NASDAQ: CLNN) - InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Announces Q3 2023 Financial Results, Operating Highlights
• Australian Study Finds Way to Detect Parkinson's Prior to Symptom Onset
• Clene Inc. (NASDAQ: CLNN) Reports Improved Survival Status in ALS Patients Treated with CNM-Au8(R) on Follow-Up Analysis; Announces Peer-Reviewed Study

Clene Inc. (NASDAQ: CLNN)

The QualityStocks Daily Newsletter would like to spotlight Clene Inc. (NASDAQ: CLNN).

Clene (NASDAQ: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., today released its third quarter 2023 financial results and provided recent operating highlights for its ALS clinical program. Among the highlights, the company reported statistically significant improved survival benefit of 19.3 months and significantly delayed clinical worsening in patients treated with CNM-Au8(R) in the RESCUE ALS open-label extension trial. "We are pleased to be approaching a meaningful regulatory discussion with the U.S. Food and Drug Administration (‘FDA') later in the fourth quarter to elucidate key next steps in our ALS regulatory submission of CNM-Au8," said Rob Etherington, president and CEO of Clene. "We are hopeful that the consistent survival, delayed time to clinical worsening and strong safety profile with CNM-Au8 treatment from two phase 2 independent trials is sufficiently compelling for FDA to consider an accelerated path forward. The unmet need remains high for treatments to improve and extend life for patients living with this highly debilitating and rapidly progressive condition."

To view the full press release, visit https://ibn.fm/Jbu6L

Clene Inc. (NASDAQ: CLNN) is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).

Its lead drug candidate is CNM-Au8®, an oral suspension developed to restore neuronal health and function by increasing energy production and utilization by driving critical cellular energy producing reactions that enable neuroprotection and remyelination to increase neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is being studied in various clinical trials, including the Harvard/MGH Healey ALS Platform clinical trial for patients with ALS; RESCUE-ALS, a completed proof-of-concept clinical trial in patients with early symptomatic ALS; the REPAIR trials, completed target engagement clinical trials showing brain energy metabolite change with CNM-Au8; and a completed MS clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing MS. The company also has a nanotherapeutic platform of drug discovery.

CNM-Au8

CNM-Au8, Clene’s lead asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Multiple pathogenic insults contribute to neuronal death. Mitochondrial dysfunction and NAD+ decline is a common final pathway in neurodegeneration, with NAD+ as a critical determinant of cell survival and function. CNM-Au8’s catalytic mechanisms target the energetic deficits, oxidative stress and accumulation of misfolded proteins that are common to many neurodegenerative diseases.

The unique catalytic mechanism of action of CNM-Au8 is hypothesized to act as a neuroprotective and remyelinating therapy in neurodegenerative disease states in order to: (1) drive, support and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed and/or damaged cells, (2) directly catalyze the reduction of harmful, reactive oxygen species (“ROS”) and (3) promote protein homeostasis via activation of the heat shock factor-1 pathway, recognized to dampen the cytotoxicity caused by misfolded and denatured proteins, which are known to occur ubiquitously in neurodegenerative diseases.

CNM-Au8 is used in combination with other agents, has no known drug-drug interactions, and is designed to improve function and survival. The clinical effects of both function and survival were seen in its clinical ALS trials, as earlier announced.

More than 500 estimated years of collective exposure across ALS, MS, and Parkinson’s disease participants in CNM-Au8 clinical trials and Expanded Access Protocol (compassionate use) programs have been recorded without any observed safety signals.

CNM-Au8 is a federally registered trademark of Clene Inc. Clene, based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland, began in 2013.

Market Opportunity

ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide, with a life expectancy of typically three to five years. Clene estimates that global ALS treatment sales will be greater than $1 billion annually within the coming few years. Additional treatments affecting daily function and survival remain the market need.

Additionally, there are more than 2 million MS patients globally, and Clene estimates the market size to be worth more than $23 billion annually. While the MS community has been successful at limiting relapses, non-relapsing MS patients continue to clinically deteriorate even while receiving effective immunomodulatory disease-modifying therapies (“DMTs”). A critical unmet medical need remains for therapeutic interventions that protect neuronal function and myelin health independent of immunomodulation to address progression independent of relapse activity.

Management Team

Robert Etherington is President, Director and CEO of Clene. He has more than 30 years of sales, marketing and leadership experience in the pharmaceutical industry. Prior to joining Clene, he worked at Actelion Pharmaceuticals, the largest biopharma company in the European Union prior to its acquisition by Johnson & Johnson in 2017, where he led that company’s U.S. commercial operations. He began his pharmaceutical sales and marketing career at Parke-Davis, a division of Pfizer, where he rose to the position of Team Leader overseeing the drug Lipitor.

Mark Mortenson is Chief Science Officer at Clene. He is co-inventor of the technology platform developed to produce the company’s therapeutics. He is the inventor or co-inventor on 32 other U.S. patents and hundreds of corresponding international patents. He is a former chief patent counsel responsible for 5,500 U.S. and international patents and patent applications. He holds bachelor’s degrees in physics and ceramic engineering from Alfred University, a master’s degree in materials science from Penn State University and a J.D. from George Washington University.

Benjamin Greenberg, M.D., MHS, FAAN, is Head of Medical at Clene. He is an internationally recognized expert in disorders of the central nervous system. He is currently professor of neurology and Vice Chair of Clinical and Translational Research in the department of Neurology at University of Texas Southwestern Medical Center in Dallas. He holds a bachelor’s degree from Johns Hopkins, a master’s degree in molecular microbiology and immunology from the Johns Hopkins School of Public Health and graduated from Baylor College of Medicine. He served residency in neurology at The Johns Hopkins Hospital.

Morgan R. Brown is CFO at Clene. He has more than 30 years of finance and accounting experience, with 23 years at biotech, pharmaceutical and medical device companies. He has served in similar roles at Lipocine Inc., Innovus Pharmaceuticals, World Heart Corp., Lifetree Clinical Research and NPS Pharmaceuticals Inc. He previously worked at accounting firm KPMG. He is a CPA with a bachelor’s degree in accounting from Utah State University and an M.S. in business administration from the University of Utah.

Clene Inc. (NASDAQ: CLNN), closed Tuesday's trading session at $0.4202, up 8.0206%, on 432,734 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.3576/$1.99.

Recent News

• Clene Inc. (NASDAQ: CLNN) - InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Announces Q3 2023 Financial Results, Operating Highlights
• Australian Study Finds Way to Detect Parkinson's Prior to Symptom Onset
• Clene Inc. (NASDAQ: CLNN) Reports Improved Survival Status in ALS Patients Treated with CNM-Au8(R) on Follow-Up Analysis; Announces Peer-Reviewed Study

Freight Technologies Inc. (NASDAQ: FRGT)

The QualityStocks Daily Newsletter would like to spotlight Freight Technologies Inc. (NASDAQ: FRGT).

Freight Technologies (NASDAQ: FRGT) ("Fr8Tech") is a technology company with a custom-developed Fr8App, an industry-leading freight-matching platform powered by AI and machine-learning offering a real-time portal for B2B cross-border shipping and domestic shipping within the USMCA region. The company today released an open letter from its CEO Javier Selgas addressing concerns regarding recent fluctuations in stock values. "In recent times, we've received inquiries about the downward trajectory of our stock... As the CEO of Fr8Tech, I hold your concerns in the highest regard. My paramount duty is to steer our company toward the realization of our objectives, and as I will outline shortly, we are making substantial strides in that direction," Selgas states in the letter, sharing several recent highlights that underscore the company's commitment to growth. "In closing, please know that Fr8Tech remains steadfast in its pursuit of innovation, growth and investment in our company's people and technologies, particularly AI, throughout our platform and its supporting systems. We appreciate your continued support and trust in our vision. We plan to file our six-month financials later this fall and will provide a broad-based update at that time. Together, we will overcome the challenges we face and emerge stronger than ever."

To view the full press release, visit https://ibn.fm/vQ6gS

Freight Technologies Inc. (NASDAQ: FRGT) (“Fr8Tech”) is a technology company developing solutions to optimize and automate the supply chain process, providing a platform for B2B cross-border shipping in the NAFTA region. The company’s mission is to revolutionize cross-border shipping by providing carriers with increased growth opportunities and shippers with flexibility, visibility and simplicity for the once-complex process of international over-the-road shipping.

Freight Technologies, formerly known as Hudson Capital Inc., assumed its current name and ticker symbol on May 27, 2022. Its primary operating subsidiary and its marketplace are known as Fr8App, and it conducts operations throughout North America under the names of Fr8App and/or Freight App. The company is headquartered in Houston, Texas, with multiple locations across the U.S. and Mexico.

The Fr8Tech Solutions Suite

Fr8Tech leverages artificial intelligence to provide cloud-based platforms aimed at automating the over-the-road transportation process, effectively reducing human touch points and expediting load booking times. The company’s suite of solutions includes:

• Fr8app – A B2B marketplace powered by AI and Machine Learning offering a real-time broker portal to connect shippers with qualified carriers
• Fr8Radar – A tracking solution providing shippers and carriers real-time locational data via Fr8app’s mobile solution or through integration with third-party GPS alternatives
• Fr8TMS – A transportation management system designed to help shippers manage their freight and all of the documents involved in shipping transactions, including invoices, customs documents, confirmation rates and proof of deliveries
• Fr8FMS – A fleet management system allowing transportation companies to better manage their fleets, reduce operational costs and provide better service to their customers
• Fr8Data – A data solution offering real-time dashboards and reports to shippers and carriers in an effort to increase visibility and control while supporting better business decisions
• Fr8Fleet – A platform that provides private fleet management, enabling large corporate shippers to purchase dedicated capacity secured by Fr8app in exchange for a fixed fee

Commitment to the Environment

Through its core focus on technology, Fr8Tech seeks to reduce the carbon footprint of the logistics industry. Its solutions aim to minimize empty miles for transportation firms and reduce overall paper consumption.

Fr8University

Fr8University is an educational program offering classroom and on-the-job training for Fr8Tech team members. Through the program, employees learn in-depth business fundamentals and applications along the truckload freight industry value chain.

Led by corporate educator Mario Mena, Fr8University is designed as an investment in the company’s human capital, providing an opportunity to communicate Fr8Tech’s corporate culture while accelerating operational growth.

Market Outlook

Fr8Tech’s established foothold in Mexico is key to its current efforts to promote sustainable growth in the cross-border shipping industry. Ongoing disruption in U.S.-Chinese trade relations have strengthened Mexico’s status as the largest trading partner of the U.S., with cross-border annual freight spending estimated at $385 billion according to data from the U.S. Department of Transportation. Annual domestic shipping in Mexico is estimated at $34 billion, while annual domestic shipping in the U.S. is estimated to total $732 billion.

Despite the size of this industry, fragmentation and inefficiencies prevail in the space. Thousands of legacy brokers, tens of thousands of shippers and hundreds of thousands of carriers still rely on outdated systems to arrange transport, spending hours on the phone negotiating pricing, waiting days to find trucks and drivers, preparing and printing forms, and operating without tracking or visibility. Add in cross-border complexity relating to customs and additional paperwork, and you have an industry ripe for technological disruption.

Fr8Tech’s recent revenue growth trends have highlighted the company’s efforts to capitalize on this opportunity. In 2021, Fr8Tech achieved revenues of $21.5 million, marking a year-over-year increase of 134%. The company issued revenue guidance for fiscal 2022 of $40 million in a February 9, 2022, press release, which would account for a further 86% year-over-year increase.

Management Team

Javier Selgas is CEO and a Director of Freight Technologies Inc. and Freight App Inc. He brings to the company over 15 years of experience developing technology and digital marketing strategies, including serving as Country Manager for Osigu, Spain, and as head of AJEgroup’s IT division for the Asia-Pacific region. Prior to joining Fr8Tech, Mr. Selgas founded digital marketing agency Lanzadera Online. He has also served as an IT consultant to major corporations, including Endesa and Ibermatica.

Mike Flinker is President of Fr8Tech. He has over four decades of experience in the transportation industry, with 30+ years focused on cross-border logistics. Prior to joining Fr8Tech, Mr. Flinker founded FLS Transportation, the largest cross-border logistics company in Canada. He also previously held positions with Clarke Transport Inc., Canadian Pacific and Reimer Express Inc. (a division of Roadway Express).

Paul Freudenthaler is the company’s CFO and Secretary to the company Board. He has over 30 years of financial expertise, having previously served as CFO for several leading companies across multiple countries, including Macquarie in Mexico, Old Mutual in Latin America and Ascentium Capital in the U.S. Mr. Freudenthaler’s experience include leadership roles from which he guided IPOs and M&A transactions.

Luisa Lopez is COO of Fr8Tech. She brings to the company 25+ years of management experience in logistics, supply chain, operations and customer service. Ms. Lopez previously served as a Director of Landstar, where she was responsible for commercial and client development strategies in the Mexican market. Additionally, she managed more than 2,000 transport units specialized in staff and school mobility while with Traxion in Mexico.

Freight Technologies Inc. (NASDAQ: FRGT), closed Tuesday's trading session at $0.3102, up 3.4%, on 245,654 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.252/$6.70.

Recent News

• Freight Technologies Inc. (NASDAQ: FRGT) - InvestorNewsBreaks - Freight Technologies Inc. (NASDAQ: FRGT) CEO Shares Open Letter to Shareholders
• Freight Technologies Inc. (NASDAQ: FRGT) Taking Part in the Trucking Industry's Ongoing Paradigm Shift with Its Fr8App Platform
• InvestorNewsBreaks - Freight Technologies Inc. (NASDAQ: FRGT) Selected by Leading Pharmaceutical Giant for Vital Logistics Operation

Electronic Servitor Publication Network Inc. (OTCQB: XESP)

The QualityStocks Daily Newsletter would like to spotlight Electronic Servitor Publication Network Inc. (OTCQB: XESP).

Electronic Servitor Publication Network (OTCQB: XESP), a digital engagement company and market disruptor, today announced that its board of directors has authorized and approved the purchase of the assets of PhiTech Management, a digital activation and engagement technology company. PhiTech provides workflow applications designed to connect people with customized content through dynamic provisioning creating relevant digital relationships. The acquisition terms include PhiTech's Digital Engagement Engine(TM), a sophisticated tech stack built on microservices architecture that helps companies enhance the reach and lift of their content to targeted and new audiences. XESP previously accessed PhiTech technologies, processes and support through a licensing agreement, signed in October 2021, which provided XESP with rights to use PhiTech technology and services for the eSports and eGaming markets and right of first refusal for other industries for additional fees. XESP was able to assess and better quantify the impact of PhiTech technologies as part of XESP's Managed Service offering in the digital engagement space via the licensing agreement and positive business interactions over the past 23 months. The decision to acquire the assets and intellectual property was the logical progression when it was demonstrated that owning the technology would provide XESP with greater control of deployment and development, along with the ability to enhance and expand client and shareholder value within additional vertical markets beyond eSports and eGaming.

To view the full press release, visit https://ibn.fm/j369m

Electronic Servitor Publication Network Inc. (OTCQB: XESP) is a digital engagement company offering a managed service which provides digital activation and engagement solutions to companies that seek to optimize their growth. Its managed service is powered by a proven, proprietary technology – the Digital Engagement Engine™. This technology provides intelligent interaction management, dynamic content provisioning, and a logic-driven workflow, which creates digital experiences that accelerate an audience from awareness to action – driving growth.

Electronic Servitor Publication Network’s services are designed to drive growth for both established and developing organizations. Through the optimization of digital interactions within current and new communities, the Digital Engagement Engine™ ensures that client content is relevant, reaches the right audience, and connects with the intended person at the right time.

The company calls it ‘Growth as a Service’.

Client implementation is nearly effortless, since the solution is completely managed by the Electronic Servitor Publication Network team. This business model allows clients to focus on their brands, core product offerings, and content creation, while the company manages the technology and outcome.

The company is headquartered in Minneapolis, Minnesota.

Technology

Electronic Servitor Publication Network’s Digital Engagement Engine™ utilizes a combination of automation, unique data management, and a modern workflow built on a microservices architecture to achieve greater reach and lift. Using sophisticated data analysis and smart technology, the Digital Engagement Engine™ provides companies with the ability to maintain complete control of their content while creating meaningful relationships with new customers and revenue streams.

The Digital Engagement Engine™ isn’t just another marketing or technology tool; it’s a way to develop real connections with target markets.

Market Outlook

According to a report by ReportLinker.com, an award-winning market research firm, the global customer engagement solutions market was estimated at $19.3 billion in 2022 and is forecast to grow to $32.2 billion by 2027, achieving a CAGR of 10.8% during the forecast period.

The report notes that these engagement solutions are vital to companies seeking to widen their customer bases, reduce customer churn rates and increase customer retention. These perceived benefits of customer engagement solutions are likely to drive their growing adoption around the globe during the forecast period, according to the report.

Management Team

Peter Hager is President and CEO of Electronic Servitor. He joined the company from Pointward Inc., a medtech customer engagement agency that provided solutions to drive market entry, growth, and commercialization for Fortune 500 health care brands and medtech startups. He has founded and managed multiple technology, professional services and medtech organizations throughout his career. Mr. Hager holds a bachelor’s degree from Macalester College in St. Paul, Minnesota, with concentrations in economics and psychology.

Jim Kellogg is CFO of Electronic Servitor. He has served as the principal of J. Kellogg & Company Inc., a business and tax consultant, since 2005. He has provided legal support to clients’ business valuations, business interruption and divorce property valuations. He has worked as a professional tax adviser since 1983. Mr. Kellogg obtained his JD with emphasis on taxation from Western State University College of Law and was certified as a financial planner by the College for Financial Planning in 1990.

Thomas (Denny) Spruce, RPh, is COO of Electronic Servitor. He oversees company infrastructure, regulatory reporting, and strategic partner relationships, among other roles and responsibilities. He joined the company in March 2022 and, since that time, has implemented foundational support processes, developed contractual relationships with service providers, managed financial and regulatory reporting and overseen contract development and management with the legal team. Mr. Spruce obtained a BS in Pharmacy from the University of Arkansas.

Electronic Servitor Publication Network Inc. (XESP), closed Tuesday's trading session at $0.1105, up 0.454545%, on 8,000 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.03/$0.22.

Recent News

• Electronic Servitor Publication Network Inc. (OTCQB: XESP) - InvestorNewsBreaks - Electronic Servitor Publication Network Inc. (XESP) to Acquire Assets of PhiTech Management LLC
• InvestorNewsBreaks - Electronic Servitor Publication Network Inc. (XESP) Announces Participation at Emerging Growth Conference
• Electronic Servitor Publication Network Inc.'s (XESP) Focused Approach to Creating Profitable Customer Interactions

GEMXX Corp. (OTC: GEMZ)

The QualityStocks Daily Newsletter would like to spotlight GEMXX Corp. (OTC: GEMZ) .

GEMXX (OTC: GEMZ), a leader in the ammolite gemstone mine-to-market segment and a partner in Canadian gold-exploration company Crazy Horse Mining Inc. ("CHMI"), is reporting on its current and future mining plans for each of its operations. At Snow Creek, which the company operates in partnership with CHMI, GEMXX has completed gold production, processing a total of 31,200 cubic yards of gold-bearing ore yielding 0.929 ounces per 100 cubic yards. The company is compiling test and mining results and is planning to triple production at the site in 2024. The two companies plan to move the test plant used at Snow Creek to Rosella Creek to prove the property is commercially viable while also completing an S-K 1300 compliant resource report during the 2024 mining season.

At its Yukon Gold property, GEMZZ is focused on completing due diligence and its 50% acquisition of the property by the end of 2023; the review of key reports is moving forward on schedule along with discussions to initiate a pilot mine on the site to confirm gold deposits indicated by reports, which could be between 2,210,660 and as much as 4 million ounces of recoverable gold. As for its ammolite strategy, GEMZZ continues preparations to open an ammolite mine on the company's south block, with a target date to start in early 2024. The company has secured 75% of mining costs for its ammolite mining and production initiatives and plans to expand its gemstone and jewelry production by 300% in 2024. For the rest of this year and into 2024, GEMXX is committed to expansion and adding shareholder value, which means more acquisitions, more mine production and more revenues. "Opening a profitable mine operation takes a tremendous amount of time and effort to do it right," said GEMXX CEO Jay Maull in the press release. "As a company interested in creating longevity and shareholder value, we take the time needed to achieve both. We look forward to updating shareholders as each milestone below is met. Everything the company has planned is focused on driving shareholder value."

To view the full press release, visit https://ibn.fm/fXUtL

GEMXX Corp. (OTC: GEMZ) is a mine-to-market enterprise specializing in gold, gemstone, and jewelry production. With ownership of mining resources, production facilities, and operational assets, the company maintains control over every aspect of its production process, from gold mining and gemstone extraction to jewelry manufacturing and global distribution.

As a prominent player in the industry, GEMXX stands out as a leading producer of high-quality finished Ammolite jewelry. Notably, it holds the distinction of being the sole public company engaged in Ammolite mining worldwide. In addition to its Ammolite operations, the company is actively involved in gold mining and prides itself on its ability to design and manufacture exquisite jewelry pieces and exceptionally rare, natural fossil decor items for clientele around the globe.

One of GEMXX’s key advantages lies in mining its own gold reserves to be utilized in its jewelry production. This strategic approach provides the company with a cost-saving edge over other producers in the market.

Ammolite is similar to black opal and is a biogenic gem like amber and pearl. It is derived from the fossilized shells of ammonites, a group of extinct marine nautiluses.

GEMXX’s world class gemstone cutters and jewelry designers are continuously leading the Ammolite industry. Its team believes in the company’s philosophy, vision and goals, and works every day to continue to drive the Ammolite industry to the forefront of the gem world.

The company has offices in Las Vegas and Hong Kong.

Projects and Operations

GEMXX has formulated an ambitious growth plan that, while challenging, is deemed attainable. The company’s strategy revolves around bolstering its market share through several key initiatives. Firstly, GEMXX aims to strengthen its position in current markets by nurturing and expanding existing relationships with customers and partners.

Secondly, the company plans to venture into untapped markets strategically. By identifying and targeting new areas, GEMXX seeks to establish a presence in regions that present promising opportunities for growth.

Additionally, GEMXX envisions growth through acquisitions. By considering and integrating key services, distribution networks and retail outlets into its fold, the company aims to consolidate its market position and capitalize on synergies for enhanced success.

To cater to the rising demand for its products, GEMXX has placed a primary focus on increasing gemstone production. The company’s southern properties, situated in Alberta, Canada, hold valuable deposits of rough Ammolite gemstone. By tapping into these resources, GEMXX is poised to meet the demand for its exquisite gemstone products and further fuel its expansion plans.

 

GEMXX possesses significant mineral assets in the form of a Mineral Work Permit covering an 800-acre area and two Ammonite Shell Mineral agreements encompassing 217 acres within the same region. The company’s management effectively operated mines in close proximity to these properties. Moreover, core sampling, along with fossil outcroppings on the riverbanks, confirms a substantial Ammolite resource present in these designated areas.

Both the Mineral Work Permit and the Ammonite Shell Mineral agreements grant GEMXX unrestricted access to all Ammolite resources within their respective demarcations. Notably, the company is not obligated to pay any royalties to third parties, thereby enabling GEMXX to fully capitalize on the potential of these valuable resources.

Furthermore, there are no stringent regulatory conditions that GEMXX must fulfill to gain or retain access to the Ammolite deposits. This freedom of access allows the company to proceed with its mining and production operations unimpeded, providing an advantageous position for future growth and success.

In March 2023, GEMXX made a significant announcement, revealing its acquisition of a 50% ownership stake in Crazy Horse Mining Inc., a Canadian gold mining company with assets situated in the province of British Columbia. As part of this deal, Crazy Horse’s assets, which encompass a 100% interest in two gold projects, called Snow Creek and Rosella Creek, spread across a substantial area exceeding 700 acres, now become part of GEMXX’s portfolio.

Under the terms of this strategic partnership, GEMXX and Crazy Horse will jointly share the expenses related to mining operations on these projects. Additionally, the two companies will share the gold produced from these ventures, leading to a collaborative and mutually beneficial arrangement.

Initial tests conducted on the property, combined with gold already recovered this season, confirm all expectations for the claims and substantiate the company’s estimated extraction target of over 100,000 ounces of easily recoverable gold. To validate and provide a more comprehensive assessment of this estimate, an S-K 1300-compliant Resource Report is scheduled to be conducted during the summer of 2023.

By acquiring this stake in Crazy Horse Mining Inc., GEMXX has positioned itself for further growth in the gold mining sector and is poised to capitalize on cost of goods savings in its jewelry business.

Market Opportunity

Leading independent market research companies such as Data Monitor and GIA estimate the worldwide market for luxury or premium lifestyle products, which include gems and jewelry, at over $90 billion annually and growing. Ammolite sales around the world have seen unprecedented growth over the past 20 years. Worldwide retail sales are now estimated to be over $100 million.

Ammolite jewelry and fossils are featured aboard cruise ships and can be found in specialty shops in almost every cruise port in North America. Asian markets have grown since feng shui master Edward Li called Ammolite the most influential stone of the new millennium, referring to it as the “Seven Color Prosperity Stone.” Home shopping channels in Japan, Australia, France, Germany, the UK, Canada and the U.S. have all featured Ammolite jewelry.

Ammolite and ammonites can also be found on many ecommerce sales platforms, including Amazon, eBay and Etsy. Ammolite is sold around the world in tourist and traditional jewelry markets. The company has established customers in home shopping channels, cruise tourism, jewelry retailers, Asian feng shui markets, Asian retail markets and ecommerce platforms.

Management Team

With over 160 years in Ammolite management, operations, and sales, GEMXX possesses an unparalleled wealth of knowledge and expertise. Its team members have extensive backgrounds in every facet of the Ammolite business, allowing the company to excel in product development, maintain rigorous quality control measures, and maximize profitability. The breadth and depth of the GEMXX team’s experience enable the company to navigate the industry with precision, ensuring that GEMXX remains at the forefront of the Ammolite market. GEMXX leverages its collective wisdom to drive innovation, deliver exceptional products, and optimize business strategies to achieve long-term success.

Jay Maull is Founder, CEO and Chairman of GEMXX. With a career spanning more than three decades, he has been deeply involved in the Ammolite industry, from mining and production to marketing. He has owned and operated the world’s largest Ammolite mine and has delivered exceptional Ammolite products to customers across all continents. He has also established the world’s largest Ammolite ecommerce platform.

Richard Clowater is President of GEMXX. He is a skilled sales and marketing professional with a focus on research, data analysis and strategic planning. He has successfully implemented initiatives to expand markets, boost profits and foster customer loyalty. He has an impressive track record of negotiating sales and contracts worth over $250 million with influential stakeholders, including key purchasing personnel, C-suite executives and government entities at all levels.

Tom Dryden is a Vice President of GEMXX and brings a wealth of experience and expertise to the production and marketing of Ammolite, spanning over 30 years. His extensive involvement in the industry has granted him unparalleled knowledge of the Bearpaw Ammonite bearing formations. As a recognized authority in the field, Mr. Dryden’s research and papers on Canadian Ammonites have garnered global recognition, being published worldwide. In his role at GEMXX, Mr. Dryden assumes the responsibility of overseeing the company’s Canadian-based production facilities. 

P. K. Chung is Business Manager Asia at GEMXX. With a track record of over 25 years in Ammolite business management, production and marketing in Asia, she is a recognized authority in the industry. Based in the Hong Kong gem district, she possesses an intricate understanding of the Asian gem and jewelry markets, including market dynamics, consumer preferences and industry trends specific to the region. Her strategic insights and deep connections enable GEMXX to thrive in this influential market.

GEMXX Corp. (OTC: GEMZ), closed Tuesday's trading session at $0.057725, up 7.8972%, on 40,220 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.023/$0.998.

Recent News

• GEMXX Corp. (OTC: GEMZ) - InvestorNewsBreaks - GEMXX Corporation (GEMZ) Releases Mining Update Report, Plans to Expand Capacity
• InvestorNewsBreaks - GEMXX Corporation (GEMZ) Reports on Key Milestones for 2023, Provides Update on Targets Moving Forward
• InvestorNewsBreaks - GEMXX Corporation (GEMZ) Releases Gold Production Report for BC-Based Snow Creek Test Mine Site

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

The QualityStocks Daily Newsletter would like to spotlight Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI).

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative inflammation and immunology ("I&I") biological products primarily for the treatment of autoimmune and infectious diseases, has been named the recipient of a grant from the Israel Innovation Authority ("IIA"). According to the announcement, the IIA, which is publicly funded and part of Israel's Ministry of Economy, approved a nondilutive grant covering 66% of the costs of an ILS 3,536,939 project aimed at ramping up Scinai's new CDMO business unit; the approximate value of the grant is $900,000. The announcement noted that the grant is not subject to repayment or tied to royalty payments of any kind. The company noted that the award was given after intense due diligence by the IIA, which recognized Scinai's capabilities to fill an underserved need in Israel's pharmaceutical R&D ecosystem; the IIA also felt that Scinai's state-of-the-art GMP biologics manufacturing facility and adjacent R&D and QC laboratories, along with its experienced personnel, are in an ideal position to provide key research and development as well as manufacturing services.

The new business unit will be marketed under the brand Scinai Bioservices and will offer manufacturing process development for protein-based drugs, including host cell transfection/transformation; upstream and downstream process development and scale-up; analytical method development; and cGMP manufacturing for clinical trial supplies, including automatic aseptic filling. "I thank the IIA for its support of Scinai's plans and their concrete belief in the potential of our business to generate value for stakeholders," said Scinai Immunotherapeutics CEO Amir Reichmanin the press release. "This meaningful nondilutive grant, which is not subject to repayment, will not only advance our CDMO business unit but also provide much-needed relief to our financial position, thereby also indirectly helping our R&D business unit's drive towards developing our innovative NanoAb-based drug pipeline and clearing the path towards developing Scinai into a company that provides significant benefits to the local and global biopharma and biotech industries, as well as to patients and investors."

To view the full press release, visit https://ibn.fm/MHJAY

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious diseases and autoimmune diseases.

In collaboration with the prestigious Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG), both in Germany, Scinai is developing a pipeline of innovative nanosized antibody (NanoAb) therapies addressing diseases underserved by current treatments and with large and growing markets, such as COVID-19, asthma and psoriasis.

NanoAbs, also known as VHH-antibodies or Nanobodies, are alpaca-derived nanosized antibodies that exhibit multiple significant competitive advantages over existing antibody therapies, including stability at high temperatures, superior binding affinity, more effective and convenient routes of administration and efficient production. Scinai is uniquely positioned to advance nanosized antibody innovation from R&D through commercialization.

The company’s highly experienced and successful pharmaceutical industry leadership team includes former senior executives from Novartis, GSK and Bristol-Myers Squibb.

Since its founding, Scinai has executed eight clinical trials, including a seven-country, 12,400-participant Phase 3 trial of a prior influenza vaccine candidate, and it built, owns and operates a 20,000 sq. ft. state-of-the-art GMP biologics manufacturing facility housing its laboratories, production facilities and offices.

Lead Candidate: Inhaled COVID-19 NanoAb

In December 2021, Scinai signed definitive agreements with the Max Planck Society – parent organization of the Max Planck Institute for Multidisciplinary Sciences– and the UMG to enter a strategic collaboration for the development and commercialization of innovative COVID-19 NanoAbs.

The company is planning a rapid development path that leverages its expertise and capabilities in biological drug development and manufacturing. Scinai anticipates preclinical proof-of-concept results for an inhaled COVID-19 NanoAb by the end of 2022, with initial Phase 1/2a human clinical trial results expected in 2023.

The intended inhaled mechanism of delivery of Scinai’s COVID-19 NanoAb formulation may serve as a significant differentiator when compared to approved monoclonal antibodies, which are injected. Inhaled delivery has shown to be cheaper, more convenient and likely safer for patients and providers.

NanoAb Pipeline: Psoriasis, Asthma and More

The COVID-19 NanoAb development agreement is part of a broader five-year research collaboration agreement signed in March 2022 covering discovery, development and commercialization of NanoAbs for several other disease indications with large market medical needs, including asthma, psoriasis, macular degeneration and psoriatic arthritis.

Scinai has an exclusive worldwide license for development and commercialization of COVID-19 NanoAbs and exclusive options for similar worldwide licenses for NanoAbs for the above mentioned additional large market disorders currently underserved by approved therapeutic antibodies.

Academic research teams from MPG and UMG have verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. They have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. Neutralization studies of the other NanoAbs are expected to begin later in 2022.

Based on the promising results, Scinai will focus development efforts beginning with the following NanoAbs:

• NanoAbs targeting IL-17 as drug candidates for the potential treatment of psoriasis and psoriatic arthritis
• NanoAbs targeting IL-13 and NanoAbs targeting TSLP as drug candidates for the potential treatment of asthma

These are conditions for which the antibody target is validated by existing treatments and the mechanism of action is well understood. Both represent large medical needs and growing markets. Scinai anticipates preclinical proof-of-concept for at least one of these NanoAbs in 2023. This is in addition to the aforementioned human clinical Phase 1/2a for the inhaled COVID-19 NanoAb therapy, which is also anticipated in 2023.

CDMO Services

While NanoAb pipeline development is Scinai’s core focus, the company also offers its cGMP manufacturing facility, aseptic fill and finish suite, laboratories and experienced professionals for contract development and manufacturing organization (CDMO) services. This offering is designed to keep the Scinai team abreast of the latest industry developments and trends while building experience and generating revenue to support the company’s NanoAb pipeline development.

Market Opportunity

COVID-19 treatment, target of the company’s lead NanoAb therapy candidate, had an estimated market size of $22 billion in 2021.

Future Scinai drug candidates will target conditions with large markets growing at attractive CAGRs.

The global asthma treatment market was valued at $18.08 billion in 2019 and is projected to reach $26.01 billion by 2027, exhibiting a CAGR of 4.5% during the forecast period, according to Fortune Business Insights. The research firm predicts that the global psoriasis treatment market will grow from $26.37 billion in 2022 to $47.24 billion by 2029, exhibiting a CAGR of 8.7% over the forecast period.

Management Team

Amir Reichman is Scinai’s CEO. He previously was Head of Global Vaccines Engineering Core Technologies at GSK Vaccines in Belgium. Prior to that, he held leadership roles at Novartis Vaccines’ Global Vaccines Supply Chain Management organization. He was the first employee of NeuroDerm Ltd., a company focused on transdermal drug delivery, and served as Senior Scientist until his departure in 2009. He earned a M.Sc. in Biotechnology Engineering from Ben-Gurion University and an MBA in Finance and Health Care Management from the University of Pennsylvania’s Wharton School.

Tamar Ben-Yedidia, Ph.D., is Chief Science Officer at Scinai. She has more than 30 years of experience in immunology, with specific expertise in the development of vaccines. She began her career with Biotechnology General Ltd., working on development of a recombinant Hepatitis-B vaccine. She later joined the Weizmann Institute of Science, working on the design of a peptide-based vaccine against several pathogens. She is widely published, with numerous refereed articles and invited reviews in various scientific journals. She received her Ph.D. from the Weizmann Institute.

Elad Mark is COO at Scinai. He has over 15 years of biotechnology industry experience encompassing diverse project stages including feasibility studies, conceptual and detailed design, commissioning, qualification and process validation. Prior to joining Scinai, he led Novartis’s $800 million investment in a biologics facility in Singapore. With Biopharmax and Antero, both global pharmaceutical engineering companies, he successfully led projects in Israel, China and Singapore. He holds a BSc. in Engineering from the Afeka Tel Aviv Academic College of Engineering and an MBA from the Open University of Israel.

Uri Ben-Or is CFO at Scinai. He has served as CFO with public life science companies traded on the TASE, OTC and Nasdaq. Ben-Or provides his services to Scinai through CFO Direct, a company he founded and for which he serves as CEO. He served as the VP of Finance of Glycominds, a leading biotechnology company, and as CFO of a spin-off from Telrad Networks. He also served as a Corporate Controller at Menorah Capital Markets and as an Auditor at PWC. He holds a B.A. in Business from the College of Administration, an MBA from Bar-Ilan University, and is a CPA.

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), closed Tuesday's trading session at $0.64, off by 5.8824%, on 25,768 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.6194/$11.49.

Recent News

• Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) - InvestorNewsBreaks - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Receive $900K IIA Grant for New CDMO Business Unit
• InvestorNewsBreaks - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Releases Status Report on NASDAQ Compliance
• Potential Complications of Untreated Psoriasis

Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF)

The QualityStocks Daily Newsletter would like to spotlight Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF).

Ucore Rare Metals (TSX.V: UCU) (OTCQX: UURAF) has announced its participation at Red Cloud's 2023 Fall Mining Showcase. The annual conference is slated to take place at the Sheraton Centre Toronto Hotel Nov. 7-8, 2023. Ucore's chairman and CEO Pat Ryan will be presenting beginning at 4:20 p.m. EST on Nov. 8. Interested parties should visit https://ibn.fm/wk3MH for more details and/or to register for the event.

To view the full press release, visit https://ibn.fm/ogZra

Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) is a critical metals (“CM”) separation technology company executing an ESG-centered plan toward establishing a comprehensive North American critical metals supply chain. The company has developed a transformative commercial-ready technology, RapidSX™, for separating and purifying critical metals. Ucore intends to deploy this technology in pursuit of a CM supply chain independent of China for Western original equipment manufacturers (“OEMs”), most notably in the automotive and renewable energy industries.

Ucore’s vision is to become a leading advanced technology company providing best-in-class metal separation products and services to the mining and mineral extraction industry. Its initial focus is on processing heavy and light rare earth elements (“REEs”), disrupting a supply chain that is dominated by China.

China currently controls about 80% of the world’s access to REE mining projects and over 90% of the world’s REE processing capabilities, and it produces about 95% of the goods containing REE components.

 

Ucore is working to scale Western supply needs by establishing REE separation and rare earth oxide (“REO”) production capabilities in cooperation with strategic upstream supply and downstream offtake partnerships. The company, along with its industry partners, aims to unlock access to Western REEs for current consumer, energy, manufacturing and military sectors.

By 2025, Ucore expects to commercially separate U.S.-friendly sources of REEs and supply OEMs with REOs required to produce rare earth permanent magnets (“REPMs”) – the essential component of electric motors and generators required to support the world’s transition to electrification and sustainable energy sources.

The company intends to contribute to this initiative through the near-term development of a heavy and light rare-earth processing facility in Louisiana and subsequent development of Strategic Metals Complexes (SMCs) in Alaska and Canada, as well as through the longer-term development of its 100%-owned Heavy Rare Earth Element (HREE) mineral resource property at Bokan Mountain on Prince of Wales Island, Alaska.

Ucore is headquartered in Halifax, Nova Scotia.

Projects & Technology

RapidSX™ Demonstration Plant

The Kingston, Ontario, RapidSX™ Demonstration Plant commissioning process is underway. Once commissioned, the plant is designed to demonstrate the commercial capabilities of the RapidSX technology platform.

The RapidSX demo plant will show:

• The techno-economic advantages of the RapidSX technology platform
• The processing of tens of tons of heavy and light mixed rare earth element concentrates in a simulated production environment
• The platform’s ability to operate for thousands of semi-continuous run-time hours
• Production of high-purity NdPr, praseodymium, neodymium, terbium and dysprosium rare earth elements for early OEM product qualification trials

The demo plant is located within Ucore’s 5,000-square-foot RapidSX Commercialization and Demonstration Facility and is run by its laboratory partner, Kingston Process Metallurgy Inc. (“KPM”).

RapidSX™ Technology

Innovation Metals Corp., acquired by the company in 2020, developed the RapidSX separation technology platform with early-stage assistance from the United States Department of Defense, later resulting in the production of commercial-grade, separated rare earth elements at pilot scale.

RapidSX combines the time-proven chemistry of conventional solvent extraction (SX) with a new column-based platform that significantly reduces time to completion and plant footprint, as well as potentially lowering capital and operating costs. SX is the international REE industry’s standard commercial separation technology and is currently used by all REE producers worldwide for bulk commercial separation of both heavy and light REEs.

Utilizing similar chemistry to conventional SX, RapidSX is not a “new” technology, but it represents a significant improvement on the well-established, well-understood, proven conventional SX separation technology preferred by REE producers.

Strategic Metals Complex

Ucore, engineering partner Mech-Chem Associates Inc. and KPM are developing the full-scale engineering for the company’s first Strategic Metals Complex (SMC). The SMC is a planned REE separation and rare earth oxide production plant slated to commence construction in Louisiana in 2023. It is scheduled to initially process 2,000 tons of total rare earth oxides by the end of 2024, increasing to 5,000 tons in 2026.

The company has three initial U.S.-friendly feedstock agreements in place for the Louisiana complex, along with multiple developing offtake agreements. It received a C$16 million+ incentive package offer from Louisiana Economic Development to support construction of the SMC.

Bokan-Dotson Ridge REE Deposit

Ucore has invested over C$35 million to establish and validate the Bokan-Dotson Ridge resource in preparation for mine design and permitting. Initial drilling is complete, and a Preliminary Economic Assessment has been issued. Next steps for the project include a feasibility study, detailed mine design and permit acquisition. The project can be “near shovel ready” for construction in less than 30 months after receipt of the next stage of development funding.

Market Opportunity

According to a report by Grand View Research, the global rare earth elements market was valued at $2.8 billion in 2018 and is forecast to reach a value of $5.6 billion by 2025, achieving a CAGR of 10.4% during the period. Market growth is driven by increasing demand for these elements in the manufacturing of magnets and catalysts for the automotive industry. Rising demand for electric vehicles to reduce CO2 emissions is expected to propel the use of permanent magnets in the production of EV batteries.

China is the major producer and consumer of REEs. To maintain self-sufficiency and to meet future demand, China has been raising the export tariffs on rare earth elements shipped to various countries, including the U.S., Japan, India, Brazil and the European Union. This led to the current supply-demand gap in these countries, as they rely on imports from China.

China reduced the exports of REEs by 72% in the second half of 2010 to preserve its reserves of these elements and continues to export REEs at reduced levels, thereby affecting industries such as automotive, oil and gas, and electronics, which require an ample amount of rare earth elements.

Management Team

Pat Ryan, P.Eng., is Chairman and CEO of Ucore Rare Metals. He began as a director with the company when he developed a heightened interest in critical metals. Before joining Ucore, he founded and led a multimillion-dollar automotive OEM design and lean manufacturing company. His understanding of complex supply chains across international markets has led to a prime positioning as the global auto industry transitions to vehicle electrification. He holds a Bachelor of Engineering degree from Dalhousie University.

Peter Manuel is Vice President and CFO of Ucore. Prior to joining the company, he practiced as a Chartered Accountant for more than 17 years, providing consulting services to companies in a range of industries, with a focus on the financial services and resource sectors. He spent 10 years in England and Ireland providing assurance, strategic planning, corporate finance and other consulting services to a portfolio of both public and private entities. He holds a Bachelor of Commerce Degree from Dalhousie University.

Michael Schrider, MEng, P.E., is Vice President and COO of Ucore. He is a multidisciplinary engineer who has been involved in manufacturing, engineering and managing complex structural and mechanical systems projects since 1989. He was the Founder, President and Chief Engineer of Schrider & Associates and Alton Bay Design, both engineering services firms. He holds a bachelor’s degree in naval architecture and marine engineering from the University of New Orleans and a master’s degree in mining, geological and geophysical engineering from the University of Arizona.

Mark MacDonald is Vice President of Investor Relations at Ucore. He has over 25 years of experience implementing award winning business development and marketing programs at regional and national levels. As Vice President of Sales, he was responsible for Mediapro Communication’s growth as AT&T Canada’s leading B2B sales partner. He subsequently became Atlantic Regional Vice President of AT&T Canada Corp. He holds a Bachelor of Commerce degree from Dalhousie University.

Ucore Rare Metals Inc. (UURAF), closed Tuesday's trading session at $0.53, off by 2.9304%, on 25,974 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.395/$1.15.

Recent News

• Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) - InvestorNewsBreaks - Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) to Present at Red Cloud's 2023 Fall Mining Showcase
• Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) Solution for REE Extraction Could Disrupt Market
• MiningNewsBreaks - Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) Introducing a More America-Centric Structure for REE Supply Chain

Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF)

The QualityStocks Daily Newsletter would like to spotlight Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF).

Appia (CSE: API) (OTCQX: APAAF) (FSE: A0I0) today announced that it has engaged SGS Geological Services ("SGS") to prepare a comprehensive NI 43-101 technical report on Appia's PCH Rare Earths Ionic Clay Project including a Maiden Mineral Resource Estimate ("MRE") on target IV. The move marks a significant step forward in the exploration and potential development of the PCH Project, which is located approximately 30 km (about 18.64 mi) from Iporá, Goya's state Brazil. The project is situated within a region well known for its significant mineral exploration potential, mining activity and well-developed infrastructure. "Appia's collaboration with SGS marks an important milestone for the PCH Project," said Stephen Burega, president of Appia. "We are confident that SGS's expertise will bring us one step closer to realizing the full potential of the PCH Project."

To view the full press release, visit https://ibn.fm/qTBpA

Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) is a mineral exploration company focused on exploration activities at its newly acquired Cachoeirinha rare earths project (“PCH Project”) in Brazil, as well as delineating high-grade critical rare earth elements (REE) and gallium at its Alces Lake property in Saskatchewan. Other properties in Appia’s portfolio include its Elliot Lake Property in Ontario’s historic mining camp, with a large NI 43-101 uranium and rare earths resource. Fully funded with over $5 million (CDN) in cash, no debt, aggressive exploration currently underway, and experienced management, Appia is progressing rapidly on multiple fronts in highly desired market sectors.

The company is headquartered in Toronto, Canada.

Projects

PCH Project-Brazil

The PCH project hosts REE mineralization in both ionic clays developed from the weathering of alkaline granites and in-situ rare earth mineralization associated with the underlying granite and a carbonatite intrusion to depths greater than 100 meters. Sampling data shows enrichment in rare earth minerals to depths of between eight meters and +30 meters.

In early 2023, Appia announced a definitive agreement to acquire a 70% interest in the PCH Project, which is 17,551 hectares in size and located in the Tocantins Structural Province of the Brasília Fold Belt, Goiás State, Brazil. It is classified as an alkaline intrusive rock occurrence with the potential for highly anomalous REE and Niobium mineralization.

The region around Iporá, a city located roughly 30 km from the PCH Project, has significant mineral exploration and mining activity and well-developed infrastructure.

In July 2023, Appia commenced an aggressive auger and reverse circulation (RC) drill campaign to delineate a potential resource estimate at the PCH project. Initial results at the site revealed significant exploration potential with impressive values that often surpass known ionic clay deposits in Brazil, particularly for the highly valuable heavy rare earths Terbium and Dysprosium.

The auger holes drilled at Target 4 have exhibited a range of total REE grades, ranging from 274 ppm to 16,648 ppm (1.66%), with an average of 1,291 ppm total REE. The valuable rare earths used in magnet applications – praseodymium, neodymium, terbium and dysprosium (Pr, Nd, Tb, and Dy) plus yttrium (Y) accounted for approximately 14% of total rare earths, reaching a maximum of 28.4%. Notably, the deposit also contains anomalous values of niobium and scandium, with average values of 736 ppm for Nb and 62 ppm for scandium in a composite sample from Target 4.

Heavy rare earths (HREEs) show maximum values of 1,624 ppm and average values of 1,291 ppm, primarily as terbium and dysprosium. Light rare earths (LREEs) show maximum values of 14,024 ppm (1.54%) with an average of 1,145 ppm. Neodymium and praseodymium, the main magnetic light rare earths, show respective maximum values of 3,131 ppm (Nd) and 885 ppm (Pr) and average values of 216 ppm (Nd) and 61.7 ppm (Pr). The overall HRRE/LREE ratio has a maximum of 39.5% and an average value of 16.67%.

“Appia is thrilled with the progress made and the promising results thus far,” CEO Tom Drivas stated in a news release. “The company remains committed to advancing its exploration plans, aiming to promptly gather significant data throughout the year, and to work towards estimating a maiden mineral resource in the coming months.”

Alces Lake Project – Saskatchewan

Appia’s Alces Lake project, located in northern Saskatchewan, encompasses some of the highest-grade total and critical REEs and gallium mineralization in the world, hosted within several surface and near-surface monazite occurrences that remain open at depth and along strike.

Following the company’s acquisition of additional new mineral claims in the area in February 2023, Appia’s Alces Lake claim block now totals 38,522 contiguous hectares (95,191 acres) – 100% owned by the Company.

Appia announced the completion of a NI43-101 technical report on the property in June 2023, providing an update on exploration previously reported in March 2021.The report is available on SEDAR under the company’s profile.

Extensive diamond drilling and geophysics surveys are underway to explore a more than 25-kilometer structural corridor. In July 2023, the company issued an update on its diamond drill program having completed the first phase of drilling at the project’s Magnet Ridge Zone to further test the extent of the mineralization to the south south-east (SSE). President Stephen Burega noted the presence of “continued mineralization at significantly thicker intercepts.”

As part of its 2023 exploration program at Alces Lake, Appia plans to target priority areas that extend SSE from the Wilson, Richard, Charles, Bell, Ivan, Dylan, Dante and AMP zones through the Magnet Ridge Zone and beyond, covering an area extending approximately 20 kilometers in length and 5 to 7 km in width. Appia will also undertake reconnaissance drilling on priority regional geological and geophysical targets in the Western Anomaly area.

Other Projects

• Appia holds a total of 75,314 hectares (186,106 acres) of land on four uranium claim blocks in the prolific Athabasca Basin (Loranger, North Wollaston, Eastside and Otherside). Exploration plans for these properties are expected to be announced once permits are in hand.
• Appia also has a 100% interest in 12,545 hectares (31,000 acres), with rare earth element and uranium deposits over five mineralized zones, in the Elliot Lake Camp, Ontario.

Market Opportunity

A report from Mordor Intelligence forecasts the global REE market is expected to grow from 168 million tons in 2023 to 206.25 million tons by 2028, marking a CAGR of 4.19% during the forecast period. The market is gradually improving following the economic and production restrictions of the COVID-19 pandemic.

Factors driving the market’s growth include high demand from emerging economies and the dependency of environmentally friendly technologies on rare earth elements.

According to UxC, one of the nuclear industry’s leading market research and analysis companies, the uranium market is rapidly becoming production-driven, where spot and long-term prices more closely correlate to the marginal cost of uranium production.

Although global reactor requirements are projected to be flat through 2024, UxC forecasts that significant demand growth from 2025 to 2040 will necessitate new production as resources are exhausted at several uranium projects. In addition, a large percentage of production exists in regions of the world with high geopolitical risk, which makes the market vulnerable to future disruptions and price volatility.

Management Team

Tom Drivas is CEO of Appia Rare Earths & Uranium Corp. He is an entrepreneur with over 30 years of experience in various industries, including over 20 years in the mineral resource industry. He is also currently a director of Romios Gold Resources Inc., a publicly traded company he founded in 1995.

Stephen Burega is President of Appia. He brings 16 years of management and operations experience in the mining and natural resources sectors. His extensive emerging markets background, along with a deep understanding of stakeholder management, social development and structured community engagement, position him well to lead Appia’s First Nations community engagements. He is also President and CEO of Romios Gold Resources which is focused on base and precious metal exploration in North America.

Frank van de Water is the company’s CFO. He holds CPA and CA designations and has been involved with international mining, metals and resource companies in North America, Latin America, Europe and Africa for more than 40 years.

Dr. Irvine R. Annesley, Ph.D., is VP Exploration at Appia. He is a licensed geoscientist (P.GEO.) and Professor in Economic (Mining and Mineral Exploration) Geology at École Nationale Supérieure de Géologie in France and an Adjunct Professor in Geology at the University of Saskatchewan. He has over 35 years of global exploration and applied research experience in uranium, gold and base metals exploration, most recently with Athabasca uranium explorer JNR Resources Inc.

Don Hains, P.Geo., is the company’s Consulting Geologist and Qualified Person Consulting Industrial Minerals Expert.

Antonio Vitor is Appia’s Country Manager, Brazil. He has a track record as a portfolio manager and board member. He has held multiple significant positions, including Territory Manager at Shell, as well as Senior Project Planning and Consulting roles at PwC and Petrobras.

Jack Lifton is the company’s Senior Technical Advisor and Consultant. He is an author and lecturer on the market fundamentals of technology metals.

Appia Rare Earths & Uranium Corp. (OTCQX: APAAF), closed Tuesday's trading session at $0.17, off by 1.2776%, on 15,000 volume. The average volume for the last 3 months is 173,185 and the stock's 52-week low/high is $0.075/$0.35685.

Recent News

• Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) - InvestorNewsBreaks - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) (FSE: A0I0) Announces Significant Milestone for Its PCH Project in Brazil
• InvestorNewsBreaks - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) (FSE: A0I0) Announces Exceptional Assay Drill Results from Its PCH Ionic Clay Project
• InvestorNewsBreaks - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) (FSE: A0I0) Completes High-Definition Survey over PCH Ionic Clay Target IV Project Area

Starco Brands Inc. (OTCQB: STCB)

The QualityStocks Daily Newsletter would like to spotlight Starco Brands Inc. (OTCQB: STCB).

Starco Brands Inc. (OTCQB: STCB) is a modern-day invention factory. The company’s unwavering mission is to invent and acquire consumer products and brands with behavior-changing technologies that spark excitement in the everyday.

This consumer product company has grown from a few million dollars in revenue to a current run rate of approximately $67 million in annual revenue in one year.

The company has succeeded by identifying whitespaces in eight core consumer categories and then either: 1) leveraging its internal R&D capabilities and dedicated manufacturing network to invent new technologies and brands or 2) utilizing the management team’s extensive M&A experience to acquire brands that fill the industry void, delighting consumers and retailers alike.

Whether the brand is developed internally or acquired, the company employs a modern marketing playbook to ensure its brands are at the forefront of culture; garnering unprecedented media attention and engagement that supports a robust sales network.

Starco Brands’ core competencies are inventing technologies, acquiring companies, marketing, building trends, pushing awareness, penetrating media (social and otherwise) and executing cutting edge pull-through strategies with a roster of globally recognized celebrities, influencers and media and distribution partners.

A commitment to changing the way people approach everyday activities is innate in the company’s corporate DNA.

The company is based in Santa Monica, California.

Brands

Whereas other consumer products companies are content with evolution, Starco Brands has its mind set on creating a revolution across the industry. From disrupting the spirits industry with Whipshots, the world’s only vodka-infused whipped cream, to Soylent, the original food tech company, Starco Brands is putting the CPG world on notice. Its portfolio of brands includes:

• Whipshots is a first-of-its-kind alcoholic whipped cream launched in 2021 with celebrity partner Cardi B. Consumers have embraced this boozy concoction, putting it on top of cocktails, coffees and desserts, or enjoying it straight from the can. In just over a year, the brand has sold over 2 MILLION cans, making it one of the fastest growing spirits in history.
• Winona Pure gives consumers movie theatre popcorn in the comfort of their own homes. All the flavor and none of the additives is the story behind these all-natural, non-GMO popcorn seasoning sprays. A simple spray is all it takes to add the perfect pop of flavor to the classic theatre treat.
• Art of Sport, co-founded by the great Kobe Bryant, is the number one body care brand for athletes. With a growing line of personal care products tested by the world’s greatest athletes, these daily skin essentials give consumers everything they need to feel fresh, stay protected and confident and perform at their peak every day.
• Skylar is the first and only line of perfumes on the market that are hypoallergenic and safe for sensitive skin. With the strong support of industry titan Sephora, the brand has quickly attracted a loyal following.
• Soylent is a technological feat. Originally funded by Google Ventures and Andreessen Horwitz, Soylent is dubbed as the world’s most perfect food. Made from sustainably grown plant-based ingredients, Soylent’s line of products is scientifically developed to provide all the functional ingredients, vitamins, minerals, fats, carbohydrates and protein that the body needs – all in convenient, delicious and affordable packages. Soylent’s innovative product line-up includes complete nutrition powders, ready-to-drink shakes, 100-calorie snack bars, high protein nutrition shakes and energy boosting nutrition shakes. Soylent was also the recipient of the 2023 Product of the Year Award by Kantar, a global leader in consumer research.

With award-winning marketing talent, Starco Brands develops robust, integrated marketing plans for every brand in its portfolio, ensuring an impactful presence across all verticals.

Market Outlook

Starco Brands’ varied brand portfolio gives it access to the growth of numerous product categories that are ripe for innovation.

Through its February 2023 acquisition of complete nutrition pioneer Soylent, Starco Brands is positioned to capitalize on the projected growth of the plant-based nutrition space. Research firm Statista valued the plant-based nutrition market at $29.4 billion in 2020 and forecasts its value at nearly $162 billion by 2030, representing a CAGR of 18.7% for the period.

Likewise, Starco Brands gained improved access to the global fragrance market through its December 2022 acquisition of Skylar. According to a report by Grand View Research, the global perfume market was valued at $50.85 billion in 2022 and is expected to grow to a value of nearly $80 billion by 2030, achieving a CAGR of 5.9% over the forecast period.

The company is primed to expand its access to other growth verticals as it advances on its path to invent and acquire behavior-changing technologies and brands.

Management Team

Ross Sklar is the CEO of Starco Brands. A chemical formulator by trade, he started his first company while still in college. Since 2004, he has made over a dozen acquisitions with multiple exits and controls an eclectic collection of industrial, household, personal care and food and beverage manufacturers covering many consumer-packaged goods categories.

Darin Brown is the Chief Operating Officer of Starco Brands. With over 20 years of experience in chemical manufacturing, business development, finance and mergers and acquisitions, he has scaled the company from the ground up. He oversees all internal operations for Starco Brands and is an integral liaison between the company and Mr. Sklar’s manufacturing facilities.

David Dreyer is Chief Marketing Officer of Starco Brands. With over 25 years of experience working with blue chip and startup brands, he oversees all marketing initiatives for the company. Mr. Dreyer comes to Starco having worked with such standout brands as Apple, Pepsi, Pizza Hut, Dr Pepper, Snapple, Infiniti, The GRAMMY’s, Honda and Stamps.com. He is also a Professor of Advertising at USC’s Annenberg School for Communication.

Starco Brands Inc. (STCB), closed Tuesday's trading session at $0.1396, up 1.1594%, on 5,000 volume. The average volume for the last 3 months is 6,446 and the stock's 52-week low/high is $0.115/$0.265.

Recent News

• Starco Brands Inc. (OTCQB: STCB) - Starco Brands to Present at LD Micro Main Event XVI
• Starco Brands Announces Whipshots® New Limited-Edition Pumpkin Spice Flavor
• Starco Brands Exceeds Three Million Whipshots® Cans Sold, Announces Largest Expansion Yet

Longeveron Inc. (NASDAQ: LGVN)

The QualityStocks Daily Newsletter would like to spotlight Longeveron Inc. (NASDAQ: LGVN) .

Longeveron Inc. (NASDAQ: LGVN) is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions. The Company’s research and therapies are aimed at improving the outcome of infants born with a life-threatening heart condition, as well as improving the healthspan for the aging population – the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging, with function and ability to perform activities of daily living.

Longeveron is involved in clinical trials in the following indications: Hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty.

The Company’s philosophy revolves around the idea that regenerative medicine may hold the potential to improve certain rare medical conditions and contribute to healthy aging. While there has been a remarkable rise in life expectancy over the last century due to medical and public health advancements, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging.

Longeveron’s lead investigational product is Lomecel-B™, an allogeneic Medicinal Signaling Cell therapy product isolated from the bone marrow of young, healthy adult donors. As humans age, they experience a decrease in immune system function, a decline in blood vessel functioning, chronic inflammation, and other issues. Clinical data has suggested that Lomecel-B™ may address these conditions through multiple mechanisms of action (MOA) that simultaneously target key aging-related processes.

The Company is headquartered in Miami, Florida.

Lomecel-B™

Lomecel-B™ is being evaluated in multiple clinical trials for aging-related chronic diseases and other life-threatening conditions under U.S. FDA-approved Investigational New Drug applications. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas.

The drug is made from special living cells called Medicinal Signaling Cells (MSCs) that are isolated from fresh bone marrow tissue that has been donated by adult donors aged 18 to 45. Once the MSCs have been isolated from the fresh bone marrow through a careful selection process, the cells are culture-expanded (allowed to replicate under controlled laboratory conditions) into the billions using specialized techniques and processes. After a specific number of expansion cycles, called “passages,” the cells are harvested, separated into specific doses (e.g., 50 million cells), and cryopreserved until future use.

These cells have been shown to have characteristics that allow them to be transplanted from a donor to host without triggering a harmful immune response in the recipient, and they can be administered on an outpatient basis in as little as 40 minutes after thawing. Because of these characteristics, Lomecel-B™ is considered an “off-the-shelf” product.

In some trials, such as for Alzheimer’s disease and Aging-related Frailty, Lomecel-B™ is administered via peripheral intravenous infusion, while, in the Company’s HLHS trial, Lomecel-B™ is administered via direct injection into the heart tissue.

Market Opportunity

Longeveron estimates the potential market size for Lomecel-B™ in the treatment of HLHS to be up to $1 billion annually, globally.

U.S. patients suffering from Aging-related Frailty are estimated using U.S. Census Bureau statistics to be approximately 8.1 million. That population potentially represents a market for Lomecel-B™ of between $4 billion and $8 billion globally per year, according to Company estimates.

Additionally, the Alzheimer’s Association puts the number of Americans with that disease at 5.1 million, highlighting another potentially addressable market for Lomecel-B™, that’s worth $5 billion to $10 billion annually.

Management Team

Wa’el Hashad is CEO of Longeveron. He has more than 35 years of experience in the pharmaceutical and biotech industries. He has launched several successful brands in the U.S. and worldwide markets. Prior to joining Longeveron, he was president and CEO of Avanir Pharmaceuticals. Before Avanir, he was the chief commercial officer of Seres Therapeutics. He also has held senior leadership positions at Amgen, Boehringer Ingelheim, and Eli Lilly and Company. He holds a bachelor’s degree in pharmacy from Cairo University and an MBA from the University of Akron.

Joshua M. Hare, M.D., FACC, FAHA, is Co-Founder, Chief Science Officer and Chairman of Longeveron. He is a double board-certified cardiologist and is the founding director of the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine. He is a recipient of the Paul Beeson Physician Faculty Scholar in Aging Research Award and is an elected member of the American Association of Physicians and The American Society for Clinical Investigation. He is also an elected Fellow of the American Heart Association. He received a bachelor’s degree from the University of Pennsylvania and his M.D. from The Johns Hopkins University School of Medicine.

Lisa Locklear is CFO at Longeveron. She previously served as the senior vice president and CFO for Avanir Pharmaceuticals. Prior to Avanir, she held senior financial roles at GSN Games, CoreLogic, Ingram Micro, the Walt Disney Company, and Price Waterhouse, with assignments in Paris and London. She holds a bachelor’s degree in plant science from the University of California, Davis, and an MBA from the University of California, Irvine. She is a licensed CPA (inactive) and is a member of the American Institute of Certified Public Accountants, the California Society of CPAs, and Financial Executives International.

Dr. Nataliya Agafonova, M.D., is the Chief Medical Officer at Longeveron. She previously served as clinical development lead, senior medical director, and product development chair at Otsuka Pharmaceuticals. Before that, she was the clinical development lead and senior medical director at Bristol-Myers Squibb. She previously held senior leadership positions at Ardea Bioscience, Biogen, Amgen, and Genzyme Corporation. She earned an M.D. from the Ukrainian National Medical University and completed her internal medicine residency at Kharkov State University Hospital in Ukraine.

Certain statements in this corporate profile that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this corporate profile are made as of the date of this corporate profile, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com

Date prepared: August 31, 2023

Longeveron Inc. (NASDAQ: LGVN), closed Tuesday's trading session at $1.94, up 0.518135%, on 61,029 volume. The average volume for the last 3 months is 346,957 and the stock's 52-week low/high is $1.50/$4.5793.

Recent News

• Longeveron Inc. (NASDAQ: LGVN) - Sex Hormones Could Influence Alzheimer's Development, Researchers Say
• InvestorNewsBreaks - Longeveron Inc. (NASDAQ: LGVN; LGVNR) Announces Plans to Release Q3 2023 Financial Report, Host Corporate Update Call
• Longeveron Inc. (NASDAQ: LGVN) Validates Safety and Therapeutic Potential of its Lomecel-B(TM) Lead Investigational Product in its CLEAR MIND Phase 2a Clinical Trial