• AzurRx BioPharma’s lead therapeutic, MS1819, is a recombinant lipase treatment for exocrine pancreatic insufficiency and is currently targeting patients with cystic fibrosis and chronic pancreatitis – an established global market of more than $2 billion
• The company is currently pursuing parallel monotherapy and combination therapy trials, which are anticipated to produce topline data in Q1 2021 and Q2 2021, respectively
• Previously completed clinical trials of MS1819 showed primary and secondary endpoint efficacy, with a positive safety profile
• To fully finance its ongoing Phase 2 trials and being preparations for a pivotal Phase 3 study in 2021, as well as to fund current operations, the company raised gross cash capital of $22.1 million as of July 2020
• AzurRx is determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy, significantly reducing the pill burden of cystic fibrosis patients

AzurRx BioPharma (NASDAQ: AZRX) is a clinical-stage biopharmaceutical company focused on developing treatments for gastrointestinal diseases using recombinant proteins.

The company’s lead drug candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients suffering from cystic fibrosis and chronic pancreatitis.

AzurRx has already completed two Phase 2 clinical trials for MS1819 and is currently pursuing approval through parallel monotherapy and combination therapy pathways.

The company was founded in 2014 and is headquartered in New York City, with scientific operations in Langlade, France, and clinical operations in Hayward, California.

MS1819 Clinical Trials

The two current ongoing clinical trials for MS1819 in cystic fibrosis (“CF”) are the Phase 2b Option 2 monotherapy trial and the Phase 2 combination therapy trial, using MS1819 together with porcine pancreatic enzyme replacement therapy (“PERT”), the current standard of care. Pending the Phase 2b trial outcome, the company intends to initiate a Phase 3 trial in cystic fibrosis.

• Phase 2b CF Option 2 Trial– The study was initiated in Q3 2020, using MS1819 doses in enteric capsule form (2240mg and 4480mg). Topline data for the trial is anticipated in Q1 2021.
• Phase 2 CF Combination Trial– The study was initiated in Q4 2019, using daily dose levels of PERT in combination with MS1819 dosages (700mg, 1120mg and 2240mg). Topline data is anticipated in Q2 2021.

These trials are currently addressing the treatment of EPI in patients with cystic fibrosis and chronic pancreatitis – an established global market with an estimated value in excess of $2 billion that has been growing at a CAGR greater than 20% over the past five years.

Results from AzurRx’s Phase 2b Option 2 trial of MS1819 in cystic fibrosis patients demonstrate that the non-porcine MS1819 lipase is well-tolerated by patients, with no significant safety signals observed at the 2240mg daily dose level.

“[W]e have evaluated four different enteric capsules and identified the best suitable formulation for MS1819 that provides gastroprotection of enzyme content and delayed release into the duodenum,” James Sapirstein, President & CEO of AzurRx, stated in a September 2020 news release (https://ibn.fm/27t4W). “Our clinical program continues to advance, and we are determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy, significantly reducing the pill burden of cystic fibrosis patients.”

Financial Highlights

As of July 2020, AzurRx had raised gross cash capital of $22.1 million, including $15.2 million from Series B convertible preferred stock and warrants in July 2020 and $6.9 million from convertible promissory notes and warrants in December 2019 and January 2020. Notably, AzurRx solidified its financial position and created an effectively debt-free balance sheet by exchanging substantially all of its outstanding convertible notes into the Series B convertible preferred stock financing.

The company secured an additional $2.5 million in French Research Tax Credits, received in 2020, for the years 2017-2019 (https://ibn.fm/Qxk7O).

In a letter to shareholder, Sapirstein noted that ensuring the company maintains sufficient capital to support its business operations has been a key focus. He further stated that the company is in “a financially secure position” to complete its two Phase 2 MS1819 clinical trial programs and to begin preparations in 2021 for a pivotal Phase 3 study.

The company has no current plans to access additional financing, as it believes it has enough cash to fund existing operational and clinical objectives through Q3 2021.

Management Team

James Sapirstein is the President and CEO of AzurRx BioPharma. He was previously the CEO and a board member for ContraVir Pharmaceuticals Inc., which is now known as Hepion Pharmaceuticals Inc. (NASDAQ: HEPA). Mr. Sapirstein has almost 36 years of experience in the pharmaceutical industry, with expertise in drug development and commercialization. He currently serves on the Emerging Companies and Health Section boards of the BIO (Biotechnology Innovation Organization) and is Chairman Emeritus of BioNJ. He earned his Bachelor’s degree in Pharmacy from Rutgers University and has an MBA in management from Fairleigh Dickinson University.

Daniel Schneiderman is the Chief Financial Officer of AzurRx. He previously served as the CFO of Biophytis SA and its U.S. subsidiary, Biophytis, Inc., clinical-stage biotechnology companies focused on the development of pharmaceutical candidates for age-related diseases. He was appointed to the AzurRx position in January 2020, bringing to the team over 18 years of experience in capital markets and finance operations. Mr. Schneiderman holds a degree in economics from Tulane University.

James Pennington, M.D., is the Chief Medical Officer of AzurRx. Before joining the team, he was the Chief Medical Officer and Senior Clinical Fellow for 11 years at Anthera Pharmaceuticals. Before becoming a part of the biotech industry, Dr. Pennington was on the Medical Faculty of Harvard Medical School for 10 years. He received his medical degree from Oregon Health & Science University.

Martin Krusin is the Senior Vice President for Corporate Development at AzurRx. He has 20 years of experience in business development, strategic marketing, financing and operations in the health care, financial services and consulting sectors. Before joining AzurRx, he was the VP for Business Development at FluoroPharma Medical Inc. Mr. Krusin received his MBA from Columbia Business School in finance and marketing, an MPhil. in political economy from Oxford University and a BA in international relations from Swarthmore College.

Dinesh Srinivasan, Ph.D., is the Vice President for Translational Research at AzurRx. He has over 15 years of experience leading drug discovery and development in the pharmaceutical industry. He began his career as a post-doctorate fellow at Roche Palo Alto. Dr. Srinivasan received his MSc in Biotechnology from the University of Mumbai, India, and a Ph.D. in Pharmacology and Toxicology from the University of Arizona – Tucson.

Ted Stover is the Product Development Director at AzurRx. He joined the company in 2020 to oversee CMC and Project Management. Before joining AzurRx, he spent 20 years focused on manufacturing operations and analytical method development for all stages of pharmaceutical drug development. Mr. Stover earned his MBA from the University of Florida.

For more information, visit the company’s website at www.AzurRx.com.

NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX

• Scientific research suggests some mushrooms can provide mental benefits, anti-tumor effects, improved immune function, anti-viral properties and detoxification
• “Psychedelic” varieties currently being studied for depression, anxiety, PTSD, bipolar disorder, Alzheimer’s disease, addiction
• Pure Extracts is expanding into functional mushroom market; Company is currently licensed by Health Canada to buy, sell, produce cannabis products

Mushrooms have been used for thousands of years in Eastern medicine to combat illness, increase mental cognition and improve digestion. As their popularity continues to increase worldwide, Pure Extract Technologies, a privately held, plant-based, Canadian extraction company is leveraging the growing acceptance by mainstream science and the general public to further develop and commercialize functional and medicinal mushroom products on a global scale.

Described by world-renowned mycologist Paul Stamets as “nature’s miniature pharmaceutical factories” (https://ibn.fm/wR7Np), mushrooms have been studied extensively by mainstream science for their various health benefits. Current research has suggested that some varieties such as Hericum Erinaceus or “lion’s mane” can help improve memory (https://ibn.fm/HVXE7) and mental cognition (https://ibn.fm/XIilg) in addition to improving the symptoms of depression (https://ibn.fm/e6nwv).

“Psychedelic” varieties such as psilocybin – or “magic mushrooms” – are increasingly being studied for possible medical benefits in treating depression, anxiety, PTSD, bipolar disorder, Alzheimer’s disease and addiction. UC Berkeley recently unveiled the UC Berkeley Center for the Science of Psychedelics (https://ibn.fm/Aj06x) with the aim of studying psilocybin for mental benefits in addition to other properties that include anti-tumor effects, improved immune function, anti-viral properties and detoxification. The FDA granted psychedelics breakthrough therapy status for treatment-resistant depression in 2020 with approvals expected in 2021 (https://ibn.fm/cgSa5), making therapy options possible in the very near future.

Pure Extracts has a solid position in the industry to partner with organizations in the sourcing, production and development of functional mushroom products and to advance its mushroom extraction techniques in order to produce, consistent, ultra-pure, compounds. Besides being licensed by Health Canada to buy, sell and produce cannabis products, the Company’s 10,000 square foot facility is designed for EU-GMP certification, which will allow Pure Extracts to sell its products throughout the world.

Along with mushrooms, Pure Extracts’ business model comprises three additional verticals that include in-house brand marketing, raw cannabis & hemp conversion into marketable products and white labeling services that supply products to other Licenced Producers. In addition to signing NDAs to explore joint development endeavors, the Company also has an advisory agreement with Dr. Alexander MacGregor, the founder of the Toronto Institute of Pharmaceutical Technology (“TIPT”), a provider of clinical trial services through its fully compliant Health Canada licensed Good Manufacturing Practice (“GMP”) manufacturing and testing facility.

The psychedelic and functional mushroom industry is currently in a transitory phase whereby dry biomass is being converted to extracts. This changing landscape is positioning Pure Extracts to emerge as a leader in the industry, allowing the Company to benefit from the growing acceptance of mushroom extracts by the scientific community and general public.

For more information, visit the company’s website at www.PureExtractsCorp.com.

NOTE TO INVESTORS: The latest news and updates relating to Pure Extract Technologies are available in the company’s newsroom at http://ibn.fm/Pure

• 180 Life Sciences is a clinical-stage biotechnology company developing anti-tumor necrosis factor (“TNF”) therapies to treat a variety of inflammatory conditions.
• Phase 2b/3 clinical trials on fibrosis and inflammation-causing TNF irregularity are currently underway with first results expected in 2021
• The company is to be acquired by a SPAC (NASDAQ: KBLM) and will be listed on the Nasdaq Capital Market under ticker symbol ATNF

Pioneering biotech company, 180 Life Sciences Corp. is bringing hope to sufferers of Dupuytren’s Disease and other inflammatory conditions caused by an impaired immune system. Currently, the company has three major programs underway focused on therapies for separate areas of inflammation. These programs are headed by a team of renowned scientists who have already developed blockbuster drugs, discovered an entire drug class and made ground-breaking discoveries in their fields. The programs are exploring therapies expected to bring relief to those afflicted by a variety of TNF conditions, including ‘frozen shoulder,’ Dupuytren disease, postoperative cognitive dysfunction (“POCD”), and non-alcoholic fatty liver disease (“NAFLD”).

TNF is one of those good things, a surfeit of which, can turn out bad. A protein released by white blood cells to mobilize the body’s defenses, i.e. the immune system, TNF plays an essential role in fighting off diseases of many kinds. TNF triggers inflammation to create an environment conducive to healing infected or damaged tissue. Typically, this state of affairs continues just long enough to repair damage to the cells. Regular or acute inflammation lasts for a short time, going away within hours or days. But sometimes, TNF sets the inflammatory process in motion when there’s no threat, a situation that can persist for a lengthy period, leading to what is known as chronic inflammation. Chronic inflammation opens a Pandora box of ailments. Conditions linked to chronic inflammation include Alzheimer’s disease, asthma, cancer, diabetes, heart disease, and a number of others that 180 Life Sciences Corp. is currently conducting research on.

The Company’s Three Research Programs Are: 

The fibrosis and anti-TNF program, based at the Kennedy Institute, University of Oxford, U.K.

The program is addressing four critical areas of inflammation:

• Dupuytren disease, a debilitating condition that causes the fingers to irreversibly curl toward the palm. Dupuytren disease affects some 15 million Americans over the age of 35, about 5 percent of the U.S. population, according to a 2014 CDC study (https://ibn.fm/1G2pt). Top line data from Phase 2b/3 trials are expected by Q4 2021.
• Frozen shoulder is a musculoskeletal impairment that makes it difficult or impossible to move the shoulders (https://ibn.fm/UBzDz). Phase 2b trials are set to begin Q3 2021.
• POCD affects patients, particularly older ones, after surgical operations. In one study, roughly 12 percent of patients over age 60 had postoperative cognitive dysfunction, three months after surgery (https://ibn.fm/fuIDp). Phase 2 trials in POCD are anticipated to commence in Q4 2021.
• Nonalcoholic steatohepatitis (“NASH”) is a type of non-alcoholic fatty liver disease, aggravated by hepatitis (https://ibn.fm/hxhA5). Preclinical studies in liver fibrosis and NASH are set to begin in late 2020.

 Synthetic CBD Analogs (“SCAs”) – Preclinical – based at the Hebrew University of Jerusalem

The SCA program is based at the Hebrew University of Jerusalem, in Israel, with additional research and trials at the Kennedy Institute, at the University of Oxford.

180 Life Sciences is aiming to develop SCAs that are safe and non-psychoactive and formulated to improve efficacy, as an alternative to naturally occurring cannabidiol (“CBD”). The program is led by a team that includes Professor Raphael Mechoulam, the first to ‘discover’ tetrahydrocannabinol (“THC”). 180 Life Sciences is aiming to create a compound that is 99.5% pure CBD, which will drastically improve medical prescriptive precision. The program is also exploring a drug delivery platform—ProNanoLipospheres (“PNL”)—to improve bioavailability.

The α7nAChR program, based at Stanford University in the US.

The α7nAChR program is searching for an effective therapy to treat ulcerative colitis in ex-smokers. α7nAChR is a nicotine receptor and is a central factor in the body’s method of controlling inflammation.

180 Life Sciences Corp. is to be acquired by KBL Merger Corp. IV (NASDAQ: KBLM), a special purpose acquisition corporation (“SPAC”), after which the combined entity will be listed on Nasdaq under the ticker symbol: ATNF.

For more information, visit the companies’ websites at www.180LifeSciences.com and www.KBLMerger.com.

NOTE TO INVESTORS: The latest news and updates relating to 180 Life Sciences are available in the company’s newsroom at http://ibn.fm/180

• Gage Cannabis is one of the leading vertically integrated operators in the cannabis industry
• Its current focus is the Michigan market, which is valued at an estimated $3 billion and recorded $109 million in cannabis sales in August 2020
• The company currently has five dispensaries across Michigan, with the potential to have 90% of the state’s population within a one-hour drive as it continues to expand its dispensary network, offering a wide range of products and even home delivery options
• Gage is planning to expand its cultivation site in Monitor Township and open an additional 3-4 provisioning centers (dispensaries) in Michigan by the end of 2020. It has detailed plans to open 10+ other locations in 2021, with a goal of operating 20-25 locations by year-end
• The company intends to go public during Q1 2021 through a Canadian listing

Gage Cannabis Co. is a leading vertically integrated operator in the cannabis industry led by the former CEO and Chairman of Canopy Growth Corp. (TSX: WEED) (NYSE: CGC), Bruce Linton. The company is currently focused exclusively on the Michigan market, working with the declared goal of building the fastest growing cannabis brand in the state.

One of the reasons Gage targeted Michigan as its location of choice is due to the state’s fast-growing legal cannabis market and consumption habits amongst consumers. In 2018, Michigan became the 10th state to legalize the recreational use of cannabis. In light of such favorable market dynamics, Gage opened its first medical provisioning center (dispensary) shortly after, in 2019. The company now has 13 medical or adult-use locations open or in the works, with an additional 10+ planned to open during 2021. Gage’s current portfolio features 19 Class C cultivation licenses across four cultivation assets and three processing licenses.

Current Asset and Brand Portfolio

Gage’s current brand portfolio consists of five unique product classes: flower products, edibles, hardware, concentrates and vape pens/disposables.

The company has already created relationships with a wealth of exclusive brand partners, including some of the most illustrious brands in the country. Notably, Gage’s exclusive partnership with Cookies, one of the most well-respected cannabis lifestyle brands in the United States, illustrates Gage’s operational prowess in cultivating quality flower and operating its branded retail stores. Today, Gage operates the 8 Mile Cookies location in Detroit, Michigan, which is one of the top performing dispensaries in the state despite being a medical-only dispensary.

Committed to providing only products of the highest quality, Gage uses small-batch, indoor-grown, high-quality cannabis that is hand-trimmed and hung to dry. Gage ensures that every gram of cannabis sold is consistently of the highest quality and offers a superb customer experience.

The company currently has four cultivation assets, located at Monitor Township (expansion planned), Harrison Township, Warren and Lenox Township, and it operates one processing facility located in Harrison Township, with plans to operate another two processing facilities in Monitor Township and Lenox.

Its operating dispensaries include Ferndale (adult-use), Adrian (adult-use), Lansing (adult-use), Traverse City (medical) and Detroit (Cookies establishment – medical). Additional dispensaries coming soon include Battle Creek (adult-use), Kalamazoo #1 (adult-use), Bay City (adult-use), Grand Rapids (medical), Buena Vista (medical), Center Line (medical), Kalamazoo #2 (Cookies establishment – adult-use) and Lenox Township.

The company offers delivery within a one-hour radius of its dispensaries – a footprint that encompasses an estimated 90% of Michigan’s population.

Financial Highlights

In Q1 2020, the company recorded sales of $5.8 million. This number grew substantially in Q2, reaching $11.9 million. Management estimates Q3 sales at roughly $13.1 million, marking a 157% growth in sales from January to September 2020, within a year of operations.

This increase reflects the company’s significant expansion efforts since the beginning of 2020. Starting with only 200 pounds per month, Gage now estimates its monthly cultivation capacity at more than 1,000 pounds of product.

This increase in cultivation capacity has helped Gage promote rapid growth through its retail locations. Average basket size, which refers to the retail value of each consumer transaction, is estimated at $85 for the Michigan cannabis industry. As of August 2020, Gage has an average basket size of $180 at its locations, more than double the state average.

Michigan Medical and Adult-Use Marijuana Market Size

The recreational marijuana market in Michigan is expected to rival the numbers currently seen in Nevada and Colorado by 2023. Approximately 3% of Michigan’s residents are medical marijuana cardholders – a much higher rate than many other medical markets – leading Brightfield to predict that the state’s recreational market could triple in size between 2020 and 2023 (https://ibn.fm/9cO0h).

Michigan saw a steady increase in sales for the first three quarters of 2020, with a recorded growth rate of 502% from January to August. In August alone, $109 million in cannabis sales occurred within the state. The Marijuana Regulatory Agency estimates that the potential market size for cannabis within the state is around $3 billion.

Neither Gage nor the state has seen any significant drop in sales in the wake of the COVID-19 pandemic. On the contrary, demand has continued to grow steadily, as dispensaries were among the few businesses deemed essential and permitted to operate throughout the shutdown. All Gage and Cookies locations have remained operational, offering curbside pickup.

Plans to Go Public in Q1 2021

Gage Cannabis is currently planning a Canadian listing for the first quarter of 2021 (https://ibn.fm/V73dL). Additionally, Gage intends to launch a Regulation A+ offering of up to 28,571,400 subordinate voting shares priced at $1.75 per share, for gross proceeds of up to $50 million before offering expenses, assuming all shares are sold (https://ibn.fm/FteTi), but it has not yet made an announcement regarding the launch of that financing.

A Regulation A+ offering, also called a mini-IPO, allows companies to raise capital without actually listing shares on a stock exchange.

Management Team

Bruce Linton is the Executive Chairman of Gage Cannabis. He joined the company in 2019 and is the founder and former CEO and Chairman of Canopy Growth Corp. (TSX: WEED) (NYSE: CGC). Mr. Linton has extensive executive and board experience in a variety of industries and is considered to be a pioneer in the global cannabis industry. He provides incomparable support to the company’s strategic and capital markets efforts.

Michael Hermiz is the Co-Founder and Director of Gage Cannabis, and he is also the founder of a federally licensed producer in Canada. Mr. Hermiz has had great success in various industries, including real estate, mortgage, telecommunications, import, export and many others.

Fabian Monaco is Gage’s President and Director. He previously worked at XIB Financial Inc., GMP Securities L.P. and Scotiabank. In addition to his vast investment banking and legal background, Mr. Monaco has 10+ years of capital markets experience. His advisory experience in the cannabis industry is also extensive.

Dr. Rana Harb is a Director of Gage Cannabis. She has 25+ years of experience handling research, compliance, quality assurance and regulatory affairs. A significant portion of her regulatory and compliance history is in the cannabis industry. Dr. Harb has worked for many pharmaceutical companies worldwide, dealing with regulatory agencies such as the FDA, the EMA and Health Canada.

Mike Finos is the President (USA) and a Director of Gage Cannabis. He is the former COO of Horizon Global, the world’s number one towing accessories company. He has experience with start-ups, M&A and business integration with both private and publicly traded companies. With 20+ years of operational leadership expertise, Mr. Finos has extensive knowledge relating to supply chain logistics, manufacturing and information technology.

David Watza is the Chief Financial Officer of Gage Cannabis. He is an experienced C-Suite executive and former CFO and board member of Perceptron Inc. (NASDAQ: PRCP). Mr. Watza has 30+ years of experience in finance, accounting, and operations, including time as a public company CFO.

For more information, visit the company’s website at www.GageUSA.com.

NOTE TO INVESTORS: The latest news and updates relating to Gage Cannabis Co. are available in the company’s newsroom at https://ibn.fm/GAGE

• CNS Pharmaceuticals is a pre-clinical-stage developer of novel brain cancer-fighting drugs, including its lead candidate Berubicin
• The company is working to build on promising results from a 2006 Phase I trial, which provided 44 percent of its limited patient pool with clinically significant improvement in disease stability and one patient with a durable complete response (no evidence of any tumor remaining) for over 14 years
• CNS Pharmaceuticals expects to launch a pivotal Phase II trial of Berubicin at the beginning of next year and has been assembling a team of partner companies help with the trial
• CNS recently announced that the partner contracted to manufacture the Active Pharmaceutical Ingredient (API) for Berubicin has received a Certificate of Analysis necessary for the drug substance to be used in the clinical trial
• The company is also preparing in collaboration with its sub licensed partner, WPD Pharmaceuticals, for the first Phase I pediatric trial of Berubicin
• CNS is continuing the pre-clinical development of the company’s second promising cancer-fighting drug candidate, WP1244

Houston, Texas-based biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) continues to achieve milestones in its drive to defeat glioblastoma multiforme (“GBM”), a relentless type of brain tumor known for very rapid progression and very short survival periods in nearly all patients once they’ve been diagnosed.

“If you get glioblastoma, the sad fact is you’re going to die from that disease,” CNS Pharmaceuticals CEO John Climaco told attendees at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit in September during a discussion about the aggressive brain tumors and the company’s investment potential as it advances tumor-fighting drug candidates (https://ibn.fm/t13u4). “We believe that [our drug candidate] Berubicin could potentially be a game-changer,” Climaco continued.

CNS Pharmaceuticals is in the process of developing the testing infrastructure for its its lead novel drug candidate, an anthracycline called Berubicin. The company announced at the beginning of this month that a partner company contracted to manufacture Berubicin active pharma ingredient (API) received a Certificate of Analysis, clearing it for use in the production of the Berubicin drug product in preparation for use in the clinical trial (https://ibn.fm/N2AMO).

Berubicin has shown the potential to stand out from other tumor-killing anthracyclines because it has the ability to cross the human body’s Blood-Brain Barrier (“BBB”) and sequester itself preferentially in tumor tissue, the company’s website states (https://ibn.fm/F8SNr).

The blood-brain barrier is a wall of specialized endothelial cells that separate the blood circulatory system from the brain and kick out recognized toxins such as anthracyclines before they can affect the body’s central nervous system. “That’s why anthracyclines kill glioblastoma cells in test tubes but don’t affect glioblastoma tumors when given to people,” the website states.

In a limited Phase I trial conducted in 2006, Berubicin showed evidence of prompting improved survival in a patient population that has a median survival rate of only 14.6 months from the date of the disease’s diagnosis, and one of the trial’s patients remains cancer-free as of the last assessment on Feb. 20 of this year, approximately 14 years later, Climaco said.

Tumors are generally first removed surgically to the extent possible, but then tend to recur.

The pharmaceutical temozolomide has been shown useful as a first-line response in temporarily extending the lifespan of fewer than 40 percent of GBM patients with a specific genetic variation, but even nearly all of those patients develop resistance to temozolomide within about a year’s time and CNS hopes to present Berubicin as a second-line therapy.

The contracts with drug manufacturers Pii and BSP will provide drug product for CNS’s Phase II clinical trial as well as two trials in Poland to be conducted by sub licensee partner, WPD Pharmaceuticals, including a Phase 2 adult trial and a first-ever Phase 1 pediatric trial, both of which are expected to launch during Q1 of 2021. The company recently announced an agreement with medical imaging company Image Analysis Group (“IAG”) to evaluate the upcoming clinical trial imaging results in real time using AI-driven technology (https://ibn.fm/TlKhu).

CNS Pharmaceuticals is also conducting pre-clinical development on a drug candidate known as WP1244 that has been shown in preclinical studies to have a DNA-binding agent 500 times more potent than chemotherapy drug daunorubicin in stopping tumor cell expansion.

For more information, visit the company’s website at www.CNSPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

• Predictive Oncology’s CEO Carl Schwartz published open letter to company’s shareholders
• Schwartz elaborated on various developments within each of POAI’s divisions, has reiterated his optimism on company’s operations going forward
• CEO also revealed that company’s revenue trends have stabilized and are now on upward trend with cash burn beginning to decline
• Company also revealed its ability to access over $10 million in undrawn equity lines of credit

Carl Schwartz, the CEO of Predictive Oncology (NASDAQ: POAI), a knowledge-driven medicine company that focuses on applying data and artificial intelligence (“AI”) to cancer personalized medicine and drug discovery, has recently published a letter to the company’s shareholders elaborating on the company’s latest achievements as well as their prospects going forward (https://ibn.fm/L1mA8).

Within his letter, Schwartz addressed the latest developments within each of the company’s business verticals and stressed that in spite of the tumultuous global economy, Predictive Oncology was witnessing both stable and rising revenues along with declining levels of cash burns. Schwartz also detailed that the company’s balance sheet was still quite resilient with access to over $10 million in equity capital able to be drawn down from their existing lines of credit.

The letter also elaborated on the company’s various operational divisions, commencing with its Skyline Medical division. Skyline Medical is charged with the manufacture and sale of POAI’s groundbreaking, FDA-cleared STREAMWAY System – providing medical facilities with a direct-to-drain fluid disposal system intended to automate the collection, measurement and disposal of waste fluids during medical procedures. POAI revealed that the division was now self-supporting from a cash standpoint, with sales of disposables used on Streamway machines more than covering the business’ operating expenses. Separately, the company explained that the continued sale of new Streamway devices would also add to the future potential revenues which the company could derive from the sale of disposables.

Schwartz also touched upon the company’s Helomics division, which seeks to assist pharmaceutical, diagnostic and biotech industries develop predictive models of how tumors could respond to drugs. Helomics recently launched a restructured clinical test offering to clinicians for ovarian cancer, which has been very well received by oncologists. The company expects that this new test, coupled with Helomic’s existing product range, will be revenue generating by year end and should be able to cover the bulk of the division’s operating expenses going forward.

Elsewhere, Predictive Oncology also provided an update on subsidiary TumorGenesis, which specializes in the field of ovarian cancer, creating laboratory-grown cancer cells which can then be used to assist researchers and clinicians identify which cancer cells bind to specific biomarkers. TumorGenesis will be introducing its Ovarian Cell Line Media at the upcoming BIO-Europe Conference, which will allow researchers to isolate and successfully culture ovarian cancer cells that have not previously been cultured. Separately, the division is also in the process of registering with the US government as a contractor for developmental work in cancer cell capture and screening of compounds for the prevention and treatment of cancer.

Finally, Schwartz discussed the ongoing progress at Soluble Biotech, a subsidiary which seeks to provide optimized FDA-approved formulations for vaccines, antibodies and other protein therapeutics in a faster and lower cost basis to its customers. Having already secured a sizable contract, POAI’s management have expressed their confidence in the business generating revenues by the end of 2020.

With a number of ongoing positive developments taking place across Predictive Oncology’s various businesses, the company’s CEO has reaffirmed his positive stance on POAI’s corporate prospects, expressing his firm belief in the fourth quarter’s being “eventful”.

For more information about the company, visit www.Predictive-Oncology.com.

NOTE TO INVESTORS: The latest news and updates relating to POAI are available in the company’s newsroom at http://ibn.fm/POAI

• KAVL recently acquired patent, announced creation of wholly owned subsidiary to develop smoking cessation products.
• Company plans to create products that satisfy smokers but are free from nicotine’s addictive traits.
• CEO says company is excited to help “all nicotine users lead healthier and higher-quality lives.”

The Centers for Disease Control and Prevention report that smoking is the leading cause of preventable death in the world today (https://ibn.fm/dxZ1W). With the help of new and innovative cessation products, the  7 million deaths that occur every year due to smoking could be prevented — and Kaival Brands Innovations Group (OTCQB: KAVL) is determined to do all it can to make it happen.

A company focused on growing and incubating innovative and profitable products into mature, dominant brands, Kaival Brands has turned its attention to the smoking cessation space (https://ibn.fm/t3k6S). The company recently acquired a patent covering the creation of all synthetic nicotine smoking cessation and synthetic nicotine addiction therapy products. In addition, the company has announced the creation of a wholly owned subsidiary — Kaival Labs — that will own the patent and develop associated products.

“The science behind these patents has discovered that within the nicotine molecule, the S-isomers control the addictive properties, whereas the R-isomers control the beneficial qualities of the nicotine that a user enjoys,” said Kaival Brands CEO Niraj Patel. “The exclusivity is that the patents allow us to control the specific ratios of each isomer in the final synthetic nicotine molecule we produce for cessation products. We can now create completely unique products for smoking cessation and nicotine addiction therapy that remain effective and satisfying for the user, but are free from nicotine’s addictive traits.

“Kaival Labs will own the patented science to create a pure, yet nonaddictive synthetic nicotine for the development and production of smoking cessation and nicotine replacement therapy products,” Patel continued. “Tobacco-Free Nicotine (‘TFN’) is a certified clean, pure, non-tobacco-derived synthetic nicotine, and a key ingredient in numerous products like nicotine patches, lozenges, gums, vape sticks, e-liquids and more.”

Efforts to help smokers who are seeking to quit — including products such as chewing gum, inhalers, lozenges, patches, sprays and sublingual tablets, and therapies such as nicotine replacement therapy (“NRT”), non-NRT therapy and e-cigarettes — are not new. However, until now, they were fairly ineffective. A National Health Information Survey reports that while 34.2 million U.S. adults smoke, an estimated 70% of them want to quit — and 55% of them have tried to kick the habit in the last year (https://ibn.fm/cgBHr). Unfortunately, the success rate for quitting is under 10% because nicotine is so addictive.

Because Kaival Brands’ newly acquired patent provides the ability to control levels of both the S-isomers and the R-isomers in the nicotine molecule, the company intends to formulate and offer patented, true step-down products that reduce nicotine addiction levels without decreasing the benefits.

“Smokers and tobacco users worldwide are looking for an answer and a real solution to their nicotine addiction problems,” Patel said. “Imagine patent-protected products, either approved pharmaceutically or made available over the counter, that offered a way to truly ease a user off their addictive cravings for nicotine without losing any of their accustomed benefits along the way. We are excited to develop these innovative patents and bring effective, enjoyable smoking cessation products to market, helping all nicotine users lead healthier and higher-quality lives.”

Kaival Brands is a fast-growing company focused on generating wealth by seeking to incubate innovative products into mature and dominant brands in their respective markets. Our vision is to develop internally, acquire or own, and exclusively distribute these profitable brands with recognizable innovation and superior quality.

For more information, visit the company’s website at www.KaivalBrands.com.

NOTE TO INVESTORS: The latest news and updates relating to KAVL are available in the company’s newsroom at http://ibn.fm/KAVL

• SGTM awarded contract for tree services in Lake County, Florida through subsidiary Central Florida Arborcare
• SGTM subsidiary Mulch Manufacturing recently awarded two additional packaging contracts
• Subsidiary ArborPro of Mississippi Inc. awarded contract for Hurricane Laura recovery efforts
• Q2 results include $12.3 million revenue and $3.4 million gross profit

Sustainable Green Team (OTC: SGTM), a leading provider of environmentally-beneficial solutions for tree and storm waste disposal, recently announced that Central Florida Arborcare, its wholly-owned subsidiary, was awarded a one-year contract to supply tree trimming and related services to the county, renewable for an additional four times over a one-year period. Along with tree services, SGTM provides debris hauling and waste removal as part of its overall operations that transform organic waste into environmentally-friendly products such as mulch and playground surfacing material.

“Getting awarded this contract is allowing us to stay on point with our growth, building relationships with municipalities and governments,” said SGTM CEO and Director Tony Raynor (https://ibn.fm/4RVW1). “We are very fortunate to be an essential business that has proven to stand strong through these economically hard times.”

Despite the economic hardships currently being experienced by businesses across the country, SGTM has grown. The new contract comes shortly after subsidiary Mulch Manufacturing Inc. was awarded a 2021 mulch packaging contract renewal from Menards Inc., the third-largest home improvement chain in the U.S. with 350 stores in operation across 15 states. Also in the pipeline for Mulch Manufacturing is another contract with Old Castle Lawn & Garden to supply large home improvement chains in the Midwest. ‘

SGTM takes its role as a caretaker of the environment seriously by providing remediation efforts in the wake of hurricanes and other natural disasters such as Hurricane Laura. Through its strategic partner, ArborPro of Mississippi Inc., SGTM contributed to recovery efforts in Louisiana by providing services that diverted damaged trees and other vegetation from landfills. The busy hurricane season is expected to contribute significantly to the company’s bottom line this quarter, building upon already impressive Q2 results that included over $12.3 million in revenue and $3.4 million in gross profit (https://ibn.fm/BjJa1).

SGTM plans to expand operations through a combination of organic growth, national partnerships and strategic acquisitions. The company’s strong commitment to environmental sustainability was a primary factor behind the recent name and ticker change from National Storm Recovery Inc. (OTC: NSRI) to Sustainable Green Team, Ltd. (OTC: SGTM). Along with driving forward its mission, the company also aims to maximize value to shareholders seeking ethical investment opportunities in businesses with significant growth potential that can withstand increasingly challenging economic conditions.

To learn more about Sustainable Green Team Ltd., view the investor presentation at https://ibn.fm/Ss6pO.

NOTE TO INVESTORS: The latest news and updates relating to SGTM are available in the company’s newsroom at http://ibn.fm/SGTM

• Pure Extract Technologies has been awarded Standard Processing License by Health Canada
• The license will enable the Company to produce, sell cannabis & hemp products to other Licenced Producers in its purpose-built facility located near Whistler, Canada
• Canada’s ability to export worldwide coupled with Company’s EU-GMP compliant facility makes Pure Extracts a natural partner for companies involved within international distribution

Pure Extract Technologies, a privately held British Columbia-domiciled plant extraction company, announced that it had been awarded a Standard Processing Licence by Health Canada under the Cannabis Act, following an extensive and meticulous five-month application and vetting process (https://ibn.fm/xElDa).

Pure Extracts achieved this licensing milestone in spite of the operational hurdles and constraints posed by the ongoing COVID-19 pandemic and has reiterated its confidence that its operational plan, coupled with the Company’s intense focus on employee safety, will allow for normal business practices to be conducted in a safe and efficient manner.

Furthermore, following the award of the Health Canada license, Pure Extracts will now proceed with application to Health Canada for a Natural Health Products Site Licence at its purpose-built extraction facility while adhering to EU Good Manufacturing Practices (“GMP”), which in turn will help ensure that its full spectrum oil (“FSO”) will be extracted to the highest possible quality.

“We are thrilled to be commencing production in our new, EU-GMP compliant, purpose-built facility and are confident that our state-of-the-art extraction and processing equipment will produce the highest-quality cannabis and hemp-derived oil available on the market,” stated Pure Extract Technologies founder and COO Doug Benville following the Health Canada license approval.

With consumer demand for edibles and infused beverages continuing to accelerate, Canadian cultivators have responded to the growth in demand by increasing the quantity of outdoor-grown biomass, which will be readily available for extraction this fall. Pure Extracts in turn has reacted to the forthcoming increase in demand by increasing its workforce, expecting to expand to 14-16 individuals by the end of 2020.

“Pure Extracts plans to position itself as an extraction industry leader in terms of its Full Spectrum Oil FSO quality,” notes CEO Ben Nikolaevsky. “We can’t wait to show our LP partners the incredible quality extracted oil that we can produce, be it for medicinal or recreational usage. Our standards are high, as you would expect from an EU-GMP compliant producer with an exceptionally experienced team. The dedication and determination our team displayed over the last two years has been exemplary.”

For more information, visit the company’s website at www.PureExtractsCorp.com.

NOTE TO INVESTORS: The latest news and updates relating to Pure Extract Technologies are available in the company’s newsroom at http://ibn.fm/Pure

• Deloitte published report earlier this year looking into growth trends driving the global TMT industry
• Study found that consumers have embraced online streaming platforms in 2020, with average customer subscribing to three streaming platforms
• The Movie Studio has sought to capitalize on sector’s growth through launch of its own streaming platform as well as through purchase of content aggregator, BINGE Networks LLC
• Deloitte ultimately expects online streaming sector to consolidate, with only handful of platforms taking lion’s share of market

As the world progresses through what can only be described as a wildly tumultuous year, it is evident that trends, such as the avid use of online streaming platforms, have emerged – a movement which independent, Florida-based film studio The Movie Studio (OTC: MVES) has sought to capitalize upon through the launch of its own eponymous online streaming platform.

With subscriber numbers for online streaming platforms more than doubling on a year on year basis, global consultancy firm Deloitte set out to delve deeper into the drivers underpinning the sector’s growth, publishing an extensive report setting forth the company’s findings on the current state of the global technology, media and telecommunications industry (https://ibn.fm/Lduh6).

In a recent survey carried out by Deloitte, a larger number of respondents indicated that they had at least one streaming video subscription (69 percent) relative to those who still possessed a traditional paid television subscription (65 percent) for the first time on record (https://ibn.fm/mN5s6). In response to an explosion in the number of online streaming platforms – the past 24 months has seen the launch of Disney+, Peacock, ViacomCBS and HBO Now amongst various others – studios have responded by withdrawing content rights from third-party streaming platforms in a bid to secure original content for their own platforms.

The move to de-aggregate media content in turn has led consumers to subscribe to multiple platforms, with Deloitte’s Digital Media Trends survey finding that consumers had subscriptions to an average of three streaming video services—a number which has remained steady over the past two years. In response to its findings, Deloitte concluded that streaming services owning the broadest content libraries would likely own the inside track to success, a strategy which has been evidenced by the likes of Amazon and Roku, both of which has attempted to bundle their media content offerings with gaming and music content in an attempt to entice subscribers to their platforms.

The Movie Studio has responded to the surge in competition within the online streaming video platform sector through an ambitious original content creation program, one that has seen the company produce and distribute major motion pictures such as ‘Exposure’, ‘Bad Actress’ and ‘Dancing on the Edge’ in recent times. Separately and in addition to its own content generation, MVES announced the acquisition of BINGE Networks, LLC earlier this year; in contrast to stand-alone streaming platforms, BINGE Networks operates as a distribution agent, providing over 100 individual OTT platforms, including the likes of Roku TV, Apple TV and Amazon with access to its content library of over 15,000 videos and 300 indie films (https://ibn.fm/t7Fdt).

Within its report, Deloitte revealed that it ultimately expected the online video streaming platform business to consolidate into a handful of businesses possessing the most extensive content libraries, with consumers selecting a handful of “must have” subscriptions. Meanwhile, those media companies boasting large libraries which did not make the cut could potentially look to launch their own ad-supported streaming services (in a bid to attract non-subscribers) or, in its stead, join an ad-supported aggregator.

Boasting its own subscription-based streaming platform as well as that gained through its acquisition of BINGE Networks, which operates as a content aggregator in its own right, The Movie Studio has taken great strides toward strengthening its hold on a sector which is expected to witness a wave of consolidation in coming years; more critically perhaps, it has also laid the groundwork needed to capitalize on the stunning growth trends within a sector set to grow at a CAGR of 20.4% over the coming seven years (https://ibn.fm/VhfG0).

For more information, visit the company’s website at www.TheMovieStudio.com.

NOTE TO INVESTORS: The latest news and updates relating to MVES are available in the company’s newsroom at http://ibn.fm/MVES