• MVES engaged services of Digital Talent Studio Inc., social media mogul Brian Breach of Sikey Corp. to promote The Movie Studio App
• The Movie Studio App leverages both advertiser-based and subscription models
• Social media models, influencers expected to promote app to hundreds of thousands of followers
• MVES’s two key verticals include open architecture for original content plus an over-the-top platform that pulls additional content through revenue sharing agreements

In a bold move to boost the promotion of The Movie Studio App, The Movie Studio Inc. (OTC: MVES), a vertically integrated motion picture production and distribution company, has engaged Digital Talent Studio Inc. and social media mogul Brian Breach of Sikey Corp. for services that include social media branding, influencer engagement and advertising on key social media platforms. Currently offered as a beta version in the Google Play Store and the Apple App Store, the app is expected to be replaced with the full version once the official launch takes place.

Designed to be a recurring revenue model, MVES’s unique video on demand (“VOD”) business goes beyond traditional feature film distribution pathways by offering innovative ways to distribute content and participate in the motion picture industry. Besides targeting relevant demographics through social media, high-profile influencers will be engaged in a revenue-sharing agreement that includes opportunities to audition in the company’s in-production “Moviesodes”.

“We are excited about engaging Digital Talent Studio Inc. and Sikey Corp. and believe they intrinsically understand the proposed app and our OTT platform architecture,” said MVES President and CEO Gordon Scott Venters (https://ibn.fm/CUKBD). “Upon completion of the app and subsequent marketing aligned with our brand, we are confident they can help us create a significant user subscription base.”

The Movie Studio app will employ a split-screen graphical interface that incorporates both advertiser video on demand (“AVOD”) and subscription-based video on demand (“SVOD”) components. Besides allowing users to watch ad-free for only $2.99/month, the SVOD component will also allow subscribers to participate in the “Be in Our Movies!” portion of the app, allowing them to audition for roles in upcoming films.

“Taking on The Movie Studio’s social media so they can reach their full potential and expand their online presence and the launch of their app could disrupt the entire independent movie industry, and I look forward to helping make that happen,” said Sikey President Brian Breach.

MVES’s two key verticals include an open architecture for the addition of motion picture content to its film library along with an over-the-top (“OTT”) platform that seeks to pull additional motion picture content into the app that leverages revenue share agreements with motion picture producers, distributors and content providers. Following the completion of the app, the initial marketing campaign will be put into play to target millennials and other demographics through high-profile influencers on top social networks like Facebook and Instagram.

“This partnership could take our models and social media influencers to the next level, launching their movie careers so they can be in films,” said Digital Talent Studio president Kevin Doyle.

“Similarly, we may provide the ultimate grassroots marketing campaign for The Movie Studio’s content delivery app and each of their films,” he continued. “Our influencers could announce their roles directly to their hundreds of thousands of followers, creating an instant demand for each movie and the SVOD component of the platform. Reciprocally, each movie can become an opportunity for our influencers to grow their follower bases and a chance to become viral stars.”

Formerly known as Destination Television, Inc., The Movie Studio Inc. acquires, develops, produces and distributes independent motion picture content for worldwide consumption in theatrical, video on demand, foreign sales, and on various media devices. With an aim to disrupt traditional media content delivery systems with its digital distribution model, MVES is well-positioned to become a unique brand within the VOD industry.

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

• Mullen Technologies begins built-out of pilot facility, accepting orders for MX-05 SUV.
• Facility slated for April 2021 completion; first MX-05 SUVs rolling off production line by Q2 2022.
• In August, Net Element, Mullen Technologies announced execution of definitive agreement to merge.

The announcement by Mullen Technologies Inc. that it has begun to build out its pilot manufacturing facility and take pre-orders for its M05 fully electric SUV bodes well for Net Element (NASDAQ: NETE). Earlier this year, Net Element, a global financial technology and value-added solutions group, and Mullen Technologies announced a merger agreement—so good news for Mullen means good news for Net Element.

“We are excited to begin the build-out of our pilot facility and pre-sales of our MX-05 SUV in October,” said Mullen Technologies chairman and CEO David Michery. “We plan on completing the build-out by April 2021 and to begin assembly of certification prototypes by July 2021. These vehicles will be used for homologation, which is expected to take 16 months and be completed by May of 2022, at which time we expect to begin delivering the first vehicles to the public.”

On Oct. 1, Mullen began work to turn its Monrovia, California-based, high-voltage battery R&D center into a state-of-the-art pilot facility where its line of fully electric SUVs will be manufactured. Plans call for the facility to be completed by April 2021, with the first MX-05 SUVs rolling off the production line to be delivered to customers by second quarter 2022.

Mullen Technologies anticipates its remodeled manufacturing facility will produce up to 1,000 MX-05 EVs per year; the facility will also manufacture all other upcoming models, including the MX-07 and MX-03. The factory will be renovated to include general assembly and battery assembly capabilities; the structure will also house R&D and serve as a warehouse.

Also on Oct. 1, Mullen will begin accepting preorders for its MX-05 model; starting base price for the innovative vehicle starts at $55,000. In addition, the company is also taking preorders for its Dragonfly K50, a limited-production super sports car being imported under Independent Commercial Importers. Information about both vehicles, as well as how to reserve the EVs, can be found on www.MullenUSA.com or at any Mullen retail location.

In August, Net Element announced the execution of a definitive agreement to merge with privately held Mullen Technologies Inc., in a stock-for-stock reverse merger in which Mullen’s stockholders will receive a majority of the outstanding stock in the post-merger company. The completion of the merger is subject to shareholder and NASDAQ approval, as well as other conditions referenced in the merger agreement.

Net Element Inc. is a global financial technology and value-added solutions group that supports electronic payments acceptance in an omni-channel environment spanning across point-of-sale, e-commerce and mobile devices. The company operates a payments-as-a-service transactional model and value-added services platform for small to medium enterprises in the United States and selected emerging markets.

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

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

• Processa Pharmaceuticals aims to develop products where existing clinical evidence of efficacy already exists in the targeted unmet medical need condition with the drug itself or a drug with very similar pharmacology
• The Processa process focuses on the advancement of drugs that are ready for clinical development or have minimal pre-IND enabling studies to complete
• Processa’s current development pipeline features multiple clinical drug candidates, given the recent acquisitions of three additional development-focused licensing agreement since June 2020
• In total, the company’s combined scientific, development and regulatory experience has resulted in more than 30 drug approvals by the U.S. Food and Drug Administration

Processa Pharmaceuticals (NASDAQ: PCSA) aims to develop products where existing clinical evidence of efficacy already exists in unmet medical need conditions. In support of this goal, the company has assembled an unparalleled management team, board of directors and product development team featuring experts in developing drug products, from IND-enabling studies to NDA submission. In total, the team’s combined scientific, development and regulatory experience has resulted in more than 30 drug approvals by the U.S. Food and Drug Administration (“FDA”) and more than 100 meetings with the FDA while working on more than 50 drug development programs, including drug products targeted to orphan disease and unmet medical need conditions.

Headquartered in Hanover, Maryland, Processa has built a pipeline of drugs which already have some proof-of-concept clinical data supporting clinical use in their selected indications.

Development Pipeline

The Processa process focuses on the advancement of drugs that are ready for clinical development or have minimal pre-IND enabling studies to complete. More specifically, Processa:

1. Acquires drugs that already have some clinical data to support the targeted treatment – whether it be the drug itself, an analog of the drug or a drug with similar pharmacological targets;
2. Navigates through the FDA, collaborating with the reviewers to define a complete development program; and
3. Develops each drug over the course of 2-5 years, out-licensing the drug either just prior to pivotal study after Phase 2b or after the completion of the pivotal study.

Processa’s current development pipeline features multiple drug candidates, including PCS499 and PCS100. The company has also announced three additional licensing agreements since June 2020, further bolstering its clinical efforts. Each drug is briefly described below.

PCS6422

On August 27, 2020, Processa announced its entry into a contingent precedent exclusive licensing agreement with Elion Oncology Inc. to develop, manufacture and commercialize eniluracil (PCS6422) globally. PCS6422 is an oral drug to be administered with fluoropyrimidine cancer drugs (e.g., capecitabine, 5-FU) to decrease the breakdown of the cancer drug to inactive metabolites or metabolites that are known to cause unwanted side effects and to increase the anti-cancer related metabolites.

An IND for a Phase 1B study was cleared by the FDA in May 2020. The study will evaluate the safety and tolerability of several dose combinations of PCS6422 and capecitabine in advanced GI tumor patients. Processa intends to enroll the first patient in 1H2021, obtain interim results, and have a final report completed in 2H2022.

“Having worked on 5-FU and other cancer agents in the past, adding PCS6422 to our pipeline and expanding our involvement in oncology was an easy decision given the significant impact that PCS6422 may have on improving the efficacy and safety of capecitabine or other fluoropyrimidines,” CEO Dr. David Young said of the agreement.

PCS499

PCS499 as a potential treatment for necrobiosis lipoidica (“NL”) was first presented to the FDA in a pre-IND meeting in 2018. In 2019, it was the subject of an IND submission and a promising Phase 2 safety study. On March 30, 2020, Processa announced a successful meeting with the FDA regarding the design and execution of the next clinical study to evaluate the ability of PCS499 to completely close ulcers in patients with NL.

“We are pleased with the outcome of the FDA meeting and the feedback we received from the FDA. We believe that the results from our completed Phase 2 trial in NL patients, especially those with more severe ulcerated forms of NL, are encouraging and we appreciate the guidance provided by the FDA regarding our next clinical trial and the requirements to support our NDA submission,” Dr. David Young, CEO of Processa, stated in the news release.

NL is a chronic, disfiguring condition affecting the skin and tissue under the skin, typically on the lower extremities, with no currently FDA-approved treatments. More severe complications can occur, such as deep tissue infections and osteonecrosis, threatening the life of the limb. Approximately 22,500 – 55,500 people in the United States and more than 150,000 – 400,000 people worldwide are affected by the ulcerated form of NL.

YH12852

On August 20, 2020, Processa announced its entry into an agreement with Yuhan Corporation, a South Korean firm, to license YH12852, a small molecule drug in development for the treatment of functional gastrointestinal (“GI”) disorders. Under the terms of the agreement, Processa will acquire the rights to a portfolio of patents with an exclusive license to develop, manufacture and commercialize YH12852 globally, excluding South Korea.

YH12852 is a novel, potent and highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. Other 5-HT receptor agonists with less 5-HT4 selectivity have been shown to successfully treat GI mobility disorders such as chronic constipation, constipation-predominant irritable bowel syndrome, functional dyspepsia and gastroparesis. The less selective 5-HT4 agonists, such as cisapride, have been removed from the market because of the cardiovascular side effects associated with the drugs binding to other receptors, especially 5-HT receptors other than 5-HT4.

CEO Dr. David Young called the agreement “further evidence of Processa’s commitment to seek out novel treatments for unmet medical conditions.” Processa intends to meet with the FDA in early 2021 to further define the clinical development program. In 2021, Processa expects to initiate a Phase 2 trial in a functional GI motility-related disorder that that needs better therapeutic options, such as postoperative ileus and opioid-induced constipation.

ATT-11T

On June 1, 2020, Processa announced its entry into a licensing agreement with Aposense Ltd. for the patent rights and know-how to develop and commercialize ATT-11T, a next generation irinotecan cancer drug. In the release, CEO Dr. David Young noted that the licensing deal fit with Processa’s strategy to “continue to bring innovative products to patients with an unmet medical need condition.”

ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Aposense molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell, with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan, such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.

The ATT-11T licensing agreement is conditioned upon Processa’s closing of a satisfactory financing round and the listing of the company’s shares on the Nasdaq or NYSE, among other conditions.

PCS100

On September 3, 2020, Processa announced its entry into an exclusive worldwide license agreement with Akashi Therapeutics to develop and commercialization Akashi’s lead drug, HT-100. Rebranded PCS100, the candidate is an anti-fibrotic, anti-inflammatory drug demonstrated to have some clinical anti-fibrotic effect in children. Processa intends to develop PCS100 first in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis (“FSGS”), idiopathic pulmonary fibrosis (“IPF”) or Scleroderma, where there are still few therapeutic options.

Management Team

David Young, Pharm.D., Ph.D. is the CEO and founder of Processa. He has over 30 years of pharmaceutical research, drug development and corporate experience. Young has served in leadership roles with a number of pharmaceutical firms throughout his career, including serving as founder and CEO of Promet Therapeutics LLC since 2015 and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. At Questcor, he was responsible for working with the FDA on modernizing the Acthar Gel label and for obtaining FDA approval in infantile spasms. In total, Young has met with the FDA more than 100 times on more than 50 drug products and has been a key team member on more than 30 NDA/supplemental NDA approvals.

Sian Bigora, Pharm.D., is Processa’s Chief Development Officer and founder. She has over 20 years of pharmaceutical research, regulatory strategy and drug development experience, working closely with Young. Prior to joining Processa, Bigora served as Co-Founder, Director and Chief Development Officer at Promet Therapeutics LLC and as Vice President of Regulatory Affairs at Questcor Pharmaceuticals from 2009 to 2015, where she led efforts to modernize the Acthar Gel label and obtain FDA approval in infantile spasms – events which were of material importance to Questcor’s subsequent success.

Patrick Lin is Chief Business & Strategy Officer and founder of Processa. He has over 20 years of financing and investing experience in the biopharma sector. Prior to joining Processa, Lin served as Co-Founder and Chairman of Promet Therapeutics LLC. He is also founder and managing partner of Primarius Capital, a family office that manages public and private investments focused on small capitalization companies.

James Stanker has served as CFO of Processa since 2018. He has over 30 years of financial and executive leadership experience in the areas of accounting principles and audit standards, regulatory reporting, and fiscal management and strategy. He served in a financial leadership role as an audit partner at Grant Thornton from February 2000 until his retirement in August 2016, where he was responsible for managing audit quality in the Atlantic Coast market territory.

Wendy Guy is the Chief Administrative Officer and founder of Processa. She has more than two decades of experience in business operations, having worked closely with Young over the last 18 years in corporate management and operations, HR and finance. Prior to joining Processa, she was Co-Founder, Director and Chief Administrative Officer of Promet Therapeutics LLC and Senior Manager, Business Operation over the Maryland office for Questcor Pharmaceuticals.

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

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

• The partnership will help InsuraGuest’s coverage potentially reach more than 9,300 hospitality customers in the United States and Canada by the middle of 2021
• Hospitality Liability coverage allows covered properties to transfer certain liabilities, lowering claim ratio and risk profiles
• InsuraGuest’s product can also help properties generate revenue by keeping a percent of the nightly software fee

Innovative insurtech leader InsuraGuest Technologies (TSX.V: ISGI) (OTC: IGSTF) has sealed a premier preferred partnership with leading global insurance brokerage Hub International Limited (“HUB”), to provide InsuraGuest’s Hospitality Liability coverage to properties in Hub International’s portfolio. Signed via wholly owned subsidiary InsuraGuest, the deal will help HUB hotel clients significantly lower their insurance premiums, transfer small property and medical guest claims as well as generate additional revenue (https://ibn.fm/AYcJB).

The coverage will start with HUB clients in the United States, with the goal of expanding to Canadian hotel clients by the middle of 2021. According to InsuraGuest CEO and Chairman Douglas Anderson, the premier preferred partnership with HUB will allow the company to expand its product offering to more than 9,300 hospitality customers in the U.S. this year and into Canada in 2021.

The InsuraGuest Hospitality Liability coverage will allow HUB hotel clients to benefit from an extra layer of protection in case a guest experiences an accident, in-room property damage, accidental medical and death and dismemberment or theft while staying at an InsuraGuest-covered property.

Currently, InsuraGuest integrates with approximately 70 different property management systems through the proprietary API. The integrated use allows for the organization to transfer liabilities that fit specific criteria to the InsuraGuest carrier. The transfer of these liabilities to the InsuraGuest Hospitality Liability coverage enables hotel properties to lower their risk profile and claim ratio, thus decreasing General Liability premiums.

Most of a hotel client’s claims are from a small property or medical claim, which frequently gets applied to the General Liability coverages. With InsuraGuest, the risk is transferred from the hotel client through the small fee applied per night to the guest’s bill. InsuraGuest will then pay these small claims, keeping them off the hotel client’s General Liability policy.

The higher frequency of claims drives up the premiums paid by a hotel client for their General Liability policy coverage. With the transfer to InsuraGuest, the hotel client presents less risk for their general liability policy, lowering premiums.

In addition, hotels properties using InsuraGuest’s product will be able to generate additional revenue through the platform’s implementation. When a hotel offers the InsuraGuest Hospitality Liability coverages, an automatic charge is placed on their folio or bundled into their resort/amenity/urban fee upon check-in. The fee for coverage and software is $4.95 a night.

“Given the current state of the hospitality industry, it is nice to have a new and exciting tool such as InsuraGuest, which will help us lower a hotel’s overall liability costs through claims avoidance,” said Kevin Eggleston, the Managing Director of HUB’s Hospitality Specialty Practice. “InsuraGuest costs a hotel owner nothing. In fact, it actually generates new revenue while giving us the means to reduce General Liability premiums by improving guest loss ratios. By minimizing the frequency of a hotel’s claims, we are able to have better underwriting conversations with the marketplace.”

The hospitality industry is only one of the sectors InsuraGuest serves. The company’s goal is to disrupt the insurance landscape by utilizing its proprietary software platform to deliver digital insurance to multiple sectors. The company aims to transform the way insurance is delivered with the revolutionary idea that insurance should be bought, not sold.

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

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

• Clinical-stage biotech developer CNS Pharmaceuticals is working to demonstrate the potential effectiveness of its novel drug, Berubicin, in treating aggressive and rare brain cancer glioblastoma multiforme (“GBM”)
• CNS expects to launch Phase II trials of Berubicin later this year or in Q1 of 2021, building on promising results shown in initial trials
• One patient in the Phase I trial has remained cancer-free over the course of 14 years, and 44 percent of the patients who could be evaluated experienced a clinically significant positive response to Berubicin
• CNS’s laser-focused strategy for developing a GBM therapy is also leading the company to prepare, through its sub-licensee partner WPD Pharmaceuticals, for a first-ever Phase I pediatric trial of Berubicin in Poland as well as continuing the development of the company’s second drug candidate, WP1244, which has shown tremendous promise in stopping cancer proliferation in preclinical studies comparing it to chemotherapy drug daunorubicin

CNS Pharmaceuticals (NASDAQ: CNSP) is building its technologically advanced strategy for demonstrating the potential brain tumor-fighting capabilities of its novel drug Berubicin, announcing recently an agreement with medical imaging company Image Analysis Group (“IAG”) to evaluate upcoming clinical phase II patient trial scansin real time.

IAG’s proprietary platform DYNAMIKA is an AI-driven technology developed to aid in the analysis of patient responses during pharmaceutical trial’s, and IAG has extensive experience in partnering with the biotech industry — oncology companies in particular — to provide a centralized reading of critical data, according to a news release about the partnership (https://ibn.fm/7OTsk).

CNS Pharmaceuticals is developing unique treatments for primary and metastatic cancers of the brain and central nervous system, including the company’s lead drug candidate Berubicin, which aims to treat the aggressive brain cancer glioblastoma multiforme (“GBM”) (https://ibn.fm/4r5U3).

“This drug was designed specifically to penetrate the Blood-Brain Barrier and to treat cancers in the brain, which we all know are extremely difficult given that the brain is the most privileged organ in the body,” CNS CEO John Climaco told attendees at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit as part of the company’s investment highlights presentation at the virtual conference Sept. 22 (https://ibn.fm/AzZv6).

During a 2006 Phase I clinical trial, Berubicin “appeared to demonstrate one durable, complete response against GBM,” Climaco said. The specified patient has remained cancer-free as of the last assessment on Feb. 20 of this year. Twenty-seven of the participating patients were able to be evaluated, and 44 percent of them experienced a clinically significant improvement in condition as a result of the trial.

Regarding IAG’s scientific and clinical imaging expertise in the field of GBM and the prowess of the company’s analytical API, Climaco stated, “IAG has an exemplary track record of partnering closely with companies in the biotech space to provide critical analysis of both efficacy and patient response, which we believe will be pivotal in advancing our Berubicin clinical trials.”

IAG CEO Dr. Olga Kubassova stated the platform will not only help CNS analyze Berubicin’s effectiveness and build scientific evidence of its performance but will also help the company efficiently reduce development costs, uncertainties about outcomes and timelines for the product’s advancement.

In addition to the Berubicin trials, CNS and its partner WPD Pharmaceuticals are preparing for a first-ever Phase I Berubicin trial for pediatric patients who have brain cancer. CNS is also developing a second drug candidate, WP1244, shown in preclinical studies to have a DNA-binding agent 500 times more potent than chemotherapy drug daunorubicin in stopping tumor cell expansion.

“We are laser-focused as a company at this point on a critical unmet medical need, and that is the treatment of glioblastoma, which is the most aggressive, common and incurable form of brain cancer,” Climaco told conference attendees. “If you get glioblastoma, the devastating fact is you’re going to die from that disease. After decades without progress in the treatment of this terrible disease, we believe that Berubicin could potentially be a game-changer.”

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

• Pharmaceutical services innovator Trxade Group Inc. has gained investor attention as it has emerged as a responsive healthcare market force during the ongoing COVID-19 pandemic
• As the pandemic began to unfold earlier this year, Trxade Group saw revenues jump effectively to three times their previous Q1 level, largely as a result of personal protective equipment products
• The company’s core mission has been to help small, community-centered retail pharmacies compete with large national chains through prescription drug price transparency and AI-driven protocols that help pharmacies stay abreast of what’s available
• Trxade Group’s advances in delivering services ranging from consultation to drug shipping via virtual, remote-access technology has kept it abreast of developments as the effects of the pandemic have led to social-distancing limitations

The surprise manifestation of the novel COVID-19 coronavirus and its spread as a global pandemic this year has led to a cascade of changes involving how health care is administered, perhaps most notably in the increased adoption of telehealth services.

Telehealth services have been ideally situated for meeting remote access needs amid conditions in which the potential spread of a highly contagious virus has led medical policy makers to discourage close contact between people and gatherings in large numbers, especially indoors.

Five hundred healthcare industry executives surveyed by marketing agency Boston Digital recently reported the growing use of telehealth amid the pandemic has delivered largely positive results and the majority of the respondents said some of the changes in care protocols would undoubtedly remain in effect after the pandemic ends (https://ibn.fm/wTD8S).

Integrated pharmaceutical services innovator Trxade Group (NASDAQ: MEDS) has seen growing enthusiasm about its business profile during the course of the pandemic, largely because of revenue growth that has far exceeded expectations. The Q2 report showed a more-than-triple increase year-over-year to $6.6 million, practically tripling sequentially after Q1 this year as reported in a July earnings call (https://ibn.fm/KNVJs), which sent the stock soaring 35 percent immediately after the announcement, as noted in a Q3 research summary (https://ibn.fm/vBuoV).

The company’s artificial intelligence API is designed to streamline the transfer of information between healthcare industry businesses. Trxade’s model thereby helps smaller, independent pharmacies in particular to competitively serve patients in spite of the proliferation of large pharmaceutical chains.

But Trxade is also rolling out a first-of-its-kind bundled service that combines telehealth performance, a COVID-19 risk assessment tool and a personal protective equipment (PPE) purchasing tool. The bundled service will help businesses better deal with the medical needs of their internal corporate structures during the changing conditions as well as once the pandemic conditions have ended.

Trxade has been working to build its capital since uplisting to the Nasdaq exchange earlier this year (https://ibn.fm/C4wWa) and more recently gaining inclusion on this year’s Russell’s Microcap Index (https://ibn.fm/2120T). The company has also brought international investor relations specialists MZ Group on board to expand the company’s strategic investor relations program across all key markets.

The growing brand in the medical technology space has attracted nearly 11,700 independent pharmacies to its network — more than 50 percent penetration among the United States’ estimated 22,000 independent pharmacies.

“Our platform lets these independents know that they’re receiving a fair price from competing suppliers on fair payment terms and often with next day delivery,” Founder, Chairman and CEO Suren Ajjarapu said during the earnings conference call. “We believe this radical price transparency, economy of scale and competition amongst suppliers leads (to) up to 10% reduction in pharmacies’ total annual drug purchase costs, with a drug-level savings of up to 90% on certain pharmaceutical products.”

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

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

• SGMD has filed updated Form 8K Current Report with SEC
• Filing includes information about issues related to company’s status, including planned expansion of BudCars cannabis-delivery service
• Sugarmade sees “major business opportunities out of both sites once operations begin”

Sugarmade (OTCQB: SGMD), a product and branding marketing company investing in operations and technologies with disruptive potential, has released the publication of a Form 8K Current Report filing with the United States Securities and Exchange Commission (“SEC”) (https://ibn.fm/Ngrsg). The filing includes specific information about several issues related to the company’s performance and outlook, including planned expansion of the BudCars cannabis delivery service.

According to the filing (https://ibn.fm/wzDZ4), the highly successful Sacramento, California-based BudCars, which has reported record sales for the past several months (https://ibn.fm/YWib6), has plans to open two hubs in Los Angeles in the coming months.

“One of the Los Angeles sites is behind schedule, and the other is well ahead of schedule,” the filing reported. “We still expect both to become operational as soon as final issues are resolved.” Sugarmade, which has a 40% interest in BudCars with an option to purchase a controlling interest, noted that last-minute regulatory issues were causing some delays in opening of the first location.

“The first of these expansions was expected to go online during July, and significant progress toward opening has taken place,” the filing noted. “Unfortunately . . . we are still working to get the security plan approved by local authorities, and we have a few minor issues relative to facilities build-out concerning the Americans with Disabilities Act (‘ADA’). As soon as these final issues are cleared, we plan to begin operations.”

“On the positive side, we are ahead of schedule at the other Los Angeles site,” the report continued. “We are happy to report the turn-up of this second site could occur sooner than was expected. Of course, we see major business opportunities out of both sites once operations begin. We will be sure to keep everyone updated. We are working hard daily on both sites.”

The filing noted that the cannabis delivery trend is growing substantially. “This is resulting in increases in the number of new customers and in the average sale size on a per-delivery customer basis,” the filing concluded. “We see cannabis delivery continuing to accelerate. Certainly, the Los Angeles market is especially robust relative to delivery services.”

BudCars is a retail business that offers same-day delivery of top-quality cannabis. Customers choose from a variety of products, including edibles, flower, pre-rolls, vapes, tinctures and concentrate across dozens of premium brands. Once consumers complete their purchases online, they receive their order the same day via BudCars Cannabis Delivery Service.

Sugarmade Inc. is a product and branding marketing company investing in operations and technologies with disruptive potential. In addition to its financial interest in the BudCars brand, SGMD’s brand portfolio includes CarryOutsupplies.com and SugarRush(TM).

or more information, visit the company’s website at www.Sugarmade.com.

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

• Rritual’s suite of premium functional mushroom and adaptogenic elixirs is designed to offer various health benefits, such as increased immunity, cognitive function, stress management and more
• The company’s products are expected to be available online through Rritual’s site and Amazon by fall 2020
• The Rritual team has extensive ties and influential relationships with leading retail businesses, providing a wide market for growth
• The functional mushroom industry has no clear and dominant leader, allowing Rritual to target this role with its premium products. Rritual is currently the only premium brand on the market
• The global functional mushroom market is expected to exceed $50 billion by 2025, putting Rritual in the position for success
• Functional mushroom demand is expected to rise from $23 billion to $34 billion by 2024

Rritual Mushrooms is a private company founded in 2019, whose declared purpose is to help people meet the demands of modern life with style and ease by incorporating functional mushrooms, adaptogens and superfoods into their diets.

The company manufactures premium plant-based products such as small-batch elixir powders, and each product features mindfully selected medicinal mushrooms and adaptogenic herbs. Pursuing customers with various need-states, Rritual offers products that fit every lifestyle.

Suite of Premium Rritual(TM) Products

Rritual recently announced the launch of its suite of premium functional mushroom and adaptogenic elixirs. These elixirs were developed by a leading team of scientists, doctors and experts across the wellness industry, under the guidance of Rritual President Dr. Mike Hart.

The initial product line includes:

• Chaga (immune booster) – Full of bioactive polysaccharides, Rritual’s Chaga blend combines the Chaga mushroom with Eleuthero root for optimal immune system benefits.
• Lion’s Mane (brain booster) – Designed to support cognitive function and brain health, Lion’s Mane is paired with Rhodiola root. The elixir can also help the body manage stress.
• Reishi (stress support) – Rich in polysaccharides, triterpenes, amino acids and fatty acids, the Reishi blend is infused with Ashwagandha root. This combination aims to help the body and mind fight anxiety, with long term effects that may improve quality of sleep for those with restless minds.

“The health and wellness benefits of mushrooms and plant-based therapies are backed by decades of scientific research. Rritual’s new line of elixirs embraces that research and provides consumers with an easy way to get a daily dose of the powerful effects,” Hart said in a news release.

Rritual CEO David Kerbel noted that the company is proud to bring together age-old mushroom consumption practices and data-backed research to create new formulas that meet the needs of modern consumers. “Whether to relieve stress, increase mental output or boost immunity, we want to be a trusted and effective component of a consumer’s daily health and wellness routine,” he added.

Rritual Timeline

According to its investor presentation, Rritual has already fulfilled most of the milestones it set for Q1 and Q2 2020 as part of its growth and development timeline. So far, the company has completed formulation R&D, product line development, test marketing, brand development, logistics partnerships and agreements, initial distributor partnerships, seed financing and the phase one launch of its product suite.

Rritual E-Commerce Rollout Strategy

The company’s strategy for e-commerce rollout success consists of direct-to-consumer (D2C) sales through the use of multiple online platforms and through team connections to facilitate rapid expansion within the market.

In the first stage, Rritual will use its own website and Amazon to facilitate its D2C initiative, followed by leveraging its team connections to sell products through planned specialty e-commerce channels such as Costco, CVS, Walmart, and Vitacost using preexisting relationships.

Brick-and-Mortar Rollout Strategy

Using partnerships already in place with The Jet Collective and leveraging the preexisting connections of its team for direct discussions with global retail brands, Rritual’s brick-and-mortar strategy features a two-stage rollout that targets 15 leading retailers.

In the first stage, Rritual aims to launch with four non-competing chains, while utilizing best practice agreements (320 Sprouts stores, 330 H-E-B stores, 240 Meijer stores and 1,600 Publix stores). In stage 2, distribution is expected to advance to additional retail establishments (100 Wegmans stores, 77 Fresh Thyme stores, 440 Whole Foods stores, 120 Shaw’s stores, 400 Stop & Shop stores, 300 Wakefern/Shoprite stores, 610 Vitamin Shoppe stores, 90 Bartell Drug stores, 40 Giant Eagle market district stores and 1,800 Target stores), while collaboration with Kroger will take place within two sub-markets (300 Ralphs stores and 120 Harris Teeter stores).

Market Growth Outlook

As it is yet in its early stages, the functional mushrooms market is rife with opportunities for growth. At this time, no dominant brand is in place, and there remains an absence of a premium brand to lead the category.

The entire functional food market is currently valued at more than $275 billion, with global shifts supporting wellness and a 7.9% CAGR forecast through 2025. Demand for functional mushrooms is also growing, with a forecast rise from $23 billion to $34 billion by 2024 as a result of growing popularity due to the superfood’s unique properties that have been shown to boost immunity, cognitive function and more. The worldwide functional mushroom market is projected to exceed $50 billion by 2025, with recent data indicating an increase in demand for key mushroom varieties of up to 800%.

Management Team

David Kerbel, CPC, is CEO of Rritual and has over 30 years of senior experience in retail, brokerage and CPG industries. From 2008 to 2011, Kerbel served as Senior Vice President of Sales for Celsius Holdings Inc., helping that company achieve a number of important milestones. During his tenure, Celsius grew its retail sales from $400,000 to a multimillion-dollar figure, developed nationwide representation with CROSSMARK Inc. and established distribution with industry giants such as 7-Eleven, Ralph’s, C&S, Costco, BJ’s Wholesale, CVS, Walgreens, Walmart, Rite Aid, Target, Duane Reade and Stop & Shop. In total, Celsius’ new distribution stemming from Kerbel’s direct efforts led to $36 million in incremental sales in 2010 alone. He also implemented new procedures that led to a 10 percent reduction in operating expenses. Kerbel brings tremendous experience to the Rritual team, as well as vital relationships with industry leaders such as Walmart, Costco, Kroger, Walgreens, CVS, 7-Eleven, Safeway, Publix, Sprouts and more.

Warren Spence is the COO and a Director of Rritual. He has over 25 years in the food and beverage industry. His roles within the industry have included senior positions with brands like Red Bull and Olivieri. His specialization is in supply chain and operations systems. He was appointed Head of Supply Chain for Nude Beverages in 2019.

Dr. Mike Hart, MD, is the President of Rritual. His work has been published in peer-review journals about therapies involving cannabis and ketamine. His outspoken stance on these subjects landed him an appearance on the Joe Rogan Experience Podcast in 2019. On-air, he discussed the use of psychedelic medicines as a treatment for mental health conditions, including PTSD.

Stacie Gillespie is CCO and Director of Formulations for Rritual. She has over 25 years of leadership in the branding and product strategies used by wellness companies. She has leveraged this expertise for companies such as Aura Cacia, MegaFood and Gaia Herbs. She is the creator of multiple award-winning consumer health products.

Sarton Molnar-Fenton is Vice President of Sales-USA for Rritual. She started her career with Vitamin Water, with other large companies under her belt, including Danone, as a District Manager. She worked with Nestle on its Tribe Hummus brand and played an integral part in relaunching the brand, gaining category share and establishing product development partnerships with companies like Trader Joe’s. She also played a key role in launching the Hydralyte brand in the United States.

Scott Naccarrato is the company’s Vice President of Sales-Canada. He is experienced in sales with a deep connection in retail. Recently, he worked with Nutiva, assisting in the pioneering of Organic MCT oil, healthy fats and the plant-based protein categories. He is data-oriented in his approach, which has resulted in over $100 million in sales and double-digit year-over-year growth for the brands of which he has been a part.

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

• Research shows psilocybin produces immediate, substantial and sustained improvements in anxiety and depression
• Global medicinal mushroom market projected to increase by almost $14 billion annually for the next several years
• Pure Extracts is a plant-based extraction company with new vertical in the mushroom space

Recent groundbreaking research indicates that psilocybin-assisted psychotherapy may be effective in treating depression, a debilitating disorder that plagues an estimated 300 million people in the United State. Psilocybin is the main psychoactive ingredient in “magic” mushrooms. With growing interest in the mushroom sector — both psychedelic and functional — companies such as Pure Extract Technologies could see exciting growth and expansion in the future.

A recent National Centre for Mental Health (“NCMH”) article reported that “a small number of studies have been conducted trialing psilocybin on patients with treatment-resistant depression. A person may be defined as having treatment-resistant depression if their symptoms of major-depressive disorder do not subside with attempted treatment from two different classes of antidepressants.”

Results of the tests showed that, after only one week — as well as after three months — depression scores significantly decreased, with the majority of participants experiencing reduced depression severity after three months. That initial test sparked intense interest, and “further research has been conducted with similar findings of efficacy,” the article noted.

“In [a] Johns Hopkins psilocybin research project, they found that 80% of healthy volunteers that returned a month after having one or two doses of psilocybin reported that the experience of taking the drug was in their top five meaningful experiences they’d ever had,” the article continued. “Around 90% reported increased positive mood and greater life satisfaction.” The report goes on to note that additional psilocybin studies have shown that for those with anxiety and patients with life-threatening cancer, the drug produced immediate, substantial and sustained improvements in anxiety and depression.

Pure Extract Technologies recognizes that psychedelic and functional mushroom industries are among the fastest-growing in North America, with the global medicinal mushroom market projected to increase by almost $14 billion annually for the next several years. As the industry transitions to meet these burgeoning needs, few companies appear to be prepared for the new opportunity.

Pure Extracts, however, is a private, plant-based extraction company with a new vertical in the mushroom space. The savvy company is ideally positioned to become a dominant extraction company in the space and a leader in the rapid development and commercialization of functional and medicinal products.

Pure Extracts is focusing on a strategic business model consisting of three verticals: in-house brands; toll processing, offering contract cannabis and hemp processing to Canadian Licensed Producers and international partners to distribute under their own brands; and white labelling, or supplying products in consumer-ready packaging for companies licensed to sell cannabis oil extracts and for CPG brands seeking licensed cannabis manufacturing partners.

Pure Extracts is positioned to enter the commercial cannabis sector, as well as a new vertical in functional mushrooms, as an experienced producer. Led by a team of qualified experts and providing cutting-edge CO2 extraction technology, the company is set up for long-term strategic distribution and product innovation.

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

• VistaGen’s product portfolio consists of three novel drug candidates that, together, target multiple anxiety disorders, depression disorders and neurological disorders
• Two of the company’s drug candidates have received an FDA fast track designation, including for the treatment of social anxiety disorder, major depressive disorder and neuropathic pain.
• The global CNS therapeutics market is estimated to reach $130 billion by 2025
• The two most common mental health conditions – anxiety and depression – cost the global economy an estimated $1 trillion each year
• VistaGen is committed to developing and commercializing multiple new generation medications that go beyond the standard of care in large markets for treatment of anxiety, depression and other central nervous system (“CNS”) disorders, potentially addressing the unmet needs of millions worldwide
• The company’s efforts are advanced by a skilled management team with decades of experience in biotechnology, pharmaceuticals, CNS drug development and more

VistaGen Therapeutics (NASDAQ: VTGN) is a biopharmaceutical company committed to developing and commercializing a new generation of medications that go beyond the standard of care for anxiety, depression and other central nervous system (“CNS”) disorders.

The company is headquartered in South San Francisco, California, the “Birthplace of Biotechnology,” among the largest cluster of biotechnology companies in the world.

New Generation Medications

VistaGen currently has three innovative CNS drug candidates in its pipeline: PH94B, PH10 and AV-101. With a differentiated mechanism of action and an exceptional safety profile in all clinical studies to date, each of VistaGen’s three drug candidates offers significant commercialization potential in multiple large CNS markets.

PH94B

Fast-acting (10-15 minutes), non-systemic and non-sedating in Phase 2 clinical studies, PH94B is a first-in-class neuroactive nasal spray that, administered in microgram doses, binds to chemosensory receptors in the nasal passage that trigger neural circuits responsible for suppressing fear and anxiety caused by stressful social or performance situations.

PH94B is currently being developed as an acute treatment of anxiety in adults with Social Anxiety Disorder (“SAD”). In December 2019, PH94B became the first drug candidate to be granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for development of a treatment for SAD, positioning it to potentially become the first FDA-approved fast-acting acute treatment for adults with the anxiety disorder, if planned Phase 3 studies are successful.

A successful Phase 2 program has been completed, and, after achieving consensus with the FDA in mid-2020 that the design of its Phase 3 studies of PH94B in SAD may mirror the design of the highly statistically significant (p=0.002) Phase 2 public speaking study of PH94B in SAD, the company’s preparations for pivotal Phase 3 clinical development of PH94B are underway.

To support Phase 3 development and commercialization of PH94B for anxiety disorders in large anxiety disorder markets in Asia, VistaGen recently entered into a strategic licensing and collaboration agreement with EverInsight Therapeutics, a company formed and currently funded by a large global venture capital firm, CBC Group. The company received a $5 million non-dilutive upfront license payment from EverInsight in August 2020. If Phase 3 development is successful, VistaGen is eligible to receive additional development and commercial milestone payments of up to $172 million, plus tiered royalties on sales of PH94B in Greater China, South Korea and Southeast Asia. VistaGen retains exclusive rights to develop and commercialize PH94B in all other markets.

VistaGen is also assessing potential Phase 2A clinical development opportunities to evaluate PH94B in a range of other anxiety disorders, including:

• Adjustment Disorder with Anxiety
• Generalized Anxiety Disorder
• Postpartum Anxiety
• Perioperative Anxiety
• Panic Disorder
• PTSD

PH10

PH10 is an investigational fast-acting synthetic neuroactive nasal spray with therapeutic potential in a wide range of neuropsychiatric indications involving depression and suicidal ideation. VistaGen is initially developing PH10 as a potential fast-acting, non-sedating, non-addictive new generation treatment of major depressive disorder (“MDD”).

Upon self-administration, a microgram-level dose of PH10 sprayed into the nose binds to nasal chemosensory receptors that, in turn, activate neural circuits in the brain that lead to rapid-onset antidepressant effects, without side effects, systemic exposure or safety concerns that may be caused by FDA-approved drug treatments for MDD, including oral antidepressants and intranasal esketamine.

In a published exploratory Phase 2A MDD study, PH10 demonstrated rapid-onset and sustained antidepressant effects without the serious psychological side effects and safety concerns of ketamine-based therapy.

Following successfully completed Phase 2A development of PH10 for MDD, the company is currently preparing for a Phase 2B program in MDD.

VistaGen is also assessing the potential for Phase 2A clinical development of PH10 in a range of other depression-related indications, including:

• Postpartum Depression
• Treatment-resistant Depression
• Suicidal Ideation

AV-101

Part of a class of new generation investigational medicine in neurology and neuropsychiatry known as N-methyl-D-aspartate receptor (“NMDAR”) modulators, AV-101 is an oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA), a potent and selective NMDAR glycine site antagonist. This drug candidate has the potential to serve as an innovative treatment for MDD and multiple neurological indications where current therapies are unsatisfactory.

VistaGen is currently evaluating AV-101, in combination with FDA-approved probenecid, in a range of neuropsychiatric and neurological indications, with both MDD and Neuropathic Pain already granted Fast Track designation by the FDA. The company is assessing the combination for a potential Phase 1B study to support a potential Phase 2A program in one or more of the following indications:

• Major Depressive Disorder
• Neuropathic Pain
• Levodopa-induced dyskinesia associated with Parkinson’s disease therapy
• Epilepsy
• Suicidal Ideation

CNS Therapeutics Market Outlook

The global CNS therapeutics market is estimated to reach $130 billion by 2025. The market was valued at approximately $82.3 billion in 2017 and is anticipated to grow at a healthy CAGR of more than 5.93% from 2018 to 2025. Even before the onset of the anxiety- and depression-provoking stressors from the COVID-19 pandemic, this growth was expected to be driven by a rise in mental illnesses and increased awareness of psychiatric disorders (https://ibn.fm/TonuU) – all likely to be amplified by the diverse impacts of the pandemic.

The two most common mental health conditions – anxiety and depression – cost the global economy an estimated $1 trillion each year. The impact of these conditions is particularly devastating among the young. Industry data suggest that approximately 20% of the world’s children and teens are affected by mental health conditions, and suicide is the leading cause of death among 15- to 29-year-olds (https://ibn.fm/4yY4d).

VistaGen’s mission is to help address the unmet needs of patients suffering from CNS disorders whose current treatments are either inadequate or generate debilitating side effects and serious safety concerns, including risk of abuse and death.

“Now more than ever, the new generation anti-anxiety and antidepressant medications we are developing at VistaGen – PH94B, PH10 and AV-101 – are relevant, necessary and demand the highly-focused and passionate efforts of our team and partners, with the support of our stockholders, to advance them to patients whose lives are disrupted by anxiety and depression disorders,” VistaGen CEO and Director Shawn K. Singh said in his closing remarks at the company’s 2020 Annual Meeting of stockholders.

Management Team

Shawn K. Singh, J.D. is the Chief Executive Officer and a Director of VistaGen. He has served on the company’s board of directors since 2000. He has nearly 30 years of experience serving in numerous senior management roles across multiple industries, including private and public biotechnology, pharmaceuticals, medical devices, venture capital, contract research and development, and law. Singh has a B.A. with honors from the University of California – Berkley. He has a J.D. degree from the University of Maryland Carey School of Law. He is also a member of the State Bar of California.

1. Ralph Snodgrass, Ph.D., is the Founder, Chief Scientific Officer and Director of the company. Snodgrass has more than 20 years of experience in the biotechnology field as a senior manager. He is recognized as an expert in stem cell biology, with over 28 years of experience using stem cells as biological research tools to promote development and drug discovery. He received a Ph.D. in immunology from the University of Pennsylvania. Snodgrass has published over 50 scientific papers with more than 17 patents and a number of patent applications.

Mark A. Smith, M.D., Ph.D., is VistaGen’s Chief Medical Officer He has over 20 years of pharmaceutical industry experience, primarily with CNS drug development. Smith has been a successful leader in the discovery and development of approximately 20 investigational new drugs. He has been a part of numerous CNS-related clinical trials. Smith received a bachelor’s and Master of Science from Yale University and a Doctor of Medicine and Doctor of Philosophy in Physiology and Pharmacology from the University of California – San Diego. He completed his residency in the psychiatry department at Duke University Medical Center.

Jerrold D. Dotson, CPA, is the Vice President, Chief Financial Officer and Secretary of VistaGen. He has over 25 years of experience in senior management positions in finance and administration at both public and private companies. Dotson is a licensed CPA in California and received his B.S. degree (Cum Laude) in business administration with a concentration in accounting from Abilene Christian College.

Mark A. McPartland is the company’s Vice President of Corporate Development and Investor Relations. He has over 20 years of experience in senior management roles in corporate development and investor relations at both public and private companies. McPartland received his Bachelor’s in business administration and marketing from Coastal Carolina University.

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

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