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An Update on Axsome Therapeutics, Inc. (NASDAQ: AXSM)

Once New York-based Axsome Therapeutics, Inc. (NASDAQ: AXSM) was founded in 2012, its team set out to establish a fully-integrated biopharmaceutical business that would develop therapies to treat and manage central nervous system (CNS) disorders. Now in 2017, the Axsome team is setting off on another exciting leg on this journey.

For years, Axsome has been laser-focused on improving the lives of patients living with pain and various CNS disorders. With an eye toward differentiated therapies, the company has concentrated on developing and commercializing both in-licensed drug candidates and internally-derived drug candidates in order to accomplish its goal of increasing the treatment options accessible to caregivers.

Along the way, industry analysts have pointed out the value in Axsome’s focus on complex regional pain syndrome, treatment resistant depression and agitation in patients with Alzheimer’s disease (AD); the lower-than-average research and development risks, as well as the tested business models that surround these disorders, hint at a faster commercialization schedule.

During the first week of 2017, a new report from AEGIS Capital Corp. (http://dtn.fm/w6MIe) also alluded to Axsome’s accelerated timeline and other investment highlights, including recent developments affecting one of the company’s two late-stage drug candidates: AXS-05, a fixed-dose combination of dextromethorphan and bupropion that is being developed for multiple indications, including treatment resistant depression and agitation in patients with AD.

According to the AEGIS report, on January 4, 2017, Axsome announced that the United States’ Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for a phase II/III clinical trial of AXS-05 in AD. This is a significant development for the company, as this IND program is the means by which a pharmaceutical company operating within the United States obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. With the FDA’s approval in tow, the placebo-controlled, randomized, double-blind, multicenter trial is now set to register the necessary 330 patients and to commence sometime in the first half of 2017.

To learn more, visit www.Axsome.com

National Waste Management Holdings, Inc. (NWMH) Turns Trash into Treasure, Records Strong Revenue Growth

National Waste Management Holdings, Inc. (OTC: NWMH) has turned the old aphorism ‘garbage in – garbage out’ on its head. It’s now ‘garbage in, revenues up’. In its last 10-Q filing, for the third quarter ended September 30, 2016, the company reported quarterly revenues of $1.8 million, which represented a 269 percent increase over 2015 same period revenues. This stellar performance in the third quarter boosted revenues in the nine-month period ended September 30, 2016, to $4.9 million, up by 262 percent over same period revenues for 2015. Not all garbage, it seems, is waste.

National Waste operates a licensed 54-acre landfill in Hernando, Florida, that disposes of roughly 240,000 cubic yards of construction debris annually. These landfill services include the disposal of asphalt and rock; lumber and wood; brick; wallboard, drywall and plaster; pallets; rock concrete; dirt, sand and uncontaminated soil; plumbing fixtures; non-asbestos insulation; roofing materials and shingles; glass; piping; waste metal; brush and land clearing; yard and tree waste; and many electrical and wiring components.

However, as extensive as those facilities are, they do not encompass the whole range of landfill services. There’s a lot more to garbage disposal than meets the eye.

Solid waste, defined as household garbage and industrial non-hazardous waste, is disposed of in a variety of landfills. Municipal solid waste landfills (MSWLF) are designed to accommodate the disposal of household waste but may accept other types of non-hazardous wastes, such as commercial solid waste, non-hazardous sludge, and industrial non-hazardous solid waste. A special kind of MSWLF is the bioreactor landfill, designed to degrade waste in a controlled manner.

Even though some commercial solid waste and industrial non-hazardous solid waste ends up in MSWLFs, there are special facilities, known as industrial waste landfills, designed to take commercial and institutional waste. In this category are construction and demolition (C&D) debris landfills, designed exclusively for construction and demolition materials, which consist of the debris generated during the construction, renovation and demolition of buildings, roads and bridges. C&D materials are typically bulky, heavy materials, such as concrete, wood, metals, glass and salvaged building components.

Another type of industrial waste landfill is the coal combustion residual (CCR) landfill, which is meant to accommodate coal ash and other residuals from coal combustion.

With such a heterogeneous landscape, there is ample opportunity for National Waste to continue the implementation of its vertical integration strategy. Apart from its landfill services, the company rents out roll-off containers of 20, 30 and 40 cubic yard capacity. It also offers recycled wood mulch and garden mulch products. The route is clear for National Waste to realize its long-term goal of servicing the entire East Coast, from Florida to New York.

National Waste is a vertically-integrated waste management company offering landfill, transfer station, garbage collection and container services for both commercial entities and residential customers in Central Florida and Upstate New York. The company presently services the counties of Citrus, Hernando, and Marion in Florida and Upstate New York with 13 roll-off trucks and approximately 800 containers.

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

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Lomiko Metals, Inc. (LMRMD, LMRMF) Offers One of the Brightest Potentials in Mining and Materials

Lomiko Metals (OTCQB: LMRMD) (OTC: LMRMF) has positioned itself on top of an extremely positive supply-demand curve, with a unique opportunity for low-cost production of a key mineral that underpins much of the growing green economy.

Lomiko’s core focus is on the exploration and development of minerals such as lithium and graphite, the latter of which is used for energy storage in products such as lithium-ion batteries, especially those used for electric vehicles (EV), and for which there is no cheaper alternative.

The demand for EVs is expected to see rapid growth for at least the next 20 years, and the demand for flake graphite is forecast to exceed the supply by 2018. For perspective, if Tesla’s (NASDAQ: TSLA) Gigafactory meets its proposed rate of 500,000 cars per year by 2020, this facility alone would require the entire supply of lithium-ion batteries available today. Tesla plans on meeting its own supply, however, and upon full capacity – expected by 2018 – the Gigafactory is expected to produce more batteries each year than the total produced worldwide in 2013.

Lomiko’s exceptional position in all this is the fact that it has acquired a superior graphite mining property in Quebec, the La Loutre Flake Graphite Property. The property’s verified quality-grade mineralization is close to the surface, which reduces costs, and it is also close to the port of Montreal for easy shipment.

As of now, China controls about 70% of the world’s graphite, only a portion of which is the desirable flake graphite. High-purity crystal flake graphite supply is especially limited and the center of demand, since it is the form of graphite needed for lithium-ion batteries and other green technologies. As demand for graphite threatens to overtake supply, companies like Lomiko with productive flake graphite properties will be in an especially commanding position.

Another reason graphite demand continues to rise is that when the mineral is processed into graphene it becomes an almost science fiction-like material, with properties that offer untold possibilities.

Graphene is the world’s first two-dimensional material, meaning that it is made from sheets of connected carbon atoms just one atom thick, but of unlimited width and breadth. It is a thousand times as conductive as copper, even at room temperature; extremely light and flexible, yet 200 times stronger than steel; and, though it is a new material, thousands of patents have already been filed relating to it, including 3D printing, where Lomiko holds an equity position with a 3D printing lab.

Graphene’s huge potential for application, in green technologies and other areas, is the reason Lomiko plans to create joint ventures through its subsidiary, Lomiko Technologies, an investor in graphene technology and manufacturer of electronic products. The company has already developed a partnership with Graphene Laboratories Inc., a Graphene 3D Lab, Inc. (OTCQB: GPHBF) company, for the development of a process whereby graphite can be efficiently converted into graphene.

Fully supporting the push for a new green economy, and driven by a highly-qualified management team with foresight into industry demand, Canada-based Lomiko is well-positioned as an active, competitive player in the broader mining and minerals sector.

For more information, visit www.Lomiko.com

Medical Transcription Billing, Corp. (NASDAQ: MTBC) Award Recognizes Best Use of Proprietary Technologies

A growing number of health care professionals and medical practices are resorting to electronic management technologies, ranging from electronic health records to revenue cycle management, practice management and scheduling software and more. As a leading provider of integrated health care technologies, New Jersey-based Medical Transcription Billing, Corp. (NASDAQ: MTBC; MTBCP) is leveraging its proprietary technology to serve a wide range of health care customers across 40+ states, currently offering one of the most comprehensive suites of practice management, electronic health records and revenue cycle solutions on the market.

Already serving hundreds of customers, the company traditionally recognizes the efforts of client practices that make the best use of the MTBC platform, on both a monthly and annual basis. Earlier this month, MTBC announced that the ‘Office Manager of The Year’ award for 2016 was going to a Maryland-based family practice that has been using the company’s integrated billing services, practice management and electronic health records software for three years. The winner, Baqar Naqvi from Progressive Medical Care, LLC, has consistently secured an ‘Excellent’ rating for his practice’s use of MTBC technologies, according to a company press release (http://nnw.fm/VS1lR).

Under Naqvi’s management and with the help of MTBC’s software, Progressive Medical Care reported a 100 percent increase in its collections. Other best practices he implemented include the exclusive electronic generation of claims, making sure that all providers were using MTBC patient engagement software and ensuring that all tests were ordered via the integrated LAB interface.

As recipient of the ‘Office Manager of the Year’ award, Naqvi will receive a cash bonus of $1,000 and other incentives. MTBC Division President Loraine Goetsch also congratulated the winner and underlined that, due to dedicated practice managers such as Naqvi, Medical Transcription Billing has been able to successfully and continually develop and evolve its platforms with new and innovative features.

Every month, Medical Transcription Billing recognizes the efforts of practice managers who make sure that their offices make the best and most efficient use of WebEHR and practice management tools provided by MTBC. At the end of the year, the company uses the same criteria to pick the Office Manager of the Year based on each practice’s score and how effectively it used its integrated technologies. MTBC has so far recognized the dedication of more than 150 office managers.

Founded in 1999, MTBC provides a fully-integrated suite of web-based health care information technology solutions and related business services. Its integrated technologies have four core components: Electronic Health Records – allowing physicians to create and review patient charts online; Practice Management – automating labor-intensive medical offices’ workflow in a streamlined platform; Revenue Cycle Management – improving the medical reimbursement process and increasing collections; and mHealth – extending the core components of the platform to the mobile environment.

Built around the company’s proprietary ChartsPro™ software, the EHR system is easy to use and intuitive, being designed to improve the productivity of any practice by automating all of its clinical activities. The system includes 13 specialty-specific modules, including Internal Medicine, Family Medicine, Podiatry, OB/GYN, Pediatrics, Psychiatry and Rheumatology.

Other top features of the MTBC software include Patient Charts, allowing for the storage of extensive patient information such as vitals, social history and care plan; a Clinical Decision Support System, which helps provide preventative care with evidence-based alerts; and a Personal Tab module, which enables detailed documentation of patient demographics.

For more information, visit www.mtbc.com, and see the company’s fact sheet at http://ir.mtbc.com/events.cfm

DelMar Pharmaceuticals (NASDAQ: DMPI) Given a ‘Buy’ Rating and $16 Price Target by Aegis Capital

Biotechnology company DelMar Pharmaceuticals (NASDAQ: DMPI) has been given a ‘Buy’ rating by Aegis Capital Corp. and a $16 price target (http://dtn.fm/jZlI7). The company was trading at $3.29 on January 11, 2016. To reach that price target, Aegis, in its initiation of coverage, said that it applied a 15x multiple after estimating the company’s 2022 EPS at $3.93, then discounting it by 30%.

DelMar Pharmaceuticals has been developing its lead product candidate, VAL-083, as a chemotherapy for cancer. Specifically, VAL-083 would be used in the treatment of glioblastoma multiforme (GBM), the most common form of a fatal and aggressive brain cancer. VAL-083 is a very different drug from other cancer medications. It avoids the repair activities that enable tumor cells to impede the impact of chemotherapy.

As a result, DelMar has an upcoming phase III trial in refractory GBM and two additional phase II studies anticipated to begin this year. VAL-083 will also be tested in the treatment of solid tumors and lung cancer, with phase I and II trials anticipated in 2017, the report stated. The report was signed by Robert LeBoyer, research analyst at Aegis, who added that Aegis expects DelMar Pharmaceuticals “to be driven” by these trials.

In its report, Aegis said that the phase III study is expected in late 1Q17 and should take place at major medicine centers, aiding enrollment. Further, it said that the Food & Drug Administration (FDA) believes that only one phase III study will be required for VAL-083, following its assessment of the results of completed phase I and II studies.

In 2016, DelMar completed its phase I/II trials of VAL-083, the report stated, and then met with the FDA. The FDA agreed that only one phase III trial would be necessary, because the company would then use a 505(b)(2) regulatory pathway. Aegis notes that this was a ‘significant development’, which may mean phase III results as early as 2019 ahead of approval in 2020.

On January 9, 2017, DelMar Pharmaceuticals received an increase in funding of up to CDN$413,000 from the National Research Council of Canada Industrial Research Assistance Program (NCR-IRAP) to support ongoing research of VAL-083 (http://dtn.fm/iWzk2). In conjunction with the BC Cancer Agency, Vancouver Prostate Centre and the University of British Columbia, research will continue, DelMar Pharmaceuticals announced.

“We are very pleased with NCR-IRAP’s continued support of our non-clinical research of our lead product candidate VAL-083,” Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals, noted in the news release.

In its most recent 10-Q filing, DelMar Pharmaceuticals reported cash and cash equivalents of $4,799,033 (http://dtn.fm/5qecY). For the quarter ended June 30, 2016, the company reported to the SEC that it had raised $7.2 million from the sale of convertible preferred stock.

For more information, visit www.DelMarPharma.com

MassRoots, Inc. (MSRT) Achieves Incredible Growth in 2016

MassRoots, Inc. (OTCQB: MSRT), a company offering cannabis enthusiasts the chance to share their cannabis content while staying connected with news and the latest legislation regarding the drug through a specialized social media platform and iOS application, has shown significant growth in the rapidly developing cannabis industry.

According to a SeeThruEquity update (http://dtn.fm/Y0Har), MassRoots achieved phenomenal growth in 2016, with revenue reaching $794,621 during the first three quarters of 2016, compared to just $63,982 during the same period of the previous year. This performance was attributed to the company’s ability to monetize its users, which increased by 1,140% as compared to the first three quarters of 2015.

The company now has a fan base of over 900,000 users and plans to introduce a range of new features to its platform, fully indexing the network’s public content on Google for search engine optimization purposes. Earlier this week, MassRoots launched an update to its iOS mobile application (http://dtn.fm/W8YeE), which is currently available through the App store. New features include geo-targeted advertisements, in-depth strain and product pages, and revamped reporting and content screening mechanisms.

In addition, MassRoots kicked off 2017 by achieving its strongest cash position in corporate history following the reception of $2 million in proceeds from the exercise of warrants (http://dtn.fm/bUC0G). According to CEO Isaac Dietrich, this capital infusion will allow MassRoots to continue building momentum in the industry. Dietrich has set an intermediate goal of reaching revenue levels similar to industry leaders such as Weedmaps and Leafly, which generated more than $25 million and $15 million in 2016 sales, respectively.

MassRoots’ substantial 2016 growth seems to be widely supported by strong industry trends. With eight states having legalized the recreational use of marijuana, MassRoots is positioned for growth, anticipating an increase in users from a number of states. Currently, the company receives three-quarters of its revenue from California and Colorado, but new markets are expected to emerge.

MassRoots also recently acquired DDDigtal, known as Whaxy, a menu management and online ordering platform for licensed cannabis businesses. In a news release announcing the acquisition (http://dtn.fm/zLsj0), Isaac Dietrich commented, “This acquisition, when completed, will expand MassRoots’ offerings to include a full suite of dispensary software solutions – online ordering, marketing, and real-time inventory management — for cannabis businesses”.

For more information, visit www.MassRoots.com

Moxian, Inc. (NASDAQ: MOXC) Raises $10 Million in 2016 Despite Drought in Technology Offerings

Moxian, Inc. (NASDAQ: MOXC) continues to buck the trend. Despite the dearth of technology issues in 2016, the company completed a successful best-efforts public offering of 2,501,250 shares of its common stock at a price of $4.00 per share in November 2016, raising $10 million in new capital. Now, Moxian is poised to extend its unique online-to-offline (O2O) platform to a wider market.

Just as the NASDAQ uplisting raises the company’s investor visibility, this infusion of capital will be used to heighten awareness of Moxian and give it a larger footprint. With its new stash of cash, Moxian is set to continue the O2O commercial innovations it has set in motion.

The IPO Intelligence Report from Renaissance Capital (http://nnw.fm/YvX5A) gives some indication of the market skepticism that afflicted the IPO market when Moxian shares were uplisted. Even though the S&P attained record levels in 2016, the capital raised by new issues fell to the lowest level in 13 years. The lack of activity was particularly noticeable in the technology sector, described in the report as the ‘the bread and butter of the IPO market’.

In light of such obvious risk aversion, Moxian’s successful uplisting signals investor endorsement of its strategy. Unlike other O2O companies that seek to add consumers and then rely on that user base to attract merchants, Moxian signs up merchant clients who pay a fee, and it intends to build a Moxian marketplace by bringing together all of those merchant clients’ customers.

The O2O market is one of great potential, particularly in mainland China, where Moxian has its operations. Inc. magazine recently published its reasons on ‘Why O2O Commerce is a Trillion-Dollar Opportunity’ (http://nnw.fm/os89P). In 2014, Jack Ma’s Alibaba (NYSE: BABA) made a $692 million investment in Chinese department store operator Intime Retail Group. It followed that up in 2015 with two major O2O initiatives.

Together with its affiliate, Ant Financial, the internet giant invested $1 million in a joint venture called Koubei. Later that year, Alibaba formed an alliance with the giant brick-and-mortar Chinese electronics chain Suning Commerce Group. Alibaba now owns about 20 percent of Suning, for which it paid $4.63 billion. Suning, in turn, has put out $2.28 billion to acquire 1.1 percent of Alibaba.

Moxian plans to use most of the proceeds from the issue to expand its business in China and throughout Asia. This will include setting up regional and sales offices in first and second tier cities in China, as well as infrastructure investment for the build-out and expansion of offices in these cities. Some part of the funds will be reserved for general corporate purposes and to finance acquisitions of complementary businesses, assets and technologies.

The market opportunities for Moxian are very promising. In 2014, the China Internet Network Information Center reported that there were approximately 618 million internet users throughout Asian countries, representing a penetration rate of approximately 46 percent. Among these internet users, over 90 percent have a social media account. For comparison, just 67 percent of U.S. internet users engage in social media. However, the opportunity in China extends beyond the ability to reach a large target audience. The Data Center of China Internet reports that 38 percent of users claim they are more likely to buy items recommended by other social media users.

Industry analysts estimate that China’s O2O market reached 418 billion yuan (approximately US$67 billion) in 2016. Moxian believes its platform will be able to capture a substantial part of this market very soon.

For more information, visit www.Moxian.com

Net Element (NASDAQ: NETE) Targets Hospitality and Restaurant Industries with Technology

Net Element, Inc. (NASDAQ: NETE) is targeting two industries on the cusp of greater revolutionary technology investments: hospitality and restaurants. Net Element’s Unified Payments subsidiary recently entered into an agreement with ReservHotel (http://nnw.fm/bO01f), providing technology-driven payment acceptance services. To the restaurant industry, Net Element offers its Aptito cloud-based point-of-sale system (http://nnw.fm/3wmF1).

The hotel industry had a terrific year in 2016, according to STR (http://nnw.fm/kp3Rd). For the week ended December 31, 2016, year-over-year, the industry had nearly flat occupancy, but the payoff was that its average daily rate (ADR) rose 2.2% to $132.79, and its revenue per available room (RevPAR) rose 2.0% to $72.38. Hotels are setting a priority on investing even more in technology to improve profit performance further.

Similarly, the restaurant industry is focusing on technology to launch and then better integrate digital menus with point-of-sale systems. Restaurants are seeking ways to offer more technology to their patrons while also cutting expenses, ensuring more accuracy in billing and improved customer retention.

Net Element’s Aptito is cloud-focused and serves as a solution to the restaurant industry’s point-of-sale issues. It is timed for a fast-growing industry that requires technology to grow more quickly. According to the National Restaurant Association (NRA), the industry did $782.7 billion in sales last year (http://nnw.fm/2Q2yi), but most restaurants are small. The NRA reports that seven out of 10 are single unit operations, making technology even more vital.

In its report, titled ‘Mapping the Restaurant Technology Landscape’ (http://nnw.fm/oI3mK), the NRA finds that, while 81% of restaurants use a point-of-sale or electronic register system and 68% offer Wi-Fi for guests, only 37% of restaurants have online ordering and just 32% offer mobile payments. As a result, 32% say their operations are lagging technology-wise. Just 12% say they have leading-edge technology. Further, 37% of operators say that customer ordering is the most important part of technology development for them over the next five years.

Annika Stensson, director of research communications for the NRA, said four of five restaurant operators believe technology can help make restaurants more productive (http://nnw.fm/g27Ge). However, she added, new technology can also complicate the experience for restaurant customers. “This research highlights the importance that user-friendly, streamlined tech solutions play in creating an innovative restaurant environment and that closing this divide will be a priority for the industry going forward,” Stensson said.

Net Element, Inc., offers Aptito, which is a point-of-sale visual system offering restaurants mobile ordering and digital menus on an iPad app. Additionally, it has a cloud-based mobile app for customers. For restaurants, Net Element also offers an Android-based retail point-of-sale software. The Aptito point-of-sale system allows for seamless integration with the restaurants’ digital menu tablets.

Net Element believes that offering customers a digital menu rather than a paper one will drive more sales, result in fewer mistakes, and cut restaurants’ labor costs. The goal is to achieve more profit, a higher retention rate, customized digital menus, and electronic payment options. The software also allows diners to split checks, merge and move orders, and change tables.

In its latest 10-Q, filed on November 14, 2016, Net Element, reported revenues of $38,963,559 for the nine months ended September 30, 2016, compared to $25,122,250 during the same period of the prior year (http://nnw.fm/Jso65).

For more information, visit www.NetElement.com

ChineseInvestors.com, Inc. (CIIX) Offers Unique Path to Global Chinese Investor and Consumer Market

Founded in 1999, and with offices in the U.S. and China, ChineseInvestors.com, Inc. (OTCQB: CIIX) acts as a growing Chinese-language investment information and services conduit to the global Chinese investor community. Primarily through its websites, the company provides different levels of investment information, both free and via subscription, including information on the U.S. market and foreign currencies, covering sectors as well as companies, real-time market news and analysis, quotes, charts, and research tools. The company is led by chairman and CEO Warren Wang, COO Brett Roper, CFO Paul Dickman, and Director James Toreson.

The company’s stated mission is to ‘educate and empower individual investors to make their own financial decisions and to achieve their financial goals at any time or place’. Its focus is on what is called the ‘ChineseInvestors Method’, a combination of technical tools, a disciplined investing process, and personalized instruction. It’s an approach that the company’s leadership team hopes to establish as the most widely recognized and used system for educated investing.

In addition, the company offers consulting services to private companies seeking to become public companies, along with advertising and public relations support. Among other things, this provides a unique opportunity for growing companies to reach the large and diverse Chinese investment community, both in the U.S. and globally.

Recently, the company announced (http://dtn.fm/JhZ83) plans to launch the world’s first online cannabidiol (CBD) health products store in the Chinese language, using the domain name of www.ChineseCBDoil.com. Through an agreement with a ‘well-known’ CBD health brand, CIIX will be able to retail nutritional CBD supplements, through both physical and online channels, to the Asian market. China alone has nearly 10 million epilepsy patients, with CBD oil seen as a desired treatment option.

For more information, visit the company’s website at http://www.chinesefn.com/english/indexen.asp

CytoDyn (CYDY) Seeks Breakthrough Therapy Designation for Innovative HIV Therapy PRO 140

A growing number of human immunodeficiency virus (HIV) patients are in need of new treatment as they start facing issues of drug resistance and their regular therapies are becoming less effective. Unfortunately, new treatment options are scarce to virtually non-existent, as the standard of care for HIV patients remains a combination of different classes of antiretroviral medications at different stages of the infection. Driven by the strong belief that HIV patients, including those newly diagnosed, should receive the treatment they need as soon as possible, Vancouver, Washington-based biotech company CytoDyn Inc. (OTCQB: CYDY) has developed a new therapy, a viral-entry inhibitor called PRO 140, which is currently in Phase 3 clinical trials with very encouraging results so far.

The company has already filed a request with the Food and Drug Administration to grant PRO 140 a Breakthrough Therapy Designation as a therapy for HIV-1 treatment-experienced patients with virologic failure, according to a press release (http://nnw.fm/T2rtg). According to CytoDyn, and based on completed and ongoing clinical trials for the therapy, PRO 140 is a viable treatment options that addresses the unmet medical needs of HIV-1 patients whose regular antiretroviral medication has stopped working. Therefore, granting PRO 140 the designation of Breakthrough Therapy would aid a growing number of heavily treatment-experienced patients in gaining access to a novel therapy to complement or replace their conventional antiretroviral therapy.

If the FDA approves the request and gives PRO 140 the status of Breakthrough Therapy, this will help speed CytoDyn’s Biologics License Application process and bring the company one step closer to releasing the product on the market. The company’s CEO and President, Dr. Nader Pourhassan, said he was hopeful that the FDA would approve the request, as PRO 140 has successfully demonstrated its value as part of a combination therapy, the population for which this Breakthrough Therapy was filed. Moreover, PRO 140 has shown great results as a single agent therapy for some HIV patients (not all) with the R5 strain of human immunodeficiency virus.

Pourhassan said his company has already received several requests to allow patients continued access to PRO 140 so as to maintain viral suppression after the end of treatment in the Phase 3 combination therapy study. He explained that seven patients have already joined a rollover study to continue deriving clinical benefits from the therapy at the end of the 25-week Phase 3 study. And in the single agent therapy study, CytoDyn currently has 10 HIV patients who’ve demonstrated suppressed viral load for more than two years.

Belonging to a new class of HIV/AIDS therapies called viral entry inhibitors and designed to protect healthy cells from infection, PRO 140 works by blocking the HIV co-receptor CCR5, therefore preventing viral entry. All clinical trials conducted so far concluded with encouraging results and have indicated that the new therapy does not have a negative impact on the normal immune functions associated with CCR5. A total of seven Phase 1 and 2 clinical trials have indicated that the new therapy can significantly reduce viral burden, while the recent Phase 2b trial showed that PRO 140 can actually prevent viral escape during a seven-month hiatus in conventional antiretroviral drug therapy.

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

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For years, speed was king in digital marketing. Agencies raced to deploy campaigns, iterate quickly, and exploit trends before they faded. But in 2025, this “move fast and break things” mindset is showing its limits. The rise of AI and the complexity of today’s customer journeys require more than just agility; they demand a strategic […]

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