medovex-logo-blue-e1421779719549Medovex Corporation (MDVX) (web site) develops medical devices primarily in the in the United States and Europe. It offers DenerveX device for the treatment of conditions resulting from the degeneration of joints in the spine, which cause back pain. The company serves healthcare providers, physicians, and third-party payors. Medovex Corporation is headquartered in Atlanta, Georgia.

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MDVX at a glance:

Shares Outstanding: 14 million
Insider Ownership: 38%
Float: 8 million
Closing Price 11/01/2016: $1.66
Market Capitalization: 23 million


Multi-Billion Dollar Market Opportunity

Osteoarthritis (OA) is the most common form of arthritis, affecting 27 million people in the United States and The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability in US adults. With the advancing age of the population and obesity epidemic, the prevalence of OA is also increasing:

  • By 2030, 20% of Americans or about 70 million people age 65 and older, will be at risk for osteoarthritis
  • Fifty percent of people age 65 and older already exhibit evidence of osteoarthritis in at least one joint

Osteoarthritis of the spine, known as spondylosis, is a degenerative disorder that can cause loss of normal spinal structure and function. Aging is the primary cause. Spondylosis can affect the cervical, thoracic and/or lumbar regions of the spine, and may involve intervertebral discs and facet joints, which can lead to disc degeneration, bone spurs, pinched nerves, and an enlargement or overgrowth of bone that narrows the central and nerve root canals, causing impaired function and pain. When spondylosis worsens, it may progress to spinal stenosis, a narrowing of spaces in the spine, which results in pressure on the spinal cord and/or nerve roots.

A related condition, degenerative spondylolisthesis (slippage of one vertebra over another) is caused by osteoarthritis of the facet joints. Most commonly, it involves the L4 slipping over the L5 vertebra, and is also related to aging, most frequently affecting people age 50 and older. Symptoms may include pain in the low back, thighs, and/or legs, muscle spasms, weakness, and/or tight hamstring muscles.

medovex-facet-joint

 

Approximately 31% of chronic low back pain is attributed to the facet joints, small stabilizing joints located between and behind adjacent vertebrae. Facet joints are in almost constant motion with the spine and quite commonly simply wear out or become degenerated in many patients. When facet joints become worn or torn the cartilage may become thin or disappear and there may be a reaction of the bone of the joint underneath producing overgrowth of bone spurs and an enlargement of the joints.

Chronic back pain caused by facet joint arthritis is a multi-billion dollar market opportunity that currently has no effective, long term/permanent solution.  

 

 


Temporary Relief vs. Permanent Solution

Current treatment for chronic back pain caused by facet joint arthritis includes medications for pain relief, spinal injections, and radio frequency (RF) ablation.

medovex-treatment-options-chronic-back-pain

Unfortunately for the many individuals suffering from chronic back pain due to facet joint osteoarthritis, these options are not permanent solutions.


Permanent Solution from Medovex

medovex-chronic-back-pain-relief

The DenerveX™ System developed by MDVX provides long-lasting relief from pain associated with facet joint syndrome.

medovex-denervex

Using a two-step procedure of facet joint capsular tissue removal and RF Ablation with the DenerveX™ System, MDVX demonstrated positive outcomes via a study of 174 patients:

  • A total of 77%, 73%, and 68% of patients with cervical, thoracic, or lumbar disease, respectively, showed at least 50% improvement in pain at 3 year follow-up
  • The majority of patients achieved a 75% to 100% improvement (VAS pain score) at 3 year follow up
  • Overall, 76%, 60%, and 75% of patients with cervical, thoracic, or lumbar facet disease, respectively, had at least a 50% improvement in Oswestry Disability Index (ODI) scoring
  • Most patients experienced a 75%-100% improvement at 3 year follow up

(see: Endoscopic Facet Debridement for the treatment of facet arthritic pain – a novel new technique)

 

 

 


DenerveX™ System Represents Immense Savings for Patients and Health Care System*

medovex-health-care-savings

 

*Estimates are for a 3 year period


medovex-generator

 

medovex-kit


CE Mark Approval in Europe Pending

MDVX management stated in a conference call yesterday (11/1/2016) that CE Mark approval in the European Union is expected in the first half of 2017, and that their recent presence at the EuroSpine 2016 Tradeshow in Berlin was very rewarding.

Medovex President and COO, Patrick Kullmann, recently stated:

“We conducted meetings and demonstrations with at least six potentially strategic companies that could open the door to future collaboration for distribution, investment, co-future development of future generations of the technology or even potential acquisition. Many of the spine surgeons and pain relief physicians visiting the booth stated that the DenerveX Design is very elegant, and represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Their clear appreciation for our different approach in performing a new procedure by way of a posterior capsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy), gives us cause for continued cautious optimism going forward.”

Medovex has opened a European distribution service center, and already has a Diagnosis-Related Group (DRG) designation in Europe. The DRG designation is a very positive milestone for MDVX as it terms of future billing for DenerveX™ System treatment and reimbursement. 


EU/Worldwide DenerveX™ System Commercialization

Investors should expect positive and frequent updates as MDVX moves along the commercialization timeline below:

medovex-product-launch


High Insider Buying/Ownership

As the saying goes, there are many reasons why insiders might sell a stock, but there’s only one reason why they buy it.

medovex-insider-buying

Source: Nasdaq.com


MDVX Investment Highlights

  • Founded by Steve Gorlin (Entremed, Medicis, Medivation, MiMedx) and James Andrews MD (world renowned orthopedic surgeon)
  • Experienced and proven management team and board of directors
  • High insider ownership (38%)
  • Huge, highly opportunistic market opportunity
  • Scalable high growth, recurring revenue model with strong margins and clean balance sheet
  • Intellectual property portfolio (300 claims)
  • Anticipated CE marking first half 2017 with already established international distribution
  • Positive news flow over the coming weeks and months as company begins commercialization and revenue generation

Best wishes for profitable investing!

Medovex corp gary

 

 

See Disclaimer/Terms of Use/Disclosures

massroots-logoMassRoots Inc. (web site) is one of the largest and most active technology platforms for cannabis consumers and businesses with over 900,000 registered users. It’s “Yelp for Cannabis” mobile applications aim to connect its passionate community with the best products and dispensaries in their neighborhoods.

We see exciting opportunity ahead for this business considering:

  • targeting a $7.2 billion cannabis market that is expected to grow to $23 billion by 2020
  • rapidly growing advertising revenue stream now count Uber and Univision as paying advertisers
  • 900,000 registered user base is growing around 30,000 new users organically per month, which does not consider new product roll-outs about to occur, the Ohio market opening up next year, or the wave of new states to join the legalization trend
  • per month costs are currently running $300,000 per month with $150,000 of revenue, but the gap is on track to close by year end 2016
  • a vast array of ancillary business opportunities for the management team, as demonstrated by the recent Flowhub investment

We believe Massroots will grow rapidly to over $100 million in market capitalization versus the $44 million current market cap considering the business has 900,000 users and is experiencing extremely rapid growth. Weedmaps was valued at $300 million with only 750,000 users. Leafly was valued at $425 million with only 1 million users.

Legalization of marijuana for medical use, or expansion to include recreational use is on the ballot in Florida, California, Nevada, Maine, Arizona, Massachusetts, and Arkansa. Polls indicate legalization likely to pass in most, or even all of these states. 


MSRT at a glance:

Shares outstanding: 52.7 million
Approximate float 19.1 million
Closing Price 10/26/2016: .81
Market Capitalization: 42.7 million

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Market Opportunity

The legal marijuana market is a booming industry that is experiencing record growth. States continue to expand both medical and adult use in the US. According to ArcView Market Research, the US. cannabis market was $5.7 billion in 2015 and is expected to reach $7.2 billion at the end of 2016. By 2020 the market is estimated to reach over $23 billion with a compound annual growth rate of 32%.

MassRoots CEO Isaac Dietrich recently stated:

“The 2016 election cycle has the potential to significantly increase MassRoots’ subscriber and revenue growth. When a state passes a medical or recreational cannabis law, MassRoots is able to start registering users and businesses in that state with minimal marginal cost.  At the same time, our financial model is not tied to the success of a particular location, brand or a particular ballot initiative – we believe we will have a significant percentage of all dispensaries and brands on our platform, making MassRoots a play on the industry as a whole.”

 


Revenue Outlook

For six months ended June2016, MassRoots generated $585,000 in revenue primarily through digital advertising for dispensaries and cannabis brands in Colorado and California. The company expects to be able to scale its annual revenues to millions of dollars as additional states regulate the production and sale of cannabis.


Strong Recent Additions to Highly Respected Management Team

The company’s leadership is well regarded. The management team, board as well as designers and engineers hail from leading companies such as: Salesforce, Microsoft, Skype, Motorola, Target, Barracuda, Blizzard Entertainment, The Walt Disney Company, Snapchat, Mashable, Coca Cola, and more.

MassRoots’ team is extremely qualified with the tools to build upon a great business in a thriving industry. Most recently, the company added a new CTO from Salesforce and a new board member from Mashable.


Recent $5 million financing completed

This occurred just this month October 2016. The fact that the equity was raised demonstrated strong commitment from investors to the company. It also highlights the bright outlook the market sees for the company heading into this year’s voting cycle.


Advertising Revenue

This revenue stream was launched in August 2015. The problem out there is that cannabis companies can’t advertise on Facebook or Google, and the “enthusiast” cannabis demographic is incredibly hard to target. MassRoots provides a self-service advertising portal that enables cannabis-related businesses to reach cannabis enthusiasts through MassRoots, social platforms, and cannabis-related websites. The advertising packages offered range from $2,000 per month to $25,000 per month. Advertisers can list on the company’s blog, it’s Facebook page, or through other forms.


Data Sales

Another angle to the business is quickly developing, data sales. Dispensaries don’t know what to stock their shelves with. Growers don’t know what to produce. New companies entering the space don’t know where to spend R&D. MassRoots has a business dashboard featuring MassRoots’ proprietary product data in easy-to-use, actionable formats. We suspect customers are going to love soon being able to pinpoint what product is best for back pain versus nausea and so on. Moreover, robust product level data is a key stair step for the company to move into other arenas long term, such as facilitating commerce between users and dispensaries, after all MassRoots is tracking all the inventory, with opportunities for loyalty programs as well.


Tremendous User Growth

massroots user growth

In only a short period of time, MassRoots has grown its user base from nothing to over 900,000. The company adds approximately 30,000 users per month primarily through organic growth. The massive community of the world’s top cannabis enthusiasts collectively engage over 300,000 times per day on the network. Average daily mobile users is 1750,000. The website gets about 200,000 unique visitors per day, and we are told the platform can easily handle 1 billion unique visitors/day. The company has 10-15% of the addressable market in Colorado. Ohio is coming online next year and the company is eager to expand. Customer acquisition costs have been around $0.80 but are now lower. Revenue per user is targeted to soon be running around $1.00.


Flowhub Investment

In May 2015, the company invested in Flowhub. Flowhub is building a dispensary point of sale system. Since formally launching in June 2016, Flowhub has facilitated more than 250,000 transactions across dozens of dispensaries in Colorado and Oregon. Through its point-of sale and grow management software, Flowhub automates and streamlines business operations for cannabis dispensaries and cultivators. MassRoots believes Flowhub is at a critical inflection point, poised to scale from dozens of dispensary locations using its platform now to hundreds of locations by the end of the year. Within the next few months, the company believes a significant percentage of all transactions occurring in the regulated cannabis industry will occur on the MassRoots/Flowhub platform. In our view, we really like the company’s effort to expand upon the legacy advertising revenue into other forms of more recurring revenue.


Valuation

By focusing on community-driven reviews rather than static information, MassRoots believes it will enable users to find the best products in the shortest amount of time. MassRoots’ recurring usage and the ability to push additional services as features rather than standalone apps presents a superior value proposition to users than both WeedMaps and Leafly. WeedMaps a dispensary locator founded in 2007. It has 750,000 users (as of April 2015), a valuation of $300 million (as of June 2014) and $25 million estimated revenue for 2016 (as of April 2015). Leafy a strain resource guide founded in 2010. It has 1 million users (as of October 2015), a valuation of $425 million (Privateer Holding company of Leafly raised in April 2015) and $16 million estimated revenue for 2016.


Execution

We spoke to CEO Isaac Dietrich. One impressive fact was how he has been nimble and willing to make changes to drive results. For instance, the company now has 3 sales reps. A new sales director will be starting soon. The sales force is paid a 10% commission. Gross margins are 93%. The sales force model is critical to monetizing the company’s assets. Though it just isn’t so easy. 8 months ago the company had now sales force. Then the time came to try to ramp revenue and headcount was increased to 33. Though as always in business not everything works out as planned. Dietrich had to lead an effort to reduce staff to 19. He wisely kept the engineering team the same size and scaled down other areas. He cut several hundred thousand dollars per month out of the budget. The sales force situation described above is now concentrated on top performers and repeating best practices that are behind the results. We think all of the above describes a savy entrepreneur in Dietric. With Ohio about to roll-out 1,000 to 1,5000 dispensaries next year and the country-wide legalization unfolding, we want management personal just like Dietrich at the helm who are taking big risks and course correcting along the way.


Legal Map

Below is our tracker of where cannabis is legalized, where cannabis is legalized for recreational use, and where there are now laws legalizing cannabis.

massroots-legal-map

 

The following states will be voting this year to further advance their laws: California, Nevada, Maine, Arizona, Massachusetts, Florida, Arkansa.

Recent polling indicates a rapidly expanding map for MassRoots to leverage following the November 8th elections:

That’s a lot of  new “mass” for MassRoots to expand into!

Based on recent high growth rates + even greater accelerating growth in both users and sales, now is a great time to average into a position inMSRT.

 


See also June 2016 Investor Presentation


massroots gary signature

 

 

See site wide Terms of Use/Disclosures/Disclaimer

KSIX Media logoKSIX Media Holdings, Inc. (KSIX) is an SEC fully reporting media and Internet company undergoing dramatic and valuable restructuring with the planned acquisition (see press release) of a profitable telecom company, True Wireless LLC.

In the past 9 months of operations, True Wireless has generated $8.75 million and $2.4 million of net income.

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Current shares outstanding: 46 million
Closing price 10/25/2016: .16
Market Capitalization: $7.4 million

 


ksix-media-and-tw-logo

True Wireless LLC (web site) is a telecommunications carrier that provides discounted and subsidized cell phone service to those who qualify. The company provides government sponsored/ supported cell phone service in Texas (TX), Oklahoma (OK), Arkansas (AR), Maryland (MD) and Rhode Island (RI).

The service is subsidized under the Federal Communications Commission Lifeline Program for Low Income Consumers. The Lifeline program is available to eligible low-income subscribers in every state, territory, commonwealth, and on Tribal lands.

Tentative deal terms include:

1) Cash payment of up to $6 million through a debt instrument
2) A promissory note of $6 million
3) The issuance of common stock in KSIX totaling 24 million of shares of common stock

Management anticipates having approximately 75 million shares outstanding post close of the transaction.

As of yesterday’s close, the post-acquisition market capitalization for KSIX is just $12 million, assuming 75 million shares outstanding.   

Considering the acquisition is for a company with nearly $9 million in sales and $2.4 million in net income during just the last 9 months, look for shares to climb much higher. 


We will be keeping subscribers updated on developments as they arise.

towerstream corp gary

 

 


See site-wide Terms of Use/Disclosures/Disclaimer

 

Towerstream Corporation (NADSAQ: TWER)

towerstream-logo

Towerstream Corporation (web site) provides fixed wireless broadband services and delivers high speed Internet access to commercial customers in the United States.  Its wireless broadband service supports bandwidth on demand, wireless redundancy, virtual private networks, disaster recovery, bundled data, and video services.

The company offers services to business customers in New York City, Boston, Chicago, Los Angeles, San Francisco, Seattle, Miami, Dallas-Fort Worth, Houston, Philadelphia, Las Vegas-Reno, and Providence-Newport.  Towerstream Corporation was founded in 1999 and is headquartered in Middletown, Rhode Island.


Towerstream currently has about 3,000 customers and $28 million in revenue. Just recently the businesses “turned the corner” delivering positive Adjusted EBITDA of >$400K in 2Q’16.

Towerstream is disrupting its landscape by offering business customers internet access for 40% below competitors.

Management sees $70 million in revenue by 2020.


Closing price 10/21/2016: $1.15
Shares Outstanding: 7.6 million
Float: 3.6 million
Market Capitalization: $8.8 million


Products & Services

Towerstream currently has 175 Major Points of Presence (POPs). POPs are located on the top of buildings such as the Empire State Building and Met Life in NYC (as shown in the picture below); the Hancock Building in Chicago, and the AON Building in Los Angeles. These POPs create a high-speed internet network in the sky. Currently, the company is working to build out networks in the 12 major US cities.

View From Towerstream’s Metlife POP In NYC

towerstream-1


Technology

Towerstream has a strong competitive advantage in technology. Today’s advanced microwave is faster than fiber and just as stable. It is a fraction of capex cost at $15,000 versus possibly as high as $200,000 for fiber. It takes a fraction of the time to deliver the service. Below is an illustration of the high-speed wireless connection in the sky created by the technology.

 towerstream-2

In an October 13th press release, CHIEF Operating Officer Arthur Giftakis explained:

“Fixed-wireless technology inherently provides a competitive advantage. The speed at which we can add buildings at our low cost also gives us a superior advantage over fiber and cable.”


On-Net Initiative Brings Path to $70+ Million Revenue

Towerstream installs high-cap radio and antenna on the roof, then an inexpensive, quick, wire run to install each customer. Towerstream can then sell aggressively to all customers in the building typically 40% below market pricing. The On-Net initiative enables all tenants in a building the potential to have access to Towerstream’s carrier-class high speed internet services with a simple cable run from a common room. Towerstream is able to leverage equipment that previously would serve only one customer to now serve many.

By year end, 440 buildings are expected to be On-Net, with 785 planned for by the end of 2017, and 1,060 likely by the end of 2018. The current average is 31 tenants per building. With a target 30% penetration and $250 ARPU (Average Revenue Per User), there is revenue potential for $2,325 per building per month. On-Net churn is typically 1%, which is half the telecom average. In summary, it is not hard to see the path to attractive future revenue potential.


Thousands of Buildings in Towerstream Network Footprint

towerstream-3

 


Mistakes by Previous Management Decimated Shares

In early 2015 Towerstream was a beloved business trading over $40/share,  invited to present at all the major investment conferences from Jefferies to Citi. Unfortunately, a lack of transparency, high cash burn, and other issues caused investors and analysts to run.

The company has since undergone major restructuring including replacing top leadership. The restructuring lasted into the first part of this year and Towerstream is in a much more stable place. Admittedly, however, it could take another 3-4 quarters for many investors to regain confidence.


New Business Model Brings Improved Transparency

The new business model is called On-Net. The old model HetNet is now shown as a discontinued operation. Under the new model, investors will receive more disclosures, such as ARPU (Average Revenue Per User) , number of customers, number of buildings, and sales productivity.


Switch to More Flexible Pricing to Achieve Desired ARPU

Towerstream is now offering a fully symmetric 100 Mbps service for as little as $450 per month, or in some cases only $300. Previously, pricing was a firm $699 for the 100 Mbps service. Moreover, Towerstream isn’t limiting itself to 100 Mbps service. Now the company is providing both larger and smaller pipes depending on customer demand. The drive is to develop a full-building ARPU in the $3,000 range monthly. This desired outcome is now build around the calculus that pricing per customer mix may float around varying levels. Increasingly Towerstream is becoming known for offering customers “offers they can’t refuse”.


Testimonials Highlight Customer Satisfaction

 “Please know that I’m a long time CIO and have had plenty of experience working with nearly all of the telecom companies in America.  I must tell you, I have never seen a more focused, competent, and coordinated team in my entire career, you were nothing short of brilliant. I was kept up to date at least daily and sometimes 2 or 3 times a day. This is extremely rare in today’s telecom world where a lot of people just go through the motions. Towerstream demonstrated the exact opposite and the Penn Virginia installation is living proof.  This was the best I’ve ever seen in my 30 years of leading and managing IT functions regarding the telecom discipline.”

Gary W. Bailey, Vice President IT, Penn Virginia Corporation

 

“Ever since the Towerstream High Speed Network service has been integrated to the Wiltern Theatre’s Corporate and Artists Network Segments the Venue can now consider itself as having contemporary Network access. The Venue for many years has had to endure slow DSL type of speeds as well as the continued failure of these types of circuits. Constant DSL modem resets caused grief to our Production and Tour Managers. Due to the Towerstream service along with an upgraded Wireless Network, the Wiltern now has a much better Network access experience. I have not once called in Towerstream Technical Support for any issues with service here at the Wiltern.”

Danny T. Speth, Manager of Global Corporate Office and Venue Technology, Live Nation/Ticketmaster

 

“In these very competitive economic times, Towerstream’s Internet connections allow us the flexibility to easily increase bandwidth as a selling point to our guests.”

Joan Rowland, Director of IT,  The Palms Hotel & Spa, Circa 39 Hotel


Digging Into The Palms Hotel & Spa Case Study Offers Deeper Insight

Offering enough bandwidth during peak season, at an affordable price, to meet traveler’s Internet needs is a must in the hotel business. Each year, the demand for Internet continues to spike. Today travelers require more bandwidth. At one time guests were using the Internet connection to check e-mail messages and web surfing. Guests are now streaming video, logging into chat rooms, and connecting to their home office putting more of a demand on bandwidth. During peak weeks, employees and guests often experienced Internet gridlock ultimately maxing out bandwidth and slowing down speed.

The time had come to install additional bandwidth, but finding affordable service with scalable features for peak weeks was a challenge. Initially, the decision was made to upgrade the property’s fractional T service to 3Mbps. The intention was to move to a full T1 connection, but the 3Mbps solution caught everyone’s attention. The price was a far better deal than most other companies T1 rates. Impressed by the service that would be received, it was an easy decision to make the switch to Towerstream.

When both hotels – Circa 39 and Palms – were up and running on Towerstream’s network, the connection between the two properties and their consultant management company was seamless. More recently, the Palms had Towerstream provide high-speed Internet for all their guest rooms. This guaranteed a reliable, fast and secure connection for all vacationing and business travelers. More importantly, Towerstream’s service featured the desired scalability. Bandwidth can be increased with just a phone call during high-occupancy periods. Initially the hotel was attracted to the low price that Towerstream offered, but the features of their 4G technology have given the Palms a competitive edge.


Conclusion

Towerstream reported $400K of EBITDA in 2Q’16, up from a negative figure in the preceding quarter unveiling “the turn”. Fundamentals are improving rapidly.

The business model of adding hardware to the top of a building then leveraging costs to deliver 40% below market price is a game changer.

At the current enterprise value of ~$35 million, we see compelling value considering the potential for the business to be $70+ million of revenue in several years, not to mention at one point shares traded for $40!

As Towerstream Corporation continues to improve transparency as well as top and bottom line numbers, we expect shares to rise accordingly.
Towerstream will report Q3 on November 9th, (press release).


Best wishes for profitable investing!

towerstream corp gary

 

 


See Disclaimer/Disclosure/Terms of Use

Stocks Finish Friday Flat, While Wielding Weekly Gains

U.S. stocks finished the regular trading session near the unchanged mark as corporate earnings reports were in focus with the domestic economic front void of any major releases.

Technology issues moved higher as Dow member Microsoft easily bested expectations, while fellow Dow component General Electric reported revenues that fell short of forecasts. Global monetary policy and political uncertainty continued to elicit concerns.  Treasuries were mixed, while gold, the U.S. dollar and crude oil prices gained ground.

The Dow Jones Industrial Average (DJIA) lost 17 points (0.1%) to 18,146, the S&P 500 Index was unchanged at 2,141 and the Nasdaq Composite gained 16 points (0.3%) to 5,257.

In moderate volume, 851 million shares were traded on the NYSE and 1.6 billion shares changed hands on the Nasdaq. WTI crude oil decreased $0.22 to $50.85 per barrel, wholesale gasoline gained $0.04 to $1.53 per gallon and the Bloomberg gold spot price added $1.27 to $1,267.03 per ounce.

Elsewhere, the Dollar Index-a comparison of the U.S. dollar to six major world currencies-was 0.4% higher at 98.66. Markets were mostly higher for the week, as the DJIA gained nearly 0.1%, the S&P 500 Index increased 0.4% and the Nasdaq Composite was 0.8% higher.

Dow member Microsoft Corp. (MSFT $60) reported fiscal 1Q earnings-per-share (EPS) ex-items of $0.76, above the $0.68 FactSet estimate, as revenues rose 3.1% year-over-year (y/y) to $22.3 billion, versus the expected $21.7 billion. The company said its 1Q results showed continued demand for its cloud-based services. MSFT rallied. We had a good day led by our largest position FB 132.+2. We rebuilt our Swing Trade Portfolio this week going from 80% cash to 15% in cash.Our portfolio contains four recent IPO’S, a gold stock, and AAPL and FB.

                     
AFTER MARKET ROUND-UP
 

Dow Jones 18,145.71-16.64 -0.09%

S&P 500 2141.16 -0.18  -0.01%

NASDAQ 5257.40 +15.56 +0.30%

WTI Crude Oil 50.86 +033 +0.45%

GOLD 1267.40 -0.10 -0.01%

SILVER 17.540 -0.009 -0.05%

10 Year Yield 1.740

DXY (USD Index) 98.651+0.33 +0.34%

Economic Activity for Monday
 
 US Chicago Fed National Activity 8:30 AM ET
 US PMI Manufacturing Index Flash 9:45 AM ET

Nasdaq Listed, EBITDA +, High Tech, Turnaround Stock Pick Released Tomorrow

coming up

We’ve discovered a fantastic turnaround stock play that we will release tomorrow morning, Monday, 10/24, at 9:30 am.

The company we’re profiling here at MicrocapResearch.com has about 3,000 customers currently and $28 million in revenue. Just recently the businesses “turned the corner”, delivering positive adjusted EBITDA of more than $400K in 2Q’16.

The company is disrupting its landscape by offering business customers Internet access for 40% below competitors, and management sees $70 million in revenue by 2020 vs. just $27 million during the trailing twelve month period. 

Our full report will be out tomorrow morning!

 tapimmune -gary pic

I love finding stocks that meet glaring needs within a particular industry…companies with technology that can dramatically improve efficiencies and even open new markets by expanding applications within an industry.

I especially love finding these stocks when the company has heavily patented the game-changing technology and is on the verge of commercializing it with top-tier partners.


nanoflex-power

Meet NanoFlex Power Corporation (OPVS)

NanoFlex Power Corporation (web site) researches, develops, commercializes, and licenses advanced configuration solar technologies that enable thin-film solar cell implementations. The company has worldwide license and right to sublicense intellectual property resulting from its sponsored research programs. Its research programs have yielded two solar thin film technology platforms, which include Gallium Arsenide thin film technology for high power applications; and organic photovoltaic technology for applications demanding high quality aesthetics, such as semi-transparency, and tinting and ultra-flexible form factors.

NanoFlex Power targets applications comprising mobile and off-grid power generation, building applied photovoltaics, building integrated photovoltaics, space vehicles and unmanned aerial vehicles, semi-transparent photovoltaic windows or glazing, and ultra-thin solar films or paints for automobiles or other consumer applications. It has developed laboratory feasibility prototypes that demonstrate key building block principles for these applications. NanoFlex Power Corporation was founded in 1994 and is based in Scottsdale, Arizona.


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Share Information

Shares outstanding: 58.8 million
Closing price 10/4/16:  .91
Market capitalization: $53.5 million
Approximate float: 21.5 million
52 week high: $3.00
52 week low: .31


NanoFlex Power (OPVS) is Commercializing Two Solar Technologies of the Future:  

  • Ultra-High Efficiency Gallium Arsenide (GaAs) Solar Cells

  • Organic Photovoltaic (OPV) Solar Cells


Ultra-High Efficiency Gallium Arsenide (GaAs) Solar Cells

Gallium arsenide (GaAs) based solar cells hold the record when it comes to the efficiency. GaAs-based solar cells also produce far more energy in high heat conditions as well as low light conditions. Simply put, the chemical and physical properties of GaAs make it the undisputed choice for high efficiency solar cells. As a result, virtually all satellites and space-bound vehicles are powered by GaAs solar cells.

So what’s kept GaAs solar cells from being the go-to technology here on earth?  Cost. Despite its ultra-high efficiency, the manufacturing process for gallium arsenide solar cells has been prohibitively expensive for terrestrial use, and this is where NanoFlex comes in.

NanoFlex Power’s Patented Technology Can Dramatically Slash Manufacturing Cost for GaAs Solar Cells

NanoFlex Power has a patented process that dramatically reduces the cost (> 90%) of GaAs solar cell production.

The production of the parent wafer is by far the most expensive part of the manufacturing process for GaAs solar cells. By using what NanoFlex refers to as “Non-Destructive Epitaxial Liftoff” (ND-ELO), the parent wafer in the manufacturing process is recycled and used again and again to make hundreds of lifted-off, flexible, thin films. NanoFlex Power has demonstrated that the GaAs cells produced from subsequent cycles maintain the same ultra-high performance characteristics as those from the initial cycle. The process also enables ultra-high performance GaAs solar materials to be available on flexible and lightweight thin-film materials for use in a much wider variety of applications.

nanoflex-power-corp-gaas

 

nanoflex-power-opvs-thin-film

 

NanoFlex’s cost breakthroughs in GaAs solar cell production creates the highest performance, flexible solar solution at the lowest cost per Watt.


A leading provider of solar cells and solar panels to satellite and spacecraft OEMs has taken notice of NanoFlex Power’s patented low-cost GaAs production process.

nanoflex-power-solaero-technologies

In August of 2015, NanoFlex Power signed a Joint Development Agreement with SolAero Technologies for “development of Gallium Arsenide (“GaAs”) solar cells utilizing NanoFlex Power’s proprietary manufacturing processes.”

 

There are three things investors need to know about this agreement:

  1. SolAero Technologies (web site) is a leading provider of solar cells and solar panels to satellite and spacecraft OEMs and has powered >170 space missions
  2. The agreement validates NanoFlex’s low cost GaAs solar cell production technology as it moves from R&D to commercialization
  3. The agreement provides a low-risk, rapid path to commercialization

SolAero has a team of engineers working on implementing NanoFlex technology in their manufacturing process & in their production-configuration solar cells.

The commercial applications arising from NanoFlex’s low-cost GaAs solar fabrication method are mind-boggling. Combine an ultra-high efficiency solar power source that’s highly flexible, extremely thin, can be used use in high heat and low light situations, and is now (thanks to NanoFlex Power) cost effective to manufacture, and it becomes easy to see why the leading provider of solar cells and solar panels to satellite and spacecraft OEMs is teaming up with them.

 


Organic Photovoltaics (OPV)

The second game-changing solar technology NanoFlex Power is developing is in organic photovoltaics (OPV).

First generation solar technologies are predominantly composed of silicon based, inorganic materials. These thick, inflexible, solar cells currently account for around 80% of all solar panels sold globally. Inorganic solar cells have lower absorptivities than organic materials, requiring thicker absorbing layers, and high purities (and high costs) to insure efficient operation.

OPV solar cells use carbon-based polymers in an aim to provide an Earth-abundant and low-energy-production photovoltaic solution. OPV has the theoretical potential to provide electricity at a lower cost than first- and second-generation solar technologies. Because various absorbers can be used to create colored or transparent OPV devices, this technology is particularly appealing to the building-integrated solar market.

According to the U.S. Department of Energy, OPV solar technology promises the following benefits:

  • Low-cost manufacturing: Soluble organic molecules enable roll-to-roll processing techniques and allow for low-cost manufacturing
  • Abundant materials: The wide abundance of building-block materials may reduce supply and price constraints
  • Flexible substrates: The ability to be applied to flexible substrates permits a wide variety of uses

nanoflex-power-opvs-comparisons

 

The Most Extensive Patent Portfolio of OPV Technologies in the World + Top Tier Research Partners

NanoFlex Power claims the most extensive patent portfolio of OPV technologies in the world, holding exclusive rights to over 130 issued and pending U.S. patents, plus foreign counterparts, which cover architecture, processes and materials for high efficiency solar technologies and flexible, thin-film organic photovoltaics.

OPV is still a developing technology, and has some efficiency limitations as well as less long-term reliability than silicon-based cells. As a result, research focuses on increasing device efficiency and lifetime. Substantial efficiency gains have been achieved already by improving the absorber material, and research is being done to further optimize the absorbers and develop organic multijunction architectures. Improved encapsulation and alternative contact materials are being investigated to reduce cell degradation and push cell lifetimes to industry-relevant values.

NanoFlex’s approach has been to advance all dimensions of OPV technology, including the development of new materials (some of which are now being sold in small quantities by materials suppliers), new high efficiency device architectures, and ultra-high-speed, energy efficient production processes such as organic vapor phase deposition developed in the company’s research partner’s laboratories, and solar cell modulization.

NanoFlex’s research partners at the University of Southern California and the University of Michigan are world leaders in OPV research. These sponsored research agreements provide NanoFlex Power with the exclusive worldwide license and right to sublicense any and all intellectual property resulting from the related research and development.


Opening New Applications for Present and Near Future 

NanoFlex has been able to form the basis for exciting new products, applications, and capabilities with patented developments in both Organic and Inorganic Photovoltaics. By redefining the materials, architectures, and fabrication processes to radically decrease cost while enabling a far more flexible and lightweight form factor, new products and markets are on the horizon.

nanoflex-power-space

 

NanoFlex’s patented, low-cost GaAs production method will dramatically reduce the cost of high performance solar arrays for aerospace applications.

SolAero Technologies and NanoFlex’s joint development agreement validates the patented NanoFlex production technology and opens multiple pathways for near term revenue generation from licensing.

 


 

nanoflex-power-flexible-filmThe combination of GaAs’ high efficiency with a lightweight thin-film form factor and competitive cost (due to NanoFlex Power’s patented technology) opens off-grid and mobile power markets to solar. The versatility and cost of this new process will enable some incredible new applications and products that would not be possible with the current constraints of solar technology.

 

 

Lightweight and flexible solar mats and sheets can be used in remote areas to provide power. These solar mats can be used by emergency response teams, in disaster situations, and in a multitude of military applications.  Moreover, emerging markets often lack access to reliable electricity. For these people, solar power can provide them with a basic need to support their lighting, heating, and communications needs.


 

nanoflex-power-solar-buildingGone will be the large, rigid, cumbersome solar panels and in their place will be windows and glass surfaces of buildings. Tinted semi-transparent OPV photovoltaic films could be used to coat all of the windows of a building, which will in turn generate electricity that will ultimately be used within the building.

NanoFlex’s technology lowers the cost of higher efficiency technologies and introduces flexible form factors that reduce installation costs and provides a more aesthetic look.

We’ve all seen solar panels on buildings, but imagine an entirely solar-powered building. You could witness this in the not too distant future, thanks to NanoFlex Power’s breakthroughs in organic photovoltaics technology.


nanoflex-power-solar-bug

 

Imagine if by simply painting a car, you could allow it to convert the sun’s energy to power its electronics or charge its battery.

Photovoltaic paints are a possibility using OPV technology.

NanoFlex Power’s proprietary organic materials can be produced at the molecular level, which enables them to be applied to highly flexible and non-planar surfaces through the application of an ultra-thin solar coating.

 

 

 


World Class Research Partners, Management, and Development Partners

It’s always exciting to catch an ultra high-tech company as it’s moving from R&D and into commercialization and revenue generation, which is where NanoFlex Power is now.

With some of the world’s best research partners, a strong, experienced, superbly qualified management team, and a top tier joint development partner in SolAero Technologies, I’m really looking forward to following the company closely.

I’ll be sharing new developments with subscribers in the coming weeks and months as NanoFlex Power (OPVS) moves from R&D to revenue generation.


 

Supplemental: NanoFlex (OPVS) August, 2016 Investor Presentation

 


Disclaimer/Disclosures/Terms of Use

Best wishes for profitable investing,

nanoflex power - gary sig

U.S. stocks closed higher on Friday, locking in their best quarterly gains since December 2015.

The S&P 500 gained 3.3% for the quarter ending September 30, the Dow advanced 2.1%, and the Nasdaq Composite rose 9.7%.

 


best small cap stocksThe monthly University of Michigan survey of consumer confidence rose in September to 91.2, up from 89.8 in August.

The reading is also 4.6% higher than this time last year.

Lynn Franco, Director of Economic Indicators at The Conference Board stated:

“Consumers’ assessment of present-day conditions improved, primarily the result of a more positive view of the labor market. Looking ahead, consumers are more upbeat about the short-term employment outlook, but somewhat neutral about business conditions and income prospects. Overall, consumers continue to rate current conditions favorably and foresee moderate economic expansion in the months ahead.”


Strong consumer sentiment bodes well for the U.S. economy (and stocks) heading into Q4, as consumer spending accounts for approximately 70% of economic growth in the U.S.

 


New Super High-Tech Solar Stock Pick Coming Wednesday

Solar stocks have had a tough time in the environment of low oil prices this year.  Sector leaders First Solar Inc. (FSLR) and SunPower Corp.(SPWR) hit lows not seen since 2013 just two weeks ago.

Then solar stocks put in a sharp rebound last week. 

The Guggenheim Solar ETF (TAN) may be putting in a double bottom, and a break above 22.00 would confirm it.

 

best-small-cap-stocks-chart

 

The bottom for solar stocks may be in, and this could be the perfect time to catch a great solar stock before it makes a major move.


The company I’ll be writing about is addressing the 3 major needs for solar technology to become truly commonplace:

  • Need for cheaper manufacturing
  • Need to reduce materials used
  • Need for greater efficiencies

The company is on the verge of commercializing heavily patented technology that sets industry-leading efficiencies, is lightweight and flexible, with low total system cost.

The company has existing top tier partnerships, positive forward drivers, and a cost effective approach to enter rapid commercialization.

Stay tuned!


Best wishes for profitable investing,

tapimmune -gary pic

john-bonfiglio

 

 

 

 

 

Cautionary Note on Forward-Looking Statements
Certain statements contained in this interview may be “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and MD&A filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov ). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

MR:   Thank you for participating in this Q&A Dr. Bonfiglio.

TapImmune Inc. appointed you President and COO in July of this year. Would you discuss your professional background, previous positions, and the experience you bring to the Company? 

JB:  I have been in the pharmaceutical/biotech industry for more than 30 years starting at Allergan Pharmaceuticals. I have been the CEO of several microcap public biotechs and have raised over the years at least $100m in financing as well as having helped to develop several drugs currently on the market. My PhD is in organic chemistry from UC San Diego and my MBA is from Pepperdine University. I believe my experience in running immune-oncology companies such as Argos Therapeutics and Peregrine Pharmaceuticals gives me the perfect background for leading development efforts for TapImmune.

 

MR:   What are your responsibilities going forward at TapImmune?

JB:  I will be leading the development efforts for the two lead products TPIV 200 and TPIV 110. This will include managing clinical trials, manufacturing and all regulatory filings. I will also be the lead on our preclinical activities for our in-house PolyStart program, which is very exciting. In addition, I will be a point person for the investor relations and shareholder relations.

 

MR:  TapImmune is currently in the process of uplisting to the NASDAQ exchange, which will obviously help increase institutional investor awareness. Can you give an update on where things are in that process?

JB: We have completed the application and have initiated a reverse split. The stock needs to trade above $4 for five trading days (end of trading on September 22nd) and the NASDAQ needs to approve the final application.

 

MR:  TapImmune has collaborations with Mayo Clinic, AstraZeneca (AZN), and Memorial Sloan Kettering Cancer Center, clearly top tier partners.  What has attracted them to TapImmune?

JB: Our collaborations and relationships are driven by data. The promising TPIV 200 Phase 1 results showing safety and robust immune responses in a majority of the patients have led organizations like the Department of Defense, Memorial Sloan Kettering and subsequently Astra Zeneca to decide to work with us and the Mayo clinic to take TPIV 200 into efficacy trials. The immune-oncology therapeutic area believes a T-cell therapy like ours could be a necessary piece to the therapeutic oncology puzzle.

 

MR:  It looks like a busy Q4 is coming up for TapImmune with four different drugs in, or starting phase II clinical trials. Would you discuss some details of the upcoming events, trials, milestones?

JB: We have ONE drug (TPIV 200) starting in FOUR different Phase 2 trials by the end of 2016. We are expecting to file an IND for our second product (TPIV 110) by the end of the year.  Expect to see news related to the trials, enrollment and data during the next 6-12 months.

 

MR:  In addition to the multiple Phase II trials, TapImmune is in preclinical development of “PolyStart”, which has been called a next generation T-cell vaccine. This sounds very exciting- would you elaborate?

JB: Polystart is a DNA vector platform not a t-cell vaccine. We are very excited about this technology as a useful tool in eliciting strong immune responses for therapies ranging from cancer to infectious disease. The technology allows for a much more robust immune response than a simple DNA vaccine would be able to accomplish and it can be adapted to a wide variety of circumstances. Ware in preclinical testing this year and will be moving forward with development some time next year. 


 

Supplemental:
For a more comprehensive drug development/clinically focused Q&A, see the July 5th ” Q&A with TapImmune CEO Dr. Glynn Wilson, on a Vaccine to Prevent Cancer Recurrence, in Multiple Phase II Trials” via The Bio Connection

 


tapimmune-john-bonfiglioJohn Bonfiglio is a highly successful Biotech CEO with broad experience in corporate strategy and financing, market interactions and business development. He was most recently President and CEO of Oragenics where he refocused the company and raised over $29 million dollars in the public markets while positioning the company for a successful re-listing on the NYSE: MKT stock exchange. He was formerly President and CEO of Argos Therapeutics where he raised over $35 million dollars for the Company and led the company in a successful Phase 2 study in renal cell carcinoma. As President and CEO of the Immune Response Corporation he was responsible for turning the Company around through improved therapeutic focus, capital raising (over $50 million) and improved investor relations resulting in a significant increase in stock price and shareholder value. John was also President and CEO of Peregrine Pharmaceuticals and Director of Business Development at Baxter Healthcare Corporation’s Immunotherapy Division. John has a Ph.D from the University of California, San Diego, and an MBA from Pepperdine University.

 


john bonfiglio of tapimmune -gary pic

Q: What do you get when a biotech company is days away from uplisting to the Nasdaq Capital Market, has recently obtained funding to proceed in not one, not two, but four Phase II clinical trials with an oncology emphasis, and has collaborative partnerships with AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic? 

A: A stock primed for a major move.

The company is TapImmune Inc., and the stock is (TPIVD).


tapimmune-logo

TapImmune, Inc. (web site) is a clinical-stage immune-oncology company specializing in the development of innovative technologies for the treatment of cancer and metastatic disease. The Company has made considerable clinical and financial progress over the last year, including the completion of positive Phase I clinical trials in breast and ovarian cancer at the Mayo Clinic, which showed that its TPV-100 and TPV-200 vaccines were safe and well tolerated, and demonstrated robust cellular immune responses in over 90% of evaluable patients. Since the results, TPIV has announced multiple phase 2 clinical studies – and was also granted an Orphan Drug Designation and received fast track designation from the FDA for TPIV 200 in ovarian cancer.

With a $13.3 million grant, the U.S. Department of Defense is fully funding a double-blinded, placebo controlled Phase II study of TPIV 200 in 280 patients with triple negative breast cancer to be conducted at the Mayo Clinic in Jacksonville, Florida.
(emphasis mine)


Shares outstanding: 8.3 million
Closing Price 9/16/16: $5.55
Market cap: $46 million


NASDAQ Uplist Pending

TapImmune Uplisting to NASDAQAs announced last week, TapImmune believes that it now meets the requirements for listing the company’s common stock on the Nasdaq Capital Market.

A number of TapImmune investors recently exercised a total of 12 million warrants, resulting in a $6 million cash infusion. Additionally, TapImmune closed on a $3 million financing through a private equity placement while certain outstanding warrants were restructured, eliminating $29 million of derivative liability. These actions successfully bolstered the Company’s balance sheet to meet Nasdaq Capital Market listing requirements, while a reverse stock split last week brought the share price above the NASDAQ listing minimum.

To be listed on the Nasdaq Capital Market, requirements include an operating history of 2 years, $5 million in shareholders equity, 1 million publicly held shares and a bid price of $4, according to the Nasdaq initial listing guide (page 9).

Having invested in many uplisting stocks over the years, I can tell you there is no grey area in this process…you either meet the requirements or you do not, and TapImmune now meets them.

The listing will open up a huge market of institutional investors that could not previously invest in TapImmune, a company with FOUR Phase II clinical trials of drugs for ovarian and breast cancer, (one with Fast Track designation and Orphan Drug status), that has collaborative partnerships with AstraZeneca, Mayo Clinic, Memorial Sloan Kettering Cancer Center.

As you read more below, it will become clear the current market cap ($46 million) does not come anywhere close to reflecting the underlying value of TPIVD. That will change with the NASDAQ listing and the resulting increased awareness of TapImmune’s world class partnerships and attractive drug pipeline by analysts and institutional investors.


Active Pipeline, Multiple Phase II Trials 

TapImune’s Chairman and CEO, Glynn Wilson, Ph.D. stated earlier this month:

“Recent events have been transformative for TapImmune. We believe we are now funded to execute on the 4 Phase 2 clinical trials for our lead cancer vaccine TPIV 200, two of which have already started treating patients, with two more trials slated to commence enrollment in the coming few quarters.”

and

We believe the Phase 1 data produced for both TPIV 200 and TPIV 110 in collaboration with the Mayo Clinic are the driving force behind the high-value collaborations we have been able to maintain and establish with organizations including Mayo Clinic, AstraZeneca, Sloan Kettering, and the U.S. Department of Defense. As we move forward into advancing the Phase 2 studies, some of which are represent collaboration with prestigious third party organizations, we believe this represents further independent vetting of potential of our technology.”

 

 

tapimmune-clinical-pipeline

 

“Fully funded to execute on the 4 Phase II clinical trials” 

 

Phase II Trial of TPIV 200 for Triple Negative Breast Cancer

About 15-20% of breast cancers are found to be triple-negative (meaning the breast cancer cells tested negative for estrogen receptors, progesterone receptors, and HER2. This breast cancer does not respond to hormonal therapy (such as tamoxifen or aromatase inhibitors) or therapies that target HER2 receptors, such as Herceptin (chemical name: trastuzumab). For doctors and researchers, there is intense interest in finding new medications that can treat this kind of breast cancer.

TapImmune has opened 8 clinical sites and is currently treating patients in a Phase 2 trial of the Company’s Folate Receptor Alpha cancer vaccine, TPIV 200, in the treatment of triple negative breast cancer, one of the most difficult to treat cancers representing a clear unmet medical need.

The open-label, 80 patient clinical trial is designed to evaluate dosing regimens, adjuvants, efficacy, and immune responses in women with triple negative breast cancer. Key data from the trial is expected to be included in a future New Drug Application submission to the FDA for marketing clearance.


Phase II Trial at Memorial Sloan Kettering of TPIV 200 in Ovarian Cancer in Collaboration with AstraZeneca

A Phase II study of TPIV 200 in ovarian cancer patients who are not responsive to platinum, (a commonly used chemotherapy for ovarian cancer), sponsored by Memorial Sloan Kettering Cancer Center, and in collaboration with AstraZeneca. TapImmune has begun enrollment for a 40 patient study.

The open-label study is designed to evaluate a combination therapy which includes TapImmune’s TPIV 200 T-cell vaccine and AstraZeneca’s checkpoint inhibitor, durvalumab.

Because they are unresponsive to platinum, these patients have no real options left.

If the combination therapy proves effective, it would address a critical unmet need. TPIV 200 has received Orphan Drug designation for use in the treatment of ovarian cancer.


Multiple Near Term Positive Drivers In Addition to Nasdaq Uplisting

 

I love stocks with multiple near term, positive drivers…and TapImmune has them:


Enrollment to Commence in Q4 2016: Phase II Mayo Clinic-U.S. DOD Trial of TPIV 200 in Triple Negative Breast Cancer

TapImmune anticipates that this Phase 2 study of TPIV 200 in the treatment of triple negative breast cancer, conducted by the Mayo Clinic and sponsored by the U.S. Department of Defense (DOD), will begin to enroll patients in the fourth quarter of this year. The anticipated 280 patient study will be led by Dr. Keith Knutson of the Mayo Clinic in Jacksonville, Florida. Dr. Knutson is the inventor of the technology and an advisor to TapImmune.

While TapImmune is supplying doses of TPIV 200 for the trial, the remaining costs associated with conducting this study will be funded by a $13.3 million grant made by the DOD to the Mayo Clinic.


Clinical Sites to Open in Q4 2016: Phase II TPIV 200 Trial in Platinum-Sensitive Ovarian Cancer (Fast Tracked by FDA)

By the end of 2016, TapImmune expects to have at least one clinical site open in a Phase II trial of TPIV 200 in 80 ovarian cancer patients who are responsive to platinum. TPIVD received the FDA’s Fast Track designation to develop TPIV 200 as a maintenance therapy in combination with platinum, in platinum responsive ovarian cancer. This multi-center, double-blind efficacy study is sponsored and conducted by TapImmune.Dr. Glynn Wilson, Chairman and CEO of TapImmune states:

“We believe that the FDA’s decision to grant Fast Track designation to TPIV 200 for the treatment ovarian cancer significantly expedites our clinical development program. We look forward to starting Phase II trials in the near future to address this highly aggressive cancer. We believe TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis.”


Open IND (Investigational New Drug) with FDA for TPIV 110 in Q4 2016:

TapImmune has reformulated a second cancer vaccine product, TPIV 110, following very strong safety and immune responses from a Phase 1 Mayo Clinic study.TPIV 110 targets Her2/neu, which makes it applicable to breast, ovarian and colorectal cancer.  The reformulated product adds a fifth antigen which should produce an even more robust immune response activating both CD4+ and CD8+ T-cells.

TapImmune has already requested a pre-Investigational New Drug (IND) meeting with the FDA and submitted questions to the FDA related to opening the IND.

A response from the FDA is expected in September and TapImmune anticipates having an open IND by year-end pending comments from FDA.

 


Preclinical Pipeline Expands TapImmune’s Breast & Ovarian Cancer Killer Therapies

 

tapimmune-preclinical-pipeline

 

Also Preclinical, A Next Generation T-Cell Vaccine: PolyStart

In February of this year, TapImmune received notice of allowance on a patent for a Next Generation T-Cell Vaccine called “PolyStart.”

This unique vaccine platform antigen expression system creates a 4 (FOUR) fold or more increase in antigen presentation.  The increased cell surface presentation increases activated Helper and/or long-lived Killer T-cell populations that then effectively seek out and work to destroy a patient’s cancer cells.

The below data from a current study showing the increased presentation and subsequent KILLING of the targeted cell population.

 

tapimmune-polystart

Dr. Glynn Wilson, Chairman & CEO of TapImmune explains:

“We are very excited about this technology, as we believe it marks a next generation of T-cell vaccines. PolyStart has unlimited application in oncology and infectious diseases not only within TapImmune’s own platforms but it can be applied to many others via licensing. As we move forward into Phase 2 trials for TPIV 200, which targets folate receptor alpha, and TPIV 100/110 our Her2/neu product, we fully expect to develop PolyStart as both a stand-alone therapy and as a ‘boost strategy’ to be used synergistically with our peptide-based vaccines for breast and ovarian cancer.” 

I believe PolyStart is the icing on the cake of this soon-to-be-discovered, Nasdaq listed, biotech standout.


Conclusion

TapImmune (TPIVD) is a biotech stock that should gain solid traction with the pending NASDAQ uplisting. The company has 4 different clinical trials in Phase II for unmet needs in breast and ovarian cancers. Collaborations and partnerships with AstraZeneca, Memorial Sloan Kettering Cancer Center, and Mayo Clinic demonstrate the potential these world class organizations see in TapImmune and in the TPIV 100 & TPIV 200 clinical trials going forward.

The company has several positive forward drivers to increase momentum and share prices following the uplisting as well.

Investors can very reasonably expect increased retail and institutional awareness,  increased volume, and increasing share prices in the coming weeks/months.


See also: TapImmune Investor Presentation

tapimmune -gary pic

 

 

Disclaimer/Disclosure/Terms of Use

 

 

 

best-microcap-stocks-during-market-volatilityVolatility was the word for the last 6 trading days, and that volatility will likely continue next week as the Federal Open Market Committee meets on Tuesday and Wednesday. The FOMC will announce their decision on interest rates Wednesday.

While there are plenty of data points to support a 1/4 point increase in long term rates in the U.S., the global economy isn’t there, and our recovery isn’t robust enough to cause meaningful inflationary pressure.  As of Friday, U.S. inflation advanced by a rate of 1.1% over the past year after gaining 0.8% in July. This is the lowest rate of inflation since the 12 months ended December, and my guess is they’ll sit pat for September and telegraph a raise in December.

At any rate 🙂 , The VIX (Chicago Board Options Exchange Volatility Index) has been very, very quiet since the June Brexit news roiled the market. Some say the VIX was too quiet during July and August, and I’m in that camp.

However, the VIX heated up this week to top 20 briefly, as some uncertainty over the Fed’s decision on rates crept into the market’s psyche.

best-microcap-stocks-chart

 

As a measure of the “wall of worry” that the market must always climb, seeing the VIX spike up with some regularity every few months is healthy for the market over the longer term and should be seen in a positive light, especially after a such a historically quiet July and August. I was VERY HAPPY to see the markets rock and roll all over the place this week, and would like to see it continue for a while.


A correction of 5% or so in the next few weeks would be very bullish from my standpoint.

Should a 5-10% correction take place, (and many experts believe it’s coming), it will be a stock picker’s market, and you’ll want to find picks that:

  • have strong, positive near term drivers
  • are unlikely to be diluting shares soon
  • are a sector that’s currently in favor

Don’t worry, I have a few great suggestions that have all the above in place and I’ll begin writing about them starting next week!

 


Biotech is Hot (fact) and Going to Get Hotter (opinion which I’ll explain)

Biotech stocks have had a solid go of it for the last few months. The S&P Biotech Index is up 19.5% for the Quarter-to-Date (QTD) period, strongly outperforming all major market averages.

It’s noteworthy that biotechs have also outperformed their (usually much larger), pharma cousins…a trend which started in the summer and began to accelerate in early September as the chart below demonstrates.

best-microcap-stocks-biotech-and-pharma-chart

 

In this presidential election year, Big Pharma is under increasing bipartisan scrutiny over pricing practices. I believe investors are defensively rotating some funds out of pharma and into biotechs as a result, as the tough talk and rhetoric over drug pricing will likely escalate as November gets closer.


Biotechs on Pharma Shopping Lists

There was a significant drop in the public valuations of biotech companies in the third quarter of 2015 that accelerated into the first half of 2016.  Average biotech share prices have only just begun to swing up in the most recent quarter.

As a result, many see biotech stocks at comparatively good values here, while at the same time, biotechnology innovation has been very successful. As we all know, pharmaceutical companies require new products and drug pipeline assets, and often look to biotechs for their pipeline needs. This is particularly true in certain therapeutic categories and for companies and products that address desirable targets. The growth of orphan drugs and drugs addressing unmet medical needs in specialty areas has been positive for biotech economics given the shortened development and approval times.

A very recent example of Big Pharma looking to smaller biotech acquisitions for pipeline assets is Japan’s largest drug company, Takeda Pharmaceutical (4502.T), Takeda announced last week they have set aside $10 billion to $15 billion for acquisitions in the United States and other markets.

Takeda’s Chief Executive, Christophe Weber explained:

“We are now much more focusing on the reinforcement of our pipeline because this is where we need to do something, so that in five years, when we start to see more significant patent expiries, we will have a pipeline to replace that.”

Biotechs that address unmet medical needs (particularly in cancer R&D) are stated targets for Takeda, and that’s true for Big Pharma in the U.S. as well. All it takes is for a few ginormous players like Takeda to start shopping around in biotech and you have a recipe for a sector that will outperform.

For these reasons I’m expecting biotech to continue to outperform pharma stocks and the market in general, at least through November.

 


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