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.


  • Loading stock data...

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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MABVAX THERAPEUTICS - logoMabVax Therapeutics (MBVX) is a promising biotech company that recently uplisted to the Nasdaq Capital Market and received noteworthy investments from Dr. Phillip Frost and OPKO health (OPK).

The company presented at the Rodman & Renshaw Global Investment Conference earlier this week, and will be presenting in San Francisco at the BIO Investor Forum in October.

 

In the video below MBVX President and CEO, David Hansen, discusses the company’s exciting near and longer term drivers, as well as:

  • MBVX’s unique vaccination development capabilities
  • Focused on, but not limited to pancreatic cancers
  • Collaborations with Memorial Sloan Kettering, Rockefeller University, and Heidelberg Pharma
  • Promising early results from antibody therapy treatment
  • New diagnostic/imaging study beginning
  • Advantages of using a fully human antibody for new drug development
  • Pancreatic cancer and the unfortunate very rapid progression of the disease with extremely high mortality, despite the newest drugs on the market today
  • Strength of the MabVax intellectual property moat, and more

 

 


See also: MabVax Therapeutics (MBVX): A Compelling, Strong Buy with Multiple Near Term Positive Drivers

MabVax Therapeutics: Investor Presentation

Seeking Alpha: MabVax Therapeutics – Looking For A Needed Pancreatic Cancer Breakthrough

MabVax Therapeutics web site


MBVX will also be releasing new trial data on both the treatment drug and the imaging drug studies later this month. We will update subscribers as soon as the the data is public.


Best wishes for profitable investing!

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MABVAX THERAPEUTICS - logoIn my previous article on MabVax Therapeutics (MBVX) last week, “MabVax Therapeutics (MBVX): Promising Early Results in Treatment of Pancreatic Cancer, I wrote about a near term positive driver in the upcoming release (expected  this month) of data from the Phase I trial of lead drug development candidates MVT-5873 (Therapeutic Agent Study) and MVT-2163 (Imaging Study).

In this article, I’ll share other considerations that make MBVX shares a compelling and STRONG BUY.

These include:

  • Recent NASDAQ uplisting
  • Cash position/no near term stock offering/dilution needed
  • Noteworthy investments from Dr. Phillip Frost and OPKO health (OPK)
  • Development pipeline
  • Strength of management team
  • Strong chart technical indicators

MabVax Therapeutics (MBVX) Share Information

Shares outstanding: 5.6 million
Approximate float: 3.8 million
Close on 9/6/16: $5.30
Market cap: ~ 29.7 million

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MabVax Therapeutics is developing novel human antibody based products for the diagnosis and treatment of metastatic solid tumor cancers. MabVax has created a platform technology to discover antibodies from patient immune responses against their cancers. The company has a portfolio of fully human antibodies that are being developed to address unmet medical needs in several difficult to treat cancers such as pancreatic, small cell lung, sarcoma, ovarian, and breast cancer.
MabVax Therapeutics’ lead antibody development program is HuMab-5B1 The company started two clinical trials this year with a therapeutic agent (MVT-5873) and as a new generation PET imaging product (MVT-2163). In addition, MabVax has identified a radioimmunotherapy agent (MVT-1075) and plans to file an Investigational New Drug Application (NDA) with the FDA later in 2016.

Nasdaq - MabVax TherapeuticsMabVax Therapeutics uplisted from the over-the-counter market to the Nasdaq Capital Market, effective August 17th. While the benefits of this uplisting are known to most investors, they bear repeating.

The listing opens MabVax Therapeutics up to an entire market of institutional investors that previously could not buy the shares. Some institutions won’t touch a stock trading below $5/share, regardless of the exchange. With MBVX trading at/near that $5 point, and an update on Phase I trials of two lead drug candidates, expect that participation to increase as more institutions discover the stock. It’s not hyperbole to say that pancreatic cancer pharmaceuticals are typically blockbuster drugs, and as MabVax progresses lead candidates in the FDA trials, institutional participation should ramp considerably. Additionally, there are many retail investors who won’t touch a stock trading under $5 as well.

The Nasdaq Capital Market requires higher standards of  corporate governance and transparency to be in place for listed companies, another obvious benefit for shareholders. The bottom line here is that the Nasdaq Capital Market listing is very positive for MabVax Therapeutics and shareholders going forward, and buying shortly after the uplisting, (as in right now), is just plain good old fashioned common sense investing.


MBVX is Well Capitalized Following Recent Raise

Pharma and biotech stocks are cash-intensive and the need for a near term capital raises is a consideration. Buying shares after a recent raise is often the best way to avoid a dramatic drop in share price, plus unwanted dilution.

Fortunately, MabVax just completed a capital raise of $9.4 million and (from my discussion with management) the company now has access to approximately $16 million in cash. The present cash burn is about $1 million/month, so chances of near-term dilution are slim to none. This is a time when I love to buy biotech and pharma stocks! I hate surprises and dilution…who doesn’t?


Noteworthy Investments from Dr. Phillip Frost

As many reading this are aware, Dr. Phillip Frost is a well known and highly respected biotech investor. Often referred to as “the Warren Buffett of biotech”, his investments in MBVX shares began back in April, 2015, See: “MabVax Therapeutics Catches Eye of Billionaire Investor Dr. Phillip Frost and OPKO Health“.

Dr. Frost and $5B market cap OPKO Health (OPK) added shares of MBVX in the just-completed capital raise. If you peruse the SEC filings from April 2015-present, you’ll discover that Dr. Frost and OPKO Health now have an approximate 15% stake in MabVax Therapeutics. As a shareholder of MBVX myself, I like that.


Ability to Develop Multiple Blockbuster Drugs with HuMab-1 Antibody

Due to the properties of MabVax’s HuMab-5B1 antibody, drug development is not limited to a single cancer type. The 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers.

The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

HuMab-5B1 was derived from a patient vaccinated with MabVax vaccine licensed from MSKCC

  • Patients repeatedly vaccinated to drive immune response against cancer antigen
  • Patient samples obtained at maximal response
  • HuMab-5B1 chosen because of optimal characteristics
  • Patient outcomes
    – Seven Stage IV patients vaccinated in 4Q08 and six are still alive (median: 197 weeks post-vaccination)
    – Patient from whom derived the HuMab-5B1 antibody remained disease free at 5+ years

The HuMab-5B1 antibody has ideal characteristics that enable development of a broad commercial platform of cancer drugs:

Characteristic Technical Description Advantage of HuMab-5B1
Targeting cancer cell Specificity Exquisitely specific; only recognizes the target on cancer cell
Binds tightly to target cell Affinity Binds quickly to cancer cell and is slow to come off
Cytotoxicity ADCC and CDC Antibody has potency to kill cancer cells through normal cell killing mechanisms
Does not target normal cells Immunohistochemistry Ability to avoid on target off tumor activity that could raise undesirable side effects
Additive effect with chemotherapy Synergy Improves potency of standard of care chemo therapy by 50% in early studies
Ability to attach additional agents Conjugation Very easy to attach a radiolabel for PET imaging or a radioactive isotope to make a radioimmunotherapy product or to attach a toxin payload to make an antibody drug conjugate (ADC)
Benign side effect profile in animal toxicology studies Clear GLP Toxicology The infusion and activity of the antibody did not cause unanticipated or worrisome side effects in our pivotal toxicology studies in primates
Precision medicine platform Directive agent for multiple products Precisely targeting cancer cells allows for localization of immunotherapy, companion diagnostics, and molecularly targeted payloads for more potent therapies

Due to the positive characteristics of MabVax’s HuMab-5B1 listed above, the drug pipeline in chart below and collaborations with Memorial Sloan Kettering Cancer Center, the NIH, Heidelberg Pharma, and Rockefeller University could be just the beginning:

MabVax Therapeutics pipeline


Early Results Beat Blockbuster Drug Paclitaxel (Taxol) in Small Cell Lung Cancer

Early studies from the MVT-5873 trial, (which management will be giving an update on in September), show that doses of 25mg/kg and 50mg/kg of MVT-5873 resulted in a greater slowing of tumor growth than 10mg/kg of Paclitaxel alone.

Moreover, the combination of MVT-5873 with Paclitaxel demonstrated a strong synergistic effect on Paclitaxel alone in slowing lung cancer tumors.

  • Keep in mind that because MVT-5873 is based on MabVax’s HuMab-5B1, side effects to date have been benign/minimal.
  • Also keep in mind Paclitaxel remains a widely prescribed chemotherapy drug and the market capitalization of MBVX is a mere $29.7 million today.

 

MabVax Therapeutics vs. Placlitaxel

 

 


Early Results also Show Much Greater Slowing of Tumor Growth when Combined with Current Standard of Care Drugs for Metastatic Pancreatic Cancer

 

MabVax Therapeutics Pancreatic Cancer efficacy

 


Strong Patent Moat

The major claims of patents awarded to MabVax Therapeutics to date cover composition of the vaccine, methods of treatment, chemical modification of antigens, and synthesis.

11 issued patents and 3 pending applications in the U.S.
– Issued patents covering monovalent and polyvalent vaccines, methods of manufacture,
methods of use
– 2 pending applications covering monoclonal antibodies
14 international patents and 3 pending applications
– Issued patents covering monovalent and polyvalent vaccines, methods of manufacture,
methods of use
– 2 pending applications covering monoclonal antibodies
Orphan drug designation available for vaccine and antibody products
– Received U.S. FDA ODD in Sept 2014 for neuroblastoma vaccine


Highly Skilled, Veteran Management Team with Extensive Drug Development and Commercialization Experience

The management team’s experience in drug development, joint ventures, and drug commercialization/product launches adds exceptional value that will be realized by more institutions as the company continues to be discovered on the Nasdaq Capital Market.

 

Founder and CEO, J. David Hansen
David Hansen has more than 30 years of industry experience as a biopharmaceutical industry executive, having held senior management roles in both private start-up companies as well as small to mid-sized public companies. His senior level experience includes executive management, finance and accounting, corporate development, sales and marketing. During his career, Mr. Hansen has executed a wide variety of in and out licensing agreements, research and development collaborations, joint ventures, divestitures, and acquisitions. Mr. Hansen has expertise in the therapeutic areas of immunology, oncology, and infectious disease. Mr. Hansen gained executive management experience at several life sciences companies prior to co-founding MabVax Therapeutics that make him particularly suited for his leadership role. He was a corporate officer of Avanir Pharmaceuticals where he held the titles of Vice President of Commercial Development, Senior Vice President of Corporate Development, and President and Chief Operations Officer of the Avanir Subsidiary Xenerex Biosciences. Prior to Avanir, Mr. Hansen served in multiple roles at Dura Pharmaceuticals including National Sales Director, Director of Marketing, and Director of Business Development. He has additional management experience with Merck & Co. (Schering-Plough), Key Pharmaceuticals, and Bristol Myers Squibb.

Co-founder and Chief Science Officer, Philip Livingston, M.D.
Philip Livingston received his MD degree from Harvard Medical School and was Professor of Medicine in the Joan and Sanford Weill Medical College at Cornell University and Attending Physician and Member in Memorial Sloan-Kettering Cancer Center (MSKCC) where he treated melanoma patients and ran the Cancer Vaccinology Laboratory research lab for over 30 years until his retirement from MSKCC October 1, 2011. Dr. Livingston’s research focused on: identification of suitable targets for immunotherapy of a variety of cancers, construction of polyvalent conjugate vaccines specifically designed to augment antibody responses against these targets, and identification of optimal immunological adjuvants to further augment the potency of these vaccines. He has over 150 publications and 4 issued and 3 pending patents concerning cancer vaccines.

Co-founder and Vice President of Antibody Discovery, Wolfgang Scholz
Wolfgang W. Scholz, Ph.D. has extensive drug discovery experience in multiple therapeutic categories and has collaborated with major pharmaceutical companies on several projects. He was Senior Director at Avanir Pharmaceuticals, where he led research and development efforts for 8 years, and was a co-founder of Xenerex Biosciences, a subsidiary owned by Avanir Pharmaceuticals. Under his leadership, the antibody discovery group at Xenerex developed human monoclonal antibodies to multiple infectious disease targets using in vitro and SCID mouse technologies, and one antibody (AVP-21D9) was successfully out-licensed and recently passed Phase I safety testing. Prior to Avanir, Dr. Scholz held positions with increasing responsibilities at Tanabe Research Laboratories. Dr. Scholz is the principal investigator on multiple National Cancer Institute grants received by MabVax totaling almost $5 million. Dr. Scholz is an inventor on three pending and three issued antibody patents, three issued small molecule patents, and author on thirty-four peer-reviewed publications. Dr. Scholz earned his Ph.D. in Microbiology and Immunology from the University of Kiel, Germany in 1985 and completed his postdoctoral training at The Scripps Research Institute, La Jolla.

Vice President and Chief Business Officer, Paul F. Resnick
Dr. Resnick has an M.D. from The Medical College of Wisconsin and an MBA from The Wharton School of the University of Pennsylvania, and recently joined MabVax Therapeutics in April of this year. Prior to joining MabVax, Dr. Resnick was Senior Vice President, Business Development for Juventas Therapeutics, where he was responsible for business and commercial strategy and working with executive management overseeing corporate clinical development, and financial and business strategies. From January 2008 to January 2012 he was Vice President, Business Development for Intellikine, Inc. (acquired by Takeda Pharmaceuticals), responsible for managing alliances and leading the business development strategy that resulted in securing an acquisition by Takeda Pharmaceuticals. Dr. Resnick also held Senior Director positions for Worldwide Business Development, and for Strategic Alliances, at Pfizer Inc., where he was responsible for networking with leaders from biotechnology companies, universities, and research institutions to gain early insights into emerging technologies, and for leading technical and business diligence, negotiations, and alliance management of science and technology initiatives for Pfizer’s Biotechnology and Bio-innovation Center. Prior to Pfizer Dr. Resnick held Director and Senior Director positions at Rinat Neuroscience (acquired by Pfizer), Intermune, Inc. and Roche Pharmaceuticals.

Executive VP of Research and Development, Paul W. Maffuid, Ph.D.
Dr. Maffuid’s management experience includes global pharmaceutical organizations, developing biotechnology companies and contract development and manufacturing organizations. His senior level management experience includes leadership for product development, manufacturing and drug disposition. Throughout his career, Dr. Maffuid’s organizations were integral for research and development activities and represented by regulatory filings for biopharmaceuticals and small molecule therapeutics indicated for oncology, diabetes, CNS disorders and obesity. Dr. Maffuid served as Executive Vice President, Pharma Operations for AAIPharma Services Corporation and was a member of the Executive Team that transformed a declining business into a leading provider of integrated drug development services. His responsibilities included formulation, manufacturing, and analytical services for clients developing biologic and small molecule therapeutics. Prior to joining AAIPharma he was the founder and President of Biopharmalogics, Inc. a consulting company supporting the development of pharmaceutical products from 2008 to 2011. Earlier in his career Dr. Maffuid was Senior Vice President of Operations at Irvine Pharmaceutical Services, Inc., and Vice President of Pharmaceutical Development for Arena Pharmaceuticals. While at Arena Pharmaceuticals Dr. Maffuid was a member of the executive management team, was responsible for drug product and drug disposition research and development operations, and led the design and construction of a cGMP compliant pilot manufacturing facility. Dr. Maffuid’s management experience also includes Amylin Pharmaceuticals, Magellan Laboratories and Glaxo Research Institute (currently GSK).

Chief Financial Officer, Gregory P. Hanson
Gregory P. Hanson, CMA, has over 30 years serving as CFO/financial executive of both public and private biotech and hi tech companies. From January 2008 to February 2014 Mr. Hanson was Managing Director of First Cornerstone, a board and management advisory service to companies and executives in the areas of international corporate development, financing strategies, commercialization of technologies and products, and M&A advisory service. Since November 2009, Mr. Hanson has served as Advisory Board Member of Menon International, Inc. involved in commercialization of biosensor devices and assays, and renewable products. Since October 2011, Mr. Hanson has served on the Life Sciences Advisory Board of Brinson Patrick Securities, a boutique investment bank. He also serves as mentor and confidential advisor to several other tech and life sciences companies. Mr. Hanson is Past-President and 9-year Member of the Board of Directors of San Diego Financial Executives International (FEI), and a member of the Capital Formation Committee at BIOCOM since 2011.  Mr. Hanson served as Senior Vice President of Brinson Patrick Securities, where he opened up the San Diego branch and introduced at-the-market financing strategies to public life sciences companies. Prior to Brinson Patrick Securities, Mr. Hanson served as Senior Vice President and Chief Financial Officer of Mast Therapeutics (MSTX—NYSE MKT), and prior to Mast Therapeutics was Vice President and CFO, Chief Accounting Officer, Compliance Officer and Corporate Secretary of Avanir Pharmaceuticals, Inc. (acquired by Otsuka Holdings Co., Ltd.), the developer of the cold sore product Abreva™, and Neudexta™, for the treatment of Pseudobulbar Affect, a central nervous system disorder. During the course of his career, Mr. Hanson has completed approximately $1 billion in financing, licensing and partnering arrangements. Mr. Hanson was a founding and 6-year member of the Small Business Advisory Committee to the Financial Accounting Standards Board, and has spoken at various national conferences, industry organizations and panels on financing strategy and mergers and acquisitions, and twice spoken to the SEC’s Committee on Improvements to Financial Reporting. He has an MBA with distinction from the University of Michigan, and a BS in Mechanical Engineering from Kansas State University.


Chart Technicals

The MBVX chart looks strong here, with a notable increase in volume since the NASDAQ uplisting, accompanied by a rise in share price as recent lows bounced off the uptrend line.

MabVax Therapeutics stock chart

 

 

Keep in mind many institutions can not buy stocks trading below $5/share.  As MBVX continues to close above $5/share, investors can expect an increase in institutional participation.


Review of Near Term Forward Drivers

In addition to increased institutional participation following the Nasdaq uplist and low float (3.8 million shares), there are several positive drivers that should push MBVX shares higher during the remainder of 2016.  These are:

  • MVT-5873 (for treatment of pancreatic cancer) and MVT-2163 (a companion diagnostic) interim program milestones expected this month (with full Phase I readout mid-2017)
  • Plans to file IND for radioimmunotherapy program Q4 2016
  • Presentation and meetings with investors at the 18th annual Rodman & Renshaw Global Investment Conference in NYC 9/11-9/13/2016 (see brochure)

Conclusion

MBVX is a compelling buy here due to:

  • Recent NASDAQ uplisting leading to increased institutional and retail investor awareness and participation
  • Cash position/no near term stock offering/dilution needed
  • Noteworthy, repeat investments from Dr. Phillip Frost and OPKO health (OPK) for an approximate 15% stake in company to date
  • Strong drug development pipeline using HuMab-5B1
  • Strength of management team
  • Strong chart technicals
  • Near term positive drivers
  • Low float + tiny market cap ($28 million) with blockbuster pancreatic cancer drug development potential

 

I’ll be attending the Rodman and Renshaw conference in NY next week.  I look forward to meeting management of MabVax Therapeutics, and sharing more near term positive developments with subscribers!

Supplemental: August, 2016 Investor Presentation


Best wishes for profitable investing!

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Part I of II: Expect Near Term Positive News on Lead Product Candidates from MBVX


MabVax Therapeutics (MBVX) Share Information

Shares outstanding: 5.6 million
Approximate float: 3.8 million
Close on 8/29/16: $5.00
Market cap: ~ 28 million

Repeat investments from Dr. Phillip Frost and OPKO Health (OPK) began in April 2015 and account for an approximate 15% stake in MabVax


Pancreatic cancers are extremely complex and, unfortunately, highly lethal.  According to the American Cancer Society the one-year relative survival rate is 20% and the five-year rate is 7% for all stages of pancreatic cancer combined. The 5-year survival rate for patients with metastatic pancreatic cancer is approximately 1 (one) percent.  This is a horrific disease in which survivability for the vast majority of patients is measured in weeks and months.

However, an area of research in pancreatic cancer treatment that shows initial and growing promise is in the development of immuno-oncology and cancer vaccines.  The American Cancer Society notes that:

“Immune therapies attempt to boost a person’s immune system or give them ready-made components of an immune system to attack cancer cells. Some studies of these treatments have shown promising results.”

and

“Several types of vaccines for boosting the body’s immune response to pancreatic cancer cells are being tested in clinical trials. Unlike vaccines against infections like measles or mumps, these vaccines are designed to help treat, not prevent, pancreatic cancer. One possible advantage of these types of treatments is that they tend to have very limited side effects. At this time, vaccines are available only in clinical trials.”


MabVax Therapeutics (web site) has shown early, promising results in clinical trials of immuno-oncology products developed from the human immune response to cancer, with an emphasis on pancreatic cancer.

MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.
The HuMab-5B1 antibody has very good tumor targeting capabilities as well as being internalized by pancreatic cancer cells. These important attributes have allowed MabVax to use the HuMab-5B1 antibody as a tumor-targeting platform upon which we have created multiple products. The antibody itself is in a Phase I clinical trial as a therapeutic agent. This same antibody when combined with a radiolabel is a potentially new generation PET imaging agent and is also in a Phase I clinical trial. We are also developing more potent HuMab-5B1 based products such as a radioimmunotherapy product when the antibody is combined with a radioisotope and lastly, an antibody drug conjugate when combined with a toxin payload. While all of the mentioned products are based on the targeting capabilities of HuMab-5B1, each product has unique characteristics and potential uses for the treatment of multiple types of solid tumors.

Additionally, MabVax has:

  • an attractive, multi-pronged drug development pipeline
  • wide and expanding patent moat
  • recent (August 17th) NASDAQ uplisting 
  • low float (3.8 million shares)
  • significant and recurring investments from Dr. Phillip Frost and OPKO Health, Inc.
  • including recent capital raise, (closed August 22), MabVax Therapeutics can access $16M cash with a burn rate of ~ $1M/month
  • positive near term drivers- early data from promising Phase 1 studies of lead product candidates expected within 5 weeks

MABVAX THERAPEUTICS - logo

MabVax Therapeutics Holdings, Inc., a clinical-stage biopharmaceutical company, engages in the discovery, development, and commercialization of proprietary human monoclonal antibody products and vaccines for the diagnosis and treatment of various cancers. It has a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers. The company generates its pipeline of antibody-based product candidates from patients who have been vaccinated with propriety vaccines licensed from Memorial Sloan-Kettering Cancer Center (MSKCC). Its lead cancer vaccines targeting recurrent sarcoma and ovarian cancer are in proof of concept Phase II multi-center clinical trials. The company’s product candidates include 5B1 antibody program, 5B1 imaging program, and 5B1 antibody drug conjugate, which targets an antigen over expressed on metastatic pancreatic, colon, stomach, ovarian, breast, and small cell lung cancers. It also develops follow-on antibody products, including 1B7 and 31F9 antibody programs to the antigen GD2, which is over expressed on sarcoma, melanoma, and neuroblastoma. The company has collaboration agreement with Heidelberg Pharma GmbH, as well as a research collaboration agreement with Rockefeller University’s Laboratory of Molecular Genetics and Immunology. MabVax Therapeutics Holdings, Inc. was founded in 2006 and is based in San Diego, California.


Lead Product Candidates MVT-5873 (Therapeutic Agent) and MVT 2163 (Imaging Agent)

MVT-5873 (Therapeutic Agent Study)

The Phase I trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first group of patients will be enrolled in a traditional dose escalation regimen to assess safety, the pharmacokinetics and determine the optimal dose of the antibody. A second group of patients will establish the safety and optimized dose of the antibody when administered with a standard of care chemotherapy as a first line therapy for the treatment of patients with advanced cancer.

 

On March 21, 2016, MabVax announced the initiation of the Phase 1 trial of MVT-5873 in patients with pancreatic cancer. This is an open label, multi-center, dose escalation clinical trial with patient enrollment initiated at three clinical trial sites: Memorial Sloan Kettering Cancer Center (MSK) in New York as well as two sites within the Sarah Cannon Research Institutes network at the Tennessee Oncology site in Nashville, TN, and Sarah Cannon Research Institute at Florida Cancer Specialists in Sarasota, FL.

The initial cohort of patients will be treated with 1, 3, 6 or 10 mg/kg of MVT-5873 to determine the MTD. This dose will then be utilized in an expansion cohort of approximately 10 subjects to examine additional safety and PK parameters. For the combination study, the first cohort will be treated with one dose below the MTD with escalation up to the MTD. This dose will then be utilized in an expansion study where MVT-5873 will be administered alongside the standard of care chemotherapeutic agent gemcitabine.

See ClinicalTrials.gov for in-depth study information.


Positive Early Results Hinted at in 10-Q Filing on 8/11/16: 

On page 24 of the 10-Q filing for the quarter ending June 30, 2016, MabVax Therapeutics disclosed (in relation to MVT-5873) that:

“Of the nine patients who have been dosed to date, five have been treated for three or more months and investigator observations have noted stable disease for a subset of those patients. We are continuing to escalate the drug dose to assess safety and reach an MTD and anticipate initiating the second portion of the trial where our drug is dosed in combination with chemotherapy in the fourth quarter of this year.  We expect to have the preliminary results of this clinical trial later in the third quarter in 2016.”

Now, a “stable disease for a subset of those patients” (with late-stage, metastatic pancreatic cancer) could be a very positive near term driver.  Expect a press release on these exciting early results by end of the current quarter…within the next 5 weeks based on the SEC filing. 


MVT-2163 (Imaging Study)

As a bit of background, part of the reason pancreatic cancers are so lethal is because they typically cause no symptoms, or (at best) vague symptoms in the earlier stages. As a result, the diagnosis of pancreatic cancer is most often made at a very late, metastatic, stage IV disease.

Widespread screening, (analogous to mammograms for breast cancer or colonoscopy for colon cancer), is not practical for this less common cancer. However, improved diagnostic imaging tests can be extremely useful in high-risk groups, such as those with a strong family history of pancreatic cancer.

Simply put, the earlier this devastating  disease can be identified and aggressively managed, the better the chance for survival. Because of this, MabVax Therapeutics received a $1.75 Million contract for development of the HuMab-5B1/MVT-2163 Imaging Agent from the National Institutes of Health (NIH).

The Phase I clinical trial for MVT-2163 (see ClinicalTrials.gov)  was initiated in the second quarter of 2016 at Memorial Sloan Kettering Cancer Center for the Company’s new generation fully human immuno-PET imaging agent. In this Phase I trial, the safety, pharmacokinetics and biodistribution of MVT-2163 is being evaluated in patients with pancreatic and other CA19-9 positive cancers. The trial will determine the ideal dose and conditions for an optimal PET scan image.

MVT-2163 has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of patients with pancreatic cancer and an attractive companion diagnostic for the MVT-5873 therapeutic product.

 

Mabvax Therapeutics - study


Like the early results from the MVT-5873 study, MabVax Therapeutics plans to provide an update on MVT-2163 in the near term according to the August 11th 10-Q filing which states:

“Investigator observations showed scans potentially highlighting smaller metastatic sites not seen on standard CT scans.  These results are preliminary and require more patients to confirm.  We expect to have the preliminary results of this clinical trial later in the third quarter 2016”


Clearly there are exciting times ahead for investors in MabVax Therapeutics, and more significantly, some cause for optimism in the future treatment of pancreatic cancer.

 

See Part II: MabVax Therapeutics (MBVX): A Compelling, Strong Buy with Multiple Near Term Positive Drivers

See also: MabVax September Investor Presentation

 


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GeospatiaGeospatial Corporation logo - Copyl Corporation (GSPH), a 3D underground infrastructure mapping solutions provider and Google for Work Technology Partner, released video showcasing their cloud-based SaaS at GeoUnderground.

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Geospatial Corporation CEO, Mark Smith, stated today that:

Geospatial continues to make substantive progress applying our underground mapping technologies and adding unique features to our powerful yet easy to use GeoUnderground Software Solution to accurately map critical underground infrastructure in both position and depth (3D). The strong interest in the country’s deteriorating infrastructure creates a growing need for Geospatial’s underground infrastructure services. As a Google for Work Technology Partner we are expanding our marketing efforts which should continue to yield promising results.


Geospatial Corporation - google logoGeospatial was selected by Google as the only Google for Work Technology Partner that offers 3 dimensional underground mapping solutions.

Since passage of the PIPES Act of 2016 which requires certification, data management, testing and mapping of all types of the more than 2.6 million miles of buried energy pipelines across the USA, Geospatial CEO Mark Smith informed me: “Inquiries have skyrocketed”.

 


Turning “Location” Only Competitors Into GeoUnderground Service Partners

Geospatial Corporation’s advanced 3D underground mapping technologies combined with GeoUnderground’s SaaS platform is a one-two punch to competitors. There is a world of difference between “locating” underground infrastructure in only 2 dimensions and 3 dimensionally mapping it. Location-only, 2 dimensional providers don’t convey depth of structures and accuracy is limited. This “location only” group would include engineering companies and companies that plant yellow flags and paint lines on streets prior to a construction project. It also over 60,000 conventional surveyors across the United States.

Between offering vastly superior data collection technologies for 3 dimensional mapping and being the only Google For Work Technology Partner for 3D underground mapping at GeoUnderground, Geospatial Corporation sees the thousands of 2 dimensional, location-only providers as future customers, not competitors.

It’s easy to see how the newly-launched Geospatial Partner Program could drive revenue growth going forward, especially as the PIPES Act of 2016 mandates the certification, data management, testing and accurate mapping of all buried energy pipelines in the USA.

 


Geospatial has collected many miles of infrastructure data for a wide variety of industries including Federal Agencies, Energy and Telecom companies and utilities, Municipal and Commercial clients, as well as, International clients.

Geospatial has worked for these pipeline operators and utilities who are among the largest in the world:

3D Underground mapping- GSPH partners


For more on Geospatial Corporation, see:

Geospatial Corporation Business Summary PDF

Article: New Federal Law Creating Big Demand for Geospatial Corporation (GSPH)

What Lies Beneath, by Geospatial CEO, Mark Smith


GSPH offers complete, precise 3D mapping solutions of our nation’s underground infrastructure.

With the PIPES Act now law, and with GSPH as the only Google for Work Technology Partner for 3D underground mapping, I look forward to writing in more detail on the accelerating growth at GSPH in the weeks ahead.

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