• TapImmune (TPIV) is proceeding on a total of four Phase II clinical trials in the development of a novel vaccine that aggressively attacks ovarian and breast cancers
  • In the earlier Phase I study of TPIV 200 at Mayo Clinic, 100% of patients demonstrated a T-Cell response lasting over 6 months and the drug was found to be safe and effective in treatment of both ovarian and breast cancers  
  • TPIV has collaborative partnerships with AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic
  • TPIV received a $13.3 million grant from the U.S. Department of Defense which is fully funding a Phase II study of TPIV 200 in 280 patients with triple negative breast cancer being conducted at Mayo Clinic
  • TapImmune is well-funded and has no meaningful long term debt
  • TPIV has several positive forward drivers in coming weeks and months
  • With a Fast Track Designation and Orphan Drug Status under its wing, TapImmune is breaking down barriers at rapid speed and could very well have an up-and-coming commercial pipeline on its hands
  • TapImmune’s current market cap of just $36 million is a bargain given the company’s cash balance + $13.3 million grant from the U.S. government, + four Phase II studies in progress

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.

 


Shares outstanding: 8.4 million
Closing Price 2/24/2017: $4.30
Market cap: $36 million
Total Cash (mrq) $9.6 million
Cash/Share (mrq) $1.14
Debt (mrq) 5k
Current Ratio (mrq) 4.40

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Four Phase II Immuno-Oncology Trials Underway with Top Tier Partners

Immuno-Oncology (or cancer immunotherapy) is a ground-breaking approach in the fight against aggressive cancer that uses the body’s own immune system to fight the disease. TapImmune has four clinical trials now in phase II for treatment of ovarian and triple-negative breast cancers.

Investors should note that TapImmune has world-class sponsors and collaborators in these trials, including AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, Mayo Clinic, and the U.S. Department of Defense. The caliber of these sponsors and partners speaks volumes about the potential for breakthrough research in the cancer immunotherapy space by TapImmune.

TapImmune Pipeline

 


  • Phase II Trial of TPIV 200 for Triple-Negative Breast Cancer with Fast Track designation from the FDA

About 15-20% of all breast cancers are found to be triple-negative (meaning the breast cancer cells tested negative for estrogen receptors, progesterone receptors, and HER2). This form of 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). Triple-negative breast cancer tends to be more aggressive with higher mortality rates than other breast cancers.

The open-label, 80 patient clinical trial by TapImmune 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.

TapImmune announced a key clinical milestone earlier this month in passing a planned safety review that was performed when enrollment had reached 25 percent benchmark (20/80 patients).

In the prior Phase I study of TPIV 200 at Mayo Clinic, 100% of patients demonstrated a T-Cell response lasting over 6 months and the drug was found to be safe and effective in treatment of both ovarian and breast cancers.  

This study has Fast Track designation from the FDA which provides an expedited review to facilitate development of the drug.  This designation is granted in studies that treat serious or life-threatening conditions and fill an unmet medical need.


  • Phase II Mayo Clinic Trial of TPIV 200 in Triple-Negative Breast Cancer Fully Funded by U.S. Department of Defense

This is a separate Phase II study of TPIV 200 for the treatment of triple-negative breast cancer, conducted by the Mayo Clinic and sponsored by the U.S. Department of Defense (DOD). The 280 patient study is being 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.

$13.3 million worth of non-dilutive capital for trial.

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. This grant is a direct result of the very positive findings of the Phase I trial of TPIV 200 and validates TamImmune’s technology.

This Phase II launch is expected to begin shortly, and the announcement should be a positive driver for TPIV shares.


  • Phase II Trial at Memorial Sloan Kettering of TPIV 200 in Platinum-Resistant Ovarian Cancer in Collaboration with AstraZeneca on FDA Fast Track

Approximately 22,000 women were diagnosed with ovarian cancer in 2016 and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the five-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy.

There is currently no FDA approved cancer vaccine available for ovarian cancer.

This is 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 in collaboration with AstraZeneca. 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 these patients are unresponsive to platinum-based therapy and have failed chemotherapy, there are unfortunately, no real options left at the present time. If the combination therapy proves effective, it would address a critical unmet need.

TapImmune received the FDA’s Fast Track designation to develop TPIV 200 as a maintenance therapy in platinum-resistant ovarian cancer.

On the Fast Track designation, Dr. Glynn Wilson, Chairman and CEO of TapImmune stated:

“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 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.”


  • Phase II Trial in Platinum-Sensitive Ovarian Cancer 

TapImmune’s fourth Phase II trial utilizes TPIV 200 in ovarian cancer that is platinum-sensitive, and is being funded by the company. This study is an 80-patient double-blind placebo controlled study designed to examine the potential benefits of using the company’s lead product candidate TPIV 200 in combination with standard of care chemotherapy. The study has Fast Track designation from the FDA and TPIV 200 has orphan drug status for ovarian cancer.

In the January press release announcing the launch of this Phase II trial, Dr. John Bonfiglio, President and COO of TapImmune explained:

“The opening of this study represents the fulfillment of a major 2016 milestone. We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients. A fourth study in triple-negative breast cancer sponsored by the Mayo clinic with a $13.3M grant from the Department of Defense is scheduled to begin shortly. We believe the depth of these clinical programs will give us an excellent understanding of how this exciting T-cell therapy can potentially be used in the treatment of both triple-negative breast and ovarian cancers.”


See video from last week on TPIV:

“Vaccine could prevent breast, ovarian, lung cancer”

 


 


TPIV 100, TPIV 110 Also in Pipeline

The Phase 1 trial of TPIV 100 in 22 patients demonstrated the drug was safe and well-tolerated. The trial also showed that 19 out of 20 patients showed robust T-cell responses to two antigens while 15 out of 20 patients responded to all four antigens. The immune responses in these patients were durable for months after their final treatment.

 

The Phase 1b/2a program for TPIV 110 is designed to examine this novel T-cell vaccine both as a stand-alone therapy as well as a combination therapy with other standard of care therapies and newer experimental therapies. TapImmune plans to initiate TPIV 110 trials in breast cancer in 2017. The strategy is to obtain positive Phase 2 data and then look for a partnership or collaboration to fund the rest of the commercialization for TPIV 110.

TapImmune TPIV 110

Existing treatments such as Herceptin and Parjeta target the Her2/neu receptor and can work well in controlling the disease. However, the patient’s tumor must have the Her2/neu receptor (~30%) and in addition have the receptor in high enough density to make the antibody effective (~18% of the 30%). This leaves a void where patients who have the receptor but are not eligible for antibody treatment are relegated to chemotherapy, radiation and surgery.

TapImmune’s investigational product TPIV 110 also targets Her2/neu by stimulating the body’s own immune system to attack cancer cells with the Her2/neu target.

TapImmune plans to file an IND (Investigational new Drug) application with the FDA this year for TPIV 110.

TapImmune TPIV 110 development plan

 


Positive Upcoming Drivers

TapImmune has multiple positive drivers going forward, including:

  • Participation in multiple oncology and biotech events in March and April
  • Launch of the Phase II trial of TPIV 200 at Mayo Clinic, fully funded by a U.S. Government grant of $13.3 million
  • Clinical data coming out of multiple Phase II trials of TPIV 200
  • IND announcement on TPIV 110 expected during Q1 this year
  • Initiation of the Phase 1b/2a studies using TPIV 110

Preclinical, A Next Generation T-Cell Vaccine: PolyStart

PolyStart is a unique antigen expression system that ‘elevates’ the expression, and consequently the processing and presentation of desired antigenic peptide(s) for the stimulation of T-killer and/or T-helper cells to recognize and kill target cells. This novel vaccine technology platform creates a four-fold or greater increase in presentation of any antigen, giving it unlimited application in oncology and infectious diseases. This allows TapImmune to not only leverage the technology for its own vaccine candidates, but also generates additional value for the platform via licensing to third parties.

In February of this year, TapImmune expanded its patent on the PolyStart Platform for use in next-generation T-cell vaccines. Glynn Wilson, Chairman and CEO of TapImmune stated that:

“This patent significantly enhances our IP position for our PolyStart platform, further positioning TapImmune as a leader in the development of next-generation vaccines for cancer. The allowed claims cover enhanced expression of class I and class II HER2 antigens, enabling us to create future vaccines that should elicit robust and long-lasting T-cell immune responses against HER2/neu+ cancers with enhanced potency. While we focus on advancing our multiple Phase 2 clinical programs in ovarian and breast cancer, we expect to continue developing PolyStart to be used synergistically with our peptide-based vaccines as well as potentially monetized through licensing or partnership with other vaccine developers in oncology and infectious disease applications.”

PolyStart 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.

PolyStart enhances immune responses in patients not only for cancer drugs but for infectious disease and other products. TapImmune believes PolyStart has unlimited application in oncology and infectious diseases not only in the Company’s own platforms, but that it can be applied to many others via licensing.

The data below is from an earlier 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 in 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.” 

Along with novel peptides and the PolyStart expression system, the TPIV vaccine platform can address multiple infectious diseases as well as pandemic and biodefense threats. TapImmune’s current Smallpox vaccine study at Mayo Clinic has already shown significant benefits over the current vaccine stockpile. It is naturally processed and peptide based, making it safer, longer lasting, cheaper and as effective (in animal studies) as the current product stockpile. The last DHHS contract for a smallpox vaccine stockpile was worth up to $2.8 billion.


Conclusion

TapImmune (TPIV) is at the forefront of the immuno-oncology space and has world-class collaborative partners in AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic. The fact that the U.S. government has fully funded the Phase II trial of TPIV 200 for the treatment of triple-negative breast cancer validates the strong data obtained from the preceding Phase I trial. Additionally, the grant provides $13.3 million of non-dilutive funding for TapImmune’s research.

Given that TapImmune has a healthy cash balance of $9.6 million (mrq) and is receiving some $13.3 million in non-dilutive grants from the U.S. government, the market cap of $36 million seems extremely low- especially given the company has four different Phase II trials on progress for what could be a game-changing vaccine in the fight against cancer.

 


See also: TapImmune January 2017 Investor Presentation

Interview With TapImmune, Inc. (NASDAQ: TPIV) President And COO, Dr. John Bonfiglio (SmarterAnalyst- January, 2017)

TapImmune Developing Vaccines for Breast and Ovarian Cancer (Biosience Technology- December, 2016)

One Big Question: How close are we to a cancer vaccine? (NewAtlas- December, 2016)

Vaccine could prevent breast, ovarian, lung cancer (Fox News- February, 2017)


tapimmune -gary pic

 

 

Disclaimer/Disclosure/Terms of Use

 

 

 

  • Nothing advances share prices like the strong top and bottom line growth DarioHealth Corp. (DRIO) is experiencing
  • DRIO reported a whopping 282% growth in sales for the previous 9 month period ending last September
  • Expect a record Q4 and full 2016 results when DRIO reports next month,a strong catalyst to drive shares higher
  • FDA approval for the Android version of the DarioSmart Diabetes Management Solution is expected by mid-2017, another positive catalyst for the company
  • Near-term launch in Germany pending, further accelerating sales
  • Coming off a $5.1 million raise last month, DRIO has a strong balance sheet to continue rapid market penetration
  • DRIO has a unique business model in the Mobile Health (mHealth) space that helps customers better manage their diabetes, and that model, (along with the Company’s proprietary technology), is the driving force behind the growth

dariohealth-logo

DarioHealth Corp. (NASDAQ:DRIO), (web site), is a digital health company that develops and commercializes patented and proprietary technologies providing consumers with laboratory-testing capabilities using smart phones and other mobile devices.

Its flagship product is the Dario Smart Diabetes Management Solution, a mobile, real-time, cloud-based, diabetes management solution based on a multi-feature software application combined with Dario Smart Meter, a pocket-sized, blood glucose monitoring device.

DarioHealth Corp. has marketing clearance in Europe and the U.S. and the Dario iOS mobile app recently launched with reimbursement in the United Kingdom, Australia, Israel, Italy, and Canada. Additionally, DarioHealth has launched in New Zealand, the Netherlands, Italy, and Belgium.

The company is also pursuing patent applications in various jurisdictions covering the specific processes related to blood glucose level measurement, as well as various general methods of rapid tests of body fluids using mobile devices and cloud-based services. The company was formerly known as LabStyle Innovations Corp. and changed its name to DarioHealth Corp. in July 2016. The company was founded in 2011 and is headquartered in Caesarea, Israel.


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Share Information

Shares Outstanding: 7.3 million
Insider ownership: ~40%
Float: 2
.9 million
Closing Price 2/17/2017: $3.86
Market Capitalization: $28 million
Revenue/Share 0.51
Quarterly Revenue Growth (yoy) 167%

 


DarioHealth Corp. Experiencing Strong Top and Bottom Line Growth

Nothing drives share price appreciation more than strong fundamentals, something DarioHealth Corp. has in spades. DarioHealth grew sales by 282% during the first 3 quarters of last year as compared to the same period in 2015, from $515,000 to $1,965,000 (see SEC filing).  Moreover, loss/share was trimmed to (.31) from (.90) during Q3 of 2016 vs. the same period in 2015. This strong improvement in top and bottom line growth is no fluke- it’s due to several factors that set DRIO apart from competitors, factors that I’ll discuss below.

Record Q4 Report Pending

DarioHealth will be reporting Q4 and full year results in March, and indications are that Q4 will be a new record for the company. This is due in part to the launch of DarioHealth Blood Glucose Monitoring System in the U.S. market, a launch in its infancy that’s producing very substantial early results. On January 23rd, DRIO gave a peek at the upcoming Q4 results from the U.S. market launch, and the numbers are impressive:

  • More than 8,500 were sold in the U.S during Q4 alone, increasing market presence by 85% compared to the end of the third quarter
  • 18,500 Dario All-in-One Smart Glucose Meter devices were purchased in the U.S. alone during the company’s 2016 U.S. launch
  • Nearly 95% of U.S. users have ordered test strips
  • DarioHealth generates recurring revenue between $150-$500/user annually from sales of disposable monitoring strips

DRIO is the classic “razor-razorblade model” on steroids. FDA approval of Android version will increase market penetration + launch in Germany also pending.

By taking the lower end of annual recurring revenue/user of only $200 and the 95% U.S customer conversion rate to disposable test strip consumers (or approximately 17,500 of U.S. customers), DRIO is looking at $3.5 million in annual recurring sales from the U.S. market alone for 2017 ($200 x 17,500). Keep in mind this is using the lower end of the $150-$500 annual recurring revenue/customer range and includes just the U.S. market alone, where DRIO is still ramping up sales. It does not account for growth in multiple other markets, (including the United Kingdom, Australia, Israel, Italy, and Canada, New Zealand, the Netherlands, Italy, and Belgium), or Germany where DarioHealth has a launch pending.

DRIO also submitted the Android version of the Smart Diabetes Management System to the FDA and expects approval in Q1 or early Q2 of this year. There are approximately 107 million users of android devices in the U.S., so this is a noteworthy market for expansion.

Given the facts above, investors can look forward to a record Q4 and full year 2016 to be reported in the DRIO 10-K filing due in early March, followed closely by a record Q1 2017.


Recent Capital Raise Will Fuel Rapid Expansion and Strong Sales Growth

DarioHealth has a strong balance sheet with current assets of $5.6 million and current liabilities of $2 million for a healthy current ratio of 2.8. Keep in mind the balance sheet is from Q3 of 2016 and does not include the cash infusion of approximately $5 million in gross proceeds expected from the Company’s recent raise announced January 12, 2017.

The financing deal was led by OurCrowd Qure, a dedicated digital health fund that invested $2.5 million of the $5.1 million. OurCrowd Qure has been granted two board seats which will be selected and announced at a later date.

On the recent funding, Erez Raphael, Chairman and CEO of DarioHealth stated:

We have received great support and belief in our product, vision, and growth strategy from investors. With this funding, we will accelerate adoption of our innovative and user-friendly remote glucose monitor platform across current markets and also expand into new geographies, such as Germany, in 2017.”

 


Analyst Sees $8 Million in Sales for 2017 and $19 Million for 2018

Analyst Joseph Gunnar & Co has a well-researched report on DarioHealth you can read here. In the report you’ll find sales estimates of $2.9 million for 2016, $8 million for 2017, and $19 million for 2018. Using a reasonable metric of 4.5X sales, Joseph Gunner has an $8/share price target on DRIO shares.

DarioHealth (DRIO) Sales Growth Chart

Additionally, Rodman and Renshaw has a $12 price target on DRIO shares, using a net present value (NPV) model, and assuming just 6.6% diabetes market penetration and $400/year sales/user (includes hardware, strips, licensing, etc.)

DarioHealth - rodman valuation

 

Clearly, DarioHealth Corp. is on to something in the rapidly expanding mobile health space.


The Diabetes Management Market

Diabetes is the 7th leading cause of death in the United States according to the Centers for Disease Control. Moreover, it greatly increases the risk for heart disease, end-stage renal disease, blindness, amputation, and complications during pregnancy. It is a chronic medical condition that has increased in its numbers at a faster pace than most other chronic conditions. In 2015, the International Diabetes Federation estimated that more than 415 million people had been diagnosed with the disease, and that number is expected to balloon to 642 million by 2040.

The importance of carefully managing diabetes cannot be overstated. In a recent study by the National Institutes of Health, people with type 2 diabetes who intensively managed their blood sugar levels were found to have cut their risk of diabetic retinopathy in half. Multiple studies have shown that well managed blood sugar levels in diabetics dramatically reduces risk of complications including heart and blood vessel disease, nerve damage, and kidney disease as well.

Mayo Clinic puts it simply and directly:

“Controlling your blood sugar levels can help prevent these complications.”

And this is where DarioHealth Corp. comes in- with 12% of all global health expenditures spent on diabetes, having a real-time diabetes management solution that is practical and user-friendly while reducing risk of costly and life-threatening complications represents an urgently needed paradigm shift in the management of the disease.


Moving the Market from “Monitoring” to “Management” is Driving Growth

The company’s focus on helping consumers manage and not just monitor diabetes is why sales are skyrocketing. Investors should understand that DarioHealth Corp. is not simply a diabetes monitoring or blood sugar measurement device company. Dario is a pioneer in effective disease management solutions, and diabetes is the first, “low hanging fruit” the company is addressing.

Unlike traditional glucose meters offered by competitors, the Dario App provides:

  • Real-time, easy-to-access information
  • Test results automatically logged and synced in the cloud for physician access (no need to write in paper log books)
  • Data insights, analysis, and pattern recognition so users can easily understand why their personal blood glucose levels change and what changes them
  • Actionable alerts and reminders
  • Insulin dose tracking
  • Log of carbs and calories
  • Database showing carbohydrate counts of half a million foods
  • Users can even set extreme hypoglycemic result alerts to text message family member(s) with GPS tracking

DarioHealth also intends to increase penetration in both the direct to consumer market and to other businesses by offering diabetes management coaching services in the future. The company plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals that will provide diabetes management coaching services.

The video below gives an overview of the DarioHealth Smart Diabetes Management System in action.

 

 

The DarioHealth Smart Diabetes Management System includes a sleek, accurate, all-in-one Smart Meter combined with a robust, real-time mobile app that allows users to record their data: blood glucose measurements, carbs & insulin intake, and physical activity. Users can view, analyze, list and compare all of this valuable information and share it with family and medical staff.

 


DarioHealth is the only diabetes management system that includes all of the features below:

 

dariohealth-features

 


Innovative B2C Sales Model = High Margins and Rapid Sales Growth

Going beyond technological innovation in disease management, DarioHealth Corp. has an innovative approach to sales. The company is using a direct business to consumer sales approach with a strong presence on social media. DarioHealth is creating demand directly from the consumer, skipping the middlemen, and generating high margins.

Ultimately, DarioHealth intends to dramatically ramp revenue by expanding the company’s diabetes management solution beyond individual consumers to include businesses by offering a cost effective mobile health solution for employees with diabetes. DarioHealth plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals to provide diabetes management coaching services. This is a huge, untapped market for Dario to penetrate with an early mover advantage.


Conclusion

DarioHealth is a pioneer in the digital health space, addressing a global market of > 400 million diabetics with patented technology that can help them better manage their disease and reduce expensive and life-threatening complications in a cost-effective manner.

With sales just beginning to dramatically increase following last year’s U.S. launch and the enormous market the Diabetes Management System addresses, the current low market capitalization of DarioHealth ($28 million) is not likely to last. To date, the company has been focused on the successful launch of the system itself, including FDA and other regulatory hurdles, obtaining patent protections, and regularly upgrading the software based on user feedback. During my conversation with management it was clear the company intends to begin doing much more in terms of investor awareness and investor relations, including taking steps to increase institutional awareness and participation in the company in 2017.

Relative to other digital health data solutions, both retail and institutional investors should find DRIO shares attractive at a $28 million market cap, especially given the “hockey-stick” growth curve the company is experiencing.

Fundamentals matter, and as a result DRIO shares shares should have a very strong showing in 2017 as the company rapidly expands revenues and is introduced to a larger investor base. 

Look for a record Q4 report in early March, followed up by another new record for Q1 2017, a launch in Germany, and FDA approval of the Android version as positive catalysts for near term share price appreciation.


DarioHealth - gary siggy

 

 

Supplemental: DarioHealth February 2017 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

Joseph Gunnar & Co. Report: DarioHealth BUY $8 PT


See: Terms of use/disclosures/disclaimer

DRIO stock

 

Nasdaq listed DarioHealth Corp. (DRIO) is pioneering the future of disease management and mobile health by providing consumers with laboratory-testing capabilities using smart phones and other mobile devices. Dario’s™ smart diabetes management solution is a platform for diabetes management that combines the Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter, native smart phone app, website portal and a wide variety of treatment tools to support more proactive and better informed decisions by users living with diabetes, their doctors and healthcare systems.


In news today, (DarioHealth Ends a Successful Diabetes Awareness Month) DarioHealth Corp. (DRIO) announced the company added over 4,000 new sign-ups using their cost-effective, direct-to-consumer model.

 

Erez Raphael, DarioHealth’s Chief Executive Officer stated:

“During Diabetes Awareness Month, we welcomed thousands of new registrants. In the U.S. alone, we had over 4,000 new sign-ups. Our primary goal is to give members of our DarioHealth community the best user experience possible to deal with their diabetes. It is extremely encouraging and inspiring when we receive positive feedback. This is the ultimate vote of confidence and the results from Diabetes Awareness Month echo this. We continue to build on our success as we head towards 2017 and beyond.”

 

Leveraging the razor/razor blade model, the average consumer will use $300 of strips at 75% grow margins…part of the reason why the company turned a gross profit in Q3…and why adding 4,000 sign-ups for the month of November in the U.S. alone is significant.

Sales grew 166% last quarter, and it looks as management is delivering on stated guidance for “market penetration and user growth to accelerate in the fourth quarter”


For more on DRIO read our initial article: DarioHealth: Digital Disease Management Pioneer Experiencing Dramatic Growth

DarioHealth BUY Recommendation w $12 price target from Rodman and Renshaw

DarioHealth Corp. November 2016 Investor Presentation


DRIO stock - gary

 

 

See Terms of Use/Disclosures/Disclaimer

dariohealth-logo

Nasdaq listed DarioHealth Corp. (DRIO) is pioneering the future of disease management by providing consumers with laboratory-testing capabilities using smart phones and other mobile devices.

The company’s flagship product, the Dario Smart Diabetes Management Solution, is a patented, mobile, real-time, cloud-based, diabetes management solution based on a multi-feature software application combined with Dario Smart Meter, a pocket-sized, blood glucose monitoring device.

Leveraging the razor/razor blade model, the average consumer will use $300 of strips at 75% grow margins…part of the reason why the company turned a gross profit in Q3.

In Q3 2016, sales grew 166%, the company recorded a gross profit, and management expects “market penetration and user growth to accelerate in the fourth quarter.”

DarioHealth Corp. has built a digital disease management platform that is used in 7 different countries and growing, is cost effective for consumers, is readily scalable at minimal additional cost, and which can be expanded into other disease management areas beyond diabetes.


 

  • Loading stock data...

Share Information

Shares Outstanding: 5.7 million
Insider ownership: ~40%
Float:
3.9 million
Closing Price 11/28/2016: $3.02
Market Capitalization: $17.3 million


The Diabetes Management Market

Diabetes is the 7th leading cause of death in the United States according to the Centers for Disease Control. Moreover, it greatly increases the risk for heart disease, end-stage renal disease, blindness, amputation, and complications during pregnancy.

It is a chronic medical condition that has increased in its numbers at a faster pace than most other chronic conditions. In 2015, the International Diabetes Federation estimated that more than 415 million people had been diagnosed with the disease, and that number is expected to balloon to 642 million by 2040.

The importance of carefully managing diabetes cannot be overstated. In a recent study by the National Institutes of Health, people with type 2 diabetes who intensively managed their blood sugar levels were found to have cut their risk of diabetic retinopathy in half. Multiple studies have shown that well managed blood sugar levels in diabetics dramatically reduces risk of complications including heart and blood vessel disease, nerve damage, and kidney disease as well.

Mayo Clinic puts it simply and directly:

“Controlling your blood sugar levels can help prevent these complications.”

And this is where DarioHealth Corp. comes in. With 12% of all global health expenditures spent on diabetes, having a real-time diabetes management solution that is practical and user-friendly while reducing risk of costly and life-threatening complications represents an urgently needed paradigm shift in the management of the disease.


Moving the Market from “Monitoring” to “Management”

Investors should understand that DarioHealth Corp. is not simply a diabetes monitoring device company. Dario is a pioneer in effective disease management solutions, and diabetes is the first, “low hanging fruit” the company is addressing.

The Dario App provides:

  • Real-time, easy-to-access information
  • Results are automatically logged and synced in the cloud for physician access (no need to write in paper log books)
  • Data insights, analysis, and pattern recognition so users can easily understand why their personal blood glucose levels change and what changes them
  • Actionable alerts and reminders
  • Insulin dose tracking
  • Log of carbs and calories
  • Database showing carbohydrate counts of half a million foods
  • Users can even set extreme hypoglycemic result alerts to text message family member(s) with GPS tracking

DarioHealth also intends to increase penetration in both the direct to consumer market and to other businesses by offering diabetes management coaching services in the future. The company plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals that will provide diabetes management coaching services.

The video below gives an overview of the DarioHealth Smart Diabetes Management System in action.

 

 

The DarioHealth Smart Diabetes Management System includes a sleek, accurate, all-in-one Smart Meter combined with a robust, real-time mobile app that allows users to record their data: blood glucose measurements, carbs & insulin intake, and physical activity. Users can view, analyze, list and compare all of this valuable information and share it with family and medical staff.

 


DarioHealth is the only diabetes management system that includes all of the features below:

 

dariohealth-features

 


Innovative B2C Sales Model = High Margins and Rapid Sales Growth

Beyond the technological innovation in disease management, DarioHealth Corp. has an innovative approach to sales. The company is using a direct business to consumer sales approach with a strong presence on social media. With numerous ads like this (Special Offer for Diabetes Awareness Month: FREE METER), DarioHealth is creating demand directly from the consumer, skipping the middlemen, and generating high margins.

Razor/Razor Blade Business Model

In the diabetes lifestyle management revenue stream, the average user will use $300 worth of strips per year at 75% gross margin.

The model is working. 

DarioHealth Corp. launched the B2C sales model in the UK in Q1 of last year, then expanded sales to Australia, Canada, and Italy within 12 months. The company entered the U.S market in March of this year.

Sales growth is in a strong uptrend as seen in the chart below:

dariohealth-revenue-growth

In Q3 2016, sales increased by 166% vs. the year ago period. Other highlights from a very impressive quarter include:

  • Record revenues of $728,000
  • Gross profit of $76,000 in the third quarter
  • 75% of quarterly revenues derived from test strips and other consumables
  • More than 5,500 Dario all-in-one smart glucose meter devices were purchased directly by U.S. customers during the third quarter; globally about 8,500 were sold during the quarter
  • About 70% of strips sales in the U.S. during the quarter were under the subscription plan
  • Direct-to-consumer model launched in Australia and in Canada
  • Ramped up inventory to $1.1 million in order to support further market penetration

DarioHealth Corp. CEO, Erez Raphael, stated:

“During the third quarter, we continued to advance our direct-to-consumer strategy in the U.S., increased device sales, delivered significant monthly user growth and established a predictable stream of high margin recurring subscription revenues from new customers. We are encouraged by the positive engagement we are achieving with new users and expect market penetration and user growth to accelerate in the fourth quarter. Our active community of users and subscribers is growing every day which is bringing positive changes to people with diabetes, and disrupting the digital, mHealth and lifestyle market.”

and

“We have the right product and the right strategy to succeed in these efforts and look forward to the opportunities ahead of us. The predictable nature of these subscription revenues will provide us greater visibility in 2017 and serve as the foundation for our long-term growth.”

Sound fiscal management has improved the balance sheet over the prior year, and DarioHealth now has cash of ~ $1.50/share on hand (see 10-Q).

$ in thousands Period Ending 9/30/16 Period Ending 12/31/15
Cash $3,339 $2,671
Total Assets $6,696 $5,077
Total Liabilities $2,336 $6,657
Shareholders’ Equity (deficit) $4,360 $(1,580)

Growth in 2017 and Beyond

At present, DarioHealth has only has FDA approval for the Diabetes Management System on Apple devices in the U.S. The company has submitted the Android version of the system to the FDA and expects approval in Q1 or early Q2 of next year. There are approximately 107 million users of android devices in the U.S., so this is a noteworthy market for expansion. Additionally, DarioHealth will be offering more user applications and expanding into new geographic territories in the coming year.

Ultimately, DarioHealth intends to dramatically ramp revenue by expanding the company’s diabetes management solution beyond individual consumers to include businesses, by offering a cost effective mobile health solution for employees with diabetes. DarioHealth plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals to provide diabetes management coaching services. This is a huge, untapped market for Dario to penetrate with an early mover advantage.


Valuation

DarioHealth is a pioneer in the digital health space, addressing a global market of > 400 million diabetics with patented technology that can help them better manage their disease and reduce expensive and life-threatening complications in a cost-effective manner.

With sales just beginning to dramatically increase following last year’s launch and the enormous market the Diabetes Management System addresses, the current low market capitalization of DarioHealth ($17 million) is not likely to last. To date, the company has been focused on the successful launch of the system itself, including FDA and other regulatory hurdles, obtaining patent protections, and regularly upgrading the software based on user feedback. During my conversation with management earlier this week it was clear the company intends to begin doing much more in terms of investor awareness and investor relations, including taking steps to increase institutional awareness and participation in the company.

Given the overall market growth, the innovative, high-growth user platform, the business model, marketing capabilities, and new market opportunities, DarioHealth is likely to deliver a “hockey-stick growth” chart in the year ahead.

Rodman and Renshaw has a $12 price target on DRIO shares, using a net present value (NPV) model, and assuming just 6.6% diabetes market penetration and $400/year sales/user (includes hardware, strips, licensing, etc.)

DarioHealth - rodman valuation

Joseph Gunnar & Co. uses a price/sales model peer group comparison, and has an $8 price target on DRIO Shares. This is 4.5x 2018 revenue estimates and multiple is in line with the peer group average.

Relative to other digital health data solutions, both retail and institutional investors should love DRIO shares here at a $17 million market cap. Consider Fitbit (NYSE: FIT) at a $2.2 billion market cap, or 23X EPS, and MyFitnessPal, acquired by Under Armour (NYSE:UA) for $475 million.

Fundamentals matter, and we think DarioHealth (DRIO) shares will have a very strong showing in 2017 as the company rapidly expands users, revenues, and is introduced to a larger investor base.


DarioHealth - gary siggy

 

 

Supplemental: DarioHealth November 2016 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

Joseph Gunnar & Co. Report: DarioHealth BUY $8 PT


See: Terms of use/disclosures/disclaimer

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.

  • Loading stock data...

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

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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