Robin McCallum manages all aspects of CMC Operations for TapImmune’s cancer vaccine programs.


Thank you, Robin, for taking part in this Q&A.

First off, what are “CMC operations”, and how do they impact clinical trials and the drug development process?

RM: CMC stands for Chemistry Manufacturing and Controls.  CMC operations come into play when drugs emerge from the drug discovery and lead optimization phases of drug development and enter the IND-enabling, preclinical phase.  An IND is an Investigational New Drug.  CMC is maintained as a drug goes through the clinical phase (Phase I, II, and III) of drug development and throughout the life cycle of the drug as it is approved by a regulatory agency (e.g., FDA, EMEA) and marketed.

CMC encompasses the nature of the drug, its manufacturing process, and the manner in which the manufacturing process is shown to be in control.  Some of the critical elements of CMC include:

  • how and where a drug is manufactured
  • what control procedures are in place to ensure reproducibility in the manufacturing process
  • what control procedures are there to maintain drug quality and consistency
  • what critical quality attributes (CQA) have been identified and characterized for the drug
  • are the CQAs appropriate for the drug and its phase of development
  • how stable is the drug
  • is the drug manufactured in an appropriate dosage form

Appropriate CMCs are essential to ensuring that drugs supplied to support human clinical trials are safe and tolerable, and will become more rigorous as a drug goes through early-stage clinical trials (Phase I and II) into late-stage clinical trials (Phase III).

What prior biotech and drug development experience do you bring to TapImmune?

RM: I bring more than 12 years of experience in biotechnology and pharmaceutical development to TapImmune.  This include broad experience in most areas of drug development and manufacturing, including research & development, process development, scale-up, GMP manufacturing, analytical method development, qualification, and validation, quality control testing, and quality assurance.  My particular expertise is in pharmaceutical and biopharmaceutical process development, GMP manufacturing, and analytical methods.

I also work closely with a technical consultant who has more than 25 years of experience and expertise in process development, analytical methods, formulation and dosage form design; technology transfer to GMP operations, GMP manufacturing, regulatory submissions and quality assurance with a broad range of drug types including  small organic molecules, peptides and proteins, biologics, and combination products.

Does the FDA require documentation of a company’s CMC operations as part of the drug development process?

RM: Absolutely!  Submission of an IND for first-in-human clinical trials (Phase I) requires submission of a CMC section as part of that IND to the FDA.  The agency is chiefly concerned that a drug administered to humans has been manufactured and characterized in an appropriate and consistent manner, and meets quality standards.  CMC along with preclinical and toxicology studies in animals ensures that any drug advanced to Phase I clinical trials is as safe as possible.

How do CMC operations change as drug development goes from phase I, into phase II, and beyond?

RM: CMC is one of the links connecting early non-clinical or toxicology batches (Engineering runs) to clinical batches and eventually commercial batches if the drug is deemed safe and efficacious, and is approved by the FDA or other regulatory agency.  The requirements for CMC expand and become more rigorous as the drug moves along the clinical development pathway toward commercialization.

At the Phase I stage, safety is the primary concern.  Typically, the drug lot that supplies this early stage trial will meet basic quality requirements; however, the manufacturing process is usually not yet optimized for yield, purity, efficiency, scalability, etc.  Further, the formulation is adequate for the dosage form and route of administration, but is not the optimal or final formulation.  Typically only one non-GMP lot (Engineering lot) and one GMP lot (clinical lot) has been manufactured; therefore, there is not adequate, statistically significant data on lot to lot variability and consistency.  Moreover, analytical methods if not performed as per compendia, have been minimally developed and qualified (method-dependent) to meet Phase I requirements, but have not been optimized and validated.  Broad, tentative specifications for CQAs are established and some tests simply have “report results”.  Also, although overall product purity and impurity has been quantified, individual specific impurities and related substances have not been identified and characterized.  Lastly, only about 1-3 months of stability data from the clinical lot will be available by the time the drug is dosed in the first patient for the first-in-man trial.  This is all acceptable from a regulatory standpoint for a Phase I drug lot.

At the Phase II stage where both drug safety and efficacy are concerns, the manufacturing and formulation process will typically be refined and improved although not optimized to the final process.  There is also usually a scale-up of the manufacturing process at this stage though not yet close to commercial scale.  The CQAs for the product will be better defined and characterized.  More stability data has been generated (12 months+) using stability-indicating methods, at multiple temperatures.  Many firms elect to finalize and validate analytical methods at this stage.

At the Phase III stage (drug safety, efficacy, and consistency), the manufacturing process is optimized to be robust, reproducible, and scalable to commercial scale with fully established in-process controls. This will be the commercial process by and large.  Using fully tested raw materials, at least three consistency batches are manufactured as part of process validation.  These batches are often used for NDA or BLA filings to regulatory agencies.  Analytical and microbiological methods are completed validated, CQAs are fully defined and characterized, and final specifications are set.  The physical, chemical, and biological properties of the drug are fully characterized. Process impurities are fully identified, defined, and quantified.  Stability data from multiple clinical or GMP lots is available and stress testing has been completed.  Also, container closure integrity testing is completed for sterile products.

I’ve read that in order to gain a competitive clinical edge, some companies may look to do the minimum amount of CMC work required while still maintaining an acceptable level of control, as required by the industry. How do CMC operations managers like yourself balance the need to keep costs down while maintaining a high level of quality required by the industry?

RM: In the competitive industry of pharmaceuticals, companies will always seek to accelerate drug development, with first-in-man trials being a critical milestone.  Whether large or small, any pharmaceutical company will have to balance three important and inter-related factors:  time, cost, and quality.  Fortunately, the FDA has defined certain basic CMC requirements for drug that supply first-in-man studies with safety being the main concern.  In some ways, the need to meet those basic requirement for safety in Phase I trials (derived in part from quality in CMC) will predefine the minimum amount of time any CMC operations manager will need to spend on the development, GMP manufacturing, and characterization of the first clinical lot.  Therefore, that mitigates some of the corporate pressures for accelerating what will be an already aggressive timeline and reducing an already streamlined budget for drug development.  TapImmune is committed to product quality and patient safety first, and we will not compromise that in favor of a faster timeline or lower cost.  Those who sacrifice quality often end up losing quite a bit more money and time in the long run.

How long does the process take of manufacturing TapImmune vaccines?

RM: The process to manufacture TapImmune’s vaccine can be broken up into two main parts:  I) manufacturing of the peptide Drug Substances or Active Pharmaceutical Ingredients (APIs) and II) manufacturing of the Drug Product or vaccine.  Part I consists of the synthesis, cleavage, and purification of the individual peptide Drug Substances (5 peptides) and this process typically takes 2-3 months depending on the peptide.  Part II consists of the formulation, filtration, vialing, and lyophilization of the Drug Product, and typically takes 1 week for manufacturing operations.  Pre-manufacturing activities such as batch record prep, etc. and post-manufacturing activities such as quality control testing will add around 1 month each.  Overall, it takes around 4 months to manufacture and fully release TapImmune’s vaccines for clinical use.

Once the vaccines are created, where are they sent to? Do you have any clinical sites in the country? If so, where?

RM: Once the vaccines are manufactured, tested, and released, they are stored at our manufacturing vendor for clinical distribution via clinical drug couriers.  At this time, all of TapImmune’s clinical sites are located in the USA in a number of states across the northeast, southeast, south, and midwest:  Florida, Kansas, Michigan, New Jersey, New York, Maryland, Missouri, Ohio, Tennessee, and Texas.

For more information on TapImune see:

Video: A Vaccine That Could Prevent Certain Breast, Ovarian, and Lung Cancers

TapImmune Investor Fact Sheet

TapImmune Reaches 50% Patient Enrollment Benchmark in Phase 2 Study of Novel T-Cell Vaccine Targeting Triple-Negative Breast Cancer

TapImmune Press Releases

U.S. Department of Defense Funds Phase II Trial of TapImmune Breast Cancer Vaccine  source: Breast Cancer News

Doctor Developing Vaccine That Would Prevent Breast, Ovarian, and Certain Lung Cancers source: WOKV News

TapImmune Improves T-cell Vaccine Ahead of Phase II Trials source: BioPharma Reporter


CannaRoyalty Marc Lustig

CannaRoyalty is a fully integrated, active investor and operator in the legal cannabis sector. Our focus is building and supporting a diversified portfolio of growth-ready assets in high-value segments of the cannabis sector, including research, consumer brands, devices and intellectual property. Our management team combines a hands-on understanding of the cannabis industry with seasoned financial know-how, assembling a platform of holdings via royalty agreements, equity interests, secured convertible debt, licensing agreements and its own branded portfolio.

Mr. Lustig holds MSc and MBA degrees from McGill University. He began his professional career in the pharmaceutical industry at Merck & Co. In 2000, he started his capital markets career in institutional equity research in the Life Sciences sector at Orion Securities. For the next 14 years, Mr. Lustig worked as a senior producer at GMP Securities L.P. and as Head of Capital Markets at Dundee Capital Markets before becoming Principal at KES 7 Capital. Mr. Lustig founded Cannabis Royalties & Holdings Corp. in early 2015.



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.

Thank you Marc, for taking time to participate in this Q&A. 

MR: There’s a myriad of cannabis stocks for investors to choose from, many of which are focused solely on growing and selling cannabis. How is CannaRoyalty’s business model different, and why have you chosen this model?

ML: I don’t care what anyone says, growing cannabis is an agricultural commodity. And while everyone claims to have a “proprietary process” and be the “greatest grower” its still a commodity which means lowest cost per unit at a good standard wins. This is not a game CannaRoyalty is interested in playing. Our model is to build assets which enhance the value of the cultivated product whether its through extraction processes for oil derivatives or through development of formulations and brands or investment into the next cannabis based therapy for medical treatment. So instead of an investor buying into a one-dimensional grower (licensed producer) we are giving investors a broadly diverse platform of assets to invest in which they would probably never have got the opportunity to invest in themselves.

MR: While it’s early in the Company’s history, are there “wins” that validate CannaRoyalty’s business model?

ML: Lets put it this way: Im not aware of any of our assets which haven’t already either created value for shareholders or are not on the cusp of generating revenue growth and synergistic effects with other assets in our portfolio. From early ownership in assets like Anandia (leading Canandian cannabis analytics and genetics), WagnerDimas (pre-rolled joint manufacturing IP), Bodhi Research (medical research into cannabis treatments for concussion), Resolve Digital (medical device innovator of what I think is a revolutionary vaporizer) to all of our other investments and royalties across Canada, the US and Puerto Rico I feel great about how things are starting to come together. I could go on for a long time on my view of our wins that validate our model but my guess is we’re still only scratching the service when I consider our pipeline of opportunities.

MR: What attributes or characteristics do you look for in cannabis-related companies that make you say yes, this is a company we want to make a strategic investment in?

ML: Character, business acumen and cannabis passion in the partner or management team of an investee company combined with strategic assets which when “plugged in” to the CannaRoyalty model or into CR Brands leads to appreciable and sustainable value for shareholders.

MR: In April, the Canadian government announced legislation to legalize marijuana for recreational use by June 1 of next yearwhich, (if passed), will greatly expand demand in Canada. Meanwhile, the U.S. has a patchwork of differing state and local laws for medical and recreational use, and there is zero support atthe federal level for recreational legalization. Given where the two countries are right now in the legalization pathway, why are the majority of CannaRoyalty’s assets are based in the United States and not Canada?

ML: Firstly, as mentioned earlier in our interview, we seeing growing cannabis as an agricultural commodity. The over-concentration of fully-valued cultivation assets compared to exceptional value opportunities in the US in more advanced, dynamic makes this equation much more attractive from our perspective. Some will be quick to point out the obvious difference in federal legislation between Canada and the US – with cannabis still a Schedule 1 narcotic in the US. However we believe that because of how careful we are about structuring our deals strictly and categorically in compliance with legal US markets we minimize this federal vs state risk. And all of this at a time in the cycle that the public support – because of the general benefits of cannabis compared to alcohol, tobacco and marginal pharmaceutical products or because of the job growth and the economic impact of this sector – continues to grow beyond the point of recision.

Secondly and a bit surprisingly I don’t think people comprehend how strong our asset base is in Canada. Our significant ownership in Anandia, Resolve Digital, Bodhi Research together with our strategic royalty relationship with Aphria one of the leading Canadian licensed producers make for a remarkable suite of assets in Canada. Whats more is we expect to grow the Canadian asset base going forward as asset values become more realistic for us to acquire or invest – all at a time that the Canadian recreational market opens up.

MR: One of the most crucial elements of success for any company is the strength of the management team. How would you describe the team you’ve assembled at CannaRoyalty and is the team complete, or do you anticipate expanding it to meet current or future needs?

ML: I’m very lucky. We are building a dynamic company in a high growth exciting sector which has attracted top tier talent and created a very cool culture where people are proud of what were doing and are obsessed with achieving our goals. Today we are 26 direct employees of CannaRoyalty across management, legal, finance, marketing/social media, sales and operations. Is the team complete? Not even close. The way were growing and the opportunities we have in front of us I have no idea how big we’ll get. All I know is we continue to attract phenomenal talent which makes me look a lot smarter than I am proving my belief in the “8s hire 10s” philosophy….

MR: What investments has CannaRoyalty made that you believe will have the greatest impact on revenue growth during the remainder of 2017?

ML: In no particular order our REIT-like investment in state of Washington, our partnership with Rich Extracts in Oregon, our strategic relationship with leading cannabis distribution company River in California, product revenues in key markets by our brand company CR Brands, sales of our cartridge hardware by our wholly-owned Dreamcatcher Labs company and the new deals that we expect to add throughout 2017 will drive the largest impact on revenues this year.

MR: CannaRoyalty finished Q1 with cash and cash equivalents of $11,946,417 and closed a bought deal financing for aggregate gross proceeds of $15 millionIn the Q1 press release, you stated that CannaRoyalty is “well positioned to continue to deploy capital and build on initiatives that will enhance shareholder value.” What verticals are you looking at deploying this capital in and why?

ML: We have built a strongly synergistic base of assets in key markets like California. Our pipeline of prospective deals in Canada and growth markets in attractive cannabis markets like Nevada, Arizona, Maryland and Massachusetts continues to grow. In terms of verticals, our product arm CR Brands will continue to develop or acquire licenses for innovative leading cannabis brands. In parallel our focus will be on the compliant, highest efficiency manufacturing processes and impactful distribution assets in focus markets.

MR: What do you see as key drivers for shareholder value in the coming 6-12 months?

ML: Current assets combining with new assets in new key markets combining synergistically to grow revenues and earnings.

See Also:

CannaRoyalty Q1 Financial Report

CannaRoyalty (CRZ.C) grows multi-million-dollar asset base over 800% in nine months (Equity.Guru)

Spotlight on CSE:CRZ – Upside from recent deal opportunities remain nascent (Viride Research Partners)

CannaRoyalty June 2017 Investor Presentation

CannaRoyalty News/Press Releases

CannaRoyalty Marc Lustig

tapimmune-logoTapImmune (TPIV) is developing immunotherapies for a variety of cancers designed to target both tumors and metastatic disease. The company’s next-generation technology has been engineered to overcome the deficiencies of earlier cancer vaccine approaches and has the potential to be a powerful standalone therapy or part of a leading combination regimen by complementing other approved or development-stage immunotherapeutics (i.e. checkpoint inhibitors). The company’s off-the-shelf vaccines boost patients’ immune systems to comprehensively stimulate both killer T-cells and helper T-cells to destroy cancer cells.

TapImmune is advancing two clinical stage T-cell vaccine candidates in multiple Phase II and Phase Ib/IIa clinical trials for treating ovarian and breast cancers, including programs in ovarian cancer that will benefit from FDA Fast Track and Orphan Disease Designation. The company is working in collaboration with industry and clinical leaders including Mayo Clinic, Memorial Sloan Kettering Cancer Center, and AstraZeneca.

On May 1st, TapImmune announced Richard Kenney, MD, FACP, was joining TapImmune to lead the Clinical Development Program. Dr. Kenney will manage TapImmune’s ongoing and planned clinical programs for its next-generation T-cell vaccine candidates, which currently include multiple Phase 2 trials in advanced breast and ovarian cancer.

Richard Kenney

Prior to joining TapImmune, Dr. Kenney served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, where he established and led the clinical development, pharmacovigilance and regulatory affairs groups to advance the development and commercialization of the company’s cancer prime-boost immunotherapeutic and vaccines.  Previously, Dr. Kenney served as Chief Medical Officer of Crucell Holland, BV, where he directed clinical development of a broad platform of vaccines. He also served as Senior Vice President, Clinical Development for Vical Incorporated, where he led the clinical development of DNA vaccines for cancer immunotherapy and infectious diseases. Dr. Kenney held key positions in vaccine development at GSK Biologicals from 2005 to 2009, most recently as Senior Director of Global Clinical R&D, Vaccines for Viral Diseases. He earned his M.D. degree at Harvard Medical School, completed his residency in Internal Medicine at Duke University Medical Center, and a fellowship in Infectious Diseases at the National Institute of Allergy and Infectious Diseases.


MR: Congratulations on your new position as Medical Director for TapImmune.
What are your responsibilities in this role?

RK: I am responsible for the clinical development of our products. Once a compound is shown to be promising in the research lab, it needs to be tested in human trials that show its safety and effectiveness. Few patients are exposed at first, when the risks are not fully known. When it is clear that more patients can be tested, larger populations are used to show whether a benefit can be expected from that product in various indications. I manage the design of future trials and help with the operational aspects of ongoing trial oversight.

MR: What prior experience do you have with clinical development programs in immunotherapy that will expedite TapImmune’s T-cell vaccine candidates as they progress through clinical trials?

RK: My career has been focused on the induction of immunity in human populations, using vaccines for infectious diseases as well as for different tumors. I have experience in both the clinical and regulatory aspects of moving a product through development in small and large projects. Much of my work has focused on the use of adjuvants, which can enhance the immune response, particularly when used in a prime-boost approach.

MR: I’m sure you could choose from any number of attractive T-cell immunotherapy companies to work with. What attracted you to TapImmune?

RK: It’s a combination of the people and the products. TapImmune is led by and employs a good group of hard-working people who are experienced in their various roles. The vaccines being developed have been shown to be safe and immunogenic and now need further work to demonstrate efficacy. We have an opportunity to use the latest scientific hypotheses to study novel combinations and are working with some of the nations’ best clinical investigators to generate robust approaches.

MR: In what way(s) is T-cell immunotherapy superior to other cancer therapies?

RK: Traditional chemotherapy is designed to kill cells directly and usually causes rapid shrinkage of the tumor. Unfortunately, that comes at a great cost in terms of the side effects on normal tissues and the cancer often becomes resistant and returns. Your immune system has been working to protect you from cancers since before you were born. Tapping into that protection by generating a targeted immune response where that system has broken down may be a better way to fight the growth of tumors and is usually much less toxic.

MR: TapImmune has multiple clinical trials underway primarily focused on aggressive breast and ovarian cancers. Would you provide an overview of these trials- where they are currently, what collaborative partnerships are involved, and the benefits of the FDA Fast Track designation where it has been granted?

RK: TapImmune has two main products in clinical trials. TPIV200, the folate receptor-alpha peptide vaccine, is in several Phase 2 trials looking at safety and immunogenicity in breast cancer and at efficacy in ovarian cancer. While the peptide vaccine itself is adjuvanted with GM-CSF, we are using the product alone, in combination with low-dose cyclophosphamide as an immunostimulant, or in combination with durvalumab, a checkpoint inhibitor of PD-L1, in collaboration with Memorial Sloan Kettering Cancer Center. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Fast Track designation has been granted for TPIV200 for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer, so we have more opportunity to work closely with FDA to resolve issues along the way.

The other vaccine, which has been called TPIV100, has 4 peptides directed against HER2/neu. We recently updated that product by adding a fifth peptide to enhance the immune response and now call the vaccine TPIV110. One of the clinical studies using TPIV100 will evaluate an early stage of breast cancer called DCIS before surgery. The other will study more advanced patients with triple-negative breast cancer (TNBC) starting later this year. Both studies are being done in collaboration with the Mayo Clinic and the Department of Defense.

MR: In addition to the T-cell vaccine development, TapImmune is working on PolyStart™, a DNA vector technology. Would you explain what “DNA vector technology” means and what the potential applications are for PolyStart™?

RK: DNA vectors have been used to generate immune responses against infectious diseases and cancers in humans for many years. Basically, we can use the gene to let the body make the protein that is required to generate an effective immune response. DNA vaccines engage different parts of the immune system that can complement the way tumors are being attacked. PolyStart is a technology that greatly augments the amount of protein that can be generated inside the cell, which should induce a more robust immune response. We can use this approach by itself or in combination with the peptide vaccines to boost the overall immune response and thereby enhance efficacy. Thus, PolyStart can be used to target any number of infectious diseases or can be studied along with our vaccines for breast and ovarian cancer.

MR: What clinical development milestones can investors in TapImmune look forward to over the next 6-12 months?

RK: We should see the data from the Phase 1 trial of the TPIV200 folate receptor-alpha vaccine published within the next few months and the ongoing Phase 1b/2 trial at MSKCC has a decision point for continuation that will be available late this summer. The Phase 2 trial in TNBC has an interim look at safety and immunogenicity by the end of the year and it should be fully enrolled by the end of the year. The preliminary efficacy trial in ovarian cancer is just starting to enroll – those results will take more time to mature as it is a larger trial, although an interim analysis is planned for late 2018. In addition, we expect to see the Mayo trials of the TPIV100 HER2/neu vaccine starting later this year. Finally, we will be amending that IND later this year for our own sponsored study in Her2neu breast cancer using TPIV110. This is an active period for TapImmune and our collaborators that will lead to multiple readouts over the next two years.

More About TapImmune:

Video: A Vaccine That Could Prevent Certain Breast, Ovarian, and Lung Cancers

TapImmune Investor Fact Sheet

TapImmune Press Releases

U.S. Department of Defense Funds Phase II Trial of TapImmune Breast Cancer Vaccine  source: Breast Cancer News

Doctor Developing Vaccine That Would Prevent Breast, Ovarian, and Certain Lung Cancers source: WOKV News

TapImmune Improves T-cell Vaccine Ahead of Phase II Trials source: BioPharma Reporter

richard kenney



Terms of use, disclosure, disclaimer

TapImmune (TPIV) is advancing two Phase II studies that are funded by ~$17 million in non-dilutive grants from the U.S. Department of Defense.

In total, the company has 4 different Phase II studies underway and is planning to submit an Investigational New Drug (IND) Application with the FDA for another breast cancer vaccine this year.

Due to the unmet medical needs targeted by TapImmune’s T-cell vaccines as well as promising Phase I results, the FDA has granted Fast Track designation in two of the studies, providing an expedited review to facilitate development of the vaccines.

Additionally, TapImmune recently added Richard Kenney, MD, FACP, as Medical Director for the Company to lead the clinical development program. Dr. Kenney brings deep clinical development and FDA process experience to the Company as it continues to develop T-cell cancer vaccines that aggressively target breast and ovarian tumors.

Shares outstanding: 8.4 million
Closing Price 5/8/2017: $3.69
Market cap: $31 million
Total Cash (mrq) $8 million
Cash/Share (mrq) $0.93
Debt (mrq) 5k
Current Ratio (mrq) 4.6


tapimmune-logoTapImmune (TPIV) is developing immunotherapies for a variety of cancers that are designed to target both tumors and metastatic disease. The company’s next-generation technology is designed to overcome the deficiencies of earlier cancer vaccine approaches and has the potential to be a powerful standalone therapy or part of a leading combination regimen by complementing other approved or development-stage immunotherapeutics (i.e. checkpoint inhibitors). The company’s off-the-shelf vaccines boost patients’ immune systems to comprehensively stimulate both killer T-cells and helper T-cells to destroy cancer cells.


TapImmune web site

Full Funding for Phase II of TapImmune’s HER21-targeted T-cell vaccine

The U.S. Department of Defense (DoD) awarded Mayo Clinic researchers $3.7 million to conduct a Phase II trial of TapImmune’s HER21-targeted T-cell vaccine in women with the breast cancer known as ductal carcinoma in situ (DCIS). Her2neu is overexpressed in about 30% of all breast cancer patients, amounting to approximately 220,00 patients per year.

See press release: TapImmune Announces Fully Funded Phase 2 Clinical Study of HER2-Targeted Vaccine in Early Breast Cancer.

The 40 to 45 women who will be enrolled in the study will receive the TPIV 110 vaccine six weeks before surgery to remove the tumor.

This is TapImmune’s second T-cell vaccine candidate to be tested in a DoD-funded Phase II study at Mayo Clinic, and it marks TapImmune’s expansion into a second breast cancer indication. In addition to ongoing and planned Phase 2 studies of TapImmune’s lead TPIV 200 vaccine for treating triple-negative breast cancer, this new study of HER2neu vaccine in DCIS has the potential to validate the Company’s novel approach to establishing lasting immunity against breast cancer and precancerous lesions.

TapImmune’s new T-cell vaccine targeting HER2 consists of five carefully selected HER2 antigens that do the best job of activating HER2-directed T-cells. The mix is expected to cover a significantly larger patient population than the HER2-targeted therapy Herceptin (trastuzumab). TPIV 110 is expected to cover 90 percent of HER2-positive cancers, versus Herceptin’s 15-20 percent. TPIV 110 is also expected to remain effective for longer periods.

To date, the U.S. department of Defense has awarded approximately $17 million towards research using TapImmune’s targeted T-cell vaccines.

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

Dr. Richard Kenney Taking Clinical Development to the Next Stage

The addition of Dr. Kenney to the team as Medical Director at TapImmune validates the Company’s technology and recent progress, and is a milestone for the Company. Dr. Kenney is superbly qualified to lead the clinical development programs TapImmune is advancing.

  • M.D. from Harvard Medical School
  • Residency at Duke University Medical Center
  • Fellowship at the National Institute of Allergy and Infectious Diseases
  • Served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, (Nasdaq: IMDZ), where he established and led the clinical development, pharmacovigilance and regulatory affairs groups to advance the development and commercialization of the company’s cancer prime-boost immunotherapeutic and vaccines
  • Served as Chief Medical Officer of Crucell Holland, BV, (a division of Johnson & Johnson), where he directed clinical development of a broad platform of vaccines
  • Served as Senior Vice President, Clinical Development for Vical Incorporated, (Nasdaq: VICL), where he led the clinical development of DNA vaccines for cancer immunotherapy and infectious diseases
  • Held key positions in vaccine development at GSK Biologicals most recently as Senior Director of Global Clinical R&D, Vaccines for Viral Diseases

Regarding his new position at TapImmune, Dr. Kenney stated:

“I am delighted to assist TapImmune during this exciting time of growth as the company advances two of its T-cell vaccine candidates though multiple Phase 1b/2 and Phase 2 clinical trials.  Each of these novel vaccines are designed to address significant unmet needs for women with ovarian and breast cancer, where recurrence is high and prognosis can be very poor.  Having led the development of multiple vaccine programs and immunotherapies for cancer and infectious disease, I am eager to utilize my experience to drive successful clinical programs for TapImmune in collaboration with the Company’s top-tier clinical partners.” 

Attracting someone of Dr. Kenney’s caliber to TapImmune speaks volumes about the current and future potential of the Company’s T-cell immunotherapy programs. 

Beyond Treatment, to Actual Breast Cancer Prevention

TapImmune believes that if the trials of HER21-targeted T-cell vaccine go well, the vaccine could replace a combination of chemotherapy and surgery as a breast cancer treatment, and could also be used as a preventive vaccine to keep healthy women from developing breast cancer.

Video: “Vaccine could prevent breast, ovarian, lung cancer”




Video: A Vaccine That Could Prevent Certain Breast, Ovarian, and Lung Cancers


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

TapImmune has four clinical trials now in phase II for treatment of ovarian and triple-negative breast cancers.


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 in February, 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 TapImmune’s technology.

  • 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.


  • 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.”

Preclinical Development of  PolyStart™ Next Generation T-Cell Vaccine

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 Bottom Line

TapImmune has multiple phase II trials underway in the development of novel vaccines for the aggressive treatment of refractory breast and ovarian cancers. The Company’s technology is validated by research grants awarded by the U.S. Department of Defense totaling some $17 million, and by top research partnerships and collaborations with Mayo Clinic, AstraZeneca, and Memorial Sloan Kettering Cancer Center.

TapImmune has added a world-class Medical Director in Dr. Richard Kenney to lead clinical development programs. His extensive experience in both clinical trials and the commercialization of oncology drugs is a huge asset for the Company.

TapImmune’s current market capitalization of just $31 million is a gross understatement of the value of this innovative, exciting, and potentially game-changing company. I’ll be providing updates on TapImmune in the weeks ahead.

See also: TapImmune Fact Sheet

Drug Trials Heating Up In The Breast and Ovarian Cancer Treatment Space

TapImmune in biotech and other media





Terms of use/disclosure/disclaimer


dariohealth-logoIn news this morning, DarioHealth (DRIO)  announced the launch of a direct-to-consumer channel in the United Kingdom. Following the success of the direct-to-consumer channels in the U.S. and Australia, DarioHealth will leverage its knowledge to provide new opportunities for the greater U.K. diabetes community to analyze and personalize their treatment.

Until today, DarioHealth was only available through pharmacies and diabetes educators in the U.K. Now, consumers will have the opportunity to receive personalized diabetes care via an online shopping experience, and be enabled to monitor their health in a more convenient way.

Erez Raphael, Chairman and CEO of DarioHealth, commented on the announcement, “DarioHealth has been operating in the U.K. market for several years now and today’s announcement strengthens DarioHealth’s commitment to the diabetes community within the U.K. Our U.K. partner, Advanced Therapeutics, has the flexibility to offer customers quick, reliable, and friendly service, which will greatly benefit our customers. Furthermore, they have over 11 years of experience in the diabetes industry which is very important to us, as this demonstrates their true understanding of our customers’ needs.”

About DarioHealth Corp.

DarioHealth Corp. is a leading global digital health company serving tens of thousands of users with dynamic mobile health solutions. We believe people deserve the best tools to manage their treatment, and harnessing big data, we have developed a unique way for our users to analyze and personalize their diabetes management. With our smart diabetes solution, users have direct access to track and monitor all facets of diabetes, without having the disease slow them down. The acclaimed Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter and native smartphone app gives users an unrivaled method for self-diabetes management. DarioHealth is headquartered in Caesarea, Israel with a regional office in Burlington, Massachusetts.
For more information, visit http://mydario.investorroom.com/.

See also:

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/Disclosure


  • CannaRoyalty Corp. (CNNRF) and (CSE:CRZ), has a unique business model in the cannabis space that minimizes risk and maximizes reward
  • Has 22 strategic, diverse cannabis assets throughout North America
  • Just one $850,000 investment in one cannabis asset now valued at $7.1M
  • Exceptionally strong management team and board of directors positioning company to capitalize on high-growth cannabis market

This article will provide an overview of CannaRoyalty’s intriguing business model and distinguished management team, and identify the company’s diversified cannabis assets. A future article will take closer look at the CannaRoyalty assets and determine a valuation range for the company.

CannaRoyalty Corp. at a glance:

Tickers: (OTC:CNNRF), (CSE:CRZ)
Shares outstanding: 42.5 million
Recent Price 4/17/17: $1.82 USD
Market cap: $78.6 million
Float: 31.4 million
Insider ownership: 20%
Web site


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CannaRoyalty Corp. is a fully integrated, active investor and operator in the legal cannabis sector. The Company’s focus is to build and support a diversified portfolio of growth-ready assets in key segments of the cannabis sector, including research, consumer brands, devices and intellectual property. CannaRoyalty’s management team combines a hands-on understanding of the cannabis industry with seasoned financial know-how, assembling a platform of holdings via royalty agreements, equity interests, secured convertible debt and licensing agreements.

CannaRoyalty was formed in late 2014 and began trading publicly on December 8th of 2016.

CannaRoyalty’s $850,000 Investment in Resolve Digital Health Grows to $7.1M Asset

CannaRoyalty’s December 2015 $850,000 investment in Resolve Digital Health is a perfect example of an early win for CannaRoyalty and the company’s business model.

Resolve Digital is launching the world’s first smart inhaler for medical cannabis to help patients suffering from cancer, arthritis, migraine headaches, chronic pain and other diseases. The company’s Breeze Smart Inhaler connects with the user’s smart phone to deliver rich information and integrated care. CannaRoyalty Smart Breeze Inhaler


The system uses color-coded, modular Smart Pods with preloaded extracts or dried herb tuned to users’ specific health condition. Together, the Breeze Smart Inhaler and Smart Pods create a complete system that patients and health care professionals can rely on to assure well-monitored, well-informed and holistic cannabis treatments.


CannaRoyalty Smart Pods from Resolve Digital Health

In late March, Resolve Digital Health announced the completion of a $5M Series A financing that values the company at just over $25.6 million CAD. See also “Resolve Digital Health Lands $5M to Launch First Smart Inhaler for Medical Cannabis.”

As a result, CannaRoyalty’s $850,000 investment in Resolve Digital Health back in December of 2015 now has an implied value of $7.1M, with CannaRoyalty owning 27.2% of existing shares. 

Marc Lustig, CEO of CannaRoyalty stated:

“We are thrilled about participating in the closing of this financing. It provides third party validation of our initial investment in Resolve at a significantly higher valuation. It is an example of the success of our business model that includes identifying high-value cannabis assets, partnering through investment and assisting in the growth and commercialization of brands, products and devices – while increasing value for our shareholders.”

Resolve Digital is launching the Smart Breeze medical device this spring at exclusive dispensary partners in California before expanding into additional key markets across the U.S. and Canada throughout 2017 and into 2018.

The North American Cannabis Market: High Growth with High Risk

The North American cannabis market is expected to achieve a whopping compound annual growth rate of 25% thru 2021 when the market will top $20 billion, according to a January 2017 article in Business Insider.  This growth estimate is bolstered by recent news that the Canadian government is beginning work on legislation that will legalize recreational marijuana by July 1, 2018, if not sooner. Meanwhile, in the U.S., recent additions of populous states like Florida, New York, Illinois, Pennsylvania, and Ohio, mean almost 200 million Americans live where they may qualify to use cannabis as medicine. That’s well over 60 percent of the US population, with multiple states still expected to either begin or expand medicinal and/or recreational marijuana legalization this year.

I believe this is a space any risk-tolerant investor should be involved in, however, pitfalls abound. Not only do companies in the cannabis space face the same risks as companies in other industries (competition, financial, market forces, product/service efficacy, etc.) but cannabis companies must deal with varying legal and compliance risks across state and national borders. Moreover, due to the flood of licensed producers, wholesale marijuana prices declined from $2,500 to $1,000 per pound last year, with some dispensaries offering recreational ounces as low as $65 according to Forbes. With margins squeezed thin, non-pharmaceutical grade marijuana is rapidly becoming another commodity, like corn or wheat.

Beyond the risks associated with legitimate cannabis companies, publicly-traded frauds have been launched by crooks and scam artists who will do anything to separate investors from their money. Most recently, the SEC charged a California-based marijuana consulting company formally called Medbox, as a complete fraud. The Medbox stock price ranged from a low of $2.50 to an all-time high of $205 between August 2012 and December 2014…those shares are now at 0.0003. Ouch!

Unfortunately, Medbox wasn’t the first pot stock scam and they certainly won’t be the last.

CannaRoyalty’s Unique Business Model Mitigates Risk, Maximizes Reward

There are many dozens of cannabis stocks trading in the U.S. and Canada, but only CannaRoyalty features a combination of diversified investments in the cannabis space in both countries that minimizes investment risk while maximizing reward.

With over 20 cannabis assets in the areas of research, devices and intellectual property, early stage strategic investments, and consumer brands, investors in CannaRoyalty have reduced risk exposure to any one company.

Furthermore, the potential for outsized gains originating from multiple assets is very real. The future valuation of Resolve Digital Health as a publicly-traded company is just one potential home run for CannaRoyalty. Of course every asset in CannaRoyalty’s portfolio won’t be a home run, but if just a handful of the company’s holdings (outlined below) are successful, investors in the company should reasonably expect to see strong returns on their investment over time.

Management to Successfully Execute Business Model

Having a great business model is meaningless if you don’t have the right people in place to carry it out and drive results. CannaRoyalty’s management team and board of directors possess deep and successful management experience in the areas of finance and capital markets, pharmaceutical development, health care, corporate strategy, marketing, brand development, and more.

This is a group that can not only identify winning assets in the cannabis space, they can provide the necessary support and expertise in key areas of genetics, cultivation, extraction, post-processing and branding for the assets to maximize their potential.

CannaRoyalty’s Investments

CannaRoyalty is a stakeholder in 22 different diverse, cannabis-related properties in four broad areas:

  • Research (3 properties)
  • Devices and intellectual property (3 properties)
  • Early stage strategic investments (4 properties)
  • Consumer brands (12 properties)

CannaRoyalty’s investments in RESEARCH

Research investments target health and wellness applications including:


CannaRoyalty / Anandia Labs logo
Vancouver, Canada

CannaRoyalty has a 20% equity stake in Anandia.

Anandia Labs is a leader in cannabis testing, extraction and genetics, using genomics and modern plant breeding approaches to develop innovative products and next generation varieties. The company holds key intellectual property positions including cannabinoid pathway patents and is the only independent Canadian testing facility specializing exclusively in cannabis. With its Health Canada dealer’s license in hand, Anandia Labs has the seal of approval to undertake research and development, and to develop products beyond those currently permitted for licensed producers under Health Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR).

Anandia Lab’s expertise in cannabis testing is essential to ensuring that patients are receiving safe and effective products in the Canadian cannabis sector. In combination with the company’s ability to leverage its dealers license to develop its expertise in developing and producing cannabis extracts, Anandia Labs has positioned itself as a leader in the Canadian cannabis industry.

CannaRoyalty bas-research
CannaRoyalty has a secured convertible loan outstanding with BAS and has concluded a strategic partnership agreement with BAS, assuring the ability to tailor product to CannaRoyalty’s specific needs.
BAS Research is a science-based company of senior PhD-level researchers and chemists, positioned to leverage its first-mover advantage. BAS is developing pharmaceutical-grade cannabis medications, and advancing quality and safety through its Purity Certified™ testing services. Their unique strengths lie in advanced tissue culture and genetics, as well as ailment specific research and product development. BAS produces high-purity extractions plus innovative post processing.

CannaRoyalty bodhi-research
Toronto, Canada
CannaRoyalty has made a strategic seed capital investment in return for an equity position in Bodhi Research with an option to increase its equity stake.

CannaRoyalty wagner-dimas-logos
Through processing, packaging, and targeted brands, Wagner Dimas is adding significant value to producers and a premium user experience for customers.



See Terms of Use/Disclosure

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.

Emblem Corp logo

Emblem Corp. is licensed under the Access to Cannabis for Medical Purposes Regulations (the “ACMPR”) to cultivate and sell medical marijuana. Emblem carries out its principal activities producing marijuana from its facilities in Paris, Ontario pursuant to the provisions of the ACMPR and the Controlled Drugs and Substances Act (Canada) and its regulations.


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See also: Emblem April, 2017 Investor Presentation


MicrocapResearch: Congratulations on the successful public launch of Emblem Corp (TSX-V: EMC.V) and (U.S. OTC: EMMBF). Can you give investors an overview of your past experience with Purdue Pharma, and how it has prepared you to function as the President of Emblem’s pharmaceutical division?

John Stewart: I was President & CEO of Purdue US from 2007 – 2013, President & CEO of Purdue Canada from 1991 – 2009 and Regional Director for Purdue for Canada, Australia and New Zealand from 2000 to 2009. Among other things, these positions provided me with an in- depth understanding of inter-country differences in healthcare systems, drug regulatory agencies and pharmaceutical reimbursement paradigms – as well as public perceptions of the value of the pharmaceutical industry. These companies were of significantly different sizes in terms of employee numbers, annual revenues and mandates – which certainly impacts daily activities and leadership style. I was fortunate to be able to lead each through period of multiple new product introductions and significant growth.

Prior to becoming President to Purdue Canada, I served as VP R&D, in which I was responsible for formulation R&D, pre-clinical & clinical development of new drugs and regulatory affairs. It was in this position that I saw first-hand the significant importance of pharmaceutical dosage forms in terms of improving healthcare outcomes. I could provide numerous examples, but none is more telling than Purdue’s development of MS Contin (controlled-release morphine sulphate) – the first long-acting opioid which was approved for marketing by Health Canada in late 1985. Within two years MS Contin was recognized as one of the most important new analgesics agents for treatment of chronic moderate to severe pain.

It was also during my time as VP of R&D for Purdue that I first became aware of the therapeutic potential of cannabinoids. One of my UK Colleagues headed clinical drug development activities, and he encouraged the company to initiate a cannabinoid research program targeted toward management of pain and movement disorders.

Purdue did not pursue the opportunity, and that colleague subsequently started what has become a very successful company in the field.

MicrocapResearch: With dozens of other cannabis companies to choose from, what drew you to Emblem?

John Stewart: The executives at Emblem were familiar with the healthcare industry and already invested in healthcare-related businesses. They agreed with me that the therapeutic benefits of cannabinoids are real, but that they would not be fully achieved if the only way the product could be administered (taken) was by smoking or vaporization. They were immediately supportive of the company establishing a “pharma” division, to research the medical benefits of cannabinoids – and help identify which strains have the greatest evidence for benefit in particular conditions. An equally important component of the Division’s activity is the formulation and development of pharmaceutical dosage forms (e.g capsules, inhalers, modified-release tablets)  containing specific cannabinoids – which for a variety of reasons will be both more acceptable and effective than currently available dosage forms.

 MicrocapResearch: Emblem Corp is divided into three distinct operating divisions: Emblem Cannabis (the production division), the division you head at Emblem Pharmaceutical, and GrowWise Health (marijuana education for patients and physicians). How will the three divisions complement and build on each other’s strengths operationally?

John Stewart: The Production Group is in a sense the lead in importance, since their responsibility is to continually and consistently cultivate at the highest quality the cannabis strains we identify as being of the greatest therapeutic impact.  They need to ensure that our core strains have the same cannabinoid profile, irrespective of the time of year they are cultivated. Only via this consistency will the pharma division be able to produce advanced formulations that reach pharmaceutical industry levels of potency and purity.

Cultivating cannabis may be seen as simple and straightforward, but in reality it is far, far from that. One of my CEO Colleagues made this clear when he said, “This my be a simple process, but it is not at all easy”. One need only look at the recalls of cannabis due to excessive microbial levels or the presence of pesticides, to realize that this is a complex process that requires detailed attention and responsible oversight.

The GrowWise Group is comprised primarily of healthcare practitioners, whose activities directly support prescribers and patients achieve optimal therapeutic benefits from cannabis. They conduct research and support the research efforts of others, and greatly assist patients in the initial process of selecting and registering with one of the Licensed Producers.  In the years ahead, they will have much more in the way of important information to share.

MicrocapResearch: What indications are cannabinoids currently used for, and where do you think we might see expansion in the near future, say 12-24 months?

John Stewart: I have seen survey results indicating that the most common reason cannabinoids are used is for the treatment of pain, which is not surprising since pain is among the most common of reasons why individuals visit physicians. In addition, although there have been meaningful advances in analgesic therapy – there remains substantial room for improvement. The Canadian Pain Society was among the first of the professional organizations to formally recognize the efficacy of cannabis in pain management. Back in 2014 they published a Consensus Statement on the Management of Neuropathic Pain – which recommended the addition of cannabis therapy to patients who were experiencing inadequate pain relief from a combination of gabapentinoids and opioid analgesics.

Much more recently, the US National Academy of Sciences published an extensive report on the health effects of cannabinoids and concluded that there is substantial evidence of efficacy in chronic pain, as an anti-nauseant and for improving spasticity symptoms in patients with MS. They noted that there is moderate evidence for efficacy for improving sleep outcomes in patients with sleep disorders and more limited evidence for efficacy for improving symptoms of anxiety and increasing appetite/weight gain.

MicrocapResearch: Medical marijuana is typically taken by inhalation by the end user, either through smoking or vaping. Is this the best delivery method, and is Emblem Pharmaceutical developing other drug delivery options?

John Stewart: From the perspective of reliable and consistent efficacy, it is difficult to imagine a less appropriate method of administration than smoking or vapourization of dried cannabis.  With smoking, a person is inhaling combustion byproducts along with the cannabinoids – certainly undesirable and likely in some ways harmful. With vaporization, there is less in the way of combustion byproducts – but dose to dose consistency remains extremely difficult. The amount of cannabinoids that reach the body depends on the depth of the inhalation, how long one hold the inhalation before exhaling – combined with the crop to crop variability in the cannabinoid content of dried cannabis.

Like pharmaceutical products, our formulations will contain a known amount of cannabinoids (e.g. THC, CBD) measured in mg and this amount will be consistent from batch-to-batch, and supported by stability data. In addition we will have bioavailability and pharmacokinetic data to hep prescribers select the optimal dose for each of their patients.

We plan on bringing to market numerous dosage form, designed to optimize performance depending on the intended use. For example, we will have rapid onset formulations for use by patients seeking an immediate effect as well as long-acting formulations designed to provide for once-daily or twice-daily dosing for patients with chronic condition looking for continuous effects.

MicrocapResearch: What are the variables and key drivers for cannabinoid growth in Canada going forward?

John Stewart: The use of cannabinoids for medical purposes has shown exceptional growth since the Licensed Producer regimen was brought forward under the direction of Health Canada, but the number of individuals being treated is very, very low when compared to the number of patients being treated with existing prescription drugs. I believe that the advanced pharmaceutical formulations we are bringing forward will significantly improve patient and healthcare professional acceptance of cannabinoid therapy, and also help maximize their therapeutic benefits.

Another significant factor will be the willingness of provincial healthcare benefit plans to cover the cost of cannabinoid therapy. I have seen clinical trial data demonstrating equal, and in some cases improved, efficacy from cannabinoid therapy than traditional pharmaceuticals. However, no province currently pays for medical cannabis – leaving patients and their physicians with somewhat of a dilemma. Hopefully this will change, and the provincial healthcare ministries will come to recognize the overall cost-effectiveness of cannabinoids.

MicrocapResearch: What is the current size of the Canadian medical marijuana market, and how big do you believe it will be in 5 years?

John Stewart: Accurate information on the size of the overall MMJ market is not readily available, but on the basis of their being some 130,000 patients registered under the current ACMPR Program, i would estimate that 2016 sales were in the range of $200 million.

Looking at the prescription pharmaceutical market for therapies used for the conditions in which cannabinoids are now recognized as being effective, it is entirely reasonable to see the medical marijuana market being between $1 billion and $2 billion in 5 years time – and note that this does not include sales in the forthcoming Recreational Use Market.

MicrocapResearch: What developments specifically at Emblem Corp. can investors look forward to over the next 12-24 months?

John Stewart:Too many to cover in the short time of this interview. At a high level we will see a very significant expansion of cultivation capacity and advances in cultivation techniques, dedication of a completely new extraction and formulation development laboratory and impressive additions to the nature of information and services available from the GrowWise Operation.

MicrocapResearch: Thank you John, for taking time to update investors on the Canadian marijuana market and Emblem Corp.

John Stewart:

You are welcome, and thanks for the opportunity to connect with your important audience.

Emblem Corp.

DarioHealth Corp. (DRIO) picked at $3.86 (see 2/21/17 report), and  MassRoots Inc. (MSRT) picked at .81. (see 3/16/2017 report) have significant news out this morning.


dariohealth-logoDarioHealth Launches Insurance Coverage Option for U.S. Consumers

This morning, DarioHealth announced that it is now offering a 3rd party insurance coverage option for U.S. consumers who want to have their DarioHealth products reimbursed by insurance.

According to the press release, DarioHealth has signed strategic alliance agreements with partners across the U.S. who will be able to verify insurance coverage benefits, and if approved, will supply and bill the customer’s insurance for their Dario™ Blood Glucose Monitoring System and test strip supplies. During DarioHealth’s pilot phase of this insurance coverage option, partners were able to verify benefits for customers covered by Aetna and various Blue Cross Blue Shield plans.


Erez Raphael, Chairman and CEO of DarioHealth, stated:

“We are extremely excited with this new opportunity and will continue seeking out partnerships to expand our insurance coverage reach. Our customers asked about this, and we are happy to be able to provide this option to them. Many of these customers are already paying significant out of pocket cost for a variety of healthcare needs, so lowering their financial burden is tremendously gratifying and a big win for everyone in our community.”

Until now, U.S.-based customers paid out of pocket for DarioHealth’s products. Despite that fact, DRIO grew sales by 172% during Q4 of last year, with 67% of quarterly revenues derived from recurring sales of test strips and other consumables.

Insurance coverage is a major win for DRIO and should rapidly accelerate growth in the Company’s major market, the U.S.

About DarioHealth Corp.

DarioHealth Corp. is a leading global digital health company serving tens of thousands of users with dynamic mobile health solutions. We believe people deserve the best tools to manage their treatment, and harnessing big data, we have developed a unique way for our users to analyze and personalize their diabetes management. With our smart diabetes solution, users have direct access to track and monitor all facets of diabetes, without having the disease slow them down. The acclaimed Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter and native smartphone app gives users an unrivaled method for self-diabetes management. DarioHealth is headquartered in Caesarea, Israel with a regional office in Burlington, Massachusetts. For more information, visit http://mydario.investorroom.com/.


See also:

DarioHealth February 2017 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

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


massroots-logoMassRoots Launches New Website and Accelerates User Acquisition

On the heels of last week’s announcements that MassRoots has registered more than one million users on its platform (press release), and that Google Play has approved its mobile application for distribution to Android devices (press release), the Company has launched a new web site at MassRoots.com.


Powered by more than one million registered users, MassRoots enables consumers to rate products and strains based on their efficacy (i.e., effectiveness for treating ailments such back-pain or epilepsy) and then presents this information in easy-to-use formats for consumers to make educated purchasing decisions at their local dispensary. Businesses are able to leverage MassRoots by strategically advertising to consumers based on their preferences and tendencies.

MassRoots Chairman and CEO, Isaac Dietrich stated:

“MassRoots’ new website enables us to broaden our audience and more effectively monetize our users and web-traffic. We are already seeing hundreds of thousands of unique page views per month and are confident that the significant functionality and SEO improvements in MassRoots’ new website will enable us to accelerate our user and web-visitor growth. At the same time, we have greatly expanded the inventory and targeting options available to MassRoots’ advertisers, which will have an immediate and direct impact on our revenue.”

As the 4/20 holiday season rapidly approaches, MassRoots is committed to rapidly growing its market share of cannabis consumers and effectively monetizing them to further drive shareholder value.

About MassRoots

MassRoots is one of the largest technology platforms for the regulated cannabis industry. The Company’s mobile apps enable consumers to make educated cannabis purchasing decisions through community-driven reviews. MassRoots is proud to be affiliated with the leading businesses and organizations in the cannabis industry, including the ArcView Group and National Cannabis Industry Association. For more information, please visit MassRoots.com/Investors.

See also:

MassRoots in the media

MassRoots December 2016 Investor Update


Disclaimer/Disclosure/Terms of Use

dariohealth-logoNasdaq-listed mHealth company, DarioHealth (DRIO), (web site) reported record Q4 and 2016 results after yesterday’s close.


2016 Highlights

  • Record revenues of $2.8 million, increased 241% compared to the full year 2015
  • Sequential quarterly revenue growth throughout the entire year
  • Direct-to-consumer model launched in U.S. with approximately 18,500 Dario™ Blood Glucose Monitoring System devices sold; accelerated in 2nd half of year with approximately 14,000 sold
  • Direct-to-consumer model launched in Australia and Canada
  • Nasdaq listing in March
  • Commenced investment discussions with OurCrowd Qure, an Israeli Digital Health Specialized Fund; subsequently closed in early 2017

Fourth Quarter Highlights

  • Record revenues of $838,000, increased 172% compared to the fourth quarter of 2015
  • Sequential quarterly revenue growth of 15% over third quarter of 2016
  • 67% of quarterly revenues derived from test strips and other consumables
  • Record 8,500 Dario™ Blood Glucose Monitoring System devices sold in the U.S.; 55% growth from third quarter of 2016
  • Consumable strips growth of 67% over third quarter of 2016
  • Nearly 95% of U.S. users have ordered test strips

According to the press release, DarioHealth expects sales to continue to accelerate in 2017 while reducing overall customer acquisition cost via:

  • execution of insurance reimbursement coverage options for U.S. consumers
  •  an increase in the percentage of higher-margin recurring consumable revenue
  • an expansion of the platform availability to include Android, which has been submitted to the FDA


Chairman and CEO of DarioHealth, Erez Raphael, commented,

“Our vision and focus allowed us to achieve a great deal over the last year, and has placed us in an advantageous position for further growth and market penetration for our Dario all-in-one smart glucose monitor and data platform. Our direct-to-consumer strategy in the U.S., launched mid-year, yielded the majority of our sales in this region, and continued to accelerate in the fourth quarter.

“We are encouraged by the fact we delivered on increased device sales, significant monthly user growth and established a predictable stream of high margin recurring subscription revenues from new customers. Furthermore, we are excited by the positive engagement we are achieving with our users, expect user growth to accelerate in 2017, and see revenue growth to continue in each sequential quarter, as it has grown until now.”

DarioHealth Conference Call Today, 9:00am ET

DarioHealth Corp. will hold a conference call today at 9am ET to discuss fourth quarter and full year 2016 results, as well as strategy and outlook for 2017.

  • The conference call will be hosted by Erez Raphael, Chief Executive Officer, and Zvi Ben-David, Chief Financial Officer.
  • The call can be accessed by dialing (866) 682-6100 or (862) 255-5401 and asking for the DarioHealth earnings conference call.
  • A live webcast of the call will also be available at: http://www.investorcalendar.com/IC/CEPage.asp?ID=175764

See also:

 DarioHealth February 2017 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

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


About DarioHealth Corp.

DarioHealth is a leader in digital health self-management solutions. DarioHealth delivers the ability to combine and analyze consumer health data to personalize treatment and advance medical knowledge. 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.  Having recently launched in the largest market in the world for glucose monitoring, U.S. sales are expected to have a significant impact on revenues and gross margins. With marketing clearance in Europe and the U.S., the Dario iOS mobile app recently launched with reimbursement in the United Kingdom, Australia, Israel, Italy, and Canada, and has also launched in New Zealand, Netherlands, Italy, and Belgium.  For more information, visit http://mydario.investorroom.com/





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  • MSRT shares lost 30% in recent weeks due to uncertainty in how the new administration in Washington will deal with the rapidly growing legalized cannabis industry in the U.S.
  • However, Attorney General Jeff Sessions took a much more pragmatic stance on the cannabis industry in the U.S. just yesterday
  • Expect shares of MSRT to rally in the coming days/weeks on yesterday’s clarification that erases much of the uncertainty that the market hates
  • MSRT shares are bouncing off the 200-day moving average of .78 and look prime for a breakout
  • MSRT is experiencing high sales growth and expects to be cash-flow positive in near term


MassRoots chart


Cole Memorandum and Legal Cannabis in the U.S.

Essentially, the Cole Memorandum states that jurisdictions that have legalized marijuana in some form are less likely to be a threat to the federal priorities under the CSA if they have implemented strong and effective regulatory and enforcement systems to control marijuana growth and distribution. The Cole Memo also gives wide prosecutorial discretion whether to prosecute state legal marijuana enterprises and hinted that it is probably not efficient use of federal resources to focus enforcement on state legal businesses.

In an appearance yesterday before local, state and federal law enforcement officials in Richmond, Virginia, Attorney General Jeff Sessions stated that:

“The Cole Memorandum set up some policies under President Obama’s Department of Justice about how cases should be selected in those states and what would be appropriate for federal prosecution, much of which I think is valid.”

See:  Jeff Sessions Suggests A Crackdown Isn’t Coming For Legal Weed

Sessions also indicated that the Justice Department doesn’t have the resources to enforce federal prohibition in states across the country.

This is a major shift from the Attorney General’s previous statements on legalized cannabis in the U.S., statements which strongly contributed to a weakness in MSRT shares.

MassRoots Overview

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

We see exciting opportunity ahead for this business considering:

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

We believe MassRoots will grow rapidly to over $120 million in market capitalization versus the $65 million current market cap considering the business has over 900,000 users and is experiencing extremely rapid growth. Weedmaps was valued at $300 million with only 750,000 users. Leafly was valued at $425 million with only 1 million users.

MSRT at a glance:

Shares outstanding: 78.9 million
Approximate float: 40.5 million
Current Price 3/16/2017: .81
Market Capitalization: 65.2 million

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Market Opportunity

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

The 2016 elections put in place new cannabis laws affecting 22% of the U.S. population, a fundamental growth catalyst for MassRoots.

MassRoots legalized states


More States Expected to Legalize Medical and Recreational Cannabis 

Isaac Dietrich, Chairman & CEO of MassRoots stated in a December letter to shareholders,

“Throughout the next two years, we expect five additional states will pass medical cannabis laws: Texas, Louisiana, Utah, Nebraska and South Carolina while an additional five states will pass recreational cannabis laws: Michigan, Maryland, Vermont, Connecticut and New Jersey. We expect that, with the exception of Michigan, these laws will be passed through the state legislature which is a fraction of the cost of running a statewide ballot initiative. Sitting at the intersection of healthcare on the medicinal side and a vice industry on the recreational side, we believe the cannabis industry can continue to grow in any economic climate.”

In a very short period of time, MassRoots has grown its user base to over 900,000 and adds approximately 30,000 users per month. The massive community of the world’s top cannabis enthusiasts collectively engage over 300,000 times per day on the network. Average daily mobile users is 1750,000. The website gets about 200,000 unique visitors per day, and we are told the platform can easily handle 1 billion unique visitors/day. The company has 10-15% of the addressable market in Colorado. Ohio is coming online next year and the company is eager to expand. Customer acquisition costs have been around $0.80 but are now lower. Revenue per user is targeted to soon be running around $1.00.

MSRT Recent Positive Highlights

  • Retired All Remaining Convertible Debt

  • Raised over $2.9 million through warrant exercises so far in 2017, almost entirely from the exercise of the Company’s $0.90 warrants, giving MassRoots its strongest cash position in corporate history

  • Reinstated in Google Play and the launch of display ads on its Andriod applications in February 2017, growing the Company’s revenue channels.

  • Completed acquisition of DDDigtal, d.b.a. “Whaxy,” an online order-ahead and menu management platform. Since launching in May 2016, Whaxy’s online ordering platform has processed over $7 million in volume across 60,000 unique transactions

  • Added Mr. Tom Angell as the Company’s Senior Political Correspondent in early February 2017 and has since increased its blog traffic by nearly 18% and received comment from White House Press Secretary Sean Spicer
  • Plans to launch its revamped website in early March 2017, in anticipation of its annual web traffic surge ahead of the 4/20 cannabis holiday
  • Targeting market share to 25-35% of cannabis consumers in regulated cannabis markets during 2017



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



Shares of MassRoots (MSRT) were hit hard in recent weeks due to market uncertainty in how the new administration in Washington would approach the cannabis industry in the United States. Clarity from Attorney General Jeff Sessions yesterday is a welcome development, and MSRT shares should find support at the 200-day moving average of .78. With continued strong sales growth, near term expectation to turn cash-flow positive, retirement of all convertible debt, and the strongest cash position in corporate history, MassRoots has a solid financial footing to execute its business plan.

See also December 2016 Investor Presentation

massroots gary signature



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