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The Future Of Drug Delivery Has Biotech Investors Focusing On One Small Company

Joe Samuel

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PharmaCyte Biotech (PMCB) is in Focus!

Over the last 10 years, biotech has been one of the best performing sectors in the entire market. It’s been for good reason too. A number of biotech stocks have produced life-changing returns because of their treatments and opportunities have only gotten bigger as time goes on.  

But this is only the beginning as top analysts are saying that the industry’s best days may be far from over especially considering that the SPDR S&P Biotech ETF is up 22% this year alone [1].

With a wave of groundbreaking products in the pipeline, biotechnology could be poised to keep churning higher for the foreseeable future. But how can you get in on the ground floor of the next big wave in biotech?

PharmaCyte Biotech (PMCB) Has Developed A Drug Delivery Platform That Could Be On The Verge Of A MAJOR FDA Event!

If you’re looking at PharmaCyte Biotech (PMCB) at this exact moment, you’re seeing it before the company begins clinical trials and just as it’s preparing to complete its Investigational New Drug application for the FDA.  Whether you’re new to biotech stocks or a seasoned vet, you should understand how important milestones like this are for a company.

The United States Food and Drug Administration’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved.

Right now, PharmaCyte Biotech (PMCB) is putting together the necessary material for its planned clinical trial for inoperable pancreatic cancer, one of the most deadly forms of cancer today. Just to give you an idea, pancreatic cancer, in general, has the highest death rate of all major cancers. Only 9% of people with this cancer will survive more than five years [2].

Could This Be The Technology Behind The Next Big Biotech Breakthrough?

Will PharmaCyte Biotech (PMCB) be considered the next supernova in biotech? Its drug delivery technology could change the way countless diseases could be treated and it starts with a “box.” Cell In A Box ® technology specifically, can be used as a platform upon which therapies for several types of cancer and even diabetes are being developed.

Essentially, PharmaCyte’s (PMCB) therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. This could mean that they’ve found a way to take a broad treatment (chemotherapy) and turn it into a targeted one.

But as smart investors, it can’t just be a “plan to do something,” and PharmaCyte (PMCB) knows this… 

Case and point: PharmaCyte’s partner, Austrianova, has successfully encapsulated the live cells used in PharmaCyte’s therapy for its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

biotech stocks to buy

Those cells are now growing and dividing inside the Cell-in-a-Box® capsules, and could suggest that all of the pieces necessary to complete and submit the long overdue IND application to the FDA are falling into place for the company’s upcoming clinical trial in the treatment of LAPC. Adding to this, PharmaCyte’s partner, Austrianova, has constructed and equipped a cGMP-compliant facility in the Thai Science Park in Bangkok, Thailand, which will be used to encapsulate the live cells using the Cell-in-a-Box® technology.

PharmaCyte’s submission of an IND application is what has its shareholder’s attention, but it’s what an FDA approval of that application could mean for PharmaCyte (PMCB) that could garner the most attention.  Once the FDA has approved the company’s IND application for Cell-in-a-Box® + low doses of ifosfamide to treat LAPC, the FDA’s approval will essentially permit PharmaCyte to open clinical activities throughout the country.

Why Is Timing So Important Right Now?

Timing is always important especially when dealing with the stock market.  What may be more crucial is when we’re talking about the biotech sector. Whether it’s phase trials or things like an investigational new drug designation, events like this could act and have acted as serious catalysts for countless companies.

Here’s why an open IND is key to PharmaCyte (PMCB) realizing a number of benefits that include:

  • Beginning the formal arrangements required to conduct its clinical trial in LAPC.
  • Working towards the major milestone of enrolling the first patient in its clinical trial.
  • Publishing that the technology behind its LAPC treatment has passed the incredibly difficult FDA screening process and met all of the FDA’s regulatory requirements.
  • Building global exposure of PharmaCyte’s Cell-in-a-Box® technology.
  • Paving the way for the development of treatments for multiple diseases including diabetes and a host of solid tumors. 

But aside from this, timing is so important right now because an approved IND submission would mean clinical trials could begin 30 calendar days from the submission date of the IND!

The best part:  the data obtained to date from the encapsulation parameters of the manufacturing process itself indicate that the encapsulation portion of the process is fault free and reproducible, which is a fundamental requirement of the FDA.

Could those looking at PharmaCyte Biotech (PMCB) at this exact moment be looking at a right place/right time scenario?  

Well, as Dr. Hidalgo, Principal Investigator of PharmaCyte’s trial, says, “If the results are very positive, these results may pave the way for an accelerated approval process through one or more avenues afforded by the FDA.”

Do you understand how big of an addressable market this could be for PharmaCyte?

Cancer drug sales are on track to eclipse the $200 billion mark early in the next decade [3], thanks to an innovation bonanza that’s transformed oncology into the fastest-growing segment across the entire pharmaceutical industry.

Specifically, a recent report [4] by EvaluatePharma estimated that global cancer drug sales could rise at a blistering compound annual growth rate of 12% over the next five years. When you talk about timing, this could be that moment in time to be actively looking for “the curve” and how to be ahead of it before the sector realizes such immense growth!

Cancer Fighting Stocks Are Getting Bought Before Investors Can Get Their Hands On Them

The global market for cancer drugs is huge and big players are investing heavily to gain an edge in this increasingly competitive market.  In many cases, the average investor hasn’t had a chance to look at game-changing biotech companies lately for the simple reason that pharmaceutical giants are hot on the acquisition trail.

Bristol-Myers, a pioneer in immunotherapy, is acquiring rival Celgene for $74 billion. On top of this, the latest headlines show that Merck is acquiring cancer drug developer Peloton Therapeutics for $1.05 billion. The announcement came at the same time that Peloton was preparing for its IPO!

Looking for more? Earlier this year, Eli Lilly bought Loxo Oncology for $8 billion. Pfizer’s deal to acquire Array Biopharma for $10.64 billion has been seen as a positive sign by investors for more deals as well. This could be just the tip of the iceberg for cancer-fighting stocks!

With PharmaCyte (PMCB) on the path of submitting and potentially gaining FDA approval of its investigational new drug application, there’s no telling which pharma companies could have this company on the radar.


We may have just uncovered a company set to take the stage for novel drug delivery.


Medical science hasn’t yet won the war on cancer, but it is scoring important victories in battles against many forms of the disease. Advances in new treatments have made cancer a hot investing theme over the past 18 months, helping to power fresh interest in biotechnology stocks. And the star power of people like Jeopardy’s Alex Trebek has put cancer treatment front and center after a very public diagnosis of stage 4 pancreatic cancer.

Major industry influencers are taking every chance they can to buy up smaller companies. The figures are becoming even more staggering as new therapies and phase trials materialize. PharmaCyte Biotech (PMCB) could be making a convincing argument to become one of the top biotech stocks to watch right now.

Not Just A Cancer Fighting Technology

This isn’t “just another cancer company.” PharmaCyte (PMCB) has developed a technology that could completely change the way cell therapies are conducted! Right now, the company isn’t just focused on cancer, they’ve also begun to apply Cell In A Box ® to other diseases like Diabetes.

Just like the method for cancer, PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell. But this time it will be the cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body.

The cell lines being studied are human liver cells, stem cells and beta islet cells. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they are designed to function as a “bio-artificial pancreas” for purposes of insulin production.

PharmaCyte has obtained from the University of Technology Sydney (UTS) in Australia an exclusive, worldwide license to use insulin-producing genetically engineered human liver cells developed by UTS to treat Type 1 diabetes and insulin-dependent Type 2 diabetes. These cells, named “Melligen,” have already been tested in mice and shown to produce insulin in direct proportion to the amount of glucose in their surroundings.

In fact, when Melligen cells were transplanted into immosuppressed diabetic mice, their blood glucose levels became normal. The Melligen cells reversed the diabetic condition.

Key Leadership With Proven Track Records

As with most biotechnology companies, management is crucial and PharmaCyte (PMCB) has built its leadership team around industry expertise:

Kenneth L. Waggoner serves as the Chief Executive Officer, President and General Counsel of PharmaCyte Biotech and is the Chairman of the Board. He has 50 years of experience in management, business, operations and law.  

Mr. Waggoner’s career includes leadership and legal positions at Chevron as Vice President and General Counsel of Chevron’s global downstream business after Chevron’s acquisition of Texaco.

Dr. Gerald W. Crabtree is the Chief Operating Officer of PharmaCyte Biotech and a Board member. He has spent almost 50 years working in academic, biotech and pharmaceutical companies with the majority of that vast experience being in the development of drugs and treatments for cancer.  He held tenure as Director of Project Planning and Management (Oncology and Immunology) at Bristol-Myers Squibb, one of the leading biotech firms in the world.

More importantly, Dr. Crabtree served as Project Manager for the development of the major anticancer agent, Taxol®, the “number one” drug under development at BMS at that time. Taxol® ultimately became a multi-billion dollar drug for BMS and is still widely used to treat a variety of cancers.

PharmaCyte’s Chief Medical Officer, Dr. Linda S. Sher is no stranger to leading trial investigations. Dr. Sher has participated in the surgery and management of more than 700 patients. She has been the Principal or Co-Principal Investigator for more than 50 clinical trials. Dr. Sher is also the Chief of the Division of Clinical Research for the Department of Surgery at USC where she oversees the implementation and conduct of clinical trials for the entire department, averaging between 50 and 70 studies at all times. She is also the Vice Chair of the USC Institutional Review Board.

Adding to this list is Dr. Matthias Löhr. He serves as the Chairman of the PharmaCyte Biotech Scientific Advisory Board. Dr. Löhr served as Principal Investigator for the Phase 1/2 and Phase 2 clinical trials of PharmaCyte Biotech’s pancreatic cancer treatment that were completed in the early 2000s.

Not only is he familiar with the Cell-in-a-Box® live-cell encapsulation technology that forms the core of PharmaCyte Biotech’s pancreatic cancer treatment, he has actually administered PharmaCyte Biotech’s treatment (the combination of Cell-in-a-Box® capsules with low doses of the well-known anticancer drug ifosfamide) in clinical trials in patients with advanced, inoperable pancreatic cancer.

The company also has a host of medical and scientific advisors, all of which have decades of experience in the biotech arena. 

Biotech Breakthroughs Set The Stage For Big Potential Ahead

Consider the base case for pancreatic cancer treatment alone and PharmaCyte (PMCB) could pose a strong argument to take a seat at the table for leading innovation. GBI Research’s latest report, Frontier Pharma: Pancreatic Cancer – Identifying and Commercializing First-in-Class Innovation could shed considerable light on PharmaCyte’s Potential.

The report states that while the pancreatic cancer treatment pipeline contains 447 therapeutics in active development across all Phases (compared to 209 currently marketed products) almost 75% of therapies are in Phase I or earlier [5].

According to Joshua Libberton, Analyst for GBI Research, “It is clear that drug developers are seeking novel approaches to pancreatic cancer treatment that differ from the present market.”

Right now, PharmaCyte (PMCB) could be on the verge of a major FDA event and a potential catalyst to become the next big biotech stock to watch. This industry is experiencing remarkable innovation, and now the race is to get behind the next breakthrough.

PharmaCyte’s (PMCB) unique technology, stand-alone therapies and top tier leadership are just a few of the key points to consider in our opinion. Being that timing could play a major role, this may be a company to take a close look at heading into the second half of 2019.


biotech stocks to buy

End Notes:

[1] https://www.cnbc.com/2019/06/28/the-best-place-to-invest-your-money-in-health-care-amid-2020-debates.html
[2] http://pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/
[3] https://www.iqvia.com/institute/reports/global-oncology-trends-2018
[4] https://info.evaluategroup.com/WP2018-CS.html
[5] http://www.gbiresearch.com/report-store/market-reports/frontier-pharma/pancreatic-cancer-identifying-and-commercializing-firstinclass-innovation


Disclaimer: Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 9/12/2019. We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Click Here For Full Disclaimer

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Biotechnology

Acadia (ACAD) Stock Price is up 60% This Month; Bullish Signal For Biotechs?

Joe Samuel

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One sector that has always been a favorite of investors of all varieties is the pharmaceutical sector and all investors like a turnaround story. Over the years, ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) had been one of the better-known strugglers in the industry. That was reflected in the stock price as well. But recent developments have breathed new life in the stock, which could be an indicator for the biotech industry at large.

Biotech Stocks To Watch: PharmaCyte Biotech (PMCB)

There has been no lack of attention on biotech penny stocks this year.  At the beginning of August, one small biotech stock broke to highs of over $10 from a starting price below $2 a share after releasing news. PharmaCyte Biotech (PMCB) focuses on ways to effectively deliver treatments to patients with diseases ranging from cancer to diabetes. 

The company’s proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®is the platform that the company uses to develop its therapy delivery methods.  For most of the quarter, shares of PMCB stock have traded between $0.033 and $0.04 with volume recently surging.

On September 12, PharmaCyte saw more than 4 million shares trade; well above its daily average. Most of the attention surrounding the company has been on two things. First, its progress with Cell-In-A-Box and the application for Pancreatic cancer has continued to progress. The company brought on Dr. Manuel Hidalgo, has confirmed that he will be Principal Investigator (PI) for PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) now that he is at Weill Cornell Medical Center.

Second, the company has been ramping up for a much-anticipated shareholder update call on September 20. The call will cover PharmaCyte’s preparations for submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to treat locally advanced, inoperable pancreatic cancer and developments related to PharmaCyte’s product pipeline on which PharmaCyte has been working and that have not yet been reported in a press release.

Acadia (ACAD) Stock Price: Important Developments

People who had held on to the stock through the barren years got a nice boost recently. This came after Acadia’s well-known medicine Nuplazid recorded better than expected sales. In addition to that, there were encouraging results from a dementia-driven psychosis study. Hence, it is important to figure out whether it is perhaps time to buy the stock.

While the signs are no doubt encouraging, it is important to note that data reveals that around 60,000 people in the United States are diagnosed with Parkinson’s every year. Out of those, a large proportion (50% to 80%) suffers from dementia. Hence it can be argued that the market is simply not too big for Acadia’s Nuplazid.

Moreover, different types of dementia are brought on by Alzheimer’s disease, which is why all of it might not actually fall into Acadia’s lap. That being said, it is also well known that antipsychotic drugs have only been approved for the treatment of Parkinson’s and hence the Alzheimer’s market is already out of the question.

Market Potential

Projections suggest that the sale of Nuplazid could grow to more than $1 billion in 2023 from $224 million in 2018. While that is encouraging, it is also important to note that the growth has been priced into the Acadia stock price.

However, if Acadia’s plans for growth somehow run into any trouble, then there is every chance of the stock price plummeting once again. The company is recovering and there is some time before the patient population for Nuplazid can be expanded sufficiently. In the meantime, investors need to be a bit more patient.

Shares of ACAD are up over 60% over the past week and made a new multi-year high of $43.98.

biotech stock price
Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 9/12/2019. We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Click Here For Full Disclaimer.

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Biotechnology

Top Biotech Stocks To Watch This Week

Joe Samuel

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best biotech stocks to watch

Biotech stocks rarely perform well during the summer months, and 2019 has proven to be no exception in regards to this historical pattern. The iShares Nasdaq Biotechnology ETF, for example, has fallen by nearly 2% since the official start of summer.

The values of biotech equities, however, do generally start to pick up as the year winds down. The underlying reason is that the latter part of the year is chock-full of key data readouts, regulatory decisions, and thousands of scientific conferences across the globe. 

Biotech Stocks To Watch

GT Biopharma (GTBP)

Earlier this quarter GT Biopharma, Inc. (GTBP) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager announced that Jeffrey Miller, M.D. has been hired by the Company as its Consulting Chief Medical Officer.

Further to this, the company confirmed that it had notified FDA that it was commencing enrollment in its first-in-human GTB-3550 Phase I/II clinical trial. The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick.

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE™) product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15.

Since making the announcement, shares of GTBP are up by 13.2%.

NewLink Genetics Corp (NASDAQ:NLNK)

NewLink Genetics Corp (NASDAQ:NLNK) said the FDA has accepted partner Merck & Co., Inc. (NYSE:MRK)’s BLA for its investigational Ebola vaccine, according to the application priority review status. The PDUFA goal date has been set for March 14, 2020.

Potential approval of the vaccine will trigger issuance of a priority review voucher, owned by Merck and in which NewLink has a substantial economic interest. NewLink can then monetize its share of interest in the voucher. The vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed to NewLink.

vTv Therapeutics Inc (NASDAQ:VTVT)

vTv Therapeutics Inc (NASDAQ:VTVT) is scheduled to present at the European Association for the Study of Diabetes 55th annual meeting being held in Barcelona, Spain with a new Phase 1/2 Simplici-T1 study of liver-selective glucokinase activator TTP399 as an adjunctive treatment for Type 1 diabetes.

Biotech IPO To Watch

IGM Biosciences priced its IPO of 10.938 million shares at $16, the midpoint of the estimated price range of $15-$17 per share. The shared of the preclinical and clinical-stage immuno-oncology biotech will be listed on the Nasdaq under the ticker symbol “IGMS.”

best biotech stocks to watch
Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $15,000 per month for 6 months by GT Biopharma (GTBP) for a period from September 4, 2019 to March 4, 2020. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click Here For Full Disclaimer.

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Biotechnology

3 Biotech Stocks Jumped Big Last Month

Joe Samuel

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biotech stocks to buy

The biotech sector has thrown up a high number of gems over the years and helped generate hefty returns for investors. Due to the advancements made in biotechnology over the years and those which are still being made, it is a sector that will continue to be a favorite of many investors.

Plenty of companies are doing revolutionary work in this space and have the potential of turning into excellent investments eventually. Here is a look at 3 biotech stocks that jumped significantly over the past few weeks and deserve to be on the watch lists of investors.

Tiziana Life Sciences (TLSA)

This biotech stock has been riding under the radar for the better part of the last 6 months. But in September, shares of Tiziana Life Sciences (TLSA) have enjoyed a much more active market. This has been due, in part to recent Phase Trial news related to the company’s pipeline therapies:

[9/16/19] Tiziana Life Sciences (TLSA) Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers

[9/10/19] Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers

[9/4/19] Tiziana Life Sciences (TLSA) Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma

Tiziana Life Sciences (TLSA) is focusing on to develop novel treatment for liver diseases such as NASH and hepatocellular carcinoma (HCC). Tiziana (TLSA) holds extensive IP and a strong pipeline of in-licensed clinical assets. Tiziana has clinical development programs for Foralumab and Milciclib. Strong IP for oral and nasal administration is for the platform technology, which is applicable to all antibodies drugs for treatment of human diseases. Click To Read More About Tiziana Life Sciences (TLSA)

Mesoblast (MESO)

The next company to watch: Mesoblast Limited (MESO Stock Report). Its shares skyrocketed last week after it emerged that it had entered into a lucrative partnership with Grunethal. Grunethal is a privately held German company. According to the terms of the deal, the companies are focusing on the development as well as sales of the product MPC-06-ID.

According to the terms of the deal, Grunethal is going to pay $15 million to Memoblast straightaway for the right to sell the medicine in South America and Europe. However, the company stands to earn as much as $135 million more if certain targets are met. The Phase 3 trials for patients in the United States are already happening and the data could be available by mid-2020.

Kodiak Science (KOD)

The other stock which made a major move last week was Kodiak Science (KOD Stock Report). The company is involved in AMD or age-related macular degeneration and similar other conditions that hamper the vision in people of advanced age.

Vision loss is one of the most important categories of treatments in the sector and there is a lot of conflict in the sector with regards to the effectiveness of anti-VEGF medicines. Kodiak is developing its own antibody known as KSI-301and recently human proof of concept data points with regards to the anti-VEGF medicine showed that the company might have actually found something that could work. That resulted in the remarkable rise in the stock price last week.

biotech stocks to watch
Disclaimer: Pursuant to an agreement between Midam Ventures LLC and Tiziana Life Sciences plc (TLSA), Midam has been paid $150,000 by Tiziana Life Sciences plc (TLSA) for a period from August 22, 2019 to September 22, 2019. We may buy or sell additional shares of Tiziana Life Sciences plc (TLSA) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Tiziana Life Sciences plc (TLSA). Full Disclaimer Click Here

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