Monday, June 24, 2019

Avalon Globocare: A Trifecta Biotech

Summary
Avalon Globocare is an investment gem because it is brewing a highly diversified pipeline of potential blockbusters.
Leveraging precision medicine, Avalon employs liquid biopsy with exosomes biomarkers to provide an accurate diagnosis for various cancers and even nonalcoholic steatohepatitis.
The crown jewel of the immunotherapy franchise is a premier multi-targets CAR-T. It has the power to circumvent prior limitations of the first generation drugs (Yescarta and Kymriah).
I never attempt to make money on the stock market. I buy on the assumption that they could close the market the next day and not reopen it for five years. - Warren Buffett
In bioscience investment, it is wise to choose a young growth company with several blockbuster prospects. When there are three blockbuster franchises, chances are that you found yourself a jackpot of gold. If one or two franchises fail, there is still the third one to deliver outsized profits. That being said, Avalon Globocare Corp. (AVCO) epitomizes this type of growth equity. The young grower, Avalon is attempting to capture fortunes in regenerative medicine, CAR-T, and precision medicine diagnostics. As such, the company is positioned to hit a "trifecta." A trifecta biotech usually yields strong investment returns due to three layers of blockbuster diversification built into one firm. If you've been reading my research, you'd realized that diversification is highly imperative for successful life science investment.
Figure 1: Avalon stock chart (Source: StockCharts)
Since biotech equities are risky, there are correspondingly high rewards. To mitigate the risk, you must employ with diversification both within the stock like Avalon as well as in purchasing a basket of equities. Keep in mind that this form of diversification is different than the diversified pipeline of a giant pharmaceutical innovator. In my opinion, it's nearly impossible for a giant to double or triple in the next several years. Investing in young growers like Avalon is the way to generate outsized returns in the long run. If confirmation is needed, you can view the phenomenal profits from the SPDR S&P Biotech (XBI) that focuses on bioscience growth equities. In this research, I'll feature a fundamental analysis of Avalon and provide my expectation on this Phillip Fisher growth stock.

About The Company

Founded in 2016, Avalon Globocare operates key subsidiaries (Avactis Biosciences and Genexosome Technologies) and is headquartered in Freehold New Jersey. Only several years old, Avalon Globocare already built a reputation for itself as the leading cell-based technology company. In delivering hopes to countless patients worldwide, Avalon is focused on the development and innovation of medicines and diagnostics to serve the strong unmet needs in cancer and various diseases. As follow, the company is poised to capture three highly promising niches, including exosome diagnostics, regenerative medicine, and cellular immunotherapy.
Figure 2: Avalon subsidiary (Source: Avalon)
Powering the diagnostic portfolio is precision medicine based on "exosomal biomarkers." Accordingly, Avalon is delivering a diagnostic avalanche against oral cancer, nonalcoholic steatohepatitis ("NASH"), leukemia, colorectal cancer, and macular degeneration. Notably, exosomal biomarkers can quickly pinpoint a diagnosis to give physicians an edge against dreaded diseases. In the battle of life and death, I believe that accuracy and precision are of paramount importance. That aside, Avalon is brewing various potential blockbusters, including AVA-101, -201, and -203 as shown below.
Figure 3: Diagnostic and therapeutic pipeline (Source: Avalon)

Strong Infrastructure And Subsidiary

Aside from the strong proprietary core technology and intellectual properties, Avalon has a unique growth infrastructure. Specifically, the company has the capability to accelerate its product development and commercialization through three strategic laboratories, including Weil Cornell Medicine, Beijing Lu Daopei, and Nanjing BenQ hospitals. You guys are probably familiar with the caliber of Cornell Medicine. Lu Daopei hospital is no less than Cornell, as it's founded by a stellar physician who is held in high regards in China. That aside, the aforementioned subsidiaries allow for great flexibility in research and development. Moreover, it enabled international investors to build shares in a company that has a strong foothold in North America and especially overseas.
Figure 4: Strong vertical integration (Source: Avalon)

Precision Medicine Powered Diagnostics

Shifting gears, I'll analyze the secret sauce that differentiates Avalon from other bioscience innovators. Representing the industry tailwind and fundamental shift, precision medicine embodies a therapeutic that is tailored to the individual patient. As such, it confers excellent efficacy and safety. The fine-quality of precision medicine is like a custom-made suit that is superior to clothing available at Walmart stores (WMT). As the pinnacle of medical management, precision medicine operates on the principle that the same drug can exhibit distinctive responses in different patients. The unique genetic makeup of one individual compared to another translates different enzymatic expression and drug metabolism. By developing specific medicine for a patient, the treatment outcomes are greatly improved.
Of note, a key component of precision medicine is a liquid biopsy. Traditionally, most confirmatory tests employ a tissue biopsy. Aside from having a higher rate of potential complications, a tissue biopsy is cumbersome and time-consuming. Like a magnet that drawn innovation toward progress, the trend nowadays is shifting in favor of liquid biopsy. In a simple blood draw, a liquid biopsy provides invaluable data on molecular biomarkers that, in and of itself, improve the diagnostic "sensitivity and specificity." In other words, a liquid biopsy expedites the diagnosis time, lowering the costs, and improving the diagnostic accuracy as well as treatment outcomes.
Figure 5: Liquid biopsy (Source: Avalon)
Traditionally, there are three biomarkers employed in a liquid biopsy. They include circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and exosomes. In my view, the trend nowadays is moving away from CTCs. Only ctDNA and exosomes remain dominant. As part of cancer cells that get pinched off and travels into the bloodstream, I believe that exosomes hold the greatest promises. Exosomes are like leaves that provide invaluable information about a tree (i.e. cell). By getting a hold of the leaves, you can pretty much tell if the tree has a disease. And given that exosomes are readily accessible in many biological fluids (blood, urine, and saliva), tapping into exosomes for diagnosis is ingenious.
Figure 6: Exosomes (Source: Avalon)

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Saturday, June 15, 2019

ArQule: Profiting From Tyrosine Kinase Inhibition

Summary
Though not exhilarating, value and growth investing usually garner outsized returns. Nonetheless, it takes time for the value of growth equity like ArQule to be unlocked.
After years of dormancy, Arqule bulls rallied to the strong clinical reporting of ARQ-531 for various blood cancers. And, I forecast that advanced trials will deliver positive results.
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Time is the friend of the wonderful company, the enemy of the mediocre. - Warren Buffett

Author's Note: In honoring my father, I'm offering a 50% membership discount to new subscribers. Message me if you'd like to receive your Father's Day gift.

Aside from his prowess for numbers, Warren Buffett has the excellent temperament for investment. In my view, Buffett's mega success is the cumulation of his hard work and rigorous learning. With a voracious appetite for knowledge, Buffett read financial report daily in his office. The man is a learning machine. That aside, the fact that Buffett lives in the golden land of opportunity also helps him grow Berkshire Hathaway (BRK) to become a multibillion-dollars franchise. In following the footsteps on the giant Buffett, I made it a habit to exercise my due diligence by researching every day and periodically reviewing my investment thesis. This learning process reinforces my growth and value investing approach that is adapted specifically for the life science industry. Over the years, I'm convinced that the Buffett wisdom - time being on your side when you hold a fundamentally sound stock - is true. As such, my pick on the oncology innovator ArQule (ARQL) exemplifies the Oracle's teaching.
Figure 1: Arqule stock chart. (Source: StockCharts)
From 2016 to early 2018, the shares were trading at a depressed level, around $1.5 per share. During the time, I realized that there is much room for growth ahead due to the quality of its molecules. And, I was even more excited because ArQule was undergoing a period of market unpopularity. Consequently, it enabled the stock to trade at a deep bargain to its true worth or intrinsic value as Buffett calls it. In just over a year, ArQule has appreciated over 37%. Despite the modest gains, the best is yet to come. In this article, I'll present a fundamental analysis of ArQule and provide my expectation on this young grower.

About The Company

As usual, I'll deliver a brief corporate overview for new investors. If you are familiar with the firm, I suggest that you skip to the subsequent section. Headquartered in Burlington Massachusetts, Arqule is focused on the innovation and commercialization of precision medicine to serve the unmet needs in oncology. Harnessing the power of various tyrosine kinase medicines, Arqule is brewing a robust pipeline of three molecules (ARQ-531, miransertib, and ARQ-751) for various cancers.
Figure 2: Therapeutic pipeline. (Source: Arqule)

Derazantinib

Viewing derazantinib as a golden nugget, Basilea and Roivant acquired the rights to this promising molecule. Thereafter, they are investigating its efficacy and safety is a Phase 3 registration trial for a liver cancer known as intrahepatic cholangiocarcinoma. I believe this is good for ArQule because the company received payments to fund its pipeline innovation.
Similar to an infant, it's important for a young company like ArQule to focus on walking first prior to running. Hence, it is much profitable to devote the efforts on a few key assets (i.e. low hanging fruits) rather than shotgunning everything. If there is plenty of cash from a partner, then why not? Nonetheless, shotgunning is not a prudent strategy for ArQule because doing can burn a hole in the balance sheet. That being said, let's shift gears to analyze the crown jewel (ARQ-531).

Phase 1 Trial Of ARQ-531

On June 14, 2019, Arqule published the robust clinical outcomes for the flagship reversible BTK inhibitor (ARQ-531) at the 2019 European Hematology Association (EHA) that was held in Amsterdam Netherlands. In Phase 1 dose-escalation study of patients suffering from resistant blood cancers, ARQ-531 demonstrated excellent efficacy and a favorable safety profile. Per trial design, patients were stratified into eight different groups consisting of lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), Richter’s Transformation, Waldenstrom macroglobulinemia, and other B-cell Non-Hodgkin lymphomas.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Additional disclosure: As a medical doctor/market expert, Dr. Tran is not a registered investment advisor. Despite that we strive to provide the most accurate information, we neither guarantee the accuracy nor timeliness. Past performance does NOT guarantee future results. We reserve the right to make any investment decision for ourselves and our affiliates pertaining to any security without notification except where it is required by law. We are also NOT responsible for the action of our affiliates. The thesis that we presented may change anytime due to the changing nature of information itself. Investing in stocks and options can result in a loss of capital. The information presented should NOT be construed as recommendations to buy or sell any form of security. Our articles are best utilized as educational and informational materials to assist investors in your own due diligence process. That said, you are expected to perform your own due diligence and take responsibility for your action. You should also consult with your own financial advisor for specific guidance, as financial circumstances are individualized.

Wednesday, June 12, 2019

Intercept: Amid The FDA Draft Guidance OCA Will Be Approved

Summary
Intercept is an excellent contrarian bet due to a stream of negative news flow amid the strong fundamental development. As such, there is definitely a silver lining in the dark.
The current pessimism against Intercept is the 2019 NASH draft guidance. Mr. Market believes that the draft will hamper the prospect of obeticholic acid's approval. This is certainly overblown.
As the light that shines in the darkness, the Phase 3 REGENERATE trial for obeticholic acid covers all bases. With strong data, OCA will gain approval for all NASH stages.
You only have to do very few things right in your life so long as you don't do too many things wrong. - Warren Buffett
In Benjamin Graham's book The Intelligent Investor, the Father of Value Investing epitomizes the fickle nature of the equity niche as "Mr. Market." Driven by emotion, Mr. Market usually makes impulsive decisions that are disconnected from the stock's fundamentals. His mood is reflective of a pendulum that swings to either extreme optimism or grave pessimism. As I'm cognizant of his behavior, I'm enthused by a good investment prospect disdained by Mr. Market. In my view, investors have a much better chance of uncovering undervalued equities during a stock's period of unpopularity. If all experts are opining positively on a stock, chances are that it's either optimally priced over overpriced. A prime example of this phenomenon is Intercept Pharmaceuticals (ICPT).
Figure 1: Intercept chart (Source: StockCharts)
The current market consensus believes that there are irreparable safety issues centering the lead medicine obeticholic acid (Ocaliva). Nonetheless, OCA is already approved for another liver disease for years. Therefore, it's acceptable safety profile is established. As I addressed those specific issues in prior articles, I'll defer from going over the same issues. That aside, it seems that Mr. Market is now having a fit regarding the latest FDA guidance for nonalcoholic steatohepatitis ("NASH"). Despite the grim outlook, the fundamental picture of Intercept is brighter than ever. In this article, I'll present a fundamental analysis of Intercept while focusing on the ramification of the FDA draft guidance.

About The Company

As usual, I'll deliver a brief corporate overview for new investors. If you are familiar with the firm, I suggest that you skip to the subsequent section. Headquartered in New York City, Intercept is focused on the innovation and commercialization of a semisynthetic bile acid known as OCA to treat serious liver conditions. In binding to the “holy grail” receptor farnesoid X, OCA activates many key regenerative responses. On May 2016, the FDA approvedOCA as Ocaliva for the treatment of a rare and chronic liver condition, primary biliary cholangitis ("PBC").
Figure 2: Therapeutics pipeline (Source: Intercept)
Currently in a Phase 3 trial, Intercept is most likely the first company to launch a medicine for managing the highly prevalent fatty liver disease, NASH. As the crown jewel of Intercept is its fatty liver disease franchise, I'll shift gears to cover the recent market concern regarding NASH.

FDA NASH Guidance

In June, the FDA published draft guidance to assist NASH innovators regarding the development of medicine for "compensated NASH cirrhosis." As a draft, the article is not a legally enforceable document. It simply represents the agency's current thinking on NASH. Specifically, the FDA stated that the guidance is a "draft - NOT for implementation and contains nonbinding recommendations." In a nutshell, the FDA is just generating ideas and getting feedback from the medical community as NASH is an untamed market.
To appreciate the guidance, it's important for investors to be cognizant of the background on this liver disease. In the nonalcoholic fatty liver disease (NAFLD) spectrum, NASH will progress from fibrosis to cirrhosis over time. At this stage, cirrhosis is stratified into two main categories, "compensated and decompensated." Of note, patients afflicted by compensated NASH exhibited significant liver scarring as shown via histology (cell imaging).
Without treatment, compensated NASH cirrhosis deteriorates toward decompensation over time. At in point, complications wreak havoc on the patients. As such, there is high blood pressure in the liver (i.e. portal hypertension). The liver function is also compromised. Ultimately, the patient succumbs to end-stage liver disease.
Regarding treatment for compensated NASH, the FDA mentioned that the goal is to either "slow or halt the disease progression toward fibrosis." Moreover, it's important to prevent clinical decompensation, reduce the need for liver transplantation, and improve survival. I strongly believe that this is a "lofty goal."
The fact is that neither therapeutic lifestyle modifications nor any drug (asides from OCA) can slow this disease in any stage, not to mention its advanced compensated progression. Unfortunately, patients with compensated NASH cirrhosis may appear healthy without any clinical symptoms. As a silent killer, NASH complicates the clinical trial endpoints because of the lack of symptoms. In finding out ways to deal with this irony, the FDA elucidated,
The FDA strongly recommends clinical outcome trials to support a marketing application. Histological improvements in fibrosis can be proposed and justified; however, at present the relationship between histological changes in cirrhosis and clinical outcomes has not been characterized, and further, reversal of cirrhosis (e.g., fibrosis stage F4) may not be feasible. Because currently there is insufficient evidence to support the use of histological improvements as a surrogate endpoint that is reasonably likely to predict clinical benefit to support accelerated approval, in general, the FDA expects to evaluate drugs for the treatment of compensated NASH cirrhosis under the traditional approval pathway.
In other words, the FDA is saying that there is no proven relationship between biopsy and the clinical endpoints. Therefore, the agency "suggests" that innovators employ clinical outcome as the primary study endpoint rather than other surrogates like biomarkers or histology. If the company chose to employ biomarker, it has to provide supporting literature to warrant approval.

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Simply put, this is worth every penny. Just earlier today, one of the companies recommended by Dr. Tran got acquired for a nice 50% premium.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Additional disclosure: As a medical doctor/market expert, Dr. Tran is not a registered investment advisor. Despite that we strive to provide the most accurate information, we neither guarantee the accuracy nor timeliness. Past performance does NOT guarantee future results. We reserve the right to make any investment decision for ourselves and our affiliates pertaining to any security without notification except where it is required by law. We are also NOT responsible for the action of our affiliates. The thesis that we presented may change anytime due to the changing nature of information itself. Investing in stocks and options can result in a loss of capital. The information presented should NOT be construed as recommendations to buy or sell any form of security. Our articles are best utilized as educational and informational materials to assist investors in your own due diligence process. That said, you are expected to perform your own due diligence and take responsibility for your action. You should also consult with your own financial advisor for specific guidance, as financial circumstances are individualized.

Sunday, June 9, 2019

IBI Top Picks For Summer 2019 Part II: Which Bioscience Stock Will Sit On The Iron Throne?

Summary
Last weekend, I featured Part I of the Top Picks for Summer 2019. I'll finish up this series by presenting four more growth companies.
As a leader in the non-alcoholic steatohepatitis space, Madrigal is most likely to deliver strong advance data and thereby takes its crown as the undisputed champion in the $25B market.
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One thing that could help would be to write down the reason you are buying a stock before your purchase. Force yourself to write this down. It clarifies your mind and discipline. - Warren Buffett

Author's note: In honor of my Father, I'm offering new subscribers a 50% discount gift in advance of next weekend's Father's Day. Send me a message if you wish to receive yours.

In Part I of my Top Picks For Summer 2019, I featured four powerful bioscience growth equities. To complete this summer expedition, I recently came out of the jungle of bioscience equities to deliver to you four more intriguing investment leads. In my view, they are low hanging fruits that can catapult your portfolio to the new high, provided that you hold them for the next several years. In my view, the most outsized returns arise from long-term investing.
If you take equity investment similar to buying a house, it'll make much more sense. One cannot expect to flip a house overnight for the most gargantuan profit. A house needs years to appreciate multiple folds. From the fundamental paradigm, equity investment works pretty much the same way. Time is simply a requisite for a growth business to unlock its full potential. Buffett said it best: "You can't produce a baby in one month by getting nine women pregnant."
My view is in line with the Oracle of Omaha, Buffett. Nevertheless, I believe that you can still bank short-term profits in bioscience. This occurs in situations known as "binary events" like an FDA approval or clinical data reporting. Nonetheless, one needs to have expert forecasting skills to have an edge over the market. Armed with all the arsenals, it's still quite risky. Moreover, the returns are not outsized as in ultra-long-term holding to make investing worthwhile.
A prime example that illustrates my assertion is Jazz Pharmaceuticals (JAZZ). Back in 2019, I learned about Jazz from my friend, Mr. Xiong. We've been good friends for over a decade. Our friendship commenced in college when we just got our feet wet into equity research. I remember we used to go to those option seminars. At the time, Jazz was trading around $1.0 per share. As we had a myopic view during the time, we sold out early for a good profit.
Over the years, our initial satisfaction turned into distraught as Jazz continues its ascension to the height of Mount Everette. Hindsight is always 20/20. And yet, had we hold Jazz through thick and thin, it would have been a 130-bagger investment. Another example is Sesen Bio (SESN). If you sold out Sesen prematurely, you would have missed a 100% rally this year. As I learned my lesson from Jazz, I harped at investors to build shares of Sesen when it tumbled early in the year. The story on Jazz and Sesen reinforced the need for investors to adopt a long-term approach. If you are into trading, I suggest you trade on a separate portfolio to keep things compartmentalized. That way, your stocks won't get mixed up.
Shifting gears, I'll feature the first growth equity that made our list in Part II, Madrigal Pharmaceuticals (MDGL). After a successful merger with a private company, Synta Pharmaceuticals back in 2016, Madrigal has an aplenty of cash to power its drug development to serve the unmet needs in the $25B non-alcoholic steatohepatitis ("NASH") market. At the same time, Synta is bailed out from its subpar clinical reporting for other developments. As a beta-thyroid agonist with specificity toward the liver, the lead molecule MGL-3196 posted the robust Phase 2 trial results.
Figure 2: Therapeutic pipeline (Source: Madrigal)
In the aforesaid investigation, MGL-3196 demonstrated statistically and clinically meaningful liver fat reduction as well as NASH resolution on biopsy. As such, I strongly believe that it'll generate similar results in the Phase 3 trial and thus positioned to gain approval. Due to the substantial (42%) fat reduction at the high dose, MGL-3196 is best positioned to treat early-stage NASH.
Ultimately, Madrigal will capture the pristine mega-blockbuster NASH market. Despite the meager 15% profits for IBI Core Portfolio ("CP Alpha"), I strongly believe that this stock will become a multibagger in the long-run. And, I ascribed a 65% "investment profitability" score on this stock. In other words, you're most likely to make big money on Madrigal in the next couple years as its data matures.
Next off the bat is a leading in gene therapy innovator known as Regenxbio(RGNX). I prefer to invest in leaders in their respective field because they usually post robust clinical outcomes. As the positive data rolls in, the stock usually garners huge profits. That being said, the proprietary platform technology for gene delivery coined NAV is essentially the heart of Regenxbio. Born out of Dr. James Wilson's Lab at the University of Pennsylvania, NAV is the prodigy child of the cumulative wisdom learned from previous setbacks in gene transfer. Accordingly, NAV employed highly advanced adeno-associated virus (“AAV”) delivery vectors that overcame previous obstacles.
Figure 3: Therapeutic pipeline (Source: Regenxbio)
Due to its excellent clinical outcomes, over ten different companies tapped into Regenxbio for NAV. And, they're currently developing NAV for over 20 different indications. A notable partner, AveXis was acquired by Novartis for $8.7B last year. With AveXis under its wings, Novartis successfully expedited for the development of Zolgensma. On May 2019, the aforesaid gene therapy is approved for the orphan condition spinal muscular atrophy Type 1.
Asides from the strong prospects in the licensee programs, I expect the crown jewel, RGX-314 to realize its mega-blockbuster prospect in the coming years. Currently in Phase 1/2 for wet age-related macular degeneration ("AMD"), RGX-314 has a 65% (more than favorable) chance of delivering good clinical results. As such, it'll cut into the $20.7B market wet AMD market. Though Regenxbio has registered over 50% profits for CP-Alpha, I believe that there are multiple folds upsides. And, I ascribed a 65% investment profitability to this innovator.

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Dr. Tran's analyses are the best in the biotech sphere, well worth the price of subscription.
Very professional, extremely knowledgeable, and very honest … I would highly recommend this service and his stock picks have been very profitable.
Simply put, this is worth every penny. Just earlier today, one of the companies recommended by Dr. Tran got acquired for a nice 50% premium.

As I reserve higher market intelligence and exclusive features for IBI members, I invite you to take my temporary offer of 2 weeks FREE TRIAL.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Additional disclosure: As a medical doctor/market expert, I'm not a registered investment advisor. Despite that I strive to provide the most accurate information, I neither guarantee the accuracy nor timeliness. Past performance does NOT guarantee future results. I reserve the right to make any investment decision for myself and my affiliates pertaining to any security without notification except where it is required by law. I'm also NOT responsible for the action of my affiliates. The thesis that I presented may change anytime due to the changing nature of information itself. Investing in stocks and options can result in a loss of capital. The information presented should NOT be construed as recommendations to buy or sell any form of security. My articles are best utilized as educational and informational materials to assist investors in your own due diligence process. That said, you are expected to perform your own due diligence and take responsibility for your action. You should also consult with your own financial advisor for specific guidance, as financial circumstance are individualized.