Difei Yang, Ph.D., is Managing Director of Equity Research at Mizuho Americas, Research Division. Dr. Yang has been covering the biotech and pharma sector for nearly a decade, most recently as Managing Director at Aegis Capital. She also worked in senior equity analyst roles at Brean Capital, R.F. Lafferty, WallachBeth Capital and Auriga Global Investors.
In addition, she has held senior science, program management and business development roles within the pharmaceutical industry and has authored many granted U.S. patents and peer-reviewed scientific publications.
She holds a Ph.D. in chemistry from UCLA, as well as an MBA from Georgia State University and a B.S. degree in physics from Peking University, China.
In this 2,716 word interview, exclusive to the Wall Street Transcript, Dr. Difei Yang explores the potential of several publicly traded biotech firms to be acquired by larger multinational pharmeceutical corporations.
One theme is the rapidly growing gene therapy biotech sector:
“Gene therapy is typically used to treat inherited rare diseases, and it usually involves single gene mutations. The first gene therapy that was approved in the U.S. is called Luxturna.
It is a gene therapy developed by a company called Spark Therapeutics (NASDAQ:ONCE). That’s a company we cover, and the drug is used to treat an inherited retinal disease, so a form of blindness. And earlier this year, Roche (OTCMKTS:RHHBY) offered to buy Spark Therapeutics for a substantial premium.”
Dr. Yang identifies the attributes that make for a good candidate for acquisition in the space:
“A few common themes we’re observing in that space is that, number one, we tend to see the highest probability of success for those companies where they target a single gene mutation, and secondarily, when these companies are vertically integrated, they’re able to control the manufacturing and basically make products to support clinical development as well as commercialization.”
One company that fits the bill, according to Dr. Yang:
“So we cover a company called Audentes Therapeutics (NASDAQ:BOLD). They have a therapy that is currently in late-stage development treating X-linked myotubular myopathy — XLMTM — an inherited form of a neuromuscular disorder.
These patients are typically diagnosed when they are babies.
The disease involves severe muscle weakness, so not only do these babies not reach developmental milestones, they probably never acquired the skills to walk.
Muscle weakness also impacts their lung function. And the result usually leads to babies not being able to breathe on their own and require ventilators for support, in some cases 24 hours per day.
Audentes Therapeutics has a gene therapy. And based on early clinical data, what we’re seeing is that not only the babies are alive, they started getting off ventilator support. That is a drastic improvement in the standard of care.”
Read the entire 2,716 word interview to get the full details on this stock pick and many others, exclusively in the Wall Street Transcript.
Mark Watson is Managing Director of the Boston Impact Initiative Fund, which offers blended capital to address the racial wealth gap in eastern Massachusetts.
He is also the Founder of Keel Asset Management LLC, a financial advisory firm that provides socially responsible financial planning and investment advisory services to nonprofits, public and corporation pension plans. He is also an investment committee member of the Fair Food Fund; Chair of the Triskeles Foundation’s asset management committee; Board President of Sustainable Cape, Inc.; and a former board member of the Social Venture Network.
In this 3,690 word interview, Mr. Watson discusses his unique investment strategy, exclusively for the Wall Street Transcript.
“The fund’s operation sits inside of a 501(c)(3), whose mission is poverty elevation broadly speaking, and the fund sells notes to investors through the range of notes.
Those notes essentially raise debt from both accredited and nonaccredited investors and philanthropists. Those stakeholders can be high net worth folks. It could be family offices. It could be donor-advised funds. It could be individual investors.
For example, it could be local churches or faith-based organizations who have different terms that allow us to mix the incoming proceeds in a variety of ways to match the deployment that’s required by the entities that we’re investing in. So all that we owe back to investors is their principal and some interest. So that’s one distinction.
The second distinction is any upside accrues to the fund and will be recycled for reinvestment. The purpose of the fund is to regenerate community wealth, not extract wealth from them.
So any of the upside that accrues from, let’s say, we invest in a business that gets purchased by a third party, the upside accrues back to the nonprofit and then gets recycled back through the deployment process.
I have worked in traditional investments for more than 20 years. Some investors are looking for market-rate returns, which can be extractive from the same neighborhood that we’re actually trying to reinvest in.
So our focus is to deploy capital in a way that rebuilds assets, building strength in communities.”
One example has already gained significant traction:
“A second business in which we made an investment is a food business that I believe will be one of the nation’s newest nut-free consumer brands, called 88 Acres, which again went from zero revenues, now has a plant in Dorchester, Massachusetts, hired from the community offering living wages and is now selling product nationally through Amazon (NASDAQ:AMZN), Whole Foods, Costco (NASDAQ:COST) and Target (NYSE:TGT) as well as public schools, and should be close to $13 million run rate on an annualized basis at the end of this year. They started with us at zero.
There are a number of exciting opportunities that are big like that.”
To get all the detail on this innovative fund, read the entire 3,690 word exclusive interview, only in the Wall Street Transcript.
Pedro Marcal is the Director of International Equities and a Portfolio Manager at Foresters Investment Management Company, Inc. — FIMCO — and joined the firm in May 2018. Previously, he was a portfolio manager of global and international products at Fred Alger Management, where he worked for more than five years.
Before that he was a portfolio manager at Allianz Global Investors and its predecessor, Nicholas‐Applegate Capital Management, for 18 years, where he focused on international equities including developed and emerging markets. He has been in the investment management industry since 1994.
He has a B.A. in economics from the University of California at San Diego and an MBA from UCLA.
In this 2,668 word interview, exclusive to the Wall Street Transcript, Mr. Marcal demonstrates how ESG investing can produce outsized returns for investors.
“We’re talking about sustainability and particularly sustainability with a focus on companies that do the least damage to the environment while providing products and services that face increasing demand, such as food production and lower-emission air conditioning and resource utilization. And I think investors are increasingly interested in ESG.
We own another company, called Ashtead (OTCMKTS:ASHTF), that might be considered controversial in terms of being an ESG-friendly company, but we don’t think so. Ashtead is a British company that leases a full range of construction, industrial and general equipment to customers.”
Another interesting pick is the famous Japanese video game company.
“The key here is that we think Nintendo will launch a less expensive Switch. It was a little Nintendo machine that people play Donkey Kong on.
So this DS hand-held replacement has the potential to triple the Street forecast for hardware units. And this is supported by sales of their DS, which has done 230 million units in all of its versions since launch in 2004. So unlike the DS, the Switch addresses both the at-home and mobile hand-held markets.
We met with Nintendo’s senior management and played their yet-to-be-released games at the E3 Conference in June, and the lines were hours long to play some of these games.
Our target price is significantly above our 20% threshold. Perhaps more importantly for us, being long-term investors, we look at our three-year target price and see significantly more upside. ”
To get more detail on these and several other ESG stocks owned in this highly respected stock picker’s portfolio, read the entire 2,668 word interview, only in the Wall Street Transcript.
Brett P. Monia, Ph.D., is a Founding Member of Ionis Pharmaceuticals, Inc., where he is currently the Chief Operating Officer. He will assume the role of Chief Executive Officer of Ionis in January 2020. Dr. Monia has extensive experience across a range of therapeutic areas, including oncology, metabolic disease, inflammation, neurological disease and cardiovascular disease, which have resulted in a broad range of successful clinical achievements and in marketing approvals for new medicines.
As Chief Operating Officer, Dr. Monia leads business, regulatory and human resource functions, as well as translational medicine. He has published more than 200 primary research manuscripts, reviews and book chapters, and he is an inventor on more than 100 issued patents.
He is a senior editor for the Journal of Nucleic Acid Therapeutics, on the board of directors for Dynacure and has been President of the Oligonucleotide Therapeutics Society. Dr. Monia is also an adjunct professor of biology at San Diego State University. He received his Ph.D. in pharmacology at the University of Pennsylvania and B.S. degrees in molecular biology and analytical chemistry at Stockton State College in Pomona, New Jersey.
In this 3,481 word interview, exclusively to the Wall Street Transcript, Dr. Monia demonstrates the upside for investors in his company:
“…Our pipeline of more than 40 medicines in development, spanning from early development to the very final stages of clinical trials before potential commercialization, is really exciting. We have drugs for all kinds of diseases that have had no treatment options available for them.
Most of them are lethal diseases; oftentimes, they are genetic diseases. And they are not just rare diseases, like the three products I just highlighted, but they’re also for many common broad populations as well. And maybe I’ll just highlight a couple of them for you.
We have a program that’s now in Phase III clinical trials that’s targeting the cause of Huntington’s disease, a genetic neurodegenerative disease that is handed down from generation to generation. We’ve known the cause of this disease for more than 30 years, but it wasn’t until a new drug platform came forward, like antisense, that allowed us to target the cause of this disease and show that we can inhibit the production of this disease-causing molecule, the protein.
This drug is now in Phase III clinical trials with our partner Roche with data expected out maybe in 2022.
Another neurodegenerative disease, a genetic disease, for the treatment of a form of Lou Gehrig’s disease, or amyotrophic lateral sclerosis, ALS, has shown strong evidence of …”
Get the complete picture of the upside for investors by reading the entire 3,481 word interview, only in the Wall Street Transcript.
Gerrit Dispersyn is President and CEO of Phio Pharmaceuticals Corp. He joined Phio Pharmaceuticals Corp. in April 2017. Dr. Dispersyn is an accomplished leader in clinical, product and business development. He most recently was Vice President, Global Head of Clinical Affairs at Integra LifeSciences Corporation.
In this role, he was responsible for Integra’s global strategy and execution of clinical development, clinical operations and medical affairs projects and a member of Integra’s senior management leadership team and several of the company’s core teams for M&A projects.
Dr. Dispersyn has also been involved in Integra’s research and business activities related to Human Cells, Tissues, and Cellular and Tissue based Products — HCT/Ps. Earlier, he was the Vice President, Product Development and Portfolio Management for Barrier Therapeutics, Inc., a pharmaceutical company focused on the development and commercialization of products in the field of dermatology.
The company was a spinout of Johnson & Johnson, and currently part of GlaxoSmithKline. There, he led planning and implementation of all aspects of R&D operations and strategy; scientific, competitive and business intelligence; and alliance management. Dr. Dispersyn is the Founder of Ingress, LLC, a consultancy company providing R&D and clinical operations support to startup companies, supporting several pharmaceutical drug development programs.
Dr. Dispersyn holds a Dr. Med. Sc. from the Faculty of Medicine, Maastricht University, Maastricht, the Netherlands, a postgraduate degree in biomedical imaging and a M.S. in biochemistry, both from the University of Antwerp, Belgium.
In this 2,908 word interview, exclusive to the Wall Street Transcript, Dr. Dispersyn details the propects for this company for investors.
“The company is focusing on using its proprietary self-delivering RNAi platform in developing innovative immuno-oncology therapeutics. So basically, we have a technology that can address the unmet need specifically occurring in the immuno-oncology space for solid tumors.
So there are two issues at hand. One is that in patients with solid tumors, their immune effector cells, such as T cells or NK cells, have an inherent low functionality. And even if these cells with their low functionality get to the tumor, they are confronted with significant immunobiological barriers within what is referred to as the tumor microenvironment that will further limit their response.
With our technology, we can do two things. We can essentially reprogram a patient’s immune effector cells to increase their inherent functionality. And secondly, we can use our compounds to reduce the immunosuppressive nature of the tumor microenvironment.
And the reason why we can do that is that our proprietary self-delivering RNAi technology is a very elegant, nongenetic way of reprogramming a cell. Essentially, we can silence a gene without the need for genetic engineering.
So it’s simple to use because its self-delivering, meaning that there is no delivery vehicle required or specific formulations. There is no specific machinery required, such as electroporation, to get our compounds into the cell, and that also compares very favorably to, let’s say, other genetic engineering technologies that will need specific formulations and/or specific delivery mechanisms.”
Get the full 2,908 word interview, only in the Wall Street Transcript.
Dr. James Breitmeyer has been President, Chief Executive Officer and Director of Oncternal Therapeutics, Inc. — formerly Tokalas, Inc. — since September 2015. Dr. Breitmeyer is a veteran biotech executive with experience successfully starting and growing biotechnology organizations. He has been responsible for both the development and implementation of both operational and drug development strategies, as well as supervising and managing both large organizations and emerging biotechnology companies.
Dr. Breitmeyer was President of Bavarian Nordic, Inc. and Executive Vice President of Bavarian A/S, a multinational corporation headquartered in Denmark, from February 2013 to July 2015 where he oversaw business operations and development strategy both for Bavarian Nordic, Inc. and Bavarian A/S. He has been a director of Zogenix, Inc., a public pharmaceutical company, since March 2014 and was their acting Chief Medical Officer from August 2012 to February 2013 where he was responsible for clinical development and regulatory strategy.
He previously was the Executive Vice President of Development and Chief Medical Officer of Cadence Pharmaceuticals Inc., a public pharmaceutical company, from August 2006 to August 2012 and the Chief Medical Officer of Applied Molecular Evolution Inc., a wholly owned subsidiary of Eli Lilly and Co., a global pharmaceutical company, from December 2001 to August 2006.
Dr. Breitmeyer was also the Founder, President and Chief Executive Officer of the Harvard Clinical Research Institute, and Chief Medical Officer and Head of Research & Development for North America at Serono Laboratories Inc., an international biopharmaceutical company.
Dr. Breitmeyer was a founding collaborator and scientific adviser to Immunogen Inc., a biotechnology company, and held clinical and teaching positions at the Dana Farber Cancer Institute and Harvard Medical School. Currently, Dr. Breitmeyer serves as a director on two public boards, Zogenix, Inc. (NASDAQ:ZGNX) and Otonomy, Inc. (NASDAQ:OTIC).
Dr. Breitmeyer received a B.A. in chemistry from the University of California, Santa Cruz and his M.D. and Ph.D. from Washington University School of Medicine, with postgraduate training at Washington University and Harvard Medical School. He is board-certified in internal medicine and oncology.
In this exclusive 2,057 word interview, only in the Wall Street Transcript, Dr. Breitmeyer explains the focus of his company:
“Our lead candidate is named cirmtuzumab. And cirmtuzumab is a monoclonal antibody recognizing the ROR1 molecule. ROR1 is an important factor in the development of the embryo, but it is not part of normal adult life unless a cancer reactivates ROR1 and takes advantages of its growth-stimulating properties for the cancer to thrive and expand.
So our anti-ROR1 antibody, cirmtuzumab, was developed to specifically target ROR1 and to inhibit the growth-stimulating activity of ROR1 when it’s expressed by a hematologic cancer. We are in the clinic, in Phase II development for the treatment of patients with chronic lymphocytic leukemia, or CLL, and are seeing some exciting results.
We recently opened the randomized Phase II portion of our ongoing Phase I/II clinical trial, based on favorable outcomes from the dose-finding and dose-confirming cohorts of the clinical trial. These data showed that the combination of cirmtuzumab plus ibrutinib resulted in an interim objective response rate — ORR — of 100% for the first nine CLL patients with evaluable data receiving the recommended dosing regimen who have completed 12 weeks.
These data were consistent, if not better, than the results that we reported at the ASCO 2019 Annual Meeting earlier this year. We continue to see a well-tolerated safety profile consistent with that seen with ibrutinib treatment alone.
TWST: I understand you also have something in the pipeline for Ewing sarcoma.
Dr. Breitmeyer: Ewing sarcoma is a very serious — in fact, catastrophic — cancer that strikes children at an average age of 15 and presents initially as a bone tumor but often evades the initial attempts to remove or control it and can become widespread in the body.
We are developing a drug called TK216, which was developed at Georgetown University and which targets a genetic abnormality that is a primary cause of Ewing sarcoma.”
Get the entire 2,057 word interview for these and other drug development prospects, only in the Wall Street Transcript.
Pamela P. Palmer, M.D., Ph.D., has been Chief Medical Officer and Co-Founder of AcelRx Pharmaceuticals, Inc. since she co-founded the company in July 2005. Earlier, she was an anesthesiologist at University California San Francisco — UCSF.
She was director of the UCSF Pain Center for Advanced Research and Education — PainCARE — between 2005 and 2009. The American Pain Society named the UCSF Pain Management Center and PainCARE jointly as one of only six centers of excellence nationwide.
Between 1999 and 2005, she was Medical Director of the UCSF Pain Management Center, which uses a comprehensive and multidisciplinary approach to treat patients with various stages and types of complex acute and chronic pain.
From 1996 to 1999, Dr. Palmer worked as a faculty member at UCSF, where she conducted research on basic science mechanisms of pain transmission in her NIH-funded laboratory. In 1994, she co-founded Omeros Corporation, a biopharmaceutical company developing small-molecule and protein therapeutics aimed at improving pain management and clinical outcomes of patients undergoing a wide range of surgical and medical procedures.
Dr. Palmer received a medical degree and a doctorate in neuroscience at Stanford University and completed her anesthesia residency at the University of California, San Francisco.
In this 2,986 word interview, exclusively in the Wall Street Transcript, Dr. Palmer illustrates the strength of her corporate strategy with detailed explanations.
“It’s a very large market. When we’re talking about treating acute pain, our label is: for acute pain severe enough to require an opioid analgesic.
It’s not only for acute post-operative pain or acute emergency room pain. It’s not a selected targeted audience within medically supervised settings. It’s in fact acute pain that requires an opioid. So it is quite broad.
It’s really difficult to go into the numbers per se because it is such a broad area, but hospitals and surgery centers, etc., are going to be using it strategically.
Obviously, an oral tablet of an opioid doesn’t cost much money nor does a generic injectable opioid. So they’re going to have to make sure they’re using Dsuvia where it makes sense for them, where they’re actually saving money.
In my attempt to solve some of these problems with opioids, I decided to come up with a solid dosage form instead of a clear liquid dosage form so that it’s very unique looking and can’t be confused with any other drug.”
Get the complete picture from Dr. Palmer in this exclusive 2,986 word interview, exclusively in the Wall Street Transcript.
Dr. Vimal Mehta is CEO and Co-Founder of BioXcel Therapeutics, Inc. He has over two decades of experience in the pharma and biotech industry.
He also has been Senior Vice President of Business Development at Inpharmatica Ltd. and Jubilant Life Sciences. In addition, he was Business Development Manager at CuraGen Corporation.
Dr. Mehta holds a Ph.D. in chemistry from the University of Delhi, India, and completed a postdoctoral fellowship in chemistry at the University of Montpellier, France.
In this 3,086 word interview, exclusive to the Wall Street Transcript, Dr. Mehta details his strategy for his company.
“…We are focusing on agitation resulting from neuropsychiatric conditions in patients, like schizophrenia, bipolar, Alzheimer’s, dementia, opioid withdrawal and hyperactive delirium.
Recently, we got a grant from the U.S. Department of Defense, which is related to treating ASUD, which is alcohol and substance use disorder. So there are multiple diseases for which you can have this agitation and the patient needs to calm down.
Our drug, 501, works through a central mechanism in the brain. There is a firing of norepinephrine, a chemical that results in agitation. And our drug can stop the release of norepinephrine.
So we believe that it can work across multiple disease pathophysiologies and multiple disease conditions. And we have designed the drug…”
Dr. Mehta has near term milestones that he seeks to achieve:
“…We are transitioning the drug to Phase III, subject to discussions with the FDA. We expect to open our trial in Q4 of 2019.
So that’s where we are with that product. And the underlying drug that is being used on the film has been in the market for 20 years.
So our innovation was we identified that microdosing can be used to treat agitation, and the current drug is used as a sedative anesthetic.
It has never been used for agitation, and it comes in a bottle, so it’s given as an IV drug. We took that drug and converted into a sublingual thin film. We have a novel new indication as well as microdosing, small doses that we are using, and it’s a sublingual thin film.
There’s a lot of safety established around the IV form of the drug with millions of people, like 10 million or so. And in our studies, the sublingual thin film in hundreds of patients.
So that’s a kind of plan for 501. Phase III study, pivotal Phase III study is expected to start this year…”
Get the entire picture from Dr. Mehta in this exclusive 3,086 word interview in the Wall Street Transcript.
Difei Yang, Ph.D., is Managing Director of Equity Research at Mizuho Americas, Research Division. Dr. Yang has been covering the biotech and pharma sector for nearly a decade, most recently as Managing Director at Aegis Capital.
She also worked in senior equity analyst roles at Brean Capital, R.F. Lafferty, WallachBeth Capital and Auriga Global Investors. In addition, she has held senior science, program management and business development roles within the pharmaceutical industry and has authored many granted U.S. patents and peer-reviewed scientific publications.
She holds a Ph.D. in chemistry from UCLA, as well as an MBA from Georgia State University and a B.S. degree in physics from Peking University, China.
In this exclusive 2,716 word interview in the Wall Street Transcript, Dr. Yang explores the valuation of certain key biotech stocks in her coverage.
“…In gene therapy, we continue to see developments for treating neurological disorders, blood disorders and liver-mediated disorders.
It’s actually across multiple therapeutic areas. A few common themes we’re observing in that space is that, number one, we tend to see the highest probability of success for those companies where they target a single gene mutation, and secondarily, when these companies are vertically integrated, they’re able to control the manufacturing and basically make products to support clinical development as well as commercialization.”
In gene therapy, we continue to see developments for treating neurological disorders, blood disorders and liver-mediated disorders…”
One example is curing a dreaded genetic disease in infants:
“…We cover a company called Audentes Therapeutics (NASDAQ:BOLD). They have a therapy that is currently in late-stage development treating X-linked myotubular myopathy — XLMTM — an inherited form of a neuromuscular disorder.
These patients are typically diagnosed when they are babies.
The disease involves severe muscle weakness, so not only do these babies not reach developmental milestones, they probably never acquired the skills to walk.
Muscle weakness also impacts their lung function. And the result usually leads to babies not being able to breathe on their own and require ventilators for support, in some cases 24 hours per day.
Audentes Therapeutics has a gene therapy. And based on early clinical data, what we’re seeing is that not only the babies are alive, they started getting off ventilator support…”
Get more detail on this and other biotech winners from this exclusive 2,716 word interview in the Wall Street Transcript.
Patrick Trucchio, Research Analyst, Therapeutics, joined Berenberg Capital Markets LLC in September 2017 to cover smid therapeutics equities.
He previously worked at Wells Fargo covering specialty pharmaceuticals for two years, with prior experience covering personal care and household products at BMO Capital Markets for eight years. Mr. Trucchio holds a B.S. in finance from the Pennsylvania State University-University Park, an MBA from St. John’s University — Queens, is a CFA charterholder and NYSSA member.
In this wide ranging 4,703, Mr. Trucchio gives investors an exclusive interview on his hot stocks for the current market.
“I think what’s really interesting is, when you look at the split in our coverage, which includes 19 stocks across U.S. specialty pharma, U.S. biotech and EU biotech, there’s definitely been, over the last year, a separation between companies that are revenue generating versus those that are not.
In those that are revenue generating, what you’ve had is all this rhetoric around pharmaceutical pricing, and the payers, the insurance companies and the pharmacy benefit managers having to become more aggressive on making sure that they hold down inflation in drug prices.
For some of these stocks, they are down 30%, 40%, 50% or more, whereas the ones where they don’t yet generate revenues — it’s all based on clinical data readouts and potential for drugs to reach the market in three or five years in the future — these stocks have tended to perform better.
It’s a function of concern regarding health policies emerging from Washington…”
The theme of opioid litigation is deeply researched by Mr. Trucchio:
“So that brings us to where we are today, which is three tracks of litigation.
What’s different from the first wave versus the second wave is that the first wave was contained to Purdue primarily and a moderate dollar amount of liability — all things considered.
Today, there are three tracks of litigation, with state attorneys general that are suing; the federal multidistrict litigation, which is in Ohio, comprising more than 2,000 lawsuits and growing by the day, and includes cities and counties primarily; and the Department of Justice — DOJ — track.
The opioid litigation has been compared by some to the tobacco litigation of the 1990s. One of the key differences between this and tobacco was that the DOJ stayed out of it. The states divided up the global settlement.
There were three tobacco manufacturers that the states negotiated with, and they came to a $250 billion settlement that was paid out over several decades. However, with the second wave of the opioid situation, the DOJ very much wants a seat at the negotiating table.
Another key difference between the tobacco litigation is the lack of a true global settlement…”
Get the complete picture of where investors can find some upside in the sector, exclusively in the 4,703 word interview, only in the Wall Street Transcript.
