2018 Biotech Watchlist: 'No One Space Is Going to Dominate'
Source: Streetwise Reports
January 11, 2018 (Investorideas.com Newswire) Michael King of JMP Securities provides a comprehensive round-up of companies he has selected for the 2018 Biotech Watchlist—companies in immuno-oncology, gene editing, and other indications that he believes offer promising opportunities for patients and investors.
The Life Sciences Report: You have selected companies for The Life Sciences Report's Biotech Watchlist since its inception. What do you find compelling about a watchlist like this? What benefit does it hold for investors?
Michael King: I think it forces us as analysts to put our money where our mouths are. Analysts, generally speaking, brag about their stock-picking prowess. If we're really as good as we think we are, then we should welcome these kinds of tracking methodologies. For investors, I think over time it helps them decide who the best stock pickers are.
TLSR: You're generally focused on oncology companies. What innovations do you see developing in this sector over the new year?
MK: I think it'll be a lot of the same, which is all to the good. I know a lot of investors have interest in the chimeric antigen receptor (CAR) T space, and I think we'll see the next wave of innovation there. In December, at the annual meeting of the American Society of Hematology (ASH), there was a lot of excitement about CAR-T therapies targeted to BCMA, which is a receptor found on B cells and plays a role in the aggressiveness of multiple myeloma. Results from bluebird bio Inc. (BLUE:NASDAQ), in particular, were outstanding, and I think it has set off a chain reaction in other stocks in the CAR-T space.
Another antigen may emerge this year—maybe CD20. CD20 has been a very good target for drugs like Roche Holding AG's (RHHBY:OTCQX) Rituxan, but so far there have been no CAR-T approaches. Fortress Biotech Inc. (FBIO:NASDAQ) is one of our Top Picks; Fortress' subsidiary, Mustang Bio Inc. (MBIO:NASDAQ), has a CD20 CAR program licensed from the City of Hope. Maybe we'll see something there.
In the immuno-oncology world—the checkpoint inhibitor space—we're going through a bit of congestion, meaning investors are trying to figure out what comes next. We've picked the low-hanging fruit, with Bristol-Myers Squibb Co.'s (BMY:NYSE) Opdivo and Merck & Co. Inc.'s (MRK:NYSE) Keytruda. Now, we're trying to find the next big thing in the immuno-oncology world. It seems to be a molecule called IDO, the most advanced of which is from Incyte Corp. (INCY:NASDAQ). There's a bit of nervousness around whether results are going to hold up. They looked encouraging at last year's SITC meeting, but they haven't been subjected to the true tests of a randomized study. That study should read out this year. Investors are a bit cautious about the prospects for what's called epacadostat in conjunction with Opdivo.
And there are lots of other agents in development out there. Companies working the space include Nektar Therapeutics (NKTR:NASDAQ), Syndax Pharmaceuticals Inc. (SNDX:NASDAQ), Corbus Pharmaceuticals Holdings Inc. (CRBP:NASDAQ) and Calithera Biosciences Inc. (CALA:NASDAQ). But it's getting more and more difficult to pick the winners among the agents trying to augment PD-1 inhibitors, which are the ruling class of immuno-oncology agents. It's not clear exactly who the next great act is going to be.
Also, I think we'll see continued excitement about small molecules. We saw two big winners last year, Loxo Oncology Inc. (LOXO:NASDAQ) and Blueprint Medicines Corp. (BPMC:NASDAQ). Small molecules are traditional medicines that you take as a pill by mouth.
This year, one of our Top Picks is Deciphera Pharmaceuticals Inc. (DCPH:NASDAQ). Deciphera has a small molecule called DCC-2618, and the company just announced it's going into a pivotal clinical trial for fourth-line and later gastrointestinal stromal tumor (GIST), which is a relatively rare tumor type. There is no cure, and patients basically cycle off one drug onto the next, then onto the next.
Deciphera just started a Phase 3 for late-stage GIST, and will start a Phase 3 for second-line GIST in H2/18. It hasn't explicitly stated its intentions to develop DCC-2618 for another rare, cancer-like condition called systemic mastocytosis, but this is an indication that Blueprint is going after very aggressively. Deciphera may draft off its success in that space. Deciphera has an ~$800 million ($800M) market cap. We think it could be worth well over $1 billion ($1B) by 2018E, and hopefully significantly more in another year or two. Looking at Blueprint, from the time it became public at about a $400M valuation to now trading upward of $3.4B, we think that Deciphera, over time, can replicate those kinds of results.
TLSR: You also follow companies working in gene editing. What innovations do you anticipate in that sector in 2018?
MK: Not that they aren't already in the public eye—and you can't delay press—but The New York Times, Wall Street Journal, Forbes, and general interest magazines are constantly writing about CRISPR and advances in gene editing. There's been news recently about restoration of hearing loss in mice, and the possibility of using CRISPR to cure HIV. Gene editing, and in particular CRISPR, will continue to remain in the public eye.
CRISPR Therapeutics AG (CRSP:NASDAQ) recently started clinical trials with hematopoietic stem cells. It's trying to basically get in the game against Kite Pharma (KITE:NASDAQ) and June Therapeutics Inc. (JUNO:NASDAQ) with its stem cell therapies. It edits out certain genes that might shorten the response periods for T cells that are infused into patients.
We will see clinical trials from Editas Medicine Inc. (EDIT:NASDAQ), probably in H1/18, for a form of blindness called LCA10. Spark Therapeutics Inc. (ONCE:NASDAQ) just got an approval for a gene therapy that treats a similar condition. There's been a lot of hoopla over the price it's charging, but the therapy's basically restoring vision to individuals. You have Intellia Therapeutics Inc. (NTLA:NASDAQ), which is another CRISPR company that will also be in the clinic this year for hemoglobinopathies, like sickle cell and beta thalassemia.
There's a lot going on. Gene editing will become a true clinical therapy in 2018. We'll see data, rather than just talking about the possibilities. Much like gene therapy, which is now starting to pay off, we think gene editing will do the same very soon.
TLSR: Please describe the work being done by companies you’ve selected for the 2018 Watchlist.
MK: The first one is Ardelyx Inc. (ARDX:NASDAQ). We like Ardelyx because we think this is the year investors will figure out that tenapanor has great potential for irritable bowel syndrome with constipation (IBS-C).
Two studies read out Phase 3 data last year: T3MPO-1 and T3MPO-2. T3MPO-1 and T3MPO-2 both had eight endpoints that needed to be statistically significant for the studies to be declared successful. Unfortunately, in T3MPO-1, tenapanor hit seven out of eight, whereas in T3MPO-2, it hit all eight. That's 15 out of 16 endpoints. Because there was one short-term endpoint—a period of 12 weeks—that wasn't statistically significant, investors threw the baby out with the bath water.
My argument is OK, yes, it's unfortunate that endpoint was not positive at 12 weeks, but if you look at the same endpoint at 24 weeks, it was positive. Tenapanor did differentiate from placebo, and it differentiated from placebo in the second study. In my mind, the drug has been tremendously derisked by these results. We think investors are overlooking the fact that, despite missing a single endpoint, the FDA is still likely to approve tenapanor for IBS-C. It has a unique mechanism of action relative to drugs currently marketed by Ironwood Pharmaceuticals Inc. (IRWD:NASDAQ) and Synergy Pharmaceuticals Inc. (SGYP:NASDAQ), which cumulatively do a couple of billion dollars in worldwide sales. Tenapanor has been very well tolerated. Ardelyx owns all of the rights to the drug. There aren't many companies with a derisked, Phase 3 asset in a multibillion dollar market opportunity that's poorly addressed and yet much, if not all, of the clinical risk is out of it. There is still obviously regulatory and commercial risk, but I would argue at a $330M market cap, that's priced into the stock. We like Ardelyx for this year.
Calithera Biosciences is in similar situation, in that it had some very encouraging Phase 1/2 data for one of two of its lead programs, CB-839, which inhibits an enzyme called glutaminase. Basically, tumor cells become addicted to glutamine, and glutaminase converts that to a form the cell can use. By blocking glutaminase, you can exert an anti-tumor effect. The company presented data at the SITC meeting last November for a trial designed in a very rigorous way, where kidney cancer patients were required to be progressing while on their checkpoint inhibitor—in this case, Opdivo. They had to have two scans eight weeks apart to verify that their tumors were in fact increasing, and it wasn't just due to random noise. Then they were enrolled onto treatment with Opdivo and CB-839.
Despite some very encouraging response rates, the feedback we've heard is that investors can't differentiate the signal from the noise. But I would say Calithera did a superb job at constructing the trial in a way that very demonstrably proves any responses seen in this study were due to CB-839, and not to random tumor fluctuations. Calithera owns all the rights to CB-839. It has a second oncology metabolism asset in development, CB-1138, which is partnered with Incyte Pharmaceuticals.
I like this name a lot. The stock has come down quite a bit this year. The company's well funded. Calithera has a ~$305M market cap and has $155M in cash, more than $4.50 per share in cash for an $8.50 stock. That's a very attractive entry point. The management team has a superb track record. They were responsible for the success of what is now Amgen's Kyprolis, a very successful multiple myeloma drug. We're very bullish on Calithera.
Next up is ChemoCentryx Inc. (CCXI:NASDAQ). The European regulatory authorities just accepted the application for its drug, avacopan, for a rare kidney condition, ANCA-associated vasculitis (AAV). This is a conditional marketing approval; the European regulators accepted an application, which means avacopan for AAV is now on the path to European approval.
This process is very much akin to the FDA's accelerated approval. It gives the drug sponsor an opportunity to gain approval while it is conducting larger trials to prove safety and efficacy. And that's the case here. ChemoCentryx is undertaking a Phase 3 trial on avacopan in this indication, which will probably read out sometime in the middle of next year. But this provides an opportunity for the drug to gain conditional approval in Europe and generate a bit of income for the company prior to formal approval by either the FDA or full approval by the Europeans.
We think ChemoCentryx has done a great job with this molecule. The company has a very good platform with some very nice pipeline assets as well. It has entered into a number of very astute partnerships that are bringing in significant capital, so it has been able to avoid tapping the public markets to fund the development of either avacopan or the next-generation molecule it calls CCX140. We think the management team has done a superb job bringing the pipeline along and doing very smart, strategic commercial partnerships to fund the company all the way to the goal line.
Fortress Biotech is an interesting company. This is basically a publicly traded biotech venture fund that trades significantly below net asset value. Fortress has a market cap of ~$210M, but has multiple subsidiaries we believe are worth significantly more—potentially as much as double the current market cap of the company.
I won't go into all of them because there are too many to discuss. But the ones we value are Mustang Bio, a company called Checkpoint Therapeutics Inc. (CKPT:NASDAQ), and a company called Caelum Biosciences Inc., which is not in registration yet. Caelum had a very exciting data presentation of its lead asset, CAEL-101, at this last year's ASH. Frankly, I thought it was one of the hits of ASH. It competes with Prothena Corp. Plc (PRTA:NASDAQ), which has an antibody, NEOD001, for AL amyloidosis. We think the Caelum antibody is every bit as good as the Prothena antibody.
Another subsidiary is a company called Helocyte Inc., which is developing a vaccine for a viral infection called cytomegalovirus. Fortress also has a publicly traded subsidiary called Avenue Therapeutics Inc. (ATXI:NASDAQ), which is in Phase 3 for a pain drug, intravenous tramadol, which is not in our model but is a source of upside. We think any one of these subsidiaries could be worth more than the entire parent of Fortress.
Idera Pharmaceuticals (IDRA:NASDAQ) has an interesting immuno-oncology pipeline. IMO-2125 is basically an immune stimulant that converts so-called cold tumors into hot tumors. This is a very big area of interest right now, because even though the checkpoint inhibitors are exciting and very effective and safe, they only work in about a third of all the patients. Many patients who don't respond to Keytruda and Opdivo have what are referred to as cold tumors, meaning the immune system is not active in those tumors. Companies have taken a variety of approaches in an attempt to convert these tumors from hot to cold.
IMO-2125 targets something called TLR9. Some very encouraging data presented at the recent SITC meeting show about half the patients are responding. Treatment is with a combination of Yervoy and IMO-2125 in patients who have relapsed after therapy with Opdivo. The response rate in that population would be expected at about 13%, and Idera is seeing more like 50%. We're hoping the results will hold up. We will get more evidence of efficacy this year; it's hard to say exactly when, but the American Society of Clinical Oncology meeting could potentially be the venue. We have a market cap here of only $450M. This is another company we're favoring for 2018.
Kadmon Holdings Inc. (KDMN:NYSE), with a ~$300M market cap, has recently has been getting more respect. The story here has emerged around KD025. KD025 is basically a multikinase inhibitor, but it has shown remarkable results in a very serious condition called graft versus host disease (GvHD). There's very little that can be done right for GvHD. There are steroids, and recently, Johnson & Johnson's (JNJ:NYSE) ibrutinib (Imbruvica) received approval for the treatment of GvHD.
But the bottom line is that there really isn't a whole lot for GvHD patients other than crude approaches like steroids. Kadmon has been generating some very exciting responses in the 60–70% range. It presented a data update at ASH this past December and a lot of people got excited about its results—some of the highest response rates ever seen. The drug looks very well tolerated, and it has a reasonably straightforward regulatory path to the market. On the basis of this drug alone, in this indication alone, we think we can justify a much higher valuation. But there are a lot of other potential indications for KD-025, and a broad pipeline behind that under the Kadmon umbrella.
Karyopharm Therapeutics Inc. (KPTI:NASDAQ) is another one of our picks. The market cap is just under $500M. Its lead drug is called selinexor; it works by a novel mechanism called XP01. It inhibits a channel in the nucleus that lets genes travel in and out. Basically, it traps the genes that suppress cancer in the nucleus, because if they get kicked out of the nucleus, the cell experiences runaway growth. With selinexor on board, those cancer-preventing genes stay in the nucleus and do their job, bringing the cell to a halt if it's out of control.
Karyopharm will have two very important data readouts this year. The first should come in late Q1/18 or early Q2/18 in a trial called STOMP, an open-labelled study of selinexor in what's referred to as pentarefractory (meaning failing five prior drugs) multiple myeloma. In this highly highly refractory patient population, Karyopharm is going for approval with a single agent, selinexor, for accelerated approval. We think there's a high likelihood that trial will hit its expected endpoint, which is a response rate in excess of 20%. That will put Karyopharm on track to file in H2/18.
Then, come H2/18, another trial, SADAL, should read out for the use of selinexor in aggressive lymphoma. Based on data shown at a conference earlier in 2017, we think the likelihood of success for SADAL is high as well, and could put Karyopharm on track to file for approval in that indication by the early part of 2019. By 2018E, the company may have two successful Phase 3 readouts and a marketing application in place. By 2019, it should have two approvals and be on its way to full approval in multiple myeloma, when a study called BOSTON reads out.
We also like the management team. CEO Michael Kauffman has two drug approvals in myeloma to his credit. Karyopharm owns all the rights to selinexor, although it did recently sign a marketing agreement in Japan with Ono Pharmaceutical Co. Ltd. (4528:TYO), which is the inventor of Bristol-Myers' Opdivo.
Kura Oncology Inc. (KURA:NASDAQ) is a very interesting, small-cap oncology company. Market cap here is about $450M. Again, there's a strong management team here, led by Troy Wilson, who's been a highly successful serial entrepreneur in the biotech space with a number of molecules to his credit.
In the case of Kura this molecule is tipifarnib. Tipifarnib was in-licensed from Johnson & Johnson. It went through a several-hundred-patient Phase 3 trial for acute myeloid leukemia and failed in that indication, but there were suggestions that subgroups with certain molecular characteristics might be amenable to responding to tipifarnib. It looks like management has figured out this subset—head-and-neck cancer patients who have a defect in the gene called HRAS—and has shown some very encouraging single-agent response rates that could allow tipifarnib to go forward with a single-arm, registration-directed study. Management has not committed to that as yet. Kura owes Johnson & Johnson very modest milestones and royalties, but for the most part it has 100% of the rights. It has also done a very nice job of backfilling the pipeline with other recently in-licensed molecules, so we like what it's doing.
Pieris Pharmaceuticals Inc. (PIRS:NASDAQ) is a protein therapeutic platform company. Its technology is referred to as anticalins. These modified proteins are normally found in the human body and do all kinds of housekeeping chores. The company has very cleverly redesigned them to become drugs. It created a portfolio of antibody-like molecules that are being developed both as immuno-oncology agents. It has one version, PRS-060 for asthma, that can be inhaled like any steroid. That was partnered late last year with AstraZeneca Plc (AZN:NYSE; AZN:LON), which is one of the world's Top 1 or 2 respiratory franchises, in a very lucrative agreement for what essentially was a preclinical asset at the time.
Another proprietary, wholly owned molecule is PRS-343, which combines the validated tumor target HER2 with an immune stimulatory molecule called 4-1BB, which is essentially is meant to draw the immune system to tumors that express the HER2 antigen. It's in clinical development right now. It's a very clever approach. The idea here is to bring the immune system to only the cells that have this offending protein on their surface, to destroy only those cells and not normal cells that express very low levels of HER2.
What my experience in this industry has shown is when technology platforms validate themselves, investors are willing to pay a premium valuation, because not only do they create interesting assets but they also have the opportunity to generate additional assets over time. Pieris is one of our favorite long-term picks; we think this company could be worth upward of $1B or more over time.
Let me wrap up with Syndax. It's another company run by a highly experienced management team. The CEO is Briggs Morrison: He's been at a lot of major pharmaceutical companies, and most recently ran the immuno-oncology group at AstraZeneca.
Syndax has a very interesting molecule called entinostat. It is an inhibitor of a protein in the cell called HDAC. It operates by an epigenetic mechanism, which means these proteins regulate genes but aren't genes themselves. The approach is twofold with entinostat. One is development of the drug in combination with hormonal therapy for metastatic breast cancer. Syndax has already shown positive overall survival and progression-free survival data in randomized Phase 2 trials. In that same population, it's running a Phase 3 trial that should read out progression-free survival sometime in the mid- to latter part of 2018. If it replicates what it did in Phase 2, it's going to be an important new addition to therapy for metastatic breast cancer.
Entinostat also has properties that make it interesting as an adjunctive therapy to checkpoint inhibition. Syndax has basically partnered with everybody that has a market-leading checkpoint inhibitor, including Merck, Bristol-Myers and Pfizer Inc. (PFE:NYSE). I think it has really spread its bets around. The relationship with Merck is proving to be highly productive. It has had a number of readouts in a series of trials that go under the rubric of ENCORE. Non-small cell lung cancer and melanoma have read out very positively. They actually passed the success hurdle, and are moving on to expansion studies. We expect a fair bit of success from the combination of entinostat and Keytruda. Syndax is doing a great job enhancing the immuno-oncology franchise for entinostat.
It has also done a nice job backfilling its pipeline with very clever and opportunistic in-licensing deals, one with UCB Group (UCB:Euronext), a European pharma company, to access a monoclonal antibody that acts by similar mechanism of one that Five Prime Therapeutics Inc. (FPRX:NASDAQ) has in its portfolio. That Five Prime antibody has been partnered with Bristol-Myers for a billion-dollar biobucks deal. Syndax got its CSF1R antibody—that's the name of the target—from UCB. It was obtained very inexpensively.
The company has also recently licensed a family of small molecules from Allergan Inc. (AGN:NYSE) against a target called menin. Menin is turning out to be a very interesting target in certain types of blood cancers. Things are shaping up very nicely for Syndax as the portfolio progresses, and yet, between everything it has in terms of assets, management, etc., the market cap is only a tiny bit over $200M as we speak today.
TLSR: Are there any other sectors or companies with significant prospects, either in terms of catalysts or novel technologies, that you would like to mention?
MK: In our 2018 Outlook, we said this year is the year of the migraine drug. We don't follow any companies that are developing migraine drugs, but Amgen Inc. (AMGN:NASDAQ), Teva Pharmaceutical Industries Ltd. (TEVA:NYSE) and Eli Lilly and Co. (LLY:NYSE) should all gain approval this year. Alder Biopharmaceuticals Inc. (ALDR:NASDAQ), which is a small-cap company, will have a Phase 3 data readout this year as well, and it will become clear whether it has a commercial product.
The migraine space jumps out at me most prominently, but we talked about others—gene therapy, gene editing. There are going to be a couple of readouts this year in the kidney space as well. FibroGen Inc.'s (FGEN:NASDAQ) roxadustat is a novel drug that could replace Amgen's Epogen in dialysis patients who are anemic. It's basically an oral drug instead of the injectable version that Amgen sells. A lot is going to happen this year. There's no one space that's going to dominate them all.
TLSR: Thank you for your insights, Michael.
Michael G. King Jr. is a managing director and senior biotechnology analyst at JMP Securities. King comes to JMP from Rodman & Renshaw LLC, where he was managing director and senior biotechnology analyst. He has more than 17 years of experience as a leading biotechnology equity research analyst, consistently ranking at the top of Institutional Investor magazine's annual sellside research survey, in addition to being named that publication's "Home Run Hitter" in 2000. King also served as senior vice president of corporate development and communication at ZIOPHARM Oncology (ZIOP:NASDAQ). Prior to joining ZIOPHARM, King was a managing director and senior biotechnology analyst at Wedbush Securities. He holds a bachelor's degree in finance from Baruch College.
1) Tracy Salcedo conducted this interview for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She owns, or members of her immediate household or family own, shares of the following companies mentioned in this article: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
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3) Michael King: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: None. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None. My company has a financial relationship with the following companies mentioned in this interview: See JMP Securities disclosures in 6) below. I determined which companies would be included in this article based on my research and understanding of the sector. I had the opportunity to review the interview for accuracy as of the date of the interview and am responsible for the content of the interview.
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6) JMP Securities Disclosures:
JMP Securities currently makes a market in the security of Fortress Biotech, Inc.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Fortress Biotech, Inc. in the next 3 months. JMP Securities currently makes a market in the security of Syndax Pharmaceuticals, Inc.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Syndax Pharmaceuticals, Inc. in the next 3 months. JMP Securities currently makes a market in the security of Calithera Biosciences, Inc. JMP Securities was manager or co-manager of a public offering of securities for Calithera Biosciences, Inc. (CALA) in the past 12 months, and received compensation for doing so.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Calithera Biosciences, Inc. in the next 3 months. JMP Securities currently makes a market in the security of Loxo Oncology, Inc.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Loxo Oncology, Inc. in the next 3 months. JMP Securities currently makes a market in the security of Blueprint Medicines Corp
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Blueprint Medicines Corp in the next 3 months. JMP Securities currently makes a market in the security of Deciphera Pharmaceuticals, Inc. JMP Securities was manager or co-manager of a public offering of securities for Deciphera Pharmaceuticals, Inc. (DCPH) in the past 12 months, and received compensation for doing so.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Deciphera Pharmaceuticals, Inc. in the next 3 months. JMP Securities currently makes a market in the security of Editas Medicine, Inc. JMP Securities was manager or co-manager of a public offering of securities for Editas Medicine, Inc. (EDIT) in the past 12 months, and received compensation for doing so.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Editas Medicine, Inc. in the next 3 months. JMP Securities currently makes a market in the security of Ardelyx, Inc.
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JMP Securities expects to receive OR intends to seek compensation for investment banking services from Kadmon Holdings, LLC in the next 3 months. JMP Securities currently makes a market in the security of Karyopharm Therapeutics Inc.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Karyopharm Therapeutics Inc. in the next 3 months. JMP Securities currently makes a market in the security of Kura Oncology, Inc. JMP Securities was manager or co-manager of a public offering of securities for Kura Oncology, Inc. (KURA) in the past 12 months, and received compensation for doing so.
JMP Securities expects to receive OR intends to seek compensation for investment banking services from Kura Oncology, Inc. in the next 3 months. JMP Securities currently makes a market in the security of Pieris Pharmaceuticals, Inc.JMP Securities expects to receive OR intends to seek compensation for investment banking services from Pieris Pharmaceuticals, Inc. in the next 3 months.
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