CEO: Dr. Paul Lammers
WSA: Good day from Wall Street. This is Juan Costello, senior analyst with the Wall Street Analyzer. Joining us today is Paul Lammers, the CEO for Mirna Therapeutics. The company trades on NASDAQ, ticker symbol is MIRN. Thanks for joining us today Dr. Lammers.
Paul Lammers: Thanks, Juan, appreciate it.
WSA: Great. So starting off, please give us a history and overview of the company.
Paul Lammers: Sure. Mirna is a clinical stage pharmaceutical company focused on developing a broad pipeline of micro-RNA based oncology therapies. We were founded in late 2007 in our headquarters at Austin, Texas, and we have 35 full time employees. We completed an initial public offering on NASDAQ on October 1st, raising approximately $44 million net of proceeds.
Regarding our technology, our therapeutic application of micro-RNAs as tumor suppressors was discovered more than ten years ago by our scientists at Mirna when they were doing micro-RNA research. Naturally occurring micro-RNA function as tumor suppressors by regulating the expression of key oncogenes that prevent the development, progression, and dissemination of cancer. However, in cancer cells, many of these naturally occurring tumor suppressors and micro-RNAs are either lost or under-expressed. So at Mirna, we have pioneered an approach that we call micro-RNA replacement therapy, whereby we administer so-called micro-RNA mimics, which are tumor suppressor micro-RNA molecules that function as natural micro-RNAs when they enter human cells. We believe that these micro-RNA mimics represent a new paradigm in cancer therapy, and they have the potential to create a new and important class of effective cancer drugs, which can potentially be used alone or in combination with other cancer therapeutics.
Our lead product candidate is MRX34, which is a double-stranded RNA mimic of the tumor suppressor micro-RNA miR-34. The micro-RNAs are delivered as an injection with the Smarticles formulation technology that we have in-licensed from Marina Biotech. MRX34 is currently in phase I clinical trials. We are currently enrolling patients in an expansion cohort in our phase I study, which we hope to complete by late 2016 and move into phase II studies late this year as well.
WSA: Great. So can you bring us up to speed on some of your recent news including the recent data you presented at the American Association for Cancer Research meeting?
Paul Lammers: Yeah, I would love to. So two updates, one on the clinical trials front and one on the corporate front. On the clinical trials front, with MRX34, our lead product, to date, we have studied more than 100 patients in an ongoing phase I trial, which helped us determine the maximum dose of MRX34, and secondly, to select the recommended dose for the phase I expansion cohort in any future clinical trials. The trial has shown SBC signals in various late stage cancers, which we’re very excited about, and we believe we have the clinical evidence needed to advance MRX34 into mid-stage studies, and look forward to initiating later this year. With the ongoing phase I trials, MRX34 achieved confirm partial responses in multiple advanced stage four cancer. We have confirmed partial responses observed in patients with advanced renal cell carcinoma, as well as in advanced eCRO melanoma and liver cancer. Furthermore, a number of patients with tumors achieved significant long-term stable disease that we’re also very excited about. We currently expect to provide a further clinical update from this trial in mid-2016 and top line data in mid-2017. We expect to initiate phase II clinical studies by the end of 2016. The studies will focus on evaluating MRX34 in patients with either melanoma or renal cell carcinoma, and these tumor types were chosen based on the clinical results generated to date on the ongoing clinical trial. We plan to provide a clinical update from these studies in the second half of 2017.
We’re also expanding our development program to include combination and additional micro-RNA therapies. Combination pre-clinical studies are planned and ongoing in models of known small cell lung cancer. The company expects that if positive results are obtained through these clinical studies, the combination program may progress towards clinical testing in 2017. Pre-clinical studies are also ongoing to support selection of a second micro-RNA product candidate from the company’s pipeline with an investigational new drug or IND application planned for late 2017, as well. Most recently, we presented new pre-clinical data at the American Association for Cancer Research, or AACR, in New Orleans from experiments demonstrating that our lead micro-RNA therapeutic, MRX34, is synergistic with widely used cancer chemotherapies and next generation tyrosine-kinase inhibitors, or TKIs. As our chief scientific officer Miguel Barbosa stated, these in-vitro studies suggest that MRX34 has a strong potential in combination with other cancer therapies. Furthermore, the ability of miR-34 to control multiple oncogenic pathways may overcome both primary and acquired resistance when used in combination with chemotherapy or TKIs, which is a huge challenge in the current treatment paradigm in cancer.
On the corporate front, we had a very productive year in 2015, very transformative, as well. We completed our initial public offering on NASDAQ, raising approximately $44 million net of proceeds, and in total, more than $100 million in funding, including approximately $70 million from CPRIT, also known as the Cancer Prevention and Research Institute of Texas, as well as a $42 million private round as well as a mezzanine round from top tier institutional investors. We also strengthened our management team with the appointment of Dr. Miguel Barbosa as chief scientific officer, Alan Fuhrman as chief financial officer, and Dr. Vincent O’Neill as chief medical officer. Dr. Barbosa recently served in roles as head of immunology research at Jensen and as entrepreneur residence at therapeutic innovation at J&J. Alan Fuhrman most recently was the chief financial officer at Ambit Biosciences, which he first took public and then was later acquired. Dr. Vince O’Neill is a medical oncologist who previously served as chief medical officer at Exosome Diagnostics in Cambridge, and he also has various senior drug development positions at Sanofi, Genentech, and Glaxo.
WSA: Great. And so what are some of the key trends that you’re seeing in the sector and how are you positioning the company to capitalize?
Paul Lammers: Sure. Well, as we all know, 2016 has not been nice to biotech, and the healthcare stage in general. But we do see, I think, that there are some signs I think that the market is on the rise, again, which is exciting. For us in particular, I think that the RNA space, companies that are working in RNA technologies, whether that is, you know, sRNAs, messenger RNAs, have truly shown incredible promise–in the clinic especially. As an example Regulus just announced that their anti-miR approach in Hep C, as well as in Alport Syndrome, shows promise in the clinic. There’s a company, miRagen, a private company in Boulder, Colorado that’s also working on anti-miRs, just like Regulus. They just started in the clinic; they did also a significant private round that they raised. There is a company from Australia known as EnGeneIC, a private company that is also, just like us, bringing a micro-RNA mimic into the clinic, but they’re about two years behind where we are right now. So overall, we see that what we would call the tree of RNA has grown substantially, especially driven by companies like Alnylam, Moderna, and others. Some of the branches of it, including the micro-RNA branch, has shown significant growth and is great for us to be the leader in that micro-RNA space.
WSA: What are some of those factors that you feel make Mirna unique from some of the other players in the sector?
Paul Lammers: Well, Mirna Therapeutics is unique for a multitude of reasons. First of all, we are first in class and first in clinic leader in a micro-RNA replacement therapy stage. We have a promising pipeline of additional micro-RNAs with broad oncogenic control and strong anti-cancer properties. Combination therapy opportunities exist with both targeted therapies as well as with immunotherapies, which we think is very exciting and promising for us. We expect to bring a second clinical candidate into a phase one trial later in 2017. We have very broad patent coverage, 42, with a number of US- and foreign-issued patents expiring in 2025 to 2032, so we have a nice life on those as well. And we have about 42 other pending applications in both the US, as well as in the rest of the world, so we have a very good IP state in this space, as well.
We’ve brought in renowned scientific leadership with the addition of Miguel Barbosa as CSO and Vincent O’Neill as our chief medical officer. And also on top of that, we have an exclusive license for the use of Smarticles as our delivery vehicle for our micro-RNA mimics, and this one is royalty free for the use of miR-34, so we don’t have to pay a royalty on our lead product, MRX34, for the use of Smarticles.
WSA: So what are the main goals and milestones you’re hoping to accomplish over the course of the next 6 to 12 months?
Paul Lammers: Well, over the next 12 months, we hope to continue to educate the street about the therapeutic potential of micro-RNA replacement therapy and establish ourselves as the leader for micro-RNA oncology company. We expect to report an additional update from the ongoing phase I study as well as launch a phase 1b translational medicine study later this year. By the end of 2016, we intend to advance MRX34 into phase II studies, one in cases with renal cell carcinoma and the other one in melanoma. These cancers were selected based on the responses observed today in the phase I trial and on the high unmet medical needs in these cancers, despite the availability of new therapies. Also planning to move our combination program forward in the upcoming year.
Our research team has found significant synergy between MRX34 and standard of care, either tyrosine-kinase inhibitors or chemotherapeutic drugs in in-vitro experiments, and we have reviewed these very encouraging findings with a number of experts in the field. We’re further validating these findings, now, by testing these drug combinations in relevant animal tumor models. In addition, our collaborator, the MD Anderson Cancer Center in Houston, has shown that miR-34 represses PDL1 [Indiscernible] [0:11:22] gene expression. So we’re also including drug combinations with either PDL1 or PD1 [Indiscernible] [0:11:29] inhibitor molecules in relevant pre-clinical animal tumor models. Regarding our discovery portfolio, we continue to progress our pipeline of unique micro-RNAs and our focus on differentiating each of our product candidates according to the potential therapeutic effect in specific indications. And we expect to select a new micro-RNA candidate in 2016 and file an IND in late 2017.
WSA: Sure. And as far as investors and the financial community are concerned, Paul, what are some of the key drivers that you wish perhaps they better understood about you guys?
Paul Lammers: Well, first of all, we are the leader in a new and exciting space of micro-RNA-based therapeutics. Which, based on the intriguing biology of micro-RNAs in nature, could become a paradigm shift in the treatment of cancer. However, similar to what happened, for example, when monoclonal antibodies came around, it takes a while for both the oncology community and the investment community to appreciate a new concept. Therefore it’s up to us at Mirna to educate oncologists and potential investors about the promise of this technology, which we realize will take some time.
What do we wish investors would better understand about Mirna? First, we are a leader in a new space, micro-RNA-based therapeutics. Second, we have an experienced management team, which draws from experiences built at leading companies in the pharma-biotech industry. Thirdly, we are the first in the clinic with a tumor suppressor micro-RNA. And our lead product, MRX34, shows promise as a mode of therapy for several very different to treat cancers. It shows promise as a combination therapy in combination with either standard chemotherapies or targeted therapies. All of this means a lot to look forward to in the coming years, a lot of potential data to be generated, which could represent potential value inflection points for investors in the coming years, as well.
WSA: Great. So once again, joining us today is Paul Lammers, CEO for Mirna Therapeutics. The company trades on NASDAQ, ticker symbol MIRN. Currently trading at $4.38 a share, market cap is about $92 million. And before we conclude, Paul, to recap some of your key points, why do you believe investors should consider the company as a good investment opportunity today?
Paul Lammers: Well, Juan, Mirna is truly the leader in a new and exciting space known as micro-RNA-based therapeutics. We have built an experienced management team. Our R&D team includes several of the leading micro-RNA scientists. Our product, MRX34, is the first micro-RNA in the clinic for cancer. It has shown promise as a mode of therapy; it’s shown promise in avoiding or reversing drug resistance against either standard chemotherapies or targeted therapies in leading cancer types. We have a promising pipeline of other tumor suppressor micro-RNAs, which all deserve to go into the clinic in the near future. And finally, although we’re focused right now in cancer, our early discovery work, as well as the platform that we developed at Mirna, could also be applied to other promising therapeutic areas of high unmet need. All in all, this should make for a very promising investment opportunity.
WSA: Well, we certainly look forward to continuing to track the company’s growth and report on your upcoming progress. And we’d like to take you for taking the time to join us today, Paul, and update our investor audience on MIRN. It was great to have you on.
Paul Lammers: Well, thanks, Juan. You’re more than welcome.