Luke Heagle - IR, Pure Communications William Marshall - President and Chief Executive Officer Jason Leverone - Chief Financial Officer Paul Rubin - Vice President of Research and Development Adam Levy - Chief Business Officer.

Liana Moussatos - Wedbush Securities.

Good afternoon ladies and gentlemen, and welcome to the miRagen Therapeutics Third Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, instructions will follow at that time. As a reminder, today’s call is being recorded.

And now I’d like to turn the call over to Luke Heagle from Pure Communications. Please go ahead sir..

Thank you and good afternoon, everyone. On the call today are miRagen’s President and Chief Executive Officer, William Marshall; Chief Financial Officer, Jason Leverone; and Executive Vice President of Research and Development, Paul Rubin and Chief Business Officer, Adam Levy.

Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the Company. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinion only as of the date of this call.

We will undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.

Factors that could cause actual results or outcomes to differ materially from those expressed in or applied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and our other periodic reports on Form 10-Q and 8-K filed with the SEC.

I would now like to turn the call over to William Marshall, President and Chief Executive Officer of miRagen. Bill..

Thanks, Luke. Good afternoon and thank you for joining us for our third quarter update and results conference call. Most importantly in the third quarter, we continue to deliver progress in the clinic and performed well against our strategic initiatives.

In the third quarter, we believe we made continued advances across our pipeline of microRNA therapeutic candidate and continued to execute on our foothold clinical development strategy.

As a reminder, in order to build efficiency into our business and clinical model, we have employed what we call a Foothold Progressive Derisking Clinical Development strategy for each of our program. The Foothold strategy is designed to potentially allow a more rapid and cost effective pathway, a first regulatory approval.

We believe that first in human clinical studies designed to measure biomarker readouts of drug action alongside the traditional safety measures helped to derisk the drug candidate and provide important insights that can help guide Phase II clinical trial design and expanded indication trial.

We also believe our approach to addressing this regulated microRNA to restore functional harmony is applicable to multiple disease areas of high unmet medical needs including oncology, fibrosis, neurodegeneration and cardiovascular disease.

Our deep expertise in microRNA biology and drug development provides strong foundation to develop product candidate to treat the broad range of diseases in which microRNA disregulation is implicated. I will begin with an update on our lead anti-cancer product candidate MRG-106.

We are currently evaluating MRG-106 and a Phase I multiple standing dose study in patients with Mycosis Fungoides or MF. The most common form of Coetaneous T-Cell Lymphoma or CTCL.

We continue to make progress in the trial, which sets the designed to evaluate systemic administration of MRG-106 we were pleased to present new interim data from the ongoing trial at the EORTC Cutaneous Lymphoma Task Force Meeting in October.

These results included observations from additional patients as well as longer term dosing data for patients who have continued on the trial as we provided an update on our second quarter call.

22 of 23 patients or 96% of systemically treated patients showed improvement in total skin disease as measured by the maximal change in each patient’s modified Severity Weighted Assessment Tool or mSWAT score which assesses the severity of skin disease over a patient’s entire body.

Under the initial Phase I protocol not all patients have the opportunity to be treated for more than one month. Based on clinical responses, we observed early in the trial we were able to amend the protocol to allow patients to continue to be treated beyond one month.

Importantly, nine of 13 patients that were treated for more than one month showed a 50% or greater maximal improvement in mSWAT scores. These responses appeared to be generally durable for patients who continued on therapy. As we reported five patients have experienced the durable response for four months or longer.

This is an important observation for MRG-106 as durability of response is an important consideration for approval of drug in this indication. Additionally, patients who showed improvement appeared to do so regardless of whether they were receiving background medication for CTCL together with MRG-106 or MRG-106 alone.

Furthermore, MRG-106 has been generally well tolerated to-date at all dose levels ranging from 75 milligrams to 900 milligrams. Based on early safety and efficacy signals we have experienced in treating patients with CTCL we recently expanded our Phase I trial and are currently evaluating MRG-106 in additional oncology indication.

These additional indications included adult T-cell leukemia/lymphoma, diffused large B-cell lymphoma, and chronic lymphocytic leukemia. In each of these three expansion indications, the disease process appears to correlate with an increase in microRNA-155 levels, the direct target of MRG-106.

We began dosing subjects in these expansion indications in the second half of 2017 and plan to release interim data from these expansion indications in 2018.

We also intend to initiate a larger controlled Phase II clinical trial with MRG-106 to treat cutaneous T-cell lymphoma patient in the second half of 2018 and we will provide further update on our progress throughout 2018.

As I mentioned MF is the most common form of cutaneous T-cell lymphoma, but sometimes deadly disease that in many cases causes painful disfiguring tumors on the skin. MF is estimated to affect between 16,000 to 20,000 people in the United States.

MF that can be a serious condition and there is a strong need for new treatment option with acceptable safety profile.

Turning to our other lead drug candidate, MRG-201 we presented results from the double blinded placebo controlled, single and multiple dose escalation Phase I trial evaluating MRG-201 in induced cutaneous fibrosis at the American Society for Dermatologic Surgery Annual Meeting in October.

A total of 54 volunteers participated in this clinical trial and MRG-201 was generally based and well tolerated at all dose levels evaluated. In this study we observed an MRG-201 may be able to regulate multiple genes involved in fibrotic tissue deposition in human.

Moreover this appear to result in a reduction in fibroplasias, a histopathological marker of scar tissue accumulation while not affecting normal wound healing. We plan to initiate a double blinded randomized Phase IIa trial to evaluate MRG-201 in subjects with a predisposition for keloid formation in the first half of 2018.

Keloids are smooth, hard, benign growth that form when scar tissue grows excessively. Future indications to be studied for microRNA-29 replacements could include fibrotic diseases of the lung and eye.

In addition new preclinical safety and feasibility data on inhaled delivery of MRG-201, which the miRagen plans to evaluate for the potential treatment of pulmonary fibrosis, were presented at the European Respiratory Society International Congress in September.

We utilized a nose-only inhalation exposure system with the Lovelace Biomedical Research Institute. In this study, to more effectively assess accurate dose, compound integrity, particle size, and exposure.

The results appeared to demonstrate that MRG-201 was nebulized with its chemical integrity maintained, and could be administered via inhalation to rats. Exposure to lung tissue after inhalation was high and we have - suppression of several markers of fibrogenesis.

We look forward to releasing additional preclinical safety and efficacy data for the potential treatment of lung fibrosis in 2018. I will now provide an update on MRG-110, the lead product candidate under our collaboration with Servier.

During the first half of 2018, we plan to initiate two Phase I clinical trials to evaluate safety, pharmacokinetic and pharmacodynamic effect of MRG-110, an inhibitor of microRNA-92a delivered both systemically and intradermally.

MicroRNA-92 has been shown in our preclinical studies and reported in multiple peer reviewed scientific publications to be a negative regulator of new blood vessel creation.

As part of our Phase I clinical trials, in addition to safety and pharmacokinetics, we intend to analyze biomarkers that may provide mechanistic proof of concept and support further study of MRG-110 in the treatment of cardiovascular disease and certain other conditions where vascular flow is compromised.

In summary, we believe we have made important progress in advancing pipeline of microRNA’s targeted therapeutic candidate in the third quarter and believe that our foothold critical development strategy is working as designed. Despite both clinical trials for MRG-106 and MRG-201 in first in human study.

We believe we have been to show mechanistic proof of concept in each of these program.

We believe achievement of mechanistic proof of concept in Phase I can help improve the probability of success in later clinical evaluation, as well as provide guidance for appropriate dose ranges to be studied both in the Foothold indication as well as other potential expansion opportunities.

We look forward to expanding the ongoing MRG-106 Phase I trial into additional oncology indication initiating MRG-106 Phase II controlled clinical trial in coetaneous T-cell lymphoma in 2018 initiating the MRG-201 Phase IIa trial in coetaneous fibrosis in the first half of 2018 and advancing MRG-110 into clinical development in collaboration with Servier in the first half of 2018.

The entire miRagen team is energized by our early clinical results and is committed delivering on our mission of developing innovative therapy for those patients need of new treatments. With that I will turn the call over to Jason Leverone, our Chief Financial Officer to summarize the financial results for the quarter. Jason..

Thanks Bill. I appreciate the opportunity to update everyone on our financial results for the third quarter of 2017. At the end of the quarter was approximately $42.8 million in cash and cash equivalents compared to $22.1 million as of December 31st, 2016.

Our total net cash used in operations was approximately $20.9 million for the first nine months of 2017. Based on our current cash position, we believe that our current resources together with amounts funded under our collaboration will be sufficient to fund our planned operations to the end of 2018.

Turning to the income statement, we recognized $1.6 million in total revenue during the third quarter of 2017. This compares to $0.9 million recognized during the third quarter of 2016.

The increase in revenue was primarily due to an increase in research and development activity under our collaboration with Servier as we prepare to advance MRG-110 to two clinical trials with Servier in 2018.

Moving now to operating expenses, research and development expenses increased to $5 million for the first quarter of 2017 from $3 million during the third quarter of 2016. The increase in research and development expense was due primarily to increase personnel cost as we added to our research and development team.

We also incurred higher clinical trial and related manufacturing costs to support our expanding development stage program during the third quarter of 2017. General and administrative expenses increased to $2.5 million for the third quarter of 2017 from $2.1 million for the third quarter of 2016.

The increase in G&A expenses was incrementally due to increases in consulting or competition and professional fees related to our expanded operations as becoming a public Company in February of 2017, as well as higher share-based compensation charges.

These increases were partially offset by a decrease in merger related legal expenses as compared to the third quarter of 2016. This brings the third quarter 2017 net loss attributable to common stock holders to $5.8 million compared to $4.2 million for the third quarter of 2016. With that, I will ask the operator to open the call for questions.

Operator?.

Thank you sir. [Operator Instructions]. And we will take first to Liana Moussatos with Wedbush Securities..

Thank you for taking my question and congratulations on your progress.

What are we going to see at ASH show is different than what we saw the last interim look and so Jason with the increasing activity with the Servier with MRG-110, what kind of revenues would we expect between now and year end and then in 2018?.

Great, thanks Liana. The upcoming presentation at the American Society of Hematology will include additional durability data and patients that maintain treatment with MRG-106 in the study.

We will also be looking at some new patients that have been dosed and we will likely be looking at the various routes of administration that we are pursuing as part of determining the path forward in the Phase II clinical trial..

And Phase II will it be either subcutaneous or intravenous or would there be more than one dosing administration?.

We are going to be data driven by the route of administration that’s chosen, there is balance of whether we see differences in efficacy be a route of administration as well as considerations around patient convenience.

So under the current protocol, we can evaluate a variety of different routes of administration subcutaneous, IV infusion over a two hour period or IV push administration over one to two minutes. We believe that from a patient convenience view point, as you know we do loading dose on day one, three and five, we then do maintenance dosing thereafter.

The notion would be that we would use the most efficacious route of administration during the loading dose and then the about most efficacious route of administration during maintenance, but also to optimize convenience for patients.

So we are able to asses all of those routes of administration and this was one of the key parts to continue in the trial to look at those different amount of routes of administration as well..

Okay.

And then for Jason, what kind of revenues can we expect from Servier this year and next year?.

Thanks Liana. So we recognized $1.5 million or $1.6 million revenue this quarter that was significantly all from Servier. Our collaboration there, amounts reimbursable to us, that was up significantly from prior quarters sort of as we prepare in DCMC activities to set ourselves ready to go into the clinic next year with Servier.

So I would expect that $1.5 number to be sort of the standard going forward for the next few quarters next year in terms of the amounts reimbursable to us under Servier.

We also expect that we would earn begin during development milestones under our collaboration agreement, and would expect to begin to recognize both of those revenues next year as well..

Okay.

So the $1.6 is base? And that might increase as the development of 110 continue?.

That's correct..

Okay. Thank you very much..

Thanks Liana..

[Operator Instructions] And Liana please go ahead..

Okay, I can’t stop asking questions. So for 201, you are doing a lot to establish the foothold in continued fibrosis.

So what are your thoughts on expansion, timing for things like IPF, and you have the good data with the inhalation formulation and maybe something like AMD for the eye?.

Thanks Liana. So, the data from the cutaneous studies really set the stage for us. The ability to affect the expression of a broad range of genes that are involved in fibrogenesis really provides that mechanistic proof of concept that independent of the type of fibrosis we know that the agent is able to regulate fibrogenesis in man.

So, our intent moving forward is really to push into the keloid trial that we can establish the relevance of the compound in a pathologic fibrotic state that we can readily monitor.

And the outcomes from the Phase I that show that we are able to in cutaneous wounds that we are able to reduce the scar tissue accumulation while not affecting normal wounds healing, it really has very significant implications from a general scarring viewpoint.

So again true to our Foothold strategy the keloids would be the initiation, but our hope is that in cutaneous manifestations of pathologic fibrosis and general fibrosis and scarring that we would be able to expand that forward in dermatological indication.

For IPF which is another area of high interest to the Company we will continue to do some additional formulation work as well as assessment of additional molecules in this area to really settle on a final clinical candidate that we would carry forward. So we will expect to go out for additional guidance on that moving forward.

As we move into 2018, I guess the last thing that in terms of MRG-201 is that we have done a lot of preclinical studies over the course of last several months that really helped us understand the distribution and potential pharmacodynamic in the eye.

As you know there are many pathologic fibrotic condition, ocular conditions, where there is high unmet need, the literature suggests that these all involve miR-29 and we are really establishing with various routes of administration the cells that we can access with the drug candidate as well as really determining the indication we would d like to move forward.

Again as things develop and the data drive is in the appropriate direction, we will be operating guidance on the expansion indications for MRG-201 and other microRNA-29 pneumatics..

Okay you mentioned just now additional molecules and additional formulation work for IPF the guidance later in 2018.

What do you mean by additional molecules?.

So we have been looking at some additional chemical modifications to the MRG-201 molecule that really we hope will lead to enhancements in both the lifetime of activity and potentially affect both the dose and the frequency of administration that would be required.

So we want to have some comparative pre-clinical studies completed so that we make the best choice on the molecule that we would move forward into clinical examination in the setting of IPF..

Okay. Thank you very much..

Thank you..

[Operator Instructions]. And with no further questions at this time, we will turn the program back over to the management team for concluding remarks.

Gentlemen?.

Thank you for your time today and for continuing to track our progress. The excitement of maRigen continues to build as we see the consistent result in safety and initial efficacy measures in the third quarter.

We believe that our Foothold Clinical Development strategy is working as designed to derisk our product candidate and provide important insights to help guide Phase II clinical trial design and expanding indication trial.

We believe our deep expertise in microRNA biology and drug development provides a strong foundation to develop product candidate to treat a broad range of disease in which microRNA disregulation is implicated, enabling the potential creation of same value for patients and shareholders.

We look forward to keeping you informed as we advance our product candidates in the months ahead and move into later staged trials in the coming year.

We also look forward to seeing many of you on the road as we attend the Anti-Fibrotic Drug Development, Stifel, Jefferies, Piper Jaffrey, Evercore and American Society for Hematology conference this quarter. In the meantime, please reach out to us if you have additional questions. Thank you and have a great afternoon..

And ladies and gentlemen, once again that does conclude today’s conference. Again, I would like to thank everyone for joining us today..