Earnings Labs

Viridian Therapeutics, Inc. (VRDN)

Q1 2017 Earnings Call· Wed, May 10, 2017

$13.64

+1.04%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+2.13%

1 Week

-3.25%

1 Month

-23.14%

vs S&P

-24.60%

Transcript

Operator

Operator

Good afternoon ladies and gentlemen, and welcome to the miRagen Therapeutics First Quarter 2017 Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I’d now like to turn the call over to [indiscernible], you may begin sir.

Unidentified Company Representative

Analyst

Thank you and good afternoon everyone. On the call today are miRagen’s President and Chief Executive Officer, Bill Marshall; Chief Financial Officer, Jason Leverone; 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 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 the new information or future events. Factors that could cause actual results or outcomes to differ materially and those expressed in or applied by these 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 Bill Marshall, President and Chief Executive Officer of miRagen. Bill?

William Marshall

Analyst

Thanks Luke. Good afternoon and thank you for joining us for our first quarter update and results conference call. This is the first quarterly conference call since our merger in public listing in February and they’re likely audience members joining us today who are new to the miRagen’s story. For that reason I’d like to take just a few minutes to highlight the strategy and what we see as the potential value diverse of miRagen Therapeutics. miRagen is a clinical-stage focused on the discovery and development of innovative RNA-targeted therapies to address the needs of patients who lacked satisfactory treatment option. We’ve specific focus on microRNA that are expressed that either abnormally high or abnormally low level and who dis-regulation contributes to disease. We believe that our approach to addressing regulated microRNA through inhibitors, antimiRs or synthetic replacement promiR is applicable to a variety of disease areas. We’ve advanced our two lead programs into human clinical trials for oncology and pathological fibrosis and have several programs at pre-clinical developments. microRNAs are short RNA molecules that regulate the expression of gene networks and whose dis-regulation has been indicated in many disease phase. Our team has made a number of scientific advancements kind of allowed us to validate the importance of pathological microRNA targets identifying characterized potentially safe and effective drug leads in pre-clinical models and then progress to first in human studies. microRNAs have been indicated in multiple diseases and we believe that some of our drug candidates may be beneficial in multiple indications. For each of our clinical programs we’ve employed what we call a foothold progressive de-risking development strategy. This means that we design early clinical trials that are focused on biomarker validation of the mechanism of drug action and [VAR] or genetically stratified disease. This foothold strategy is…

Jason Leverone

Analyst

Thanks Bill. I appreciate the opportunity to update everyone on our first quarter financial results for 2017. While I do so, I first want to comment on the merger and other financing related activities surrounding merger. As Bill mentioned we recently committed our merger with Signal Genetics. The connection with the closing of the merger, our common stock again trading on the NASDAC capital market under the ticker symbol MGEN in February. Nearly prior to closing the merger we also completed a $40.7 million private placement with participation from both new and existing investors. I believe this financing provided the resources necessary for us to reach important clinical milestones, we will need to raise additional capital in the future. As such, and to further improve our financial flexibility, we file the shelf registration with the SEC minted into an aftermarket financing facility or ATM with Cowen and Company under which we may raise additional capital at some point over the next three years. It is important to note that we have no obligation to make any sales under ATM and we have yet to make any sales under this facility. Turning now to our first quarter 2017 financial results. We ended the quarter with approximately $54.3 million in cash and cash equivalent which included net proceeds of $39.5 million from our private financing. Our first quarter operating investing cash burn was $7 million, which included approximately $0.5 million in net recurring nonrecurring cash outflows related to the merger. But we do not expect these one-time items in future quarters, we do anticipate that our average quarterly burn for the remainder of 2017 will be consistent with that at the first quarter as we continue to invest in our lead development program potentially expand their clinical obligation. At this time, based…

Operator

Operator

Thank you. [Operator Instructions] Your first question will come from [Clutchy Gigory] with Wedbush Securities.

Unidentified Analyst

Analyst

Yes, good afternoon. And thank you for taking my question. Just a few quick ones here. Can you provide any additional details on the updated data that's people have been in that ASCO and also how that data or the data that you've collected so far help you design a future trials and other malignant? And lastly I guess is there any reason to believe that the state you demonstrated so far will not translate to patients with other types of cancer? Thank you.

William Marshall

Analyst

Thanks, Clutchy. I appreciate the questions. The data that will present at ASCO will be data that we've generated now in IV dosing cohorts with the compound will be both presenting safety data as well as additional clinical response data. In addition to that we'll be presenting some additional molecular data which really have to do with the sort of gene expression changes and drug quantities that we're observing. As in regards to the sort of this lane basis for additional information and helping to foreshadow design and additional trials, our ability to really come back is if you remember in part A of the trial, we did some high dosing in locally in the tumor that then allowed us to really understand some nice mechanistic proof-of-concept data with the now systemic dosing and additional analysis tumors after systemic dosing. We can really begin to zone in on the dose requirements as well as potential frequency of dosing and we believe that those would be translatable to multiple other indication. The final part about the safety profile really are I think the safety so far that we've reported is done pretty exceptional. The primary or one of the reasons that we wanted to explore IV dosing was the ability to avoid the potential for hematomas with subcutaneous administration in other indication. And I don’t have a real reason fact that the safety would be altered in other conditions however will be testing that obviously as we move forward into additional expansion indication. Add something to, sure? Paul, will just add something.

Paul Rubin

Analyst

Just in addition, one of the things obviously you're looking at mechanistic related tolerability but you're also looking at just the general tolerability related to the fact that you're administering an hour ago. So, the fact that we've given now, dose is probably higher than any other power go has ever administrative. We haven’t seen any of the typical pharmaco related side effects, I think that is extrapolatable to other indications. It is not mechanistic or disease-related, its --. So, I think that aspect of the safety should carry over to all the additional indications as well.

Unidentified Analyst

Analyst

Alright, thank you.

Paul Rubin

Analyst

Thank you.

Operator

Operator

[Operator Instructions] From [indiscernible].

Unidentified Analyst

Analyst

Hi guys, thanks for taking my question. So, thinking about MRG-201, as you move in into keloid studies, what are the kind of endpoints you as you're looking at or are you using like POSAS or is there some other type of lesion assessment approach you guys are considering for keloids moving forward?

William Marshall

Analyst

Thanks Manjil, it's a great question. We're right now we're really finishing up analysis of the final cohort in the Phase 1 trial and healthy normal. So, as we induce fibrosis, we measure a variety of biomarker responses and we are also will measure histopathological effects then in a if extend both wound healing as well as reductions in fibroplasia. I think an important part and again as we generate this data and really understand it better, we are then going to have a better view on more details around the design and what the Phase 2 keloid trial could look like. And right now we're in discussions with a variety of KOL to really look at the type of measurement that maybe most efficient as well as design parameters that may allow for powering with a relatively efficient clinical trial. So Paul, I don’t know if you have anything to add?

Paul Rubin

Analyst

Yes. One of the things that we will look and we spoke with a number of experts is to in our initial proof-of-concept is to find subgroups where there is a high rate of recurrence. So, for example, if patients with frequent keloids have had revision and after revision they developed a second keloid, if you did a third revision, the chances of another recurrence are very high. So, by increasing the potential recurrence rate that would definitely decrease the number of patients we would have to study in order to understand whether or not we had the effect. So, there's a couple of models using that concept that we would consider and I think in any case, we'll be able to really prove the concept in the QA model without either a long or expensive or a very highly populated study.

Unidentified Analyst

Analyst

Okay, great, thanks. And then thinking about MRG-106, I'm understanding that the federal strategy, how far do you think you go with 106 in mycosis fungoides and then if you're going like kind of full development of mycosis fungoides. What stages and what line of treatment are you really looking at for microRNA inhibition in this setting?

William Marshall

Analyst

That's a great question. We are committed to carrying forward the compounds long as we can bring benefit to the patients with the -- again in terms of the current studies have been done with a variety of patients either treatment naïve or those who have been treated with a variety of background therapies, the fact that we see some responses that don’t appear to be related to background therapies, leads us to believe that this could be an indication where we could move forward. Then again the clinical synopsis is currently being worked on by the team here at mirage and we will be having discussions with the FDA to understand what the Phase 2 trials design would be.

Unidentified Analyst

Analyst

Okay, great. Thanks for taking my questions.

William Marshall

Analyst

Thank you.

Operator

Operator

[Operator Instructions] And we have no other questions at this time. I would like to turn the conference back over to management for any additional or concluding remark.

William Marshall

Analyst

Great. Thank you, operator. I want to thank you all for your time today. I hope you gained some insight today and appreciate the exciting pace of activity in the first part of 2017. You may go without saying but the entire miRagen team is committed to consistently delivering on our commitment views investors. And most importantly do those patients in need of new treatments. We look forward to keeping you informed as we execute against our strategic objective and timeline in the month in the year ahead. We also look forward to seeing many of you on the road and as we attend the upcoming UBS and Jefferies Investor Conferences this quarter. In the meantime, please reach out to us if you have any additional question. Thank you and have a great afternoon.

Operator

Operator

Ladies and gentlemen, and this concludes today's presentation. We do thank everyone for your participation.