Earnings Labs

Voyager Therapeutics, Inc. (VYGR)

Q1 2016 Earnings Call· Thu, May 12, 2016

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Transcript

Operator

Operator

Good morning and welcome to the Voyager Therapeutics First Quarter 2016 Financial and Operating Results Conference Call. At this time all participants are in a listen-only mode. Following the formal remarks we will open the call up for your questions. Please be advised this call is being recorded at the company’s request. At this time I would like to turn it over to Matt Osborne, Voyager’s Head of Investor Relations and Corporate Communications. Please proceed.

Matt Osborne

Management

Thank you, operator. Good morning and welcome to the Voyager Therapeutics first quarter 2016 financial and operating results conference call. This morning we issued a press release which outlined these results and provides the business update that we plan to discuss today. The release is available at www.voyagertherapeutics.com. Today on our call, Steve Paul, Voyager’s President and CEO will discuss the business and product program highlights; Jeff Goater, Voyager’s CFO will review the financial results and then we will open up the call for your questions. Bernard Ravina, VP of Clinical Development is also on the call and will be available for Q&A. Before we begin just a reminder that the estimates and other forward-looking statements included in this call represents the company's view as of today May 12, 2016. Voyager disclaims any obligation to update these statements to reflect future events or circumstances. Please refer to today's earnings release as well as Voyager's filings with the SEC for information concerning risk factors that could cause actual results to differ materially from those expressed or implied by such statements. With that let me pass the call over to the Steve.

Steven Paul

Management

Thank you, Matt and good morning everyone. Thank you for joining us today. For those of you who may not be aware this is Matt’s first week here at Voyager. We are very pleased to have him join the team and all of you should be anticipating hearing from Matt soon. As you can see from our update this morning and recent R&D day we are off to a strong start in 2016. Our lead program VYAADC01 for Advanced Parkinson’s disease remains on track to deliver key milestones this year. We announced today that we have completed enrollment of the second cohort of the ongoing Phase 1b dose-ranging safety trial and we have also enrolled our first patient at the recently initiated second clinical trial site. We continue to anticipate announcing top line human proof-of-concept results from the ongoing Phase 1b trial in the fourth quarter, which will include six month follow-up on safety, efficacy and bio-marker data from the first 10 patients cohorts one and two enrolled in the trial. As an interim update on June 22 we will be presenting surgical coverage data from cohorts one and two at the 20th International Congress of Parkinson's disease and Movement Disorders being held in Berlin, Germany. We also continue to make good progress advancing and expanding our pipeline. And at our recent R&D Day in New York City we announced two new preclinical programs focused on the molecular targets tau and Nav1.7 which have the potential to be important treatments for several severe CNS disorders including frontotemporal dementia and Alzheimer's disease as well as severe chronic pain respectively. The company remains in a strong financial position with $214 million of cash, cash equivalents and marketable securities as of the end of March which we believe will be sufficient to take…

Jeff Goater

Management

Thank you, Steve. In this morning’s press release we reported cash, cash equivalents and marketable securities totaling approximately $214 million, as of March 31, 2016, compared to approximately $224 million on December 31, 2015. Our GAAP net loss for the first quarter of 2016 was $7.2 million or $0.29 per share, compared to a net loss of $15.8 million or $15.79 per share, for the same period in 2015. Our R&D expenses for the first quarter of 2016 were approximately $8.7 million compared to $5.5 million for the same period in 2015. The increase was largely due to expenditures in advancing development of our pipeline and product engine, including increased R&D personnel costs associated with the growth of the company. Our G&A expenses were $3.6 million for the first quarter of 2016 compared to $1.9 million for the same period in 2015. The increase was largely due to expenditures in G&A personnel, associated with the growth of the company and expenses related to operating as a public company. This morning, we are reiterating the financial guidance that we initially provided on March 17, 2016. Based on our current operating plans, we expect to end 2016 with cash, cash equivalents and marketable securities of approximately $160 million and we project that our existing cash, cash equivalents and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements in to 2019. Now before I turn the call over to the operator for your questions, I do just want to take a moment to briefly highlight our upcoming Investor events mentioned in our press release. All of these events are being held in New York City. On May 17, we will present at the Piper Jaffray GenomeRx Symposium; on May 23, we will present at the UBS Global Healthcare Conference; and on June 7 we will present at the Jefferies Healthcare Conference. With that, we would now like to open up the call for questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from the line of Phil Nadeau of Cowen & Company. Your line is now open.

Phil Nadeau

Analyst

Good morning. Thanks for taking my questions and congratulations on the progress. First, just a couple on the Phase 1, 2, what are your plans for future enrollment of patients? Is there going to be a cohort three and how will cohort three differ from cohorts one and two if there is going to be one?

Steven Paul

Management

Yes, Phil thanks for that question. And indeed there will be a cohort three. We do plan to continue to dose patients. While we're seeing encouraging data in cohort two clinical data, we must be mindful of a couple of facts. One is that this is still a Phase 1 safety dose ranging safety study. And number two these are uncontrolled trials. So we don't have a sham group in this trial. So we want to be absolutely sure before we go to a pivotal trial which will be a sham controlled trial that we've optimized the dose. Now the current dose may be optimal. But we have flexibility with the current formulation to actually increase the dose at least fivefold by increasing the concentration of the vector that we're administering. So assuming we get a green light from the Data Safety and Monitoring board in late June. We will continue a cohort three most likely at a fivefold higher dose as we -- or at least threefold higher dose for sure as we go up. And again, exactly what the results are from the five patients in this cohort two, but we want to continue to explore higher dose given the safety profile that we've seen so far.

Phil Nadeau

Analyst

Okay, that's great. And just so I'm clear that vector concentration will be increased but the coverage of the curtailment will probably remained the same in cohort three versus cohort two?

Steven Paul

Management

That’s right. As you know we increased the volume. We've doubled the volume to 900 microliters in cohort two. We're getting pretty good coverage right now. And so we don't think we need to increase the volume any further. We'd like to explore a higher concentration which will increase the transduction and increase the delivery of AADC.

Phil Nadeau

Analyst

That's great. And second on the PET scans, sounds like from your prepared remarks, there is just two PET scans being taken, one at baseline and then one at six months. Is that correct or do you have intermediate PET scans where maybe you can get some idea of the return toxin [ph] efficiency?

Steven Paul

Management

No, just two PET scans. This is a radio tracer, it's an isotope. So we want to minimize the amount of radiation patients get. And we think that this six time point, pre-six months post-surgery is long enough in terms of optimizing expression to see the signal that we're going to see. And as you recall in the earlier studies done by Professor Bankowitz [ph], he actually did PET scans every year for up to four years in patients and saw a very durable response. No diminution in the PET signal post-surgery versus pre-surgery. So we're encouraged by this and we may in fact follow patients subsequently but for the purposes of the readout later this year it will be the six month point in all 10 of the patients.

Phil Nadeau

Analyst

Got it. And then last question on VY-SOD01 what type of optimization are you doing before the IND? Do you have a lead candidate now or are you still in the processes of selecting one?

Steven Paul

Management

Yeah, we have several potential lead candidates now and we’ve narrowed the capsen [ph] that we’re going to use and we’d like to see the capsen that gives us -- the vector that gives us the maximum silencing of SOD1 in the most motor neurons in monkeys. And that’s kind of where we’re at right now. So before we pull the trigger and say this is our candidate that we would move to the pre-IND safety testing we want to make sure it's optimized at least in our hands in non-human primates.

Phil Nadeau

Analyst

Got it. Thanks for taking my questions and congratulations again on the progress.

Steven Paul

Management

Thank you, Phil.

Operator

Operator

Thank you [Operator Instructions] And I'm showing no further questions at this time. I’d like to turn the conference back over to Mr. Paul for any closing remarks.

Steven Paul

Management

In closing we are extremely excited about the transformative potential of AAV gene therapy and we are highly motivated to develop our novel therapies for patients suffering from a variety of disabling and fatal CNS diseases. Thanks again for your time this morning and we look forward to updating you on our progress again soon.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Have a great day everyone.