Trevena, Inc. (TRVN) Q1 2019 Earnings Call Transcript

Good day, ladies and gentlemen, and welcome to Trevena’s First Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference, Bob Yoder, Chief Business Officer. Please go ahead.

Thank you, and welcome, everyone. Thanks for joining us on this morning’s call. With me today are Carrie Bourdow, our President and CEO; Mark Demitrack, our Chief Medical Officer; and John Hamill, our Vice President of Finance. Before we begin, we wish to inform participants that we will be making forward-looking statements on this call, which are made pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties, including risks detailed from time-to-time in the company’s periodic reports filed with the Securities and Exchange Commission, and we undertake no obligation to update these statements beyond today. During today’s call, Carrie and Mark will review the feedback we recently received from FDA on healthy volunteer study for oliceridine, provide an update on study timelines, and outline our plans for the rest of our pipeline, and give a brief summary of our financials. We'll then open the line for questions. I'll now turn the call over to Carrie.

Thanks, Bob. Good morning, everyone. Thank you for joining us today. We are excited to have the feedback from FDA on our protocol and stats plan for the oliceridine healthy volunteer study. And as you saw in the press release, I'm pleased with the agency's feedback because it confirms key elements of the study design and we can now move forward confidently preparing for study initiation. At the beginning of the year, I laid out a plan to position oliceridine for potential approval, advance the pipeline and create value for shareholders. The team has accomplished a great deal of work in a short amount of time, and we now have a clear path for resubmitting the NDA for oliceridine. With the FDA feedback in hand, we're also able to make well-informed decisions on investing in the rest of the pipeline. Our primary focus is oliceridine, but we're making the right choices on all of our pipeline assets to achieve important future milestones. Let me now turn the call over to Mark, who will provide details on the oliceridine study and our pipeline work.

Thanks, Carrie, and good morning, everyone. To echo Carrie's comments, we're very pleased to now have all the information we need to move forward with initiating the healthy volunteer study for oliceridine. As I’ve mentioned in an earlier call, the primary objective of this study is to collect the additional QT interval data requested by FDA. We submitted the detailed study protocol and statistical analysis plan less than one-month after receiving the Type A meeting minutes and maintained productive dialogue with the agency throughout their review. Back in March, I discussed key study features that FDA had indicated were acceptable. Specifically, that the study could be conducted in healthy volunteers over a 24-hour period and should include both the placebo and a positive control arm. Let me take some time to frame the general study design. In a typical three-period crossover design, each subject transits through every phase of the crossover. The phases are randomized in sequence across the overall subject population, with a short intervening watch-out period between phases. The feedback from the agency and our protocol confirms our proposed study population and dosing duration. In addition, we plan on conducting the study at a single site as a three-period crossover design with oliceridine, placebo, and moxifloxacin as a positive control. And we have contracted with an established clinical research organization with whom we have collaborated for prior oliceridine healthy volunteer studies. The feedback from the agency on our analysis plan has also enabled us to determine the necessary total sample size for proper statistical powering of the study. We plan on submitting data on approximately 60 participants with at least 20 of these participants receiving a cumulative dose of 27 milligrams of oliceridine, the proposed maximum daily dose. We're pleased to have reached an understanding with FDA on these critical study elements. In particular, the ability to conduct this in healthy volunteer population and the overall sample size required gives us confidence that the study can be completed in a relatively short period of time and in a cost effective manner. Over the past few months, the team has been actively working on preparations of the study logistical details, while we were waiting for FDA feedback. As a result of these efforts, we believe we are ready and well positioned to initiate this study at the earliest possible timepoint, no later than the end of June. Presuming this timely study start, we anticipate reporting top-line data sometime in the fourth quarter of this year. As Carrie mentioned, we're also looking ahead to the second half of this year, as we begin to think about our plans for progressing our pipeline and building out our presence in the CNS space. With a clear path forward for oliceridine, we now feel well positioned to move forward with advancing our development compounds. So, I'd like to take a few minutes to outline the next steps we plan on taking for our three pipeline assets. We plan to initiate a proof-of-mechanism study for TRV250, our novel delta receptor agonist aimed at the potential treatment of acute migraine, sometime in the second half of this year. We believe this will offer a focused and cost-effective approach for us to determine target engagement using the validated biomarker model. I'd like to emphasize that this would not be a large diary-based Phase 2 study that you may be used to seeing with migraine drugs. Instead, this would leverage the use of an invoked migraine model with actual migrainers as study participants. With its novel biased mechanism of action, we believe TRV250 has great potential to be the first delta receptor modulator to reach this stage of clinical testing, a remarkable milestone for drug development of this pharmacologic target. Our collaboration with the Intramural Research Group at the National Institute on Drug Abuse or NIDA remains active as they continue to explore TRV734 our orally available new receptor agonist, which we believe holds immense promise as a potentially safer and better tolerated option for patients undergoing oral maintenance therapy for opioid use disorder. We're proud to be tackling this area of urgent need through this important partnership with NIDA. Finally, following our recent success in identifying TRV045 as our lead candidate in our S1P receptor program, we plan to initiate additional in vivo pharmacology studies, and other work necessary to progress our IND-enabling activities this year. We're very excited to continue investigating this new mechanism of action, which we believe presents a unique opportunity to tap into the benefits of targeting the S1P receptor in the Central Nervous System directly. We believe TRV045 could be developed for an entirely different set of clinical indications, for example, as a non-opioid based treatment option for chronic pain. Ultimately, we will be aiming to progress this asset to IND, either through a potential partner or by ourselves. I'd now like to turn the call back to Carrie for some closing remarks.

Thank you, Mark. Let me summarize our plan. Our priority remains oliceridine. With feedback from FDA, we will initiate the healthy volunteer study no later than the end of June, with the expectation that we will have top-line data in the fourth quarter of this year. We also remain on track to complete the two other non-clinical items FDA asked us to address. As a result, we believe we have a clear path towards a successful resubmission of the NDA for oliceridine. Also in the second half of this year, we will begin the work Mark mentioned on the other pipeline assets. With that, let me end with a quick review of our finances. As we disclosed in our earnings release on Friday, as of March 31, we had cash, cash equivalents, and marketable securities of $60.1 million, which we believe will fund our operations into the third quarter of 2020. Importantly, this cash runway includes our assessment of the cost of the healthy volunteer study and the anticipated costs for the development work we'd like to initiate with the pipeline assets. I’d now like to open up the call for questions. Operator?

[Operator Instructions]. Our first question comes from the line of Jason Butler with JMP Securities. Your line is now open.

Hi, it's Roy [ph] in for Jason, and thanks for taking our question. So, a quick question maybe you can answer on the healthy volunteer study. So data in the fourth quarter, is it possible that you resubmit the NDA yet this year? Are you targeting first quarter of next year? And then also on the trial, what's the maximum dose the subject will receive in a single administration during the trial?

I'll tackle the submission time line. Good morning, Roy thank you for your question. So, we're going to get the study rolling and then we'll come back and update everyone on the resubmission timeline. So right now, what we're -- as you know, these studies enroll fairly quickly, but we really want to get started. And then, I'll come back and update on resubmission timeline. Do you want to answer the …?

Sure. So Roy, you asked also the question about the maximum single dose that a subject would receive in the study, and the study dosing paradigm is designed to follow the label use that we proposed in draft label to the FDA, and under that circumstance, the maximum single dose is 3 milligrams of oliceridine. Across the 24 hours, a cumulative dose of 27 milligrams, which again is the maximum daily dose labeling.

And then for TRV250, you're going to start this proof-of-mechanism study in the second half. Should we expect data from that in the first half of ‘20 -- 2020? Can you give us any sense of that?

Certainly, the data will be in 2020. We just are not in a position at this point to give I would say clear statement about endpoint of the study. I anticipate in the coming months, we'll have a lot more clarity on the timing of the milestones for that project.

So, sorry to come back to oliceridine. But you’re partnered in China and Korea, do you guys yet have any sense of the timelines for those programs? And what are you guys are thinking about other geographies, like, what are you thinking about Europe at this point? Thanks.

Yes. So we’ve -- yes, we have a partnership with Nhwa in China and PharmBio in South Korea. And we're engaged with them, we're having productive discussions, we have a joint development committee, but no real updates yet on timelines. That will be really up to them working with their regulatory agencies. And we are actively looking at additional ex-US partnerships, but nothing to update as of yet.

Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.

Bob, you maybe could provide a little bit more color in terms of the endpoints for the proof-of-mechanism study? And then my second question is on the S1P modulator. Just curious, is that work that you anticipate doing, is that going to be IND enabling or is that just going to be sort of more [indiscernible]?

Mark?

Sure. Yes. It’s Mark Demitrack. So, the TRV250 end points, we've discussed in the past, I didn’t mention it formally in my remarks that we've developed a validated model using a nitroglycerin challenge as an evoked migraine intervention. So, the endpoints since this will be done in actual migrainers, the endpoints will be resolution of an invoked headache. That model has been validated to show delayed onset headache in migrainers that for our practical purposes is just like a spontaneously occurring migraine in life. So, we would look for resolution of the headache as the endpoint in that study. You'd asked about also 045, the S1P compound. And that work that I outlined, as I mentioned is IND-enabling work. So, we have announced a lead candidate in that program at the end of the year, that is the 045 molecule. And we are in the process and the early stages of the path along the IND enabling work to filing the IND. I'm not in a position today to give you an exact date on that, obviously, it's very early on in the development of the program. But as it progresses, we'll get a bit more clarity about when we expect the timing of actual IND to be available to us.

Okay, great. And then I guess, maybe one follow-up question for Carrie, I mean you obviously have a lot of programs ongoing in the early stages. Is it, have you begun to think [ph] about sort of the sequencing and prioritization of any of these compounds certainly in terms of sort of thinking about the sort of funding the development work?

Yes, great question. So obviously, as we said, our priority is oliceridine. And as we look at the pipeline assets, we're looking at market assessments, we're looking at potential interest from other partners. We haven't yet declared our second sort of focus, but TRV250, 734 are obviously further along, but the S1P modulator program is a really exciting program. So, stay tuned for more discussion around the pipeline in the upcoming calls.

Thank you. We have no further questions in the queue at this time. I would now like to turn the call back to Carrie Bourdow for any further remarks.

Thank you. Thank you, everyone, for your questions. We will continue to share updates with you as the year progresses. It is an exciting time at Trevena. We are engaged in important work as you've heard, and we remain committed to delivering novel medicines for patients impacted by CNS conditions. Thank you all for joining us this morning.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day.