Trevena, Inc. (TRVN) Q2 2019 Earnings Call Transcript

Good day, ladies and gentlemen, and welcome to the Trevena Inc., Second 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 conference call is being recorded. I would now like to introduce your host for today's conference, Mr. Bob Yoder, Chief Business Officer. Mr. Yoder, you may begin.

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 Barry Shin, our Chief Financial Officer. 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're 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 will summarize our recent corporate highlights and review the progress we made across our pipeline, and Mark will provide an update on the healthy volunteer QT study for oliceridine, and outline in further detail our plans for the proof-of-concept study for TRV250. Barry will then review our financial results followed by some time for questions. I'll now turn the call over to Carrie.

Thanks, Bob. Good morning, everyone. Thank you for joining us today. In the second quarter, we made significant progress on our plan to resubmit the oliceridine NDA. Thanks to the team's hard work. We were able to initiate the healthy volunteer study on time and we are encouraged so far with study enrollment. Over half of all subjects have begun dosing and more than 20 subjects have already received the maximum daily dose of 27 milligrams of oliceridine, one of the FDA requirements from the CRL. We expect topline data in the fourth quarter and all other activities also remain on track to support NDA resubmission as early as possible in the first quarter of 2020. We continued to publish the clinical trial data for oliceridine and are developing a robust set of peer-reviewed evidence to support our future commercialization. The journal Pain Practice recently published the second of our pivotal Phase III results, highlighting the efficacy, safety, and tolerability of oliceridine for patients with moderate-to-severe acute pain following soft tissue surgery. I am also excited to announce that all of our submitted abstracts for oliceridine have been accepted for presentation at the 2019 American Society of Anesthesiologists meeting to be held in October. This is the largest global meeting of Anesthesiologists. And we are pleased that this important group of healthcare professionals is interested in learning more about oliceridine. We also made progress across our pipeline. We announced this morning that we have advanced the acute migraine study protocol for TRV250 and expect to initiate this proof-of-concept study next quarter. TRV250 is another new and differentiated mechanism of action, this one at the delta receptor. Delta receptors are located in the brain and play an important role in the regulation of pain, anxiety and mood. Migraine pain continues to be a large market with over 600 million migraines treated annually in the U.S. We believe a sizable market opportunity exists for TRV250 and we look forward to exploring the potential of this asset not only for migraine, but also in the CNS space more broadly. The National Institute on Drug Abuse or NIDA has remained engaged in progressing TRV734 as a potential maintenance therapy for opioid-induced disorder. NIDA will be fully funding a proof-of-concept study in patients and anticipates starting this study before the end of this year. And finally, we've begun the non-clinical in CMC activities to support a future IND filing for TRV045, our novel S1P receptor modulator. TRV045 has the potential to be a new mechanism for non-opioid treatment of chronic pain, including chemo-induced peripheral neuropathy. Importantly, our current cash runway supports the oliceridine topline data readout, NDA resubmission and the pipeline work I just outlined. One last highlight from the quarter, we added an important member to our leadership team. Barry Shin has joined Trevena as our Chief Financial Officer and brings more than 17 years of strategic and financial experience focused in the biopharmaceutical sector. I'm thrilled to have Barry on Board. And his leadership and expertise will be invaluable as we prepare for our busy remainder of the year and for continued momentum into next year. With that, let me hand the call over to Mark to provide more details around our recent accomplishments with oliceridine and TRV250. Mark?

Thanks Carrie, and good morning, everyone. To recap the current status of our oliceridine program, we successfully initiated the healthy volunteer QT interval study for oliceridine at the end of June. We're conducting this study at a single site as a three-period crossover design. Each subject moves through all three study periods, receiving oliceridine, placebo and the moxifloxacin positive control in a randomized sequence with a short intervening washout in between each treatment. Combined the total study period for each subject lasts about 20 days. We plan to submit data on approximately 60 healthy subjects with at least 20 receiving a cumulative dose of 27 milligrams of oliceridine, the proposed maximum daily dose. As Carrie mentioned, I'm pleased to report that as of today, over half of our target total study population have initiated dosing. Of the subjects who have completed dosing, more than 20 have received a cumulative dose of 27 milligrams of oliceridine, meeting FDA's minimum required number of subjects exposed at this level. Based on this progress and enrollment, we believe this study is proceeding on schedule for topline data readout next quarter. We've also made significant strides with our TRV250 program, our novel delta receptor agonist, aimed at the potential treatment of acute migraine. We've developed a protocol for an acute migraine proof-of-concept study. I'll spend a few minutes outlining some of the key study design elements. This will be a double-blind, placebo-controlled clinical study that will leverage a nitroglycerin provocation migraine model, a well validated approach for the study of migraine headache that has been evaluated in the scientific literature over the past several years. Patients suffering from migraine are known to be particularly vulnerable to developing a sustained headache following nitroglycerin challenge that carries all of the clinical features of a spontaneously occurring migraine, making it a very attractive clinical model to study potential treatment interventions like TRV250. The primary objective of this study is to determine target engagement at the delta receptor, which will be measured by the ability of TRV250 to reduce the number of subjects who experience a sustained nitroglycerin induced headache. We plan to enroll approximately 120 migraineurs at a single site. All subjects will be randomized before receiving a continuous nitroglycerin infusion, followed by administration of a 20 milligram subcutaneous dose of TRV250 or placebo at a fixed time point, after which they will be monitored in a hospital setting for 24 hours. We expect to initiate this study next quarter and I'm looking forward to studying this new mechanism of action in actual migraine sufferers, an important clinical development milestone for this exciting program. I'll now hand the call over to Barry to review our second quarter financials.

Thanks, Mark, and thank you, Carrie for the introduction. It's great to be here this morning. I'm excited to be joining Trevena at this critical inflection point. We have clarity on the regulatory pathway, our healthy volunteer study for oliceridine is well underway and we're making solid cost-effective progress on our pipeline candidates. The leadership team has done a great job addressing the CRL quickly and efficiently. I look forward to supporting the efforts to resubmit the NDA and advance our other pipeline assets. Now to the numbers. We disclosed key financial measures earlier today in our press release and full financial statements in our Form 10-Q. For now, I'll summarize the headline numbers. For the second quarter of 2019, we reported a net loss to common stockholders of approximately $4.7 million or $0.05 per share, compared to approximately $9.3 million or $0.13 per share for the second quarter of 2018. This decrease in net loss and net loss per share was driven primarily by a decrease in expenditures resulting from the 2018 restructuring and reduction in force and associated cost saving initiatives. As planned, we expect expenditures will increase in the second half of 2019, mainly due to the healthy volunteer study for oliceridine, which we initiated in June of this year. Cash, cash equivalents, and marketable securities were $54 million as of June 30, 2019. Our guidance remains unchanged and we continue to expect this amount together with interest income. We'll fund our operating expenses, debt service and capital expenditures for at least 12 months into the third quarter of 2020. This period covers key milestones including the completion of healthy volunteer study for oliceridine initiation of the proof-of-concept study for TRV250 in the fourth quarter of this year, IND-enabling activities for TRV045 that have already begun and resubmission of the NDA for oliceridine in the first quarter of 2020. We'll now open the call for questions, after which Carrie will provide some closing remarks. Josh?

Thank you. [Operator Instructions] Our first question comes from Jason Butler with JMP Securities. You may proceed with your question.

Hi. Thanks for taking the questions. Just first one on oliceridine, can you just maybe frame for us, what we should expect you to disclose from the QT study, for example, as well as the topline conclusions? Will you provide any quantitative information on QT intervals on an average basis or any patients crossing outlier thresholds? Thanks.

Great. Good morning, Jason. Mark?

Well, when we report topline data, Jason, that's exactly what we'll report. We'll be looking, at the placebo corrected change from baseline in the QT interval rate corrected, so this is so-called QTc interval. And then we will also be reporting the proportion of outliers at standard categorical thresholds for magnitude of change from baseline as well as the absolute length of the corrected QT interval itself.

Great. Very helpful. And then on TRV250, can you just give us a little bit more background around the nitroglycerin induction? How many patients would you expect to get a headache post NTG induction? What's the time course of onset for the headache? And then when you're looking at a treatment effect for 250, how do you define whether a patient gets – how do you define the reduction in headaches? Is that a categorical? Yes, no. Has a headache don't or is it passing some kind of threshold or using a scale? Thanks.

Sure. So this model is conducted with a 20 minute infusion of intravenously of nitroglycerin. And that approach and the dosing paradigm that's been used has been well established in the literature over a couple of decades of research of this model. And we also, with the research site that we're working with, we actually validated the performance of this model at that site in an early study in migraineurs. So we know a lot about the parameters of performance. What typically is seen is there is a brief vascular type headache during the infusion. For a healthy individual that would be the end of it. Then the infusion is done and there is no sequelae of it. In someone with migraine, virtually all individuals with migraine experienced not just that immediate vascular headache, but it progresses over several hours, usually around the next six to eight hours to a headache that has all of the clinical features of a spontaneously occurring migraine. And it's really very, very characteristic of migraine sufferers this pattern of headache. Our outcome will use rating scales, standard rating scales that are used to grade the intensity of a headache and we will use categorical cut points to determine whether a headache is present or absent. We'll have obviously several secondary outcome measures that we'll look at various other thresholds and durations and that sort of thing. But that's in general terms the approach that we take with this study.

Okay, great. Thanks for taking the questions.

Thank you. And our next question comes from Douglas Tsao with H.C. Wainwright. You may proceed with your question.

Hi, good morning. Thanks for the questions. Just in terms of – for oliceridine in terms of completion of the study. Once that's completed, is there anything else that needs to be done in terms of the resubmission or is it just simply compilation of that data? Is the final step towards refiling?

Yes. Good morning or good afternoon, Doug. I'm not quite sure where you are, so I'll…

Good morning.

Okay. Good morning. So you may remember that the other area that we need to finalize is the PK work that we need to do to characterize the metabolites. That will be done before the QT study is finished. So that will be part of the submission as well. And then the other two questions were really – the other one question that will be involved in the submission in the validation reports that we have already completed. And now it's really more of a clerical thing that we need to provide in the data package. So we should be well on our way once the study is finished to resubmit as early as we can in the first quarter of next year.

Okay. And then just in terms of the – how long once you enroll a patient, does it take them to go through the three period crossovers?

It's about 20 days. Mark, right?

Right. It's about 20 days from the day they come in to the day they complete the last period.

Okay, great. Thank you very much.

Thank you.

Thank you. And I'm not showing any further questions at this time. I would now like to turn the call back over to Carrie Bourdow, CEO for any further remarks.

Great. Thank you. Thank you for your questions. As you heard today, we have important work ahead of us and we look forward to sharing updates with you as we enter a busy second half of 2019. Our focus remains on progressing oliceridine towards the successful resubmission. Topline data from the healthy volunteer study is expected next quarter and we will refile the NDA as early as possible in first quarter of next year. We also continue to advance our CNS pipeline with plans to move all our assets towards key development milestones over the next six months. We're on track to initiate the acute migraine proof-of-concept study for TRV250 also next quarter, and we're supporting our partners at NIDA as they finalized preparations for the TRV734 proof-of-concept study by year-end, and IND-enabling work for TRV045 has already commenced. In summary, we remained discipline, optimistic and committed to developing novel medicines for patients with CNS conditions. Thank you. Thank you for joining us today.

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