Q2 2022 Trevena Inc Earnings Call
F.
The St So.
Oh.
you
of being recorded. I would now like to turn the conference over to your host, Barry Shen, CFO . Please proceed.
Thanks. Good morning and welcome everyone. With me today are Carrie Bordeaux, our President and CEO , Patty Drake, our Chief Commercial Officer, and our Chief Medical Officer, Mark Demantrak.
As a reminder, Olindvig was approved by the FDA in August 2020 and indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate.
The important safety information, including the box warning and full prescribing information, are all available on olymbic.com.
We'll also be making forward-looking statements within the meaning of Federal Security Law.
These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SEC. We undertake no obligation to update these statements beyond today.
I'll now turn the call over to Kerry for an overview of her second quarter and recent business accomplishment.
Kerry for an overview of our second quarter and recent business accomplishments.
Thank you, Barry. Good morning, everyone, and thanks for joining.
Today, we'll provide an update on Olympic progress, upcoming milestones for our pipeline assets, and the corporate actions we've taken to ensure our company resources are focused on our highest priorities.
Let's start with an update on Olympic.
It's important to acknowledge that the market environment remains challenging.
The good news is that hospitals continue to reopen, but the pace remains slow and inconsistent due to the emerging COVID variants and staffing shortages. This impacts the timing of formulary meetings and the cadence of decision making among hospital key opinion leaders. For more information, visit www.cctexas.gov
Despite these challenges, we've stayed focused on delivering a robust post-market clinical outcomes program, building a first-class field sales force, and ensuring we have the appropriate amount of financial and human resources necessary to efficiently drive performance.
A few key highlights from this quarter I'd like to reference. On the clinical front, we announced positive top-line cognitive function data last month for artists like Carol associate haller for a lin adapted6
We've been speaking with physician experts in this space about the data, and they recognize that this is an important outcome for Alenvig, as cognitive function may impact hospital length of stay and other health economic events that potentially drive cost to the overall system.
Mark will provide a more comprehensive review of the data during his comments.
Remember that we previously announced positive respiratory physiology data for Olympic.
And we're on track to complete the Cleveland Clinic Outcome Study looking at respiratory, GI, and also cognitive function later this year.
We believe these data sets will further strengthen the case for LYNDVIC to physicians, formulary committees, and payers. We believe these data sets will further strengthen the case for LYNDVIC to physicians, formulary
We were also very excited to announce a significant contract win in July with Visian, a leading hospital group purchasing organization. Patty's team did a great job getting this contract and she'll provide more details in her section.
On the business side, we recently announced the decision to reduce costs and realign company resources.
This included an approximate 25% reduction in company full-time employees.
We also ended the agreement with our contract sales organization Cineos, and we now have our sales and medical affairs team completely in-house.
These decisions enable us to sufficiently resource our ongoing key strategic priorities, driving commercial adoption of Alindick, and developing TRV045.
On the topic of TRV045, this is our novel S1P receptor modulator. We remain on track to complete the Phase I study in the second half of this year. And as a reminder, we're developing O45 as a potential treatment for acute and chronic neuropathic pain, secondary to diabetic peripheral neuropathy.
This is a large market opportunity. Over 5 million people in the US suffer from DNP or diabetic peripheral neuropathy.
And there's a need for new mechanisms of action and more efficacious medications.
In addition to neuropathic pain, we're also working with the NIH to study TRV045 as a potential treatment for epilepsy.
with possible application in refractory epilepsy and other rare or orphan seizure disorders. And today, Mark's excited to share with you an update on that program during his comments.
We finished the quarter with $49.5 million in cash, and we believe we have sufficient runway to fund our operating expenses and capital expenditure requirements to mid-2023.
Let me now turn the call over to Patty to talk more about the Olympic Lodge. Patty?
Thanks, Carrie. Good morning, everybody. On our last call, I shared with you that we were in the midst of negotiation on an important contract.
And as you've already heard, we closed a multi-year agreement with the largest member-driven health care performance improvement company in the country, Visient.
Vivian's member network includes 95% of academic medical centers.
50% of acute care hospitals and 20% of ambulatory surgical centers in the United States.
Trevita's goal is to educate VIZIANCE members on the clinical and health economic benefits of the lyndick, particularly in the difficult-to-treat populations of elderly and obese.
Additionally, Vizient has already begun communicating this contract to their member hospitals through announcements to their field teams, monthly webinars and newsletters.
Their member facing catalog also now includes information about the limbic.
As you've heard me say previously, this top-down approach is a key component of our new strategy.
We're looking to expand on this strategy with other key customer groups.
As a reminder, another important component of our strategy is a 100% Trevena Employee Salesforce, which is now in full effect.
This team is targeting areas of the country where we have good access to customers and that there's a high market opportunity.
As a result, although the baseline is small, we have seen an increase in the number of unique accounts ordering a limbic and the number of hospital orders in the first half of this year versus the second half of last year.
The third and final part of our strategy has been focusing on core specialties, concentrating on the critical care setting of burn, colorectal, and anesthesiology.
The burn specialists most appreciate the pain relief their patients achieve on a limbic.
particularly when they have lengthy hospital stays.
And while these are strong clinical arguments for the use of a limbic, our team is also armed with the health economic benefit that demonstrates
a potential cost offset that may be seen across the entire institution.
The new cognitive function data and the recent respiratory data has helped us reinforce the potential health economic value of Olympics.
So, with that, I'll turn the call over to Mark to discuss this further.
Thanks, Patty.
This quarter has been an exciting one for our clinical research accomplishments.
with new findings from our post-approval olymphic studies and continued progress in the development of TRV045, our novel S1P receptor modulator.
I'll start with our recent news on Alembic.
At the end of July , as we had promised, we reported the top line outcomes of the cognitive function study.
You may recall that we were prompted to conduct this study based on clinical observations from investigators in our Phase III development program and from clinicians currently using a limbic in practice.
who have noticed that in their experience use of olymphic appeared to have a favorable clinical profile with regard to sedation and other opioid-related central nervous system adverse effects.
These outcomes are meaningful to clinicians in routine practice because they may have implications for a patient's postoperative recuperation.
For instance
If a patient is too sedated or runs steady on their feet while standing,
They may remain confined to bed for longer periods of time, thereby delaying their ability to participate in their own recovery.
These adverse effects may also lead to downstream increases in length of stay and other potentially important health economic consequences.
This study was our first controlled clinical investigation of these phenomena.
and was performed as a randomized placebo-controlled crossover study.
directly comparing two different doses of olymphic, one and three milligrams.
with two different doses of IV morphine, five and 10 milligrams.
There were 23 participants in the study, which was conducted in collaboration with the Netherlands-based Center for Human Drug Research.
We were very pleased with the study's findings.
The primary endpoint was saccadic eye movement peak velocity.
A sensitive and valid index of the sedating effects of a medication.
On this measure, Olenbic showed a statistically significant reduced impact compared to IV MM time.
In addition, we also saw positive results on several other secondary outcomes, including measures of reaction time, postural stability, and eye-hand coordination.
While not all of the secondary outcomes were able to demonstrate differences between the drugs.
We were impressed with the magnitude and consistency of the results we observed.
Especially as this was our first formal study of this important clinical domain.
We are now working quickly to submit this data to the peer-reviewed scientific literature and look forward to wider dissemination of these results at upcoming scientific meetings in the coming months. Alright.
In early conversations with our KOL advisors, we are encouraged by the positive responses we have received on this work.
Given the potential practical implications of these observations for clinical care, we also believe that this data will be a useful addition to the hospital dossier used by our medical team.
to respond to questions from formulary committee members.
And we look forward to making progress in those discussions.
Let me now turn to a discussion of our progress with TRV045.
Our non-opioid selective S1P receptor modulator.
As I previously mentioned, we have multiple opportunities available to us with this compound.
We opened our initial IND for 045 to investigate its potential for the treatment of diabetic neuropathic pain.
In parallel, we have had an active collaboration with NIH.
investigating animal models in another promising target of interest for this compound.
refractory epilepsy.
I'll comment on our progress in both of these areas.
Our Phase I development program remains on track to complete by the end of this year.
The first two segments of that study, the single ascending dose phase and examination of the effect of co-administration of 045 with food.
are both fully enrolled.
And we're making progress on the final study segment, which looks at multiple dose administration.
Once that work is completed,
will consider options to move forward, including a potential proof of concept study.
Turning to other major opportunities that TRV045 offers, I've spoken in the past about our important collaboration with the NIH's Epilepsy Therapy Screening Program.
This collaboration has examined 045 in a number of non-clinical models for refractory epilepsy.
I'm pleased to announce that TRV045 has shown positive test results in several of the models studied to date. With all due herr the TRVrint cards and TRVspelled from the
For example,
Acute anticonvulsant activity of 045 has been demonstrated in the maximal electroshock model.
which has been replicated in three different experiments.
using both subcutaneous and oral drug administration.
Based on these acute results,
TRV045 was advanced into several chronic models.
045 has shown activity in these chronic models and the results have been replicated in two different models in particular.
The corneal kindled seizure test.
and the post-kalanic acid spontaneous recurrent seizure model.
Interestingly, at the highest dose tested in the post-canic acid model, TRV045 reached statistical significance on both of the main test outcomes.
a reduction in total seizure burden, and an increase in the proportion of animals achieving seizure freedom.
the latter being the more stringent end point indicating success in that model.
While additional work will continue with NIH, we plan to present this information to the scientific community in the coming months.
Also, based on these outcomes, we're beginning to examine our path forward to study 045 for its potential use for certain epilepsies in humans.
We plan to provide FDA with details of the data we have assembled, and if successful, anticipate being IND-ready for epilepsy in the coming year.
We're very excited by these results.
and will provide further updates as these studies progress.
As you can see, this has been a very active quarter for our research and development team.
The investment we made at the beginning of the year is yielding compelling results.
And we're looking forward to further progress to meet the goals that we laid out at the start of this year.
Let me now turn the call over to Barry to discuss our financials before we open it up for Q&A. Barry?
Thanks, Mark.
In the second quarter, we continued to see hospital orders but reported no new net sales till we'll see how it is.
Our net loss is $15 million or $0.09 per share compared to $14 million or $0.09 per share for the same period last year.
These changes were mainly due to costs associated with our ongoing Olympic launch.
We finished the quarter with $49.5 million in cash, equivalent, and marketable securities.
With our recently announced cost reductions, we believe this will fund our operations and capital expenditures to mid-2023, past our expected timeline for TRV045 Phase 1 data and Olympic post-approval data from our Volition Study with Cleveland Clinic.
I note the cash balance includes proceeds from the first $15 million Ourbridge financing tranche in April , but not from our targeted registered direct offering of preferred shares in late July .
We'll now open the call for questions, after which Carrie will provide some closing remarks.
Operator.
At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please, while we poll for questions.
Our first question comes from Jason Butler with JMP Securities. Please go ahead with your question.
Hi, it's Royan for Jason. Thanks for taking our questions. I had a few on 045. Congrats on the positive data. Any feedback from the investigators from the epilepsy study about the compound and the results from the chronic models? And how are you thinking of prioritizing indication? Sounds like you're thinking to go forward in both DNP and epilepsy. And how does the dose form play into it since you're getting good effects with both the subcutaneous and the oral? Thanks.
Great, thanks. I'll let Mark start and then I may add on a couple of comments. Go ahead, Mark. So there are a series of questions in there. Let me make sure I touch on all of them. The studies done in collaboration with NIH's program, they were as equally encouraged by the results as we are. That's in part why we're so happy to announce the results today. So the breadth and pattern of the outcomes is really quite strong. The fact that we...
we see efficacy in these models compared to the pain models that we've looked at. We're seeing efficacy across a comparable dose range. So we believe that the – that, you know, hard to predict obviously at this point, but translating to use in the clinic, we would expect comparable dose ranges for either target.
So at this point, obviously the opportunities present themselves in both the chronic pain and the epilepsy arena. We're taking a close look at this data and we'll have more to say about our thoughts and path forward as we dig into it.
Yeah. And I would say that the phase one program that we're doing.
really allows us to pursue either path, as you said, both, or to move forward on one into a proof of concept study, as you've mentioned, or as Mark mentioned in his talk. So as Mark indicated, as we complete, as we finish out the phase one study, we'll provide more guidance on the path forward.
Thanks Roy, thanks for your questions.
Thank you. Sorry, was there a follow up? I didn't mean to interrupt you. I was going to ask maybe how soon you might think about partnering the compound or discussing potential partnerships.
We are always interested in partnering. We're excited about the compound. I think others are excited about the S1P platform in general. But no news to report on that right now.
Okay, thank you. Thank you. Thank you.
Our next question is from Doug South.
Wayne Wright, please proceed with your question.
Hi, good morning. Thanks for taking the questions.
I'm TRV045, just curious...
in terms of the path forward, in particular epilepsy, how much is determined by you?
as well as in collaboration with NIH on that indication, and how much support may they provide down the road in terms of actual patient studies.
Well, let me be clear that the collaboration that we have with NIH was under the Epilepsy Therapy Screening Program, which is an industry NIH collaborative program that's been in place since 1975. And this program is entirely focused on animal model development. So that information is information that we...
we basically own, if you will. So the collaboration is really limited to the non-clinical work at this time. That program does not play a role in clinical development activities. So the path forward that we would take in clinical development, as I mentioned a moment ago, is something that we're gonna take a close look at. Whether or not there are other opportunities for partnership.
with NIH or with other outside organizations on that development is something that we'll be able to comment on as we move forward.
On the data, yeah, we're sort of on our own deciding the strategic implications of the data and how we want to move forward. But great question, yeah.
Okay, and so at this point, given the signal you've seen, it sounds like the signals were for both acute as well as chronic development.
At this point, would you most likely make a choice between the two, or is that something that would still be determined based on some of the phase one data and what you learned there in terms of exposures in the profile?
When you say make a choice are you talking between pain and epilepsy or between acute and chronic epilepsy between epilepsy between sort of acute and seizures versus sort of
Well, broadly speaking, these data, the outcome that we see has implications for administration as a chronically administered anti-epileptic. So the question of...
amongst refractory epilepsy targets, which ones would be most suitable, you know, is something that we're gonna take a look at and we'll have more to comment on in the coming months.
Okay, and then just on the Visian contract, congrats on executing that. How quickly do you think that might begin to affect Zelle?
Yeah, Patty, I know you've been chatting with that team and so any comments you'd like to make on some of the things they're working on.
Yeah, for sure. I mean, it's obviously early days into the contract, but as I shared with you, they've done some communicating to their field team, but also the communication to their member base, their very large member base. And they do have in their field team a farm deed that actually go out and represent the value proposition of the product, including Alindick.
and that would include also the health economic data that's beneficial for them. Another
of a limbic that they find attractive as a large group purchasing organization is when there are shortages. There are shortages of morphine, there are shortages of fentanyl at times. Now they have another product that they could offer when those happen.
Yeah, and Doug, I will say I got to give credit to Patty and her team as well. We have run a list of customers that we're calling on that are part of the Visient membership team, and that's also something that we've begun to execute around. So, you know, we'd like to get this moving as quickly as possible, but with organizations like this, you know, it may take a little bit of time, as Patty's indicating.
Okay, I mean given...
Does the sort of representation, you know, I think in the past you sort of targeted community hospitals a little bit more than acute medical centers Does that change given? violence spurred byusions. Just raised cancer of physicians that only
I think we can actually get sort of two shots on goal. Our folks can continue to focus on community and ASCs, although I will say Visian has a pretty good footprint in the ASCs as well. One thing I was really interested in with Visian is that they have a large membership of academic medical centers.
And that's been an area where I've been surprised at how some of the AMC's have jumped on with Alindvig. I think it may be in part some of the patient population that's coming into academic medical centers. They may be a little more complex, right, and may fit the profile of Alindvig. So I think this is where Visian's gonna help us in the AMC's and our folks will continue to focus on those community and ambulatory surgery centers.
Okay, great. Thank you very much.
Ladies and gentlemen, we have reached the end of the question and answer session, and I would now like to turn the call back over to Carrie Cordova.
for closing remarks.
Great, thank you. And thank you for your questions and for joining us this morning. As I said at the outset of the call, we've made choices around our business.
For Alenvig, although they're certainly outside factors that continue to impact the launch, we've secured now a contract with Visient, the largest member-driven health care performance improvement company in the country, as you heard us discuss. And we've just announced this new cognitive data that will potentially set Alenvig apart with more data coming out of the Cleveland Clinic and Wake Forest to come. We've made strategic decisions to efficiently drive Alenvig performance.
continue to advance TRV045 to these important milestones and extend our cash runway. And we look forward to updating you on our continued progress. So thank you again for joining us on the call.
This concludes today's conference. You may disconnect your lines at this time. Thank you for participation.
you