EXHIBIT 99.2
Published on March 13, 2020
Exhibit 99.2
Trevena, Inc. NasdaqCM:TRVN
Fourth Quarter and Full Year 2019 Earnings Call Transcript
Thursday, March 12, 2020 8:00 AM EST
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
Call Participants | ||
EXECUTIVES Barry Shin Senior VP & CFO Carrie L. Bourdow President, CEO & Director Mark A. Demitrack Senior VP & Chief Medical Officer Robert T. Yoder Senior VP & Chief Business Officer ANALYSTS Douglas Dylan Tsao H.C. Wainwright & Co, LLC, Research Division Jason Nicholas Butler JMP Securities LLC, Research Division ATTENDEES Timothy L. Beard |
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
Presentation
Operator
Greetings, and welcome to the Trevena Fourth Quarter and Fiscal Year 2019 Earnings Call. [Operator Instructions] As a reminder,
this conference is being recorded. It is now my pleasure to introduce your host, Bob Yoder, Chief Business Officer. Please go ahead.
Robert T. Yoder
Senior VP & Chief Business Officer
Thank you, and welcome, everyone. Thank you for joining us on this morning's call. With me today are Carrie Bourdow, our President
and CEO; Mark Demitrack, our Chief Medical Officer; Barry Shin, our Chief Financial Officer; and Timothy Beard Chair of the Department
of Surgery at Summit Medical Group in Bend, Oregon.
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 will review our 2019 and recent corporate achievements and lay out our plan for 2020. Mark will provide
an overview of the data from our IV oliceridine program that was recently resubmitted to FDA. Dr. Beard has also joined us this
morning to provide his perspective on the current role of IV opioid analgesics in his clinical practice. Barry will then review
our financial results followed by some time for questions. I'll now turn the call over to Carrie.
Carrie L. Bourdow
President, CEO & Director
Thanks, Bob. Good morning, everyone. Thank you for joining us this morning. At the start of 2019, you'll remember that I laid
out a plan to resubmit oliceridine for approval and to advance the pipeline. What you're going to hear this morning on this call
is that we've delivered on the plan. And you'll hear that with successful resubmission of oliceridine, we'll now turn our attention
to preparing for expected approval in August of this year.
And on the pipeline front, what you'll hear is that we've hit key development milestones. We now have 2 proof-of-concept studies
underway, one for acute migraine and another for opioid use disorder. And we're studying TRV045, a novel S1P modulator in epilepsy
and a variety of other CNS conditions. Importantly, we completed all of this work while we managed our expenses very carefully.
And I have to say, I am extremely proud of this team and what was accomplished in 2019.
Let me give you just a few more details on the highlights, the high points from my perspective from the year. As you saw last
week, FDA accepted our resubmission of the oliceridine NDA and it’s great. They told us that it was a complete response
to their action letter. They set a PDUFA date of August 7, and we're looking forward to working with them as they review our application.
In the past, you've heard me talk about the market opportunity for oliceridine. It's large. Over 45 million patients each year
in U.S. hospitals receive drugs like IV morphine for acute pain. And about 9 million of those patients are at greater risk of
developing adverse events. Hospitals are seeing a rise in these at-risk patients and an increase in the number of severe acute
pain surgeries.
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
And we believe this at-risk patient
population alone, represents a total addressable market of $1 billion to $1.5 billion. That's impressive. But at the end of the
day, it's important that we focus on why we developed a novel analgesic like oliceridine, and the reason is to improve patients'
lives. Later on this call, we've invited Dr. Tim Beard to talk with you about some of his high-risk patients, and the challenges
that he faces in managing post-op acute pain.
Beyond oliceridine, we made significant progress on the pipeline. Late last year, we initiated an acute migraine proof-of-concept
study for TRV250. Migraines are also another large market, approximately 650 million migraines are treated annually in the U.S.,
and there's still a need for novel treatment options.
TRV250 is a novel new mechanism and this one at the delta receptor. And the delta receptor is located in the brain -- throughout
the brain, and the delta receptors regulate mood, anxiety and pain, including migraine pain. We're evaluating the ability of TRV250
to reduce the occurrence of headaches and also to reduce -- potentially reduce symptomatic anxiety. About half of all migraine
patients experience anxiety. There are no approved treatment options that can treat both migraine and anxiety. So obviously, this
would be a large market opportunity for us, for TRV250. It's a really exciting asset, and we're expecting top line results on
this study in the second half of this year.
Another proof-of-concept study we started late last year was in collaboration with the National Institute on Drug Abuse, or a
group called NIDA. And this study is for TRV734 for opioid use disorder. NIDA is looking at the potential of 734 as a safer and
better tolerated treatment option for patients suffering from addictions. We're really pleased to be working with NIDA to help
fight the opioid crisis, and I'll keep you updated as the study progresses.
And then lastly, as you saw this morning, we announced that we've initiated another collaboration with the NIH to investigate
the potential of TRV045 as a treatment for epilepsy.
045, another new mechanism, represents a novel approach to treating neurological disorders. And it's a next-generation S1P receptor
modulator that activates the receptor target without any of the immunosuppression that you get with other S1P modulators. NIH
has already initiated the first round of assays for epilepsy, and we believe this asset holds promise, not only for epilepsy,
but for a variety of CNS indications.
With all of our assets, including oliceridine, we're actively investigating collaborations and strategic partnerships. Remember,
we already have 2 ex-U.S. partnerships for oliceridine and these collaborations are going really well. We're expecting to receive
a $3 million milestone payment upon FDA approval of oliceridine.
As we continue to make progress on oliceridine and the pipeline, we're going to continue to look for ways to advance all of our
assets and to maximize shareholder value. With that, let me now turn the call over to Mark.
Mark A. Demitrack
Senior VP & Chief Medical Officer
Thank you, Carrie. I'm also very pleased that we've successfully resubmitted our NDA for IV oliceridine. This milestone represents
more than a year of work by members of our clinical, non-clinical, manufacturing and regulatory teams, and I'm extremely grateful
for the opportunity to work with such a dedicated group of individuals.
I believe the outcome of that work is compelling, and further strengthens our evidence in support of oliceridine as a potential
new treatment option for patients with moderate to severe acute pain. The promise of oliceridine as a distinctive addition to
a clinician's armamentarium of IV analgesics is built on its novel mechanism of action and unique pharmacokinetic profile.
Oliceridine is a new chemical entity, a first in this space in decades. And was designed to optimize G-protein-coupled receptor
pharmacology by preferentially engaging the G protein signaling pathway responsible for analgesia, with reduced recruitment of
ß-arrestin, which is largely involved in development of adverse effects. Oliceridine has a rapid onset of action, with perceptible
pain relief as early as 2 to 5 minutes after the first dose, and lasting approximately 3 hours, providing a highly differentiated
analgesic profile for clinicians.
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
Oliceridine also has no evidence
of active metabolites, which can complicate dosing and result in the emergence of delayed adverse events.
Finally, our recently published studies in special populations have shown that no dosage adjustment is necessary in patients with
underlying renal impairment or in the elderly. These attributes distinguish oliceridine from currently available IV analgesics,
like morphine. As a reminder, we've amassed the comprehensive clinical data set for oliceridine across multiple efficacy and safety
studies involving over 1,800 individuals.
On past calls, we've spoken about the respiratory safety data. But today, I'd like to highlight the GI tolerability data collected
during our pivotal Phase III studies, using a complete GI response outcome measure. This is a common endpoint used in drug development
for antiemetics, and defines a complete responder as a patient who reaches the end of the study period without vomiting and without
receiving a rescue antiemetic. The results of this analysis for oliceridine are extremely compelling.
In the Phase III hard tissue study, patients on oliceridine were 3x more likely to complete the study without vomiting and without
needing a rescue antiemetic, compared to patients on morphine. We saw a similar pattern in the Phase III soft tissue study. Importantly,
these results held true when we control for differences in level of pain relief achieved. Put a different way, oliceridine doses
that provided pain relief comparable to morphine had strikingly lower GI side effects.
In addition, the improvements in GI tolerability were not due to differences in pre-existing risk for nausea or vomiting among
the treatment groups. We believe this data reinforces the overall GI tolerability data for oliceridine.
I'd now like to introduce Dr. Tim Beard, who's a practicing general surgeon and is the Chair of the Department of Surgery and
Medical Director of Research at Summit Medical Group in Bend, Oregon. Tim also serves as an Affiliate Professor of Surgery at
Oregon Health Sciences University. We'd asked Tim to join us this morning to provide his perspective on the current clinical challenges
he faces in his hospital and outpatient practice, and his thoughts on the oliceridine data. Tim?
Timothy L. Beard
Thank you, Mark, for the introduction. I'm pleased to join the Trevena team this morning to provide my perspective on the current
role of IV opioid analgesics in my clinical practice, and to share my thoughts on the body of data that the company has amassed
on their investigational product, oliceridine.
I'm speaking on my own accord, and not in my position as a General Surgeon at the Summit Medical Group. I am a paid consultant
with Trevena. I practice as a General Surgeon in a large multi-specialty group, and split my time between a community hospital
and a physician-owned busy outpatient surgery center.
I perform approximately 750 cases a year, with 1/3 of those being done as in-patients. I have spent a considerable amount of time
reviewing the published data for this compound, and I have assisted Trevena's R&D group in data analysis and participated
as an author on some of the key publications. I believe this experience has provided me some insights into what can be expected
from oliceridine's potential use in practice. While the role of IV opioids in the postoperative pain management has undergone
an evolution over the years, these medications remain the pillar and standard of care for acute pain management.
In my practice, drugs such as IV morphine, Dilaudid and fentanyl remain an integral part of all postoperative pain management
strategies. The main reason for this is that only these medications can provide the definitive pain relief required in certain
highly painful postoperative circumstances. I can't perform surgeries in my clinical practice without them.
Poorly managed pain can have many undesirable consequences, including lack of mobility, poor appetite and disrupted sleep patterns.
On the flip side, drugs like IV morphine also has side effects, including respiratory depression, ileus, nausea and vomiting.
So we're left with few options but to prescribe opioids when they're required, and then to supplement their use with several additional
medications in order to try to minimize or counteract these side effects.
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
Because of this, I frequently
find it necessary to prescribe as many as 5 to 7 different additional drugs in the postoperative setting.
This unavoidable polypharmacy poses additional challenges to patients' recovery, including an increased risk of drug-drug interactions
and a poor rate of adherence to these additional medications. In my opinion, Trevena's investigational product, oliceridine, offers
the first truly novel advance towards a solution to this problem.
I have been impressed with the quality and amount of data Trevena has gathered and published in peer-reviewed journals. The 2
pivotal Phase III studies provide the initial clinical data in bunionectomy and abdominoplasty surgeries, and these results showed
great pain relief with a potentially differentiated and improved side effect profile what we expect with conventional opioids.
The results from the Phase III or real-world open-label safety study extended these findings. A particular interest to me was
the diverse patient population of this study, many of them with multiple comorbidities, including older age, obesity and diabetes.
These types of high-risk patients represent ones I operate in my practice all the time.
These complicating risk factors can pose significant challenges to a patient's postoperative course. A recent patient I treated
does come to mind. This is a 52-year-old woman who needed surgery for near-obstructing tumor in her distal transverse colon, and
at the same time, came to surgery with a history of poorly controlled diabetes and a BMI of 53. The challenge here was not the
surgical procedure itself, but the risks that emerge in our post-op recovery given her high-risk health history. For example,
her surgical wound presented a huge infection risk, so any occurrence of nausea, vomiting or retching could disrupt the integrity
of her wound and lead to an infection.
This is just one example of the type of patient who I could potentially benefit from the profile that oliceridine appears to offer.
In his remarks, Mark noted the complete GI responder analysis from the clinical trials. Overall, these data suggest that when
the magnitude of analgesic benefit is so constant across treatment groups, patients treated with oliceridine are more likely to
achieve a complete GI response compared to patients treated with morphine. This is an important endpoint, and I feel relevant
to me when considering the management of patient I just discussed.
Decreasing the risk of vomiting by two or threefold, might make the difference for this patient of having a relatively straightforward
postoperative course versus the risk that I would see -- I would be seeing her back in the operating room to repair wound dehiscence.
I also see the potential advantage that oliceridine could provide in the outpatient setting. My ambulatory surgery center performs
about 1,300 cases per month. One of our limiting factors in this setting is the availability of recovery room beds. If patients
are delayed in the recovery, it prevents us from starting more cases, by far the most common reason for prolonged recovery time,
or pain, nausea and vomiting.
As a result, the recovery room nurses are hesitant to give too much opioid medications as that makes patients sleepy, and they
do not breathe as well. On the other hand, if they give too little, patients will have too much pain, which, itself, may contribute
to increased rates of nausea and vomiting.
Oliceridine's pharmacokinetic profile offers several attributes that could provide advantages in this setting of care. For example,
its rapid onset of analgesic effect makes it very easy for physicians to use. There also appears to be no need to adjust the dose
for renal insufficiency, which, again, makes it easy on physicians. This is especially important in my practice, as all the nephrologists
in our town are in our group. Thus, I see a lot of renally patients.
Oliceridine also appears to have no active metabolites, which makes pain management in a short-term setting, like an ambulatory
surgery center, more straightforward. All of these factors could contribute to a decreased length of stay in our recovery room
and increase patient satisfaction.
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
To sum up, I'm excited by
the oliceridine data that I have seen, and I believe that oliceridine has the potential to help address some of the post
operative challenges that physicians and their patients still face. Thank you, again, for the invitation to speak. And now
let me pass the call back to Mark.
Mark A. Demitrack
Senior VP & Chief Medical Officer
Thanks, Tim, for your remarks. We greatly appreciate hearing your perspective on the challenges you face in your practice,
and what improvements you really hope to see in the current treatment landscape that would benefit both you and your
patients.
Tim will be available to answer questions during the Q&A later on this call. I'd now like to turn the
call over to Barry for a review of our full year financials.
Barry Shin
Senior VP & CFO
Thanks, Mark. We issued a press release and we filed our Form 10-K with our full financial results. For now, I'll summarize
the headline numbers.
For the fourth quarter of 2019, we had a net loss of $6.4 million or $0.07 per share compared
to $8.0 million or $0.10 per share for the fourth quarter of 2018. For the full year 2019, we had a net loss of $24.9 million
or $0.27 per share compared to $30.8 million or $0.42 per share for 2018.
This decrease in net loss is mainly due to
a headcount reduction in 2018, and a decrease in R&D expenses related to TRV250. At year-end 2019, we had cash, cash
equivalents and marketable securities of $35.8 million. With additional clarity following completion of our healthy volunteer
study, I'm very happy to update our guidance and report that we expect this amount will fund our operations and capital
expenditures into the first quarter of 2021.
This includes pre-commercial preparation and post-approval activities
to ensure oliceridine will be available for distribution, either by us or with a commercial partner in the fourth quarter of
2020. It also includes completion of the proof-of-concept study for TRV250 in acute migraine and IND-enabling work for
TRV045.
We'll now open the call for questions, after which Carrie will provide some closing remarks. Operator?
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
Question and Answer
Operator
[Operator Instructions] The first question is from Jason Butler of JMP Securities.
Jason Nicholas Butler
JMP Securities LLC, Research Division
I had 2 for Dr. Beard. First of all, you talked about the types of patients that you might use the drug in. Can you talk about
how you think about the procedures that you're doing and which procedures maybe warrant using the drug more than others? And then
can you just give us any thoughts you have on cost considerations of using a new drug like oliceridine? And how those cost considerations
compare and contrast in different institutions. For example, the community hospital you work in versus the outpatient clinic?
Carrie L. Bourdow
President, CEO & Director
Great. Thanks, Jason. I actually think those are 3 questions, but okay, well, that will be all right. So Tim, I don't know if
you can hear. The first question is around the types of procedures in addition to the patients that you mentioned, and then secondly,
talking a little bit more about cost, contrasting between the hospital and your ambulatory surgery center business.
Timothy L. Beard
Sure. Well, the procedures, I kind of split them up in 2 different and then same with the cost. So if you look at our in-patient,
the procedures, I think, that were illustrated and will be best are procedures that cause more pain. So any sort of laparotomy
where you're making big incisions, any sort of thoracotomy where you're going into the chest with, again, big incisions, we're
trying our best to manage those with multimodal analgesia, but opioids play a key role.
So I would say any, again, procedure that causes a lot of pain, so maybe not as much minimally invasive, although, I still see
a role in minimally invasive surgery, which is laparoscopic robotically, I guess, that would be for the in-patient.
And outpatient, what I'm excited for is the fact that this drug with -- what appears to be lower side effects, that we'd be able
to get people pain free and out of the recovery room faster. So any patient I do in an outpatient surgery center, I think there
would be a role for this drug. Because, again, we are limited in space by recovery room. And if we get backed up in the recovery
room, everything kind of slows down. So I do the majority of my patient cases in an outpatient surgery center, to be honest with
you. And that's just -- that's the trend nationally as more and more stuff is being done as outpatients, and a big part of that
is controlling costs.
So all -- I would say, almost all patients we do as outpatients would be good candidates for this drug.
Now costs are interesting. In the hospital, it would get absorbed in what's called the DRG, and the hospital looks at costs somewhat,
but not super strict because it seems to me that like, in our hospital, the DRG payments are fairly large and they don't micromanage
us very much on -- if we're using a drug that is a little bit more expensive than others. Sometimes a little bit, we'll get pushback,
that's mostly on antibiotics, and that's mostly sort of not changing the floor of antibiotics in our area.
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
The -- in the outpatient surgery
center, the margins on the cases are much smaller, and so costs are looked at more. So it'd be -- I don't have any idea of what
this drug is going to come out as cost-wise, but that would be looked at a little more as far as do we see a benefit from that.
But again, I think most of us, at the surgery center, look at the bigger picture. So if the drug does cost a little more but people
are happier, getting out of the surgery center faster, and we're more efficient, then the overall efficiency, I think, would far
outweigh the cost of the drug. An example of that is when IV Tylenol came out, that's a lot more expensive than oral Tylenol,
but yet we use it quite a bit because we see a benefit with that drug, even though the cost is more. So I hope that answers your
question.
Operator
The next question is from Douglas Tsao of H.C. Wainwright.
Douglas Dylan Tsao
H.C. Wainwright & Co, LLC, Research Division
I guess, my first question is for Dr. Beard, in terms of you think about your overall patient population, both in-patient and
outpatient, or if you could address them separately. What percentage of them do you think fall into this high-risk category and
would be candidates for use once it is eventually hopefully approved?
Carrie L. Bourdow
President, CEO & Director
Great. Thanks, Doug. Great questions. So Dr. Beard, I don't -- if you hear the questions, the percent of patients, yes...
Timothy L. Beard
Yes. So that percent goes up daily, it seems, I don't know. The -- and that patient -- that was a real patient example that I
gave. And I don't -- she was 5’ 1” , 325 pounds. So that was an extremely difficult case and extremely difficult postoperative
recovery.
So I would think, in our hospital, if this -- when this drug gets approved in August, we'd probably be able to get it to the P&T
pretty fast, would be my guess. And we'll probably start using it on high-risk patients, so people with pulmonary issues, people
that are at risk for nausea and vomiting. For example, I do a lot of laparoscopies for GERD surgeries, which are called Nissen
fundoplication or paraesophageal hernia repairs, mostly from heartburn and reflux. And if those patients retch or vomit, you can
totally disrupt the wrap that you've done.
So I would say, if I had to give a number of in-patients that I would say -- what I would consider higher risk and this drug is
just tailor-made for, probably at 50% or 60%. Unfortunately, I don't have a practice where I can operate on all the thin, healthy
patients all the time, I wish, but this doesn't exists, the reality. And again, in the outpatient, these are healthier patients
by definition. We don't do anyone over an ASA III in an outpatient surgery center. So they're healthier. But I think their benefit,
again, is a little different. It's not just so much for the postoperative risk. The drug would be used for what appears to be
a lower side effect profile and patient satisfaction and ease of getting them to our system.
Douglas Dylan Tsao
H.C. Wainwright & Co, LLC, Research Division
Okay. And then just one follow-up, or 2 follow-ups. One for Dr. Beard. I know you mentioned you're often treating, sort of taking
a polypharmacy approach. Just curious what drugs oliceridine, alone, would be able to replace? And then just a question for Carrie
in terms of TRV045, the S1P, which are going into epilepsy, just curious how it was -- epilepsy was the first indication selected
for development?
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
Carrie L. Bourdow
President, CEO & Director
Great. Yes. Tim, I'll let you start on oliceridine.
Timothy L. Beard
Sure. So we've developed these massive, what are called, ERAS pathways after surgery for a lot of our surgeries, which is enhanced
recovery after surgery. I'm sure you're familiar with them.
And in that pathway, we do everything we can to optimize patients postoperatively. So let's say I do a colectomy on someone, take
out a colon for colon cancer. We obviously, do a lot of stuff preop for those patients. But postoperatively, even though they
may get TAP blocks or these rectus sheath blocks, they all get IV opioids.
So the drugs we give to counteract IV opioids, we give a drug called alvimopan or Entereg, which is a peripheral acting new opioid
receptor antagonist, which blocks the side effects that opioids have on the gut. So opioids cause an ileus, where they cause the
gut not to move, you can't pass gas or stool. So we get that drug. We give a whole bevy of antiemetics, probably at least 3 different
antiemetics to prevent the nausea and vomiting, including sometimes we give Decadron in surgery or Zofran or Phenergan or Compazine,
any of those we can give to stop the postoperative nausea and vomiting. We also, then, are super aggressive with respiratory care
on these patients, so we give a respiratory therapy consult, do incentive spirometers, and may or may not give them nebulizers
if they need it.
So I think those are the 3 sort of main areas that -- where we're giving drugs to counteract the side effects of opioids.
Carrie L. Bourdow
President, CEO & Director
And it sounds like it's difficult for you right now to say what oliceridine may replace, you got to get it in your hands, I think,
and use it, right? But your -- is really Doug's question around what potentially oliceridine could replace..
Timothy L. Beard
Right. We're hoping -- because, yes, and what I tried to mention in my talk is that when you give so many different drugs, the
polypharmacy, the compliance to that regimen is fairly low. That's what we're finding out with our ERAS protocol is that we give
all these different drugs and then people actually don't really get them scheduled because it's too much. The compliance is fairly
low. So yes, we don't know. That's why I'm excited for this drug to get approved to try to see how much we can eliminate because
anything we can do to simplify, it would be great.
Carrie L. Bourdow
President, CEO & Director
Great. And then, Doug, to follow-up on your question around S1P, so quick reminder, and I'll turn it over to Mark to talk specifically
about epilepsy. But there are other areas that we've studied with TRV045 or in the process of looking at, chemo-induced peripheral
neuropathy is another area that we've looked at on the animal data. And then epilepsy was really -- Mark's going out and talking
to folks that are involved in looking at epilepsy drugs and epilepsy trials. So Mark, I'll let you talk a little bit about...
Mark A. Demitrack
Senior VP & Chief Medical Officer
Yes, Doug, it's a great question. And as you know, when we've talked in the past, the S1P target is really quite interesting because
of its broad representation in the CNS. So really, the challenge for us is more focused, since there's an enormous number of targets
that are potential interest. And as Carrie mentioned, most of our early work was focused on chemotherapy-induced peripheral neuropathy
and rodent model. That's one of the best studied animal models for the S1P system.
TREVENA, INC. FQ4 and FYE 2019 EARNINGS CALL | MAR 12, 2020
But because of S1P localization
on cell types in the brain, particularly glial cell types or astrocytes, it has a demonstrable impact on various measures of membrane
stability. And as a result, people became interested in the idea of exploring it in epilepsy models. And although it's not as
well studied as the CIPN work, there has been some animal work done with some of the available S1P ligands like fingolimod, for
example.
Now you know that fingolimod is a nonselective S1P modulator, and it also is accompanied by peripheral immunosuppression. The
S1P receptor target, which is what 045 is directed at, is a bit more selective to the CNS receptors. And it also is absent immunosuppression
in our studies to date. So it allows us to build on some of the literature that exists for the epilepsy target in animal models
with earlier tool compounds, and that really is kind of the thing that prompted our interest.
The collaboration with ETSP emerged from those discussions. ETSP program is a long-standing, well-regarded preclinical screening
program that's sponsored by NINDS through the NIH. It's been in existence for about 30 years and has actually shepherd it along
several pretty key antiepileptics to the market in their experience. So we're pretty gratified that -- in our discussions that
we've engaged in this program. So further updates in the future.
Operator
This concludes the question-and-answer session. I would now like to turn it back to Carrie Bourdow for closing comments.
Carrie L. Bourdow
President, CEO & Director
Great. Thank you, and thank you for your questions. Thank you to Dr. Beard for addressing the questions, we appreciate that. Let
me close with some of the key points that you heard today. First, we've executed on our plan. We did what we said we were going
to do. We resubmitted the NDA for oliceridine, got confirmation from FDA that the submission was complete, and we also advanced
the pipeline, as we carefully managed our expenses.
I'd like to add my thanks to the team for their hard work and commitment. We expect 2020 to be a transformational year for Trevena.
With the oliceridine NDA now under FDA review, we're preparing for expected approval in August. And we're also going to continue
to make progress on the pipeline. So I will continue to provide updates as the year progresses. Thank you, again, for joining
us this morning on the call.
Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.