Q3 2021 Trevena Inc Earnings Call

Yeah.

Operator: Today's conference is scheduled to begin shortly. Please continue to stand by, and thank you for your patience.

Today's conference is scheduled to begin shortly please continue to standby and thank you for your patience.

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Operator: Good day, and thank you for standing by. Welcome to the Trina third quarter.

Okay.

[music].

Operator: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Barry Shin, Senior Vice President and Chief Financial Officer.

Okay.

Good day, and thank you for standing by welcome to.

For the third quarter 2021 financial results conference call. At this time, all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded I would now like to hand the call.

Over to your speaker today fashion Senior Vice President and Chief Financial Officer. Please go ahead.

Barry Shin: Good morning and welcome everyone. With me today are Kerry Bourdow, our President and CEO, Patty Drake, our newly announced Chief Commercial Officer, Bob Yoder, our Chief Business Officer and Head of Commercial Operations, and our Chief Medical Officer, Mark Demitrack. We're also joined by Dr. Paul Ryder from the University of South Alabama. Dr. Ryder will share his first-hand experience with OLINVIC both as an investigator in our Phase III Open Label Safety Study and in his colorectal surgery practice, where OLINVIC is approved for use.

Good morning, and welcome everyone with.

With me today are Kerry Bordeaux, our president and CEO Patty Drake, our newly announced Chief Commercial Officer, Bob Yoder, Chief business Officer, and head of commercial operations, and our Chief Medical Officer Mark demographic.

We're also joined by Dr. Paul Rider from the University of South Alabama.

Doctor Ryder will share his firsthand experience with Olympic both as an investigator in our phase III Open label safety study and in this colorectal surgery practice, where Olympic is approved for use.

Barry Shin: At the end of the call, we'll open it up for questions. As a reminder, Olympic is approved 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 the full prescribing information, are all available on thelindic.com.

At the end of the call will open it up for questions.

As a reminder, Olympic is approved in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate.

[noise] safety information, including the box warning and the full prescribing information are all available on the Olympic Dot com.

Barry Shin: Also, we'll be making forward-looking statements within the meaning of federal securities 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 Kari for an overview of our third quarter and recent business accomplishments.

Also we will be making forward looking statements within the meaning of federal Securities 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 our third quarter and recent business accomplishments.

Gary.

Kari: Thank you, Barry. Good morning, everyone. And thanks for joining us today. Over the past quarter, we continue to make progress in launching a LENDC despite the pandemic. And we have a number of exciting announcements to make today that we strongly believe will position us for success in 2020. First, as you may have seen in our press release last week, we are thrilled to announce that Patty Drake, a seasoned biopharma executive with over 30 years of sales and marketing experience, will be joining Trevena as chief commercial officer.

Thank you Barry.

Good morning, everyone and thanks for joining us today.

Over the past quarter, we continued to make progress watching Olympic despite the pandemic and we have a number of exciting announcements to make today that we strongly believe will position us for success in 2022.

First as you may have seen in our press release last week, we are thrilled to announce that Patty Drake a seasoned biopharma executive with over 30 years of sales and marketing marketing experience will be joined <unk> as chief commercial officer.

Kari: While at Merck, Patty led the successful launch of numerous hospital and specialty commercial products. Recently, she has been serving as a consultant to Trevena, partnering with Bob to assess the landscape and put together a plan for commercial success.

While at Merck had he led the successful launch of numerous hospital and specialty commercial products.

Recently, Patti has been serving as a consultant to trevino partnering with Bob to assess the landscape and putting together our plans for commercial success.

Kari: Key components of the plan include an accelerated focus on integrated health systems to drive formulary adoption, the addition of burn care as a target, and optimizing field sales. Patty is with us today and will speak in more detail about her plan.

Key components of the plan include an accelerated focus on integrated health systems to drive formulary adoption.

The addition of burn care is a target specialty.

Optimizing the field sales organization.

Pat He is with US today, and we will speak in more detail about her plans.

Kari: Importantly, Patty coming on board will allow Bob to focus on commercial operations for Olimic and our growing five... We also announce today a new study designed to assess the impact of a limbic system on cognitive function compared to IV morphine. We're initiating this study based on the positive feedback we continue to hear from physicians. And you'll hear directly from one of those physicians today, Dr. Paul Reiter, who will share his experiences treating patients with a limb.

Importantly, Patti coming onboard will allow Bob to focus on commercial operations for Olympic and our growing pipeline.

We also announced today a new study designed to assess the impact of Olympic on cognitive function compared to IV morphine.

We're initiating that study based on the positive feedback we continue to hear from physicians and Youll hear directly from one of those physicians today, Dr. Paul Rider, who will share his experiences treating patients with Olympic.

Kari: In addition, later in the call, Mark will provide details about the two ongoing Olympic studies we're conducting to further evaluate its clinical profile and the important progress we've made with our pipeline. With that, let me turn the call over to Patty to say a few words about the Olympics. Thanks, Keri.

In addition later on the call Mark will provide details about the two ongoing Olympics studies, we're conducting to further evaluate its clinical profile.

And the important progress we've made with our pipeline this quarter.

With that let me turn the call over to Patty to say a few words about the Olympic launch.

Patricia M. Drake: And hello to all of you joining us today. I'm thrilled to be joining the Trevena management team at this time. After a 32-year career at Merck, I have an appreciation for novel, innovative advancements in medical care that deliver a differentiated patient experience, and I certainly see that with Olimbic. As Terry mentioned, I've had the opportunity to spend some time in the field talking with customers, and this is why I'm optimistic about LINVIC.

Thanks, Carrie and Hello to all of you joining us today I'm thrilled to be joining the Trevino management team at the time after a 32 year career at Merck I have an appreciation for novel innovative advancements in medical care that deliver a differentiated patient experience and I certainly see that.

Olympic.

Carey mentioned I've had the opportunity to spend some time in the field talking with customers and this is why I'm optimistic about Olympic what's clear to me is that physicians, who use the lindbergh are very happy with the results.

The more we're able to get in front of physicians and formulary the better position, we'll be and I do believe that we're turning a corner here.

There are early signs that face to face engagement may be returning having launched dozens of products without the challenge of the global pandemic I can tell you. It does take time the trevino team has done a great job of laying the necessary groundwork.

Patricia M. Drake: What's clear to me is that physicians who use LINVIC are very happy with the results. The more we're able to get in front of physicians and formularies, the better position we will be in. And I do believe that we're turning a corner here. There are early signs that face-to-face engagement may be returning. Having launched dozens of products without the challenge of a global pandemic, I can tell you it does

Taken advocacy that we've built over the past few months represents important early progress and we're now in a strong position to initiate the second part of our launch strategy.

As part of a top down approach to efficiently expand formulary adoption, we've begun to engage with leadership in integrated health system and group purchasing organization.

This represents a significant opportunity for us to drive rapid adoption at the national level and facilitate expanded access to Olympic.

Patricia M. Drake: The Trevena team has done a great job of laying the necessary groundwork. The uptake and advocacy that we've built over the past few months represent important early progress, and we're now in a strong position to initiate the second part of our launch strategy.

We're still in the early stages of discussion, but I'm confident that the positive reception, we see from health care decision makers about both our clinical profile and health economic data will support their interest and making Olympic available to their member hospitals.

I'm also thrilled about the opportunity to expand in the burn care and conversations with our customers. We started to recognize that Olympic is an ideal match for use in burn patients.

Patricia M. Drake: As part of a top-down approach to efficiently expand formulary adoption, we've begun to engage with leadership at integrated health systems and group purchasing organizations. This represents a significant opportunity for us to drive rapid adoption at the national level and facilitate expanded access to a limbic system. We're still in the early stages of discussion, but I'm confident that the positive reception we see from health care decision makers about both our clinical profile and health economic data will support their interest in making a limbic system available to their member hospitals.

There are several key consideration when treating burn patient.

Absolute top priority is achieving rapid and powerful pain relief. The H C piece, we've spoken with appreciate Olympics rapid onset.

Ration of action lack of active metabolite and no dosing adjustment needed for the renal impaired patients and ideal attributes for their practice.

Approximately 30000 burn patients are admitted each year to the major burn centers.

These patients on average have length of stay of eight to nine days and burn patients often have extended course of treatment.

Physicians have told us that they're looking for and advance it in pain care to offset some of the known complications with current treatment options.

Based on this early feedback we believe there's a significant potential opportunity for Olympic as a new pain option in burn care.

Patricia M. Drake: I'm also thrilled about the opportunity to expand into burn care. In conversations with our customers, we've started to recognize that a limbic system is an ideal match for use in burn patients. There are several key considerations when treating burn patients. The absolute top priority is achieving rapid and powerful pain relief. The HCPs we've spoken with appreciate a limbic rapid onset, duration of action, lack of active metabolites, and no dosing adjustment needed for the renally impaired patient as ideal attributes for their practice. Approximately 30,000 burn patients are admitted each year to major burn centers.

I'm excited to be joining this experienced team with an innovative pipeline of products and I really look forward to updating you on our progress and with that I'll turn the call over to my colleague Bob.

Thank you Bobby we're thrilled to have you on board and I look forward to partnering with you over the coming months.

As Patty said physician interest in the clinical value prop of Olympic remains high Olympic is currently approved at 41 institution in.

Various stages of formulary review and over 125 institutions or accounts.

We've also expanded our list of target accounts to approximately 700 hospitals, representing nearly 60% of the IV opioid market.

Like many of our peers Covid has impacted our ability to access our customers and provide on the ground support for the formulary process.

The third of the delta varying over the summer significantly affected many hospitals.

Not only did many institutions restrict access but physician head space was once again dominated by COVID-19 patient care or related impacts such as staffing shortages, which hindered advocacy development and the formulary process.

Patricia M. Drake: These patients, on average, have lengths of stay of eight to nine days, and burn patients often have an extended course of treatment. Physicians have told us that they're looking for advancements in pain care to offset some of the known complications with current treatment options. Based on this early feedback, we believe there's a significant potential opportunity for a limbic as a new pain option in burn care. I'm excited to be joining this experienced team with an innovative pipeline of products, and I really look forward to updating you on our progress. And with that, I'll turn the call over to my colleague Bob. Thank you, Patty.

We do believe this is changing and bringing patio on board at this time will allow us to leverage the momentum we've built.

The feedback from the field and positive trends across many of our watch metrics continued to give us confidence in the Olympic value proposition.

On that note I would now like to introduce Dr. Paul Wright, the colorectal surgeon at the University of South Alabama Dr.

Dr. Rider was one of our investigators in the Athena Open label safety study and have been using the Olympic and his practice for the past seven months Dr.

Dr writer.

Thank you Bob for the introduction and good morning, everybody.

I'm pleased to be here. This morning, but I'll provide my firsthand experience regarding Olympics use of byproduct us by way of disclosure from a paid consultant with Davina and I wasn't investigator as part of a phase three open label safety study.

The views that I'll be discussing today are my own and I'm not speaking on behalf of the University of South Alabama, Let me share with you a little bit about my practice self served as the chief of colorectal surgery Division here at the University of South Alabama for nine years.

I focused primarily on complicated than last resort cases in the thinking that hospital that serve roughly $1 5 million in the mobile metropolitan and surrounding areas.

Bob: We're thrilled to have you on board, and I look forward to partnering with you over the coming months. As Patty said, physician interest in the clinical value proposition of Olympic remains high. Olympic is currently approved at 41 institutions and at various stages of formulary review in over 125 institutions or accounts.

Many of our patients are complicated.

More complex procedures that can yield a higher magnitude of pain.

While we try to provide the least invasive intervention possible what types of procedures either as a result of post operative pain that requires judicious and meticulous treatments.

Typically we try to adhere to opioid sparing concepts, but we see many cases, where we can't afford to go them entirely in fact, it's uncommon for a patient in my practice to not need any IV opioids in the post operative setting.

The clinical care of these complex patients can be challenging due to their medical comorbidities such as advanced age.

So the renal disease.

<unk> them at a higher risk for side effects to combat. This we often utilize concomitant medications and an advanced recovery. After surgery protocol, which is generally considered to be a standard practice is apart multiple therapy.

Bob: And we've also expanded our list of target accounts to approximately 700 hospitals, representing nearly 60% of the IV opioid market. Like many of our peers, COVID has impacted our ability to access our customers and provide on-the-ground support for the formulary process. The surge of the Delta variant over the summer significantly affected many hospitals. Not only did many institutions restrict access, but physician headspace was once again dominated by COVID patient care or related impacts, such as staffing shortages, which hindered advocacy development and the formulary process. We do believe this is changing, and bringing Patty on board at this time will allow us to leverage the momentum we've built.

However that introduces yet more risk for complications from additional side effects of these additional medications, while further increasing the complexity and the cost of their care.

Me Olympic offers a new treatment option to pivotal trials provide evidence that simply stated it works and it provides a powerful means to control post operative pain in my patients who have acute pain severe enough to require an IV opioid.

In addition, the data from the Athena Open label Safety study provided important insights into the safety and Tolerability of 11, most notably in these challenging patients I. Just described is the lack of active metabolites and no need for dose adjustments in patients with kidney disease.

We believe that Olympic is an overdue advancement and the IV opioid pharmacotherapy.

I'll add that we're not participated as an investigator in Athena favorable personal experience with what compelled me to submit Olympic for formulary review at my institution.

If it was added to our corner in April of this year I'm currently using Olympic and my electric procedures in my experience that's continued to be very positive.

This real world performance as parallel of the outcomes I observed during the Athena study one recent case come to mind.

Bob: The feedback from the field and positive trends across many of our launch metrics continue to give us confidence in the Olympic value proposition. On that note, I'd now like to introduce Dr. Paul Reiter, a colorectal surgeon at the University of South Alabama. Dr. Ryder was one of our investigators in the Athena Open Label Safety Study and has been using a LinVic in his practice for the past seven months. Thank you, Bob, for the introduction. Good morning, everybody.

This was a female with end stage renal disease on dialysis, who underwent surgery.

We've got an extensive past surgical history and actually had a very similar procedure done 18 months prior where she experienced significant challenges with pain control. This summer. After your experience what I would consider would be truly maximal benefit from alembic effective pain management and a favorable safety profile.

A positive post operative experience. She even commented that not only did our pain field under control, but she also didn't feel as fuzzy.

He remembered from her previous surgery.

Based on my experience I have encourage trevino to further explore the possible favorable effects on cognitive function in a clinical study and I'm excited that they are now exploring this in two post approval studies, because it's something that's significantly impacts both patients' recovery and their satisfaction.

I look forward to seeing what the data generated.

Dr. Paul Ryder: I'm pleased to be here this morning to provide my firsthand experience regarding Olympics use in my practice. By way of disclosure, I'm a paid consultant with Trevena, and I was an investigator as part of the Phase 3 Athena Open Label Safety study. The views that I'll be expressing today are my own, and I'm not speaking on behalf of the University of South Alabama.

To close I'm extremely happy with my experience with Olympic I've seen how my patients have benefited from this novel therapeutic in I believe it will continue to demonstrate a favorable profile in my practice.

Thanks for your attention.

Let me now turn it over to Mark.

Thank you Paul.

We appreciate your clinical insights on Olympic.

I'd like to spend some time, providing a few updates on the progress we are making with the Olympics post approval research plan.

As you just heard from Dr. Rider in this echoes what we heard from other positions.

<unk> from our Athena study suggests that Olympic may have a potential differential effect on cognitive function.

Though this has not been evaluated in clinical trials to date.

That's why I am pleased to be embarking on a new study designed to be a rigorous clinical investigation of this intriguing observation.

We're partnering with the center for human Drug research a world class facility in the Netherlands that has a wealth of study experience with CNS therapeutics.

Dr. Paul Ryder: Let me share with you a little bit about my practice. I've served as the Chief of the Colorectal Surgery Division here at the University of South Alabama for nine years. I focus primarily on complicated and last resort cases at a safety net hospital that serves roughly 1.5 million in the Mobile metropolitan area and surrounding areas. Many of our patients are accomplished and require complex procedures that can yield a high magnitude of pain. While we try to provide the least invasive intervention possible, the types of procedures I do result in post-operative pain that requires judicious and meticulous treatment.

This will be a randomized double blind placebo controlled study and will investigate the effects of Olympic and IV morphine on cognitive function and pain thresholds.

Broad array of cognitive outcomes will be evaluated including motor performance.

<unk> reaction time memory and executive function.

Enrollment is expected to begin in the first quarter of 2022, and we expect data to be reported by the middle of next year.

We also continued to advance our two other ongoing clinical studies.

Olympic outcome study led by Cleveland clinic, known as the Volition study has begun enrolling patients and we expect topline data from this study in mid 2022.

And the Olympic respiratory Physiology study led by Dr. Albert to Han at Leiden University Medical Center is on track to finish by the end of this year with top line data readout shortly thereafter.

I look forward to providing additional updates on our post approval program over the next few months.

I'd now like to turn to our pipeline, which also saw several exciting developments last quarter.

We announced positive proof of concept data for <unk> <unk> seven from this study led by Imperial College, London.

Dr. Paul Ryder: Typically, we try to adhere to opioid sparing concepts, but we see many cases where we can't forego them entirely. In fact, it's uncommon for a patient in my practice to not need any IV opioids in the first operation.

This biomarker study evaluated <unk> seven as a potential treatment.

For acute lung damage and abnormal blood clotting associated with COVID-19.

We believe these findings provide encouraging preliminary evidence of <unk> potential to help hospitalized COVID-19 patients early on in the course of their illness.

And we look forward to Imperial College, London, working rapidly to submit these data for peer review and publication.

Dr. Paul Ryder: The clinical care of these complex patients can be challenging, placing them at a higher risk for cytokines. To combat this, we often utilize cytotoxic medications and an advanced recovery after surgery protocol, which is generally considered to be a standard practice as a part of multimodal therapy. However, that introduces yet more risk for complications from additional side effects of these additional medications.

As a reminder, these data from Imperial college momentum to the implementation of two global multi arm platform trials that are evaluating <unk> two seven.

NIH funded active trial led by Vanderbilt University Medical center in the U S.

The remap cap trial in the U K.

Data from the active trial is expected as early as mid 2022.

If positive results from this study will help elucidate whether <unk> seven may have even broader applications in other forms of lung injury or acute respiratory distress beyond COVID-19 infection alone.

Finally, I'm also pleased to provide an update on our path toward clinical development of <unk> <unk> five hour selective <unk> modulator targeted for treatment of diabetic neuropathic pain.

In October we received a clinical hold letter from FDA regarding certain phase one study design elements.

Bonding to the Fda's comments, we re file the IND and are prepared to initiate the phase one program. Once the agency provides final feedback.

Dr. Paul Ryder: All further, Unknown Attendee, Barry Shin, Trevena Inc., For me, Olympic offers a new treatment. Two pivotal trials provide evidence that, simply stated, it works, and it provides a powerful means to control post-operative pain in my patients who have acute pain severe enough to require an IV. In addition, the data from the Athena Open Label Safety Study provided important insight into the safety and tolerability of Alevis, challenging patients I just described as the lack of active metabolites and no need for dose adjustments in patients with kidney disease, which makes me believe that a limbic system is an overdue advancement in the IV opioid.

Let me now turn the call over to Barry to discuss our third quarter financial results.

Barry.

Thanks Mark.

In Q3, we reported $181000 in Olympic net sales and license revenue.

Our net loss for the quarter was $13 9 million.

Compared to $5 $6 million for the same period last year.

This change was mainly due to costs associated with our Lindbergh launch.

Our operating expense was $14 million for the quarter and this should increase moderately as we commercialize Olympic and advance our product pipeline.

We finished the quarter with $78 $6 million in cash and equivalents, which we continue to expect will fund our operations through the fourth quarter of 2022.

We'll now open the call for questions after which Carey will provide some closing remarks.

Operator.

Yeah.

Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press. The pound key again, if you would like to ask a question press the star one key.

On your Touchtone telephone and we have a question from Jason Butler with JMP Securities.

Your line is open hi.

Thanks for taking the questions.

First one maybe is for Patty congrats on.

Joining the company.

Dr. Paul Ryder: I'll add that when I participated as an investigator in ATHENA, my favorable personal experience was what compelled me to submit a LIMVIC for formulary review at my... Olympic was added to our corner in April of this year. I'm currently using a limbic system in my elective procedures, and my..., continue to be very positive. This real-world performance is parallel to the outcomes I observed during the Athena study. One recent case comes to mind, a female with end-stage renal disease on dialysis who underwent surgery.

Maybe you could give us some thoughts here on product messaging.

Any thoughts on what you think about the company is targeting of patients or procedures and then just more on what youre doing to expand formulary adoption. Thanks.

Thanks, Jason Thanks for the question and it's nice to meet you.

In terms of the <unk>.

<unk> positioning and what I've seen so far.

Is that the powerful efficacy data with the differentiation on the side effect profile is really resonating very very well.

As we talked about in terms of where we want to move to in the future you've heard a couple of those strategic choices being.

Now the right time to engage with the integrated health systems and the G. P M as well as the pivot to the burn centers in the burn patients.

Dr. Paul Ryder: She had an extensive past surgical history and actually had a very similar procedure done 18 months prior, where she experienced significant challenges. This time around, she experienced what I would consider to be truly maximal benefit. Effective pain management and a favorable safety profile. Unknown Attendee, Barry Shin, Trevena Inc., Based on my experience, I've encouraged Trevena to further explore the possible favorable effects on cognitive function in a clinical study, and I'm excited that they're now exploring this in two post-approval studies, because it's something that significantly impacts both patients' recovery and their satisfaction. I look forward to seeing what the data generates. Unknown Attendee, Barry Shin, Trevena Inc., Thanks for your attention, and let me now turn it over to Mark. Thank you, Paul.

And what we what we truly believes because so many of our surgeons and anesthesiologists.

Move to the burn profile because of the fact that we have this opportunity in both the medical and a commercial perspective and it fits the pie.

Really perfectly.

And we see par or not really.

In terms of pain management, and with about 141 centers across the United States, we can really efficiently and effectively.

New set of customers as well, so that's where we're at and that's where we're heading.

Great and then I just had a couple for mark.

Cognitive study is this something where you think ultimately you could get data reflected in the product label.

Are you also looking at cognition in for example, the Cleveland Clinic study and then just how did you think about designing the endpoints for for this new study and then just lastly on <unk> five has there been any dialogue with FDA since the <unk> was not approved and then.

I guess, what gives you confidence now that the resubmission will be approved thanks.

Great Jason Thanks for the question. So let me start with the last one.

So the in terms of correspondents, we did have.

As we talked about before.

Variable communication from FDA, and then follow up letter specifying the specific.

Aspects of the phase one study design that they wanted.

Mark A. Demitrack: We appreciate your clinical insights on the limbic system. I'd like to spend some time providing a few updates on the progress we are making with the LENVIX post-approval research plan. As you just heard from Dr. Ryder, and this echoes what we heard from other physicians, observations from our Athena study suggest that the limbic system may have a potential differential effect on cognitive function.

US to address we've done that we've re file D. I N D and so we believe we're on track.

If all goes well to be in the clinic with O 45.

The beginning of the year.

In regard to your other questions around the cognizant study.

Can you remind me when I get to the end device touched on all the points that you that you raised but as you heard and Dr. Rogers comments and as we've talked about before.

We've heard anecdotally comments on differences in the profile of cognition.

Mark A. Demitrack: Although this has not been evaluated in clinical trials to date, that's why I'm pleased to be embarking on a new study designed to be a rigorous clinical investigation of this intriguing observation. We're partnering with the Center for Human Drug Research, a world-class facility in the Netherlands that has a wealth of study experience with CNS Therapeutics. This will be a randomized, double-blind, placebo-controlled study and will investigate the effect of olimbic and IV morphine on cognitive function and pain threshold. A broad array of cognitive outcomes will be evaluated, including motor performance, attention, reaction time, memory, and executive function.

In patients.

With who are treated with Olympic level of alertness that is distinctive and the clinicians view. So that's given us some insight into aspects of cognition that we should investigate things.

Things like Alertness reaction time motor performance executive function and.

We've designed the current study to explore those specific domains of cognitive function and yes, we are looking at a global indices.

Attention alertness.

And sleep quality as well as risk of delirium within the context of the work that we're doing in the volition study. So both of those studies gives us an opportunity from different angles.

To evaluate the outcome of cognizant function.

Regard to the potential for this information to have.

Mark A. Demitrack: Enrollment is expected to begin in the first quarter of 2022, and we expect data to be reported by the middle of next year. We also continue to advance our two other ongoing clinical studies. The Olympic Outcomes Study, led by Cleveland Clinic, known as the Volition Study, has begun enrolling patients.

Regulatory implications.

Certainly provides us information that we could then.

A discussion with FDA, how we get to the point.

Beyond that of information that might be necessary.

Two to enlarge the label in any way it would be a matter for for future discussion I think I've covered most of what you had asked.

Mark A. Demitrack: And we expect top-line data from this study in mid-2022, and the Olympic Respiratory Physiology Study led by Dr. Albert Kahan at Leiden University Medical Center is on track to finish by the end of this year, with top-line data readout shortly thereafter. I look forward to providing additional updates on our post-approval program over the next few months. I'd now like to turn to our pipeline, which saw several exciting developments last quarter. We announce positive proof-of-concept data for TRV027 from a study led by Imperial College London.

Yeah, I guess, just a real quick follow up.

Any color here would there potentially be or is the thought process that there could be a cost benefit as well.

Less negative effect on <unk>.

No negative effect on cognition, you can get the patients out of the hospital faster or is that.

The way to think about it.

Oh, absolutely and in fact, we.

We saw a hint of this in fact, when we look at the adverse events of <unk>.

Sedation and sedation you May remember is one of three major.

Economic contributors to our health economic model, the other two being vomiting, and respiratory depression, and you're absolutely right improvements in cognitive function whether reflected in sedation.

Or alertness have a great impact on the patient's ability to.

Cooperate and participate.

In their own recuperation, which.

Mark A. Demitrack: This biomarker study evaluated TRV027 as a potential treatment for acute lung damage and abnormal blood clotting associated with COVID-19. We believe these findings provide encouraging preliminary evidence of TRV-027's potential to help hospitalized COVID-19 patients early on in the course of their illness, and we look forward to Imperial College London working rapidly to submit these data for peer review and publication. As a reminder, these data from Imperial College lend momentum to the implementation of two global multi-arm platform trials that are evaluating TRVF27.

Generally has a measurable impact on things.

Things like length of stay.

<unk>.

In hospital or time to critical milestones and hospitals. So the potential from both a clinical recovery point of view and an economic point of view is potentially significant and that is something that we're very interested in looking at.

Okay, great. Thanks, Thanks for taking questions.

Questions.

Thank you. Our next question comes from Jeff Jones with Oppenheimer. Your line is open.

Great. Thanks, Scott and thanks for taking the question guys.

Just two quick follow up question.

Can you give us a feel for the number of P&C committees.

Our scheduled to review Olympic through the end of the year.

And where your rate of approval stance in terms of TNT committees.

At this point.

And then just one quick follow up on the cognitive function study.

Mark A. Demitrack: The NIH-funded ACTIV trial, led by Vanderbilt University Medical Center in the U.S., and the Remap CAP trial in the UK. Data from the ACTIV trial are expected as early as mid-2022. If positive, results from this study will help elucidate whether TRV-027 may have even broader applications in other forms of lung injury or acute respiratory distress beyond COVID infection alone.

If I heard right. This is head to head versus IV morphine can you give us a feel for what the <unk> looks like in that number how many patients are involved thank you.

Okay.

Geoff Hi, it's karri.

You can hear my voice.

Thankfully the call was recorded so let me ask Mark to take the first day, a coffee question and then Bob will take the DMT question.

Thanks, Jeff This is mark so the cognitive function study, you're right will be head to head comparison there'll be a range of doses.

Mark A. Demitrack: Finally, I am also pleased to provide an update on our path toward clinical development of TRV045; our selected S1P modulator targeted for the treatment of diabetic neuropathic pain. In October, we received a clinical hold letter from FDA regarding certain Phase I study design elements. Responding to the FDA's comments, we've refiled the IND and are prepared to initiate the Phase I program once the agency provides final feedback. I will now turn the call over to Barry to discuss our third quarter financial results. Barry?

<unk> a range of doses of IV morphine.

A double blind placebo controlled crossover design, we expect somewhere in the order of about 25 or so.

Subjects will be participating in that study and that should give us on the on the endpoints. We're looking at that should give us the necessary sensitivity to both look.

Look at the group effects as well as.

PK PD model that we were derived from the data.

Okay.

Yes, Thanks, Marc Hi, Jeff. Thanks, Thanks for the question so regarding the formulary review process.

Barry Shin: Thanks, bye. In Q3, we reported $181,000 in Olympic Mint sales and licenses. Our net loss for the quarter was $13.9 million compared to $5.6 million for the same period last year. This change is mainly due to costs associated with our lending. Our operating expense was $14 million for the quarter, and this should increase moderately as we commercialize Olimbic and advance our product pipeline.

We track every step along the way of that process to go from submission all way through our PMT review it right now we've got over 125 institutions that are in various stages of that process more specifically there is over 40 that are further along in that process either in subcommittee review, we're awaiting scheduling for.

P&G meeting.

So that's sort of a status of where we're at with the in review as far as rate of approval.

Goes back to what Patti described about what she is seeing in terms of the profile I'd say, we have a pretty pretty good hit rate on the on the approvals once we get to that process. It's just that we're seeing a lot of the COVID-19 headwinds pushing back pmt's, we've seen some meetings being delayed and pushed back and rescheduled, but but I am happy with the approvals that were that were.

Barry Shin: We finished the quarter with $78.6 million in cash and equivalents, which we continue to expect will fund our operations through the fourth quarter of 2022. I will now open the call for questions, after which Kerry will provide some closing remarks. Operator. Thank you. As a reminder, to ask a question, you'll need to press star one on your telephone. To withdraw your question, press the pound key. Again, if you would like to ask another question,

Seeing as that hit rate.

Great. Thanks, guys.

Thank you and we have a question from Doug Tsao with H C. Wainwright Your line is open.

Oh, Hey, everyone crispy all of us here on for Doug.

A couple of quick ones. So I was wondering what is your current physician interaction right.

Do you know how many positions can you see versus digital interaction.

And then I was wondering if you can kind of give us a little more color on how you plan on leverage your leverage your expanded MSL team. Thanks, so much.

Yeah, Hi, Chris.

Go ahead please.

Sorry, Yes, I was just I was just going to say Chris to answer. Your first question. So obviously COVID-19 has an impact on physical access, but what I'm happy to see as that of our engagements with customers a little over 70% plus now our live engagements and Thats, obviously the goal to get to obviously, there's many lives.

Operator: Press the Start and the 1 key on your touch-tone telephone. Now, we have a question from Jason Butler.

As we can and I will say you mentioned the digital program, we're really happy with how the digital program is performing where we're basically above many of the industry benchmarks in terms of.

Operator: I'm Jason Butler with JMP Securities. Your line is open.

The engagement metrics that you watch things like open rates click through rates and your engagement with our various digital platforms and we can understand which of those physicians are what we call active engages with it they engage with us across multiple platforms multiple times in the field has those that information as well to follow up on what I would call sort of our warm leads in that case.

Jason Nicholas Butler: Thanks, Jason. Thanks for the question. And it's nice to meet you.

unknown: In terms of the product's positioning, and what I've seen so far, the powerful efficacy data with the differentiation on the side effect profile is really responding very, very well. As we talked about in terms of where we want to move to in the future, you've heard a couple of those strategic choices being, Now is the right time to engage with integrated health systems and the GPOs, as well as a pivot to the burn centers and the burn patients.

I don't know Pat if you want to add anything else to that.

Bob just a little color commentary on that.

Been out in the field for the last five weeks, probably have called on more than 15 accounts and so on.

Okay.

There are probably more than.

Those two are at least 100 customer visit.

Visits across those five weeks and I am seeing early signs of things opening back up appointments being made and programs being held both live and virtually.

With very good attendance and so while you're absolutely right.

They have been the COVID-19 headwinds.

unknown: And what we truly believe, because so many of our surgeons and anesthesiologists have said to move to the BURN profile because of the fact that we've assessed this opportunity from both a medical and a commercial perspective and it fits the product profile really perfectly, and we see BURN as really the experts in terms of pain management, and with about 140 BURN centers across the United States, we can really efficiently and effectively target these new set of So that's where we are at, and that's where we're headed, Jason. Great, and then I just had a couple for Mark.

I think anecdotally anyway things are really starting to turn a corner.

Awesome and the NFL.

Yeah, Bob I'd be happy to answer that this is a this is marc the MSL team.

Chris is composed of a fairly rich collection of.

Individuals with Palm D background, we're pretty deep experience of the PMT process. So the two major.

Goals that we have in deployment of the MSL team is first and foremost to assist in the in.

And the conversations with the formulary committees, particularly around the health economic model, which has generated a considerable amount of interest and in our discussions. So they did the early success. We had with the initial group of five has led us to be expansion and of <unk>.

unknown: Just on the cognitive study, is this something where you think, ultimately, you could get data reflected in the product label? Are you also looking at cognition in, for example, the Cleveland Clinic study? And then just how did you think about, you know, designing the endpoints for this new study? And then, just lastly, on 045, has there been any dialogue with FDA since the initial IND was not approved? And then I guess what gives you confidence now that the resubmission will be approved?

The other aspect with a larger MSL team it gives us that much greater ability to engage in scientific dialogue.

With the clinicians so on both of those fronts those are.

Ways that our MSL team is utilized and field interactions.

Do you want to add anything to that.

No I think that covers it well mark thanks.

Awesome. Thank you so much.

Thank you and I'm showing no other questions in the queue I'd like to turn the call back to Mr. Barry Chen for closing remarks.

unknown: Thanks. Great, Jason. Thanks for the questions. Let me start with the last one first. So, in terms of correspondence, we did have, as we talked about before, verbal communication from FDA, and then a follow-up letter specifying the specific aspects of the Phase I study design that they wanted us to address. We've done that.

Great. Thanks, operator thanks.

Thanks for the questions and let me also add my thanks to Dr Rider for joining us this morning.

Today, you've heard about the progress, we're making with Olympic and a robust pipeline. We are pleased to have Patty on board as you look ahead to the next phase of the Olympic lunch.

We're initiating an exciting study to evaluate its impact on cognitive function and we have two studies already underway to further characterize the profile.

In addition, we continued to advance our novel pipeline assets with multiple catalysts on the horizon for 2022.

Mark A. Demitrack: We've refiled the IND, and so we believe we're on track, if all goes well, to be in the clinic with 045 at the beginning of the year. Unknown Speaker In regard to your other questions around the cognitive study, and please remind me when I get to the end if I've touched on all the points that you raised. But as you heard in Dr. Ryder's comments, and as we've talked about before, we've heard anecdotally on differences in the profile of cognition in patients who are treated with a limbic, a level of alertness that is distinctive in the clinician.

We remain focused on delivering long term value for our shareholders and look forward to updating you as we continue to make progress on all fronts.

Thank you for your time and continued interest in Trevino that concludes today's call.

This concludes today's conference call. Thank you for participating you may now disconnect.

Yes.

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Okay.

Yeah.

Yes.

Yes.

[music].

Mark A. Demitrack: Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Patricia Drake, Unknown Attendee, Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Patricia Drake, Unknown Attendee, Barry Shin, Trevena Inc. It certainly provides us with information that we could then begin a discussion with FDA. How we get to the point beyond that of information that might be necessary to enlarge the label in any way would be a matter for future discussion.

Mark A. Demitrack: I think that covered most of what you had asked. Yeah, I guess just a real quick follow up. Any thought here on, you know, would there potentially be or is the thought process that there could be a cost benefit as well, if you have a less negative effect on or no negative effect on cognition, you can get the patient out of the hospital faster? Is that it? A good way to think about it is

Mark A. Demitrack: Dr. Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host of the Goldstein on Gelt radio show, to our health economic model, the other two being vomiting and respiratory depression. And you're absolutely right. Improvements in cognitive function, whether reflected in sedation or alertness, have a great impact on the patient's ability to cooperate and participate in their own recuperation, which generally has a measurable impact on things like length of stay and time.

unknown: Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Patricia Drake, Unknown Attendee, Okay, great. Thanks. Thanks for taking questions.

Operator: Thank you. The next question comes from

Operator: From Jeff Jones with Oppenheimer, your line is open. Great.

Jeff Jones: Thanks for taking the question, guys. Just two quick follow-up questions. Can you give us a feel for the number of P&T committees that are scheduled to review Olympic through the end of the year and where your rate of approval stands in terms of P&T committees at this point?

Jeff Jones: And then just one quick follow-up on the cognitive function study. If I heard right, this is head-to-head versus IV morphine. Can you give us a feel for what the end looks like in that number, how many patients are involved? Thank you. Jeff. Hi, it's Carrie. Unfortunately, you can hear I've lost my voice.

Kari: Thankfully, that call was recorded, so let me ask Mark to take the first cognitive function question, and then Bob will take the P&T question.

Mark A. Demitrack: Thanks, Jeff. This is Mark. So the cognitive function study, you're right, will be a head to head comparison. There will be a range of doses of the limbic system, a range of doses of IV morphine, in a double blind, placebo-controlled crossover design. We expect somewhere in the order of about 25 or so subjects to be participating.

Mark A. Demitrack: Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Patricia Drake, Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Bob? Yeah, thanks, Mark. Hi, Jeff.

Bob: Thanks. Thanks for the question. So regarding the formulary review process, you know, we track every step along the way of that process to go from submission all the way through a P&T review. And as of right now, we've got over 125 institutions that are in various stages of that process. More specifically, there are over 40 that are, you know, further along that process, either in subcommittee review or awaiting scheduling for the P&T meeting.

[music].

Bob: So, that's sort of the status of where we're at with the review. As far as rate of approval, it sort of goes back to what Patty described about what she's seeing in terms of the profile. I'd say we have a pretty, pretty good hit rate on the approvals once we get to that process. It's just that we're seeing a lot of COVID headwinds pushing back P&Ts. We've seen some meetings being delayed and pushed back and rescheduled. But, I am happy with the approvals that we're seeing as a hit rate.

Operator: Thank you. And we have a question from Doug Tsao on HC Wainwright. Your line is open.

Operator: Hey everyone, Chris Bialis here on behalf of Doug. Just a couple quick ones. So, what is your current physician interaction rate as to how many physicians can you see versus digital interaction? And then I was wondering if you could kind of give us a little more color on how you plan to leverage your expanded MSL team. Thank you.

unknown: Unknown Attendee Yeah, I agree. Go ahead, Bob, please.

Bob: Sorry, yeah, I was just going to say, Chris, to answer your first question. So, obviously, COVID has an impact on physical access. But what I'm happy to see is that of our engagements with customers, a little over 70% plus now are live engagements. And that's obviously the goal to get to, obviously, as many live as we can.

Bob: And I will say, you mentioned the digital program. We're really happy with how the digital program is performing. We're basically above many of the industry benchmarks in terms of the engagement metrics that you watch, things like open rates, click-through rates, and, you know, engagement with our various digital platforms. And we understand which of those people are what we call active engagers, where they engage with us across multiple platforms multiple times. And the field has that information as well to follow up on what I would call sort of our warm leads in that case. There's no pad if you wanted to add anything else to that.

Patricia M. Drake: You know, Bob, just a little color commentary in that I've been out in the field for the last five weeks, probably called on more than 15 accounts and spoken with and observed probably more than close to at least 100 customer visits across those five weeks. And I am seeing early signs of things opening back up, appointments being made, and programs being held both live and virtually with very good attendance. And so while you're absolutely right, Bob, there have been COVID headwinds, I think, anecdotally anyway, things are really starting to turn a corner.

Mark A. Demitrack: And the MSL. Yeah, Bob, I'd be happy to answer that. This is this is Mark.

[music].

Mark A. Demitrack: The MSL team, Chris, is composed of a fairly rich collection of individuals with a Form V background and pretty deep experience of the P&T process. So the two major goals that we have in the deployment of the MSL team are first and foremost to assist in the conversations with the formulary committees, particularly around the health economic model, which has generated a considerable amount of interest in our discussions. So the early success we had with the initial group of five has led us to this expansion.

Mark A. Demitrack: And of course, the other aspect of having a larger MSL team is that it gives us that much greater ability to engage in scientific dialogue with the clinicians. So on both of those fronts, those are ways that our MSL team is utilized in field interaction. Bob, do you want to add anything to that? No, I think that covers it well, Mark.

unknown: Thanks. It's awesome. Thank you so much.

Operator: Thank you, and I'm showing no other questions in the queue. I'd like to turn the call back to Mr. Barry Shin for closing remarks.

Barry Shin: Great. Thanks, operator. Thanks for your questions.

Barry Shin: And let me also add my thanks to Dr. Ryder for joining us this morning. Today, you heard about the progress we're making with Olinvik and our robust pipeline. I'm pleased to have Patty on board as we look ahead to the next phase of the Olympic launch. We're initiating an exciting study to evaluate its impact on cognitive function. And we have two studies already underway to further characterize this profile. In addition, we continue to advance our novel pipeline assets with multiple catalysts on the horizon for 2022.

Barry Shin: You remain focused on delivering long-term value for our shareholders and we look forward to updating you as we continue to make progress on all fronts. Thank you for your time and continued interest in Trevena. That concludes today's call.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. BF-WATCH TV 2021

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Okay.