Q3 2021 Trevi Therapeutics Inc Earnings Call
Good afternoon, and welcome to the Chubby Therapeutics third quarter 2021 earnings Conference call.
Operator: Good afternoon, and welcome to the Chubby Therapeutics third quarter 2021 earnings conference call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Starkey followed by Zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Star plus one on your Touchtone phone. To withdraw your question, please press Starvin 2.
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You asked the question in My Press Star then one on your phone.
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Operator: Please note, this event may be recorded. Various remarks management makes during this call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent quarterly report on Form PEMQ, which the company filed with the SEC this afternoon.
Various remarks management makes during this call about the company's future expectations plans and prospects constitute forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act.
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Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent quarterly report on Form 10-Q, which the company filed with the SEC. This afternoon.
In addition, any forward looking statements represent the company's views only as of today.
Operator: In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its views change. Participating on today's call from Trumpy Therapeutics are Jennifer Good, president and CEO, Bill Forbes, Chief Development Officer, and Lisa Delphini, Chief Financial Officer.
Should not be relied upon as representing the company's views as of any subsequent date.
While the company may elect to update these forward looking statements at some point in the future. The company specifically disclaims any obligation to do so even if its views change.
Participating on today's call from shopping Therapeutics are Jennifer good President and CEO, Bill Forbes Chief Development Officer at.
At least to Delphine, Chief Financial Officer, I would now like to turn the conference over to Jennifer. Please go ahead.
Operator: I would not like to turn the conference over to Jennifer. Please go ahead. Good afternoon, and welcome to our third quarter 2021 earnings call and business update. As mentioned, joining me today on this call is Lisa Delphi.
Good afternoon, and welcome to our third quarter 2021 earnings call and business update as mentioned joining me today on the call are Lisa Delphine our CFO.
Jennifer L. Good: Good afternoon, and welcome to our third quarter 2021 earnings call and business update. As mentioned, joining me today on this call are Lisa Delphini, our CFO, and Bill Forbes, our chief development officer. Lisa and I have some prepared remarks, and then the three of us will be available for questions at the end.
Our Chief Development Officer, Nathan I have some prepared remarks, and the three of us will be available for questions at the end.
Jennifer L. Good: As we head into the end of the year, we are excited to share the progress we've made on enrollment for both of our trials. I will give you a bit more color on the progress and how we're preparing for the next stages in development. Our most advanced program in clinical development is for severe chronic paritis in parigo nodularis or PN, which is a serious and debilitating disease characterized by papuels and nodules on the skin, as well as incessant and severe itching. There are no approved therapies for this indication. Paragonodularis is a chronic neuroinflammatory disease, and because of the repeated scratching, patients are stuck in a hard-to-break-it scratch cycle.
As we head into the end of the year. We are excited to share the progress we've made on enrollment for both of our trial I will give you a bit more color on the progress and how we're preparing for the next stages in development.
Our most advanced program in clinical development is in severe chronic pruritus in Prurigo, Nigel Arris, RPM, which is a serious and debilitating disease characterized by capsules and I'll dwell upon the skin as well as incessant and severe itching.
No approved therapies for this indication.
Oh, not declared as a chronic neuro inflammatory disease and because of the repeated scratching patients are stuck in a hard to break it scrap cycle due to the scratching the patio doors continued to develop and worse than across the patient's body.
Jennifer L. Good: Due to the scratching, the papules and nodules continue to develop and worsen across the patient's body. We estimate the global prevalence of PN is approximately 730,000 patients, with 300,000 patients in the U.S. and 430,000 in the rest of the world. We believe in the potential and utility of our mechanism of action in this indication, along with the benefit of being an oral candidate in late phase development. This positions us with an important competitive advantage and a potentially valuable option for patients in a space where the majority of compounds in development are biological.
We estimate the global prevalence of Pn is approximately 730000 patients with 300000 patients in the U S and 430000 in the rest of the world.
We believe in the potential utility of our mechanism of action in this indication along with the benefit of being an oral candidate in late phase development. This positions us with an important competitive advantage and a potentially valuable option for patients in a space, where the majority of compounds in development are biologics.
We are currently conducting a phase two be slashed III trial in this condition, which we call. Our prism trial. The present trial is recruiting in both the U S and Europe and to date, we have more than 60 sites activated the primary endpoint. In this study is a responder analysis defined as a four point reduction from baseline.
Jennifer L. Good: We are currently conducting a phase 2B slash three trial in this condition, which we call our PRISM trial. The Prism trial is recruiting in both the U.S. and Europe, and to date, we have more than 60 sites activated.
Jennifer L. Good: The primary endpoint in the study is a responder analysis defined as a four-point reduction from baseline, as measured by the worst-itch numerical rating scale. The blinded study includes 14 weeks of treatment. We currently have randomized approximately 90% of the planned 360 subjects and are excited to be getting to the end of enrollment and closer to top-line data. The percentage of subjects continuing into the open-label extension remains high at also approximately 90%.
As measured by the worst itch numerical rating scale. The blinded study includes 14 weeks of dosing.
Currently had randomized approximately 90% of the planned 360 subjects and are excited to be getting to the end of enrolment and closer to the top line data the percentage of subjects continuing into the open label extension remains high at also approximately 90%.
Jennifer L. Good: This will provide not only long-term safety data but also important efficacy data around skin healing and quality of life for these subjects. We believe that by treating the symptomatic endpoint of reducing itch, an effective therapy has the potential to disrupt the itch scrape cycle, leading to skin healing and resulting in disease modifications over time. We are taking photographs at certain sites in the study and continue to hear good success anecdotes from patients on long-term therapy who we know are on the drug in our extended open label study.
This will provide not only long term safety data, but also important efficacy data around skin healing and quality of life for these subjects, we believe that by treating the symptomatic endpoint everyday thing it that an effective therapy has the potential to disrupt the etch scrap cycle, leading to skin healing and resulting in disease modifications.
Over time, we are taking photographs at certain sites in this study and continue to hear good success anecdotes from patients on long term therapy, who we know are on dragging our open label extension. There is also an investigator initiated study in Germany, which is tracking the return of itch for subjects, who have completed one year of therapy.
Jennifer L. Good: There is also an investigator-initiated study in Germany, which is tracking the return of itch for subjects who have completed one year of therapy on Hadovio. The investigators are studying subjects for a year once they complete therapy for the return of itch, the use of concomitant meds, and the overall health of the skin. This will provide valuable data for clinicians about the disruption of the itch scrap cycle, lesional healing, and how long those benefits last.
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Instigators are studying subjects for a year once they complete therapy for the return of it they use of concomitant meds and the overall health of the skin. This will provide valuable data for clinicians about the disruption of the scrap cycle regional healing and how long those benefits laughed.
Turning now to our second clinical program, which is in chronic cough and idiopathic pulmonary fibrosis or IPF IPF is a progressive and severe condition in which the scarring of the lung tissues.
Jennifer L. Good: Turning now to our second clinical program, which is chronic cough in idiopathic pulmonary fibrosis or IPF. IPF is a progressive and severe condition in which there is scarring of the lung tissues. One of the leading debilitating symptoms of this disease is chronic coughing, which affects up to 70 to 85% of these patients and for which there are no approved therapies.
One of the leading debilitating symptoms of this disease is chronic coughing, which affects up to 70% to 85% of these patients and for which there are no approved therapies in the U S. We estimate that there are approximately 130000 patients with IPF and an equal amount in Europe due to the high five year mortality.
Jennifer L. Good: In the U.S., we estimate that there are approximately 130,000 patients with IPF and an equal amount in Europe. Due to the high five-year mortality associated with IPF, both are markets we will consider for further clinical development with positive data in IPF cough. We are conducting a phase two double-blind crossover study with a 14-day washout period between each three-week treatment arm. The primary endpoint assessment is the mean percent change in daytime cost frequency from baseline.
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Our markets, we will consider for further clinical development with positive data in IPF cough.
We are conducting a phase two double blind crossover study with a 14 day washout period between each three week treatment arm. The primary endpoint assessment is the mean percent change in daytime cough frequency from baseline.
Jennifer L. Good: The daytime cost frequency is measured by a digital cost monitor between the treatment and placebo arms. This trial is currently being conducted in the UK, and because of the lung impairment associated with this disease, this trial has been more significantly impacted by COVID-19 restrictions than our PM study. However, the restrictions were eased over the summer and continued that way.
The daytime cough frequency as measured by a digital cough monitor between the treatment and placebo arms.
This trial is currently being conducted in the U K and because of the lung impairment associated with this disease. This trial has been more significantly impacted by COVID-19 restrictions then our Pn study.
However, the restrictions were eased over the summer and continue that way.
This study is designed to enroll approximately 60 subjects with a goal of getting 44 completer.
Jennifer L. Good: This study is designed to enroll approximately 60 subjects with a goal of getting 44 completers. We have reopened 10 of our targeted 15 sites in the UK, and we are pleased to see those sites screening and enrolling subjects. We have seen steady activity, which has continued into November. We will continue to work closely with our remaining qualified sites in the UK to get them up and enrolling as well.
We have reopened 10 of our targeted 15 sites in the U K and we are pleased to see those sites screening and enrolling subjects. We have seen steady activity, which has continued into November we will continue to work closely with our remaining qualified sites in the U K to get them up and enrolling as well topline data.
Jennifer L. Good: Topline data for this study is expected in the first half of next year. We are coming upon a very important period of clinical data for the company. Over the next few months, we believe we will complete enrollment in both the PN and IPF COF TRIALs and report data on both. These indications are large market opportunities, and the potential for indication expansion in both Pyritis and chronic COPS is significant.
This study is expected in the first half of next year.
We're coming upon a very important period of clinical data for the company over the next few months. We believe we will complete enrollment in both the piano and IPF cough trials and report data on bolt.
Indications are large market opportunities and the potential for indication expansion and bolt pruritus and chronic cough is significant.
In addition to the focus on completing our trials. The team has also been active preparing for the next stage of development for both of these indications as well as evaluating other potential indications for future development. We are also actively publishing our data and participating in conferences in the past few months, we took part in pulp.
Jennifer L. Good: In addition to the focus on completing our trials, the team has also been active preparing for the next stage of development for both of these indications, as well as evaluating other potential indications for future development. We are also actively publishing our data and participating in conferences. In the past few months, we took part in Pulmonary Fibrosis Awareness Month in September, alongside action for pulmonary fibrosis.
Fibrosis awareness month during September alongside accident for pulmonary fibrosis. We also attended call clinical on Las Vegas, the 11th World Congress on edge, which took place virtually and bill spoke at a panel discussion and we were active in the bio Europe conference. So it has been a busy time at <unk>.
Jennifer L. Good: We also attended fall clinical in Las Vegas, the 11th World Congress on Itch, which took place virtually, and Bill spoke at a panel discussion, and we were active at the Bio Europe conference. So that's all I have on the business update for the quarter. I will now ask Lisa to review our financial results, and then we will open it up for questions.
That's all I have on the business update for the quarter I will now ask Lisa to review our financial results and then we will open it up for questions. Lisa. Thank you Jennifer and good afternoon, everyone. As a reminder, the full financial results for the three and nine months ended September 30th 'twenty 'twenty. One can be found in our press release issued ahead of this call and our 10-Q.
Lisa Delfini: Thank you, Jennifer, and good afternoon, everyone. As a reminder, the full financial results for the three and nine months ended September 30th, 2021, can be found in our press release issued ahead of this call and our 10Q, which was filed with the SEC today after the market closed. For the third quarter of 2021, we reported a net loss of 7.3 million compared to a net loss of 7.4 million for the same quarter of 2020.
Which was filed with the SEC today after the market closed.
For the third quarter of 2021, we reported a net loss of $7 3 million compared to a net loss of $7 4 million for the same quarter of 2020.
R&D expenses were $4 7 million during the third quarter of 2021 compared to $4 8 million in the same period of 2020. This was primarily due to decreased purchases of clinical trial supplies as we near the end of our trial, partially offset by an increase in personnel related expenses as a result of an increase in our R&D employee head count.
Lisa Delfini: R&D expenses were $4.7 million during the third quarter of 2021 compared to $4.8 million in the same period of 2020. This was primarily due to decreased purchases of clinical trial supplies as we near the end of our trials, partially offset by an increase in personnel-related expenses as a result of an increase in our R&D employee headquarters. G&A expenses were 2.2 million during the third quarter of 2021 compared to 2.4 million in the same period of 2020.
G&A expenses were $2 2 million during the third quarter of 2021 compared to $2 4 million in the same period of 2020. This was primarily due to decreased market research costs and lower stock based compensation expense, partially offset by higher legal and other professional fees.
Lisa Delfini: This was primarily due to decreased market research costs and lower stock-based compensation expense, partially offset by higher legal and other professional fees. Other expenses also increased by approximately 161,000, representing a full quarter of interest expense on our term loan with SBB, which was executed in August of 2020. As of September 30th, 2021, our cash and cash equivalents totaled 29.3 million compared to 45 million as of December 31st, 2020. Subsequent to the end of the quarter, we raised $14.8 million through the sale of common stock and warrants to both a new investor and NEA, an existing investor who also chose to participate. The proceeds will be used to fund the development of Hidubio and company operations. This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A.
Other expenses also increased by approximately 161000, representing a full quarter of interest expense on our term loan with SBB, which was executed in August of 2020.
As of September 30th 2021, our cash and cash equivalents totaled $29 3 million compared to 45 million as of December 31, 2020 subsequent to the end of the quarter, we raised $14 8 million through the sale of common stock and warrants to both a new investor and NEA and existing Investor who also.
Jos to participate the proceeds will be used to fund the development of <unk> and company operations.
This concludes our prepared remarks, I will now turn the call back over to the operator for Q&A.
Thank you we will now.
Operator: Thank you. We will now begin the question and answer session. To ask a question, you may press Starvin 1 on your Touchtone phone. If you are using a speakerphone, we ask that you please hold your handset before pressing the key. To listen to your question, please press Starlin 2. Today's first question comes from Annabal Samimi on Stiefel. Please go ahead.
Give him a question around your assertion to ask of course Union ROFO Starwood warm you touched on phones.
Using a speaker phone we ask you. Please forgive me for having a whole person with Qs.
George a question please press star one to today.
Today's first question on coastal honorable Subaru with Stifel. Please go ahead.
Good afternoon, everyone.
Nick Rubino: Good afternoon, everyone. This is Nick Rubino on behalf of Annabel. Thanks for taking our questions. We're just trying to get a sense of expectations for the upcoming Prism Readout.
On for Annabel, Thanks for taking our questions.
We're just trying to get a sense of expectations for the upcoming prism readout.
Nick Rubino: So you've made several adjustments to hopefully improve the prism design from phase two. Does it benchmark the phase two results where you saw a 15% delta in the MITT and 30% delta in the completer groups? Or do you have improved expectations for the percent of responders with a four-point reduction?
So you've made some adjustments to hopefully improve the prism design for phase two.
So as the benchmark.
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15% Delta.
And 30.
<unk>, 30% Delta in the Completer groups, where do you have improved expectations for the percent of responders for the four point reduction.
Nick Rubino: And then, just kind of separately, where does LID sit currently?
And then just kind of separately.
It does.
Currently.
Thank you.
So I'll, let you take on the Prism answer and then I'll comment on L. I D.
Jennifer L. Good: So I'll let you take on the prism answer, and then I'll comment on LID.
Okay, Hi, Nick This is bill thanks for your questions.
Bill Forbes: Okay, hi Nick, this is Bill. Thanks for your questions. So we obviously did an interim analysis, but that was done by an independent statistician. So if you're talking about the sample size reestimation on prism, we don't know what those results were. Obviously, they fell into a promising conditional power zone that was spelled out in the protocol. And so from that perspective, we feel confident that as the study continued to perform the way that it was, that the current prism study, as designed and powered, should reflect positive results based on that interim analysis. So I don't know if that answers your question, Nick.
So we obviously, we did a joint interim analysis, but that was done by an independent statistician.
So if you're talking about the sample size re estimation on prism, we don't know what those results, where obviously they fell into a promising conditional power zone that was.
Was spelled out in the protocol and so from that perspective, we feel confident that the study continue to perform the way that it was that the current prism study is designed and powered should should reflect positive results based on that interim analysis. So.
So I don't know if that answers your question Nick as.
As far as is.
Nick Rubino: Yeah, that's definitely helpful. I guess in terms of, you know,
The delta between the active and placebo.
Yeah, that's definitely helpful. I guess in terms of.
Bill Forbes: Oh, you're referring to the previous study? Yep, yeah.
You've provided kind of a.
As to look at it.
Bill Forbes: Yeah, no, I mean, look, in this particular study, the previous study was just a little over 60 patients and three treatment groups. Obviously, the current study is 360 patients in two treatment groups. Obviously, we feel pretty good that we're powered to where we need to be to show a difference between active and placebo in this based on those results. So obviously, this is about execution at this point in time. I can tell you that the centers are anxious to finish. This study. I mean, they've had a very good October.
In terms of.
You are referring to the previous study.
Yeah, Yeah yeah.
Yeah, No I mean, I think look in this particular study that previous study was just a little over 60 patients in three treatment groups. Obviously, the current studies 360 patients in two treatment groups.
Obviously, we feel pretty good that would power to where we need to be to show a difference between active and placebo on this based on those results. So on the previous study. So obviously this is about execution at this point in time I can tell you that the centers are.
Anxious to finish that study I mean, they've had a very good October the screenings in November had been very good.
Bill Forbes: The screenings in November have been very good, so we hope that we can continue to drive this and get to the, you know, the analysis part of this study. Obviously, it's the 14 week double blind period, so that's why we say, and we're aiming towards reading out results sometime in the first half of next year.
So we hope that we can continue to drive this and get to the <unk>.
Alex as part of this of this study obviously its a 14 week double blind period. So that's why we say we're guiding towards reaching out results sometime in the first half of next year.
Great.
Jennifer L. Good: Nick, that was a crystal ball question. We all ask Bill every week, but unfortunately, he doesn't know, but I'm glad you asked it.
That was a crystal ball question, we all ask Bill every week.
He doesn't know, but I'm glad you asked it your question on L. I D. It's it's an indication we still continue to be quite interested in we've got the IP rights around that and what I would say as we've as we've communicated we're going to we're focused on these two indications depend.
Jennifer L. Good: Your question on LID is an indication of what we still continue to be quite interested in. We've got the IP rights around that. What I would say is we've, as we've communicated, we're going to, we're focused on these two indications. Depending on the data and both, we've looked at other opportunities to expand within paritis and cough and also sort of the opportunity at LID. And I think there will be a good sort of sort of.
Depending on the data involved we've looked at other opportunities to expand within price and cost and also sort of the opportunity our idea and I think there'll be a good sort of strategy decision based on final results from both trials, where we had an accident and sort of what we can absorb and afford so I would say, it's still on the table, but it'll be evaluated against other opportunities in the.
Jennifer L. Good: Strategy decision based on the final results from both trials as to where we head next and sort of what we can absorb and afford. So I would say it's still on the table, but it'll be evaluated against other opportunities in the parietas and cough space as well.
Price and cost base as well.
Great Yeah that makes a lot of sense. Thank you yep. Thank you Nick.
Nick Rubino: Great, yeah, that makes a lot of sense. Thank you.
Operator: Yeah, good. Thank you, Nick. See you guys next week.
Guys next week.
Well, Oh blah blah blah.
Operator: And ladies and gentlemen, as a reminder, if you'd like to ask a question, please press Star Than One. Our next question comes from Rohit Basin with Needham and Company. Please go ahead.
Can I ask a question. Please press Star then one or.
Our next question comes from Rohit machine, where we were one company. Please go ahead.
Hi, This is Robert on for Serge Thanks for taking my question.
Rohodon: Hi, this is Rohodon for Surge. Thanks for taking my question. What are your thoughts on the recent Depixent phase three results in PN, and where do you see that product fitting in the treatment paradigm for PN?
What are your thoughts on the recent depicts the phase III results in Pn, and where do you see that product sitting in the treatment paradigm for peers.
Yeah. It's a good question. So we looked at the results I generally try to not comment on others. I think the good news is it's a tough condition. They had statistical significance, which is obviously good for the patient I mean, everybody knows do pick them a good drug they've done great with that you know the results weren't so daunting, though that.
Jennifer L. Good: Yeah, it's a good question. So we looked at the results. I generally try not to comment on others.
Jennifer L. Good: I think the good news is it's a tough condition. They had statistical significance, which is obviously good for the patient. I mean, everybody knows Pixons is a good drug. They've done great with it. You know, the results weren't so daunting, though, that I think that they're beatable, if you will.
I think that there they're beatable if you will so I think that is a good opportunity for us. This is a market that has become pretty biologics and trench. So my own feeling on it. This is a personal opinion I was glad the drug works, but I was glad it was not overwhelming result, either because I think that puts us in a really good position as an oral therapy.
Jennifer L. Good: So I think that is a good opportunity for us. This is a market that's become pretty biologics and trenchant. So it might be my very own feeling on it. This is a personal opinion. I was glad the drug worked, but I was glad it was not overwhelming results either, because I think that puts us in a really good position as an oral therapy to be in that treatment paradigm. So we obviously have our eye on the ball about how we become step-through therapy to biologics, but, you know, it'll depend on our own results and our own label to be able to do that.
To being that treatment paradigm. So we obviously have our eye on the ball about how we become step through therapy to the biologics them, but you know it will depend on our own results and are on label to be able to do that.
Great. Thanks, and just as a follow up.
Rohodon: Great, thanks. And just as a follow-up, was the enrollment in the prison trial affected at all by the depiction trial at all? You know, not so much by PICS.
Enrollment in the <unk>.
Pete Prism trial affected at all by a grid control at all.
Jennifer L. Good: You know, not so much DuPixen because they had a lot of sites in different countries, China, Russia, kind of around Europe. We crossed with them at a couple of sites. So I would not say we were so affected by DuPixen. I think they'd finished enrollment in their second trial, so they're out of the way. But we did not run into them all that much out in the field.
You know not so much to pick them because they had a lot of sites in different countries, China, Russia kind of around Europe, we crisscrossed with them in a couple sites. So I would not say we were so effective baidu picks there and I think they finish they finished enrollment in our second trial, so they're out of the way that.
But we did not run into them all that much in the out in the field.
Great. Thank you mhm.
Operator: And ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to Jennifer Goodfrey, and see you tomorrow.
Ladies and gentlemen, this concludes our question and answer session I'd like to turn the calls as well go over to Jennifer good for any closing remarks.
We would like to thank everybody for participating in today's call I'd also like to thank the <unk> team our study investigators and all of the subjects, who continue to participate in our clinical trials, we will be at several conferences over the next three months starting with the Stifel Healthcare Conference next week, we hope to see you there. Thank you.
Jennifer L. Good: We would like to thank everybody for participating in today's call. I'd also like to thank the Trevi team, our study investigators, and all the subjects who continue to participate in our clinical trials. We will be at several conferences over the next three months, starting with the Steeful Healthcare Conference next week. We hope to see you there. Thank you.
Operator: And thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may disconnect your lines and have a wonderful day.
This concludes today's conference call. We thank you all for attending today's presentation. You may disconnect your lines and have a wonderful day.