Q4 2022 Trevi Therapeutics Inc Earnings Call
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Yes.
Good afternoon, and welcome to the Chubby Therapeutics Q4, and year end 2022 earnings conference call.
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Various remarks that management makes during this conference 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 annual report on Form 10-K, which the company filed with the SEC. This afternoon.
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As of any subsequent date.
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I would now like to turn the conference call over to Jennifer Good tribute President and CEO . Please go ahead.
Good afternoon, and thank you for joining our fourth quarter and year end earnings call and business update joining me today on this call or at least adult Feeney, Travis Chief Financial Officer, and Dr. David Clark Travis Chief Medical Officer, Lisa and I have some prepared remarks, then the three of us will be available for questions.
2022 with a transformational year for Travis with regard to validating the broad utility of the mechanism of our drug to Duval with our trials in IPF cough and prego Nigel Arris, both reading out positive it left us in a strong position to decide how best to grow the company first stakeholders based on the strength.
[noise] of the Comdata in Ips as well as the lack of competition in that space. We feel we can carve out a strong and unique position in therapy for IPF. We also believe that because of the differentiated central and peripheral mechanism of our drug we have the potential to provide therapy across a range of chronic cough indications regardless of what the.
Your line diseases.
So with those decisions made and strong capital raising in 2022, we are now buckled in and focused on executing against our plans for the next stage of development let.
Let me now provide an update on each of our programs starting with our lead program in chronic cough and IPF I tee up as a serious end of life disease and chronic cough is a major cause of morbidity significantly impacting the patient's quality of life. It is estimated that up to 85% of IPF patients are suffering from <unk>.
Chronic coughing as.
As we prepare for our next trials in this indication there are many learnings we can take from the development work occurring in refractory chronic cough. However, there are also unique aspects of the IPF patient population related not only to a potential effect on the underlying disease, but safety in this frail patient population that we offer.
I need to keep in mind.
We are planning to conduct two studies in parallel during this next phase of development and our IPF chronic cough program. The first is a phase two b dose ranging trial that will study three doses. The doses. We are planning to study our 27 54, and 108 milligram B I D based on the data.
From the phase two study we have dropped the highest dose as it appears the efficacy occurred very early in that trial and at the lower doses.
Because of the severity of illness and these patients it will be important to understand the minimally effective dose.
We are planning for approximately 50 subjects per arm for a total and in the study of 200 and dosing for approximately six weeks. We are planning on conducting the study and multiple countries to be able to complete enrollment in a timely manner.
We will give better guidance on enrollment timelines once we initiate the study in parallel we are planning for a phase one b respiratory physiology study.
You May now all opioids have a class label Black box warning regarding respiratory depression. This is not something we have seen in our safety data across our various studies to date that because of the lung impairment and IPF patients. We feel this is an important question to study early.
We plan to run an inpatient study in IPF patients with levels of varying disease severity and increasing doses of <unk> to determine if we see a clinically significant impact on respiratory depression.
These two studies will help to find the optimal dose or doses and the patient population in our pivotal program.
We have submitted the respiratory physiology protocol to the FDA and are awaiting their feedback. We are also preparing for submissions in the U K and Europe to support. These trials there is a new regulatory process in the EU called C. T. I S, which became mandatory as of January 31, 2023 under the new <unk>.
Process, the health authority and the ethics committees perform their reviews in parallel as a result, there's more information required upfront to make the submission in theory. This new process will streamline the review process, although theres little data to show how the implementation is going and companies expect there will be growing pains.
So we will keep you informed of our expected timelines, but I wanted to make you aware there is a new process in play which makes timelines difficult test to me.
In parallel our clinical operations team is preparing for these studies. So that we can initiate once we have regulatory agreement on the protocol in an open I M D.
We expect to initiate both of these IPF studies in the second half of 2023, and we will provide guidance on the overall final design as well as the estimated timing for the trial once we begin the studies.
In addition to the preparations in IPF cost. We are also developing a protocol for a phase two refractory chronic cough study that study will look a lot like the canal trial and will seek to establish proof of concept in refractory chronic cough. There have been a lot of trials in this condition with only one mechanism which has been.
Successful the P. Two X rays, Pedro x-rays work preferably in the lung. However, we believe there is still a significant opportunity for a mechanism that works both centrally in the brain and preferably in the lungs and has the potential to provide strong and consistent efficacy and a broader set of RCC patients.
Our cough data generated to date has continued to garner a lot of attention globally and has been presented at various respiratory meetings by Kols and Pulmonology during the fourth quarter Doctor Philip Mollinedo presented data at the British Thoracic Society meeting we have also finalized a manuscript on the.
Trial results and will be submitting it for publication shortly.
On March 29th there will be another presentation at the annual German Pulmonology meeting.
On Monday May 22nd and Washington D. C. Additional results from canal will be presented at the American Thoracic Society meeting and on June 9th to attempt in Reston, Virginia at the American Cop Conference there will be a presentation on our central and peripheral mechanism of action and why it is unique and could be <unk>.
[noise] broadly and cough.
I think it is important to note that almost all of our conference submissions have been chosen for oral presentations.
Think that speaks to the medical community's interest in our program and the importance of the unmet medical need we are trying to address.
The other program, where we have ongoing work is for the treatment of prego, Nigel Arris, RPM, which is a serious and debilitating disease characterized by papules and naturals on the skin as well as an assessment and severe itching.
In June of last year, we also reported positive data in the phase two b slash III prism trial in P. N. The trial achieved statistical significance on the primary and all key secondary endpoints during the first quarter of 2023, we completed the one year open label extension study that was associated with prism we.
Should receive the data from that study in the second quarter and will prepare for an end of phase two meeting with the FDA, which we expect to have this year.
Finally, we also commenced the human abuse liability study in the fourth quarter of last year. The objective of this study is to compare the abuse potential of oral now bluefin two butorphanol.
The injectable version of now Bufete is currently on schedule, but in the U S by the drug enforcement agency or D. A.
And all of the scheduled for drug. This study is a randomized double blind active and placebo controlled five way crossover design. This.
Study is conducted in two parts with the first part characterizing various butorphanol doses one of your dwarfing all dose will be selected to be studied in the second part of the protocol to determine the abuse potential of oral now do you feel relative to the selected dose of Butorphanol. The company is currently completing.
Part one of this study and expect top line data from the complete trial by the end of 2020 three.
It is a busy time at trevi working to initiate or conduct four separate studies and completing the open label extension in P. M. This is a critical part of the process to get right and David and his team are making good progress against each of these we will announce the start of each study with more details as we initiate each one.
As I look back on 2022, I'm extremely proud of the execution by our team and the positive trial results in both of our lead indications the trial data and subsequent financings have positioned us well to continue the development of <unk> and not only IPF chronic cough, but also others.
Serious chronic cough conditions, such as RCC and pop in interstitial lung diseases for P. And we are in discussions with potential partners to advance that program into the next stage of clinical development at the end of phase two meeting with the FDA will help determine next steps for this program I will now turn it over to Lisa to review.
Our financial results, then we will open it up for questions.
Thank you Jennifer and good afternoon, everyone.
The full financial results for the three and 12 months ended December 31, 2022 can be found in our press release issued ahead of this call and our 10-K, which was filed with the SEC today after the market closed.
I'll start with fourth quarter 2022 result for.
For the fourth quarter of 2022, we reported a net loss of $5 5 million compared to a net loss of $8 5 million for the same quarter in 2021.
This is a net loss per share for the quarter of six cents as compared to a net loss per share of <unk> 28 for the same quarter of 2021.
R&D expenses were $4 3 million during the fourth quarter of 2022 compared to $6 2 million in the same quarter of 2021.
The decrease was primarily due to decreased clinical trial costs, reflecting the completion of both the blinded portion of the prism and canal trials prior to the fourth quarter of 2022.
Partially offset by an increase in costs related to the human abuse liability study, which we initiated in the fourth quarter of 2022.
G&A expenses were $2 3 million during the fourth quarter of 2022 compared to $2 1 million in the same period of 2021. The increase was primarily due to higher legal fees associated with intellectual property filings and other professional fees.
Other income net was $1 1 million in the fourth quarter of 2022 compared to other expense net of 300000 in the same period of 2021.
The change was primarily due to an increase in interest income in 2020 two as a result of investing the funds from our capital raises completed during 2022, coupled with higher interest rates than were available in the fourth quarter of 2021.
Now turning to the full year results for the year ended December 31, 2022, we reported a net loss of $29 2 million compared to a net loss of $33 9 million for 2020 one.
Our net loss was lower in 2022 as a result of decreased R&D expenses, which were $19 8 million during the full year 2022 compared to $23 million in 2021.
This was offset by increased G&A expenses, which were $10 1 million for the full year 2022, compared to $9 5 million in 2021.
Other income net was <unk> 7 million in 2022 compared to other expense net of $1 5 million in the same period of 2021. The drivers of these changes were largely the same as the drivers I just discussed related to the fourth quarter changes.
A few comments on cash and cash runway during the fourth quarter of 2022, we received $3 1 million in gross proceeds from the underwriters option for the Green shoe related to our September offering.
These funds together with the funds we raised earlier in the year enabled us to end the year with cash cash equivalents in marketable securities of $125 million. This gives us cash runway into 2026, which includes completing the trials that Jennifer laid out today and paying off our term loan in accordance with its terms.
Finally, I want to take a moment to address recent.
That's related to S V B as many of you know last Friday, the FDIC closed S V B and appointed the FDIC as receiver we bank with SBB. However, the substantial majority of our cash cash equivalents and investments were held in custody accounts in our name at another large financial institution. So we had very limited.
Sure.
On Monday, the FDIC announced that all S. V. B deposits are protected. So this is now become largely an operational matter, which we are managing through.
This concludes our prepared remarks, I will now turn the call back over to the operator for Q&A.
Thank you we will now begin the question and answer session.
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This time, we will pause momentarily to assemble our roster.
Our first question comes from Leland commercial with Oppenheimer. Please go ahead.
Okay.
Hey, good afternoon. Thanks for taking my question wanted to ask Jenny.
Jennifer this.
Most of my questions are really dosing related questions.
As you approach the.
The abuse liability study will you be looking to harmonize the doses of <unk>.
With the dose ranging study that youre, starting up as well or will you looked at maybe.
Higher doses to see if there is any.
It could be that occurs in and similarly for the for the trial in RCC.
If you're able to share at this point and how might the doses in the RCC study look versus the doses you've looked at so far in the doses that are being tested.
And the IPF to be thank you.
Thank you Leland for the question.
David I'll take the first one on the house since I lived through that and then why don't you take the RCC dose since you're working on that protocol as we speak but we were in the process and the how we actually already ran through that to identify the dose for now.
Now, you're saying, we did that a year or two ago, where you essentially try to find a maximum tolerated dose and so we sort of pushed up and really there's a limit in the guidance that says once you get to three actually are effective dose in the market you can stop which is why we were able to get to we have not found an M. T D on they'll do fine. So the exact doses I think 480.
David might correct me, a little bit, but the that dose will be compared to the work being done on Butorphanol, which is also basically three asks what's in the marketplace. So so the doses they'll get nailed down and it'll be sort of three times, what you see in our clinical trials.
Okay.
Then David he wanted to talk about RCC, and how youre thinking about dosing.
Yeah, Yeah, and by the way you're quite right the top dose.
Used.
All studies 46, since you say Jennifer.
So, yes, we will be.
Bringing the doses together for the RCC study, which as Jennifer explains the design will be very similar to the two way crossover design.
Approximately 60 subjects.
The top dose we would plan to study there wouldn't be 100.
Milligrams due to the good signals, we see at the lower end the intermediate doses in the canal study and the IPF clinical population so.
The phase two b chronic cough IPF study also such a dose ranging study as you know, 27% and 54 in one way it would be the three selected doses versus placebo.
So yes, we are planning to do anything stupid.
Okay.
The two programs.
Oh, great. Thank you both for the added color.
Thank you Leland.
Yeah.
Our next question comes from Thomas Smith with <unk> Securities. Please go ahead.
Hi, This is natural and so on for Tom Smith.
First question is like what party getting factor to initiate a phase <unk> dose ranging study corn cost IPF, which is now expected in the second half of 'twenty three and have a full.
But I didn't catch the first part of that like what are the gating factors to getting the phase to be going is that what you asked.
Oh, Okay, I mean, basically David why don't you talk about the phase two b and sort of how we get from here to starting up since you're sort of managing that daily.
Yes, yes, I mean.
Jennifer said in the introduction, we will give precise guidance on the conduct phase for that study once we've finalized our planning studies.
Studies of the sort of size that we're talking about 200 subjects you would usually aim for about 12 months.
Jim go ahead.
The real gating factor has been a slight delay in the study start for that study, primarily driven by our global supply chain issues with packaging materials.
So we have packaging materials were substantially coming in later than we would have planned and that's probably the largest driver of the studies don't change them and then the other piece to Jennifer alluded to in terms of study trial conduct.
Precision.
Estimate would be for how long the study conduct.
The other major factor there is this new <unk> process that you both hurdles. So there is a new global U K.
The trial submission process is no longer optional this monday through this year and the expectation is that will slow down a lot of that you use.
Proceeds will be anything up to three plus months fluor for stocking EU countries because of this new process. So those are the two biggest factors.
Got it that's very helpful and maybe another one like so you guide the full data from the open label extension of accretion in.
In quarter three so what do you plan to report and what are your expectations at the theater.
Yeah, we get this question a lot and we haven't sorted that out yet I think what we want to see the data and sort of why does it show. What's there we will definitely report it at a medical meeting. Its you know got a lot of interest by the dermatology community for sure how we handle that sort of from an IR perspective, if you will we still need to sort out the best way to do that.
So I'm going to defer that once we see the data and sort out the messaging from it we'll figure out the best way to do that.
Got it and last one if I may.
Yeah sure expectation on the R&D and SG&A expenses in 2003 compared to Q2.
Ah I think R&D expenses will increase in 2023 as we conduct all of these studies that were that Jennifer referred to as opposed to 2022 and G&A lease. He asked about I think G&A will also increase slightly.
Yeah.
Perfect got it thank you so much.
Thank you.
Okay.
Okay that if you'd like to ask a question. Please press Star then one our next question comes from Sean Kim with Jones trading. Please go ahead.
Alright. Thank you for taking my questions. So I guess one question on buffets won't be risk portrays the geology study.
Can recoup a little more color on what torching renewables, you're intending to try it out for the trial.
And also how that might inform the potential first or school comes all their trials and.
Just a quick point.
Yeah, David go ahead.
Yes so.
Most likely we will go to the 162 dose that was included as the highest dose that was titrated to the canal study so that is likely to be.
Will titrate to the similar amount left to the commands study I'm sorry, what was the other component of your question about ill informed David that phase III program and what doses we use.
So these two studies really are critical coming together Super phase three what we need to know is how broad a population of the IPF patients and their comorbidities comorbidities, including Cooper, but he's he switches disorders sleep breathing, but just sleep apnea and we incur.
Food so the respiratory physiology study will really answer that question for us.
Because as we've explained in the introductory comments.
We will include them.
Subjects with increased severity on with these comorbidities that were not included in phase two to allow us to make that call for phase III.
Okay. Thank you and just one quick follow up question on the phase <unk> dose ranging studies do.
Now the controversy.
You shoot in second half 'twenty, three or what would be the expectations for a read out in terms of timing.
Yes, Sean let their first sort of giving hard guidance on that until we actually initiate it I mean, David told you and sort of his last answer that we're planning for a roughly a 12 month recruiting process, that's going to be six months dosing, our six week dosing I'm sorry, so it's not a long trial, but I thought I want to wait until we actually get it initiated and then well.
Give some at our time line guidance, but that allows you to kind of do the math in your head and think about where do you think it could come in.
Okay, great. Thank you.
Yeah and thank you for your report this week appreciate it.
Our next question comes from that.
Bobby would you only securities. Please go ahead.
Good afternoon, and thanks for taking our questions and appreciate the level of detail about the canola upside being accepted.
As you know.
If you could comment on that but also.
My understanding is that there's the fastest by a driver that is expected from our Doctor Molino.
But for marketing and post I invested in Ibs do you have any thoughts on.
Your expectation for the add on.
Any relevant safety efficacy data that could be rather than doing a deal and then I have a follow up.
Yeah sounds good my own so are our poster I don't know.
Exactly what it's about I know they've been tugging and pulling on all different looks at the data. So I David I don't know do you know exactly what's being covered there might be the anti fibrotic data, but I'm not sure go ahead, yes, there will be additional analyses, including some additional.
That would be the schools before that's right.
Yep.
And I think you were asking about the Philip Molly a new trial in the U K around morphine is that what you were asking me about and how do I think that's relevant to our program.
That's correct and I think that there'll be some data around that at all.
Yeah.
No that's great I think from our perspective, we're excited about that study because I think it just builds more critical evidence around the mechanism here in this whole opioid pathway them.
Morphine has its own set of issues certainly around respiratory depression, and also just the whole scheduling schedule too but from our perspective, we think it just continues to build them critical scientific evidence around the pathway. So I think it should work they use low doses of morphine now and as I've heard from several kols. It's.
Really the only thing that works on cough, it's part of what drew us to the space, but we felt that first of all we work on two receptors and we felt that because of more of the safety profile and abuse addiction profile around our drag that we could be a much better chronic option. So I'm excited to see it I I would expect that it should work I'm not.
I don't feel threatened by it because of all the things I just mentioned to you and theyre going to have a hard time patenting that so you know likely people may use it off label, but they're out there there's other challenges with prescribing morphine in today's environment.
Got it. Thank you and then about the the two studies phase two be Ips in RCC.
Could you could you just comment on the difference when you go to sponsors factoring in obviously based on them.
Some technology, but also some of the prior ongoing due to extreme developing.
Developing programs.
Yeah, and again when we lay these studies out we can get into that a little better I would say in the IPF, which is probably a little more advanced here. We you know there's a sort of accepted right around 25%, we saw slightly lower roughly 23% in our study, but when you look across the trials that have been done and that's a pretty good estimate I think in <unk>.
RCC you know, we're working with sort of the the experts here in the space who have all the data.
David I don't know if you know the the powering assumptions were using on placebo you'd been working on that protocol.
Absolutely I think just agree totally with what you said it'll be Ips for the Ips, including recent studies.
Below 30% placebo response consistently.
The RCC the key there is it's a two way crossover design like come out now in RCC studies like that including recent RCC studies. The placebo response has been around about 20%.
So it's not it's quite it's quite a different placebo response than has been seen.
So your longer duration parallel group studies in RCC.
Got it thanks for taking our questions.
Yeah.
Thank you Mike.
Okay.
I'm not showing any further questions.
Question and answer session I would like to turn the call back over to Jennifer good for closing remarks.
We would like to thank everybody for participating in today's call and hope to talk with some of you at the Needham Investor Conference being held April 17th through the 20th virtually thank you.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.