Q2 2022 Trevi Therapeutics Inc Earnings Call
The first assessment of promise was made at week six of the trial, which also showed a statistically significant improvement.
So we are pleased that the primary and all the key secondary endpoints were positive and that <unk> demonstrated an early response. This data has been accepted for oral presentation at the European Academy of Dermatology and <unk> in September , which I plan to attend if any of you will be there.
The next steps for the Pn program include completing the one year open label extension study. The last patient is scheduled to complete one year in January of 2023 in parallel we will continue analyzing the blinded data and preparing a request for an end of phase II meeting with the FDA.
It has been a busy year at Trevi and the trial data has positioned us well for potential growth in these two important indications along with other potential lifecycle management opportunities.
As a reminder, this quarter, we will have the full canal data for <unk> in IPF.
D. A meeting on cost in IPF and an R&D day later in the quarter to outline the going forward strategy and development plans.
I will now ask Lisa to review our financial results and then we will open it up for questions.
Thank you Jennifer and good afternoon, everyone. As a reminder, the full financial results for the three and six months ended June 32022 can be found in our press release issued ahead of this call and in our 10-Q, which was filed with the SEC today after the market closed.
In the second quarter of 2022.
We recorded a net loss of $8 1 million compared to a net loss of $9 8 million for the same quarter of 2021.
R&D expenses were $5 1 million during the second quarter of <unk> 22, compared to $6 5 million in the same period of 2021. The decrease was primarily due to reduced purchases of clinical trial supplies and clinical trial subject recruitment costs a reduction in our use of consulting services and the non recurrence of professional recruiting.
Fees related to hirings in the prior year period.
G&A expenses were $2 7 million during the second quarter of 2022, which was flat compared to the same period of 2021.
As I discussed on last quarter's call in early April we raised approximately $55 million through the sale of common stock and pre funded warrants the offering was priced at the market with no warrant coverage with more cash on hand, and interest rates rising we are now investing our cash in a portfolio of high credit quality marketable securities to provide interest income.
We also received proceeds of $5 9 million in the second quarter related to the exercise of warrants that were originally issued in our October 2021, private placement or.
Our cash cash equivalents in marketable securities balance at the end of June was $78 9 million. We received another $4 1 million in proceeds also from the exercise of warrants that were issued in our October 2021 private placement in July .
So we end July with cash cash equivalents in marketable securities balance of approximately $79 8 million.
This gives us cash runway into Q4 of 2023 to fund our ongoing operations, including completing the open label extension of the Prism trial like Jennifer referred to and preparing for the end of phase two meeting with the FDA and planning for and conducting our next trial for chronic cough and IPF.
In addition, we currently have approximately 11 million warrants still outstanding which can provide us up to $15 million in proceeds if exercised.
With the $55 million raised in April our cap table has gotten a little more complicated. So I wanted to lay it out for you as of today. We have 42 8 million shares outstanding in the April private placement. We also issued $24 4 million pre funded warrants. They are called pre funded warrants because substantially all of the strike prices.
At the time they are issued so while they are not legally outstanding they're required to be included in our calculation of weighted average shares outstanding and basic and diluted loss per share also as I mentioned before we have approximately $11 million in warrants outstanding from our October 2021, private placement and $4 1 million stock options outstanding.
So our fully diluted shares outstanding is a little over $82 million.
We continue to pay down our term loan in the principal balances now under $11 million.
In closing we're excited about the recently reported data in Pn in the strength of our balance sheet to continue executing on our plan. This.
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.
You May press Star then one on your Touchtone phone, you're using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble roster.
Our first question comes from the Bill.
From Stifel. Please go ahead.
Taking my question.
Just curious if you had any.
Idea is I realize it's a little bit too early.
We'll have to report the final data for the chronic cough, but do you have any ideas what a phase III might look like based on what others have done.
Hey, Eddie.
Pathic refractory chronic cough and how large it might have to be.
And then.
With regard to the promise scale can you just remind us what's in the promise scale.
Just to get a sense of the meaningfulness of the.
About the.
Doug.
And points and then finally.
For <unk>, So I guess Theres now a couple of additional.
<unk>.
Targeted antibodies that have been brought out.
Obviously it depicts imposed.
Filed under their weighting of Paducah for Pn in then.
<unk> no.
Alright, I forgot the name suddenly but their program is in the second phase III trial.
And.
I realize that you are an oral you might come ahead, but whats your suspicion as to how that development landscape, our competitive landscape might shape out because it raised awareness for pn or hinder your opportunity in P. M. So I just wanted to.
A sense of how youre thinking about it.
Starting to heat up in this space.
Thank you Annabel Bill you want to take the first two on trial design and the promise scale and then I can talk to the competitive landscape.
Hi, Annabel thanks for the questions I'm going to absorb promise, although you started with the core which is our next study in IPF, but let.
Let me just kind of give a little bit of a descriptor with the promise scale and just to kind of back up a little bit as you know we had three key secondary endpoints in prism and <unk>.
Obviously, the itchy qual and.
The prego activity scales more read out previously as Jennifer noted and so now here, we have got the promise, which is the sleep disturbance.
That was a short form that we used so theres a questions in it.
And then there's some question here was really developed as a general tool for accessing sleep in controlled clinical trials and so we utilize that here essentially as I said.
Eight open ended statement with really five options and the options.
Very core to very good or not at all to very much and so the.
The questions are really around sleep and sleep quality.
And so.
Hopefully that helps you a little bit on the promise.
Of course, it was statistically significant at six I'm, sorry monthly one two and three are fixed so we were really happy to read those out.
To now obviously, you're right we've got some data coming out still but given the strength of the data that we have we're not expecting to see much different though although we will be able to read out some some new data, we'll take a look at the 24 hour data.
As well as the data that we've reported out earlier and you can expect about a 50% increase in the amount of data that we'll have in that new readout going forward in the coral.
What we've what we've conveyed to the FDA in anticipation of a meeting coming up is that we would like to do a six month study with three treatment groups.
So we'll take a look right now we're looking at primary endpoint using the digital cough monitor.
Weeks, two four and then monthly after that over the six months, we'll probably put the primary endpoint early.
At one month, but of course since we'll be getting additional data in subsequent months and we will have that information as well as far as durability.
And I think the question that we often get is why do a six month study because obviously it doesn't take very long for the onset with the onset of effect using now <unk> seen as very rapid so.
The goal on the six months is to collect important safety information that we believe.
Will benefit the understanding upon the abusing may affect these patients and you can imagine along the lines of things like FCC, but also hospitalization for respiratory causes are things that we're interested in it allow us to go out six months in two active doses that will give us about a 100 patient exposure years, so we'll be able to accumulate.
Enough safety data.
Population too to really have a firm understanding of the safety and of course the efficacy in it. So I hope that helps you handle.
Yes that was very helpful. Thank you.
You want to handle that in your lap.
Yeah, no happy to do that the competitive landscape.
So annabel <unk> been following us long enough to know we came to a fork in the road around <unk> and we actually chose pn largely because of the biologics in the space and sort of what we felt they would be able to help develop the market. Although the pricing would be set at a good level I think to reflect the disease state and so we've always known and they would be.
There I think if you ever talk to dermatologists, there's also sort of a treatment paradigm. They follow which is topical to oral to biologics. So not everybody is going to always follow that but I think that there is a big unmet need in that oral systemic piece of this whole equation. So I think overall, it's positive we obviously knew they were there on both.
<unk> and Nemo lithium AB, which is the one you are forgetting so yes. It is.
I think it actually helps overall in the market now I know, it's a hard one to remember and and.
And we think we can compete if you look at the <unk> data sorry, the week three months, which is sort of where we read out.
Sort of in the same swim lane on Delta they've been reported out a six month trial, which gets a lot bigger and I think thats sort of the hallmark of this disease youre trying to break that it's scrap cycle and overall nodule appeal, which youre seeing already in three months and over time that it's really there's really an exponential effect. So as bill is able to open up the open label extension.
Data, hopefully, we'll be able to share more of sort of the impact of that longer term.
Perfect. Thank you.
Yes. Thank you.
Our next question comes from Serge Belanger from Needham and company. Please go ahead.
Hi, good afternoon.
Just a couple of questions for us.
First on.
The cough indication.
Just curious what your current thinking is about exploring indications beyond IPF costs.
And if thats something you plan on discussing.
With the agency at the upcoming meeting.
And then on <unk> I think you have another FDA meeting.
For that indication and just curious what the goal.
<unk> will be for that specific engine.
Yeah. So just each of those points as far as comp we are looking at other indications beyond IPF.
That's something we'll discuss with the agency and our meeting we're really going to stay focused on that program and locked down and get agreement. There. We are having some discussions internally over the summer and it's why we are I mentioned in my comments, we will have an R&D day in probably the latter half of September where we can clearly lay out the development strategy around the.
<unk> and timelines and sort of trial guidance et cetera. So.
<unk> look to that or will be sort of clear beyond IPF, if we're going to pick up any other lifecycle management opportunities.
And you're right, we still have actually our end of phase II meeting ahead of us. So we'll take advantage of that that's a major meeting will taken the data go over with them talk about what we hope is our lap.
Pivotal trial to be able to get approval. So it's been awhile since we checked in with the agency around that program, but I do think a lot of that is <unk> with the other competitors in the space.
And at this point for the Pn program.
We expect only one additional phase three trial would be needed.
Correct.
Yeah, I mean, bill if you want to answer that yes.
Yes.
That's the expectation.
We always like to be opportunistic, but I think guiding everybody to one more trial is is the most appropriate thing to do here I think everybody's had a chance to look at the data. It is certainly strong.
A lot there.
There is a lot of quality data in there, but I think for this just for that indication doing another study makes sense.
Okay. Thank you.
Thank you Serge.
Okay and if you have a question. Please press Star then one.
Our next question comes from Leland <unk> from Oppenheimer. Please go ahead.
Hi, good afternoon, thanks for taking my questions.
Just wanted to ask in terms of timing expectations I know, it's a bit early and we will we will try to be patient for the letter September .
LNG dates, but any sense of kind of timing on starts of mixed studies in both indications as we get into 2023.
Yeah, So leland on IPF cough, which we've been sort of more hustling on and getting things done we're looking to try to start that in the first half of next year and we're still accumulating all of the data and have to request our ft da meeting and we're sort of doing all of that in parallel. So we don't have enough visibility on that one yet to probably give good guidance.
But IPF comp we are moving towards trying to start that in the first half of next year earlier.
Okay, Great and then one more question just as you think strategically about.
Sort of a high class problem you have with these two indications.
Available for <unk>.
And within that you can share in terms of your cost evolution with respect to prioritization of one over the other or do you really see that.
To marching forward kind of alongside each other as you head into.
Steps for approval.
Yeah. That's a good question I mean, something you always have to be mindful of there will be a little bit of a cadence that has to go on but I will say for instance in pn. As this is a space. We know while we've been doing trials here protocols kind of mapped out we've got our CRO partners in place so that shouldn't move along our con ops teams kind of all.
Over that.
<unk> got a bit of a jump on it because of the interim data. So we will sort of naturally scheduled things out and find our way, but I would think largely and so I'll. Let you comment on it too I think largely they should be able to move along roughly in parallel.
Yeah.
Yes, I think thats going to be the trade I'm just trying to.
Keep things going in parallel.
Great. Okay. Thanks, very much for taking the questions.
Yes, Thanks Leland.
The next question comes from Nathan Weinstein from Aegis. Please go ahead.
Hi, Jennifer Elisa Bill. Thank you for taking my questions.
Two questions. One was a follow up on comments with regards to sleep and can you just help us think about this from a perspective of patients since you got you.
Some doctors in Ohio, the patients manage sleeves that have trouble with sweet.
Pn indication that's the first question.
Bill do you want to take that or you want me to take it yeah no.
I've had some conversations with.
Some of the investigators on this one and as you can imagine with something that has a severe age with it sleep disturbances is extremely high on the list of things that they want to be able to handle.
You can imagine how how anxiety ridden these poor patients are having to H all day long and then of course to not be able to sleep. So.
We're excited about sleep component of it I think to be able to move the scaled in the way that we've been able to do.
Shows that it's clinically meaningful kind of improvement we believe at this point with the promise we're still we're still <unk>.
Shopping it around to some of the investigators and the thought leaders, but we're happy with it.
Great. Thank you it makes sense and then just one follow up and that's on the CRO partner engage for the next call. Just a reminder for me if you don't mind, we hit the same CRO you've been.
Working with them on the trial central there'll be significant overlap with the <unk>.
Enrolled historically.
Yeah, So ciara partners under CDA, So I can't disclose that but it is a partner we worked with them in the last round of trial. So they've been terrific. So thats good kind of an easy start announced precise in pn definitely will be overlap with the sites. We ran before and cough, we'll have we will go back.
The UK is one of our countries, but recall, we only ran that in the UK. So we're going to have to now broaden out and tap the U S and we're looking at other country opportunities as well.
Got it thanks, and congrats on a very strong first half of the year.
And we're looking forward to the back half.
Thank you Nathan.
I'm not showing any further questions. This concludes our question and answer session I would like to turn the conference back over to Jennifer good for closing remarks.
We would like to thank everybody for participating in today's call I Hope you all enjoy the rest of your summer. Thank you.
Conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Okay.
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