Q3 2022 Trevi Therapeutics Inc Earnings Call

Were reported in September and confirmed the positive interim results previously reported showing a significant reduction in the frequency of costs from baseline and were highly statistically significant on both the primary and several key secondary endpoints.

Included objective measures of cough patient reported outcomes on cough frequency and severity along with investigator reported improvements in cost.

In mid September we hosted an R&D day to review these results in detail along with the Pn results and heard from prominent Kols and coffee niche instead of reviewing all of the information I would like to provide you with an update on our activities since our R&D day.

Chronic cough in IPF has emerged as our lead indication and we are busy developing protocols for the next phase of development and interacting with both the FDA and preparing for interactions with European regulatory authorities <unk> as the lead therapy in development for cough in IPF and is the only one to have shown positive.

It results in a blinded study in this indication.

IPF is a serious end of life disease, and chronic cough is a major cause of morbidity significantly impacting the patients quality of life. Although there are many learnings we can take from the development that is ongoing in the refractory chronic cough space. There are unique aspects in the IPF patient population related not.

Only to the potential effect in the underlying disease, but also safety as it relates to this fast frail patient population.

So as we prepare for this next step in development, we want to make sure we are aligned with the regulators.

In parallel the clinical teams are preparing for this study so that we can initiate once we have agency agreement on the protocol call in an open IND.

We expect to initiate the next study in the first half of 2023, and we will provide guidance on the overall design as well as the timing for the trial and results when we begin the study.

Our data and cop in IPF has been presented by Dr. Toby Mayer as a late breaker at the European Respiratory Society and also was presented it I class Dr. Filip <unk>, who will present the full data this month that the British thoracic Society meeting. We are also currently preparing a manuscript published the trial result.

The IPF Comdata has gained the attention and support from Kols and Pulmonologists globally.

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 popular modules on the skin as well as in separate and severe itching in June . We also reported positive data in the phase two b slash III prism trial in Pn.

The trial achieved statistical significance on the primary and all key secondary endpoints.

Still have several patients in the one year open label extension study with the last patient forecast to complete in February 2023.

In parallel we are completing all of the various clinical reports and documents and preparing to request an end of phase II meeting with the FDA, which we expect to hold in the first half of 2023.

P. M data was presented orally at the European Academy of Dermatology and neurology by doctors Sonya Stander in September and we are currently working on a manuscript published the full study results as well as abstracts at several other dermatology meetings.

It is a busy time at trevi preparing for upcoming regulatory meetings across indications designing the protocols for the next phase of development and identifying sites for our next study we are making good progress and look forward to updating you with more details as we get ready to initiate the next studies.

As I look back on 2022, I am 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 other serious chronic cough condition.

<unk> for Pn, we are in discussions with potential partners to advance that program into the next stage of clinical development.

I'll 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.

As a reminder, the full financial results for the three and nine months ended September 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 third quarter of 2022, we reported a net loss of $8 3 million compared to a net loss of $7 3 million for the same quarter of 2021.

R&D expenses were $5 8 million during the third quarter of 2022 compared to $4 7 million in the same period of 2021. This was primarily due to startup activities for our planned trials, including purchases of clinical trial supplies and increased expense related to the timing of activity in our phase II canal trial as compared to the third quarter.

For a 2021.

These increases were offset by decreased expenses for activities in our prism trial due to the completion of the blinded portion of the trial in the second quarter of 2022.

G&A expenses were $2 6 million during the third quarter of 2022 compared to $2 2 million in the same period of 2021. The increase was primarily due to higher legal fees related to intellectual property and increased market research costs.

During the quarter after the announcement of the positive results for the full data in our canal trial, we raised gross proceeds of approximately $55 million from both new and existing investors through a public offering. We also received proceeds of $5 9 million in the quarter related to the exercise of previously issued warrants.

Subsequent to quarter end, we received another $3 1 million in proceeds from the underwriters option for the Green shoe related to the September offering.

So we end of October with a cash and investments balance of approximately $125 7 million, which we have invested in a portfolio of high credit quality and marketable securities and is providing us with healthy interest income in today's higher interest rate environment.

This gives us a cash runway into 2026 to execute the plans that Jennifer laid out today and to pay off our term loan in accordance with its terms between now and February one 2024.

In closing I'm happy to welcome our new investors to Trevi and I'm thankful for our existing investors, including those who participated in this latest funding round.

I look forward to supporting our Trevi team with financial discipline, as we negotiate agreements and execute the next phase of development for <unk>.

This concludes our prepared remarks, I will now turn the call back over to the operator for Q&A.

We will now begin the question and answer session. As a reminder to ask a question you May Press Star then one on your telephone keypad.

If you were 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 our roster.

Today's first question comes from Annabel <unk> with Stifel.

Hi, guys. Thanks for taking my question.

I had a few I guess one of them has to do with I guess, what youre going to be asking of the regulatory agencies with regards to design of the.

Future IPF trial do.

Are you thinking of looking at any new endpoints.

Corporate <unk> combined usage on top of standard treatment in these patients.

And also what are your thoughts about potential enrollment.

Now the Covid seems to have come down and did.

Did you do you think that you might have some grid or is it enrolling at enrolling these trials given that it took so long to do.

The first phase to it so maybe I could just start with us. Thanks.

Yeah. Thank you Annabel.

So we are in discussions with the agency I would say, we're not trying to sort of reinvent the wheel here on endpoints. The FDA has been supportive of this objective cost monitor and that's what we use in our phase II study. So I anticipate we'll do that we will need to validate it in the IPF population.

Also we will need to find some patient or a patient reported outcome that also moves the same direction, but given the given the fact that all of our secondaries were statistically significant as well I think it's a matter of just picking one and then doing the work so I'm not too worried about that in this trial, we actually let people take the drug on top of standard of care. If you remember about half.

Of our patients were on anti fibrotic. They just had to be stable for at least eight weeks. So again kind of sticking to what we've done I would say that we're at.

Just working through inclusion exclusion criteria, making sure. The overall study design I mean, the purpose of the next phase II trial is really going to be around finding the minimally effective dose as you saw from our data we had an impact really early and so.

We'll need to work through that and really get at the dosing question. So just trying to make sure. We've got the protocol nailed down as far as your enrollment question. It's a good question and I wish Covid was our only enemy, but what these guys anything RSV called everything I would say the difference here, though we were running that study just in the U K. So you are limited to.

10, or 12 site, we will open this up in the U S and also probably Germany. So we'll just have a lot more sites to be able to move through the enrollment so hopefully that sort of hedges at a little better.

Sure and if I could just ask a couple of follow ups.

You have 120, almost 126 million now.

Is there any thought to.

Flooring additional chronic cough indications right now or is it just something that's going to stay on the back burner and then.

Separately on Pn.

It sounds like you are obviously still seeking a partnership but if there.

Or no bites on that are you willing to go it alone.

And do you have the funds to be able to explore all of those.

Opportunities. Thanks.

Yeah, so as far as other chronic cough indications we are interested in doing a phase III refractory chronic cough study I think we've sort of signaled that we'll look to initiate that hopefully roughly mid year I do want to get IPF costs sort of up and on its way you know that's going to be our primary focus here as well as wrapping up <unk> and getting through the agency meeting.

I would anticipate by midyear, we'll be hopefully initiating a refractory chronic cough study that should be pretty quick to enroll those trials enroll much quicker. So we'd hope to get that done and sort of six to nine months as far as pn.

We have not planned on that in the $126 million I think we're in active discussions with various partners at this point in time, we don't plan to run the final study ourselves.

Think that hopefully we'll be able to find a partner to do that because we really want to take this money and invested into those cost portfolio as a priority.

Okay, great. Thank you.

Yeah.

The next question comes from its Serge Belanger with Needham and company.

Hi, good afternoon.

A couple of questions I guess first on the cost program, maybe just any feedback.

Since releasing a full data set.

Two months ago.

And it looks you mentioned that.

So it will be presented.

Terrific meeting.

Later this month just curious if there's any additional analyses of the data that will be part of the presentation.

Well I'll start with that.

Yeah. Thank you Serge.

Feedback on the full data set I mean, you've seen it it was amazingly consistent with the interim so that was good news for US I would say it was just a strong we were able to link it to our 24 hour 24 hour cough data, which we expect to move.

Forward with as an end point, because we had that in the full analysis set. So I think the feedback has just been really strong I've been to a lot of these medical meetings and I definitely got the attention not only pulmonologists, but also the whole cost community. So I would say the feedback has been strong.

Your second question was thoracic Oh, Yeah, British thoracic society, we shared so much so that happens to be over the Thanksgiving weekend. So we've actually won't be there because of that I think the brits do that on purpose.

But I would say we showed so much data as part of our R&D day, there's probably some incremental things and theyre in surge I can send you the presentation, if you're interested but I think we've been so extensive incentive sharing with there where I think you'll see sort of a full review is when we get the manuscript out because there's a lot of work going on with all the really thought.

There's around this area on the manuscript of the data.

Okay, and then maybe just.

You know I know.

Early since you made the decision to look for a partner there, but maybe some of the conversations you've had and whether the <unk>.

Isn't it takes an approval.

To generate additional interest for that indication.

Yeah. So people definitely understand this need I mean P. N is on People's radar screens, they're interested everybody accepts that an oral has an important place in sort of the treatment line of therapy. So I think it picks up will help drive patient numbers I was just presenting at a conference last week and there was a lot of discussion about how big pharma.

Does a great job of identifying these diseases in driving patient numbers. So I think that's all really helpful.

I would like to get through our FDA meeting and get clear sort of FDA guidance. So as we move forward a patient or a partner will be very clear on sort of the path forward. So yeah. I think it does help I think it's always been part of our thesis that having a biologic here is actually helpful to the overall market.

Okay. Thanks for the update.

Yes, Thank you Serge.

At this time there are no further questioners in the queue and this concludes our question and answer session.

I'd now like to turn the conference call back over to Jennifer good for closing remarks.

We would like to thank everybody for participating in today's call and hope to see some of you at the Stifel Investor Conference next week and in San Francisco in January Thank you.

The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.

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