This company is on our watch list because there is no insider buying on the open market despite SP being an all time low. Insider buying is important because it shows shareholders that management is willing to buy at the same levels. After all, if management isn't buying the opportunity, why should shareholders?

If we see management buying in big (>$100K), we will immediately invest in this company and give it our rating.

Trevi Therapeutics (TRVI)

FN Rating

NR
0/10

FN Summary: Lead asset (Haduvio) is in P3 testing for Pruritis associated with Prurigo Nodularis, which represents a $3B global market. Haduvio is being tested as the first orally administered drug for Pruritis. P3 results are due Q2 2022. Company is also testing Haduvio for Chronic Cough in IPF, which is in Phase 2, and results due Q2 2022. Trevi market cap is only $30M, which is an all time low since going public in 2019.

Table of Contents

This company hits most the right spots!

Experienced Management

High Institutional Ownership

Good Phase 2

Recent Insider Buying

Decent Cash (as of July 2021)

SP at all time low (as of Sept 2021)

X

Next Catalyst

Completion of Phase 3 enrollment ~ 4th Q 2021
Countdown Timer 👇
days until Oct 1
P3 readout any day!

Interactive Chart

Catalyst-Chart Overlay

Caveat! Stock movement can be very finicky and, at times, seemingly random. This is FN's best explanation of the price movement.

May 7 - IPO

March 2020 - Covdid-19 affected all US equities negatively)

July 13, 2020 - DMC recommends increasing sample size from 240 to 360

Cash on Hand

.

Est Monthly Cash Burn

$$$$

29M

3M

Notes

nice cushion...

just an estimate

Est Cash End of Nov 2021

23M

Enough cash until (expected) 4Q enrollment completion, but not enough until P3 readout.

Pipeline

Products & Sales Potential

Indication

Pruritus Associated with Prurigo Nodularis
Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)

US Market

$700M

.

Global Market

$3B

$4B

For Context: Trevi Tx Market Cap ~ $26M as of Nov 26, 2021

Management

Yes, we know. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management
  • Co-founder and has served as a member of our board of directors and as our President and Chief Executive Officer since our inception in March 2011.
  • Previously, Ms. Good served at Penwest Pharmaceuticals, where she held various positions including President and Chief Executive Officer, Chief Operating Officer and Chief Financial Officer.
  • Currently serves on the board of Rhythm Pharmaceuticals, Inc., a publicly traded rare disease company.
  • Ms. Good previously served on the board of Juniper Pharmaceuticals, Inc., a publicly traded healthcare company, from September 2017 until it was acquired in August 2018.
  • Currently serves as a board member of the Friedreich’s Ataxia Research Alliance (FARA), a patient advocacy group advancing treatments for the cure of Friedreich’s Ataxia, and is as the Treasurer for a non-profit organization, Newtown Youth and Family Services, which provides mental health services and programs to support the community.
  • Ms. Good is also one of the board members of the newly-formed Executive Women in Bio, CT Chapter and is a Co-Chair of the New Haven Regional Bioscience Collaborative.
  • Thomas Sciascia, M.D. is our co-founder, and has served as our Chief Medical Officer since our inception in March 2011.
  • Previously, Dr. Sciascia was the Senior Vice President of Clinical Development and Regulatory and Chief Medical Officer at Penwest.
  • Prior to joining Penwest, Dr. Sciascia worked at Quintiles, Inc. as a consultant to pharmaceutical and biotechnology companies.
  • Dr. Sciascia also worked as Medical Director at Transkaryotic Therapies, Inc. (later acquired by Shire Pharmaceuticals Group plc). 
  • David Meeker, M.D. has served as a member of our board of directors and our chairman since July 2017.
  • Dr. Meeker has served as Chairman, President and Chief Executive Officer of Rhythm Pharmaceuticals, a biopharmaceutical company, since July 2020.
  • Prior to joining Rhythm Pharmaceuticals, Dr. Meeker was Chief Executive Officer and director of KSQ Therapeutics, Inc., from September 2017 to July 2020 and worked at Sanofi Genzyme from October 2011 to June 2017, in a variety of roles, including President and Chief Executive Officer of Genzyme, a Sanofi Company from October 2011 until January 2016, as a member of Sanofi’s Executive Committee from 2012 to June 2017 and as Executive Vice President and head of Sanofi Genzyme, Sanofi’s specialty care unit with responsibility for rare diseases, multiple sclerosis, oncology and immunology franchises, from January 2016 to June 2017.
  • Prior to the acquisition of Genzyme by Sanofi in 2011, Dr. Meeker worked at Genzyme Corporation, beginning in 1994 as medical director, and held positions of increasing responsibility, ultimately serving as Chief Operating Officer.
  • Prior to joining Genzyme, Dr. Meeker was director of the Pulmonary Critical Care Fellowship at the Cleveland Clinic and an Assistant Professor of medicine at Ohio State University. Dr. Meeker has served as a director of Rhythm Pharmaceuticals, Inc., a publicly traded biopharmaceutical company, since November 2015 and as its chairman of the board since April 2017.
  • He has served as Chairman of Pharvaris, a publicly traded company, since January 2021 . Dr. Meeker has also served as a director of MyoKardia, Inc., a publicly traded biopharmaceutical company, from June 2017 to December 2020. 

Company PDFs

Read all of this 👇

Corp Presentation - Aug 2021

Phase 3 Clinical Trial

Understanding the Phase 2 trial is crucial to anticipate the success of the current Phase 3 trial. In summary, the Phase 2 trial was sort of a success.

Phase 2 did meet its primary endpoint, but only at the higher 162 mg dose.

It is clear from the chart in the upper left there is a separation from placebo that increases over time. This is very good as it achieved statistical significance of p=0.028 after 10-weeks. Also shown is that lesions improved, improved excoriations/crusts and improved Quality of Life after 6 weeks.

As shown in the chart below this Phase 2 trial required a titration period. Titration is a way to limit potential side effects by taking time to see how your body will react to a drug. Titrations is needed when a drug has a narrow therapeutic index. Titration is especially important because the range between the dose at which a drug is effective and the dose at which side effects occur is small.

The specific adverse events (AE) associated with Haduvio are shown on the right. These are a concern, but they are not considered serious adverse events (SAE) which could potentially warrant stopping a trial. These same AE are expected to show up in the Phase 3 trial.

With these impressive results, the company worked with the FDA to design the Phase 3 trial. Here is a summary of the Targeted Differences the Phase 3 trial hopes to reach.

This is exactly what we like to see in a Phase 3 trial - a design almost identical to their Phase 2 trial. This reduces the chance of unknown variables entering the trial (although it is still possible).

Regarding the Open-Label Extension portion of the trial, according to the Q4 2020 conference call the CEO Stated: 

Encouragingly, almost all of the subjects that have reached the end of the blinded dosing period have chosen to roll into the open label extension portion of the study, enabling us to get long term safety and efficacy data on these subjects.

This is a very good sign as it shows the treated population was most likely seeing benefits and wants to continue the trial.

Two slight changes were made to the Phase 3 trial. 1) comparison to placebo will be over 12 weeks vs. 10, and 2) the itch severity score (WI-NRS) was increased form a 5, to a 7, or greater. If we see a similar enrolled population as Phase 2, we should expect to see even more statistical significance.

Analyst Price Targets

Analyst Price Target History

One year ago 3 analysts had a Buy rating with an $11 price target. Now the company is closer than ever to finishing their P3 trial and the SP has dropped significantly, yet only 1 analyst still covers this stock. One would think analysts would jump at the opportunity to recommend this stock. Go figure.

Ownership

Insider Ownership % (not precise)

Insider Transactions

Unfortunately, there have been no insider buys recently. Considering the SP is near a 1 year low, it would be nice to see.

Institutional Holdings

The high % of Institutional Owners is a very positive sign.

Notable Institutional Holdings (as of 6/30/21)

Short Interest

Daily Short Volume Chart

Shares Available to Short

Sign up for Trevi Therapeutics emails! If you invest in this company, this is not optional.

You must stay updated on every development.

Best TRVI Seeking Alpha Article

Yes, we read them all and this is the best one if you are short on time. But serious FN investors read all of them.  🙂

Q. What is the anticipated cost for Haduvio for PN?
A. We are not aware of any management guidance, but we did find this source for Korsuva pricing, a drug for Pruritis related to Chronic Kidney Disease in dialysis patients. The plan to charge $17k/year.

TRVI Videos

We don't include TA videos - sorry, not sorry

Risks

Phase 3 was slowed as hospitals focused exclusively on Covid patients. It is possible that a data variation was created which will adversely affect the results.

Phase 3 pulls in a much larger group of patients. Anytime this occurs, new variables can be introduced that Phase 2 did not uncover. These variables can cause adverse results resulting in the company not hitting their endpoints.

On July 13, 2020, the company announced that it needed to increase the P3 sample size from 240 to 360 patients. This was a pre-planned analysis built into the trial design. The PR stated they needed to increase enrollment to maintain statistical power. This most likely means the Phase 3 trial was showing good results (since it was allowed to continue) but was not as good as the Phase 2 trial. P-values work such that the more difference shown from placebo, the less patients you need to reach a P-value less than 0.05, and vice versa.

Competition

On Aug 25, 2021, the FDA approved Korsuva as treatment for pruritis in patients on hemodialysis. This drug uses the same mechanism of action as Haduvio, which is a kappa opioid receptor agonist.  However, Korsuva is an injectable. Injectables are a significantly less desired form of administration compared to an oral option, but the approval gives Korsuva an entry into the market.

Despite Korsuva only being approved for the Hemodialysis market, you can be sure this drug will be also written in off-label indications.

Email us at info@frugalnorwegian.com if you have more.  We want to list all risk factors for the drug & trial.

Have questions about this info? Did we miss a fact? We want to hear from you.

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