FN Summary: Lead asset (Exebacase) has fast-track & ‘breakthrough’ status and is in a Superiority Phase 3 Trial for MRSA. Pfizer is on the BOD and invested $6M. Possible new class of drug (lysins). $88M matching BARDA grant received. Missed Phase 2 endpoint, but MRSA subgroup discovered. Futility readout (for superiority) in 1H 2022. If futility readout shows superiority is on track, SP should start to climb.
Table of Contents
This company hits most the right spots!
High Institutional Ownership
Good Phase 2 (requires explanation)
Recent Insider Buying
Plenty of Cash (as of June 2021)
Breakthrough Therapy Designation - Possible Takeover Target
Interim Futility Analysis on Exebacase P3 Superior Study Trial ~ 1H 2022
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Caveat! Stock movement can be very finicky and, at times, seemingly random. This is FN's best explanation of the price movement.
Cash on Hand
Est Cash End of Jan 2022
Enough cash until 1H 2022 interim readout
Products & Sales Potential
For Context: ContraFect Market Cap ~ $112M as of Feb 4, 2022
Yes, we know. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management
- Dr. Pomerantz was appointed ContraFect’s President, Chief Executive Officer and Chairman of the board of directors in April of 2019, prior to which he served as Vice Chairman of the Company’s board of directors since May 2014. He currently serves as Chairman of the board of directors of Seres Therapeutics, where he served as Chairman and CEO from June 2014 until January 2019.
- From 2011 to 2013, he was Worldwide Head of Licensing & Acquisitions, Senior Vice President at Merck & Co., Inc. where he oversaw all licensing and acquisitions at Merck Research Laboratories.
- Previously, he served as Senior Vice President and Global Franchise Head of Infectious Diseases at Merck.
- Prior to joining Merck, Dr. Pomerantz was Global Head of Infectious Diseases for Johnson & Johnson Pharmaceuticals. He joined Johnson & Johnson in 2005 as President of Tibotec Pharmaceuticals, Inc.
- Dr. Cassino has over 20 years of experience as a clinician and executive in healthcare, including over 14 years of experience in pharmaceutical product development and over 20 successful regulatory submissions in the US and globally.
- Prior to joining ContraFect, Dr. Cassino served as Senior Vice President at Forest Laboratories, Inc (acquired by Actavis plc, now Allergan plc), where she oversaw Global Clinical Development. While at Forest, she was responsible for pre- and post-marketing clinical activities for a portfolio of 35 compounds, and also clinical due diligence for M&A activity including the $2.9 billion acquisition of Aptalis Pharma and the $1.1 billion acquisition of Furiex Pharmaceuticals.
- Previously, Dr. Cassino held a number of senior executive positions at Pfizer, including Global Medical Team Leader of Pfizer’s antibacterial franchise which included Zyvox (linezolid) and Medical Development Group VP for Pulmonary Vascular Disease and Rare Diseases.
- Dr. Cassino also served as Executive Medical Director for the late stage US respiratory franchise at Boehringer-Ingelheim Pharmaceuticals, Inc, and was a member of the academic faculty of the Division of Pulmonary and Critical Care Medicine at New York University School of Medicine.
Dr. Anderson is an Observer on our Science & Technology Committee. She has over 20 years of pharmaceutical research and development experience and is currently the Vice President and Chief Scientific Officer for Bacterial Vaccines, within the Vaccine Research and Development Unit at Pfizer Inc. In addition to this role she is the Chief Scientific Officer for the Hospital Business Unit. Her responsibilities include infectious disease vaccine research and development and providing oversite for Pfizer’s anti-infective and diagnostic strategies. Dr. Anderson’s experience includes leadership roles for bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Neisseria meningitidis, Staphylococcus aureus, Clostridium difficile and Group B Streptococcus. In these roles, she has made substantial contributions to vaccine antigen discovery, preclinical proof of concept, clinical proof of concept, and vaccine licensure.
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 not meet its primary endpoint. Exebacase + SOC resulted in a 70% response rate in staph improvement vs. 60% for SOC alone. However, after the company looked at the data they saw a few patterns.
Phase 2 included Left-Sided Endocarditis (LSE) (a very difficult condition to treat), which was significantly more prevalent (more than double the cases - 15.5% vs. 6.7%) in the Exebacase group. In addition about 20% of the patients were in Europe, which has a different SOC for bacteremia. FYI - Europe does a better job at treating S. aureus infections so it is harder to show a difference.
The current Phase 3 trial excludes LSE and is conducted exclusively in the US. When these 2 constraints are used and applied to the Phase 2 data, Exebacase would shows superiority for treating MSSA & MRSA. See chart below.
Most impressive are the MRSA results (shown below). [Caution: the MRSA sub-group was only 27 patients.] Significant responder rate was shown using Exebacase. Left graph shows actual study results, and right graph shows how the Phase 2 group would have responded had Phase 3 criteria been applied.
With these impressive results, the company worked with the FDA to design the Phase 3 trial. Below is a link to the Phase 3 Trial, which is currently in progress.
Here is a summary of the Targeted Differences the Phase 3 trial hopes to reach.
CFRX Discussion Forums (listed in order of best DD potential)
Best CFRX 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. Why do you think this company is a takeover target?
A. 2 Reasons. 1) Pfizer has invested and is on the BOD giving them some insight into the inner workings of the trial and the drug. 2) Exebacase has Breakthrough Therapy Designation (BTD) and any company that has BTD, has a significantly higher chance of being acquired than one that doesn’t. See this article.
Q. What is complicated staph bacteremia vs. staph bacteremia?
A. Complicated staph bacteremia is a condition in patients who are in or near septic shock, or have right sided endocarditis.
May 2019 R&D Day Presentation - Audio Recording: 2 Hrs 16 Min
Vance Garrison Fowler M.D. Duke University School of Medicine link
- 13:00 – What antibiotics do you give someone who has e-coli in the blood?
- 17:20 – We have no good treatment for devices (prosthesis or pacemaker)
- 17:30 – If you have a device that has an infection, you need to take out the device
- 17:50 – The cost associated with device removal and replacement is b/w $80-100K
- 36:00 – The Contrafect Phase 2 study ‘was a robust study. These are data you should be able to bank on b/c the quality of the study.’
- 40:15 – ‘We need new treatment’ for Staph bacteremia
Cara Cassino M.D. (ContraFect CMO)
- 42:50 – study was a novel Phase2 superiority designed trial – very rare as unicorns
- 46:35 – FDA only has 2 approved agents to treat MRSA
- 48:50 – Day 180 – Exebacase did not appear to be sensitizing for allergic hypersensitivity – similar to Phase 1 should they be exposed to it in the future (they will not have a reaction when dosed a 2nd time)
- 51:30 – Daptomycin, Vancomycin – only 2 drugs to treat MRSA
- 52:00 – Exebacase was associated with consistently MRSA higher responder rates regardless the source of the infection
- 55:00 – Health economic signal – Exebacase reduced the median length of stay in Mrsa patients by 4 days ( 6 vs. 10)
- 56:50 – For all cause 30-day readmission rates for Staph (MRSA & MSSA), Exebacase reduced the rates essentially in half (16% vs. 31%)
- 1:01:30 – In summary Phase 2 study represents a landmark 1st step towards a brand new treatment paradigm for treating serious life-threatening antibiotic resistant infections. The first new step in decades. Exebacase is a first in class direct lycit agent with a completely new treatment modality – distinct from conventional antibiotics.
Dr. Ralph Corey – Duke Global Health Institute – Infectious Disease Expert link
- 1:04:45 – What has been said today is astonishing from all aspects
- 1:05:30 – lists all the areas that MRSA affects/destroys (skin – okay, joints – not okay, heart valves – bad, spinal tissues – real bad) They are the darth vaders of ____
- 1:06:00 – most people thing staph is soft tissue infections, but this perception is misguided
- 1:06:20 – Story of a male construction worker who scrapped his harm and the infection spread to his liver in the form of an abscess, which tested positive for MRSA. The Patient was in the hospital for 4 weeks. 5-day after completing the antibiotics he complained about a sudden onset of pain in his back. After enough MRI scans, they eventually found the problem – inflamed disc. He was then treated for 6 weeks.
- 1:14:45 – I think the results of the phase 2 trial were fantastic. I didn’t expect it at all, and I have been on 30 trials.
- 1:16:25 – 8 different trials looking for a vaccine that prevented S. aureus…and they all failed
- 1:19:05 – I think this is huge for a lytic agent ‘to destroy a biofilm’. If you can do this the antibiotics can get to the bacteria more easily.
- 1:20:35 – I think we have a really, really good chance of making this (Exebacase) a key player of treating staph infection
Roger Pomerantz M.D. (ContraFect CEO)
- 1:30:25 – CEO came out of retirement 2x, helped bring 12 drugs to FDA approval
- 1:31:10 – I am excited To see 42% improvement is remarkable
- 1:31:30 – If we can repeat MRSA results in Phase 3, this does change the world
- 1:33:05 – $500M peak sales for MRSA in the US alone (stated in 2019)
- 1:35:20 – SOC in eastern Europe and Boston, MA are different
- 1:35:30 – To get the cleanest dataset, we will start in the US
- 1:36:05 – We want to make the trial as molecularly clean as possible to not have confounding variables. We will figure out what other populations can use it separately.
- 1:36:20 – Phase 2 helped us figure out which are the syndromes you want to target. We have that answer now.
- 1:37:15 – If Execabase does not succeed, the MRSA needle will not move for the next decade.
- 1:37:50 – A safe, easy to give drug that is not an antibiotic is something that…I am honored to be here and work with it.
We don't include TA videos - sorry, not sorry
Sept 29, 2021 - Global Virtual Healthcare Conference with CEO Roger Pomerantz
Other CFRX Videos
Drop of Lysin Destroying Anthrax - Real time
Lysin Mechanism of Action
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.
The MRSA Phase 2 results are pulled from a smaller cohort of 27 patients. This is not a large group. There is a chance the larger Phase 3 trial will show less responder difference, or none at all.
The BARDA grant is matching. Therefore, the company must hit progress goals to unlock more funding. And CFRX must put in $1 for every $1 they get from BARDA. If they don't hit their goals they will not get any more funding.
Company only has 1 product (Exebacase) in clinical trials. All other drugs are pre-clinical. If Exebacase fails, the stock will drop 80-90%.
The most recent 10K did not mention anything related to resumption of enrolling patients for P3. As of the 10K coverage date (12/31/20) they most likely were having enrollment issues (just like everyone else doing clinical trials). In addition, the recent conference call by CEO Roger Pomerantz (on March 12, 21) did not discuss any P3 enrollment updates, either.
MRSA Rates are Declining
The following document indicates MRSA rates are declining. While this would not affect the potential results of the P3 trial, it would suggest a reduced Total Addressable Market (TAM).
Results Abstract: In 2017, an estimated 119,247 S. aureus bloodstream infections with 19,832 associated deaths occurred. During 2005–2012 rates of hospital-onset MRSA bloodstream infection decreased by 17.1% annually, but the decline slowed during 2013–2016. Community-onset MRSA declined less markedly (6.9% annually during 2005–2016), mostly related to declines in health care–associated infections. Hospital-onset MSSA has not significantly changed (p = 0.11), and community-onset MSSA infections have slightly increased (3.9% per year, p<0.0001) from 2012 to 2017.
In summary the 10K states that no Lysin has entered US clinical trials which appears to be confirmed by the clinicaltrials.gov website. Any competition to Exebacase for Staph aureus bacteremia appears to be several years off.