FN Summary: Larazotide, for Celiac Disease, is in P3 trials and is 2 years ahead of competition. Also have proprietary NM-002 for Short Bowel Syndrome (SBS), which had outstanding Phase 1b/2a results. Excellent analyst coverage, recent insider buying and good cash reserves until next catalyst (Topline P2 readout of NM-002) in Q4 2021.
Table of Contents
This company hits most of the right spots!
High Institutional Ownership
Several Phase 2 Trials (requires explanation)
Great Analyst Coverage
Plenty of Cash (as of Apr 2021)
Recent Insider Buying
Countdown Timer 👇
Cash on Hand
Est Cash End of May 2021
Enough until next catalyst in 4Q 2021
Products & Sales Potential
9 Meters Market Cap: ~ $305M as of April 30, 2021
Yes, we get it. This is the most dry part of the page. But, it is also the most important. Read this: Importance of Management
- Mr. Temperato is an industry veteran with a wealth of gastrointestinal (GI) focused experience in both the operational and commercial aspects of the business. Prior to joining RDD, John held various leadership roles including, President & Chief Operating Officer/Chief Commercial Officer with Melinta Therapeutics, and Senior Vice President of Sales and Managed Markets with Salix Pharmaceuticals.
- Notably, at Salix Pharmaceuticals (Salix), Mr. Temperato played a critical role in the successful commercialization and growth of their broad GI portfolio and executed over ten launches during his tenure at the company driving growth of company revenues from $119 million in 2004 to $2 billion in 2015, when Salix was acquired by Bausch Health (NYSE: BHC) for ~$16 B. Across his career, John has been instrumental in defining and executing capital efficient go-to-market strategies, business development strategy and overseeing the commercialization and life-cycle management for small molecules, devices, and biologics. Additionally, he has developed strategies for reimbursement and external healthcare policy. John also brings with him extensive financial strategy and investor relations experience.
- Dr. Griffin became our chief medical officer in February 2019. Previously, Dr. Griffin served as executive vice president and chief medical officer of Synergy Pharmaceuticals from January 2015 through November 2018, and senior vice president and chief medical officer May 2013 through January 2015.
- From March 2012 to April 2013, Dr. Griffin served as chief medical officer and senior vice president of development at ImmusanT, Inc.
- From March 2009 until January 2012, Dr. Griffin served as associate vice president, clinical development and head of external innovation at Sanofi-Aventis (now Sanofi). He is a board-certified physician in both internal medicine and gastroenterology, and is a Fellow of the American College of Physicians. He received his medical degree from Columbia University, completing a residency in internal medicine at Presbyterian Hospital in New York, and a fellowship in gastroenterology at Brigham and Women’s Hospital in Boston. Following his residency and fellowship, Dr. Griffin joined the medical faculty of Columbia College of Physicians and Surgeons, where he held a number of academic, clinical research, teaching and management positions, and a private practice in New York.
- Dr. Appajosyula helped shape the strategy to create 9 Meters Biopharma Inc. (Nasdaq: NMTR) through targeted transactions to create a diversified pipeline and accessing the public capital markets. At 9 Meters, he is responsible for corporate development including portfolio strategy, in-licensing transactions and alliances for the company’s core assets as well as monetization of non-core assets.
- Prior to joining 9 Meters, Sireesh spent about 8 years at Salix Pharmaceuticals in various roles of increasing responsibility in medical affairs, product commercialization and business development culminating in Salix’s acquisition for $16 billion by Bausch Health. Prior to Salix, he was involved in medical affairs and commercial roles at Amgen, Critical Therapeutics and Aventis (now Sanofi).
Clinical Trial for Celiac Disease
Understanding the Phase 2 trial is crucial to anticipate the success of the current Phase 3 trial.
Larazotide has been in 4 Phase 2 trials starting 2006 (albeit under a different co. name). The first 3 are listed below with the year they were started.
These 3 trials resulted in hits and misses. They were constantly adjusting the dosage, and 'yardstick' for how they gauged success. But the final 2009 results gave them the information on how to design what would be the final P2 trial.
The 4th Phase 2 trial was started in 2011. The results are shown below.
The 14.3% trial treatment effect was also better than drugs such as Xifaxan, Viberzi, Linzess, etc. to reduce pain symptoms associated with Irritable Bowel Syndrome (IBS) as reported in other Phase 3 trials. This gives a hint that if Phase 3 is positive, Larazotide may be used for the IBS market. This is considered ‘off-label’ and oftentimes, off-label markets can be larger than intended markets.
With these results in hand, 9 Meters worked with the FDA to design the Phase 3 trial, which is currently in progress. The trial design is shown below.
There will be an futility analysis in 2022 with topline readout a few months later.
Clinical Trial for SBS
more information coming soon...NM-002 has the potential to become a massive sales generator
(FN posts only the most recent documentation)
This is not really DD. It is just info to help you understand the condition.
NMTR Discussion Forums (listed in order of best DD potential)
March 23, 2021 - KOL Perspectives on Short Bowel Syndrome & NM-002 Program
John Temperato – CEO
0:50 Creating a company with unwavering commitment to GI disorders
4:20 – We have global rights to everything
5:57 – SBS debilitation disease, lifestyle that we can’t imagine, tethered to the bathroom
6:35 – Current GLP-2 only address ½ the population
6:45 – If current GLP-2 drugs did work well it would probably have more than 1,400-1,500 patients with 9 years on the market [20,000 patients in the US & 20,000 patients in the EU]
7:00 – NM-002 (GLP-1) turns the gut from a ‘smooth carpet to a shag carpet’
8:00 – takes 2-30 months for the GLP-2 glass drugs to work
8:12 – costs $40K/month
Dr. Patrick Griffin – Chief Medical Officer
9:30 – start the largest SBS study ever
9:50 – SBS is not only difficult for the patients, but it is difficult for the caretakers (doctors)
10:10 – one of the most debilitating diseases we face
10:25 – a large portion of the gut has been removed due to a surgical event
10:30 – end results is a major impact on the quality of life b/c patients are no longer able to absorb food or fluid normally
10:55 – some patients are on life-long parenteral support
11:20 – 4 major reasons for leading patients to this post surgical anatomy of SBS:irreversible inflammatory disease, unresponsive chrons, automobile accident, congenital diseases
12:15 – With SBS, I go so much I have no life, I always have plastic bags with me
12:30 – current treatment options – very important to maintain peripheral nutrition (PN) and IV support
14:50 – All GLP-2 analogues work the same – the require a long time to work (several months to years)
17:00 – SBS patients have no GLP-1
17:25 – Primary purpose of GLP-1 is to slow the upper gut down
18:40 – everytime normal people eat, GLP-1 is released by the ileum (which slows the food down so nutrients can be absorbed)
19:30 – GLP-2 analogs do not appreciably glow down the food in the gut
Carol Rees Parrish, MS, RDN
21:55 – SBS has tremendous quality-of-life toll
22:05 – diarrhea is the most common complaint of patients, pts can’t go out b/c they have to know where a bathroom is
23:00 – too much diarrhea leads to low urine output, which sets patients up for kidney stones and kidney damage
23:50 – not only will you mal-absorb patients, you can mal-absorb medications
Dr. Patrick Griffin – Chief Medical Officer
38:35 – even patients taking 3-4 anti-diarrhea medications don’t have relief from incessant diarrhea associated with SBS
38:90 – We believe NM-002 addresses the root cause of SBS diarrhea
39:00 – With SBS, the Ileal brake is missing
41:40 – NM-002 has a half-life of ~170 hrs vs 2 hours for Exenatide
49:30 – Patients in the 1b/2a study had a reduction in Bowel Movement Frequency (this is very good)
51:25 – The pain score, which is usually high with SBS patients, improved such they were normal with the US population
52:20 – Study met its primary objective
53:03 – drug showed rapid improvement in a clinically relevant output (Total Stool Output)
53:20 – Avg TSO reduction of 42% from baseline – This is quite remarkable
53:30 – Efficacy was seen with both the 1st and 2nd dose
56:59 – meal related diarrhea can be a real problem – patients have to run to the bathroom minutes within taking in food
57:05 – nocturnal diarrhea can result in patients going to the bathroom up to 8x a night. But some patients in the trial went to the bathroom only once per night with some saying they slept better than they have in a long time.
1:01:38 – For Phase 2 We have 5 trial sites and 2 backups
1:01:45 – Initiation is on target for 2Q 2021
1:05:35 – Q&A