Tuesday, February 02, 2021 11:00:55 AM
DD
I'm going to write my DD in a style that Deadnsyde preaches. In his previous video, he mentioned about the 'cushions' that he takes into consideration whenever investing in a stock. This company has quite a few cushions that I think makes it a pretty safe yet high reward play.
The company is Iterum Therapeutics and their main product is Sulopenem. A little bit about the product:
"Sulopenem was discovered in the laboratories of Pfizer Inc. in the 1980s and was first developed with an intravenous (IV) formulation only. The company completed an extensive pre-clinical program, followed by human studies. Later, an oral formulation was developed and tested in Phase 1 and Phase 2 trials.
Although the results were encouraging, development of sulopenem was abandoned when Pfizer shifted focus towards other therapeutic areas.
In November 2015, Iterum successfully negotiated the license of sulopenem and its prodrugs and restarted the development program. The company is now planning its Phase 3 program.
Sulopenem is the first oral and IV penem antibiotic demonstrating a potent spectrum of activity against multi-drug resistant gram-negative infections in both the hospital and community settings"
So in a nutshell, this company is reviving a product that was developed by Pfizer in the 1980s. It wasn't that the product wasn't successful - Pfizer just had too many other areas to focus on at the time and it got canned.
As for the cushions in order:
Cushion #1:
- The company is expected to meet Nasdaq 180 day compliance (price has to remain above $1 for 10 consecutive days) and this will happen either today AH or tomorrow.
Cushion #2:
- The NDA acceptance is set to happen later this month. We only have ~6 trading days until next week closes. The NDA is likely to be approved as pre-NDA discussion went very well. They weren't successful in their previous FDA discussions but they've figured out how to work through them. It wasn't an issue with the drug but just the way they held the trial. Here's the pre-NDA positive discussion from last year:
https://ir.iterumtx.com/press-releases/detail/48/iterum-therapeutics-announces-positive-pre-nda-meeting-with
NDA officially submitted in Nov 30
https://www.iterumtx.com/news/press-releases/detail/53/iterum-therapeutics-submits-new-drug-application-to-u-s
Cushion #3:
- Sarissa Capital owns ~30% and they're about to exercise a ~60% ownership very soon. Sarissa's run by Alex Denner. This guy's a living legend in the biopharma world based on my DD. Here's his insane profile:
"Alex Denner, Ph.D., has been investing in healthcare companies for the past two decades. In 2013, he founded Sarissa Capital Management to capitalize on the compelling opportunities for positive shareholder activism created by the unique dynamics of the healthcare sector.
Dr. Denner has led Sarissa’s involvement in some of biopharma’s most successful strategic transactions and activist campaigns, including the sales of Idenix to Merck and ARIAD to Takeda and the spinoff from Biogen and subsequent sale of Bioverativ to Sanofi.
Prior to founding Sarissa, Dr. Denner was the healthcare portfolio manager of Icahn Capital. At Icahn, he developed Icahn’s activist strategy in healthcare and was responsible for some of the firm’s most successful investments, including ImClone, Genzyme, Amylin, MedImmune, Biogen and Forest Laboratories. Prior to joining Icahn, he was a healthcare portfolio manager at Morgan Stanley Investment Management and at Viking Global.
Dr. Denner currently serves as a director of Biogen and as Chairman of The Medicines Company. He previously served as Chairman of ARIAD and director of Amylin Pharmaceuticals, Bioverativ and ImClone. Dr. Denner received his S.B. degree from the Massachusetts Institute of Technology and his M.S., M.Phil. and Ph.D. degrees from Yale University."
Being an activist, his focus is to spearhead the transformation of a company to a highly successful state then sell them to a big pharma company. To me, that's exactly what he's trying to do here with ITRM.
Cushion #4:
- Institutional ownership. ~70%. You don't see this type of ownership level very often with small cap biopharma companies.
Please do your own DD on this company but I really like the potential growth of this company based on what I've found so far.
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Recent ITRM News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/13/2024 11:30:38 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 11:15:13 AM
- Iterum Therapeutics Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/13/2024 11:00:00 AM
- Iterum Therapeutics to Report First Quarter 2024 Financial Results on May 13, 2024 • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem • GlobeNewswire Inc. • 04/29/2024 12:00:00 PM
- US Stock Futures Stable in Pre-Market On Path for Consecutive Quarterly Gains, Oil Prices Rise • IH Market News • 03/28/2024 11:42:00 AM
- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 03/28/2024 11:00:00 AM
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- Iterum Therapeutics to Participate in H.C. Wainwright Virtual @Home Fireside Chat • GlobeNewswire Inc. • 03/15/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 01:16:14 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 12/29/2023 09:30:15 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 12/14/2023 12:45:02 PM
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