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Iterum Therapeutics (itrm)

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Last Post: 3/8/2021 9:57:04 AM - Followers: 81 - Board type: Free - Posts Today: 2

ITRM Website https://ir.iterumtx.com/press-releases/detail/58/iterum-therapeutics-announces-u-s-fda-filing-acceptance-of

ITRM Corey Fishman CEO discusses ITERUM and Sulopenum. He also tells you his last 2 companies and how they developed the drug and sold the company lol. It is clear as day the plan here. https://youtube.com/watch?v=w2nbF_kb5Gw&feature=youtu.be

 

Lengthy DD on $ITRM - Sarissa Capital, Alex Denner, and the case for a Billion Dollar buyout opportunity

 

 

Fellow penny flippers, a week or 2 ago, someone posted about ITRM and it grabbed my attention immediately. Partially because its a Bio stock and another reason is the technical setup/gaps looked promising. I have dived into the company further and posting my DD:

Provide DD for bullish sentiment

 

Iterrum Therapeutics is a Biotech company backed by some very well known prominent industry veterns / team. There primary product is Sulopenum which is developed by Pfizer in the 1980s, shelved due to Pfizers other product focus. ITRM's staff is compromised of the well known bio legend - Alex Denner who owns Sarissa Capital. Alex Denner is more prominently known as the head of Carl Ichans bio division who spearheaded his portfolio and knows the Bio industry inside/out. Denner left Ichan's bio portfolio to spinoff Sarissa Capital and leverage his decades of knowledge. Sarissa Capitals' main focus in investing in bio stocks with the intention of buyouts (Denner & MDCO --- Medicines company buyout $9.7 billion.

A large majority of ITRM staff and board are from a very well known company back in 2005 Duratta / Vicuron boards. Back in 2005, Vicuron was developing a drug that passed the NDA for andidulafungin for fungal infections. Pfizer jumped in after NDA approval and bought Vicuron out for $1.8 billion as it was a revolutionary drug.

source: Pfizer buy out Vicuron $1.9 billion merger

What ended up happening at Pfizer was Vicuron had to now go through FDA approvals. From the little research available back then, it appears Vicuron ended up getting shelved as there was a lot of R&D involved and too expensive to push forward (Dunne link below shows Pfizer splitting off from R&D, trial, FDA approval costs). Vicuron ended up being bought by Durata (source: https://www.pharmaceutical-business-review.com/news/durata_acquires_vicuron_from_pfizer_091221-2/. Duratta picks up where Pfizer left off, conducted the studies, R&D, and NDA/FDA process. When Vicuron's drug become close, Duratta reached back out to Pfizer to continue the trial study to keep moving forward. Pfizer had to fork up another $6million apart of their licensing deal

(source: Faded star at Pfizer leads to discounted $68M IPO for Durata

What ended up happening 2 years later in 2014? Actavis buys out Durata for $675 million @ $23 a share, prior to buyout, stock was trading at $11. (source: Durata stock graph.

source: Actavis snaps up Durata, newly approved antibiotic in $675M buyout

After this buyout in 2014, ITRM was formed. A large amount of the Board of Directors, Senior Management are from the previous buyout. There prior Durata employees and now focusing their efforts on ITRM.

source: ITRM Board of Directors & Senior Mgmt

Sulopenum

Pzier chief scientist Michael Dunne left Pfizer to work at ITRM. He was the scientist behind a lot of Pfizer's major drugs. He currently resigned from ITRM for a new opportunity -- working as Chief Scientist at the Bill & Melinda Gates Foundation. Back in 2017 as he was speaking on behalf of ITRM / Sulopenum, he had a very strong positive sentiment to the drug when it gets the NDA / FDA passed:

While this is an old compound, sulopenem has good patent protection. The IV product should garner ten years of regulatory exclusivity in the U.S. due to its status as a “Qualified Infectious Disease Product”. Given that the oral form of sulopenem is an NCE, patent protection for this version exists through 2028 with the possibility of Hatch-Waxman as well as pediatric use extensions.

Source: Former Pfizer Scientist Is Resurrecting Projects To Solve The Multidrug Resistant Bacteria Problem

NDA Approval

NDA approval is set for end of January or potentially first week of February. They had a preliminary meeting back in Sept 2020.

Positive Pre-NDA Meeting with FDA for Sulopenem - 95% approval from ITRM Board

The same board members, staff, and ties on the Duratta deal are now working at ITRM. Almost all of ITRM employees are from Durrata. During the NDA filing review, Pfizer had some senior members during the NDA review with FDA (pre filing). Some names -- Treacy Vargas (worked at Pfizer for 17yrs, retired, and ITRM brought her out of retirement to be head of their submission applications). They brought her in on contract, then after they submitted the NDA in October, she left.

Treacy Vargas

Sarissa Capital & Alex Denner

Alex & Sarissa are known from above link and many others of turning Bio companies in to large profitable buyouts. Sarissa currently owns 33% of ITRM with a special clause for obtaining 60% total ownership of the outstanding shares.

Sarissa discloses 33% ownership of ITRM

Alex& Sarissa have a clause where after Jan 21, they can invoke the exchange of exchangeable notes to take FULL ownership of ITRM after NDA approval. Sarissa AGM meeting for exchangeable notes. So they have a additional 27% ish to exchange if they want. Starting of the ability to exercise I think is Jan 21 from the filing: ITRM AGM Meeting & Sarissa Ownership clause vote

Current outstanding shares is roughly 70-85% are owned by Sarissa, RA Capital, and other institutions / insiders.

source:ITRM Share distribution / ownership

SO WHAT?

If you haven't read between the lines this far and clued the pieces together, this may be a potential buyout under the covers. Past Durata employees are familiar with what it takes to pass NDA / FDA approvals. Chief Scientist Michael Dunne has been developing this drug and trials since 2015, he also advocates that a NDA approval and distribution would cause this drug to have a EconomicMoat (Warren Buffet talks a lot about Economic Moat companies).

The potential here is after NDA and possibly prior to the FDA or PDUFA approval in Mar/Apr, this could have Pfizers eye along with a few large pharma companies. The current market cap of ITRM is around $100 million which is absolutely peanuts when compared to a blockbuster drug (500-1billion market cap). This could potentially mean a large buyout anywhere from $10-20 / share. However a fair warning, this is very speculative play but given the consensus of Durata previous staff now at ITRM, Pfizer drug that is in a market sector that has no new competitor in 20years, and Sarisa / Alex Denner eyeing for a ownership stake of ITRM, the sentiments are pointing to a positive influx of catalysts over the coming months.

This is a 1st mover advantage in a market that has traditionally been stagnant. My wife works in the medical field and a lot of the verbage is confusing, so I had her review Supolenum. Her findings were this is a fairly well received new drug and something that is much needed in the space. General UTI drugs have terrible side effects and cause intestine and gut bacteria which results in additional anti-biotics. Selopenum has similar side effects, however, much lower then the older products on the market.

****************************ITRM> Institutional ownership. ~70%. You don't see this type of ownership level very often with small cap biopharma companies
**************************Received a CRL from FDA in July last. Something about revising data submitted. PR from ITRM said they didn't have the financing to complete the study. Sarissa Cap and R A Capital invested in Sept/ Sarissa to the tune of 40% ownership with rights to buy more. (activist investment). ITRM recently applied and was given NDA approval for their drug. PDUFA date for approval of drug is early July 21. The company is set up for a buyout. They only have 4 employees/ no sales staff/ Denner from Sarissa is a turnaround-buyout specialist/ ITRM recently partnered with an outside company to market and sell drug (IMO just to increase buyout price/ and just did a shelf BOUGHT offering, possibly so Sarissa can exercise it's right to buy more (just my theory)/ and by increasing number of shares it also increases buyout price. If they went in to a buyout negotiation with only 4 employees and no sales infrastructure they would get raped on the price, hence the recent moves. Fascinating!

I'm sure someone will correct a fact here or there but that's it in a nutshell.
 
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itrm News: Statement of Changes in Beneficial Ownership (4) 03/03/2021 05:01:29 PM
itrm News: Current Report Filing (8-k) 02/22/2021 04:31:34 PM
itrm News: Iterum Therapeutics to Present in Upcoming Investor Conferences 02/19/2021 05:30:53 PM
itrm News: UTILITY Therapeutics Joins Antimicrobials Working Group 02/17/2021 10:04:00 AM
itrm News: Amended Statement of Beneficial Ownership (sc 13d/a) 02/12/2021 06:22:51 PM
PostSubject
#498  Sticky Note Iterum Therapeutics******** February 2021 ********* Overview swanlinbar 02/13/21 07:24:48 AM
#627   Okay, hope the conference call also touches on Johnstonj27 03/08/21 09:57:04 AM
#626   ITRM-Iterum Therapeutics to Announce Fourth Quarter and Full swanlinbar 03/08/21 08:38:17 AM
#625   Your very welcome...Yes Indeed...hit $1.15 bottom and now georgie18 03/05/21 04:05:23 PM
#624   wow, talk about being right on...thanks for vintagesake 03/05/21 03:52:10 PM
#623   Announcing a Dividend would send them packing... Johnstonj27 03/05/21 12:24:33 PM
#622   Shorts are here. We need news to screw Harbor6460 03/05/21 11:38:54 AM
#621   Patience will pay off...imo...we shall see... georgie18 03/05/21 10:10:48 AM
#620   A lot of people really got F. on Johnstonj27 03/05/21 09:58:55 AM
#619   Been buying dips last couple days and then Johnstonj27 03/05/21 09:58:18 AM
#618   Looks to be about a $1.14 range bottom...Lets georgie18 03/05/21 05:18:16 AM
#617   Dam stock should have gone up a $1.50 Johnstonj27 03/05/21 02:15:56 AM
#616   Yeah, there is some shady attack on the Johnstonj27 03/05/21 02:14:18 AM
#615   This is strange. A lot of tickers are pillskill 03/04/21 09:23:49 PM
#614   If ITRM gets a deal similar to Cubist/Trius Phoenix300 03/04/21 03:46:07 PM
#613   Odd that everything is down about 20% I Johnstonj27 03/04/21 02:19:47 PM
#612   Total disconnect, bio world, what has changed...nothing material IMO Phoenix300 03/04/21 01:51:17 PM
#611   This drop is like un real... no news Johnstonj27 03/04/21 01:50:03 PM
#610   FDA Approval will be a rocket PDUFA date set Phoenix300 03/04/21 01:47:45 PM
#609   Yeah.. serious... like a big WTF? it's Johnstonj27 03/04/21 01:29:28 PM
#608   it acts like there's been another offering or vintagesake 03/04/21 01:28:16 PM
#607   I keep adding but getting crazy low... from Johnstonj27 03/04/21 01:21:12 PM
#606   1.21 better hold vintagesake 03/04/21 01:20:21 PM
#605   Almost 20% of you PPS tanks in a Johnstonj27 03/04/21 01:18:28 PM
#604   been adding to... stupid cheap today Johnstonj27 03/04/21 12:37:28 PM
#603   ITRM added 3000 @ 1.4 glta swanlinbar 03/04/21 11:33:57 AM
#602   Did the CEO shoot someone... crazy going down Johnstonj27 03/04/21 11:17:18 AM
#601   Merciless.... Johnstonj27 03/04/21 11:16:12 AM
#599   Hi georgie...curious what the charts say...bottom in, or vintagesake 03/04/21 10:57:38 AM
#598   Adding. Phoenix300 03/04/21 10:34:17 AM
#597   For weeks they been doing here Harbor6460 03/04/21 10:06:32 AM
#596   Company needs to put out a PR to Johnstonj27 03/04/21 09:54:16 AM
#594   What is with the full blown BEAR ATTACK here? Johnstonj27 03/04/21 09:49:13 AM
#593   Yes, time to go bullish.. should be killing Johnstonj27 03/03/21 05:01:35 PM
#592   What now why tanking again? Johnstonj27 03/02/21 02:10:15 PM
#591   ITRM...$1.77...Bullish Kicking Reversal Pattern to the Upside formed georgie18 03/02/21 06:44:36 AM
#590   All the Futures are Green... Make it a Johnstonj27 03/01/21 09:29:49 AM
#589   Way Undervalued... and stupid to be short on. Johnstonj27 03/01/21 01:07:16 AM
#588   Great post and comparison Vector... learningthetruth 02/28/21 07:58:22 PM
#587   Relypsa was projected to bring in peak annual Vector93 02/28/21 07:49:57 PM
#586   It’s a joke how undervalued and oversold (umm, proftstocksny2 02/28/21 05:28:05 PM
#585   This is being shorted. When news hits we Harbor6460 02/27/21 01:02:32 PM
#584   Undervalued. Phoenix300 02/26/21 04:45:29 PM
#583   if i was a flipper i would be cervelo 02/26/21 11:44:32 AM
#582   sure looks like shorts covering today... Johnstonj27 02/26/21 10:07:39 AM
#581   This is getting very undervalued right now... Johnstonj27 02/26/21 10:04:21 AM
#580   ITRM i quess you are a flipper because swanlinbar 02/26/21 09:02:11 AM
#579   it is a nice article on UTI's, so cervelo 02/26/21 08:45:07 AM
#578   ITRM https://www.cnn.com/2021/02/24/health/uti-wrong-antibiotics-study-wellness/ swanlinbar 02/26/21 07:07:51 AM
#577   Looks like shorts were some how able to Johnstonj27 02/25/21 08:14:48 PM
#576   Wait till word from the conference gets out Johnstonj27 02/25/21 07:20:01 PM
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