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Will see if its more than just traders. They need to sh!t or get off the pot pretty soon.
Was some nice share price climbing today. alot of buys
If they can parter up or do something to get them restarted in a new Phase 3 is about the best we can hope for here.
Strange... buyout or something acting like Quiet Period...
You'd have to wonder what else is going on here.
Still waiting . . .
Remember when I said this was going to a $0.25?
While I certainly hope you're right, I'd like to see the company's plan for gaining the necessary data to get the regulators to reconsider their decision before the end of 2022. If they have such a plan, and the regulators agree, double digits in 2022 is certainly possible.
I believe that approvals will be in the future, I just don't know how far in the future and am not convinced it will be in 2022.
Gary
I disagree. This is one approval from $17.26 premarket. I have 11 all in’s I am thinking about for 2022 and this is in top 3
$6 by March 2022.
I’ve got a truck of cash for anyone at $0.29. Cya soon. Xoxo
I bet the SEC has some algo programs that can test the barcoding and detect manipulation. Hope they are looking at this ticker...
$ITRM setup a nice base today to go to dollarville, imo
First sign of life in DAYS.... amazing started moving immediately following FED.... decision not sure why the fed should matter too much here.
This is beyond tax loss selling... The daily trading is almost always right there balanced buys to sells. They are running a program and keeping this down hard core.... There is lights at the end of the tunnel... once again all the complete corruption was exposed here when the 40 % pop happened and on the COVID trial discovery day and at open buyers were ready to load the train hard and the MM's Bid Whacked this down like an anchor was attached lower than it even started the trading from the day before.
This is PURE MANIPULATION I don't care if others believe it and want to just the usual excuses but TAX loss isn't responsible for this not ever being able to progress up.
I think Corey Fishman should have some explaining to do to. I am not sure why he seems to be okay letting shorts mutilate my companies PPS.
Tax loss selling will continue until the end of the year. Then you might see some buying back in after 31 days of sale date.
Maybe not.
Drop a BEAR TRAP PR... BULLs need to regroup and take this stock back... Period company is back on track to go at FDA and been secretly working on COVID drugs in trials.
News Today get ready for this company to start finally delivering updates
https://www.iterumtx.com/news/press-releases/detail/81/iterum-therapeutics-appoints-sailaja-puttagunta-md-as
No Way on Earth Company hasn't gotten updates on FDA status yet.
Stock pricing makes zero sense nothing organic about it. Year tops till full FDA approval almost a guarantee that next time FDA will have to approve if they work on the trial set up with ITRM and they have cash till 2023... So why would there possibly be all these sellers at .4581 today..
GOT TO BE NAKED SHORTING.... why we don't get any squeeze run ups they just flood more shares and with running an algo that will trade between the bid and ASK never allowing the ASK to get ahead Bulls are unable to make any progress..
VERY SEC TIP LINE WORTHY ...
Did thet get notice yet for being under 1$?
From this Article... wow
The Urinary Tract Infection Treatment Market has emerged as one of the most profitable businesses on the planet. The market has experienced significant growth as a result of abundant raw materials, rising population, expanding regions, rapidly rising demand, and advanced technologies. Analysts predicted that the report would be performed vigorously in the coming phase after studying the market at a minute level.
https://chipdesignmag.com/urinary-tract-infection-treatment-market-detailed-in-new-research-report-2021-cipla-ltd-bayer-ag-pfizer-glaxosmithkline-boehringer-ingelheim/
https://seekingalpha.com/article/4468899-iterum-therapeutics-plc-itrm-ceo-corey-fishman-on-q3-2021-results-earnings-call-transcript
Iterum Therapeutics plc (ITRM) CEO Corey Fishman on Q3 2021 Results - Earnings Call Transcript
Nov. 12, 2021 10:57 AM ETIterum Therapeutics plc (ITRM)
Q3: 2021-11-12 Earnings Summary
EPS of -$0.03 beats by $0.01 | Revenue of $0.00 beats by $0.00
Iterum Therapeutics plc (NASDAQ:ITRM) Q3 2021 Earnings Conference Call November 12, 2021 8:30 AM ET
Company Participants
Corey Fishman – CEO
Louise Barrett – Senior Vice President Legal Affairs
Judy Matthews – CFO
Conference Call Participants
Gregory Renza – RBC Capital Markets
Thomas Yip – H.C. Wainwright
Operator
Hello and welcome to the Iterum Therapeutic Q3 Financial Results Conference Call. My name is Alex and I will be your operator for today. [Operator Instructions] I'll now hand over to your host, Louise Barrett, Senior Vice President for Legal Affairs. Louise, over to you.
Louise Barrett
Thank you, Alex. Good morning, and welcome to Iterum Therapeutic's Third Quarter 2021 Financial Results and business update conference call. A press release with our third quarter results was issued earlier this morning and can be found on our website. We're joined this morning by Corey Fishman, CEO, and Judy Matthews, CFO. Corey will provide some opening remarks, Judy will provide some details on our financial results, and then we will open the lines for Q&A. Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning our plans, strategies, and prospects for our business, including with respect to planned interactions and communications with the FDA, and our ability to reach agreement with the FDA on the design of any potential future clinical trials. Our expectations with regard to our ability to resolve the matter set forth in the complete response side of receipts in July 2021, and obtain approval to for sulopenem, the conduct of potential future clinical and non-clinical development of sulopenem, and the sufficiency of our cash resource to execute on our strategy. Actual results may differ materially from those indicated by these forward-looking statements.
As a result of various important factors including; uncertainties inherent in the initiation, conduct of clinical and non-clinical development, availability and timing of data from such clinical trials and non-clinical development, the timing or likelihood of Reg SEC filings and approvals, including the potential lease of mission of our NDA for oral suitor panel, changes in public policy or legislation, the actions of third-party clinical research organization, suppliers and manufacturers, the accuracy of our expectations regarding high far into the future, the Company's cash on hand will fund our ongoing operations, including completing potential additional clinical and non-clinical development of orals sulopenem, the impact of COVID-19 and related response measures thereto, our ability to maintain our listing on the asset capital markets and other risk factors set out in our filings with the SEC, including our most recently filed quarterly report on Form 10-Q. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We have provided reconciliations of GAAP reported to non-GAAP adjusted information in the press release issued this morning. With that said, I'll turn it over to you, Corey, for your opening remarks.
Corey Fishman
Thanks, Louise. Welcome and thank you for joining us today. I'll be providing a brief update this morning. As we previously mentioned, we had requested a Type A meeting with the FDA to discuss our complete response letter that we received in late July. We recently had that meeting and the FDA informed us that in their opinion, the totality of our NDA package was not sufficient to warrant approval for oral sulopenem at that time, even though they acknowledged that sulopenem showed statistical significance in the overall response rate by treatment arm against ciprofloxacin in the ciprofloxacin-resistant population in the treatment of uncomplicated urinary tract infections. We then discussed with additional clinical work would be required in order to have a package that they deemed potentially adequate for approval, assuming the trial results were successful. The FDA feedback received with that one additional Phase III clinical trial should be sufficient, subject of course to reaching agreement with the FDA and the design of that trial. We have since requested a Type B meeting with the FDA to discuss the details of that additional trial, including the protocol, endpoints, and other relevant factors.
Our hope is that after this meeting, which we expect to occur around year-end, we will have clarity on all major aspects of the additional trial required to support potential re-submission of our NDA and be able to work expeditiously to get that study enrolling patients in the first half of 2022. It's important to note that given the urgent unmet medical need for new oral treatments for uncomplicated urinary tract infections, We remain confident in the value of oral sulopenem to treat multi-drug resistant infections, and strongly believe sulopenem could be an important and valuable product for physicians and patients. Lastly, I'll spend just a moment on our cash position and outlook. We ended Q3 with a strong cash balance of approximately $86 million on the balance sheet. Based on our latest forecasts, we anticipate this cash balance will fund the Company into 2024 and allow us to complete the proposed additional clinical development of sulopenem to support, if successful, the re-submission of our NDA to the FDA for the treatment of uncomplicated urinary tract infections. Now, I'll turn the call over to Judy for details on our financial results.
Judy Matthews
Thanks Corey. Total operating expenses were $4.9 million in the third quarter of 2021 compared to $6.3 million in the third quarter of 2020. Operating expenses include research and development expenses, and general and administrative expenses. R&D costs were $1.8 million for the third quarter of 2021 compared to $3.9 million for the same period in 2020. The R&D category includes expenses for our clinical and development programs, our CMC costs, and our regulatory expenses. The primary driver of the $2.1 million decrease in R&D costs was the completion of our Phase III program in 2020. G&A costs were $3 million for the Third Quarter of 2021, which is $600,000 higher than G&A costs of $2.4 million in the Third Quarter of 2020, due primarily to higher share-based compensation for employees and directors.
Moving onto non-operating item. Interest expense was $800,000 for the Third Quarter of 2021 compared to $4.2 million in the Third Quarter of 2020. The primary reason for the $3.4 million decrease in interest expense was non-cash interest expense associated with a lower exchangeable note balance of $12.6 million as of September 30, 2021 versus $51.8 million as of September 30, 2020. On a strictly cash basis, we paid interest related to our term loan with FCB of approximately $90,000 in the third quarter of 2021 versus approximately $220,000 in the third quarter of 2020. The reduction in cash interest is largely due to a lower principal balance on our term loan as monthly amortizations began in the Fourth Quarter of 2019 and will continue until our final payment in March 2022. As of September 30, 2021, there was a remaining balance of $3.2 million on our term loan with FCB.
Our net income on a US GAAP basis of $3.7 million was driven by a $9.8 million non-cash adjustment to record a decrease in the value of the derivative components associated with our exchangeable notes as a result of a decrease in the price of our ordinary shares and market capitalization during the period. There was no impact of this adjustment on cash or cash runway, which I will turn to in a moment. On a non-GAAP basis, which excludes certain non-cash adjustments, including adjustments to record derivatives at a fair value, a net loss of $5.2 million in the third quarter of 2021 was $1.8 million less than our non-GAAP net loss of $7 million in the third quarter of 2020 as a result of the lower operating expenses previously discussed.
At the end of September, we had cash and short-term investments of $85.7 million. Based on our current operating plan and subject to final determination of the design and planning conduct of potential additional clinical and non-clinical development for sulopenem, we have cash into 2024. As such, we anticipate that our existing cash will be sufficient to allow us to complete the proposed additional development of oral sulopenem to support, if successful, a re-submission of the NDA to the FDA for the treatment of UUTI. As of September 30, 2021, we had approximately $183 million ordinary shares outstanding. Also as of the end of September, we had $7.2 million warrants outstanding at an average price of $1.61 per share and $12.6 million of exchangeable notes, which can be exchanged for approximately 18 million shares, which includes accrued interest at the option of the note-holder. Now I will turn it back over to Corey for some closing comments.
Corey Fishman
Thanks, Judy. We'd like to take a moment and just open the lines up for questions now.
Question-and-Answer Session
Operator
Thank you. We will now proceed with the Q&A. [Operator Instructions] Please ensure you're unmuted likely when asking a question. Our first question for today comes from Gregory Renza from RBC Capital Markets. Gregory, your line is now open.
Gregory Renza
Good morning, Corey. Thanks for taking my question and look forward to all the upcoming progress. Corey, as you head into the Type B meeting, I'm just wondering if you could provide us with, perhaps, what your base case is on a trial design or any additional color at this point That you could touch on to just help us understand and maybe even baselining it to perhaps share one how you're thinking about that in size and scope. And then just second question it's just around certainly a great deal of data you've generated already. I'm just curious if you have plans or how are you thinking about kind of reengaging the clinical and medical community and maybe sharing that data in parallel as you initiate a second pivotal trial. Thank you very much.
Corey Fishman
Sure. Thanks, Greg, for the questions, appreciate it. With regard to the first question, we really don't have a lot of details that are in a state that we're able to share yet regarding the study design simply because we have not yet solidified with the agency what that study design will be and I'd rather not share our thinking now and then have to come back to you all and say, well, the FDA said this and they said that and we have to change it. Suffice to say that we will be doing a study per the guidance that FDA has issued a couple of years back for those trials and uncomplicated urinary tract infections, and our goal of the Type B meeting is to work with them on the specifics of that. We also aren't just sitting on our hands as you'd imagine; we have begun conversations with a number of external vendors, including CROs to talk about the generalities, talk about the sites, talk about -- we don't have specific shift to be able to say, here's exactly what we want to do, but we've begun all those conversations and our CMC team has been working very hard on making sure we have plenty of clinical supply, which we do, and figuring out the timelines for all of that to be able to get us to start this study in the first half of next year.
I think that's probably as much as I can tell you that is valid and important for now. With regard to your second question, which was regarding the data, I agree with you and we do actually have a plan to reengage in the medical community talking about the data that we've generated because as you know, it is very strong and we have a great deal of data in uncomplicated UTI. And we also have data in complicated UTI as well that I think is interesting and important and certainly was supportive. And we want to make sure we get that out to the physicians, to the KOLs. And so we'll be working on presentations for upcoming meetings and conferences, as well as manuscripts to try to least help people understand the data that was generated, why we feel so good about the fact that we believe very strongly that this drug works well. And just figuring out how to get that into the hands of the physicians. And treating physicians and KOLs at the appropriate time is certainly on our radar for what we will be doing here over the next 6 to 12 months.
Gregory Renza
That's really helpful Corey, I appreciate all the color.
Corey Fishman
Thanks Greg.
Operator
Thank you, Gregory. Our final question for today comes from Ed Arce from H.C. Wainwright. Ed, your line is now open.
Thomas Yip
Good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. Happy to see that sulopenem is back on track. Perhaps first we would like to narrow down the bidding timelines. Can you tell us when was the request formally accepted and when do you expect the meeting to take place?
Corey Fishman
We put the request in I want to say probably 1 to 2 weeks ago and we're expecting given that timeline, that the meetings should be granted around the end of the year. We'll provide more data as we get a solid date on that and have that conversation, but it should be in that year-end timeframe and that should allow us Thomas to be able to continue our planning as we've started to get this study up and running and importantly, as we've talked about, I think having the capital to do that is incredibly, important for the Company. So we are in a position that's pretty favorable from that standpoint.
Thomas Yip
Yes. Understood. As you alluded to earlier, details for the new Phase III, you prefer not to discuss well ahead of the Type B meeting. Have you given any thoughts on specific geographical location that you would like to focus on to open sites and considering the ongoing impact of COVID-19?
Corey Fishman
Yes. It's a really good question, and it's actually one of the things that our clinical folks, as well as the rest of our team have been talking to the CROs. As I mentioned, we've started the conversation to better understand what's happening in various geographies. And that is -- from our perspective, that's not only in the US geographies, but also in other countries. Historically, what we had done was predominantly in the US for the uncomplicated UTI study, and we will continue to look at that as an option, but we will also look at other countries where there is an opportunity to get the highest quality work done in the most efficient time manner, which is of course what everybody does when they're looking at a study. But as you said, in the COVID world, that can be a little bit different. And so we're going to be sure that we are working with the CROs to understand what the flexibility is in various geographies here, as well as other countries to be sure that we've got the best sites from a quality standpoint, but also from a timeline standpoint. It is an important consideration that we're taking into account as we look at who we choose in terms of a CRO and also the timelines for that study.
Thomas Yip
Okay. That makes sense. Perhaps one last question. This one's for Judy. We know this, that the cash runway estimate, it was previously into second half of 2023 and now it's into 2024. Can you outline some main factors that led to this adjustment?
Judy Matthews
We had a little more specificity internally about the type of trial that we might run and the cost. So we were able to build that in a little more specifically than -- and as you know, there has been no financing since the last quarter. But we just have some more specific estimates as we've begun working with the CROs and have been doing some planning during the last quarter.
Thomas Yip
Got it. And just to confirm that you just said that your current cash holding is sufficient to see this entire Phase III trial through.
Judy Matthews
Right through the Phase III that we plan as well as a re-submission to the FDA.
Thomas Yip
Okay. Got it. Thank you, Judy and Corey for taking our questions. We look forward to your final details of this new Phase III study.
Corey Fishman
Thanks, Thomas
Judy Matthews
Thanks, Thomas.
Operator
Thank you. That concludes the Q&A session. I will now hand back over to Corey Fishman for any closing remarks. Corey, over to you.
Corey Fishman
Thank you very much. I just want to take one more moment to say thank you again to all the folks on the call for joining us today. We appreciate the continued support. As stated earlier, we remain very confident in the value of oral sulopenem to treat multi-drug resistant infections. We will continue to work collaboratively with the FDA to provide the additional clinical data requested in the complete response letter that we received in July to support the approval of oral sulopenem as an important treatment option for physicians and patients. And perhaps most importantly, we expect our existing cash will allow us to complete the additional development of sulopenem to support, if successful, the re-submission of the NDA to the agency. So we are in a very good position from a cash perspective to get that work done without the need for additional financing. Thanks again to everyone and have a great day.
Operator
Thank you for joining today's call. You may now disconnect.
There numbers on dates and dollars look reasonable, though will be a bit tight so I would not be surprised with a modest raise in a year or so if the PPS supports it.
For the trial, I really hope they run a trial in patients not suitable for cipro with solupenam vs all comers with a non-inferiority endpoint. They might know enough to select a better subset, but that will be a smaller label so less upside.
Next significant news should be late Dec or early next year when they disclose the trial details.
Iterum(ITRM) Therapeutics EPS beats by $0.01
https://seekingalpha.com/article/4468899-iterum-therapeutics-plc-itrm-ceo-corey-fishman-on-q3-2021-results-earnings-call-transcript
Check out this you tuber's targets here.
Start the Party,,, ER this Friday....
Looks like that worked. Very cool, thanks Johnston.
I submit the change to a admins through the moderator portal see what happens..
To iHub Admins - can you please capitalize itrm (ITRM) stock ticker in the board name? Thanks!
I left a support request to one of the iHub admins. I am not a mod, but anyway.
minor issue - could one of the Mods get Admin to change things so that the symbol shows in caps ("ITRM") like all the other boards instead of "itrm"? TIA
The path forward on their oral penam is what matters here. Good to see them actually having the decision on this.
Hopefully they will describe a specific trial they plan to run. Ideally one that would give them a broader label than the previous trial would have by being able to show NI to one (or more) of the non-cipro drugs.
Be interesting to see how this plays out. Could be the first glimmer of light since the letter.
Have zero interest in that Covid trial.
Conference Call BOOM... finally get some info... better take questions.. what the hell was going on with COVID DRUG
https://www.stonkmoon.com/news/ITRM/1c7c2e1ccbae5de5ea3e74b6d590c3eb
ITRM -
0.59
+ 4.24%
(+0.17%)
extended hours
2021-11-05 07:00:00 ET (3 hours ago)
Iterum Therapeutics to Provide Business Update and Report Third Quarter 2021 Financial Results on November 12, 2021 Iterum Therapeutics plc
DUBLIN, Ireland and CHICAGO, Nov. 05, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company will release its third quarter 2021 financial results before the open of the U.S. financial markets on Friday, November 12, 2021. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company’s financial results and provide an update on its business.
To access the call please dial 844-200-6205 (domestic) or 929-526-1599 (international) and refer to Access Code 442364. The audio webcast can be accessed under “Financials & Filings” in the Investors section of the Company’s website at www.iterumtx.com following the call.
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem also has an IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit .
Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company’s control, including uncertainties inherent in the initiation and conduct of clinical and non-clinical development, including any additional trials that may be conducted in response to the Complete Response Letter received by the Company in July 2021, availability and timing of data from such clinical and non-clinical development, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, including the potential resubmission of a new drug application for sulopenem etzadroxil/probenecid, change
Good, because the shorts always seem to have the inside line on this so hopefully it means. There is a big catalyst about to happen.... wish some whale would step up and create a MOASS here because this is heavily shorted......
Could be an easy one of those tickers that shoots up 300% the way this has been coiled down.... so badly
Seems like it's starting to get ready to go with shares being bought and shorts being covered very quietly.
Going Green... See some shorts cover and this flys.
This other company in same situation going this route... another one that had safe trials with good results but denied by FDA the same month as us.
https://finance.yahoo.com/news/ardelyx-pursue-formal-dispute-resolution-120000673.html
Hedges going to start loading up here or what? How is this not the bottom?
I just added 6k shares minutes ago
Join u here ....loooks bottom
Lots of BagHolders whining about shorts and posting links with veiled threats… YAWN… The truck is set to back up between 12/1/2021-12/31/2021. $0.37-42. Then poof it will go to $3.89.
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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.
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.
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