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ITRM under $2
Thank you, sir, for the update
ITRM 10Q due March 13
https://stockcharts.com/h-sc/ui?s=ITRM">https://stockcharts.com/h-sc/ui?s=ITRM" />
$ITRM Buying Continues to come in, something Good is in the Works glta
ITRM>Iterum Therapeutics plc (NASDAQ:ITRM) Q3 2023 Earnings Call Transcript November 14, 2023
https://finance.yahoo.com/news/iterum-therapeutics-plc-nasdaq-itrm-172208812.html
ITRM new 52 week high
$ITRM > Iterum Therapeutics to Present Data at ASM Microbe 2023
June 12 2023 - 06:23PM
GlobeNewswire Inc.
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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 three posters will be presented at ASM Microbe 2023 conference.
The hybrid conference will be held from June 15-19 at the George R. Brown Convention Center in Houston, TX.
Data to be presented include:
Presentation title: ß-Lactamase Characterization of Baseline Enterobacterales Pathogens from a Phase 3 Trial of Sulopenem for the Treatment of Uncomplicated Urinary Tract Infection
Presentation type/category: P002-AAR01 Surveillance of antimicrobial resistance in clinical isolates; ß-lactamases (AAR-Friday-410)
Presenter: Steven I. Aronin, MD
Time/location: June 16, 2023, 10:00 a.m. – 5:00 p.m. CDT; Exhibit and Poster Hall B, C, D
Presentation title: ß-Lactamase Characterization of Baseline Enterobacterales Pathogens from a Phase 3 Trial of Sulopenem for the Treatment of Complicated Urinary Tract Infection
Presentation type/category: P002-AAR01 Surveillance of antimicrobial resistance in clinical isolates; ß-lactamases (AAR-Friday-417)
Presenter: Sailaja Puttagunta, MD
Time/location: June 16, 2023, 10:00 a.m. – 5:00 p.m. CDT; Exhibit and Poster Hall B, C, D
Presentation title: ß-Lactamase Characterization of Baseline Enterobacterales Pathogens from a Phase 3 Trial of Sulopenem for the Treatment of Complicated Intraabdominal Infection
Presentation type/category: P002-AAR01 Surveillance of antimicrobial resistance in clinical isolates; ß-lactamases (AAR-Friday-401)
Presenter: Sailaja Puttagunta, MD
Time/location: June 16, 2023, 10:00 a.m. – 5:00 p.m. CDT; Exhibit and Poster Hall B, C, D
These Posters will be made available on the Company’s website on the “Publications: Posters & Presentations” page under the “Our Science” tab once the conference ends.
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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and 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 Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Investor Contact:
Judy Matthews
Chief Financial Officer
312-778-6073
IR@iterumtx.com
ITRM > Dear Iterum Therapeutics plc Shareholder,
You are cordially invited to our Extraordinary General Meeting of Shareholders (“EGM”) to be held at 3 Dublin Landings, North Wall Quay, Dublin 1, Ireland on August 1, 2023 at 3.00 p.m., Irish time (10.00 a.m., Eastern Time).
The purpose of the EGM is to ask shareholders to grant the board of directors an updated power under Irish law to issue shares for cash without first having to offer those shares to existing shareholders under pre-emptive rights that would otherwise apply to the issuance. This pre-emption opt-out proposal is required as a matter of Irish law and is not otherwise applicable to the non-Irish, Nasdaq listed companies with which we compete. Receipt of this authority would merely place us on par with other Nasdaq-listed companies and provide us with the flexibility to undertake the capital raising that we believe may be necessary from time to time to allow us to continue to execute on our business plans and strategy.
The enclosed Notice of EGM and the accompanying proxy statement set forth more detail on the proposal that will be presented at the meeting. Our board of directors unanimously recommends a vote “FOR” Proposal No. 1 as set forth in the proxy statement.
We hope that you will participate in the meeting by voting through acceptable means as described in this proxy statement as promptly as possible. Your vote is important – so please exercise your right.
Sincerely,
____________________________
Corey N. Fishman
President and Chief Executive Officer
$ITRM some Insider Buying showing up !
$ITRM >Iterum Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results
March 16 2023 - 07:00AM
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Iterum Therapeutics plc (Nasdaq: ITRM), 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 reported financial results for the fourth quarter and year ended December 31, 2022.
“We made significant progress in 2022 to move the clinical development of oral sulopenem forward leading to a potential resubmission of our new drug application (“NDA”) next year,” said Corey Fishman, Iterum’s Chief Executive Officer. “Enrollment in our REASSURE trial, which is being conducted under a Special Protocol Assessment (“SPA”) agreement with the U.S. Food and Drug Administration (“FDA”), is expected to be completed in the first half of 2024.”
Highlights and Recent Events
Enrollment in REASSURE Clinical Trial Ongoing: Iterum began enrollment in its pivotal Phase 3 clinical trial, REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales), for the treatment of uncomplicated urinary tract infections (“uUTI”) in adult women in October 2022. Enrollment is ongoing and expected to be completed in the first half of 2024. An interim analysis at 50% patient enrollment is expected to occur in the second half of 2023. This trial is being conducted under a SPA agreement with the FDA. The SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of Iterum’s NDA for oral sulopenem.
Two New U.S. Patents Issued: The United States Patent and Trademark Office has issued Iterum two new patents: 1) US Patent No. 11,478,428, directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (“oral sulopenem”) and its related uses, and 2) US Patent No. 11,554,112 directed to the method of use of oral sulopenem in treating multiple diseases, including uncomplicated urinary tract infections. These U.S. patents are scheduled to expire no earlier than 2039, excluding any additional term for patent adjustments or patent term extensions. Existing patent protection for sulopenem etzadroxil is scheduled to expire in 2029, subject to potential extension. Iterum’s patent portfolio also contains pending patent applications outside the U.S., including Europe and China, submitted following receipt of the Written Opinion of the International Search Authority indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive.
Shareholder Lawsuit Dismissed: On January 25, 2023, the putative class action lawsuit filed against Iterum, its Chief Executive Officer and Chief Financial Officer in the United States District Court for the Northern District of Illinois on August 5, 2021, was dismissed and cannot be brought back to court (dismissed with prejudice).
Fourth Quarter and Full Year 2022 Financial Results
Cash, cash equivalents and short-term investments were $60.8 million at December 31, 2022. Based on the current operating plan, Iterum expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations until mid-2024. As of February 28, 2023, we had approximately 12.6 million ordinary shares outstanding.
Research and development (R&D) expenses for the fourth quarter and full year 2022 were $5.8 million and $17.6 million, respectively, compared to $3.7 million and $10.7 million for the same periods in 2021. The increase for the three-month period was primarily due to an increase in costs to support our REASSURE trial, which began enrollment in October 2022, partially offset by lower non-cash amortization of an intangible asset. The increase in R&D expenses for the full year was primarily due to the REASSURE trial, including an increase in headcount to support trial activities, partially offset by a decrease in consulting fees for R&D activities in 2022. Consulting fees for the year ending December 31, 2021 primarily related to consultants used during the FDA review of our NDA for oral sulopenem.
General and administrative (G&A) expenses for the fourth quarter and full year 2022 were $2.0 million and $12.8 million, respectively, compared to $3.1 million and $13.8 million for the same periods in 2021. The decrease for the three-month period was primarily due to a decrease in share-based compensation expense. The decrease for the full year period was primarily due to lower consulting fees used to support pre-commercialization activities versus the prior year, partially offset by an increase in compensation and headcount and an increase in legal fees associated with the lawsuit filed in August 2021 and dismissed with prejudice in January
2023.
Adjustments to the fair value of derivatives for the fourth quarter and full year 2022 were $3.0 million and $5.5 million, compared to $3.6 million and ($61.0) million for the same periods in 2021. The non-cash adjustment in the fourth quarter and full year 2022 primarily related to a decrease in the value of the derivative components associated with Iterum’s 6.500% Exchangeable Senior Subordinated Notes due 2025 (the “Exchangeable Notes”) as a result of a decrease in the price of its ordinary shares and market capitalization during the period. In addition, during the fourth quarter of 2022, a change in the discount rate impacted the fair value of the Limited Recourse Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”). The non-cash adjustment in the fourth quarter of 2021 primarily related to a decrease in the value of the derivative components associated with the Exchangeable Notes as a result of a decrease in the price of its ordinary shares and market capitalization during the period. The non-cash adjustment for the full year 2021 was largely due to the fair value adjustments recorded at the time of conversion of $39.2 million of the Exchangeable Notes in 2021.
Cancellation of share options for the full year 2022 was $17.4 million and related to the non-cash charge in connection with employee share options that were surrendered and cancelled in July 2022.
Net loss for the fourth quarter and full year 2022 was $5.1 million and $44.4 million, respectively, compared to a net loss of $4.2 million and $91.6 million for the same periods in 2021. Non-GAAP1 net loss for the fourth quarter and full year 2022 of $6.4 million and $22.9 million, respectively, compared to a non-GAAP1 net loss of $3.3 million and $19.4 million for the same periods in 2021.
Conference Call Details
Iterum will host a conference call today, Thursday, March 16, 2023 at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows: United States: 1 844 200 6205; International: 1 929 526 1599; Access code: 846586
About Iterum Therapeutics plc
$ITRM starting the New Year off right!
$ITRM >Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
December 15 2022 - 08:00AM
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Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”), 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 United States Patent and Trademark Office (“USPTO”) has issued Iterum a Notice of Allowance for U.S. patent application number 16/372,075 entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” that covers the use of Iterum's candidate combination of sulopenem etzadroxil and probenecid in treating multiple diseases, including uncomplicated urinary tract infections.
“Following on from the patent recently issued by the USPTO directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (“oral sulopenem”) and its related uses, we are very pleased to strengthen our oral sulopenem patent estate further with the addition of this new patent which, when issued, will afford protection until at least 2039 and further enhance its commercial opportunity. If approved, oral sulopenem will be the first oral penem available in the United States,” said Corey Fishman, Chief Executive Officer. “Enrollment in our pivotal Phase 3 clinical trial for oral sulopenem for the treatment of uncomplicated urinary tract infections is ongoing, and we expect to provide an update following an interim analysis at 50% patient enrollment.”
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire April 1, 2039, absent any extensions. The recently issued U.S. patent for oral sulopenem entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” also expires in 2039, absent any extensions.
The Company’s patent portfolio also contains pending patent applications outside the U.S. including Europe and China, submitted following receipt of the Written Opinion of the International Search Authority indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive.
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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and 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 Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
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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.
