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$ITRM starting the New Year off right!
After Hours, someone buys a few shares at a much higher price.
Just start doing it during regular trading hours.
$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.
P.S. I don't see a merger to be a likely outcome.
I believe this will lose compliance with tax loss selling. It will need something other than " third quarter of 2024" to regain . It's either a merger, another RS or a down grade to OTC. Does anyone have any valid info to change my pessimistic view?
ITRM > Third Quarter 2022 Financial Results
Cash, cash equivalents and short-term investments were $64.3 million at September 30, 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 into 2024, including through topline data from the REASSURE clinical trial. As of October 31, 2022, Iterum had approximately 12.2 million ordinary shares outstanding.
Research and development (“R&D”) expenses for the third quarter of 2022 were $4.4 million compared to $1.8 million for the same period in 2021. The increase was primarily due to an increase in costs incurred to support the activities for the REASSURE clinical trial.
General and administrative (“G&A”) expenses for the third quarter of 2022 were $2.7 million compared to $3.0 million for the same period in 2021. The decrease was primarily due to lower share-based compensation expense, partially offset by an increase in legal fees associated with the class action lawsuit filed in August 2021.
Adjustments to the fair value of derivatives for the third quarter of 2022 were $4.8 million compared to $9.8 million for the same period in 2021. The non-cash adjustment in the third quarter of 2022 related to an increase in the fair value of the Limited Recourse Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”) due to the newly issued patent directed to oral sulopenem to the composition of the bilayer tablet which provides patent protection at least until 2039, partially offset by a decrease in the value of the derivative components associated with Iterum’s Exchangeable Notes, primarily as a result of a decrease in the price of our ordinary shares and our market capitalization during the period. The non-cash adjustment in the third 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, partially offset by an increase in the fair value of the Royalty-Linked Notes.
Cancellation of share options for the third quarter of 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 third quarter of 2022 was $29.1 million compared to net income of $3.7 million for the same period in 2021. Non-GAAP1 net loss was $5.3 million in the third quarter of 2022 compared to the non-GAAP1 net loss of $3.7 million for the same period in 2021.
Conference Call Details
Iterum will host a conference call today, Thursday, November 10, 2022 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: 819977
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 http://www.iterumtx.com. https://finance.yahoo.com/news/iterum-therapeutics-reports-third-quarter-120000143.html?p=ITRM&.tsrc=fin-srch
You may be right.
"If the resubmission addresses all deficiencies in the complete response letter received in July 2021 from the FDA, then the FDA’s review and action will occur six months from receipt of the resubmission...."
"Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications including uUTI."
One of the Big Pharma companies could make a contingency partnership, but wondering why it takes so long to recruit patients?
If successful ka-ching, ka-ching in late 2024.
" Second half of 2024" At this rate we will need 2 R/S just remain compliant. They desperately a partner.
ITRM >FDA warns common antibiotic amoxicillin in short supply
"In addition to ear infections, amoxicillin is commonly prescribed to children for strep, whooping cough and some urinary tract infections."
https://6abc.com/fda-warns-common-antibiotic-amoxicillin-in-short-supply--/12402353/?fbclid=IwAR1BPxYwwXVM8uM9jDtL1PBDMt8m1b71GD0E2XjskmLBE3ObFI-G4cuaxo8
Good to see they got the trial launched. I had thought from their messaging it might not be till next year.
A "me too" Augmenitin is not worth much (as it is already generic). They will have to show a win in the 3rd primary for resistant bugs to get more than pocket change.
Have a ways to go here
EDIT: I would have liked to see a trial that focused on some subset of resistant bugs with endpoint of non-inferiority to doctor's choice. The space is messy though wrt to trial designs that will be allowed by the FDA (for the purpose of aprorval).
The SPA is good.
ITRM >Iterum Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
October 20 2022 - 07:30AM
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Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company developing antibiotics to treat infections caused by multi-drug resistant pathogens, today announced that the first patient has been dosed in its Phase 3 clinical trial, known as REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales (REASSURE), comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).
“We are pleased to have successfully dosed our first patient in our Phase 3 clinical trial for oral sulopenem for the treatment of uUTI, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA),” said Corey Fishman, Chief Executive Officer. “We anticipate completing the trial in the first half of 2024 with our existing cash resources. With positive results, we would resubmit our new drug application (NDA) to the FDA in the second half of 2024.”
About REASSURE
The REASSURE trial is designed as a non-inferiority trial comparing oral sulopenem and Augmentin® in the Augmentin susceptible population and is entitled “A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.” Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin® twice daily for 5 days. The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the trial. The trial is expected to enroll approximately 1,966 patients and is being conducted under a SPA agreement with the FDA.
Iterum expects to complete enrollment in the first half of 2024 and, if the Phase 3 clinical trial is successful, resubmit its NDA in the second half of 2024. If the resubmission addresses all deficiencies in the complete response letter received in July 2021 from the FDA, then the FDA’s review and action will occur six months from receipt of the resubmission.
The one analyst covering this stock has a $15 target. I'd say more like $40 but they do have to rerun a Phase 3 comparing it with another known drug. Hopefully this will go fairly quickly. Women's urinary tract infections is a huge market.
Overall market down but ITRM up on volume 2 times 10 day average
$ITRM >Iterum Therapeutics to Present Data at IDWeek 2022
October 17 2022 - 05:19PM
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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 two posters will be presented at the Infectious Disease Society of America’s IDWeek 2022.
The hybrid conference will be held from October 19-23 at the Walter E. Washington Convention Center in Washington, D.C. Posters will be available for registrants on the IDWeek Interactive Program and the IDWeek Mobile App starting on October 19, 8 a.m. ET. Onsite attendees can view posters from Oct. 20-22 from 8 a.m. to 6 p.m.
Data to be presented at IDWeek 2022 include:
Presentation Title: Impact of Asymptomatic Bacteriuria on Primary Efficacy Analyses in the Evaluation of Novel Antimicrobials for the Treatment of Patients with Urinary Tract Infection
Poster #: 227
Presenter: Steven Aronin
Time/Location: Thursday, October 20, 12:15 p.m. - 1:30 p.m. in Hall B+C
Presentation Title: Murine Efficacy Studies of Sulopenem Against Bacillus anthracis
Poster #: 1724
Presenter: Sailaja Puttagunta
Time/Location: Saturday, October 22, 12:15 p.m. - 1:30 p.m. in Hall B+C
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
Has a long ways to go - They must be restarting Phase 3 trial finally. $40 minimum once they get approved.
Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
September 19 2022 - 07:30AM
GlobeNewswire Inc.
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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 the United States Patent and Trademark Office has issued the Company a Notice of Allowance for U.S. patent application number 16/972,300 entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (“oral sulopenem”) and its related uses.
“This patent allowance provides up to 10 years additional patent protection for our lead candidate and is a significant milestone for Iterum in protecting the long-term commercial potential of oral sulopenem, which, if approved, would be the first penem available orally in the U.S. as well as the first new oral treatment for uncomplicated urinary tract infections in over 20 years,” said Corey Fishman, Chief Executive Officer. “We remain focused on preparing for our planned pivotal Phase 3 clinical trial for oral sulopenem for the treatment of uncomplicated urinary tract infections, and look forward to commencing enrollment in the coming weeks.”
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 no earlier than 2039, absent any extensions. Existing patent protection for sulopenem etzadroxil is scheduled to expire in 2029, subject to potential extension.
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.
Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the potential approval of oral sulopenem by the U.S. Food and Drug Administration (the “FDA”), the timing and conduct of a planned Phase 3 clinical trial for oral sulopenem and the expected issuance of a U.S. patent in connection with the notice of allowance described above, including the timing thereof, and the protection provided by such patent. 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 design, initiation and conduct of clinical and non-clinical development, including the planned clinical trial and non-clinical development to be conducted in response to the complete response letter received from the FDA in July 2021, availability and timing of data from the planned 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 the new drug application to the FDA for oral sulopenem, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of Iterum’s expectations regarding how far into the future Iterum’s cash on hand will fund Iterum’s ongoing operations, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of Iterum’s evaluation of corporate, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic, financial or financing alternative and Iterum’s ability to complete one at all and other factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10- Q filed with the Securities and Exchange Commission (the “SEC”) on August 12, 2022, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
Investor Contact:
Judy Matthews
Chief Financial Officer
312-778-6073
IR@iterumtx.com
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Latest ITRM Messages
swanlinbar Wed Sep 7, 2022 10:22 AM (12 days ago)
ITRM > Iterum Therapeutics to Present at the
velcro Wed Aug 17, 2022 6:05 PM (32 days ago)
For a macabre laugh, Mark Malone is in
swanlinbar Wed Aug 17, 2022 8:19 AM (33 days ago)
ITRM > Iterum Therapeutics Announces Date of 1-for-15
velcro Wed Aug 3, 2022 5:51 PM (46 days ago)
There maybe a Board vote prior to August
exwannabe Sun Jul 17, 2022 1:36 PM (63 days ago)
Good to see they have not gone dead,
swanlinbar Mon Jul 11, 2022 2:06 PM (69 days ago)
We are pleased to have concluded discussions with
Harbor6460 Mon Jul 11, 2022 1:44 PM (69 days ago)
Says pending future possibility to apply again. Lol
swanlinbar Mon Jul 11, 2022 12:32 PM (69 days ago)
$ITRM>Iterum Therapeutics shares are trading higher after the
declaes Mon Jul 11, 2022 12:22 PM (69 days ago)
Will go past $1 again soon imo... great news
swanlinbar Mon Jul 11, 2022 9:52 AM (70 days ago)
$ITRM Therapeutics Announces Special Protocol Assessment (SPA)
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Current Report Filing (8-k)
Edgar (US Regulatory) • Mon Sep 19, 2022 8:33 AM (3 hours ago)
Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
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ITRM > Iterum Therapeutics to Present at the H.C. Wainwright 24th Annual Global Investment Conference
September 07 2022 - 09:15AM
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 Corey Fishman, Chief Executive Officer, and Judy Matthews, Chief Financial Officer, will provide a company overview and business update at the H.C. Wainwright 24th Annual Hybrid Global Investment Conference at 12:00pm(ET) on Wednesday, September 14, 2022. Management will also host investor meetings on September 13-14, 2022.
Following the conference, a webcast of the presentation will be available to view for 90 days by visiting the "Investors" section of the Company's website under the "Events and Presentations" tab at www.iterumtx.com.
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
For a macabre laugh, Mark Malone is in charge of Investor Relations at Newspring
https://newspringcapital.com/team/mark-malone
ITRM > Iterum Therapeutics Announces Date of 1-for-15 Reverse Share Split
Download as PDFAugust 16, 2022
DUBLIN, Ireland and CHICAGO, Aug. 16, 2022 (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, announced today that it will effect a 1-for-15 reverse share split of its outstanding ordinary shares at 5.00 p.m. Eastern Time on August 17, 2022, which will be effective for trading purposes on the Nasdaq Capital Market as of the commencement of trading on August 18, 2022.
At the Annual General Meeting of Shareholders on June 15, 2022, the Company’s shareholders approved, subject to and conditional upon the Board of Directors of the Company determining, in its sole discretion, that a reverse share split is necessary for the Company to comply with the minimum $1.00 per share requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (“Bid Price Rule”), a reverse share split (i.e., a consolidation of share capital under Irish law) whereby every fifteen ordinary shares of $0.01 (nominal value) each in the authorized and unissued and authorized and issued share capital of the Company be consolidated into one ordinary share of $0.15 (nominal value) each, and the subsequent reduction in the nominal value of the ordinary shares in the authorized and unissued and authorized and issued share capital of the Company from $0.15 each to $0.01 each. The Company’s Board of Directors subsequently determined that the reverse share split was necessary for the Company to comply with the Bid Price Rule.
The Company’s ordinary shares will continue to trade on the Nasdaq Capital Market under the symbol “ITRM” and the new CUSIP number for the Company’s ordinary shares following the reverse share split will be G6333L 200. The reverse share split will reduce the number of ordinary shares outstanding from approximately 183.3 million to approximately 12.2 million post-split and will also proportionately reduce the number of authorized ordinary shares from 300 million to 20 million. The reverse share split will also apply to ordinary shares issuable upon the exercise of the Company’s outstanding restricted share units, share options, 6.500% Exchangeable Senior Subordinated Notes due 2025 and warrants, with a proportional increase in the respective exercise prices, as applicable. No fractional ordinary shares will be issued in connection with the reverse share split. Shareholders who would otherwise be entitled to a fractional ordinary share will be entitled to receive a proportional cash payment.
The Company’s transfer agent, Computershare, which is also acting as the exchange agent for the reverse share split, will provide instructions to shareholders regarding the process for exchanging physical share certificates. Shareholders holding their ordinary shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse share split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions. Additional information regarding the reverse share split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on April 25, 2022.
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.
Forward-Looking Statements
There maybe a Board vote prior to August 17 authorizing a 15:1 Reverse Split.
Good to see they have not gone dead,
I do hold it against management that they were not working on this trial design even prior to the CRL notice. They knew it was an ifffy decision back then. And even if they were approved then a P4 such as this would have been useful to expand the label.
Anyway, that is water under the bridge.
I have to assume the odds of the new trial being a success are good. They have the data in hand to pick the patients and comparison to trial. In this space that is fine because all they are trying to be is just another weapon in the arsenal (they do not need to be the best).
This will take time though. I would have late 2024 as reasonable for results based on the previous oral trial. Supposedly they have enough cash to get into 2024. Sounds like one more raise is going to be needed.
We are pleased to have concluded discussions with the FDA and reached agreement on key elements of the trial design to support the potential resubmission of the NDA for oral sulopenem for uUTI under the SPA process," said Corey Fishman, Chief Executive Officer. "The SPA underscores our alignment with the FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial in uUTI and reflects our ongoing commitment to bring this valuable therapy to market. We are excited about this important milestone and are looking forward to ******starting recruitment for this trial as soon as possible.*******
Says pending future possibility to apply again. Lol
$ITRM>Iterum Therapeutics shares are trading higher after the company announced that it has reached an agreement with the FDA under the special protocol assessment process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid to begin in Q4. Nice!
Will go past $1 again soon imo... great news
$ITRM Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
July 11 2022 - 07:30AM
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, announced today that it has reached an agreement with the U.S. Food and Drug Administration (“FDA”) under the special protocol assessment (“SPA”) process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated urinary tract infections (“uUTI”). 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 the Company’s new drug application (“NDA") for oral sulopenem.
“We are pleased to have concluded discussions with the FDA and reached agreement on key elements of the trial design to support the potential resubmission of the NDA for oral sulopenem for uUTI under the SPA process,” said Corey Fishman, Chief Executive Officer. “The SPA underscores our alignment with the FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial in uUTI and reflects our ongoing commitment to bring this valuable therapy to market. We are excited about this important milestone and are looking forward to starting recruitment for this trial as soon as possible.”
The pivotal study to be conducted pursuant to the SPA agreement is designed as a non-inferiority trial comparing oral sulopenem and Augmentin® (amoxicillin/clavulanate) and is entitled “A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.” Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin® twice daily for 5 days. The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the study. The study is expected to enroll approximately 1,966 patients and is anticipated to start enrolling in the fourth quarter of 2022. Study start-up activities have already been commenced by the Company to enable timely initiation and recruitment.
$ITRM Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
July 11 2022 - 07:30AM
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, announced today that it has reached an agreement with the U.S. Food and Drug Administration (“FDA”) under the special protocol assessment (“SPA”) process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated urinary tract infections (“uUTI”). 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 the Company’s new drug application (“NDA") for oral sulopenem.
“We are pleased to have concluded discussions with the FDA and reached agreement on key elements of the trial design to support the potential resubmission of the NDA for oral sulopenem for uUTI under the SPA process,” said Corey Fishman, Chief Executive Officer. “The SPA underscores our alignment with the FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial in uUTI and reflects our ongoing commitment to bring this valuable therapy to market. We are excited about this important milestone and are looking forward to starting recruitment for this trial as soon as possible.”
The pivotal study to be conducted pursuant to the SPA agreement is designed as a non-inferiority trial comparing oral sulopenem and Augmentin® (amoxicillin/clavulanate) and is entitled “A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.” Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin® twice daily for 5 days. The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the study. The study is expected to enroll approximately 1,966 patients and is anticipated to start enrolling in the fourth quarter of 2022. Study start-up activities have already been commenced by the Company to enable timely initiation and recruitment.
Good time for me to reinvest in ITRM. Thank you swanlinbar for the update.
ITRM>Development Considerations of Antimicrobial Drugs for the Treatment of Uncomplicated Urinary Tract Infections (UTI) (Virtual)
JUNE 3, 2022
Scheduled
https://www.fda.gov/drugs/news-events-human-drugs/development-considerations-antimicrobial-drugs-treatment-uncomplicated-urinary-tract-infections-uti?fbclid=IwAR1oTIu8v0UAXGZJuIecyLvsrsb1AZWor3D965NyO2_hzuafLFRtsaOXy1U
Iterum Therapeutics plc
Iterum Therapeutics plc
-General Alignment with FDA on Key Aspects of Design of Proposed Additional Clinical Trial-
-Cash Runway into 2024-
DUBLIN, Ireland and CHICAGO, May 13, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (“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 reported financial results for the first quarter ended March 31, 2022.
“As reported earlier this week, we have reached general alignment with the U.S. Food and Drug Administration (“FDA”) on key aspects of the proposed design of an additional clinical trial comparing oral sulopenem to Augmentin® (amoxicillin/clavulanate) for the treatment of uncomplicated urinary tract infection (“uUTI”) in adult women to support a potential resubmission of our new drug application (“NDA”) for oral sulopenem,” said Corey Fishman, Iterum’s Chief Executive Officer. “We plan to request an agreement with the FDA regarding the proposed protocol under the special protocol assessment (“SPA”) process. Subject to finalizing the SPA agreement with the FDA, we expect to initiate enrollment in the second half of 2022
Highlights and Recent Events
Met with FDA: We reached general alignment with the FDA at a meeting in early May 2022 on key aspects of the design of an additional clinical trial required to support the potential resubmission of the NDA for oral sulopenem for uUTI.
Reduced outstanding debt: We completed the repayment of our term loan with Silicon Valley Bank in March 2022.
First Quarter 2022 Financial Results
Cash, cash equivalents and short-term investments was $75.3 million at March 31, 2022. Based on the current operating plan, which includes the planned conduct of the additional Phase 3 clinical trial, Iterum expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2024. As of April 30, 2022, Iterum had approximately 183.4 million ordinary shares outstanding.
Research and development (R&D) expenses for the first quarter of 2022 were $3.4 million compared to $2.5 million for the same period in 2021. The increase was primarily due to the non-cash amortization of an intangible asset in 2022, trial start-up costs associated with the registrational trial expected to begin in the second half of 2022, higher personnel costs due to an increase in headcount to support additional clinical trial efforts and higher share-based compensation, partially offset by lower consulting spend.
General and administrative (G&A) expenses for the first quarter of 2022 were $3.9 million compared to $3.4 million for the same period in 2021. The increase was primarily due to an increase in share-based compensation expense, partially offset by lower consulting spend.
Adjustments to the fair value of derivatives for the first quarter of 2022 were $5.2 million compared to ($90.1) million for the same period in 2021. The non-cash adjustment in the first quarter of 2022 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, as well as a reduction in the liability associated with the Limited Recourse Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”) due to a change to the expected timing of payments. The non-cash adjustment in the first quarter of 2021 related to an increase in the value of the derivative components associated with the Exchangeable Notes and the Royalty-Linked Notes primarily as a result of an increase in the price of Iterum’s ordinary shares and an increase in Iterum’s market capitalization during the period.
Net loss for the first quarter of 2022 was $3.5 million compared to a net loss of $98.9 million for the same period in 2021. Non-GAAP1 net loss of $5.6 million in the first quarter of 2022 was relatively flat compared to the non-GAAP1 net loss of $5.8 million for the same period in 2021.
Upcoming Presentations
Corporate presentation at the 2022 H.C. Wainwright Global Investment Conference to be held on Wednesday, May 25, 2022 at 11:30am ET
Presentation at the FDA’s Public Workshop for uUTI to be held on June 3, 2022. The purpose of this virtual public workshop, entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Uncomplicated Urinary Tract Infections (uUTI),” is to discuss nonclinical and clinical considerations regarding developing antimicrobial drugs for the treatment of uUTI.
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 http://www.iterumtx.com.
Non-GAAP Financial Measures
To supplement Iterum’s financial results presented in accordance with U.S. generally accepted accounting principles (“GAAP”), Iterum presents non-GAAP net loss and non-GAAP net loss per share to exclude from reported GAAP net loss and GAAP net loss per share, intangible asset amortization ($0.4 million); share-based compensation expense ($1.9 million); the interest expense associated with accrued interest on the Exchangeable Notes, payable in cash, shares or a combination of both upon exchange, redemption or at January 31, 2025 (“the Maturity Date”), whichever is earlier ($0.2 million); the non-cash amortization of the Exchangeable Notes and Royalty-Linked Notes ($0.6 million); and the non-cash adjustments to the fair value of derivatives ($5.2 million) for the three months ended March 31, 2022, and share-based compensation expense ($0.3 million); the interest expense associated with accrued interest on the Exchangeable Notes payable in cash, shares or a combination of both upon exchange, redemption or at the Maturity Date, whichever is earlier ($0.4 million); the non-cash amortization of the Exchangeable Notes and Royalty-Linked Notes ($2.3 million); and the non-cash adjustments to the fair value of derivatives ($90.1 million) for the three months ended March 31, 2021.
Iterum believes that the presentation of non-GAAP net loss and non-GAAP net loss per share, when viewed with its results under GAAP and the accompanying reconciliation, provides useful supplementary information to, and facilitates additional analysis by, investors, analysts, and Iterum’s management in assessing Iterum’s performance and results from period to period. These non-GAAP financial measures closely align with the way management measures and evaluates Iterum’s performance. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net loss or other financial measures calculated in accordance with GAAP. Non-GAAP net loss and non-GAAP net loss per share are not based on any standardized methodology prescribed by GAAP and represents GAAP net loss, which is the most directly comparable GAAP measure, adjusted to exclude intangible asset amortization; share-based compensation expense; the interest expense associated with accrued interest on the Exchangeable Notes payable in cash, shares or a combination of both upon exchange, redemption or at the Maturity Date, whichever is earlier; the non-cash amortization of the Exchangeable Notes and Royalty-Linked Notes; and the non-cash adjustments to the fair value of derivatives for the three months ended March 31, 2022 and March 31, 2021. Because of the non-standardized definitions of non-GAAP financial measures, non-GAAP net loss and non-GAAP net loss per share used by Iterum Therapeutics in this press release and accompanying tables has limits in its usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. A reconciliation of non-GAAP net loss to GAAP net loss and non-GAAP net loss per share to GAAP net loss per share have been provided in the tables included in this press release.
I wonder if these guys are going to try to get to $1.00 organically or will they R/S to do it. They say they have the money to redo their P3, so why don't they get going, that's what I wonder.
$ITRM added another 5k @ .299 I don't know why!
$ITRM added 5k @.376
$ITRM >Iterum Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results
Download as PDFMarch 28, 2022
--Registration Trial for uUTI Planned in Second Half of 2022--
--Cash Runway into 2024--
--Company to host conference call today at 8:30am ET--
DUBLIN, Ireland and CHICAGO, March 28, 2022 (GLOBE NEWSWIRE) -- 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, 2021.
“Based on several recent interactions with the FDA, we believe that we have made progress towards an agreement on the additional Phase 3 trial design required to support the resubmission of our NDA for oral sulopenem in uUTI. Subject to finalization of the clinical program, we expect to start the study in the second half of 2022,” said Corey Fishman, Iterum’s Chief Executive Officer. “Based on the current operating plan, which includes an additional Phase 3 study, we believe that we are well positioned financially to fund operations into 2024 with our existing cash resources.”
Highlights and Recent Events
Reduced outstanding debt: We completed the repayment of our term loan with Silicon Valley Bank in March 2022.
Received 180-day extension of Nasdaq listing deficiency: On March 9, 2022, we received written notification from Nasdaq that a 180-day extension to regain compliance with Nasdaq's minimum bid price requirement was granted. We now have until September 5, 2022 to meet this requirement.
Published two articles in scientific journals: In February 2022, we published two articles highlighting anti-bacterial resistance and the unmet medical need for new oral agents for urinary tract infections. The articles can be accessed under “Scientific Publications” in the Our Science section of the Company’s website at www.iterumtx.com.
Fourth Quarter and Full Year 2021 Financial Results
Cash, cash equivalents and short-term investments was $81.3 million at December 31, 2021. Based on the current operating plan and subject to final determination of the design and planned conduct of potential additional clinical and non-clinical development of sulopenem, Iterum expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2024. As of February 28, 2022, we had approximately 182.8 million ordinary shares outstanding.
Research and development (R&D) expenses for the fourth quarter and full year 2021 were $3.7 million and $10.7 million, respectively, compared to $2.4 million and $21.1 million for the same periods in 2020. The increase for the three-month period was primarily due to the non-cash amortization of an intangible asset in 2021. The decrease in R&D expenses for the full year was primarily due to the completion of Iterum’s Phase 3 trials in 2020.
General and administrative (G&A) expenses for the fourth quarter and full year 2021 were $3.1 million and $13.8 million, respectively, compared to $2.3 million and $11.1 million for the same periods in 2020. The increase for three-month period was primarily due to an increase in share-based compensation, and the increase in G&A expense for the full year was primarily due to higher spend on pre-commercialization activities in the first half of 2021 and higher share-based compensation expense, partially offset by lower G&A headcount.
Adjustments to the fair value of derivatives for the fourth quarter and full year 2021 were $3.6 million and ($61.0) million, compared to ($2.7) million and ($1.7) million for the same periods in 2020. The non-cash adjustment in the fourth quarter of 2021 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. The non-cash adjustment for the full year was largely due to the fair value adjustments recorded at the time of conversion of $39.2 million of the Exchangeable Notes in 2021.
Net loss for the fourth quarter and full year 2021 was $4.2 million and $91.6 million, respectively, compared to a net loss of $11.2 million and $52.0 million for the same periods in 2020. Non-GAAP1 net loss for the fourth quarter and full year 2021 of $3.3 million and $19.4 million, respectively, compared to a non-GAAP1 net loss of $4.4 million and $30.9 million for the same periods in 2020.
Upcoming Investor Presentations
Corporate presentation at the 2022 H.C. Wainwright Global Investment Conference to be held May 23-25, 2022
Conference Call Details
Iterum will host a conference call today, Monday, March 28, 2022 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: 096194
1 Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release
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 http://www.iterumtx.com.
Non-GAAP Financial Measures
To supplement Iterum’s financial results presented in accordance with U.S. generally accepted accounting principles (“GAAP”), Iterum presents non-GAAP net loss and non-GAAP net loss per share to exclude from reported GAAP net loss and GAAP net loss per share, intangible asset amortization ($1.7 million and $1.7 million); share-based compensation expense ($2.0 million and $4.3 million); the interest expense associated with accrued interest on the Exchangeable Notes, payable in cash, shares or a combination of both upon exchange, redemption or at January 31, 2025 (“the Maturity Date”), whichever is earlier ($0.2 million and $1.1 million); the non-cash amortization of the Exchangeable Notes and Royalty-Linked Notes ($0.6 million and $4.1 million); and the non-cash adjustments to the fair value of derivatives ($3.6 million and $61.0 million) for the three and twelve months ended December 31, 2021, respectively, and share-based compensation expense ($0.1 million and $2.8 million); the interest expense associated with accrued interest on the Exchangeable Notes payable in cash, shares or a combination of both upon exchange, redemption or at the Maturity Date, whichever is earlier ($0.8 million and $3.2 million); the non-cash amortization of the Exchangeable Notes and Royalty-Linked Notes ($3.1 million and $10.5 million); one-time, non-capitalized financing transaction costs ($0.0 million and $2.8 million); and the non-cash adjustments to the fair value of derivatives ($2.8 million and $1.7 million) for the three and twelve months ended December 31, 2020, respectively.
Iterum believes that the presentation of non-GAAP net loss and non-GAAP net loss per share, when viewed with its results under GAAP and the accompanying reconciliation, provides useful supplementary information to, and facilitates additional analysis by, investors, analysts, and Iterum’s management in assessing Iterum’s performance and results from period to period. These non-GAAP financial measures closely align with the way management measures and evaluates Iterum’s performance. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net loss or other financial measures calculated in accordance with GAAP. Non-GAAP net loss and non-GAAP net loss per share are not based on any standardized methodology prescribed by GAAP and represents GAAP net loss, which is the most directly comparable GAAP measure, adjusted to exclude intangible asset amortization; share-based compensation expense; the interest expense associated with accrued interest on the Exchangeable Notes payable in cash, shares or a combination of both upon exchange, redemption or at the Maturity Date, whichever is earlier; the non-cash amortization of the Exchangeable Notes and Royalty-Linked Notes; one-time, non-capitalized financing transaction costs and the non-cash adjustments to the fair value of derivatives for the three and twelve months ended December 31, 2021 and December 31, 2020. Because of the non-standardized definitions of non-GAAP financial measures, non-GAAP net loss and non-GAAP net loss per share used by Iterum Therapeutics in this press release and accompanying tables has limits in its usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. A reconciliation of non-GAAP net loss to GAAP net loss and non-GAAP net loss per share to GAAP net loss per share have been provided in the tables included in this press release.
Forward Looking Statements
This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding Iterum’s plans, strategies and prospects for its business, including with respect to planned interactions and communications with the FDA and Iterum’s ability to reach agreement with the FDA on the design of any potential future clinical trials, Iterum’s expectations with regard to its ability to resolve the matters set forth in the complete response letter (CRL) received by Iterum in July 2021 and obtain approval for oral sulopenem, the timing and conduct of potential future clinical and non-clinical development of sulopenem, and the sufficiency of Iterum’s cash resources. 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 Iterum’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 Iterum’s control, including uncertainties inherent in the initiation and conduct of clinical and non-clinical development, including any potential additional clinical trials and non-clinical development that may be conducted in response to the CRL, availability and timing of data from such potential clinical and non-clinical development, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, including any potential resubmission of the NDA for oral sulopenem, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of Iterum’s expectations regarding how far into the future Iterum’s cash on hand will fund Iterum’s ongoing operations including completing potential additional clinical and non-clinical development of oral sulopenem, the impact of COVID-19 and related responsive measures thereto, Iterum’s ability to maintain its listing on the Nasdaq Stock Market, risks and uncertainties concerning the outcome, impact, effects and results of Iterum’s evaluation of corporate, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic, financial or financing alternative and Iterum’s ability to complete one at all and other factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2022, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum’s beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
Investor Contact:
Judy Matthews
Chief Financial Officer
312-778-6073
IR@iterumtx.com
https://www.iterumtx.com/news/press-releases/detail/86/iterum-therapeutics-reports-fourth-quarter-and-full-year
$ITRM i haven't added since Jan but may go for a few more soon!
ITRM >Iterum Therapeutics to Provide Business Update and Report Fourth Quarter and Full Year 2021 Financial Results on March 28, 2022
https://finance.yahoo.com/news/iterum-therapeutics-business-report-fourth-120000023.html
This company is a joke. No updates
Nothing.
Has anyone grilled IR lately? FDA says it wants a Phase 3? I am not feeling this one anymore.
There is no new clinical news. ITRM initiated 3 P3 trials several years ago. 2 failed and the 3rd had mixed results. They went to the FDA for approval in late 2020 and the FDA said no last spring.
There has been no news out of them on any path forward. Last update was in Sep when they said the FDA agreed that one more P3 would be needed. ITRM said they would update around end of 2021 on what that trial would be. Still waiting.
The only recent news is that they have issued more shares.
NEWS: WOW!!!
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.
Investors seem to think ITRM hit bottom and are now taking a chance on signifcant rebound in near future.
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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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