Highest-materiality recent filing
Iterum Therapeutics to be delisted from Nasdaq on April 1 after winding-up petition
Nasdaq will suspend ITRM shares at open on April 1, 2026; Form 25-NSE to follow.
Filed winding-up petition in Irish High Court; joint provisional liquidators appointed (Damien Murran, Jennifer McMahon of Teneo).
Iterum Therapeutics requests Nasdaq hearing to appeal delisting; warns of possible wind-down
On March 3, 2026, Iterum requested a hearing before Nasdaq Hearings Panel to appeal delisting for failure to maintain $1.00 bid price.
Iterum Therapeutics receives Nasdaq delisting notice; shares to suspend Mar 5, 2026
Received delisting determination letter on Feb 24, 2026 for failing minimum bid price of $1.00 per share.
Iterum shareholders reject all four EGM proposals; company warns of possible wind-down
Shareholders voted against increasing authorized share capital (12.8M for vs 17.9M against).
Iterum Therapeutics receives Nasdaq delisting notice for MVLS below $35M
Nasdaq notified Iterum on Dec 11, 2025 that MVLS <$35M for 30 consecutive business days; given 180 days until June 9, 2026 to regain compliance.
Iterum Therapeutics Q3 2025: ORLYNVAH launch nets $0.4M revenue; cash runway extended to Q2 2026
Net product revenue of $0.4M from ORLYNVAH launch in August 2025; 2026 sales guidance $5M-$15M.
Iterum files $20M ATM offering; ORLYNVAH launched Aug 2025 with modest sales expected
Filed prospectus supplement for ATM offering of up to $20M aggregate gross proceeds (max ~21.8M ordinary shares).
Iterum shareholders reject say-on-pay, share increase, and equity plan at AGM
David Kelly elected Class I director with 10.8M for, 2.8M against, 0.7M abstain, 8.2M broker non-votes.
Iterum Therapeutics receives Nasdaq delisting notice for bid price below $1.00
Nasdaq notice for non-compliance with minimum bid price rule; shares traded below $1.00 for 30 consecutive business days.
Iterum launches ORLYNVAH, first oral penem antibiotic in U.S., for uUTI
FDA approved ORLYNVAH in Oct 2024; commercial launch announced Aug 20, 2025.
Iterum reports Q2 net loss $6.5M; ORLYNVAH launch on track for August 2025
Net loss $6.5M (non-GAAP $5.1M) vs $5.0M prior year; cash $13.0M at June 30, 2025.
Iterum Therapeutics enters 5-year manufacturing supply agreement with ACS Dobfar for ORLYNVAH
Agreement covers commercial manufacture and supply of ORLYNVAH bilayer tablets and sulopenem etzadroxil bulk drug substance.
Iterum sets 2025 AGM for Sept 10; shareholder proposals due July 28
Annual General Meeting scheduled for September 10, 2025.
Iterum Therapeutics enters commercialization agreement with EVERSANA for ORLYNVAH in US
Eversana will be exclusive provider of sales, marketing, logistics, regulatory, and medical affairs services for ORLYNVAH.
Iterum extends $20M Pfizer milestone payment to Oct 2029; interest rises to 10%
$20M regulatory milestone due Oct 2026 extended to Oct 2029 via amended promissory note.
Iterum Therapeutics Q1 net loss $4.9M; preparing for ORLYNVAH launch by Q4 2025
Net loss of $4.9M in Q1 2025 vs $7.1M in Q1 2024; non-GAAP net loss $3.3M vs $5.8M.
Gross proceeds of $5.0M from sale of 5,555,556 shares/warrants at $0.90 each.
Iterum Therapeutics appoints Joseph Whalen to board; David Kelly named Chairman
Joseph J. Whalen appointed as Class III director effective March 10, 2025; term expires at 2027 AGM.
Iterum Therapeutics loses audit committee compliance after Chairman Ronald Hunt resigns
Chairman Ronald Hunt resigned Feb 14, 2025, ending 9+ year tenure; no dispute with board.
Iterum Therapeutics Q4 net loss $6.6M; cash $24.1M, ORLYNVAH approved
Net loss Q4 2024 $6.6M vs $12.4M in Q4 2023; full year $24.8M vs $38.4M.
Iterum Therapeutics upsizes ATM offering by up to $25M, previously raised $16M
Filed prospectus supplement on Dec 10, 2024 for additional gross proceeds up to $25M.
Iterum Therapeutics regains Nasdaq compliance, hearing cancelled
Nasdaq confirmed Iterum cured its Listing Rule 5550(b) deficiency; previously scheduled Nov 21 hearing cancelled.
Iterum Therapeutics Q3 net loss $6.1M; FDA approved ORLYNVAH in October 2024
Cash, cash equivalents and short-term investments totaled $14.5M at Sept. 30, 2024.
Iterum issues $20M promissory note to Pfizer at 8% interest for deferred milestone payment
FDA approved ORLYNVAH (sulopenem) on Oct 25 for uncomplicated UTIs in adult women.
Iterum receives FDA approval for ORLYNVAH for uUTIs; first product approval
FDA approved ORLYNVAH (oral sulopenem) for uUTIs in adult women with limited/no alternative oral antibiotics.
Iterum receives Nasdaq delisting notice, hearing set for Nov 21 on equity compliance
Nasdaq notified Iterum on Oct 1 of delisting for failing to meet $2.5M stockholders' equity requirement after Sep 30 extension deadline.
Iterum shareholders approve authority to issue shares without pre-emptive rights at Oct 8 EGM
Proposal to allow board to allot shares for cash without offering to existing shareholders passed with 9,785,120 votes for, 3,103,525 against, 133,633 abstain.
Nasdaq notified Iterum on Oct 1, 2024 that it failed to meet terms of extension to comply with minimum $2.5M stockholders' equity requirement.
Iterum reports Q2 2024 net loss $5.0M; PDUFA date Oct 25, 2024; AdCom Sept 9
Net loss $5.0M Q2 2024 (vs $12.2M Q2 2023); cash $11.7M; expects runway into 2025 through PDUFA date.
Iterum Therapeutics rights offering expires; expects $7.4M gross proceeds
Rights offering expired Aug 6, 2024; gross proceeds est. $7.4M, net ~$6.3M after $1.1M expenses.
Iterum Therapeutics launches rights offering of up to $10.3M in Units at $1.21/unit
Maximum 8,503,800 Units offered at $1.21/unit; each Unit includes one ordinary share, a 0.5-share 1-year warrant, and a 1-share 5-year warrant.
Iterum Therapeutics sets July 16 record date for $1.21/unit rights offering of 8.5M units
Record date: July 16, 2024; subscription period expected July 22 to August 6, 2024.
FDA Advisory Committee to discuss NDA for oral sulopenem (first oral penem in U.S.) for uUTI in adult women; proposed date September 9, 2024.
Iterum receives FDA acceptance of oral sulopenem NDA resubmission; PDUFA date Oct 25, 2024
FDA accepted resubmission of NDA for oral sulopenem for uUTIs in adult women; PDUFA action date set for October 25, 2024.
Iterum submits NDA for oral sulopenem; Q1 net loss narrows to $7.1M, cash runway into 2025
NDA resubmitted in April 2024 for oral sulopenem; FDA action expected early Q4 2024.
Iterum CMO Sailaja Puttagunta resigns effective May 31; Steven Aronin to lead clinical development
CMO Sailaja Puttagunta resigns for personal reasons, effective May 31, 2024; no disagreement with company.
Iterum resubmits NDA for oral sulopenem to FDA for uUTIs; potential approval early Q4 2024
Resubmitted NDA on April 29, 2024, for oral sulopenem (sulopenem etzadroxil/probenecid) for uncomplicated UTIs in adult women.
Iterum Therapeutics receives Nasdaq delisting notice for equity deficit of $6.4M
Stockholders' equity deficit of $6.4M as of Dec 31, 2023, below Nasdaq's $2.5M minimum.
Iterum Therapeutics posts Q4 net loss $12.4M; NDA resubmission planned early Q2 2024
Net loss of $12.4M for Q4 2023; full year 2023 net loss $38.4M; non-GAAP net loss $10.7M (Q4) and $43.8M (FY).
Iterum expects NDA resubmission for oral sulopenem in Q2 2024; cash runway into 2025
NDA resubmission for oral sulopenem to FDA expected in first half of Q2 2024, earlier than originally planned.
Iterum's oral sulopenem meets Phase 3 uUTI endpoint, shows superiority over Augmentin
Primary endpoint met: overall success 61.7% (sulopenem) vs 55.0% (Augmentin); 95% CI lower bound >0 showing statistical superiority.
Iterum Therapeutics shareholders reject proposal to issue up to 5M shares without pre-emptive rights
Proposal required 75% approval; received 3,139,498 For vs 2,724,101 Against and 26,719 Abstentions.
Director Mark Chin resigns from Iterum board effective Dec 31, 2023
Mark Chin notified Company on Dec 28, 2023 of resignation from Board effective Dec 31.
Iterum regains Nasdaq compliance with minimum bid price rule
Received letter from Nasdaq on Dec 4, 2023 confirming compliance with Bid Price Rule.
Iterum completes REASSURE enrollment; NDA resubmission for uUTI expected Q2 2024
Enrolled 2,229 patients in pivotal Phase 3 REASSURE trial; top-line data expected early Q1 2024.
Iterum completes enrollment in Phase 3 uUTI trial; topline data expected early Q1 2024
Completed enrollment in REASSURE trial of oral sulopenem vs Augmentin in uncomplicated UTIs ahead of schedule.
Received deficiency notice on Sep 26, 2023 after 30 consecutive business days of closing bid price below $1.00.
Iterum Therapeutics Q2 net loss $12.2M; REASSURE trial 50% enrolled, topline data expected Q2 2024
Net loss $12.2M in Q2 2023 vs $6.7M in Q2 2022; non-GAAP net loss $10.0M.
At extraordinary general meeting on Aug 1, 2023, shareholders voted against granting board authority to issue ordinary shares for cash without first offering to existing shareholders.
approved the appointment of Joseph J. Whalen as a member of the Board, effective as of March 10, 2025.
the Board also appointed David Kelly, an existing director of the Board, as Chairman of the Board, effective as of March 10, 2025.
On February 14, 2025, Ronald Hunt, Chairman and director of the Company, notified the Company of his resignation as Chairman and director of the Company, effective immediately.
Dr. Puttagunta, whose previously announced resignation as CMO is effective as of May 31, 2024
On May 8, 2024, Sailaja Puttagunta M.D. notified Iterum Therapeutics plc (the “Company”) of her decision to resign as Chief Medical Officer the Company, effective May 31, 2024.
On December 28, 2023, Mark Chin informed management that he would be resigning as a member of the Board of Directors of Iterum Therapeutics plc (the "Company") with effect from December 31, 2023.
Max materiality 1.00 · Median 0.65 · Most common event other_material