Executive Summary

Q2 saw materially lower R&D spend as REASSURE Phase 3 enrollment had completed, driving operating expenses down 63% year over year to $4.0M and narrowing GAAP net loss to $5.0M (vs. $12.2M LY) and non-GAAP net loss to $3.8M (vs. $10.0M LY) .
Regulatory catalysts firmed: FDA Antimicrobial Drugs Advisory Committee on September 9 to discuss stewardship/target population and a PDUFA action date set for October 25, 2024 for oral sulopenem in adult women uUTI; if approved, it would be the first oral penem in the U.S. .
Liquidity extended: cash, cash equivalents and short-term investments were $11.7M at June 30; a rights offering closed August 9 added $5.8M net; management reiterated runway into 2025 including through PDUFA, but noted $14.7M due on exchangeable notes in January 2025 (if not exchanged) as a key near-term obligation .
Strategic update: company continues to pursue sale/licensing of sulopenem to maximize value; shareholder vote sought to disapply preemption rights to allow faster capital raising if needed, citing costly/time-consuming prior rights offering .

What Went Well and What Went Wrong

What Went Well

Meaningful operating leverage as REASSURE costs rolled off: R&D fell to $2.1M from $9.0M YoY; total opex fell to $4.0M from $10.8M YoY; GAAP net loss improved to $5.0M from $12.2M YoY; non-GAAP net loss to $3.8M from $10.0M YoY .
Regulatory momentum and IP expansion: AdCom scheduled; PDUFA set; multiple Notices of Allowance in U.S. and Canada extend IP runway for oral sulopenem and combinations to 2039–2041 (absent extensions) .
Management confidence on safety and data strength: “sulopenem has presented a very clean safety profile,” and REASSURE showed non-inferiority with statistical superiority in specified cuts vs. Augmentin; management sees potential label discussion on superiority, subject to FDA .

What Went Wrong

Balance sheet overhang remains: ~$11.1M exchangeable notes outstanding and a $14.7M cash obligation (incl. accrued interest) in Jan 2025 if notes are not exchanged; management flagged need for financing flexibility via preemption opt-out .
Capital raises are costly/time-consuming: recent rights offering (net $5.8M) took ~3.5 months and >$1.6M in costs, underscoring financing friction for a pre-revenue company .
Stewardship/label scope uncertainty: FDA plans AdCom discussion on antimicrobial stewardship and most appropriate uUTI patient population; management acknowledged potential complexities if label narrowing were considered beyond studied populations .

Financial Results

Note: Iterum is pre-commercial; no product revenue reported. Condensed statements include no revenue line; operating loss equals total operating expenses for the periods shown .

Metric	Q2 2023	Q1 2024	Q2 2024
Research & Development ($M)	$9.0	$4.0	$2.1
General & Administrative ($M)	$1.9	$2.2	$1.9
Total Operating Expenses ($M)	$10.8	$6.2	$4.0
Net Loss – GAAP ($M)	$12.2	$7.1	$5.0
Net Loss – Non-GAAP ($M)	$10.0	$5.8	$3.8
EPS – GAAP (Basic & Diluted)	$(0.95)	$(0.46)	$(0.30)
Weighted Avg Shares (Basic & Diluted)	12,942,969	15,432,693	16,552,214

Balance sheet and cash KPIs

KPI	Q4 2023	Q1 2024	Q2 2024
Cash, Cash Equivalents & ST Investments ($M)	$24.0	$18.2	$11.7
Exchangeable Notes (Carrying Value, $M)	$11.5	$12.2	$13.0
Royalty-Linked Notes ($M)	$7.5	$7.9	$8.3
Total Liabilities ($M)	$32.7	$25.8	$25.1
Shareholders’ (Deficit)/Equity ($M)	$(6.4)	$(6.2)	$(10.9)

Notes:

Post-quarter financing: rights offering closed Aug 9 added $5.8M net proceeds; management reiterated runway into 2025 including through the Oct 25 PDUFA date .
Capital structure: ~22.7M ordinary shares outstanding post-rights offering; ~$11.1M exchangeable notes outstanding, exchangeable into ~1.9M shares; if not exchanged, $14.7M due Jan 2025 (principal+interest) .

Margins/Segments/KPIs:

Revenue/Margins: Not meaningful pre-commercial; no segment reporting .
Operating drivers: Opex decline driven by completion of REASSURE enrollment and winding down related costs .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
FDA Action Timing (PDUFA)	NDA for oral sulopenem (uUTI)	“Early Q4 2024” expectation (upon resubmission)	October 25, 2024 (PDUFA date assigned)	Specified timing
FDA Advisory Committee	NDA for oral sulopenem	Not previously scheduled (noted as expected)	AdCom set for Sept 9, 2024; focus on stewardship and target population	Scheduled
Cash Runway	Corporate	Into 2025, including through expected PDUFA in early Q4 2024	Into 2025, including through Oct 25 PDUFA; supported by Aug 9 rights offering	Maintained (funding enhanced)
Capital Structure Flexibility	Corporate	Not highlighted	Seeking shareholder approval to disapply preemption rights to enable faster cash raises	New proposal

Earnings Call Themes & Trends

Topic	Q4 2023 (Q-2)	Q1 2024 (Q-1)	Q2 2024 (Current)	Trend
Regulatory path (NDA)	Resubmission planned early Q2 2024; SPA-backed REASSURE positive topline in Jan 2024	NDA resubmitted; FDA action expected early Q4 2024	AdCom Sept 9; PDUFA Oct 25; engagement ongoing	Increasing visibility, firm dates
Antimicrobial stewardship/label scope	Not highlighted	Not central	FDA AdCom to discuss stewardship and most appropriate uUTI population; management cautions against narrowing beyond studied populations	Key discussion point emerging
Clinical efficacy/safety	Positive REASSURE; addressing CRL with compelling data	Management underscores superiority in specified analyses and clean safety profile	Reinforced: comprehensive safety across 4 Ph3s; label discussions may consider superiority	Consistently positive
Financing/liquidity	Cash into 2025 post ATM; strategic alternatives initiated	Cash into 2025; 16.6M shares O/S at 4/30	$5.8M net rights offering; runway into 2025; preemption opt-out sought	Bolstered near term; 2025 notes loom
Strategic alternatives	Advisor engaged to explore sale/license	Ongoing; no specifics	Ongoing; proceeds support process	Ongoing, undisclosed
Competitive landscape	Not highlighted	Pivya approval noted; Iterum positions for elevated-risk uUTI patients; large addressable market	Stewardship/appropriate use emphasized; first oral penem if approved	Narrative taking shape

Management Commentary

“If approved, oral sulopenem would be the first oral penem approved in the U.S.” .
“We reported positive topline data in January 2024 and resubmitted our NDA in April 2024… the FDA has assigned a PDUFA action date… October 25, 2024.” .
“As we look at our cash as of June 30, we had $11.7 million… [and] $5.8 million of net proceeds [from the rights offering]… provides a runway into 2025, including through the expected PDUFA date” .
“Sulopenem has presented a very clean safety profile… we will have a comprehensive safety database across all… patients.” .
On label scope: narrowing to subgroups not studied “would be very difficult… that could potentially be why they want to talk with the advisory committee.” .

Q&A Highlights

AdCom focus and FDA stance: Management doesn’t view FDA as “reluctant to approve,” but expects deliberation on appropriate patient targeting given first-in-class oral penem status .
Label narrowing risk: Management noted it would be challenging for FDA to restrict label to prerequisite failures not studied; expects AdCom to examine stewardship and population .
Superiority in labeling: While REASSURE showed non-inferiority and statistical superiority in certain analyses, management is unsure if superiority will appear in the label but views the data as compelling .
Safety dataset: Company plans to present comprehensive safety across four Phase 3 studies; reiterated clean safety profile .

Estimates Context

Wall Street consensus (S&P Global) for Q2 2024 revenue/EPS was unavailable at the time of query due to data access limits; therefore, no vs-estimates comparisons are included [S&P Global consensus unavailable].
Given no reported revenue and a development-stage profile, near-term estimate revisions likely center on operating expense trajectories, financing runway, and probability-weighted regulatory outcomes post-AdCom/PDUFA rather than top-line/earnings.

Key Takeaways for Investors

Binary catalysts ahead: Sept 9 AdCom and Oct 25 PDUFA are the primary stock movers; topics include stewardship and target population, not just efficacy/safety .
Balance sheet risk into early 2025: $14.7M due Jan 2025 absent note exchanges; management pursuing flexibility to raise equity more quickly; recent rights offering netted $5.8M but was costly/time-consuming .
Operating burn materially lower as trial costs fade, reducing financing needs versus 2023 levels; Q2 opex $4.0M vs. $10.8M LY .
IP position strengthening with multiple allowed patents potentially extending protection into 2039–2041, supporting commercial durability if approved .
Competitive/market positioning: management targets elevated-risk uUTI patients within a large market; stewardship discussions may support focused use while enabling clinician adoption if approved .
Label dynamics matter: any narrowing could constrain early uptake; conversely, any acknowledgment of superiority in labeling could be a positive surprise; management is prepared for both discussions .
Strategic alternatives remain on the table; a partnership/license or sale outcome could de-risk commercialization and financing requirements ahead of 2025 maturities .

Appendix: Additional Quantitative Details

Non-GAAP adjustments disclosed (Q2 2024)

Excluded items include share-based compensation ($0.1M), interest expense associated with accrued interest and amortization on exchangeable notes ($0.7–0.8M), and non-cash fair value adjustments to derivatives and royalty-linked notes ($0.4M), leading to non-GAAP net loss of $3.8M vs. GAAP net loss of $5.0M .

Capital structure and shares

Weighted average shares increased to 16.6M in Q2 from 15.4M in Q1; post-rights offering ordinary shares outstanding ~22.7M (includes newly issued shares) .

Disclosures and regulatory schedule

AdCom: Sept 9, 2024; PDUFA: Oct 25, 2024; FDA communication stated AdCom topics include stewardship and most appropriate target population .

Iterum Therapeutics plc (ITRM)·Q2 2024 Earnings Summary