Core Insights - Biotech and healthcare stocks experienced significant movements in after-hours trading, driven by corporate updates and investor anticipation [1] Company Updates - Butterfly Network, Inc. (BFLY) shares increased by 6.04% to $2.81 after a 14.22% rise to $2.65 at market close, following the announcement of CEO Joseph DeVivo and Interim CFO Megan Carlson's participation in the 8th Annual Evercore Healthcare Conference [2] - Citius Pharmaceuticals Inc. (CTXR) saw a 7.90% increase to $1.23 after a 15.15% rally to $1.14, attributed to a deeper collaboration with Verix for the commercialization of LYMPHIR, an FDA-approved immunotherapy expected to launch in Q4 2025 [3] - ProQR Therapeutics N.V. (PRQR) rose 6.80% to $2.20 after a flat close at $2.06, with no specific news indicating that the movement may be due to investor sentiment [4] - Perrigo Company plc (PRGO) advanced 3.97% to $13.14, building on a 3.10% gain at the close, reflecting steady investor interest despite no new announcements [4] - Tempest Therapeutics, Inc. (TPST) added 4.86% to $3.67 after reversing a decline, following the announcement of plans to acquire CAR-T programs from Factor Bioscience, expected to close in early 2026 [5] - Iterum Therapeutics plc (ITRM) rose 2.77% to $0.3969 after a 4.38% gain at the close, with no new updates released [6] - Processa Pharmaceuticals, Inc. (PCSA) edged up 1.86% to $0.26 despite a steep decline at the close, with no news issued [6]

Financial Data and Key Metrics Changes - Iterum generated net product sales of $0.4 million in Q3 2025, which included initial stocking at specialty pharmacies [21] - Total operating expenses were $8.1 million in Q3 2025, compared to $4.9 million in Q3 2024, reflecting increased commercialization activities [21][22] - The net loss on a US GAAP basis was $9 million for Q3 2025, compared to a net loss of $6.1 million for Q3 2024 [24] Business Line Data and Key Metrics Changes - The launch of Orlyvah began on August 20, 2025, with over 280 prescriptions generated by more than 100 unique prescribers by November 12, 2025 [9][12] - Approximately 40% of Orlyvah prescriptions have been filled through payer approval processes, aligning with expectations [10] Market Data and Key Metrics Changes - Orlyvah's access now reaches 16% of insured lives, with increasing adoption by employer groups and payer formularies [16] - A signed rebate agreement with a top Medicare Part D pharmacy benefit manager allows Orlyvah to be added to formularies for coverage beginning in 2026 or 2027 [15] Company Strategy and Development Direction - The company plans to raise additional capital to support ongoing commercialization efforts and potentially expand into high-value territories [19] - Iterum aims to generate revenue in excess of expenses and become self-funding over the next couple of years [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the feedback from physicians, payers, and patients regarding Orlyvah, indicating a positive trajectory for revenue growth [20] - The company expects modest sales in Q4 2025 and anticipates net product revenue for 2026 to be between $5 million and $15 million [18] Other Important Information - Iterum's cash and cash equivalents at the end of September 2025 were $11 million, providing an operating runway into Q2 2026 [24][25] - The company has reduced its in-person field team to 10 representatives and is augmenting efforts with virtual sales representatives [14] Q&A Session Summary Question: Will the company report specific launch metrics in the coming quarters? - The company plans to report metrics such as prescriptions, growth, and number of physicians to track the launch [27][28] Question: Can the company provide more details on payer coverage and uptake? - Feedback from physicians has been positive, particularly regarding Orlyvah's ability to keep patients out of the hospital [31][32] Question: What marketing strategies are being considered to drive uptake? - The company is focusing on field organization investments and is considering social media and other marketing channels for future engagement [40][52]

Commercialization of ORLYNVAH™ - ORLYNVAH™ was commercially launched in the United States in August 2025, with modest sales expected during the early stages of commercialization efforts[166]. - The commercialization partner EVERSANA will provide sales and commercial operations services for ORLYNVAH™ under a five-year agreement[168][169]. - The company plans to continue commercialization efforts for ORLYNVAH™ and expand its research and development programs, which will require additional capital[243][246]. - The company has limited net product sales to date since the launch of ORLYNVAH™ in August 2025, with revenues expected to fluctuate in future periods[182]. - Product revenue for the three months ended September 30, 2025, was $0.4 million, compared to $0.0 million for the same period in 2024, reflecting the launch of ORLYNVAH™ in August 2025[198]. - For the nine months ended September 30, 2025, product revenue was $0.4 million, up from $0.0 million in 2024, driven by ORLYNVAH™ sales[208]. Financial Performance and Losses - The company incurred net losses of $20.4 million and $18.2 million for the nine months ended September 30, 2025 and 2024, respectively, and an accumulated deficit of $506.5 million as of September 30, 2025[172]. - The company expects to continue incurring significant expenses and increased operating losses as it focuses on maximizing the commercial potential of ORLYNVAH™[167]. - The operating loss for the three months ended September 30, 2025, was $7.7 million, compared to a loss of $4.9 million in 2024, an increase of $2.8 million[197]. - Loss before income taxes for the nine months ended September 30, 2025, was $20.1 million, compared to a loss of $18.0 million in 2024, an increase of $2.1 million[207]. - Total operating expenses for the three months ended September 30, 2025, were $8.1 million, an increase of $3.2 million from $4.9 million in 2024[197]. - Total operating expenses for the nine months ended September 30, 2025, were $17.4 million, an increase of $2.3 million from $15.0 million in 2024[207]. Cash Position and Funding - As of September 30, 2025, the company had cash and cash equivalents of $11.0 million, raising substantial doubt about its ability to continue as a going concern[176]. - The company had cash and cash equivalents of $11.0 million as of September 30, 2025, but does not believe this will cover operating expenses for the next 12 months, raising substantial doubt about its ability to continue as a going concern[243][244]. - The company sold 11,875,589 ordinary shares under the Sales Agreement at an average net price of $1.07 per share, generating net proceeds of $12.7 million[220]. - The company registered for sale up to $150.0 million of various securities under the 2025 Shelf Registration Statement, effective February 19, 2025[219]. - During the nine months ended September 30, 2025, net cash provided by financing activities was $2.2 million, primarily from the sale of ordinary shares and the April 2025 Registered Direct Offering[241]. - The company generated net proceeds of approximately $42.1 million from the February 2021 Underwritten Offering, which included the sale of 2,666,666 ordinary shares[233]. Expenses and Cost Management - Selling, general and administrative expenses increased significantly to $6.5 million for the three months ended September 30, 2025, compared to $1.8 million in 2024, an increase of $4.7 million[202]. - Research and development expenses decreased to $1.3 million for the three months ended September 30, 2025, from $3.1 million in 2024, a reduction of $1.8 million[201]. - Research and development expenses for the nine months ended September 30, 2025, were $2.9 million, down from $9.2 million in 2024, a decrease of $6.3 million[211]. - Personnel related costs decreased by $0.3 million due to a reduction in accrued bonuses, while professional and consulting fees increased by $8.2 million, primarily for pre-commercialization and commercialization activities[212]. - The company anticipates increased expenses due to inflation and a competitive wage environment, which may affect future operating costs[245]. Strategic Planning and Future Outlook - The company is continuously evaluating corporate, strategic, financial, and financing alternatives to maximize value for stakeholders[178]. - The company is actively considering contingency plans, including alternative sourcing strategies, to mitigate potential future impacts from increased tariffs and trade tensions[249]. - The company is evaluating corporate, strategic, financial, and financing alternatives to maximize shareholder value while managing resources prudently[251]. Regulatory and Market Considerations - The company received FDA approval for ORLYNVAH™ on October 25, 2024, for the treatment of uncomplicated urinary tract infections[225]. - The company is obligated to pay Pfizer sales milestones upon achievement of net sales ranging from $250.0 million to $1.0 billion for each product type, as well as royalties ranging from single-digit to mid-teens percentage based on marginal net sales of each licensed product[252]. - Payments to holders of RLNs will be due within 75 days of the end of each six-month payment measuring period, with a payment rate of 15% based on specified net revenues from U.S. sales of sulopenem products[254]. - The company has agreements with contract service providers that represent significant costs in research and development and commercial activities[253]. - The new reciprocal tariff rates range from 10% to 41%, with imports from Switzerland receiving a 39% rate, while the baseline tariff on China remains at 10%[248]. - The company may face a 100% tariff on all branded or patented drugs imported into the U.S. starting October 1, 2025, unless manufacturing facilities are built in the U.S.[248]. Foreign Currency and Inflation Impact - The company has not engaged in any hedging activities against foreign currency exchange rate risk, and realized net foreign currency gains and losses did not materially affect operations[257]. - Inflation has not had a material effect on the company's financial statements to date, but future operations may be adversely affected by inflation[258]. - The company experienced a net cash decrease of $13.1 million for the nine months ended September 30, 2025, compared to an increase of $7.3 million in the same period of 2024[237].

Product Launch and Sales - Iterum Therapeutics launched ORLYNVAH™ in the United States in August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs) after over 25 years without new branded launches in this space[3] - Net product revenues for the third quarter of 2025 were $0.4 million, reflecting initial sales of ORLYNVAH™[7] - The company expects net product sales of ORLYNVAH™ to range between $5 million and $15 million in 2026, depending on market uptake and payer coverage[3] Financial Performance - The net loss for the third quarter of 2025 was $9.0 million, compared to a net loss of $6.1 million for the same period in 2024[13] - Product revenue for the three months ended September 30, 2025, was $390 million, with no revenue reported for the same period in 2024[25] - The net loss for the three months ended September 30, 2025, was $8,979 million, compared to a net loss of $6,094 million for the same period in 2024, indicating a 47% increase in losses[25] - Non-GAAP net loss for the three months ended September 30, 2025, was $7,342 million, compared to $4,837 million for the same period in 2024, reflecting a 52% increase[25] Expenses - Research and development expenses decreased to $1.3 million in Q3 2025 from $3.1 million in Q3 2024, primarily due to lower chemistry, manufacturing, and control expenses[10] - Selling, general, and administrative expenses increased to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, attributed to the commercialization of ORLYNVAH™[11] - Total operating expenses for the three months ended September 30, 2025, were $8,121 million, compared to $4,887 million for the same period in 2024, representing a 66% increase[25] - Research and development expenses for the three months ended September 30, 2025, were $1,261 million, compared to $3,107 million for the same period in 2024, showing a decrease of 59%[25] Cash and Assets - Cash and cash equivalents were $11.0 million as of September 30, 2025, with an extended cash runway projected into Q2 2026[6] - Cash, cash equivalents, and short-term investments decreased to $11,002 million as of September 30, 2025, down from $24,125 million as of December 31, 2024[27] - Total assets decreased to $32,503 million as of September 30, 2025, from $44,595 million as of December 31, 2024[27] - Total liabilities decreased to $39,884 million as of September 30, 2025, from $48,676 million as of December 31, 2024[27] Shareholder Information - The company reported a weighted average of 45,801,927 ordinary shares outstanding for the three months ended September 30, 2025, compared to 20,044,270 for the same period in 2024[25] Intellectual Property and Research - Iterum has been granted a patent in China for a combination treatment related to sulopenem, projected to expire in March 2041[4] - The company presented two posters at the IDWeek 2025 conference, highlighting its focus on urinary tract infections[5] Derivatives and Amortization - Adjustments to the fair value of derivatives for Q3 2025 were $0.7 million, compared to $0.4 million for the same period in 2024[12] - The amortization of intangible assets for the three months ended September 30, 2025, was $349 million, with no amortization reported for the same period in 2024[25]

Core Insights - Iterum Therapeutics has commercially launched ORLYNVAH™ in the United States in August 2025, targeting uncomplicated urinary tract infections (uUTIs) [1][2] - The company has extended its cash runway into Q2 2026, with cash and cash equivalents reported at $11.0 million as of September 30, 2025 [1][4] - The company anticipates modest sales for ORLYNVAH™ in 2025, with expected net product sales ranging between $5 million and $15 million in 2026 [2] Financial Performance - Net product revenues for Q3 2025 were $0.4 million, primarily from initial stocking at specialty pharmacy locations [5] - Research and development expenses decreased to $1.3 million in Q3 2025 from $3.1 million in Q3 2024, attributed to lower chemistry, manufacturing, and control expenses [9] - Selling, general, and administrative expenses increased to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, driven by the commercialization of ORLYNVAH™ [10] Loss and Adjustments - The net loss for Q3 2025 was $9.0 million, compared to a net loss of $6.1 million in Q3 2024 [12] - Non-GAAP net loss for Q3 2025 was $7.3 million, compared to a non-GAAP net loss of $4.8 million in Q3 2024 [12][14] - Adjustments to the fair value of derivatives for Q3 2025 were $0.7 million, up from $0.4 million in Q3 2024 [11] Product and Market Development - ORLYNVAH™ is positioned as a novel oral penem antibiotic with potent activity against resistant strains of bacteria, addressing a significant unmet need in the uUTI market [18] - The company has expanded its patent estate, receiving patents in China and Mexico for formulations related to ORLYNVAH™, with expiration dates projected in 2041 and 2039, respectively [7] - Iterum presented at the IDWeek 2025 conference, highlighting its commitment to addressing antibiotic resistance and promoting ORLYNVAH™ [7]

Earnings Reports Overview - The earnings season is slowing down, but several retail-favorite companies are set to report this week [1] - Key companies reporting include Barrick Mining Corp., Plug Power Inc., Oklo Inc., Cisco Systems Inc., Walt Disney Co., and Applied Materials Inc. [2][3][5][10][11] Company-Specific Insights - Barrick Mining Corp. reported its third-quarter results before the market opened on November 10 [2] - Plug Power Inc. is expected to report losses of 12 cents per share and revenue of $179.54 million, having missed earnings expectations for the last 18 quarters [3] - Oklo Inc. is anticipated to report losses of 13 cents per share and revenue of $17.01 billion, with stock volatility noted ahead of the report [5] - Cisco Systems Inc. is expected to be a focal point for investors, particularly regarding management's guidance and updates on AI and cybersecurity business momentum [10] - Walt Disney Co. and JD.com Inc. will release earnings reports before the market opens on November 13 [11] - Applied Materials Inc. is set to release its Q4 results after the market closes on November 13 [11] Additional Companies Reporting - Other companies reporting this week include Workhorse Group Inc., Beyond Meat Inc., Microvision Inc., and Virgin Galactic Holdings Inc. [4][6][12]

Core Insights - Iterum Therapeutics plc is set to release its third quarter 2025 financial results on November 14, 2025, before the U.S. markets open, followed by a conference call at 8:30 a.m. ET to discuss the results and business updates [1] Company Overview - Iterum Therapeutics plc focuses on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [3] - The company is advancing its first compound, sulopenem, which is a novel penem anti-infective with both oral and IV formulations, showing potent in vitro activity against various resistant bacteria [3] - Iterum has received FDA approval for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women, along with QIDP and Fast Track designations for its formulations in seven indications [3]

Core Insights - Iterum Therapeutics plc is focused on developing next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens in both community and hospital settings [1] Group 1: Conference Participation - The company will present two posters at the IDWeek 2025 conference in Atlanta, GA from October 19-22, 2025 [1] - A Learning Lounge session titled "An Overview of Urinary Tract Infection in Adult Women: Focus on Oral Sulopenem" will be conducted on October 21, 2025 [2] - The two posters include: 1. "Risk factors for treatment failure in patients with uncomplicated urinary tract infection" presented by Steven I. Aronin, MD on October 20, 2025 [2] 2. "In vitro activity of sulopenem and comparator agents against U.S. Enterobacterales clinical isolates, SENTRY antimicrobial surveillance program, 2023" presented by Steven I. Aronin, MD on October 21, 2025 [2] Group 2: Product Information - ORLYNVAH™ is a novel oral penem antibiotic specifically designed for treating uncomplicated urinary tract infections (uUTIs) [3] - ORLYNVAH™ is effective against Enterobacterales species that produce extended spectrum beta-lactamases (ESBL) or AmpC-type β-lactamases, which confer resistance to third-generation cephalosporins [3] Group 3: Company Overview - Iterum Therapeutics plc aims to address the global crisis of multi-drug-resistant pathogens with differentiated anti-infectives [4] - The company is advancing sulopenem, a novel penem anti-infective compound, which has shown potent in vitro activity against various resistant bacteria [4] - ORLYNVAH™ has received FDA approval for treating uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited treatment options and is commercially available in the U.S. [4]

Core Insights - Iterum Therapeutics is focused on developing next-generation oral and IV antibiotics to combat multi-drug resistant infections in both community and hospital settings [1] Financial Overview - As of June 30, 2025, Iterum expects its cash and cash equivalents, along with $2.2 million raised from its at-the-market offering, to fund operations into 2026 [3] - The company is exploring various financing opportunities, including non-dilutive funding, to extend its operational runway [3] Product Launch and Market Access - ORLYNVAH™, an oral antibiotic, was launched in August 2025 in targeted territories across seven U.S. states, with sales representatives actively engaging with physicians [5] - The product is broadly accessible via prior authorization and medical exception pathways, with ongoing discussions for expanded access and long-term formulary positioning [5] - Iterum has received 510(k) clearance from the FDA for its Antimicrobial Susceptibility Test Disc, aiding in effective therapy for patients [5] Patent Developments - Iterum has been granted a patent in China for a combination treatment, projected to expire in March 2041, and a patent in Mexico for a bilayer tablet, set to expire in December 2039 [6] - The company is optimizing its patent strategy to ensure the expansion of its valuable patent portfolio [6] Upcoming Events - Iterum will conduct a Learning Lounge at IDWeek 2025 on October 21, 2025, focusing on urinary tract infections in adult women [6] Company Overview - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens with its lead compound, sulopenem, which has shown potent activity against various resistant bacteria [7] - ORLYNVAH™ has received FDA approval for treating urinary tract infections caused by specific bacteria in adult women with limited treatment options [7][8]

Core Viewpoint - Iterum Therapeutics has launched ORLYNVAH™, the first oral penem antibiotic in the U.S. for treating uncomplicated urinary tract infections (uUTIs) in women, addressing a significant unmet medical need in the face of rising antibiotic resistance [1][5]. Group 1: Product Launch and Approval - ORLYNVAH™ (sulopenem etzadroxil and probenecid) received FDA approval in October 2024 for adult women with uUTIs caused by specific pathogens [1][5]. - This product is the first new branded treatment for uUTIs in over 25 years, providing a critical option for patients with limited oral antibacterial alternatives [1][5]. Group 2: Market Need and Impact - Approximately 60% of women experience a urinary tract infection in their lifetime, with 44% having three or more episodes annually, highlighting the prevalence of this condition [2]. - The increasing resistance to antibiotics is expected to inflate healthcare costs and lead to poor patient outcomes, emphasizing the urgent need for new therapies [2]. Group 3: Clinical and Patient Benefits - Clinicians have expressed that ORLYNVAH™ offers impressive efficacy data and a much-needed treatment option for women suffering from difficult-to-treat uUTIs [3]. - The introduction of ORLYNVAH™ is anticipated to reduce emergency department visits and hospital admissions, positively impacting patients' quality of life [3]. Group 4: Company Mission and Future Plans - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens by developing differentiated anti-infectives [5]. - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its formulations, indicating a strong commitment to innovation in this therapeutic area [5].