Financial Data and Key Metrics Changes - Consolidated net sales for Q2 2025 were $12.7 million, a decrease of approximately $800,000 or 6.7% compared to Q2 2024 [9] - Gross profit was $2 million, representing 16% of sales for Q2 2025 [9] - Adjusted EBITDA for the first half of 2025 was $1.469 million, a decrease of $306,000 or 17% from the prior year [10] - The company reported a net loss of $422,000 or $0.11 per share in 2025, compared to net income of $298,000 or $0.09 per share in 2024 [10] Business Line Data and Key Metrics Changes - The company faced delays in customer approvals and extended lead times from subcontractors, impacting overall results [4] - Cost-cutting initiatives, including a workforce reduction, are expected to save approximately $1 million annually [5] - The backlog grew to record levels, indicating sustained demand for products, with significant contracts such as a $5 million order for landing gear components for the B-52 aircraft [6] Market Data and Key Metrics Changes - The company noted that long lead times for raw materials and complex product manufacturing mean that sales from the backlog will primarily be realized in fiscal 2026 and beyond [6][7] - The business development team has been actively pursuing new opportunities, particularly following the Paris Air Show [7] Company Strategy and Development Direction - The company is focused on recovering from decreased revenue streams with legacy customers while reinforcing relationships with existing clients and expanding into new markets [12] - Recent accomplishments include receiving a significant long-term agreement from Northrop Grumman and increasing content on the CH-53K helicopter [13] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the disappointing results for Q2 2025 but expressed confidence in the long-term business outlook despite recent headwinds [5] - The company anticipates that the fourth quarter of 2025 will be the strongest quarter of the year [5] - Management emphasized that the backlog is healthy and that delays in customer approvals are temporary [32] Other Important Information - The company successfully completed an at-the-market offering, raising nearly $4 million, which enhances liquidity and reduces net debt [11] - Total debt has declined by over $1 million, while inventory has increased by about $1.3 million [11] Q&A Session Summary Question: Concerns about credit facility and liquidity - Management is in discussions with the current lender and is confident about extending the credit facility [19][20] Question: Nature of recent capital raise - The capital raise was part of a planned process initiated in December 2024, not solely opportunistic [21] Question: European sales potential - The company does not have significant European customers but is optimistic about potential sales due to increased European defense spending [23][26] Question: Clarification on declining sales - Sales decline is attributed to timing issues with customer approvals and delays in first articles [32][33] Question: Consideration of selling the company - Management stated that while sales have been stagnant, there has been growth in certain operations, and they are open to opportunities that benefit shareholders [36][39] Question: Backlog conversion rates - The backlog consists of firm and full backlog, with a significant portion being firm orders that cannot be easily canceled [41][43] Question: Future of manned aircraft vs. drones - Management believes that manned aircraft will continue to play a crucial role alongside drones, as they are not expected to be replaced in the near future [46][48]

Financial Data and Key Metrics Changes - For Q2 2025, the company generated total revenue of $1.7 million, consisting of $1.6 million in net product sales from Zunveil and $81,000 in licensing revenue from CMS [13] - Total costs and expenses for the quarter were $7.4 million, leading to an operating loss of $5.7 million compared to a loss of $2.4 million in Q2 2024 [14] - The net loss for Q2 2025 was $10.5 million or $0.65 per share, compared to a net loss of $2.1 million or $0.35 per share in the same quarter last year [15] Business Line Data and Key Metrics Changes - The commercial launch of Zunveil has seen prescriptions written in over 300 nursing homes, with 65% of these facilities placing repeat orders, indicating strong product trial [6][18] - The company reported approximately $2 million in net product revenues for Zunveil since its launch [13] Market Data and Key Metrics Changes - The company engaged with over 3,700 healthcare providers (HCPs) in the long-term care market during the quarter [6] - By the end of Q2, Zunveil had been ordered in over 300 long-term care homes, with 90% of orders filled despite increased prior authorization hurdles [20] Company Strategy and Development Direction - The company is focused on expanding Zunveil's presence in the long-term care market and optimizing its commercial strategy to enhance engagement with prescribers [27] - The company plans to advance its sublingual formulation and conduct a comparative pharmacokinetic study, with an IND submission anticipated in 2026 [7][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the initial traction of Zunveil and the potential for scalable growth in the coming quarters [13][17] - The company remains committed to disciplined expense management and anticipates full-year operating expenses in the range of $34 million to $38 million [16] Other Important Information - The company has made significant progress with its first ex-US partner, CMS Pharmaceuticals, which is on track to file in four additional countries by 2025 [11] - The company is well-capitalized with approximately $39.4 million in unrestricted cash as of June 30, 2025 [15] Q&A Session Summary Question: Can you characterize the typical profile of a repeat prescriber of Zunveil? - The company has identified high-volume nursing home facilities with a significant number of Alzheimer's patients as key targets for repeat prescriptions [31] Question: What is the expected state of contracting by the end of the year? - The company expects to have at least one more large national plan contracted by the end of the year, in addition to the existing contract [33] Question: Can you provide insights on prior authorization challenges? - The company has seen an increase in prior authorizations but reports that 90% of orders are being filled, albeit with some delays [39] Question: What is the anticipated monthly net revenue run rate for Q3? - The company anticipates a range of $5.75 to $6.25 million for the monthly net revenue run rate [41] Question: When should the second $3 million tranche from CMS be expected? - The company expects to receive the tranche in the last quarter of this year based on current progress [52] Question: Do you see any changes to the expected hockey stick-shaped revenue curve? - The company maintains its expectations for a hockey stick-shaped revenue curve, with significant growth anticipated in late 2026 and early 2027 [56]

Financial Data and Key Metrics Changes - For the second quarter of 2025, the company reported revenues of approximately $422,000 from commercial sales of the RenovaCATH device, driven by new customer purchase orders and early repeat orders [17] - Research and development expenses were $1.4 million, reflecting a $100,000 decrease from the same quarter year over year [17] - The company ended the quarter with $12.3 million in cash and cash equivalents [17] Business Line Data and Key Metrics Changes - The RenovaCATH device achieved over $400,000 in sales in the second quarter, marking a significant accomplishment shortly after its launch [7][11] - The company has randomized 95 patients in the Phase three TIGER PACT trial, with 61 events occurring, keeping it on track to complete enrollment later this year or early next year [10][13] Market Data and Key Metrics Changes - The initial U.S. total addressable market for the RenovaCATH device is estimated at $400 million in peak annual sales opportunity [12] - The company believes there is potential for a several billion dollar total addressable market as it expands into additional cancer applications [12] Company Strategy and Development Direction - The company aims to transform patient outcomes through safer, more effective targeted therapy, particularly for difficult-to-treat cancers like locally advanced pancreatic cancer [10] - The company is focused on building commercialization momentum while maintaining a lean operational structure [11] - The company plans to explore international markets after establishing a strong presence in the U.S. [41] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the positive recommendation from the independent data monitoring committee (DMC) to continue the TIGER PACT trial, indicating confidence in the trial's potential outcomes [9][13] - The company anticipates a ramp-up in enrollment pace due to the addition of larger cancer centers [29] Other Important Information - The company launched a multicenter post-marketing registry study called PANTHER to evaluate the safety and effectiveness of the RenovaCATH device in real-world clinical settings [14] - The company is exploring the use of the RenovaCATH device for various solid tumors beyond pancreatic cancer, including cholangiocarcinoma and non-small cell lung cancer [52][53] Q&A Session Summary Question: Clarification on trial patient numbers - Management confirmed that the DMC's feedback was positive, and the trial will maintain the same sample size without adding patients [22] Question: Timing for data from the PANTHER trial - Management indicated that data from the PANTHER study will be published as interesting findings arise, without a specific timeline [31] Question: Update on partnerships with top cancer centers - Management reported that they are currently in 13 hospitals with approvals to purchase the device, with four centers already treating patients [39] Question: Revenue from clinical studies vs. commercial sales - Management clarified that the reported revenue of $422,000 is from new customers outside of the clinical trial, with no revenue recognized from the TIGER PACT trial [46] Question: Plans for international market expansion - Management stated that while the focus is currently on the U.S. market, there are plans to explore international opportunities in the future [41] Question: Gross margins sustainability - Management expressed confidence that gross margins could increase towards the 70% to 90% range as the company scales [72] Question: Future revenue expectations - Management anticipates growth throughout the year, with a significant ramp-up expected in 2026 as the sales team is fully established [76]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 totaled approximately $0.061 million, a decrease from $0.183 million in the same quarter of the previous year [15] - Gross margin increased to 43% from 32% year-over-year, although it remains variable at current revenue levels [15] - Net loss attributable to common stockholders was $36 million for Q2 2025, compared to a net loss of $5 million in Q2 2024 [17] - Total assets increased to $426 million as of June 30, 2025, up from $154 million at the end of 2024 [18] - Cash and equivalents rose by $270 million in the first half of 2025 to $349 million, bolstered by net proceeds of $188 million raised in Q2 [18] - Total liabilities decreased to $30 million, down approximately $16 million compared to year-end 2024 [19] - Stockholders' equity rose to $396 million as of June 30, 2025, reflecting a strengthened capital position [19] Business Line Data and Key Metrics Changes - The company is focused on two revenue streams: quantum machines for complex optimization and a photonic chip foundry for next-generation communication [5] - Significant orders were secured for quantum photonic systems and entangled photon sources, indicating growing commercial adoption [8][9] - A major automotive manufacturer purchased an EMUCORE reservoir computing system, showcasing real-world applications of the technology [10] Market Data and Key Metrics Changes - The company is positioned in a rapidly accelerating market for quantum technologies, with increasing awareness of their role in various sectors [6] - The domestic semiconductor and photonic manufacturing momentum is creating new commercial opportunities for the foundry [6] Company Strategy and Development Direction - The growth strategy is centered on delivering practical, high-performance quantum and photonic technologies rather than theoretical performance [5] - The company aims to integrate quantum machines with nanophotonic chips to enhance performance and reduce costs [23] - The foundry is expected to support both the development of quantum machines and offer services to other companies [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's progress and the potential of its technologies to deliver real-world solutions [20] - The focus for the next two to three years will be on integrating quantum machines with nanophotonic chips to enhance performance [23] Other Important Information - The company completed a $200 million financing round, strengthening its capital position [16] - Key leadership appointments were made to support the next phase of execution, including a new CFO and COO [13] - The company was added to the Russell 3000 and Russell 2000 indices, increasing visibility among institutional investors [14] Q&A Session Summary Question: What are the most important milestones for the next one to three years? - Management highlighted the integration of quantum machines with nanophotonic chips as a key focus, aiming to enhance performance and reduce costs [23] Question: Will there be an acceleration in spending or M&A activities? - The CFO indicated that while they are hiring additional staff to accelerate technology development, there are no current plans for acquisitions, although strategic opportunities are being explored [27][28]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $32,500,000, reflecting a 2% sequential increase and a 29% year-over-year growth, driven by strong new customer growth and expanding deployments [13][30] - Annual recurring revenue (ARR) as of June 30, 2025, was $110,500,000, representing a 27% year-over-year increase [13][32] - Adjusted EBITDA was positive at $2,000,000, compared to a loss of $8,000,000 in the same quarter last year, resulting in an adjusted EBITDA margin of 6% [34] - Total cash, cash equivalents, and marketable securities increased by $2,000,000 sequentially to $37,000,000, marking the first quarter of sequential cash increase [14][35] Business Line Data and Key Metrics Changes - The company welcomed over 60 new customers in Q2 2025, bringing the total to over 1,000 customers globally [14][92] - The company surpassed 7,000 active subscriptions, on track to meet the goal of at least 8,000 by year-end [15] - Approximately 54% of booked units and 56% of booked ARR in Q2 came from existing customers, indicating strong customer trust and value [16] Market Data and Key Metrics Changes - In the education market, the company expanded its presence by approximately 20 new school districts across the U.S., including a significant $15,000,000 contract with Gwinnett County Public Schools [19][20] - In healthcare, the company secured contracts with major institutions like Ohio State University Wexner Medical Center and Broward Health, reflecting growing demand for security solutions [21][22] - The sports and entertainment sector saw new wins with teams like Inner Miami CF and FC Cincinnati, along with significant upgrades from existing customers [24][25] Company Strategy and Development Direction - The company is shifting its go-to-market model to focus more on direct purchase subscriptions, which are expected to yield higher revenue and ARR compared to distribution fulfillment [26][27] - The company aims to build a durable, high-growth business with predictable results, focusing on operational efficiency and customer satisfaction [10][93] - The company is raising its revenue growth outlook for 2025 to 27-30%, up from the previous guidance of 20-25% [28][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver on 2025 goals, citing strong visibility into key business drivers and a growing backlog [28][38] - The company is focused on disciplined execution and improving operational efficiency, with a commitment to generating positive cash flow in Q4 2025 [29][40] - Management noted that the DOJ investigation is no longer a concern, allowing the company to focus on growth [9][93] Other Important Information - The company has secured a new $75,000,000 nondilutive credit facility to support its subscription-based sales model [36] - A settlement in principle was reached regarding a securities class action lawsuit, with expected direct financial exposure of no more than $1,000,000 [9][37] Q&A Session Summary Question: What is the expected mix of subscription deals versus purchase subscription deals going forward? - Management indicated a shift towards more subscription deals over time, with a balanced mix expected by 2026 [43][44] Question: What is the cost to refurbish Gen one Express machines for the new certified pre-owned program? - The program, named Evolve Flex, is new, and while refurbishment costs are being kept reasonable, traction is still early [45][46] Question: What is the hiring strategy for the remainder of the year? - Targeted hiring in R&D and services teams is expected, with a slight uptick in operational expenses [51][52] Question: What are the early signs regarding renewals and net revenue retention? - The company reported a net unit retention of over 100% for early renewals, with a focus on derisking renewals [62][63] Question: Where are the biggest opportunities in end markets? - Management highlighted the diversity across verticals, with strong opportunities in education, healthcare, and industrial workplaces [66][67] Question: Will the new credit line be drawn down sooner if business momentum continues? - The first $30,000,000 should suffice for a while, but the credit facility provides flexibility if needed [68][69]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $3.3 million, a significant increase from $1.1 million in Q2 2024, representing a 200% year-over-year growth [17] - Gross profit for Q2 2025 was $2.7 million, up from $0.7 million in Q2 2024, marking a 267% increase [7][17] - Gross margin improved to 83% in Q2 2025, an increase of 1,390 basis points compared to 69.1% in Q2 2024 [18] - Annual recurring revenue (ARR) reached $12.6 million in Q2 2025, a 182% increase from $4.5 million in Q2 2024 [7][17] - Net loss for Q2 2025 was $7.8 million, compared to a net loss of $4 million in Q2 2024 [18] Business Line Data and Key Metrics Changes - The company reported substantial growth driven by its subsidiaries, Vidello and OpenReal, contributing to the overall revenue increase [6] - The operational momentum was highlighted by the strong performance of the product suite, particularly in the AI-powered marketing solutions [6] Market Data and Key Metrics Changes - The global Martech market is expanding rapidly due to digital transformation and demand for personalized experiences, which the company aims to capitalize on [5] - The customer base expanded to over 140,000, including major clients like RBC Capital Markets, Cisco, and Adobe, indicating strong market penetration [12] Company Strategy and Development Direction - The company is focused on a dual strategy of organic growth and acquisitions, targeting key areas such as lead attraction, engagement, tracking, and intelligence [6][9] - The leadership team has been strengthened with the appointment of experienced executives to drive growth and operational efficiency [8][11] - The company aims to increase product capabilities through strategic acquisitions while also focusing on organic growth to reach $50 million in ARR within three years [32][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the operational position and cash flow improvements, emphasizing the importance of reducing capital costs over merely cutting operating expenses [22][29] - The leadership is optimistic about the potential for sequential revenue growth driven by the new team and improved sales processes [26][27] Other Important Information - The company secured an $11 million debt facility to support acquisitions and ongoing operations, enhancing its financial flexibility [7] - The focus remains on targeting mid-market and enterprise segments while also supporting small business customers [12] Q&A Session Summary Question: What is your sales cycle for mid-market and enterprise customers? - The sales cycle varies, with mid-market sales typically between 30 to 60 days, while larger deals may take over a year to close [24][25] Question: Will you be able to continue reducing operating expenses sequentially over the next few quarters? - Management indicated a focus on reducing capital costs rather than operating expenses, with opportunities for efficiency improvements identified [28][30] Question: What is ARR growth normalized for each acquisition? - The target for ARR growth is in the 20% to 30% range over the next year, with potential for outperformance depending on acquisitions [31] Question: Can there be development and profitability with the urgent time? - Management believes slight improvements in adjusted EBITDA could lead to positive cash flow, with ongoing efforts to explore options for profitability [34] Question: How do you drive revenue up significantly? - The company is focused on customer expansion through cross-sales and upgrades, with a strategy to increase revenue from existing customers over time [41][48]

Financial Data and Key Metrics Changes - For Q1 fiscal 2026, revenue increased by 21% to $3.9 million compared to $3.2 million in the prior year quarter [10] - Gross profit totaled $3.1 million, up 31.9% from $2.4 million in the prior year, with a gross profit margin improvement to 80.5% from 73.8% [11] - The company achieved positive EBITDA of $333,000, marking the first quarter in its history to reach this milestone [14] Business Line Data and Key Metrics Changes - Recurring revenue from technology as a service and usage-based subscriptions remained robust, driven by the popularity of the FDA cleared cardiac monitoring technology [10] - Technology fees accounted for 87% of total revenue, indicating strong customer retention and quality of support services [10] - Operating expenses decreased by 18.5% to $2.8 million from $3.5 million in the same period last year, with SG&A expenses down by 27.9% [12] Market Data and Key Metrics Changes - The company has expanded its market access through strategic partnerships with three major group purchasing organizations, providing access to approximately 90% of hospitals in the U.S. [5][13] - Regulatory approvals have been obtained in Canada, Saudi Arabia, Argentina, and other smaller markets, aligning with the strategy to promote accessible, high-quality care [6] Company Strategy and Development Direction - The company is focused on advancing its Cardiac AI cloud platform and pursuing FDA clearance for its AI clinical model, aiming to set new standards in cardiac care [4][5] - Strategic partnerships are being sought to further expand U.S. market access and capitalize on advantageous terms for solutions [6] - The company is diversifying into pulmonary neurology fields through partnerships with leading home-based diagnostic solutions [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's market position and the growing demand for its products dedicated to chronic cardiac disease prevention and management [16] - The focus on innovation and development continues to yield advancements in remote monitoring solutions, bringing the company closer to profitability [16] - The company is optimistic about maintaining margins, increasing growth, and achieving sustained profitability [19] Other Important Information - The net loss attributable to common stockholders for Q1 was $754,000, a significant improvement from a net loss of $6.9 million in the prior year [14][15] - The company has achieved positive free cash flows for the last four consecutive quarters, indicating a path towards profitability [13] Q&A Session Summary - No questions were raised during the Q&A session, and the call concluded with management expressing excitement about the next fiscal year and the milestone of moving to positive EBITDA [18][19]

Financial Data and Key Metrics Changes - The company ended the quarter with approximately $5 million in cash and cash equivalents and a working capital deficit of approximately $12.6 million [17] - General and administrative expenses were $2.4 million compared to $2.5 million in 2024, primarily due to decreases in personnel costs and stock-based compensation [18] - Research and development expenses were $1.4 million, a 71% decrease versus Q2 2024, mainly due to reductions in R&D expenses recognized from non-dilutive funding awards [18] Business Line Data and Key Metrics Changes - The company is on track to support the commercial availability of DARE2PLAY Sildenafil Cream through a 503B outsourcing facility in Q4 2025, representing a significant milestone in women's sexual health [5][6] - Ovaprene, a hormone-free contraceptive candidate, continues to progress with the Phase three trial, receiving a recommendation to continue from the Independent Data and Safety Monitoring Board [10] - DARE HRT1, an intravaginal ring for hormone therapy, is pursuing both FDA approval and a 503B compounding opportunity, targeting availability in late 2026 [12][13] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in the contraceptive landscape with Ovaprene, which could transform the market for hormone-free birth control [11] - The compounded hormone therapy market is estimated at $4.5 billion, where DARE HRT1 is expected to generate meaningful revenue [12] Company Strategy and Development Direction - The company is executing a dual path strategy, focusing on commercializing proprietary formulations while pursuing FDA approval for innovative women's health solutions [2][5] - The strategy includes leveraging non-dilutive capital and a disciplined investment approach to unlock value efficiently [6] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant interest and unmet need in supporting women with arousal concerns, as evidenced by the feedback from the direct-to-patient awareness campaign [7] - The company remains optimistic about the potential of DARE2PLAY Sildenafil Cream as a near-term revenue driver and is excited about the ongoing clinical programs addressing women's health needs [9][15] Other Important Information - The company received approximately $17.6 million in net proceeds from sales of common stock and a $6 million grant payment after the quarter end, strengthening its balance sheet [17] - The company is preparing to launch two non-prescription vaginal probiotics designed to support vaginal microbiome health, complementing its prescription offerings [13] Summary of Q&A Session - Due to technical difficulties, there was no Q&A session held during the call [18]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was €614.2 million, representing a 4.5% year-over-year growth, with a 1% growth in organic constant currency and 0.5% sequential growth [6][30] - Non-IFRS adjusted operating margin was 15% for the quarter, maintaining stability despite foreign exchange headwinds [30] - Non-IFRS adjusted diluted EPS for the quarter was $1.53, an increase from $1.51 in the previous year [30] - Free cash flow for the quarter was negative $2.9 million, an improvement from negative $28 million in the same period last year [31] Business Line Data and Key Metrics Changes - The AI Pods subscription model has gained traction, with 18 clients adopting this new model, contributing significantly to recent pipeline growth [8][41] - The company is focusing on high-value clients in sectors such as healthcare, financial services, consumer packaged goods (CPG), and gaming [6][30] Market Data and Key Metrics Changes - North America accounted for 54.1% of revenue, Latin America 19.7%, and Europe 19.6%, with Europe being the fastest-growing region at 8.1% sequentially [16] - New markets grew 84% year-over-year, currently representing 6.6% of total revenue, with the Middle East leading this surge [17] Company Strategy and Development Direction - The company is implementing a business optimization plan to align workforce skills with strategic priorities, resulting in a reduction of approximately 1,000 employees or 3% of the workforce [33] - The focus is on building a structurally agile organization to compete effectively in an evolving landscape while delivering strong results for shareholders [6][30] - The company aims to enhance its AI capabilities through partnerships with major AI leaders like OpenAI and AWS, integrating advanced models into its offerings [14][28] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding pipeline conversion, noting that while the macro environment remains uncertain, there are positive signs of recovery in North America and Latin America [48][72] - The company expects revenue for the full year 2025 to be at least $2.445 billion, representing a 1.2% year-over-year growth [35] Other Important Information - The company recorded a one-time charge of $47.6 million in Q2 due to the optimization plan, which is expected to generate $80 million in annualized savings [33] - The AI Pods model is designed to provide guaranteed time and cost savings, shifting the value proposition to concrete results [8][30] Q&A Session Summary Question: Can you provide more details on the AI-based delivery model and subscription side? - The company has 18 paying customers under the subscription model, which has been well received, generating code and software needed by clients [41][42] Question: How far along are the initial changes from the optimization plan? - Additional reductions are expected in Q3, with most of the plan already implemented [50][51] Question: How is the creative performance of the GUT relative to other studios? - The creative pillar has been growing nicely, with no significant impact from AI on high-level strategic work [56][59] Question: Is the enterprise AI platform creating enhanced stickiness with customers? - The enterprise AI platform is becoming essential for clients, integrating complex AI ecosystems and enhancing client engagement [64][66] Question: Can you discuss the revised growth outlook and assumptions? - The revised outlook reflects stabilization in Latin America and a positive trend in the pipeline, with expectations for recovery in the US market [78][80]

Financial Data and Key Metrics Changes - The net loss for the second quarter of 2025 was $25.4 million or $0.43 per share, compared to a net loss of $33.5 million or $0.58 per share in the first quarter of the same year [9][24] - As of June 30, 2025, the company had $28.7 million in cash and investments, bolstered by a registered direct offering that raised $20.6 million in net proceeds [9][10] - Total operating expenses from continuing operations for the second quarter were $32.4 million, a decrease of $2.6 million from the first quarter [26] Business Line Data and Key Metrics Changes - Research and development expenses in the second quarter were primarily focused on Zaltanopart and narsoplimab [27] - Interest expense for the second quarter was near zero, primarily due to an $8.5 million non-cash remeasurement adjustment related to the DRI Amidrea royalty obligation [27] Market Data and Key Metrics Changes - The global market for paroxysmal nocturnal hemoglobinuria (PNH) is projected to grow at 11% annually, reaching over $10 billion by February 2032 [20] - The complement inhibitor segment is expected to more than double from $2.2 billion today to $4.7 billion over the next seven years [20] Company Strategy and Development Direction - The company is focused on the anticipated approval and launch of narsoplimab, targeting the initial indication of stem cell transplant-associated thrombotic microangiopathy (TATMA) [11][12] - The company aims to leverage its experienced field marketing team and skilled sales force to drive rapid uptake of narsoplimab upon approval [18] - Discussions regarding potential asset acquisition and licensing agreements involving clinical assets are ongoing, with one transaction expected to be a multibillion-dollar deal [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the approval process for narsoplimab, with the FDA indicating that labeling discussions are planned to begin no later than October 2025 [13] - The company is optimistic about the market opportunity for narsoplimab, especially given the safety and efficacy data compared to existing treatments [14][15] Other Important Information - The company has adequate supply for narsoplimab for the first several years post-launch, ensuring no supply challenges [53] - The company is advancing its oncology platform, including IND enabling studies for its Oncotox biologics program targeting acute myeloid leukemia (AML) [23] Q&A Session Summary Question: Comparison of narsoplimab launch to Omidria - Management noted that the market for narsoplimab is significantly more focused than that for Omidria, with fewer salespeople needed due to the limited number of transplant centers [37][38] Question: Comfort level of clinicians regarding narsoplimab - Physicians are eagerly awaiting the approval of narsoplimab, viewing it as a much-needed solution for patients facing lethal complications post-transplant [44] Question: Anticipated launch timeline post-approval - If approved in December, the launch would occur in the first quarter of the following year, with substantial supply already in place [50][51] Question: FDA's request leading to PDUFA delay - The FDA requested additional analyses, which were extensive, leading to the three-month delay in the PDUFA date [58][60] Question: Potential partnerships - There is substantial interest in partnerships across the company's programs, but specific details are limited due to confidentiality requirements [61]