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 - 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 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 - 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 - 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 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 - Operating expenses were reduced by 26% from Q1 to Q2 2025, declining to $3.3 million from $4.5 million [29] - Year-to-date operating expenses are down 14% compared to the same period last year, from $9.1 million to $7.9 million [29] - Cash flow improvements were noted, with net cash used in operations declining by $2.2 million for the first six months of 2025, down to $5 million compared to $7.2 million in the same period of 2024 [29] - Cash and cash equivalents increased by 16% to $4.2 million as of June 30, 2025, up from $3.6 million at December 31, 2024 [29] - Revenue for Q2 was $1 million, with year-to-date revenue at $1.8 million [30] Business Line Data and Key Metrics Changes - BolaWrap deployments are increasing across diverse law enforcement agencies, with strong usage reported in Colorado, North Carolina, and Canada [10] - Agencies in Florida are evaluating BolaWrap as a strategic replacement for traditional electronic control devices like TASERs [10] - The crisis intervention team in a major Floridian agency reports more frequent BolaWrap use than TASERs, indicating a shift towards safer tools [11] Market Data and Key Metrics Changes - Favorable federal regulatory changes, including the Supreme Court decision in Barnes v. Felix, are driving adoption and sales of BolaWrap [15][16] - Increased inquiries and strategic discussions with customers are being observed due to heightened awareness around safer alternatives to traditional use of force tools [17] Company Strategy and Development Direction - The company has completed its restructuring efforts and is now focused on a renewed go-to-market strategy that emphasizes pre-escalation [5][40] - The introduction of new subscription models, Wrap Ready and Wrap Plus, aims to address customer concerns regarding replacement costs and enhance value propositions [31][32] - The company is expanding into adjacent markets such as healthcare, transportation, and private security, leveraging its existing technology and partnerships [26][64] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum building for Wrap Technologies, citing a sharp increase in purchase orders and positive customer feedback [4][40] - The company believes it is well-positioned to capitalize on the evolving regulatory landscape and increasing demand for safer policing tools [40] - Management highlighted the importance of training and partnerships in driving adoption and success in the market [25][52] Other Important Information - The company has applied for nearly $1 million in DOJ-funded grants to support pre-escalation tools and training [33] - A new counter UAS capability has been developed, targeting a growing market projected to reach $6.8 billion by 2030 [38] - The rebranding of the body-worn camera business line to WrapVision aims to address data sovereignty concerns and enhance product offerings [39] Q&A Session Summary Question: How do you plan to accelerate adoption among law enforcement agencies in the US and internationally? - Management noted that adoption is being driven by regulatory changes and direct engagement with departments, emphasizing the importance of training and connectivity with officers [42][45][50] Question: How do you plan to penetrate non-law enforcement sectors? - The company is already seeing interest from hospitals and correction facilities, with a focus on scaling operations and leveraging data to drive adoption [56][60][64] Question: Are there adjacent product lines or technology upgrades planned in the next eighteen months? - Management confirmed ongoing developments, including counter drone capabilities and enhancements to the body-worn camera line, indicating a strategic focus on expanding product offerings [67][70] Question: What is the status of the company's move to Virginia, and when do you expect production to ramp up? - The company has fully moved to Virginia and is prepared to scale production in response to increasing demand [76][78] Question: How do you see one-time sales versus subscription services as a portion of your revenues? - Management highlighted a strategic shift towards recurring subscription models, which are expected to provide more stable revenue streams compared to one-time sales [80][81]

Financial Data and Key Metrics Changes - Comstock reported a gross proceed of $30 million from a recent offering, with net proceeds of $27.6 million, increasing cash position to over $45 million [8][9][12] - The company eliminated approximately $8.4 million in promissory notes and $2.2 million in convertible notes, enhancing its financial stability [9][10][11] Business Line Data and Key Metrics Changes - The metal recycling business is experiencing rapid growth, with a focus on solar panel recycling, which is projected to scale significantly [7][16] - The company has developed a unique technology for recycling solar panels, achieving a zero landfill solution and high recovery rates of valuable metals [24][26][32] Market Data and Key Metrics Changes - The market for end-of-life solar panels is expected to grow exponentially, with projections of 33 million panels reaching the end of their life in four and a half years [42][43] - The demand for silver is at an all-time high, driven by industrial applications, particularly in electronics and solar panels, with prices rising significantly [37][38] Company Strategy and Development Direction - Comstock aims to establish itself as a leader in the solar panel recycling market, with plans to expand its facilities and increase production capacity [56][58] - The company is also focused on monetizing its mining assets and exploring opportunities in the oil and gas sector following the separation of Biolium [61][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to scale operations and meet growing market demand, emphasizing the importance of securing permits and equipment [56][89] - The company is optimistic about its competitive advantages, including a zero landfill solution and the capacity to handle large volumes of solar panels [95][96] Other Important Information - Comstock has secured land for additional storage capacity to accommodate the anticipated influx of solar panels [40] - The company is preparing to deconsolidate Biolium from its financials, which will provide clearer visibility into its metals and fuels businesses [72] Q&A Session Summary Question: Has the equipment for solar recycling been ordered? - Yes, the company has finalized the design and is ready to purchase the equipment, with deposits being made to ensure timely delivery [79] Question: What are the lead times for the equipment? - Lead times are estimated at four to six months, with all equipment being manufactured domestically to avoid tariffs [80][81] Question: Can the capital for a facility be phased in? - The company plans to deploy the entire system at once rather than phasing it in, as it makes more sense for operational efficiency [82] Question: Can facilities be permitted and built in parallel? - The company is exploring the possibility of permitting multiple sites simultaneously to expedite the process [88] Question: What is the potential market for solar panels? - The market is projected to grow significantly, with millions of panels reaching the end of their life in the coming years, translating to hundreds of thousands of tons of material [92] Question: Will long-term contracts be established for metal recycling? - The company believes that as its capabilities become clearer, longer-term contracts will be negotiated with customers [94][102] Question: Why are asset sales taking so long? - Delays in asset sales are attributed to power grid bottlenecks caused by increased demand from data centers and industrial developments [104][106]

Financial Data and Key Metrics Changes - The company reported a net loss of $45.3 million or $1.04 per share for Q2 2025, compared to a net loss of $23.7 million or $0.62 per share for Q2 2024, indicating a significant increase in losses [26] - Non-GAAP adjusted net loss was $40.5 million or $0.93 per share for Q2 2025, compared to a non-GAAP adjusted net loss of $22.2 million or $0.58 per share for Q2 2024 [26] - Research and development expenses increased to $40.2 million for Q2 2025 from $22.5 million in Q2 2024, driven by increased employee and consulting expenses and costs related to ongoing clinical trials [26][27] - General and administrative expenses rose to $3.8 million for Q2 2025 from $1.8 million in Q2 2024, primarily due to increased employee and consulting expenses [27] - The company ended the quarter with approximately $168.4 million in cash, cash equivalents, and short-term investments, which is expected to increase to approximately $455 million after accounting for recent financing activities [28] Business Line Data and Key Metrics Changes - The company achieved significant milestones in its clinical trials, including positive top-line data from the VICTORIA-one trial for patients with HR positive HER2 negative advanced breast cancer, demonstrating unprecedented improvements in progression-free survival (PFS) [6][10] - The median PFS for the gadatholitinib triplet was reported at 9.3 months compared to 2 months for fulvestrant, with a hazard ratio of 0.24, indicating a 4.2 times higher likelihood of survival without disease progression [10][11] - The company also dosed the first patient in the VICTORIA-two trial, which evaluates gadatholitinib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment [8][18] Market Data and Key Metrics Changes - The addressable market potential for a standard of care second-line therapy for the targeted patient population is estimated at approximately $5 billion [18] - There are approximately 34,000 patients moving to second-line treatment after progressing on a CDK4/6 inhibitor, with around 60% being PIK3CA wild type, indicating a large opportunity for the company's therapies [14] Company Strategy and Development Direction - The company aims to establish gadatholitinib as a new standard of care therapy for patients with HR positive HER2 negative advanced breast cancer, focusing on both PIK3CA wild type and mutated populations [6][10] - The company plans to submit a new drug application to the FDA in 2025 based on data from the PIK3CA wild type cohort [13] - The company is preparing for a potential launch of gadatholitinib, having built a commercial team and infrastructure to support the launch [48][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the market landscape for gadatholitinib, highlighting the significant unmet need for more efficacious therapies in the second-line treatment space [14][15] - The company believes that the favorable safety profile and efficacy of gadatholitinib will position it well against currently available therapies [12][15] - Management is confident in the robustness of the data and the preparations for the NDA submission, indicating a strong belief in the potential approval and market entry [70] Other Important Information - The company raised approximately $287 million through public offerings of convertible notes, common stock, and pre-funded warrants, providing necessary funding for its operations and clinical trials [10][24] - A new patent was issued extending the exclusivity of gadatholitinib into 2042, allowing the company to optimize its development strategy [23][24] Q&A Session Summary Question: What to expect from the upcoming full data presentation for the PIK3CA wild type portion of the Phase III study? - The company will focus on primary analyses and endpoints, with additional subgroup analyses expected at subsequent meetings [30][31] Question: What benchmarks for success are considered for the PIK3CA mutant population? - A statistically significant result would be clinically meaningful if it shows an improvement of less than three months compared to historical data [32] Question: Can more safety data be provided ahead of the full presentation? - Detailed safety data will be provided at the upcoming conference, with a general summary available at this stage [37] Question: Will PFS analysis based on investigator assessment be presented later this year? - The selection of BICR for the study was to eliminate investigator bias, and the investigator data will be used for exploratory analysis [40][42] Question: How is the company preparing for launch readiness? - The company has been building its team and infrastructure since last year, focusing on key positions to support the launch [48][52] Question: What are the practical ramifications for physicians with both doublet and triplet options? - Having both regimens allows physicians to optimize treatment based on patient needs, providing flexibility in managing disease progression [55][56] Question: Is there a consideration for a commercial partnering strategy for the launch? - The company plans to launch itself, believing it has the necessary infrastructure and capital to do so effectively [58][59] Question: What are the competitive landscape thoughts regarding the mutant population? - The company believes that positive data will position it well against competitors, particularly in the context of PIK3CA mutations [65][66]