Financial Data and Key Metrics Changes - In Q3 2025, the company achieved total revenue of $84 million from continuing and discontinued operations, with $69 million from continuing operations, representing a year-over-year increase of 156% [39] - Gross mining profit from continuing operations was $21 million, with a gross mining margin of 35% and an average direct cost of $48,200 per Bitcoin mined [39] - Adjusted EBITDA from continuing operations was $20 million, or 28% of revenue, up from $2 million, or 8% of revenue year-over-year in Q3 2024 [40] Business Line Data and Key Metrics Changes - The company confirmed that 100% of its 170 megawatts in Quebec are currently utilized for Bitcoin mining, with plans to convert these megawatts for HPC and AI, potentially increasing total data center megawatts in the province by 25% [18] - The Washington site has 18 megawatts of secured power, with a fully funded agreement for $128 million to develop the full capacity for HPC and AI workloads [19][20] Market Data and Key Metrics Changes - Lease rates for data center infrastructure have increased from an average of 3% over the last 20 years to an average of 12% since 2022, with expectations for this trend to continue [6][9] - Analysts predict a massive shortfall of nearly 45 gigawatts of power for data centers by 2030, confirming the increasing demand for data center capacity [9] Company Strategy and Development Direction - The company aims to prioritize infrastructure development to minimize the time between signing leases and generating revenue, thereby optimizing lease rates and margins [11] - Plans include developing infrastructure for NVIDIA's next-generation Vera Rubin GPUs, which are expected to command significantly greater economics due to their higher energy density [12][13] Management's Comments on Operating Environment and Future Outlook - Management believes that the demand for HPC and AI infrastructure will continue to grow, driven by the increasing need for data center capacity and the limitations in power and infrastructure [5][10] - The company is well-capitalized with over $1 billion available for funding its development projects, indicating strong financial health and a clear vision for advancing its HPC and AI initiatives [41][42] Other Important Information - The company has transitioned to a multi-strategy program for digital asset management, designed to offset Bitcoin production costs and fund energy infrastructure investments [39][40] - The company is actively pursuing GPU as a service or cloud monetization strategy, which could provide significant cash flow and returns compared to Bitcoin mining [21][56] Q&A Session Summary Question: Can you share more on how you guys are thinking about economics for the Vera Rubin GPU infrastructure? - Management indicated that the economics will improve due to the increasing shortage of infrastructure and the specific requirements of the new GPU models, which will drive higher economics [44][46] Question: What is the expected timeline for expanding power capacity at Panther Creek and Scrubgrass? - Management mentioned that positive indications have been received for the conversion of existing agreements, with potential expansions happening quickly, but specific timelines remain uncertain [51][52] Question: What are the biggest challenges to meeting timelines for Washington, Sharon, and Panther Creek? - Management noted that construction bottlenecks are hard to forecast, but having strong partners and project management teams in place will help mitigate risks [59] Question: How does the company evaluate GPU as a service compared to standard colocation? - Management explained that GPU as a service offers compelling benefits in terms of free cash flow and operational knowledge, which could significantly exceed the returns from Bitcoin mining [56][57]

Financial Data and Key Metrics Changes - In Q3 2025, total revenue reached $1.5 billion, landing at the high end of expectations, with a gross margin of 17.2%, exceeding guidance due to strong contributions from energy storage shipments [5][22] - Net income attributable to shareholders was $9 million, resulting in a net loss of $0.07 per diluted share, impacted by preferred shareholder effects [6][22] - Operating expenses normalized to $222 million, reflecting lower shipping costs and ongoing internal cost reductions [22] Business Line Data and Key Metrics Changes - Solar module shipments totaled 5.1 gigawatts, in line with expectations, while energy storage shipments reached a record 2.7 gigawatt-hours [5][11] - CSI Solar reported revenue of $1.4 billion, with a gross margin decrease of 730 basis points to 15%, driven by margin changes in both solar and storage businesses [11] - Recurrent Energy generated $102 million in revenue with a gross margin of 46.1%, primarily from profitable project sales [16] Market Data and Key Metrics Changes - The contracted backlog for energy storage solutions increased to $3.1 billion, supported by new projects in North America and Europe [12] - The company is expanding into new markets like Germany and Australia for residential energy storage, which is on track to become profitable in 2025 [9][14] Company Strategy and Development Direction - The company is focusing on U.S. manufacturing investments, with plans for solar cell production in Indiana and lithium battery production in Kentucky [8] - The strategy includes increasing project ownership sales in 2026 to enhance cash recycling and reduce leverage [26] - The company aims to differentiate itself through a resilient combination of strategy and execution amid a complex macro environment [6][7] Management's Comments on Operating Environment and Future Outlook - Management noted that the solar industry is at an inflection point, with market conditions stabilizing after a downturn [6] - The rise of AI-driven data centers is creating unprecedented global electricity demand, which the company aims to address with solar plus storage solutions [8][9] - Management expressed confidence in meeting OBBBA requirements and maintaining financial discipline while pursuing growth [34][50] Other Important Information - The company plans to maintain disciplined volume management, projecting module shipments of 4.6-4.8 gigawatts for Q4 2025 [25] - Total debt increased to $6.4 billion, primarily due to new borrowings tied to project development assets [24] Q&A Session Summary Question: Can you talk about the strategy of timing and leverage for project sales? - Management indicated they have enough operational projects to sell without needing to sell early, focusing on maximizing value post-COD [30] Question: Can you discuss the maturity of supplier relationships for U.S. manufacturing? - Management stated that there are many suppliers outside China, and they are confident in meeting OBBBA requirements for domestic content [32][34] Question: How do you bridge the gross margin gap with your A-share subsidiary? - Management clarified that the gross margin for project sales was significantly higher, supporting overall margins despite lower manufacturing margins [38][46] Question: What is the expected growth rate for U.S. installations in 2026? - Management expects stable demand for solar installations, while energy storage is anticipated to grow, particularly driven by data center-related demand [70][72] Question: How much of the 14-17 gigawatt-hours of shipment is expected to be in the U.S.? - Management indicated that around two-thirds of the shipments will be outside the U.S., reflecting a diversified portfolio [78]

Financial Data and Key Metrics Changes - GoHealth reported a cash balance of approximately $32 million at the end of Q3 2025, with access to an additional $40 million from a new super-priority term loan facility [44][47]. - The company emphasized cash management and maintaining liquidity to support operations and strategic opportunities [45][48]. Business Line Data and Key Metrics Changes - The company shifted focus from Medicare Advantage (MA) to GoHealth Protect, prioritizing retention and stable member profiles over volume growth due to tightening health plan economics [5][9]. - GoHealth Protect has been instrumental in retaining business, with a strategy to enhance consumer peace of mind through complementary product offerings [19][20]. Market Data and Key Metrics Changes - The Medicare Advantage market is experiencing strong demand, but health plans are prioritizing retention and stable member profiles rather than broad expansion [5][9]. - The total available non-special needs plan products are declining for 2026, while special needs plan options are increasing, indicating a shift in industry priorities [9]. Company Strategy and Development Direction - The company is focusing on quality over quantity, retention over short-term submissions, and cash preservation to maintain strategic flexibility [7][8]. - GoHealth aims to lead consolidation in a fragmented broker landscape, leveraging its strong balance sheet and governance structure to create long-term value [10][11]. Management's Comments on Operating Environment and Future Outlook - Management believes that the current actions taken by health plans are justified and prudent, reflecting a focus on retention and quality [6][9]. - The company expects the Medicare Advantage market to stabilize over the next 12-24 months, allowing for potential revenue growth with improved margins and cash profiles [12][17]. Other Important Information - GoHealth has retained its highest-quality agents and adjusted compensation structures to reinforce retention strategies [8][53]. - The company has invested in AI and automation to improve agent effectiveness and consumer experience [8][58]. Q&A Session Summary Question: What is the growth trajectory for Medicare Advantage over the next 12 to 24 months? - Management indicated that growth will depend on health plans stabilizing their cost structures and focusing on retention, with expectations for a return to growth as the market rationalizes [15][17]. Question: Can you discuss the key drivers of growth for GoHealth Protect? - The growth of GoHealth Protect is driven by enhancing consumer peace of mind and serving both existing and new customers effectively [19][20]. Question: Why did the company decide to pull back on Medicare Advantage? - The decision was based on feedback from health plans prioritizing retention and stability over new enrollments, as well as the need to focus on existing members [25][26]. Question: What are the implications of the company's current strategy if the market conditions change? - If the assessment proves correct, the company retains its capabilities and cash position, but if wrong, it may need to ramp up operations quickly [28][30]. Question: Why should the industry consolidate, and how is GoHealth positioned to lead? - The company believes that consolidation can reduce duplicative costs and enhance efficiency, positioning GoHealth as a leader due to its strong consumer base and technology investments [31][32].

Financial Data and Key Metrics Changes - The company reported a recurring EBITDA of 1.3 billion BRL, an increase of almost 8% compared to the same period last year [4] - Recurring net income was 375 million BRL, reflecting a decrease of 36.5% year-on-year due to increased negative financial results despite the EBITDA growth [18] - Total CapEx for Q3 was 981 million BRL, with year-to-date investments totaling 2.6 billion BRL, indicating a strong commitment to service quality and infrastructure modernization [4][19] Business Line Data and Key Metrics Changes - Copel Gen's recurring EBITDA grew by 11% over Q3 2024, driven by better asset performance and strategic asset consolidation [12][13] - The distribution segment (Copel Discom) saw a recurring EBITDA increase of 7.2%, supported by a 1.7% growth in the billed energy market and effective cost management [14] - Copel Com's recurring EBITDA dropped by 7.3% due to legacy contracts and increased expenses, although sales volume for 2026 to 2030 grew by 96.2% compared to Q2 2025 [15] Market Data and Key Metrics Changes - The sales volume reached almost 5 gigawatt-hours, with a market growth of 1.7% [6] - The PLD spot market increased by approximately 50% compared to Q3 2024, reaching about 250 BRL per megawatt-hour [6] Company Strategy and Development Direction - The company is focused on simplifying its portfolio, as evidenced by the divestment of four photovoltaic solar plants and the Baixo Iguaçu HPP [5] - A strategic shift towards a more integrated company with a solid presence across all four operational segments is emphasized [7] - The company is preparing for a historical tariff review in 2026, which is expected to be a significant milestone [10] Management's Comments on Operating Environment and Future Outlook - Management highlighted the resilience of the business despite challenging conditions, including a GSF of approximately 65% and a curtailment of almost 35% [6] - The management expressed confidence in achieving a recurring net income target of around 18 billion BRL during the upcoming tariff review [47] - The company is committed to maintaining a healthy capital structure to support ongoing investments and value creation for shareholders [21] Other Important Information - The company is migrating to a simpler and more transparent shareholder structure, which is expected to enhance liquidity and attract new investors [10] - A new cultural framework was introduced, emphasizing the importance of culture in achieving long-term strategic goals [11] Q&A Session Summary Question: Confirmation on the completion of migration to Novo Mercado and dividend payout expectations - Management confirmed the expectation to complete the migration by year-end and indicated that dividends would be announced following the completion of the migration process [22][23] Question: Insights on cost efficiency and potential for further reductions - Management stated that they continue to seek efficiencies and anticipate further cost reductions in 2026, with specific initiatives planned [24][25] Question: Strategy for the Generation and Transmission segment and energy pricing - Management discussed the successful portfolio strategy and the importance of market intelligence in energy purchasing, indicating a focus on maximizing value [27][28] Question: Expectations for the upcoming tariff review process - Management emphasized the significance of the tariff review and the proactive measures being taken to ensure a favorable outcome [46][47] Question: Implications of MP 1304 on energy contracting and hydroelectric power plant renewals - Management addressed the potential impacts of MP 1304, indicating that while it may affect LR Cap dynamics, the overall impact would be manageable [49][51] Question: Discussion on extraordinary dividends and taxation implications - Management is studying the implications of potential taxation on dividends and is preparing a strategy to address this in light of the current shareholder base [55][56]

Financial Data and Key Metrics Changes - The company reported record third-quarter revenue of $39 million, representing a 21% year-over-year increase [13] - Adjusted EBITDA grew 3% year-over-year to $13 million, with an adjusted EBITDA margin of 33% compared to 39% in the previous year [16] - Gross profits increased 17% to $35.6 million, while the gross profit margin decreased to 91.2% from 94.7% year-over-year [13][14] - Free cash flow was $9.6 million, down from $14.2 million in the previous year due to timing differences [16][17] - The company revised its full-year guidance to approximately $165 million in revenue and $58 million in adjusted EBITDA, reflecting continued headwinds from poor search dynamics [18][19] Business Line Data and Key Metrics Changes - Sports data services revenue quadrupled to $9.2 million, accounting for 25% of total revenue [5][13] - The marketing business revenue remained flat year-over-year, with new depositing customers (NDCs) down 13% to 101,000 [13] - Subscription revenue constituted 24% of total revenue, and recurring revenue was 49% of total third-quarter revenue [13] Market Data and Key Metrics Changes - The North American market saw a 55% year-over-year growth in the third quarter, primarily driven by sports data services [45] - The marketing business in the U.S. grew year-over-year, while it was flat globally, with a decline in Canada impacting overall performance [45] Company Strategy and Development Direction - The company is focusing on the growth of its sports data services business, which is expected to continue growing organically at a healthy pace in 2026 and beyond [6][12] - The marketing business is expected to grow in 2026 and beyond, with a focus on diversifying away from SEO channels [20][41] - The company aims to leverage its strong cash flow to invest in product development and diversification strategies [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the recovery of search rankings and the potential for revenue improvement as Google addresses quality issues in search results [26][28] - The company anticipates mid-teens revenue growth and around 10% adjusted EBITDA growth as it heads into 2026 [39] - Management acknowledged the challenges faced in the marketing business but emphasized the resilience and potential for future growth [21][22] Other Important Information - The company acquired Spotlight.Vegas for $8 million and repurchased approximately 562,000 shares for a total of $4.7 million during the quarter [17] - The company has $70.5 million of undrawn capacity in its credit facility, providing flexibility for capital structure optimization [17][63] Q&A Session Summary Question: What gives confidence to grow the business in 2026 despite current challenges? - Management noted improvements in Google search rankings towards the end of October, leading to better traffic and revenue [26][27] Question: How is the B2C side of the business performing? - Consumer data services revenue grew marginally, with RotoWire subscriber numbers up 21% year-on-year [30] Question: What is the progress on OpticOdds commercialization? - Management indicated a clear product-market fit and a long runway for growth, with opportunities beyond data and bet settlement [35] Question: How does the company view the upcoming U.K. budget? - An increase in gaming duty could negatively impact player lifetime values, but management does not expect significant growth or decline in the U.K. market next year [61] Question: How is the company thinking about leverage and capital allocation? - Management is focused on optimizing capital allocation, with no plans to leverage beyond existing credit facilities until there is more growth visibility [63]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of EUR 56.4 million, providing runway through the end of Q3 2026 to deliver on key milestones [26] Business Line Data and Key Metrics Changes - Lacutamab received FDA clearance to initiate the TELLOMAK III phase three trial in cutaneous T-cell lymphoma, with expectations for accelerated approval in Sézary syndrome based on robust phase two data [4][12] - IPH4502 is progressing well in its phase one trial, having reached a pharmacologically active dose and showing early signs of clinical activity [10][24] - Monalizumab is advancing in the PACIFIC-9 phase three trial, with top-line data expected in the second half of 2026 [11][24] Market Data and Key Metrics Changes - The annual incidence of Sézary syndrome is estimated at around 300 patients, with a prevalence of approximately 1,000 diagnosed patients in the U.S. [19] - For mycosis fungoides, approximately 3,000 new patients are diagnosed each year in the U.S., with one in four receiving systemic therapy [20] Company Strategy and Development Direction - The company is focusing investments on high-value clinical assets, including IPH4502, Lacutamab, and Monalizumab, while advancing next-generation ADC programs [6][24] - The development strategy for Lacutamab includes a stepwise approach starting with Sézary syndrome, followed by mycosis fungoides, and expanding to peripheral T-cell lymphoma [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory path for Lacutamab, indicating that the FDA has not requested additional substantial analyses beyond existing phase two data for accelerated approval [31] - There is growing momentum among KOLs for Lacutamab to become the preferred second-line option, with expectations that it may be used ahead of Mogamulizumab in mycosis fungoides [32][33] Other Important Information - The company is streamlining its organization to align with strategic objectives and ensure it remains fit for purpose [6] - The confirmatory phase three trial for Lacutamab is set to begin in the first half of 2026, with a potential BLA submission anticipated in early 2027 [12][31] Q&A Session Summary Question: What needs to be done for the potential Lacutamab commercial launch in Sézary syndrome? - The company aims to ensure Lacutamab is included in the NCCN guidelines prior to the BLA approval [27][28] Question: What can be expected from the upcoming data set for IPH4502? - The company hopes to present data from a cohort of patients in the Padcev resistance setting, with an interesting response rate and safety data [28][29] Question: Is the FDA looking for additional analyses for Lacutamab's accelerated approval? - The FDA has not indicated a need for further substantial analyses; the BLA approval will be based on existing TELLOMAK study data [31] Question: What are the expectations for the PACIFIC-9 study readout? - The company has good expectations based on previous studies, anticipating a positive outcome for the PACIFIC-9 study [40]

Financial Data and Key Metrics Changes - Cash-based operating expenses for Q2 2026 totaled $28.5 million, up from $18.2 million in the same period last year, indicating a significant increase in operational costs [17] - Net loss for Q2 2026 was $33.7 million, compared to a net loss of $41.9 million in the same period last year, showing an improvement in financial performance [17] - Cash flows used in operating activities were $34.5 million for Q2 2026, compared to $19.1 million in the same period last year, reflecting increased operational spending [17] - The company ended the quarter with cash, cash equivalents, and investments of $83.8 million [17] Business Line Data and Key Metrics Changes - CYB003, a proprietary deuterated psilocin analog, is in phase 3 studies for major depressive disorder, while CYB004, a deuterated dimethyltryptamine program, is in phase 2 for generalized anxiety disorder [5][8] - The phase 3 CYB003 program has received breakthrough therapy designation and has been granted additional clearances to commence a second phase 3 study in new geographies [5] - Enrollment for the phase 2 CYB004 study has been completed, with top-line data expected in the first calendar quarter of 2026 [9] Market Data and Key Metrics Changes - The phase 3 study for CYB003 targets approximately 330 participants across about 60 clinical sites globally, indicating a broad market reach [8] - The design of the studies aims to reflect real-world clinical populations, allowing for concomitant antidepressants or anxiolytics [9] Company Strategy and Development Direction - The company is focused on patient-centered care, rigorous science, and clear communication, with an emphasis on operational efficiency and scalability in clinical settings [3][4] - The capital plan is aligned with advancing programs towards major data readouts, following a recent financing of $175 million [4][14] - The strategy includes making therapies practical for clinics, with predictable session scheduling and minimal infrastructure requirements [11][12] Management's Comments on Operating Environment and Future Outlook - Management emphasized a conservative regulatory posture and disciplined capital deployment to navigate upcoming data events [20] - The company is preparing for scale with a model built for clinical reality, aiming to deliver clean data on time [20] - The CEO search is active, and the company is focused on maintaining operational stability during the transition [19][20] Other Important Information - The company has strengthened its capital position through a registered direct offering, which provides flexibility to execute its plans [14] - The repayment of $20 million in convertible debt to High Trail was completed, with a 10% prepayment penalty [61] Q&A Session Summary Question: What would give confidence to move forward with CYB004 into phase 3? - Management is looking for directional data and trends in separation between the two arms of the study, with statistical significance being a bonus [24][25] Question: What is the minimum durability threshold needed to compete with Spravato for CYB003? - A minimum of 12 weeks of maintained effects is expected, with hopes for better durability based on phase 2 data showing effects lasting up to a year [30][31] Question: What is the operational status of the Approach trial and site activations? - Enrollment for CYB003 is on track to complete by mid-next year, with top-line data expected by the end of next year [34][35] Question: What engagement has occurred with payers regarding CYB003 and CYB004? - Preliminary market research has begun, but it is still early for detailed payer engagement [38] Question: What criteria were used for selecting clinical trial sites for the Approach trial? - A mix of experienced and less experienced sites were chosen, focusing on those with a proven track record in delivering high-quality data [44][45] Question: What is the status of the preclinical CYB005 program? - Preclinical profiling studies are ongoing, with no specific updates available yet [46] Question: How important is patient compliance with background antidepressant use in the pivotal trial for CYB003? - Patients are required to remain on their background antidepressant medication during the treatment period [69]

Financial Data and Key Metrics Changes - For the first nine months of 2025, total revenues were $43.6 million, a 24% increase compared to the same period last year [4] - Total revenues for the third quarter were $17.9 million, reflecting a decrease of 1% compared to the same period in 2024 [4] - The net loss for the nine-month period ended September 30, 2025, was $1.1 million, or $0.01 per share, compared to a net loss of $3.6 million, or $0.05 per share for the same period in 2024 [17] - For the three months ended September 30, 2025, net income was approximately $2.4 million, or $0.03 per share, compared to net income of $3.2 million, or $0.04 per share for the same period in 2024 [18] Business Line Data and Key Metrics Changes - Total revenues from selling goods for the nine months ended September 30, 2025, were $43.1 million, an increase of $8.3 million, or 24%, compared to $34.8 million for the same period in 2024 [10] - Revenues consisted of $18.6 million in sales of Elefabrio to Chiesi, $15.4 million in sales of Elelyso to Pfizer, and $9.1 million in sales of Elelyso to Fiocruz in Brazil [10] - For the three months ended September 30, 2025, total revenues from selling goods were $17.7 million, a decrease of $0.1 million, or 1%, compared to $17.8 million for the same period in 2024 [10] Market Data and Key Metrics Changes - The company recognizes revenues from sales to partners, and individual purchases vary from quarter to quarter as each partner controls its own inventories [11] - The company anticipates a significant increase in the overall gout market in the next five to six years, particularly for uncontrolled gout patients requiring uricases [22] Company Strategy and Development Direction - The operating strategy focuses on three pillars: driving commercial success with Elefabrio, advancing PRX-115 and other early-stage pipeline programs, and maintaining financial discipline [7] - The company is preparing for the phase two clinical trial of PRX-115, which is viewed as a strategic investment in the pipeline and long-term growth [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Elefabrio's long-term potential and is working closely with Chiesi to support the re-examination of the once-in-four-weeks dosing regimen [6] - The company believes that the achievements in 2025 position it for long-term growth and value creation [19] Other Important Information - Research and development expenses for the nine months ended September 30, 2025, totaled $13.9 million, an increase of 58% compared to the prior year period [13] - Selling general and administrative expenses for the nine months ended September 30, 2025, were $8.2 million, down 11% from the same period last year [14] - The company had $29.4 million in cash and cash equivalents at September 30, 2025, sufficient to satisfy capital needs for at least 12 months [18] Q&A Session Summary Question: Timeline for the re-examination of the CHMP opinion on Elefabrio - The company expects to have an answer in Q1 of 2026 regarding the re-examination request [22] Question: Comments on the competitive landscape in treatment refractory gout - The company foresees a significant increase in the overall gout market and believes that if the phase two trial is successful, it could capture a substantial market share [22] Question: Predictability of royalty-based revenue recognition related to Elefabrio sales - The company continues to recognize what it sells to Chiesi's inventory and is optimistic about future revenue [23][24] Question: Cash runway guidance - The cash runway guidance is based on both operating expenditures and continued receipt of royalty-based revenue on Elefabrio [25][26] Question: Anticipated R&D growth during the phase two of PRX-115 - The company is taking into account the expenses associated with the phase two trial and has sufficient cash for more than 12 months to fund this trial [45]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company's cash, cash equivalents, and short-term investments were $55.3 million, an increase from $30 million as of June 30, 2025, and $44.1 million at the end of the previous year [14] - The net cash used in operating activities for the nine months ended September 30, 2025, was $21.3 million, compared to $15.6 million for the same period in 2024, primarily due to an increase in net loss [14][15] - The net losses for the three and nine month periods ending September 30, 2025, were $8.6 million and $24.0 million, respectively, higher than the $6.3 million and $16.5 million reported during the same periods in 2024 [17] Business Line Data and Key Metrics Changes - R&D expenses for the three and nine month periods ending September 30, 2025, were $6.4 million and $17.9 million, respectively, an increase from $5 million and $12.6 million in the same periods of the prior year, driven by the progress of the ReMEDy2 clinical trial and the expansion of the clinical team [16] - General and administrative expenses were $2.6 million and $7.3 million for the three and nine month periods ending September 30, 2025, up from $1.9 million and $5.7 million in 2024, attributed to increased non-cash share-based compensation and personnel costs [16][17] Market Data and Key Metrics Changes - The enrollment rates for the ReMEDy2 stroke trial have been lower than initially projected due to changes in stroke referral patterns, with current enrollment approaching 50% of the target for the interim futility analysis [10][11] - The company is currently utilizing actual enrollment rates from clinical trial sites instead of historical rates for more accurate forecasting [11][36] Company Strategy and Development Direction - The company is focusing on advancing its clinical programs, particularly DM199, which is positioned as a first-in-class treatment for preeclampsia and other vascular-related conditions [3][4] - Plans include expanding clinical studies into early onset preeclampsia and fetal growth restriction cohorts, with a U.S. phase two trial anticipated to begin soon [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the current cash position to fund planned clinical studies and operations into the second half of 2027 [14] - The management team remains optimistic about the potential of DM199 based on encouraging interim results and the unique safety profile of the drug [4][22] Other Important Information - The company completed an in-person pre-IND meeting with the FDA, which was deemed productive, and is preparing for a phase two trial in the U.S. [9] - The Independent Data Safety Monitoring Board reported no safety concerns in the ReMEDy2 trial, allowing enrollment to continue without modification [12] Q&A Session Summary Question: Discussion on preeclampsia KOL community engagement and trial site considerations - Management highlighted extensive outreach to KOLs, receiving encouraging feedback regarding DM199's safety profile and efficacy in reducing blood pressure [20][22] Question: Details on protocol amendments and dosing outcomes - Management explained that part 1B will focus on IV dosing until delivery, allowing physicians to adjust dosing as needed based on patient response [23] Question: Clarification on the purpose of the 12 patient expansion cohort - The 12 patient cohort was intended to supplement the original plan for part 1B, focusing on the highest dose observed in cohort 10 [27][28] Question: Expectations for enrollment rates and site activation for the stroke trial - Management noted that historical enrollment rates were around 0.25, but current rates are slightly lower, with over 35 sites activated and more coming on board [35][36] Question: Meaningful change expectations for the modified Rankin Scale score at interim analysis - A 15% absolute improvement in the mRS score is expected to be meaningful, with adjustments made to the protocol to exclude severe stroke patients [42][43]

Financial Data and Key Metrics Changes - The company reported a net loss of $9 million or $0.19 per basic and diluted share for Q3 2025, compared to a net loss of $10.7 million or $0.29 per basic share in the prior year's quarter, indicating a decrease in net loss primarily due to lower operating expenses [15][16] - Research and development expenses were $4.6 million for Q3 2025, down from $6.8 million in the prior year, attributed to lower manufacturing and clinical expenses [16] - General and administrative expenses increased to $3.6 million in Q3 2025 from $3.4 million in the prior year, mainly due to higher professional fees [16] - Total operating expenses were $8.1 million for Q3 2025, down from $10.2 million in the prior year [17] - Cash balance as of September 30, 2025, was $26.2 million, down from $41.7 million at the beginning of the year [17] Business Line Data and Key Metrics Changes - The VERSATILE-002 trial showed a median overall survival of 39.3 months for patients with a combined positive score (CPS) of greater than or equal to one, with a progression-free survival (PFS) of 6.3 months among these patients [5][6] - The company plans to amend the VERSATILE-003 trial to include PFS as a primary endpoint alongside median overall survival, based on the strong data from VERSATILE-002 [8][9] Market Data and Key Metrics Changes - The company highlighted that HPV-positive head and neck cancer is becoming a significant medical issue, with over 90% of HPV-positive oropharyngeal cancers being HPV-16 positive [11][30] - Recent market research indicates a growing incidence of HPV-positive head and neck cancer, with traditional causes like tobacco and alcohol declining [30] Company Strategy and Development Direction - The company is focusing on HPV-16 positive head and neck cancer, believing it will become the dominant type of head and neck cancer in the next decade [30][31] - The company is engaging with the FDA to discuss amendments to the VERSATILE-003 trial protocol, aiming to potentially shorten the time to regulatory submission while maintaining median overall survival as an endpoint for full approval [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of PDS0101 as a well-tolerated treatment option for HPV-16 positive patients, who currently lack effective therapies [11][30] - The management noted that the industry is recognizing the growing problem of HPV-positive head and neck cancer, which is reflected in recent publications and market research [10][30] Other Important Information - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer meeting, validating the scientific basis of the company's immunotherapy platforms [12][13] - The colorectal cancer cohort of the phase two clinical trial with PDS01ADC met criteria for expansion to stage two following positive results [13] Q&A Session Summary Question: How will the company handle patients already enrolled in the VERSATILE-003 trial during the protocol pause? - The company will continue to treat patients already enrolled in the trial and will discuss their incorporation into the trial with the FDA [20][22] Question: What is the expected PFS for the control Keytruda? - The company conservatively assumes that the PFS in the control arm will be around three months, based on previous studies [26][27] Question: How is the company addressing physician training and awareness regarding pseudoprogression in the VERSATILE-003 study? - The company has trained investigators to recognize pseudoprogression and will conduct central reviews of scans to ensure accurate assessments [39][40]