Summary of Crescent Biopharma Conference Call Company Overview - Crescent Biopharma is focused on becoming a leading biotech and oncology company with a dual strategy involving their PD1 VEGF bispecific asset (CR001) and an internal ADC pipeline [2][4][5] - The PD1 VEGF bispecific is designed to replace Keytruda as a backbone therapy and is expected to enter clinical trials in early Q1 of next year [2][4][19] Key Strategies and Assets - The company is targeting a $50 billion-plus market with its PD1 VEGF bispecific and believes it stands out among competitors [3][4] - The ADC pipeline, starting with ADC 002, is expected to enter the clinic by mid-next year, with a robust data flow anticipated by 2026-2027 [4][5][39] - Crescent aims to leverage the design of its 001 asset to accelerate combination therapies, which is a significant focus for the company [11][14] Clinical Development and Trial Design - The first in-human trial for CR001 will be a global study addressing safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity [20][21] - The trial will focus on previously treated populations initially, with plans to explore earlier lines of treatment based on competitive landscape data [21][22] - The company emphasizes the importance of robust phase one data to inform future registration trials and combination studies [23][34] Competitive Landscape and Market Position - Crescent acknowledges the competitive nature of the oncology space but believes there is ample opportunity for multiple players to succeed [24] - The company is particularly interested in lung cancer as a potential indication for CR001, with plans to explore various other indications [24][25] - The data generated from the phase one trial will guide the company's strategy in pursuing additional cancer types [26] Intellectual Property and Freedom to Operate - Crescent has a strong intellectual property position and complete freedom to operate in the PD1 VEGF space, which has been validated through their IPO process [6][9] Financial Position and Future Outlook - The company reported $133 million in cash, which is expected to fund operations through 2027, covering significant data readouts and clinical trials [39] - The focus is on generating high-quality phase one data to enhance the potential for future partnerships and collaborations [36][38] Conclusion - Crescent Biopharma is positioned to make significant strides in the oncology market with its innovative PD1 VEGF bispecific and ADC pipeline, backed by a strong financial position and strategic planning for clinical development and market entry [2][4][39]

Financial Data and Key Metrics Changes - For the third quarter ended September 30, 2025, the company reported a net loss of $6.1 million, compared to a loss of $4.8 million during the same quarter in 2024 [12] - General and administrative expenses increased by $0.3 million, primarily due to higher employee-related expenses as the company expands its team [12] - Share-based compensation expense rose by $0.9 million, reflecting a focus on aligning employee compensation with share performance [13] - The company ended the quarter with cash and working capital positions of $32.1 million and $29 million, respectively [14] Business Line Data and Key Metrics Changes - The South West Arkansas (SWA) Project is expected to have an initial production capacity of 22,500 tons per annum of battery-quality lithium carbonate, with proven reserves of 447,000 LCE tons over a 20-year operating life [3] - The DFS for the SWA project indicates a 20.2% unlevered pre-tax IRR and competitive average operating costs of about $4,500 per ton [4] - The Franklin Project in East Texas has an inferred resource report highlighting 2.2 million tons LCE of lithium at an average grade of 668 mg/L [5] Market Data and Key Metrics Changes - The company closed an underwritten public offering of 29.9 million common shares at a price of $4.35 per share, generating gross proceeds of approximately $130 million [6] - The company received strong support from institutional investors, underscoring confidence in its strategy and asset quality [6] Company Strategy and Development Direction - The company aims to reach production of over 100,000 tons of lithium chemicals per year in Texas through multiple projects [5] - The company is focused on advancing towards a final investment decision (FID) for the SWA project, with construction expected to commence in 2026 and first production targeted in 2028 [4][11] - The company is also working on expanding its leasehold footprint in East Texas and moving towards a preliminary feasibility study for the Franklin Project [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the critical milestones achieved in the third quarter and the strong positioning of the company in the domestic lithium supply chain [17] - The company is actively working on project financing and customer offtake processes, with a goal to finalize these before year-end [18] Other Important Information - The company appointed Michael Lutgring as General Counsel to strengthen its leadership team [6] - The company is in the final stages of selecting contractors for the construction of its central processing facility and well field [10] Q&A Session Summary Question: How does the $40 million FID payment structure work? - The payment is triggered as soon as the JV board decides to take FID and move forward with the SWA or East Texas projects, with Equinor owing Standard Lithium $40 million upon FID approval [22] Question: If the FID is made and later changes, does Standard Lithium still receive the $40 million? - Yes, the payment is secured upon taking FID, and it is unlikely that the company would back out after making the decision [23]

Financial Data and Key Metrics Changes - Q3 group revenue reached $146 million, representing a year-over-year increase of nearly 355% and a quarter-over-quarter increase of 39% [7] - Annualized run rate revenue for the core business at the end of September was $551 million, with the core infrastructure business growing 400% year-over-year and 40% sequentially [7][9] - Adjusted EBITDA margin for the core infrastructure business expanded to nearly 19% quarter-over-quarter [7] Business Line Data and Key Metrics Changes - The core infrastructure business accounted for nearly 90% of total revenue, with significant growth attributed to capacity constraints limiting revenue growth [7][9] - The company sold out all available capacity in Q3, indicating strong demand and a bottleneck in revenue growth due to capacity limitations [2][4] Market Data and Key Metrics Changes - The company signed a major deal with Meta valued at approximately $3 billion over the next five years, following a previous deal with Microsoft valued between $17.4 billion and $19.4 billion [3][12] - The demand environment is characterized by overwhelming interest in capacity, with a 70% quarter-on-quarter expansion in pipeline generation [22] Company Strategy and Development Direction - The company is focused on building its core AI cloud business while also pursuing large long-term deals to support growth [3][4] - Plans to grow contracted power to 2.5 gigawatts by the end of 2026, up from 1 gigawatt previously discussed, with significant investments in capacity and infrastructure [4][10] - The launch of new enterprise-ready cloud platform version 3.0, called Aether, and the inference platform Nebius Token Factory aims to expand the addressable market [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving an annualized run rate revenue of $7 billion to $9 billion by the end of 2026, driven by strong demand and capacity growth [6][17] - The company remains focused on maintaining healthy margins and a sustainable business model while navigating the rapid growth in the AI sector [42][63] Other Important Information - The company is raising its 2025 CapEx guidance from approximately $2 billion to around $5 billion to support aggressive growth plans [10] - The company is actively evaluating financing options, including corporate debt, asset-backed financing, and equity, to support its growth strategy [8][32] Q&A Session Summary Question: Can you tell us more about the new Meta deal? - The Meta deal is approximately $3 billion, limited by available capacity, indicating strong demand for larger contracts [12][13] Question: What is included in the $7 billion-$9 billion ARR target? - The target includes contracted power and existing capacity, with more than half already booked [15][17] Question: What is the timeline for infrastructure build-out? - The company is ramping up capacity in various regions, with new data centers expected to come online in 2026 [18][19] Question: How will Microsoft and Meta revenue contribute in 2025? - Microsoft revenue will ramp up in 2026, while Meta is expected to reach full revenue run rate in 2026 [21] Question: What does the demand environment look like? - Demand is accelerating, with a 70% increase in pipeline generation in Q3 [22] Question: Why is incremental ARR down? - Incremental ARR decreased due to capacity constraints, but is expected to increase significantly in Q4 [24] Question: How is the U.K. facility progressing? - The U.K. facility is progressing well, with strong demand leading to pre-sold capacity [35][36] Question: What is the company's approach to financing? - The company is focused on maintaining a disciplined capital structure while exploring various financing options [32][34] Question: How is the enterprise initiative ramping up? - The company is making strides in becoming enterprise-ready with new product launches and compliance certifications [48]

enGene Holdings (NasdaqCM:ENGN) Update / Briefing November 11, 2025 08:00 AM ET Company ParticipantsRon Cooper - President and CEOSuzanne Merrill - Senior Physician, Urologic Oncologist and Bladder Cancer Regional LeadSean McCutcheon - VP of Biotechnology Equity ResearchLauren Hopfer - Executive Director of Investor RelationsHussein Sweiti - CMOConference Call ParticipantsLeland Gershell - Managing Director and Senior Biotechnology AnalystYanan Zhu - Senior AnalystDavid Dai - Senior Biotech AnalystSilvan Tü ...

Financial Performance & Growth - Mako generated revenues of US$111.9 million TTM and US$67.3 million in 1H 2025[7] - Adjusted EBITDA was US$55.7 million TTM[9], with US$48.6 million in EBITDA[55] - Net income reached US$23.3 million TTM and US$18.2 million in 1H 2025[7,55] - The company sold 34,695 oz of Au in 2023 and 39 Koz of Au in 2024[7] Asset Development & Expansion - Mako intends to acquire Mt Hamilton Project for approximately US$40 million[9] - Eagle Mountain Project PEA highlights potential for production of +60k oz/year Au[9] - San Albino mine is permitted up to 1,000tpd[43] Capital Structure & Investments - Mako's market capitalization is US$436 million[10] - The company has US$60.3 million in cash and no debt[10] - US$2.9 million in share repurchases in TTM[9]

Endava (NYSE:DAVA) Q1 2026 Earnings Call November 11, 2025 08:00 AM ET Speaker0Good day, and welcome to Endava's first quarter fiscal year 2026 conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, th ...

Precision BioSciences (NasdaqCM:DTIL) Update / Briefing November 11, 2025 08:00 AM ET Speaker3Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Precision BioSciences AASLD update call. All lines have been placed on mute to prevent any background noise. After this speaker's remarks, there will be a question-and-answer session. To ask a question, simply press star followed by the number one on your telephone keypad. ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $71.6 million, a 45% increase year-over-year and a 12% sequential increase from Q2 2025 [12][13] - Adjusted EBITDA for Q3 was $22.7 million, with GAAP-based net income of $1 million [14] - For the first nine months of 2025, total revenue reached $183.2 million, with an updated full-year revenue outlook of $270-$280 million [13][17] Business Line Data and Key Metrics Changes - VEVYE generated approximately $22.6 million in revenue during Q3, a 22% increase from Q2 2025, and is expected to finish the year strong [14][15] - IHEEZO revenue for Q3 was $21.9 million, up 20% from Q2, with strong demand expected to continue into Q4 [15][16] - TRIESENCE and the specialty portfolio generated $6.9 million in revenue, showing a 33% sequential increase, with new strategies in place to reignite growth [16][30] Market Data and Key Metrics Changes - VEVYE captured 10.5% of the total dry eye market by the end of Q3, up 2.7 share points from the prior quarter [22] - IHEEZO's unit demand was up 47% year-over-year, indicating strong market resonance [25] - TRIESENCE is gaining traction in the retina market, with a 67% sequential increase in unit demand [28] Company Strategy and Development Direction - The company aims to become a leading U.S. ophthalmic company, with plans for four new product launches over the next two years [6][11] - A focus on building a scalable commercial infrastructure to support multiple product launches without heavy additional investment [6][11] - The acquisition of Melt Pharmaceuticals and the expansion of the Access for All program are key strategic moves to enhance growth [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the overall trajectory of the business, despite some areas underperforming due to seasonal factors [7] - The company anticipates a strong finish to 2025, with expectations for continued growth in 2026 driven by improved coverage and commercial investments [18][24] - Management is actively working to resolve licensing disputes in California, which could impact future revenue [11] Other Important Information - The company is preparing for the launch of new products, including BioViz, OpioViz, Biclovi, and Melt 300, which are expected to drive future growth [11][30] - The ImprimisRx business remains stable, generating approximately $20.1 million in revenue, but may face challenges due to ongoing regulatory disputes [17] Q&A Session Summary Question: Why was VEVYE prescription data not available this quarter? - Management decided to withdraw from certain reporting services to ensure accuracy and maintain competitive positioning [34][35] Question: Can you discuss the operating leverage achieved? - The company is seeing operating leverage from new revenue growth, with expectations for moderate increases in operating expenses as investments are made in commercial infrastructure [36][37] Question: What is the expected impact of VEVYE's coverage win on ASP? - Management anticipates that improved coverage will lead to a stabilization and potential increase in ASP, particularly as the ratio of covered prescriptions increases [39][40] Question: What proportion of cash-pay patients is expected to transition to insurance coverage? - While precise figures are not available, management believes that many cash-pay patients will transition to covered prescriptions due to favorable coverage wins [46][47] Question: What are the dynamics expected between Q3 and Q4 revenue? - Management expects Q4 to be strong, driven by volume growth across the portfolio, particularly from VEVYE and TRIESENCE [55][58]

November 2025 Investor Presentation tdw.com Forward-looking Statements This presentation contains "forward-looking statements" within the meaning of the U.S. federal securities laws – that is, any statements that are not historical facts. Such statements often contain words such as "expect," "believe," "think," "anticipate," "predict," "plan," "assume," "estimate," "forecast," "target," "projections," "intend," "should," "will," "shall" and other similar words. Forward-looking statements address matters tha ...

Investor Presentation Q3 2025 Results NASDAQ: WPRT / TSX: WPRT Speaking Today... November 11, 2025 Westport Fuel Systems Disclaimer and Forward-Looking Statements This presentation contains forward-looking statements that are based on the beliefs of management and reflects our current expectations as contemplated under the safe harbor provisions of Section 21E of the United States Securities Act of 1934, as amended. Such forward-looking statements include, but are not limited to, future strategic initiative ...