Financial Data and Key Metrics Changes - Revenue for Q1 fiscal 2026 increased by 79% to $15.1 million compared to $8.4 million in the same quarter of the previous year [19] - Gross profit rose by 58% to $4.5 million, representing 30% of total revenues, down from 34% in the prior year due to non-recurring orders with higher margins [20] - Operating expenses increased by 66% to $7 million, primarily due to the integration of G5 Infrared and increased sales and marketing spending [20] - Net loss for Q1 fiscal 2026 totaled $2.9 million, or $0.07 per share, compared to a loss of $1.6 million, or $0.04 per share, in the same quarter last year [21] - Adjusted EBITDA was positive at $0.4 million, compared to a loss of $0.2 million in the prior year [21] - Cash and cash equivalents as of September 30, 2025, totaled $11.5 million, up from $4.9 million as of June 30, 2025 [21] Business Line Data and Key Metrics Changes - Revenue from infrared components was $4.3 million (28% of total revenue), visible components generated $3.8 million (25%), assemblies/modules accounted for $5.9 million (39%), and engineering services brought in $1.1 million (7%) [19] - The backlog reached approximately $90 million, with over two-thirds in systems and subsystems, indicating a successful shift up the value chain [11] Market Data and Key Metrics Changes - The company is experiencing strong demand in border surveillance and Counter-UAS applications, with over $15 million of the backlog dedicated to Counter-UAS [12] - Anticipation of over 1,000 new border surveillance towers, with expected placements priced between $150,000 and $250,000 per camera [12] Company Strategy and Development Direction - The company is transitioning from a component supplier to a vertically integrated provider of high-value infrared optics and camera systems, focusing on engineered solutions [3][4] - Strategic investments from Ondas Holdings and Unusual Machines aim to accelerate commercialization, particularly in uncooled infrared solutions for drone applications [11] - The proprietary Black Diamond Chalcogenite glass is central to the strategy, providing a domestic alternative to germanium and enhancing supply chain resilience [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing a record backlog and the successful integration of G5 Infrared [18] - The focus for fiscal year 2026 includes expanding Germanium-free product variants, hardening the supply chain, and converting backlog into revenue at healthy margins [25] - The company is optimistic about sustaining growth and expanding profitability through strategic investments and operational scaling [18][25] Other Important Information - The company is moving its Texas team to a larger facility to support production needs for the Lockheed NG SRI program [16] - Mark Kahlo has been appointed to the Board of Directors, bringing extensive experience in the defense industry [17] Q&A Session Summary Question: About the availability of germanium and the transition to Black Diamond glass - Management noted that while China may open up germanium availability, customers are cautious due to past supply chain disruptions and are transitioning to Black Diamond glass for better performance [28][29] Question: Supply chain resiliency and capacity improvements - Management indicated that capacity needs to be added across various operations, particularly in glass manufacturing and camera systems, with ongoing investments to meet demand [33][35] Question: Sales progression and EBITDA expectations for the December quarter - Management refrained from providing specific guidance but expressed a desire to maintain the positive sales momentum seen in Q1 [39] Question: Status of the NGSRI program and facility upgrades - Management confirmed that the timeline for the NGSRI program remains uncertain due to government delays, but investments are being made to prepare for potential scaling [44] Question: Gross margin expectations and capacity expansion impact - Management expects gross margins to improve despite fluctuations in sales mix, with a goal of reaching 35% by the end of the fiscal year [46] Question: Pipeline of $10 million plus annual revenue opportunities - Management indicated there are approximately seven to eight programs in the pipeline that could generate significant revenue [62] Question: Integration of systems and technology for counter-UAS applications - Management confirmed that systems are integrated for tracking and validation, emphasizing the importance of visual confirmation in defense applications [84]

Financial Data and Key Metrics Changes - Total net revenues decreased by 13.3% to $70.2 million in Q3 2025 compared to $81 million in the year-ago period, primarily driven by a 10.3% decrease in the volume of products sold and a 3.3% decrease in net revenue per pound [20][21] - Gross margin fell to 10.3% in Q3 2025 from 17.7% in the year-ago period, impacted by lower volumes and higher trade discounts [8][26] - Net loss was $110.7 million in Q3 2025 compared to $26.6 million in the year-ago period, with net loss per common share increasing to $1.44 from $0.41 [30][31] Business Line Data and Key Metrics Changes - U.S. retail net revenues decreased by 18.4% to $28.5 million, driven by a 12.6% decrease in volume and a 6.6% decrease in net revenue per pound [23] - U.S. food service net revenues decreased by 27.3% to $10.5 million, primarily due to a 27.1% decrease in volume [24] - International retail net revenues decreased by 4.6% to $15.8 million, with a 12.5% decrease in volume partially offset by a 9.1% increase in net revenue per pound [24][25] Market Data and Key Metrics Changes - The plant-based meat category continues to face general softness, with two of the top three markets in the EU also experiencing year-over-year declines [22] - The U.S. market is seeing reduced points of distribution and weak category demand, impacting overall sales [22][23] Company Strategy and Development Direction - The company is focused on a turnaround strategy, including addressing misinformation about plant-based meats, rebuilding distribution, and reducing operating expenses [10][15][17] - New product innovations, such as Beyond Chicken Pieces and the Beyond Test Kitchen, are aimed at enhancing consumer engagement and product visibility [11][12][14] - The company is targeting a gross profit margin of over 30% and aims to achieve EBITDA-positive operations as soon as possible [31][40] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment with the current quarter's results but emphasized ongoing efforts to reset the business for sustainable growth [6][19] - The macroeconomic environment remains challenging, making it difficult to forecast operating results beyond a limited horizon [33] - The company anticipates net revenues in Q4 2025 to be in the range of $60 million to $65 million, reflecting ongoing demand weakness [33] Other Important Information - The company successfully reduced debt levels by approximately $900 million, nearly 75% of total leverage, and extended the maturity of most of its debt profile [6][34] - Cash and cash equivalents were $131.1 million as of September 27, 2025, with net cash used in operating activities increasing to $98.1 million for the nine months ended September 27, 2025 [31][32] Q&A Session Summary Question: What is currently holding the company back from achieving higher gross profit margins? - Management indicated that lower top-line revenue is the main drag on margins, along with higher material costs and the impact of a depreciation charge related to China operations [38][39] Question: Can you provide an update on the cash balance following recent financing activities? - Management noted that the cash balance would include proceeds from the ATM program, but specific figures could not be provided at that time [41][42]

Financial Data and Key Metrics Changes - The company achieved strong year-over-year revenue growth of 8%, with total revenues for Q3 2025 reaching $12.5 million [5][14] - Operating expenses were reduced by 12% to $5.4 million compared to $6.2 million in Q3 2024, contributing to improved financial performance [5][18] - Adjusted EBITDA improved by $1.3 million, resulting in a loss of $131,000 for Q3 2025, compared to a loss of $1.4 million in the prior year [5][18] - Cash and cash equivalents totaled $5.6 million at the end of Q3 2025, a decrease of $1.2 million from the previous quarter [18] Business Line Data and Key Metrics Changes - The glaucoma product line saw a revenue increase of 13% year-over-year, totaling $3.5 million [15] - Retina product revenue increased by 4% to $6.7 million, driven by higher Pascal system sales, despite a decrease in surgical retina probe sales [15] - CycloG6 system sales increased to 30 units from 26 in the prior year, indicating strong demand and utilization [9] Market Data and Key Metrics Changes - International glaucoma performance was strong, particularly in Europe, the Middle East, and Africa, with positive contributions across geography [10] - The Asia market faced challenges due to macro factors, including a tariff dispute with China and currency fluctuations affecting Japan [10][12] - Latin America and Canada showed improved momentum following the appointment of new distributors [11] Company Strategy and Development Direction - The company is focused on streamlining operations and advancing towards profitability, with a goal of achieving cash flow positive operations in 2026 [4][20] - Cost reduction programs implemented in late 2024 have significantly lowered operating expenses and improved the financial position [5][18] - The company is negotiating with contract manufacturers to reduce the cost of goods sold and enhance gross margins [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive cash flows in Q4 2025 and positive adjusted EBITDA for the full year [4][19] - The company remains committed to cost discipline and improving financial performance, with expectations of sustained cash flow positivity [20] - Management acknowledged the challenges in the Asia market but noted solid underlying demand for products [12] Other Important Information - A one-time inventory write-down impacted gross profit, but excluding this charge, gross margin would have improved to 38.7% [16][18] - The company is relocating certain administrative functions to generate savings, expected to be approximately $165,000 quarterly starting Q1 2026 [6] Q&A Session Summary - No specific questions or answers were provided in the content regarding the Q&A session.

Financial Data and Key Metrics Changes - Operating revenue for Q3 2025 was $114.3 million, a 24.9% increase compared to Q3 2024 [11] - Adjusted operating ratio improved to 96.3%, up 250 basis points from 98.8% in Q3 2024 [11] - Units delivered totaled 605,341, representing a 21% increase year-over-year [11] - Free cash flow from operations was approximately $11.5 million during the quarter, contributing to a reduction in debt [13] Business Line Data and Key Metrics Changes - OEM contract business generated approximately 93% of total transportation revenue, consistent with previous quarters [12] - Dedicated fleet business revenue was $4.2 million, aligning with the expected run rate for 2025 [12] - Sister hauls or load sharing increased to 11% of revenue from 9% in the prior quarter, enhancing asset utilization [9] Market Data and Key Metrics Changes - July auto sales and deliveries were stronger than expected, with SAR finishing at 16.4 million units [5] - October SAR slowed to 15.3 million, with forecasts for the remainder of the year in the high 15 to low 16 million range [7] - The pricing environment remains weak, with excess supply impacting revenue per unit [33] Company Strategy and Development Direction - The company aims for sustainable profitability and reinvestment while pursuing new business opportunities [6] - Focus on controlling costs and advancing targeted cost savings initiatives to produce sustainable benefits [8] - Plans to continue strategic objectives for margin expansion, market share gains, and acquisitions [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving growth and margin expansion despite market complexities [6] - Anticipated a modestly lower revenue outcome for Q4 compared to Q3, but similar adjusted operating ratio and cash flow [8] - The company is well-positioned to operate profitably with strong cash flow and respond quickly to market improvements [10] Other Important Information - A restructuring charge of $1.9 million was recognized, expected to yield over $3 million in annual savings starting in 2026 [8] - Cash and equivalents increased to $14.5 million, while aggregate debt decreased to approximately $79.2 million [12] Q&A Session Summary Question: Clarification on revenue growth for the full year - Revenue growth for the full year is expected to be 10-12% based on a pro forma base of $388.8 million [19] Question: Update on systems transition - The company has fully transitioned to a unified operating platform across all operating companies [21] Question: Update on OEM contracts - Several OEM contracts are still awaiting awards, with no material results impacting overall revenues yet [26] Question: Expectations for CapEx and cash flow - CapEx is expected to increase in 2026, with a target of $15 million to $20 million as the fleet expands [50] Question: Impact of regulatory changes on capacity - Regulatory changes are not expected to materially impact Proficient, but may affect smaller carriers [53] Question: EV demand impact on quarterly results - The company does not track EV versus internal combustion engine volumes, but EVs may affect load factors [56]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $8.8 million, a 6% increase from $8.3 million in Q2 2025, but a decrease from $9.5 million in Q3 2024 [18] - Non-GAAP gross profit margin improved to 49.9% from 46% in Q2 2025, but decreased from 51.3% in Q3 2024 [18] - Non-GAAP operating expenses decreased to $9.2 million from $9.7 million in the prior quarter and $12.4 million year-over-year [19] - Net loss for Q3 2025 was $3.8 million, or a loss of $0.69 per share, compared to a net loss of $5.3 million, or a loss of $1 per share in Q2 2025, and a net loss of $7.1 million, or a loss of $1.45 per share in Q3 2024 [19] - Cash burn from operations reduced by over 60% year-over-year to under $3 million in Q3 2025 [6] Business Line Data and Key Metrics Changes - Home and enterprise revenue was approximately $7.4 million, while mobile revenue was approximately $1.4 million in Q3 2025 [18] - The sequential increase in revenue was attributed to growth in both end markets, particularly in home and enterprise [18] Market Data and Key Metrics Changes - The proposed transaction involving the Shanghai subsidiary is expected to yield net cash proceeds of between $50 million and $60 million upon closing [10] - The Shanghai subsidiary was valued at approximately $133 million, but obligations to minority shareholders and transaction costs will reduce the net proceeds [24][25] Company Strategy and Development Direction - The company aims to transition into a global technology licensing business specializing in cinematic visualization solutions post-transaction [11] - The focus will shift to an asset-light, IP-rich model, enhancing competitive differentiation and long-term growth potential [11] - The TrueCut Motion platform will anchor the company's portfolio, with plans to expand into high-growth enterprise and consumer visualization markets [13] Management's Comments on Operating Environment and Future Outlook - Management noted that geopolitical tensions have impacted the Shanghai subsidiary, but opportunities have emerged since the announcement of the transaction [27][28] - The company is not providing financial guidance for Q4 2025 due to the pending sale of the Shanghai subsidiary [20] - Management expressed optimism about the future growth of the TrueCut business, emphasizing the need for increased investment and focus post-transaction [31] Other Important Information - The company closed a registered direct offering and the sale of patents in October 2025, contributing approximately $10 million to its cash position [20] - As of October 31, 2025, the cash and cash equivalents balance was approximately $22 million, with half associated with Pixelworks Shanghai and the other half with Pixelworks [20] Q&A Session Summary Question: Can you help bridge the $133 million consideration to the $50-$60 million expected proceeds? - The company owns 78% of the Shanghai entity, valued at $133 million, but obligations to employees and investors, along with transaction costs and a 10% withholding tax, will reduce net proceeds to $50-$60 million [24][25] Question: Have there been impacts on the Shanghai subsidiary due to geopolitical issues? - Management indicated that there has been a noticeable impact, but opportunities have arisen since the announcement of the transaction, which may not have occurred if ownership remained unchanged [27][28] Question: How will the TrueCut business be run differently post-transaction? - The focus will be on accelerating investment and energy into the TrueCut business, which had been constrained due to previous headwinds in China [31]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $1.15 billion, up 2.8% year-over-year in pro forma constant currency, exceeding the midpoint of guidance [6][24] - Non-GAAP diluted earnings per share (EPS) was $1.83, slightly above guidance midpoint, with a 12-month backlog of $4.19 billion, up 3.2% from a year ago [7][32] - Profitability improved by 300 basis points year-over-year, with a non-GAAP operating margin of 21.6%, up 290 basis points from the previous year [25][26] Business Line Data and Key Metrics Changes - Cloud revenue grew by double digits, contributing over 30% of total revenue, compared to roughly 25% in the prior year [26] - Managed services revenue reached a record $3 billion in fiscal 2025, up 3.1% from a year ago, with managed services accounting for 66% of overall revenue [27][28] Market Data and Key Metrics Changes - North America saw over 2% sequential improvement, marking its strongest quarter of the fiscal year, while Europe experienced a decline following a record quarter [24] - The rest of the world showed mixed trends, with expectations for continued growth despite fluctuations due to project orientation [24] Company Strategy and Development Direction - The company is focusing on cloud, digital, and generative AI solutions to support telco customers, with a strategy to enhance customer experiences and operational efficiencies [9][10] - A significant investment in generative AI is planned, with the development of a next-generation platform called Cognitive Core, aimed at transforming telecom operations [19][20] Management's Comments on Operating Environment and Future Outlook - The company is entering fiscal 2026 with a healthy backlog and strong visibility, expecting revenue growth between 1.7%-5.7% as reported [21][22] - Management acknowledged potential impacts from the uncertain global macroeconomic environment on customer demand and spending behavior [22] Other Important Information - Free cash flow for fiscal 2025 was $645 million, with a healthy cash balance of approximately $325 million and a $500 million revolving credit facility [30][31] - The company plans to return the majority of free cash flow to shareholders, including an 8% increase in quarterly cash dividends [31] Q&A Session Summary Question: Impact of AI on the telecom industry - Management discussed the gradual improvement in productivity through generative AI, emphasizing its potential to enhance operations and customer offerings [37][38] Question: R&D capital allocation - The decision to reallocate capital into R&D was driven by the need to capture growth opportunities, with ongoing productivity gains expected to support this investment [40][41] Question: Customer pricing expectations - There is ongoing dialogue with customers regarding pricing, with efforts to expand the scope of agreements to include new technologies and services [44][46] Question: Cash flow and growth expectations - Management clarified that cash flow levels are consistent, with expectations for stronger growth in the second half of fiscal 2026, despite some pressures from major customers like T-Mobile [48][49] Question: Long-term growth positioning - The company aims to establish multiple growth engines, including cloud and generative AI, to drive sustainable growth beyond current levels [56][57]

Financial Data and Key Metrics Changes - Oklo reported a third-quarter operating loss of $36.3 million, which includes a non-cash stock-based compensation expense of $9.1 million [39] - The loss before income taxes for the third quarter was $29.2 million, reflecting an operating loss adjusted for net interest income of $7.1 million [40] - The company closed the quarter with approximately $1.2 billion in cash and marketable securities, with cash burn tracking in line with expectations [11][41] Business Line Data and Key Metrics Changes - Oklo's Advanced Fuel Center represents a significant investment of up to $1.68 billion, anchoring the long-term fuel supply chain [9] - The company achieved a key regulatory milestone with the Department of Energy's approval of the Nuclear Safety Design Agreement for the Aurora Fuel Fabrication Facility, completed in under two weeks [10] - The Atomic Alchemy pilot facility was selected under the Department of Energy's Reactor Pilot Program, creating a faster pathway to construction and operations [22] Market Data and Key Metrics Changes - Oklo was selected for three projects under the Department of Energy's new Reactor Pilot Program, which is expected to accelerate deployment timelines [7][12] - The company is evaluating potential power sales with the Tennessee Valley Authority as part of its Tennessee Fuel Center initiative [11] - Oklo signed new international partnerships with European companies Moltex and Nucleo to advance joint technology and fuel manufacturing capabilities [38] Company Strategy and Development Direction - Oklo's mission is to deliver clean, reliable, affordable energy at a global scale, focusing on advanced nuclear power as a transformative energy solution [4] - The company is building on its proven liquid metal sodium-cooled technology, which has over 400 combined reactor years of operating experience [6] - The strategy includes a build, own, operate model that allows for direct power sales under long-term contracts, creating recurring revenue [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Oklo's unique positioning to thrive in the current advanced nuclear sector environment, driven by federal programs and growing customer interest [4] - The company anticipates that the DOE authorization pathway will de-risk the regulatory process and allow for faster construction and operation timelines [16] - Management highlighted the importance of a diversified fuel strategy to adapt to changing market dynamics and ensure long-term supply security [27] Other Important Information - The Advanced Fuel Center in Tennessee is expected to create over 800 permanent jobs and is the first privately funded recycling facility of its kind in the U.S. [34] - The Nuclear Refuel Act of 2025 aims to provide regulatory clarity for licensing advanced fuel recycling facilities, which could streamline the licensing process for Oklo's Tennessee facility [36] - Oklo's partnerships with international companies are expected to enhance its supply chain strategies and expand its technology base [38] Q&A Session Summary Question: Does the INL plant shifting to the DOE pathway change the requirement to submit a COLA with the NRC? - Management confirmed that they no longer need to submit a COLA and will go through the DOE authorization process instead [43][44] Question: Are you still targeting commercial operations at INL to commence between late 2027 and early 2028? - Management stated that they are still targeting that timeline, but the DOE pathway may allow for accelerated milestones [55][58] Question: Can you help me understand the conversion math regarding the 20 tons of plutonium reserves potentially being made into 180 tons of Aurora fuel? - Management expressed enthusiasm about the question and indicated that the conversion process could significantly accelerate deployment schedules [64]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $115.3 million, a 37.7% increase year-over-year from $83.7 million in Q3 2024, driven by a 39% increase in brokerage revenue [17][19] - Gross profit increased by 39.1% year-over-year, reaching over $9.6 million, with a gross profit margin consistent at 8.3% [6][18] - Adjusted EBITDA improved to $6,000 in Q3 2025 from a negative $1.4 million in Q3 2024, reflecting higher revenue and improved operating leverage [20] Business Line Data and Key Metrics Changes - Brokerage segment revenue was $109.2 million, a 39% increase year-over-year, primarily due to the acquisition of My Home Group [20][21] - Mortgage segment revenue increased to $3.5 million from $2.9 million, with adjusted EBITDA of $161,000 compared to a loss of $319,000 in the prior year [23] - Veras Title revenue grew by 28.6% to $1.8 million, although adjusted EBITDA showed a loss of $191,000, worsening from a loss of $92,000 in the previous year [24] - Technology segment revenue was $829,000, up from $785,000, with adjusted EBITDA improving to $488,000 from $152,000 [25] Market Data and Key Metrics Changes - The residential real estate market is showing early signs of recovery, with narrowing spreads between the 10-year Treasury yield and the 30-year mortgage rate [26] - The company anticipates that small brokerages will explore opportunities to merge with or partner with larger firms, indicating a trend towards consolidation in the industry [28] Company Strategy and Development Direction - The company aims to diversify revenue streams with higher margin products and services, expand flagship programs like Elevate and Start, and strengthen attach rates across mortgage and title [29] - The Elevate program is designed to enhance agent productivity and profitability, with over 165 agents already onboarded [12][29] - The acquisition of Start Real Estate is expected to capture a significant share of the first-time home buyer market, with plans to expand into more states [13][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the housing market's recovery and the potential for programs like Start Real Estate and Elevate to gain momentum [26][27] - The company is focused on achieving operational cash flow breakeven by Q2 2026, with a commitment to disciplined execution [29] Other Important Information - The company ended the quarter with $9.8 million in cash, including $6.5 million from a public stock offering [25] - The company has not made any share repurchases during the first nine months of 2025 [25] Q&A Session Summary Question: Can you elaborate on the go-to-market strategy for IntelliAgent licensing? - The company has established relationships with several hundred small brokers and plans to accelerate discussions with the identified 18,000 brokers in Q1 of next year [31] Question: What are the attach rates for Start Real Estate as it expands into more states? - The attach rate for Start Real Estate is over 70%, and the company anticipates maintaining this rate as it expands into new states [33][34]

Financial Data and Key Metrics Changes - Research and development revenue decreased to $3.8 million in Q3 2025 from $8.2 million in Q3 2024, reflecting reduced reimbursements under the BARDA Project Bioshield contract [9] - Gross margin decreased to 42.7% from 44.8% year-over-year due to a lower percentage of direct labor as a part of total reimbursed costs [10] - Net loss for Q3 2025 was $3.6 million, compared to a net loss of $1.5 million in Q3 2024, attributed to reduced revenue and higher administrative expenses [10] - Cash and cash equivalents totaled $10.5 million as of September 30, 2025, up from $5.2 million at the end of 2024, with a consistent cash balance since June 30, 2025 [11][12] - Revenue guidance for 2025 was reduced from $21.5 million to $18.5 million due to anticipated reduced work on the BARDA contract and timing effects from the U.S. government shutdown [12] Business Line Data and Key Metrics Changes - The company continues to focus on the DeepView System, with plans for a U.S. launch next year, supported by a recent registered direct offering that added $7.6 million to cash reserves [5][12] - The company is working on a commercialization strategy for the DeepView System, which includes broad applications beyond burns [8] Market Data and Key Metrics Changes - The company has received positive feedback from international markets where units have been placed, indicating ease of use and effectiveness in treating burn patients [22] - Discussions are ongoing to expand into the U.K. and parts of Europe, with plans to upgrade the current device based on U.S. market learnings [42][43] Company Strategy and Development Direction - The company is focused on three principles: finance, focus, and finish, as it prepares for the commercialization of the DeepView System [4] - The company aims to leverage its existing relationships within the burn community to facilitate initial sales post-FDA clearance [40] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the FDA submission process, indicating no anticipated delays despite the government shutdown [17] - The company expects 2026 to be a transitional year with relatively flat revenue compared to 2025, with significant growth anticipated in 2027 and 2028 [20] Other Important Information - The company is actively communicating with the FDA regarding its submission, with positive interactions noted, particularly concerning the statistical analysis plan [27] - The handheld module for military use is under development, with positive feedback received on its preliminary design [30] Q&A Session Summary Question: Impact of government shutdown on FDA submission - Management confirmed that the FDA submission is on track for approval in the first half of 2026, with delays primarily affecting discussions with BARDA [17][18] Question: Revenue expectations for 2026 - Management indicated that 2026 may see a slight reduction in revenue compared to 2025, but overall expectations remain stable [20] Question: Feedback from international units - Positive feedback has been received from international sites, informing preparations for the U.S. launch [22] Question: Progress with FDA communications - Management reported good communication with the FDA, with ongoing discussions about additional testing and adjustments [27] Question: Status of the handheld module development - Development is progressing well, with military testing ongoing and plans for civilian applications [30] Question: Commercialization preparations - The company is hiring additional personnel for commercialization efforts and leveraging existing relationships in the burn community [40]

Summary of Oruka Therapeutics Conference Call Company Overview - **Company**: Oruka Therapeutics (NasdaqGM: ORKA) - **Focus**: Advancing the standard of care in psoriatic disease with a pipeline centered around two co-lead assets, ORCA-001 and ORCA-002, both extended half-life monoclonal antibodies targeting plaque psoriasis, psoriatic arthritis, and related conditions [2][3] Key Products and Pipeline - **ORCA-001**: Modeled after Risankizumab (Skyrizi), targeting IL-23p19, with a 100-day half-life, aiming for once-a-year dosing [2][6][7] - **ORCA-002**: Modeled after Bimekizumab (Bimzelx), targeting IL-17A/F, with expected half-life around 75 days, aiming for twice-yearly dosing [2][17] - **Clinical Development**: - ORCA-001 is in phase 2 development, with readouts expected in the second half of next year [3][10] - ORCA-002 is in phase 1, with data anticipated around year-end [16][17] Market Opportunity - **Psoriasis Pipeline**: The current pipeline for psoriasis is relatively empty, presenting a significant opportunity for Oruka to introduce new biologics [4][5] - **Patient Preference**: The company believes that patients and physicians would prefer less frequent dosing with biologics over oral options, which are currently being explored by competitors [5] Clinical Data and Efficacy - **Efficacy Expectations**: - ORCA-001 aims for PASI 100 (fully clear skin) rates potentially in the 50s or 60s, compared to Skyrizi's 43% and Bimekizumab's 62% [11][12] - The innovative design of the phase 2A study includes a primary endpoint of PASI 100 at week 16, which is a novel approach in psoriasis trials [9][10] - **Durability of Response**: The study will also assess how long patients can maintain clear skin without additional doses, with expectations of 20-30% of patients remaining clear for two years or more after initial doses [10][14] Financial Position - **Cash Reserves**: The company is well-capitalized with over $500 million in cash, providing a runway through multiple significant inflection points, including phase 2 readouts for both programs [3][27] Future Directions - **Expansion into Hidradenitis Suppurativa (HS)**: The company plans to pursue HS after establishing its psoriasis programs, leveraging the success of Bimekizumab in psoriasis and psoriatic arthritis [21][22] - **Combination Therapy Concept**: ORCA-021 aims to explore the potential of using IL-17 for induction followed by IL-23 for maintenance, which has received positive feedback from experts [25][26] Conclusion - Oruka Therapeutics is positioned to capitalize on a significant market opportunity in psoriatic disease with its innovative pipeline of extended half-life monoclonal antibodies, backed by strong clinical data and a solid financial foundation. The company is strategically planning to expand its indications and explore combination therapies to enhance treatment outcomes for patients.