Kura Sushi USA(KRUS) - 2026 Q1 - Earnings Call Transcript
2026-01-07 23:02
Financial Data and Key Metrics Changes - Total sales for the fiscal first quarter were $73.5 million, compared to $64.5 million in the prior year period, representing a year-over-year increase of approximately 12.4% [9] - Comparable sales growth was negative 2.5%, with a negative traffic of 2.5% and flat price and mix [9] - Adjusted net loss was $2.8 million, or negative $0.23 per share, compared to an adjusted net loss of $1 million, or negative $0.08 per share in the prior year quarter [13] - Restaurant-level operating profit as a percentage of sales was 15.1%, compared to 18.2% in the prior year quarter [13] Business Line Data and Key Metrics Changes - The company opened four new restaurants in the first quarter and has 10 units under construction, including locations in new markets [7] - Labor as a percentage of sales improved to 32.5% from 32.9% in the prior year period due to operational initiatives [6] - Cost of goods as a percentage of sales increased to 29.9% from 29% in the prior year quarter, impacted by tariffs [10] Market Data and Key Metrics Changes - Comparable sales in the West Coast market were negative 2.8%, while the Southwest market saw negative 2.7% [9] - The company expects full-year costs to stabilize around 30% after considering tariffs and menu price adjustments [6] Company Strategy and Development Direction - The company aims to open 16 new restaurants in fiscal 2026, maintaining an annual unit growth rate above 20% [13] - Marketing efforts include a campaign with Kirby, coinciding with the release of Kirby Air Riders for Switch 2, and the introduction of a reservation system decoupled from the rewards program [7][8] - The company is focused on aggressive cost management, reducing G&A as a percentage of sales by 80 basis points on an adjusted basis [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive comparable sales for the year, citing strong performance in November and December [25] - The company anticipates that the pricing taken in November will continue to support sales growth and improve traffic [25] - Management noted that the broader industry is showing signs of improvement, which is encouraging for future performance [53] Other Important Information - The company has $78.5 million in cash, cash equivalents, and investments, with no debt [13] - General and administrative expenses as a percentage of sales were 13%, down from 13.5% in the prior year quarter [11] Q&A Session Summary Question: What led to the decision to decouple the reservation system from loyalty? - Management noted that more than half of visits by rewards members are through the reservation system, indicating better-than-expected uptake [20] Question: Do you expect positive comps in the February quarter? - Management confirmed expectations for positive comps in Q2, supported by strong performance in November and December [25] Question: How long would it take for tariff relief to impact financials? - Management indicated it would take 60 to 90 days to see benefits from reduced tariffs due to inventory turnover [30] Question: Can you comment on the impact of tariffs on other expense lines? - Management stated that tariffs have significantly impacted promotional costs, particularly for items sourced from overseas [100] Question: How are rewards members performing in terms of spending? - Management reported that rewards members spend about $6 more per person compared to non-members, with a significant increase in visit frequency [75] Question: What are the future planned promotions for the year? - Upcoming promotions include Sanrio for February and Jujutsu Kaisen for March and April [108]
Franklin Covey(FC) - 2026 Q1 - Earnings Call Transcript
2026-01-07 23:02
Financial Data and Key Metrics Changes - Total first quarter reported revenue was $64 million, down 7% from the prior year, driven by an 8% decline in the Enterprise Division and a 2% decrease in the Education Division [28][31] - Adjusted EBITDA was $3.7 million compared to $7.7 million in the previous year, reflecting lower reported revenue and higher SG&A expenses [32] - Cash flows from operating activities were $0.1 million compared to $14.1 million in the previous year, primarily due to timing-related changes in working capital [32] Business Line Data and Key Metrics Changes - Enterprise Division invoiced amounts grew 4% to $45.5 million, with North America segment invoiced amounts growing 7% to $34.9 million, and 13% excluding government contracts [33][34] - Education Division revenue was $16.1 million, down 2% from the prior year, primarily due to decreased material sales [38] - Subscription revenue in the Education Division increased 12% to $11.8 million compared to $10.5 million in the prior year [40] Market Data and Key Metrics Changes - International segment revenue was $11.2 million, down slightly from $11.4 million in the prior year, primarily due to challenges in China [37] - Excluding China, revenue from the International segment increased 4%, and licensee revenue increased 8% compared with the first quarter of fiscal 2025 [38] Company Strategy and Development Direction - The company views fiscal 2026 as a year of execution and return to growth, with expectations for strong growth in invoiced amounts and reported revenue in fiscal 2027 [4][46] - Strategic investments in transforming the go-to-market strategy are gaining traction, with a focus on solution selling and bundling content with services [34][19] - The company aims to be the partner of choice for organizations seeking to achieve breakthrough results, emphasizing the importance of human capabilities alongside AI [17][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong growth in invoiced amounts, particularly in North America, and expects this momentum to continue [5][26] - The company anticipates that the meaningful growth in invoiced amounts will translate into substantial growth in reported revenue, Adjusted EBITDA, and free cash flow in fiscal 2027 [12][46] - Management acknowledged the impact of macroeconomic conditions and government actions on revenue recognition and deferred revenue [28][12] Other Important Information - The company has a strong liquidity position with $80 million available, including $17.5 million in cash and no drawdowns on its credit facility [41] - The company repurchased approximately 582,000 shares in the open market at a cost of $10.4 million during the first quarter [42] Q&A Session Questions and Answers Question: Clarification on guidance and Adjusted EBITDA timing - Management confirmed that the Adjusted EBITDA will be more back-end loaded due to the timing of large Education contracts, which are expected to be recognized in Q3 and Q4 [52][53] Question: Update on North American Enterprise sales force performance - Management confirmed that invoice growth in North American Enterprise was up 7%, with a significant increase in new logo subscription invoiced amounts growing 25% year-over-year [57][91] Question: Drivers of growth in new logo subscription invoiced amounts - Management indicated that the growth was driven by a combination of larger deals and a successful go-to-market transformation, with a focus on strategic clients [98][97]
Applied Digital (APLD) - 2026 Q2 - Earnings Call Transcript
2026-01-07 23:02
Financial Data and Key Metrics Changes - Revenues for the fiscal second quarter of 2026 were $126.6 million, up 250% from $36.2 million in the prior year [12] - Adjusted EBITDA for the quarter totaled $20.2 million [15] - Net loss was $31.2 million, or $0.11 per share, while adjusted net income was positive $100,000 or $0 per share [15] Business Line Data and Key Metrics Changes - The data center hosting segment generated $41.6 million of revenue, up 15% compared to the prior year, driven by increased capacity online [13] - Turnkey fit-out services associated with the HPC hosting business contributed $73 million to revenue [12] Market Data and Key Metrics Changes - The company has secured two hyperscale leases in North Dakota, representing 600 MW of lease capacity and approximately $16 billion in prospective lease revenue [6] - Inbound demand has increased significantly, with advanced discussions ongoing with another investment-grade hyperscaler across multiple regions [6] Company Strategy and Development Direction - The company aims to surpass its long-term goal of $1 billion in NOI within five years, leveraging low-cost energy and a supportive regulatory environment in the Dakotas [17] - A non-binding letter of intent has been entered to combine Applied Digital Cloud with Exo to form Chronoscale, allowing each to scale independently [20] Management's Comments on Operating Environment and Future Outlook - Management noted that the contracting environment has become more favorable over the past six months, with stable to slightly better pricing and improved contract terms [31] - The company is focused on scaling construction across multiple sites and ensuring timely delivery to customers [49] Other Important Information - The company ended the second fiscal quarter with $2.3 billion in cash and cash equivalents, compared to $2.6 billion in debt [15] - The company is exploring ways to add power to the grid without increasing costs to customers, reinforcing its leadership in data center design [18] Q&A Session Summary Question: Growth appetite in the cloud business and future GPU purchases - Management highlighted the advantage of having access to large-scale data center facilities for deploying accelerated compute, which will benefit the cloud business as it spins out [22][23] Question: Landscape for leases and pricing changes - Management indicated that pricing has been stable to slightly better, with more favorable terms in contracts [30][31] Question: Advanced discussions on new sites - Management confirmed advanced discussions on three sites totaling 900 MW [46][47] Question: Expansion opportunities at PF1 and PF2 - Management stated that each campus has the potential to scale to at least a gigawatt, with a clear path to grow capacity to 5 GW by 2030 or 2031 [72][75]
Resources nection(RGP) - 2026 Q2 - Earnings Call Transcript
2026-01-07 23:02
Financial Data and Key Metrics Changes - Consolidated revenue for Q2 was approximately $117.7 million, reflecting an 18.4% decline year-over-year on a constant currency basis [19][20] - Adjusted EBITDA was $4 million, resulting in a 3.4% adjusted EBITDA margin, despite a GAAP net loss of $12.7 million due to one-time expenses [19][20] - Gross margin decreased to 37.1% from 38.5% in the prior year, impacted by healthcare costs and holiday pay [20][21] Business Line Data and Key Metrics Changes - On-demand segment revenue was $43 million, down 18.4% year-over-year, with segment-adjusted EBITDA at $4.1 million, a margin of 9.5% [25] - Consulting segment revenue declined 28.8% to $42.6 million, with segment-adjusted EBITDA at $4.5 million, a margin of 10.4% [25] - Europe and Asia Pac segment revenue grew 0.6% to $20.1 million, maintaining stable gross margins [25][26] Market Data and Key Metrics Changes - North America saw improved pipeline activity due to expanded go-to-market initiatives, while Europe and Asia Pac segments delivered growth [12][17] - Outsourced services revenue remained steady year-over-year at $9.4 million, with improved gross margins [26] Company Strategy and Development Direction - The company aims to align its cost structure with current revenue levels, refocus on-demand offerings, and scale its consulting business [6][7] - Emphasis on providing relevant skills and solutions to clients at competitive prices to enhance value [6][9] - The integration of Reference Point is expected to enhance collaboration and strengthen focus on CFO Advisory and Digital Transformation [13][14] Management's Comments on Operating Environment and Future Outlook - The management acknowledges a challenging market but believes in the potential for growth due to a large market of client needs [6][11] - Future strategies will focus on improving sales execution and optimizing talent to meet client demands [51][52] - The company expects Q3 revenue to be between $105-$110 million, with gross margins projected at 35%-36% [27][28] Other Important Information - The company has a strong balance sheet with $89.8 million in cash and no outstanding debt, allowing for balanced capital allocation [26] - A reduction in force was executed, impacting 5% of management and administrative headcount, expected to yield annual savings of $6-$8 million [22][23] Q&A Session Summary Question: Areas where AI is impacting finance and accounting roles - Management noted that operational accounting roles are most affected by AI and automation, with ongoing experimentation by clients [31][33] Question: Impact of AI on decision-making - Management clarified that while AI is causing clients to reassess roles, it is not significantly delaying decisions [57][59] Question: Clarification on SG&A expenses - SG&A expenses for Q3 are expected to be $40-$42 million, excluding $6-$7 million in non-cash and restructuring costs [47][49] Question: Impact of healthcare costs on margins - Healthcare costs had a significant impact, estimated at over $1 million, affecting both SG&A and gross margins [48][62] Question: Broader strategic focus for the next 12-24 months - The company will focus on aligning cost structures, enhancing on-demand services, and growing the consulting segment [51][52]
Franklin Covey(FC) - 2026 Q1 - Earnings Call Transcript
2026-01-07 23:00
Financial Data and Key Metrics Changes - Total first quarter reported revenue was $64 million, down 7% from the prior year, driven by an 8% decline in the enterprise division and a 2% decrease in the education division [27] - Adjusted EBITDA was $3.7 million compared to $7.7 million in the previous year, reflecting lower reported revenue and higher SG&A expenses [31] - Cash flows from operating activities were $0.1 million compared to $14.1 million in the previous year, primarily due to timing-related changes in working capital [31] Business Line Data and Key Metrics Changes - The enterprise division generated 74% of the company's overall revenue, with invoiced amounts growing 4% to $45.5 million [32] - Invoiced amounts in North America grew 7% to $34.9 million, and excluding government contracts, it grew 13% [32][33] - The education division's revenue was $16.1 million, 2% lower than the prior year, primarily due to decreased material sales [37] Market Data and Key Metrics Changes - International segment revenue was $11.2 million, down slightly from $11.4 million in the prior year, primarily due to business conditions in China [36] - Excluding China, international segment revenue increased 4%, and licensee revenue increased 8% compared to the first quarter of fiscal 2025 [36] Company Strategy and Development Direction - The company views fiscal 2026 as a year of execution and return to growth, with expectations for significant growth in invoiced amounts and reported revenue in fiscal 2027 [4][42] - Strategic investments in transforming the enterprise North America go-to-market strategy are gaining traction, with a focus on solution selling and bundling content with services [33][21] - The company aims to be the partner of choice for organizations seeking to achieve breakthroughs in performance, emphasizing the importance of human capabilities alongside AI [16][18] Management's Comments on Operating Environment and Future Outlook - Management anticipates strong growth in invoiced amounts in fiscal 2026, particularly in Enterprise North America, with a strong pipeline and significant year-over-year increase in advanced bookings [6][12] - The company expects education to achieve strong growth in both invoiced and reported sales in fiscal 2026, despite the seasonality of revenue recognition [11][39] - Management remains optimistic about the company's ability to deliver sustainable growth, supported by strong client retention and expanding demand for leadership development services [44][45] Other Important Information - The company incurred $3.4 million in restructuring expenses during the first quarter, reflecting efforts to streamline operations [30] - The balance of billed deferred subscription revenue in North America increased 8% to $49.1 million, indicating a solid foundation for future growth [36] Q&A Session Questions and Answers Question: Guidance reaffirmation and adjusted EBITDA timing - Management reaffirmed guidance for the full year, noting that adjusted EBITDA will be more back-end loaded due to the timing of large education contracts [46][47] Question: North American Enterprise sales force performance - The invoiced growth in North American Enterprise was up 7% in Q1, with a significant increase in new logo subscription invoiced amounts growing 25% [49][50] Question: Lifecycle of new logos and attachment rates - The company has seen success in transitioning new logos to client partners, maintaining retention rates and expanding revenue through dedicated focus on customer success [65]
Applied Digital (APLD) - 2026 Q2 - Earnings Call Transcript
2026-01-07 23:00
Financial Data and Key Metrics Changes - Revenues for the fiscal second quarter of 2026 were $126.6 million, up 250% from $36.2 million in the prior year [12] - Adjusted EBITDA for the quarter totaled $20.2 million [16] - Net loss was $31.2 million, or $0.11 per share, while adjusted net income was positive $100,000 or $0 per share [16] Business Line Data and Key Metrics Changes - The HPC hosting business generated $73 million in revenue from turnkey fit-out services, and $12 million from the first CoreWeave lease at Polaris Forge One [13] - The data center hosting segment contributed $41.6 million in revenue, up 15% compared to the prior year, driven by increased capacity online [14] Market Data and Key Metrics Changes - The company has secured two hyperscale leases in North Dakota, representing 600 megawatts of lease capacity and approximately $16 billion in prospective lease revenue [5] - Inbound demand has increased significantly, with advanced discussions ongoing with another investment-grade hyperscaler across multiple regions [5] Company Strategy and Development Direction - The company aims to maintain a competitive advantage in the Dakotas due to low-cost energy and ample land for expansion [7] - Plans to spin out Applied Digital Cloud to form Chronoscale, a dedicated GPU-accelerated compute platform, allowing each business to scale independently [20] - The company is committed to responsible development and community partnerships, investing in initiatives that support local development [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in surpassing the long-term goal of $1 billion in NOI within five years, driven by robust hyperscaler investment exceeding $400 billion annually [18] - The company is focused on maintaining a strong balance sheet and liquidity position to support future investments [16] Other Important Information - The company completed a $2.35 billion private offering of senior secured notes to finance the Polaris Forge One site [12] - The company has a multi-layered financing framework that allows leveraging third-party capital while retaining majority ownership of each site [11] Q&A Session Summary Question: Growth appetite in the cloud business and Chronoscale's future - Management highlighted the advantage of having access to large-scale data center facilities for Chronoscale, which will help attract customers [24] Question: Landscape for leases and pricing changes - Management noted that lease pricing has been stable to slightly better over the past six months, with more favorable contract terms being secured [31] Question: Expansion opportunities at PF1 and PF2 - Management confirmed that each campus has the potential to scale to at least a gigawatt, with a clear path to grow capacity to 5 gigawatts by 2030 or 2031 [72]
Resources nection(RGP) - 2026 Q2 - Earnings Call Transcript
2026-01-07 23:00
Financial Data and Key Metrics Changes - Consolidated revenue for Q2 was approximately $117.7 million, reflecting an 18.4% decline year-over-year on a constant currency basis [16][17] - Gross margin was 37.1%, down from 38.5% in the prior year quarter, with a significant impact from healthcare costs and holiday pay [17][22] - Adjusted EBITDA was $4 million, representing a 3.4% margin, despite revenue falling below consensus [10][16] Business Line Data and Key Metrics Changes - On-demand segment revenue was $43 million, a decline of 18.4% year-over-year, with segment-adjusted EBITDA at $4.1 million, or a 9.5% margin [20] - Consulting segment revenue decreased by 28.8% to $42.6 million, with segment-adjusted EBITDA at $4.5 million, or a 10.4% margin [20] - Europe and Asia Pac segment revenue grew by 0.6% to $20.1 million, maintaining stable gross margins [21] Market Data and Key Metrics Changes - North America saw improved pipeline activity due to expanded go-to-market initiatives, while Europe and Asia Pac segments delivered year-over-year and sequential growth [10][11] - Outsourced services revenue remained steady at $9.4 million, with improved gross margins compared to the prior year [21] Company Strategy and Development Direction - The company aims to align its cost structure with current revenue levels, refocus on-demand offerings, and scale its consulting business to deliver high-value solutions [6][10] - Emphasis on providing relevant skills and solutions to clients at competitive prices to enhance market positioning [5][8] - The integration of Reference Point is expected to enhance collaboration and strengthen focus on CFO Advisory and Digital Transformation [12] Management's Comments on Operating Environment and Future Outlook - The management acknowledges a challenging market environment but believes in the potential for growth due to a large market of client needs [5][6] - Future strategies will focus on improving sales execution, optimizing talent, and enhancing consulting solutions to meet client demands [45][46] - The company expects to see incremental improvements over the next quarters, although significant results may take time [48] Other Important Information - The company has a strong balance sheet with $89.8 million in cash and no outstanding debt, allowing for balanced capital allocation between growth investments and shareholder returns [22] - A reduction in force was executed, impacting 5% of management and administrative headcount, expected to yield annual savings of $6-$8 million [19] Q&A Session Summary Question: Areas of AI impact on finance and accounting roles - Management noted that operational accounting roles are most impacted by AI and automation, with ongoing experimentation in client organizations [26][27] Question: Client decision delays due to AI implementation - Management indicated that while there is uncertainty in the market, it is not significantly causing decision delays; clients are exploring how to leverage AI effectively [52][54] Question: Impact of healthcare costs on gross margins - Healthcare costs had a significant impact, estimated at over $1 million, affecting both gross margin and SG&A [43][57] Question: Future focus areas in consulting - The company will focus on high-demand areas such as financial transformation, technology, and data analytics to enhance consulting capabilities [41][46]
Kura Sushi USA(KRUS) - 2026 Q1 - Earnings Call Transcript
2026-01-07 23:00
Financial Data and Key Metrics Changes - Total sales for Q1 2026 were $73.5 million, up from $64.5 million in the prior year, with comparable sales growth of negative 2.5% [5][10] - Cost of goods sold as a percentage of sales increased to 29.9% from 29% in the prior year quarter, influenced by tariffs [5][11] - Labor costs as a percentage of sales decreased to 32.5% from 32.9% in the prior year, due to operational initiatives [5][11] - Net loss for the quarter was $3.1 million, or negative $0.25 per share, compared to a net loss of $1 million, or negative $0.08 per share in the prior year [12][13] - Adjusted net loss was $2.8 million, or negative $0.23 per share, compared to an adjusted net loss of $1 million, or negative $0.08 per share in the prior year [13] Business Line Data and Key Metrics Changes - The company opened four new restaurants in Q1 2026, with ten more under construction [6] - Restaurant-level operating profit as a percentage of sales was 15.1%, down from 18.2% in the prior year quarter [13] Market Data and Key Metrics Changes - Comparable sales in the West Coast market were negative 2.8%, and in the Southwest market, they were negative 2.7% [10] - Effective pricing for the quarter was 3.5%, with expectations for the second quarter to be 4.5% [10] Company Strategy and Development Direction - The company aims to open 16 new restaurants in fiscal 2026, maintaining an annual unit growth rate above 20% [14] - The company is focusing on aggressive cost management, reducing G&A as a percentage of sales by 80 basis points on an adjusted basis [4] - Marketing efforts include a campaign with Kirby, coinciding with the release of Kirby Air Riders for Switch 2, and the introduction of a reservation system [6][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving qualitative comparable sales for the year, with expectations for positive comps in Q2 [4][23] - The company noted that the first quarter created a strong foundation for growth, with momentum continuing into December [5][23] - Management acknowledged the impact of tariffs on costs but expressed optimism about negotiations with suppliers mitigating some of the pressures [28][81] Other Important Information - The company has $78.5 million in cash and no debt, indicating strong liquidity [13] - General and administrative expenses as a percentage of sales were 13%, down from 13.5% in the prior year quarter [12] Q&A Session Summary Question: Discussion on decoupling the reservation system from loyalty - Management reported that over half of visits by rewards members are through the reservation system, indicating better-than-expected uptake [19] Question: Expectations for Q2 comps - Management expects positive comps for Q2, citing strong performance in November and December [23] Question: Impact of tariffs on food costs - Management indicated that it takes 4-6 months to see the impact of tariff changes on food costs due to inventory cycles [27] Question: Future promotions and collaborations - Management confirmed ongoing promotions with Kirby and upcoming collaborations with Sanrio and Jujutsu Kaisen [88] Question: Long-term growth target - Management did not revise the long-term growth target of 300 units in the U.S. but will provide updates as necessary [78]
Ensysce Biosciences(ENSC) - 2025 FY - Earnings Call Transcript
2026-01-07 18:02
Financial Data and Key Metrics Changes - Ensysce Biosciences has achieved significant progress in the development of its next-generation analgesics, PF614 and PF614 MPAR, with the latter receiving Breakthrough Therapy designation from the FDA in 2024 [13][14] - The company received a second $5 million installment of a multi-year $15 million grant from the National Institute on Drug Abuse to support the development of PF614 MPAR [13] Business Line Data and Key Metrics Changes - The Phase III Pivotal Study for PF614 was initiated mid-year, with subject enrollment starting in December [13][14] - The clinical development of PF614 MPAR has progressed, with parts one and two of a three-part trial completed [14][15] Market Data and Key Metrics Changes - The FDA has provided support for the manufacturing approach of PF614, allowing the company to move towards commercialization scale [14] - The company is working with the FDA to position PF614 MPAR as the first opioid with overdose protection approved for severe pain treatment [15] Company Strategy and Development Direction - Ensysce aims to continue executing the Phase III trial for PF614 and prepare for an NDA submission in early 2026 [16] - The company is expanding its patent portfolios to include novel treatments for opioid use disorder and ADHD [15] Management's Comments on Operating Environment and Future Outlook - Management expressed gratitude for the continued support from stockholders and emphasized the dedication of the team in providing safer medications for pain relief [17] - The financial support from the National Institutes of Health and public markets has positioned the company to enter the last phase of development for its novel opioid analgesic [16] Other Important Information - The company held its 2025 Annual Meeting of Stockholders virtually to ensure safety and accessibility for all stockholders [2] - The preliminary voting results indicated approval for several proposals, including the issuance of shares and the amendment of the Omnibus Plan [19] Q&A Session Summary - No specific questions and answers were documented during the meeting, as the company indicated that any questions submitted by registered stockholders would be answered electronically after the meeting adjourned [21][22]
Ensysce Biosciences(ENSC) - 2025 FY - Earnings Call Transcript
2026-01-07 18:02
Financial Data and Key Metrics Changes - Ensysce Biosciences has had an exceptional year with significant progress in the development of its next-generation analgesics, PF614 and PF614 MPAR, which have received Fast Track and Breakthrough Therapy designations from the FDA respectively [13][14] - The company received a second $5 million installment of a multi-year $15 million grant from the National Institute on Drug Abuse to support the development of PF614 MPAR [13] Business Line Data and Key Metrics Changes - The pivotal trial for PF614 is currently evaluating its analgesic and safety properties in subjects undergoing abdominoplasty, with enrollment initiated in December [14] - Clinical development of PF614 MPAR has progressed with the completion of parts one and two of a three-part trial [14][15] Market Data and Key Metrics Changes - The FDA has provided support for the manufacturing approach of PF614, allowing the company to move towards commercialization scale [14] - The company is working with the FDA to position PF614 MPAR as the first opioid with overdose protection approved for treating severe pain [15] Company Strategy and Development Direction - Ensysce aims to continue executing the phase 3 trial for PF614 and plans to move towards an NDA submission in early 2026 [16] - The company is expanding its patent portfolios to include novel treatments for opioid use disorder and ADHD [15] Management's Comments on Operating Environment and Future Outlook - Management expressed gratitude for the continued support from stockholders and emphasized the dedication of the team in providing safer medications for pain relief [16] - The company is positioned to enter the last phase of development for its novel opioid analgesic, indicating a strong outlook for future market entry [16] Other Important Information - The company has successfully approved several proposals during the annual meeting, including the issuance of shares and the amendment of the Omnibus Incentive Plan [19] - The election of two nominees to the board and the ratification of the independent registered public accounting firm for fiscal year 2025 were also approved [19] Summary of Q&A Session - There were no specific questions or answers documented in the provided content regarding the Q&A session during the meeting.