Financial Data and Key Metrics Changes - Total net revenues for Q1 FY2026 were $18.2 million, down from $34.3 million in Q1 FY2025, reflecting a strategic transition to Sunkist and exiting brokerage operations [15][16] - Agribusiness revenues decreased to $16.8 million from $32.9 million year-over-year [15] - Adjusted net loss was $8.5 million or $0.48 per diluted share, compared to an adjusted net loss of $2.5 million or $0.14 per diluted share in the prior year [20][21] - Operating loss increased to $10.6 million from $5.3 million in the prior year [19] Business Line Data and Key Metrics Changes - Fresh packed lemon sales were $11.9 million, down from $21.2 million, with a decrease in volume to approximately 681,000 cartons sold at an average price of $17.41 per carton [16][17] - No avocado revenue was recorded in Q1 FY2026 compared to $162,000 in the prior year due to harvest timing [17] - Specialty citrus, wine grape, and other revenues increased to $700,000 from $500,000 year-over-year [18] Market Data and Key Metrics Changes - The transition to Sunkist has resulted in a shift in sales cadence, with the first and second quarters being seasonally softer [15][24] - Lemon pricing averaged $17.42 per carton in Q1 FY2026, down from $18.44 in the same period last year, with expectations of pricing recovery as the season progresses [42][43] Company Strategy and Development Direction - The company is focused on sustainable long-term value creation through strategic transformation, including a partnership with Sunkist to enhance customer access and reduce pricing pressure [5][7] - Expansion of avocado production is underway, with 1,600 acres planted and expectations for significant increases in production capacity by FY2027 [8][24] - The company is pursuing real estate development projects with expected proceeds of $155 million over the next five fiscal years [9][24] Management's Comments on Operating Environment and Future Outlook - Management anticipates improvements in financial results throughout FY2026, particularly in the second half of the year [11][24] - The company expects to realize approximately $10 million in annual selling, general, and administrative savings due to the Sunkist partnership [23][24] - Positive weather conditions in California are expected to support avocado growth and production in the coming years [33][34] Other Important Information - The company is actively working on monetizing water rights and has identified significant value in its Colorado River water rights amid ongoing negotiations among states [46][48] - The company has incurred specific costs of $2.5 million in Q1 FY2026, which are considered non-recurring [6][19] Q&A Session Summary Question: On the $10 million in expected SG&A savings, how much will be visible in the first half versus the back half? - Management indicated that the savings will not be linear and will be more visible in Q2, Q3, and Q4, with a total reduction of $10 million expected by the end of the year [29][30] Question: Update on avocado weather conditions? - Management reported ideal weather conditions in California, with good rain and temperatures expected to accelerate fruit growth [33][34] Question: Impact of fruit pricing and weather on lemons? - Management noted that lemon pricing has softened due to market supply but expects it to recover as the season progresses [42][43] Question: Opportunities for monetization of water assets? - Management highlighted ongoing demand for conserved water and the potential value of Colorado River water rights amid state negotiations [46][48]

Financial Data and Key Metrics Changes - For the full year 2025, the net loss was $21 million or $0.62 per basic and diluted share, while the net loss for the fourth quarter was $5.3 million or $0.15 per share, aligning with expectations [26][27] - Net cash used in operating activities was less than $14 million for the full year and just $2.9 million for the fourth quarter, representing a 3% decrease year-over-year and a 30% decrease compared to the same quarter last year [27][28] - Cash and cash equivalents and restricted cash combined totaled $4.4 million at December 31, 2025 [28] Business Line Data and Key Metrics Changes - HeartBeam's initial product, the HeartBeam System, received FDA 510(k) clearance for arrhythmia assessment, marking a significant milestone for the company [5][6] - The company is focusing on a limited commercial launch targeting concierge and preventive cardiology practices, with a target price per patient of $500-$1,000 per year [10][11] - The HeartBeam 12-lead patch is expected to disrupt the ambulatory cardiac monitoring market, which is a $2 billion revenue market [7][18] Market Data and Key Metrics Changes - The company aims to capture a small portion of the 1.5 million Americans currently paying for concierge medicine, focusing on high-net-worth individuals who show a strong willingness to pay for advanced health technology [10][11] - The market research indicates that 86% of physicians would shift a portion of their patches to the 12-lead patch, implying a potential market shift [20][21] Company Strategy and Development Direction - HeartBeam is adopting a staged approach to commercialization, starting with a focused rollout in concierge cardiology and executive health [12][14] - The company plans to validate its model in a concentrated market before scaling to a broader patient base, including direct primary care practices and telehealth networks [11][12] - The strategic collaboration with Mount Sinai aims to combine expertise in clinically annotated ECG data with HeartBeam's signal collection technology [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's trajectory, highlighting the FDA clearance as a de-risking milestone and the potential for significant advancements in 2026 [29][30] - The company expects to achieve cash flow breakeven at approximately 30,000 patients, with a subscription model that has margins above 70% [13][28] Other Important Information - The HeartBeam 12-lead patch is designed to provide better diagnostic capabilities and integrate into existing workflows, leveraging existing reimbursement [19][22] - The company has completed the development of a working prototype of the 12-lead patch and is conducting clinical studies [24][25] Q&A Session Summary Question: Can you talk more about the timeline for the ALIGN pilot study and the patch initiatives? - Management indicated that the ALIGN-ACS pilot study is expected to enroll quickly due to its design and aims to complete by the end of Q3 2026, which will inform the pivotal study [35][36] Question: What does the account pipeline look like for the commercialization strategy? - The company is focusing on several anchor accounts in the first couple of quarters to validate its premium value proposition before scaling [38][40] Question: How should we think about R&D expenses trending in the upcoming quarters? - R&D expenses are expected to step up slightly in the first half of the year due to clinical trials and advanced developments, then return to current levels in the second half [46][48] Question: Are there plans for profit-sharing models as the company expands? - Management is open to exploring profit-sharing models as they expand but is currently focused on establishing a strong engagement with practices [81][84] Question: What are the thoughts on targeting telehealth providers? - The company sees significant opportunities in telehealth, emphasizing the unique capability of providing clinical-grade ECG technology directly to patients [88][90] Question: Can you provide background on the Mount Sinai relationship? - The relationship with Mount Sinai has been built over time through mutual respect and collaboration, leading to a deeper partnership focused on AI algorithms [94]

Financial Data and Key Metrics Changes - Total revenue for the second quarter was $8.3 million, up 18.3% year-over-year, marking the seasonally strongest quarter due to holidays [15] - Advertising revenue increased by 18.3% for the quarter, driven by strong growth in the Zedge Marketplace, despite lower ad revenue at Emojipedia [16] - GAAP loss from operations was $2.9 million, compared to a loss of $2.2 million last year, with a non-cash impairment charge of $3.7 million related to Emojipedia [21] - Non-GAAP net income was $0.8 million, with EPS of $0.06, compared to a loss of $0.2 million and a loss per share of $0.01 last year [21] - Cash flow from operations was $0.9 million, and free cash flow was $0.8 million for the quarter [21] - Cash strengthened to $19.1 million with zero debt, and the company generated solid free cash flow even after investments in innovation [13][22] Business Line Data and Key Metrics Changes - Zedge Marketplace revenue was up over 21% year-over-year, driven by strong advertising and subscription revenue [15] - Zedge Plus subscription revenue increased by 33% year-over-year, with the net active subscriber base growing by 49%, reaching nearly 1.2 million subscribers [17] - Deferred revenue reached $6 million, up 5% sequentially and 39% year-over-year, reflecting future revenue with a 100% gross margin [17] - Zedge Premium GTV was up 15.7% from the year-ago quarter, and ARPM increased by 47.6%, indicating improved monetization efficiency [18] Market Data and Key Metrics Changes - The company is experiencing MAU contraction but is focused on acquiring higher-value users and monetizing the audience more effectively [5] - The digital goods and services revenue includes contributions from both GuruShots and DataSeeds.AI, with the majority generated by GuruShots at this stage [19] Company Strategy and Development Direction - The company aims to strengthen monetization in the marketplace, build DataSeeds deliberately, and expand the innovation pipeline in a disciplined manner [14] - The operational focus is on building a high-quality outbound pipeline and better qualifying inbound requests to ensure long-term credibility in the enterprise market [9] - The company is exploring multimodal data, including images, audio, and video, to enhance its offerings [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the quality of monetization improving, leading to record results, and highlighted the importance of investments in ad inventory and subscription offerings [5] - The appetite for AI training data is described as insatiable, with the company focusing on productizing offerings to meet the needs of model builders [7] - Management acknowledged structural headwinds tied to the evolving field of search, particularly affecting Emojipedia, but noted that the business remains profitable [12] Other Important Information - The company launched two more alpha products, bringing the total to four out of six planned for the fiscal year, with a focus on modular development to accelerate product delivery [11][32] - The company is paying a quarterly dividend while continuing to invest in innovation and share repurchases when market conditions are favorable [22] Q&A Session Summary Question: Can you walk us through the DataSeeds pipeline and margin perspective? - Management indicated that the progression of a deal depends on the success of proof of concept, with margins being attractive but variable based on deal type [26][28] Question: How are you thinking about multimodal data? - The company is focusing on multimodal data, including images, audio, and video, with completed proof of concept on the video side and discussions on audio work [30] Question: Can you comment on the new alpha products? - The new products are being built on an evolving foundation to allow for modular development and faster market entry, with ongoing refinement in selecting what to produce next [31][32] Question: What is driving the momentum in subscription revenues? - The ongoing investment in optimizing subscription offerings and targeting prospective subscribers is driving the momentum [34] Question: What is driving the success of the Zedge Marketplace? - The fiscal Q2 coincides with year-end advertising spend, and efforts in data science to better segment users have contributed to the marketplace's success [36][38] Question: How is the Tapedeck product progressing? - The KPIs for Tapedeck are trending positively, with a focus on expanding the music catalog to attract users [42]

Financial Data and Key Metrics Changes - Consolidated revenue for 2025 was $493 million, a 3% increase from $480 million in 2024 [19] - Gross margin improved to 7% of revenue in 2025, up from a negative 12% in 2024, reflecting a $90 million increase in total gross margin [19] - Adjusted EBITDA for 2025 was $5 million, a significant improvement from a loss of $61 million in 2024 [20] Business Line Data and Key Metrics Changes - Revenue from Shimmick projects was $395 million in 2025, a 12% increase year-over-year, representing 75% of total revenue [2][19] - Non-core project revenue decreased to $96 million in 2025 from $125 million in 2024, indicating a focus on winding down low-margin projects [3][19] - Gross margin for Shimmick projects was 10% in 2025, a 400 basis point improvement from 2024 [3] Market Data and Key Metrics Changes - The backlog grew to $793 million at the end of 2025, with a book-to-burn ratio of 1.4x, indicating strong demand [18][20] - The company expects a robust pipeline supporting $600 million to $1 billion in bidding volumes per month [7] - New awards booked during Q4 2025 were $135 million, reflecting a sequential increase of over $39 million from Q3 2025 [18] Company Strategy and Development Direction - The company is focused on three strategic pillars: growing the top line, winding down legacy low-margin projects, and driving operational improvements [2][24] - The strategy includes diversifying the customer base and focusing on growth markets geographically to lower risk [4] - The company aims to enhance its competitive position by pursuing collaborative delivery methods and improving operational efficiency [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026, expecting revenue growth between 12% and 22%, with adjusted EBITDA projected to increase by 200% to 500% [22] - The market environment remains healthy, with a strong backlog and a healthy pipeline of new work [11][24] - Management acknowledged challenges from weather-related delays but remains confident in the execution of new projects [21] Other Important Information - The company ended 2025 with total liquidity of $44 million, consisting of $20 million in cash and $24 million available under credit agreements [18] - The attrition rates have improved, reflecting efforts to enhance employee experience and retain top talent [11] Q&A Session Summary Question: How does the mix of projects impact margins going into 2026? - Management expects gross margins to increase, influenced by the mix of projects, with a focus on maintaining efficient SG&A expenses [30][32] Question: What is the visibility on overall spend and macro environment across territories? - Management noted strong activity in California and Texas, with no shortage of opportunities in the next 12-24 months [34] Question: What is the guidance for 2026, especially regarding EBITDA and non-core revenue? - Management indicated that non-core work is expected to be minimal, with a focus on new work generating revenue and margins [44]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10.9 million, marking a 23% year-over-year growth, and full-year revenue reached $41.1 million, a 22% increase from $33.6 million in 2024 [9][22][23] - The company achieved positive cash flow from operations for both Q3 and Q4, and for the full year, with cash ending at $8.9 million [11][25] - Gross margin for the full year was 62.3%, with a slight reduction of 30 basis points year-over-year due to higher material costs [24][25] Business Line Data and Key Metrics Changes - Domestic core business grew 18% year-over-year in Q4, while international core business saw a significant growth of 71% [9][22] - The PST business decreased by 30% year-over-year, attributed to the timing of contract milestones [22][23] - The recurring global patient base increased by approximately 20% to 59,000 chronic SCIG patients [14] Market Data and Key Metrics Changes - The SCIG market grew approximately 10% in 2025, with KORU's domestic and international core businesses outperforming this growth [9][12] - In Europe, KORU's market share increased from 10% to 20%, with a total addressable market of approximately $50 million [16][35] - The company anticipates significant growth opportunities in the oncology market with the entry of new drugs [29][68] Company Strategy and Development Direction - KORU is focused on three strategic pillars: protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients [12][62] - The company is diversifying its business with new drug collaborations and entering new therapeutic areas, including oncology [10][15] - The shift from hospital to home care is seen as a significant opportunity for large volume subcutaneous infusion [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, projecting 2026 revenue guidance of $47.5 million to $50 million, representing a growth of 15%-22% [11][26] - The company is prepared for geopolitical risks and anticipates a ramp-up in revenue in the second half of 2026 [27] - Management highlighted the importance of operational excellence programs to maintain margins and manage costs effectively [28] Other Important Information - Linda Tharby announced her retirement effective June 30, 2026, with Adam Kalbermatten set to succeed her as CEO [4][5] - The company received EU MDR certification for the Freedom60 system, enabling the conversion from vials to prefilled syringes [10][16] Q&A Session Summary Question: What does the Freedom60 product do for the market? - The Freedom60 product opens up a $50 million total addressable market in Europe, with significant share gain potential [35][36] Question: Can you provide more detail on the guidance composition? - The guidance range is influenced by the speed of prefill conversions and new drug approvals, with potential impacts from geopolitical factors [64][66] Question: How is the company positioned in Japan? - Japan is seen as a significant market opportunity, with both pumps and consumables approved, and potential growth driven by prefilled syringes [68][70]

Financial Data and Key Metrics Changes - In Q4 2025, net sales decreased by 20.6% to $87.7 million compared to $110.5 million in Q4 2024 [14] - Full-year net sales were down 6.7%, totaling $368.3 million in 2025 versus $394.9 million in 2024 [14] - Adjusted non-GAAP profit for Q4 2025 was $26.1 million, or 29.7% of sales, up from 28.4% in Q4 2024 [15] - Full-year adjusted non-GAAP net income was $4.2 million, or $0.31 per share, compared to a loss of $0.6 million, or $0.05 per share in 2024 [19] Business Line Data and Key Metrics Changes - Connected Home channel sales increased by $17.1 million, or 15.8%, to $125.4 million in 2025, driven by new orders in climate control and HVAC [14] - Home entertainment sales decreased by $43.7 million, or 15.2%, to $242.9 million for the full year [15] - In Q4 2025, home entertainment sales were down 23.8% to $58 million, reflecting lower demand for subscription broadcasting products [15] Market Data and Key Metrics Changes - The company noted a slowdown in the connected home market, which began in the second half of 2025, due to industry consolidation in HVAC and shifts in retail demand in Europe [9] - Customer forecasts and orders indicated that revenue inflection in the connected home segment would take longer than expected [10] Company Strategy and Development Direction - The company is focused on restructuring to align with the revenue and margin profile expected for 2026, which includes a reduction in force and cost reductions across various areas [11] - The strategy emphasizes optimizing R&D and portfolio focus on high-revenue and high-margin opportunities [11] - The company aims to improve operational efficiency, strengthen profitability, and generate more free cash flow as part of its long-term strategy [22] Management Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in the home entertainment business and the slower-than-expected growth in the connected home segment [8] - The company is adopting a conservative outlook for 2026, expecting a decline in revenue due to market headwinds [20] - Management emphasized the importance of maintaining operational discipline and focusing on profitability amid economic uncertainties [9][22] Other Important Information - The company achieved a positive net cash position for the first time since 2021, with a net cash balance of $8.2 million [19] - The company plans to provide adjusted non-GAAP diluted profit per share guidance in the range of $0.45-$0.65 for 2026 [21] Q&A Session Summary Question: Guidance for 2026 revenue decline - Management could not specify the exact decline percentage but emphasized a focus on improving cash flow and profits [24] Question: Details on expense reductions - Management indicated that significant operating expenses would be reduced holistically to align with revenue [25] Question: Size of the reduction in force (RIF) in Q4 - The RIF in Q4 involved approximately 50 employees [26] Question: Percentage of headcount affected by RIF - Management did not provide a specific percentage but indicated that transitions would occur over time [27][28] Question: Licensing revenue sources in Q4 - Licensing revenue in Q4 was primarily from the traditional home entertainment business, with plans to expand in connected home [31]

Financial Data and Key Metrics Changes - In 2025, Nephros achieved a total revenue of $18.8 million, reflecting a 33% increase from $14.2 million in 2024 [9][10] - The net income for 2025 was approximately $1.2 million, marking the second consecutive year of profitability, compared to $0.1 million in 2024 [13] - The gross margin for the full year remained stable at 62%, while the fourth quarter gross margin was 58%, down from 64% in Q4 2024, primarily due to tariff impacts [11][12] Business Line Data and Key Metrics Changes - Active customer sites grew to over 1,680 by the end of 2025, up from just over 1,500 at the end of 2024, indicating strong customer retention and outreach efforts [10][20] - Programmatic sales accounted for over 90% of total revenues in both the fourth quarter and the full year, with emergency response contributing to growth in the high single digits [22][25] Market Data and Key Metrics Changes - The company is expanding its market reach beyond healthcare into commercial sectors such as hospitality and food services, driven by increased awareness of waterborne pathogens and regulatory expectations [9][28] - Nephros is focusing on non-patient care applications, including correctional facilities, schools, and aviation facilities, where water safety is critical [41][42] Company Strategy and Development Direction - Nephros' strategy is built around three core pillars: products, services, and education, aimed at establishing the company as a leader in water safety solutions [5][8] - The company is developing channels to penetrate new markets through key relationships and educational initiatives, addressing the need for reliable filtration solutions [4][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's positioning at the intersection of several trends, including increased regulatory expectations and aging infrastructure [9][10] - The focus on education is seen as crucial for overcoming barriers to market entry in non-healthcare sectors, with a multi-year strategy to build these verticals [30][31] Other Important Information - Nephros remains debt-free with approximately $5.4 million in cash at year-end 2025, reflecting financial discipline [10][15] - The company has launched the Nephros Water Institute to enhance knowledge around waterborne pathogen mitigation and compliance-driven filtration solutions [8] Q&A Session Summary Question: What percentage of revenues for the fourth quarter and the full year were programmatic sales? - Programmatic sales accounted for over 90% of the business in the fourth quarter and for the full year, with emergency response contributing in the high single digits [22][25] Question: Can you discuss the pipeline potential outside of medical in the commercial space? - The company is focusing on educating different markets about the importance of water safety, which is expected to drive growth in non-medical applications [27][28] Question: Can you elaborate on some of the successes in newer markets? - Successes have been noted in correctional facilities, schools, and aviation facilities, where large populations are at risk of waterborne pathogens [41][42]

Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $82.4 million, a decrease of 1.3% year-over-year, but an improvement from the double-digit decline in Q3 [10] - Consumables revenue increased to $57.7 million from $56.7 million, representing a growth of 1.7% year-over-year [10] - Device revenue was $24.7 million, down 7.9% year-over-year, but showed improvement compared to Q3 [10] - Adjusted gross margin expanded to 67.4%, while GAAP gross margin increased to 64.4% [11] - Adjusted EBITDA for Q4 was $15 million, up from $9 million in the prior year, marking a significant margin expansion [11] - For the full year, net sales were $300.8 million, down from $334.3 million in 2024, with adjusted EBITDA increasing to $45.1 million from $12.3 million [21][22] Business Line Data and Key Metrics Changes - The company placed over 1,000 devices in Q4, ending the year with over 36,000 systems in the global install base [12] - The installed base is viewed as underutilized, with potential for significant consumables revenue growth through improved utilization [12] Market Data and Key Metrics Changes - The U.S. med spa market has grown from approximately 1,600 locations in 2010 to over 13,000 today, indicating a significant market expansion [7] - Consumer demographics are evolving, with increased engagement from men, Gen Z, and younger consumers seeking skin health treatments [7][8] Company Strategy and Development Direction - The company aims to shift from a device placement model to a device utilization model to drive long-term growth [9] - Key strategic priorities include salesforce excellence, marketing discipline, and focused innovation [14] - The company plans to enhance its commercial model by improving provider education and marketing strategies [16][18] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the demand for non-invasive treatments, despite macroeconomic pressures affecting capital equipment sales [12][39] - The first half of 2026 is expected to be modestly below the prior year, with a stronger trajectory anticipated in the second half [25][28] - The company expects to return to growth in 2027 as operational changes take effect [19][28] Other Important Information - The company has strengthened its balance sheet and improved its cost structure, exiting 2025 in a stronger position than the previous year [20] - The average spend per treatment in the U.S. for consumables is up 10% year-over-year, driven by premium boosters [62] Q&A Session Summary Question: Guidance for 2026 and sales organization overhaul - Management expects revenue to be flat year-on-year, with Adjusted EBITDA slightly below 2025 due to reinvestment in R&D [32][33] Question: Underlying market environment assumptions - Consumer spending remains selective, with a focus on clinically proven results; the aesthetics category has faced pressure due to credit tightness [38][39] Question: Churn trends and marketing to new demographics - Churn improved in Q4 to about 1.1%, with expectations to hold flat year-over-year; marketing strategies are being adjusted to target new demographics [46][49] Question: New system launch timeline and features - The next-generation HydraFacial is planned for launch in 2028, aimed at providing compelling reasons for upgrades [55] Question: Consumables performance and pricing strategy - A 5% price increase on consumables was well-received, and the company is evaluating overall pricing strategy moving forward [76]

Financial Data and Key Metrics Changes - For the full year 2025, the net loss was $21 million or $0.62 per basic and diluted share, while for Q4, the net loss was $5.3 million or $0.15 per share, aligning with expectations [33] - Net cash used in operating activities was less than $14 million for the full year and just $2.9 million for Q4, representing a 3% decrease year-over-year and a 30% decrease compared to the same quarter last year [33] Business Line Data and Key Metrics Changes - HeartBeam achieved FDA 510(k) clearance for its 12-lead synthesis software in December 2025, marking a significant milestone for the company [5][6] - The company is focusing on a limited commercial launch targeting concierge and preventive cardiology practices, with a target price per patient set between $500 and $1,000 per year [12][17] Market Data and Key Metrics Changes - The ambulatory cardiac monitoring market is valued at $2 billion, with HeartBeam's technology expected to disrupt this market through its innovative 12-lead patch [7][23] - 86% of physicians indicated they would shift a portion of their patches to the HeartBeam 12-lead patch, suggesting a potential market shift [25] Company Strategy and Development Direction - HeartBeam's strategy includes a phased rollout starting with concierge cardiology and executive health, aiming to validate adoption before expanding to a broader market [14][15] - The company is also developing AI algorithms to enhance the diagnostic capabilities of its devices, with a strategic collaboration announced with Mount Sinai to leverage clinically annotated ECG data [30][100] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's trajectory, highlighting the importance of the recent FDA clearance and the potential for significant advancements in 2026 [36][37] - The company aims to achieve cash flow breakeven at approximately 30,000 patients, with a subscription model expected to yield margins above 70% [17][34] Other Important Information - HeartBeam has developed a working prototype of its 12-lead patch, which is currently undergoing clinical studies [26][32] - The company has demonstrated access to capital markets and continues to have multiple vehicles available for funding [34] Q&A Session Summary Question: Can you talk about the timeline for the ALIGN pilot study and the patch initiatives? - Management indicated that the ALIGN-ACS pilot study is expected to enroll quickly due to its design, with completion anticipated by the end of Q3 2026 [42][43] Question: What does the account pipeline look like for the commercialization strategy? - The focus is on a small number of anchor accounts initially, with plans to validate the premium value proposition before scaling [45][48] Question: How should we think about R&D expenses trending in the coming year? - R&D expenses are expected to step up slightly in the first half of the year due to clinical trials, then return to current levels in the second half [55][56] Question: Are there plans for profit-sharing models as the company expands? - Management is open to exploring profit-sharing models as the company scales, but currently focuses on a straightforward subscription model [87][90] Question: What are the thoughts on targeting telehealth providers? - There is significant interest in partnerships with telehealth providers, as HeartBeam's technology offers clinical-grade ECG capabilities that are currently lacking in the market [91][95]

Financial Data and Key Metrics Changes - The company reported a net income of $3.8 million for Q4 2025, translating to $0.06 per share, while the full-year net loss was $84.9 million or $1.81 per share [25][26] - Total operating expenses decreased from $112.6 million in 2024 to $86.9 million in 2025, marking a 23% reduction [25] - Cash equivalents and short-term investments decreased from $94.1 million at the end of 2024 to $58.5 million at the end of Q4 2025 [25] Business Line Data and Key Metrics Changes - The primary focus remains on advancing INO-3107 towards FDA approval, with significant resources allocated to this lead candidate [5][24] - The company has also advanced its DNA medicine platform, including promising phase 1 proof of concept data for dMAb technology [21] Market Data and Key Metrics Changes - The market for recurrent respiratory papillomatosis (RRP) treatment is characterized by a significant burden on patients, with many requiring numerous surgeries throughout their lives [15] - Market research indicates that INO-3107 could become the preferred treatment option based on its efficacy and tolerability [16] Company Strategy and Development Direction - The company is focused on optimizing resources to extend its cash runway towards the October 30, 2026 PDUFA date for INO-3107 [24][60] - Strategic partnerships are being leveraged to advance other promising candidates in the pipeline, including collaborations in glioblastoma research [8][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in INO-3107's ability to meet an unmet medical need and provide a meaningful therapeutic benefit over existing treatments [7][11] - The company is preparing for a meeting with the FDA to discuss the BLA for INO-3107 and is awaiting feedback on an updated protocol for a confirmatory trial [10][30] Other Important Information - The company has reduced headcount by approximately 15% to conserve financial resources [24] - The FDA has accepted the BLA for INO-3107 under the Accelerated Approval Program, with a standard review timeline of 10 months [5][9] Q&A Session Summary Question: Additional data needed for FDA conversations regarding accelerated approval - Management confirmed that no new clinical data is required, but they have submitted new documentation to the FDA [30] Question: Impact of a potential priority review on launch preparations - The focus is currently on ensuring alignment with the FDA for accelerated approval, with commercial preparations well advanced [34][35] Question: Feedback from KOLs and patients on recent publications - Research indicates a strong preference for INO-3107 based on its efficacy and tolerability, with significant reductions in surgeries reported by patients [37][38] Question: Incorporating learnings from competitor's rollout into distribution strategy - The company is learning from competitor experiences and ensuring that their distribution strategy is well-prepared for launch [42][44] Question: Biological rationale of the dual PD-1/CTLA-4 blockade in partnership with Akeso - The combination aims to enhance immune responses against tumor-associated antigens, building on previous encouraging data [48][49] Question: Plans for INO-3112 if INO-3107 is approved - The company plans to focus resources on INO-3107 first, with potential to advance INO-3112 following approval and available financial resources [55]