Financial Data and Key Metrics Changes - The company provided forward-looking statements regarding its potential future business operations and performance, particularly in the treatment of neurodegenerative disorders such as ALS [2] - There is an emphasis on the sufficiency of the company's existing capital resources for continuing operations in 2025 and beyond [2] Business Line Data and Key Metrics Changes - Specific financial data and metrics for different business lines were not disclosed in the provided content [1] Market Data and Key Metrics Changes - The company discussed the market potential for the treatment of neurodegenerative disorders, indicating a focus on this area for future growth [2] Company Strategy and Development Direction - The management highlighted the importance of developing strategic collaborations and partnerships to support business planning efforts [2] - The company is focused on the safety and clinical effectiveness of the NurOwn technology platform and its related clinical development programs [2] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the numerous risks and uncertainties that could affect the company's results, which are beyond its control [2] - There was no specific commentary on the current operating environment or future outlook provided in the content [1] Other Important Information - The call included a reminder that forward-looking statements are subject to risks and uncertainties, and the company undertakes no obligation to publicly update these statements [2] Q&A Session Summary - No specific questions or answers from the Q&A session were provided in the content [1]

Financial Data and Key Metrics Changes - The combined net revenue for Q2 2025 was approximately $3 million, representing a 35% increase compared to Q1 2025 and a 10% increase compared to Q2 2024 [6][29] - Loss from operations increased by $800,000 from $7.2 million in Q2 2024 to $8 million in Q2 2025 [30] - Net loss attributable to common shareholders increased by approximately $900,000 from $9.5 million in Q2 2024 to $10.4 million in Q2 2025 [30] Business Line Data and Key Metrics Changes - Mytesi prescription volume increased by approximately 6.5% in 2025 compared to 2024, with Q2 2025 volume equal to Q2 2024 [29] - The company is focusing on business development partnerships for licensing rights to its products, aiming to generate non-dilutive funding [7] Market Data and Key Metrics Changes - The company is conducting trials for Crofelimer in pediatric patients with MVID and short bowel syndrome, with initial results showing significant benefits [10][11] - The prevalence of MVID is estimated to be just a couple of hundred patients globally, indicating a niche market opportunity [12] Company Strategy and Development Direction - The company aims to seek business development partnerships to enhance funding opportunities during a period of reduced investor support for emerging pharma companies [7] - The strategy includes expanding the indication of Crofelimer for cancer therapy-related diarrhea, targeting metastatic breast cancer patients [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the convergence of key clinical and regulatory catalysts in 2025, which are expected to enhance value for stakeholders [6][31] - The company is preparing to submit a protocol to the FDA for a pivotal treatment trial for Crofelimer in metastatic breast cancer patients [23] Other Important Information - The company is also pursuing regulatory approval for Canalevia, a product for chemotherapy-induced diarrhea in dogs, with plans to expand its indication [25][26] - The company is in discussions with potential partners for both human and animal health products [26] Q&A Session Summary - No specific questions or answers were recorded in the provided content, indicating that the session may have concluded without a formal Q&A segment [34]

Protalix BioTherapeutics (PLX) Q2 2025 Earnings Call August 14, 2025 08:30 AM ET Speaker0Good morning, ladies and gentlemen, and welcome to the Protalix Biotherapeutics Second Quarter twenty twenty five Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host Mr. Mike Moyer with LifeSci Advisors. You may begin your conference.Speaker1Thank you, operator, and welcome to the Protalix Biotherapeutics Second Quarter twenty ...

Financial Data and Key Metrics Changes - The company reported an adjusted EBITDA of INR 27.2 billion, representing a 43% year-over-year growth [6] - Profit after tax for the quarter was INR 5.1 billion, exceeding the profit for the entire fiscal year 2025 [6] - The leverage at the operating asset level was around 5.7 times EBITDA, which is below the six times threshold set by the company [14] Business Line Data and Key Metrics Changes - The manufacturing business produced 900 megawatts of modules and 400 megawatts of cells in the quarter, contributing INR 5.3 billion to adjusted EBITDA [7][10] - The operational capacity of the manufacturing business is 6.4 gigawatts for modules and 2.5 gigawatts for cells [7] - The company revised its FY 2026 adjusted EBITDA guidance from the manufacturing business upwards to INR 8 billion to 10 billion [8] Market Data and Key Metrics Changes - The company commissioned around 2.25 gigawatts of renewable energy capacity, marking a 23% growth in its portfolio after adjusting for asset sales [5] - Year-to-date, the company has commissioned more than 700 megawatts, with over 650 megawatts of solar capacity and about 50 megawatts of wind [9] Company Strategy and Development Direction - The company aims to be a global leader in clean energy and is focused on improving margins and capital discipline to create shareholder value [4][5] - The company plans to complete the construction of 1.6 to 2.4 gigawatts of capacity in fiscal 2026 and is selective in bidding for future growth [6][23] - The company is committed to its ESG initiatives, having reduced Scope one and Scope two emissions by 18.2% from the FY 2022 baseline [8][17] Management's Comments on Operating Environment and Future Outlook - Management noted that while there are factors beyond their control, they remain focused on executing their strategy and improving operational efficiency [5] - The bidding environment is steady, with the government aiming for 500 gigawatts by 2030, but competition has become more irrational, affecting win ratios [32][33] - Management expressed optimism about signing PPAs from the current pipeline in the fiscal year [9] Other Important Information - The company received a final, revised non-binding offer at USD 8 on July 3, with ongoing discussions expected to update shareholders by September 30, 2025 [14] - The company secured a significant investment from British International Investments for over USD 100 million for a 10% stake in the solar manufacturing business [10] Q&A Session Summary Question: Inquiry about manufacturing business production volumes - The company sold almost 700 megawatts of modules to third parties in Q1 FY 2026, with a balance used for internal consumption [28] Question: Expectations for the back half of the year regarding sales - The company anticipates continued contribution from third-party sales throughout the year, with visibility on guidance provided [31] Question: Update on the bidding environment - The bidding environment remains steady, with the government auctioning 50 to 70 gigawatts annually, but competition has become more aggressive [32][33] Question: Key issues facing the renewable sector - Management noted occasional delays in transmission infrastructure and land acquisition as key issues, but overall capacity addition is proceeding at a reasonable pace [43][44] Question: Participation in recent ammonia tenders - The company did not participate in the ammonia tenders due to concerns over contract structures and the need for selective bidding [51][52]

Cellectar Biosciences (CLRB) Q2 2025 Earnings Call August 14, 2025 08:30 AM ET Speaker0Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen only mode. Following the presentation, we will conduct a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Ann Marie Fields, Managing Director at Precision AQ.Please go ahead.Speaker1Thank you, operator. Good morning, and welcome ...

Financial Data and Key Metrics Changes - The company reported net product sales of $9.7 million for Q2 2025, representing a 33% increase year-over-year and a 10% increase sequentially, marking the highest quarterly net product sales in the company's history [14][20][24] - Total cash operating expenses for the quarter were approximately $11 million, an increase of roughly $2 million compared to Q1 2025, driven by ongoing investments in marketing and additional headcount [22][24] Business Line Data and Key Metrics Changes - The company achieved three consecutive quarters of growth in Pedmark sales, with the addition of 14 new accounts in Q2, including large community oncology groups [15][20] - The company is focused on establishing Pedmark as the standard of care for cisplatin-induced ototoxicity (CIO) prevention, with positive feedback from existing accounts strengthening confidence in clinical value [10][11] Market Data and Key Metrics Changes - The AYA (adolescent and young adult) market is identified as significantly larger than the pediatric market, with approximately 20,000 patients treated with cisplatin in that demographic [31] - The company is seeing strong momentum in both large community practices and academic centers, indicating a growing recognition of the need for Pedmark [9][10] Company Strategy and Development Direction - The company aims to stabilize the business and build a foundation for sustainable growth, focusing on increasing awareness and adoption of Pedmark [6][8] - The strategic imperatives include enhancing patient support services, cementing Pedmark as the standard of care, and expanding educational efforts beyond oncologists to other healthcare professionals [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the scalability of the business model and the growing demand for Pedmark, anticipating significant quarterly growth in 2025 [20][21] - The company is optimistic about the partnership with Norgene in the EU, expecting to provide updates on milestones and royalties in future quarters [21][40] Other Important Information - The company has made significant progress with payers and providers to ensure smoother coverage and fewer barriers for treatment sites [12] - The company plans to ring the closing bell at NASDAQ on September 5, 2025, symbolizing its mission to help patients [14] Q&A Session Summary Question: Can you share the active prescribers number, particularly within AYA? - The company does not disclose cumulative active prescriber numbers but acknowledges the importance of protecting relationships with accounts [28][30] Question: What is the mix of new and repeat customers? - Initially, the company focused on new customers, but there is now a shift towards a higher percentage of repeat customers as the business grows [44][46] Question: Can you elaborate on the Japanese market opportunity? - Japan represents about a third of the size of the U.S. and Europe in terms of CIO usage, with ongoing discussions about regulatory approaches and potential partnerships [49][50] Question: What are the expectations for operating expenses in the second half of the year? - The company expects cash operating expenses to decrease in the second half of the year, consistent with previous years [55][56] Question: How proactive has the FDA been regarding compliance with guidance on Pedmark? - The FDA has been supportive of the use of Pedmark and continues to emphasize its status as the only FDA-approved product for preventing cisplatin-induced hearing loss [70][71] Question: What is the timeline for the Norgene partnership in the EU? - The Norgene partnership has launched in the UK and is expected to expand to other EU markets early next year, with significant enthusiasm for the product [74][75]

Marpai (MRAI) Q2 2025 Earnings Call August 14, 2025 08:30 AM ET Speaker0Good morning, and welcome to the Marpay Second Quarter twenty twenty five Earnings Webcast. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Steve Johnson, Chief Financial Officer.Please go ahead.Speaker1Thank you, and welcome this morning to our Marpay Second Quarter Earnings ...

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was approximately $13.2 million, down from approximately $17 million in the same period last year, representing a decline of about 22% [7] - Year-to-date revenue was approximately $27.8 million compared to approximately $34.5 million for the same period last year, indicating a decrease of about 19% [7] - Gross profits from the healthcare segment decreased to approximately 20% in 2025 from 35% in 2024, primarily due to decreased prescription volume and changes in 340B revenue [10] - Gross profits from the e-commerce segment decreased to approximately 26% in 2025 from 32% in 2024, attributed to new airtime costs and temporary rate reductions for some customers [10] - Cash position at the end of Q2 was approximately $16.6 million [11] Business Line Data and Key Metrics Changes - Healthcare operations revenue declined due to decreased pharmacy prescription volume and changes in provider relationships [8] - E-commerce operations experienced an increase in revenue driven by growth in recurring airtime revenue and hardware sales [9] Market Data and Key Metrics Changes - E-commerce sales in China showed steady progress, limited by inventory import capabilities [4] - The tariff situation in the U.S. remains volatile, affecting operations in Florida [4] Company Strategy and Development Direction - The company is focused on refining healthcare operations, including personnel changes and improving operational efficiency [13] - New hires include pharmacy operations managers to enhance long-term growth and strategic planning [14] - The company is pursuing specialty pharmacy accreditation to access new revenue sources [15] Management Comments on Operating Environment and Future Outlook - Management acknowledges challenges in healthcare operations but sees potential for growth through cost reductions and operational efficiencies [5] - The company is committed to transparency and proactive steps to address challenges and invest for long-term success [16] Other Important Information - The company has not yet repurchased any shares under its repurchase program but plans to be active in the coming quarter [17] - The company is closely monitoring compliance with NASDAQ requirements and is prepared to utilize the grace period if necessary [18] Q&A Session Summary Question: What is the status of the buyback? - The company has not repurchased any shares yet but expects to be active in the coming quarter while being prudent with cash deployment [17] Question: What is the plan to regain compliance with NASDAQ? - The company is monitoring the situation and believes that executing strategic developments will be central to regaining compliance [18] Question: Should the company consider closing its business in China? - The company acknowledges tariff challenges but sees potential in the OpCo products and plans to launch animal health products in China [19]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $5.7 million, up from $5.1 million in Q2 2024, reflecting a 43% sequential growth and an increase year over year [10] - Gross profit for the quarter was $1.3 million, representing 23.5% of revenue, compared to $400,000 or 8.8% in the prior year period, indicating a significant margin increase [11] - Net loss for Q2 2025 was $13.3 million or $1.23 per share, compared to a net loss of $6.3 million or $0.68 per share in the same period last year [12] Business Line Data and Key Metrics Changes - NexoBrid reported a 52% year-over-year revenue growth in Q2 2025, driven by increases in hospital unit orders and the number of ordering centers [8] - Research and development expenses rose to $3.5 million in Q2 2025 from $1.9 million in Q2 2024, primarily due to investments in the EscharEx VALUE Phase III study [11] Market Data and Key Metrics Changes - The EscharEx VALUE Phase III trial is actively enrolling patients, aiming to enroll 216 patients across 40 sites in the U.S. and Europe [5] - The commissioning of the new manufacturing facility is on track for completion by year-end 2025, which is critical for supporting global growth [9] Company Strategy and Development Direction - The company remains focused on three core objectives: advancing the EscharEx VALUE Phase III trial, completing the commissioning of the expanded manufacturing facility, and building global recognition of EscharEx through clinical collaborations and publications [17] - The company has established new collaborations with ConvaTec and SCT to support ongoing trials, reinforcing the validation of EscharEx within the wound care ecosystem [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving several key milestones over the next twelve months, which are expected to advance strategic and financial objectives [5] - The company noted that the demand for NexoBrid is rising, and they are addressing capacity issues to support global growth [67] Other Important Information - The company received an additional $3.6 million in non-dilutive funding from the U.S. Department of Defense, bringing total program funding to $18.2 million [9] - As of June 30, 2025, the company had $32.9 million in cash and cash equivalents, down from $43.6 million at the end of 2024 [14] Q&A Session Summary Question: Are there any upcoming publications to be aware of? - Management indicated that there are several publications planned, particularly focusing on diabetic foot ulcer trials, with expectations for additional publications around major conferences [20] Question: Can you provide an update on the head-to-head trial versus Santyl? - The randomized study comparing EscharEx directly to collagenase is on track, with plans to enroll 45 VLU patients [21] Question: What is the status of the U.S. facility and BARDA funding? - The U.S. facility planning is fully funded by BARDA, and the company is preparing for the next steps in discussions with the U.S. government regarding the facility's funding [23][24] Question: How is the patient recruitment for the VALUE study progressing? - Enrollment is progressing well, with most U.S. sites active and recruiting, while European site activation is slightly slower due to regulatory timelines [41] Question: What areas are underserved for NexoBrid? - Demand is substantial across all regions, and the company is focused on meeting guidance for upcoming years, with expectations for better clarity on demand after the new facility is completed [46] Question: What are the expected timelines for the new NexoBrid facility? - The company expects to file for regulatory approvals in the EU and the U.S. in 2026, with EMA approval anticipated first [68]

Financial Data and Key Metrics Changes - Product revenue increased 105% to $1,700,000 in Q3 2025 compared to $800,000 in Q3 2024, with a year-to-date increase of 100% to $6,400,000 from $3,200,000 [4][13] - Product gross margins improved to 53.9% in Q3 2025 from 34.1% in Q3 2024, with gross profit rising to $900,000 from $300,000 [4][14] - Net loss improved to $1,500,000 or a loss of $0.03 per share in Q3 2025, compared to a net loss of $2,800,000 or a loss of $0.10 per share in Q3 2024 [17] - Cash and cash equivalents increased to $8,000,000 as of June 30, 2025, from $1,500,000 as of September 30, 2024 [18] Business Line Data and Key Metrics Changes - Licensing revenue of $3,000,000 was generated in the first nine months of fiscal 2025, compared to no licensing revenue in the same period of fiscal 2024, derived from an expanded agreement with Zimmer Biomet [13][14] - Total operating expenses decreased 9% to $2,800,000 in Q3 2025 compared to $3,100,000 in Q3 2024, with R&D expenses stable at $1,200,000 [15][16] Market Data and Key Metrics Changes - The company is pursuing market opportunities in pain management, including trigeminal neuralgia and lower back pain treatments, with potential revenue generation expected in late 2025 [6][7] - The spinal cord stimulation market is estimated to generate over $3,000,000,000 in annual revenue, representing a significant opportunity for the company [8] Company Strategy and Development Direction - The company aims to expand its product portfolio in pain management and other therapeutic applications, leveraging its thin film ablation technology [6][7] - Plans to initiate a post-market registry to collect outcomes data for patients treated with the 1RF ablation system, highlighting positive patient outcomes [5][6] Management's Comments on Operating Environment and Future Outlook - Management reiterated expectations of being funded through at least fiscal year 2026 based on contractual minimum orders and potential cash flow breakeven if key milestones are achieved [5][18] - The company is confident in its fiscal year 2025 guidance, expecting product revenue to be in the range of $8,000,000 to $10,000,000, representing a significant increase over fiscal year 2024 [12] Other Important Information - The company has received its first international patent for its spinal cord stimulation electrode and is in the process of securing ISO certification for international commercialization [10][11] - New hires in the management team are expected to contribute positively and bring cost savings [11] Q&A Session Summary Question: Can you provide an update on the drug delivery platform and its testing status? - The devices are currently ordered for initial bench testing, followed by animal testing, with human trials planned if animal testing is successful [21][22] Question: What is the market potential for trigeminal ablation and the physician specialties involved? - Approximately 150,000 people in the US suffer from trigeminal neuralgia, with potential procedures being similar to brain ablations, targeting the same physician specialties [25][26] Question: Can you discuss the design and target levels for spinal cord stimulation? - The therapy targets lower back pain, likely from L3, L4 to S1, with multiple components expected in the system [27][28] Question: Any outlook for 2026? - The company is not providing a forecast for 2026 at this time, but remains confident in its current range due to minimum purchase requirements from Zimmer [30]