Lineage Cell Therapeutics (LCTX) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0Welcome to the Lineage Cell Therapeutics Second Quarter twenty twenty May. At this time, all participants are in a listen only mode. An audio webcast of this call is available on the Investors section of Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage and recordings, reproductions or transmissions of this call without the expressed written consent of are strictl ...

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was approximately $2.9 million, a 100% increase year over year and a slight sequential increase [5][17] - Gross margins improved to 43.6%, more than double the 20.3% reported in Q2 2024, and increased from 42.4% sequentially [5][18] - Adjusted EBITDA loss narrowed to negative $420,000 compared to negative $790,000 for the same period last year [6][20] - Net loss attributable to stockholders was $670,000, down from $890,000 in Q2 2024 [20] Business Line Data and Key Metrics Changes - Contract manufacturing revenue increased to $863,000, a 103% year over year increase from approximately $425,000 in 2024 [6] - Consumer products revenue increased by 95% year over year, driven by growth across the brand portfolio [12] Market Data and Key Metrics Changes - The company is seeing increased demand from domestic companies due to tariffs, although the impact on margins has been mild [35][36] - The partnership with Cintas remains strong, with ongoing sales of the SilverSeal product included in their wound care kits [7][75] Company Strategy and Development Direction - The company aims to continue expanding its contract manufacturing and white label business as a major driver of growth [11] - New product launches are planned, including an expanded beauty line and additional skincare solutions, reflecting the commitment to innovative, high-quality products [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive EBITDA by the end of the year and maintaining guidance for $13 million in revenue [15][81] - The company is preparing for potential economic downturns by focusing on high-margin consumer products and evaluating cost structures [66] Other Important Information - The company received $1 million in non-dilutive funding from STATA to support upcoming product launches and marketing initiatives [15][21] - The company has sufficient cash on hand, including recent capital raises, to support growth initiatives [21] Q&A Session Summary Question: Market opportunities for upcoming launches - Management discussed the potential for new digestive enzyme products, which target larger markets compared to existing products [22][23] Question: Retail strategy and brand consolidation - Management clarified that brands will maintain their unique identities and are currently exploring private label opportunities [25][27] Question: Manufacturing capacity and onboarding new customers - Current manufacturing capacity is underutilized, allowing for onboarding of new customers without immediate expansion [29][30] Question: Impact of tariffs on the business - Management noted a mild negative impact on margins but increased interest from domestic companies [35][36] Question: Status of AbbVie partnership - Management confirmed delays in the AbbVie project but remains optimistic about future developments [40][44] Question: New product details from Silly George - Management highlighted successful new product launches and strong sales performance [48][51] Question: Cash position and recession preparedness - Management is considering strategies for potential economic downturns while maintaining a focus on high-margin products [66] Question: Ranking of partnerships - Management identified key partnerships, including Cintas and AbbVie, as significant opportunities for growth [75]

Stoke Therapeutics (STOK) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0Good afternoon and welcome to Stokes Therapeutics second quarter twenty twenty five conference call. I'm Tommy Leggett, Chief Financial Officer at Stokes. Joining me for prepared remarks are Ian Smith, our Interim Chief Executive Officer Doctor. Barry Tico, Chief Medical Officer and Doctor. Kimberly Parkerson, Head of Neurology Clinical Development.In addition, Jason Hoyt, our Chief Patient Officer will participate in Q and ...

Financial Data and Key Metrics Changes - Total GAAP costs and expenses increased by $8.5 million to $20.3 million compared to $11.7 million in the prior year period [20] - GAAP net loss in 2025 was $19.2 million compared to $11.4 million in the prior year period [21] - Cash and cash equivalents totaled $106.3 million as of June 30, 2025, compared to $26.2 million as of June 30, 2024 [21] Business Line Data and Key Metrics Changes - The NSPFA Percutaneous Electrode System is FDA cleared for the ablation of soft tissue, with over 140 patients treated in the pilot program to date [9][12] - Surgeons are transitioning procedures to ambulatory surgery centers (ASC) or operating rooms (OR) for better patient and surgeon experience [10] - The company expects to generate initial revenue from the percutaneous electrode in the second half of the year [23] Market Data and Key Metrics Changes - The market potential for the NSPFA device in benign thyroid disease is significant, with hundreds of thousands of patients in the US alone [7] - The prevalence of thyroid nodules is estimated to be 50% or greater in the population, increasing with age [28] - Approximately 250,000 patients are diagnosed with thyroid issues annually, with 150,000 undergoing thyroidectomy [32] Company Strategy and Development Direction - The company is focused on advancing its NSPFA technology and expanding its market presence through pilot programs and clinical studies [5][19] - A strategic partnership in the electrophysiology space is being pursued to enhance market opportunities [19][39] - The company aims to demonstrate that NSPFA may be a better treatment than surgery for many patients suffering from benign thyroid disease [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value proposition of NSPFA technology and its potential to transform treatment options [16] - The company anticipates increased cash usage as it invests in commercial infrastructure and clinical studies [22] - Management highlighted the importance of generating high-quality clinical data to support technology adoption and regulatory filings [17] Other Important Information - The company is engaged in a multicenter prospective clinical study to generate additional clinical data for the NSPFA technology [11] - The FDA awarded Breakthrough Device Designation for the Cardiac Surgical Clamp Ablation Device, which is under review for IDE submission [13][14] Q&A Session Summary Question: Can you share some patient baseline characteristics driving the pull through for NSPFA? - Management noted that symptomatic patients with benign nodules often seek therapy due to discomfort and the risks associated with thyroidectomy [28][30] Question: Is the expectation still for a single-arm study for catheter ablation? - Management confirmed it would be a single-arm study for electrophysiology [35] Question: Is Pulse collaborating with a market leader in cardiac ablation? - Management affirmed ongoing partnership discussions with a market leader in cardiac ablation [38][39] Question: How does the ASC opportunity position the NSPFA platform? - Management highlighted that the NSPFA system is well-suited for ASCs due to rapid procedure times and low neuromuscular stimulation [44][46] Question: Will the data collected overseas play into the PMA application for the clamp? - Management confirmed that human data collected will be included in IDE submissions, which is beneficial for FDA approval [53][55]

Financial Data and Key Metrics Changes - The company ended Q2 2025 with cash, cash equivalents, and investments of $324.9 million, up from $198.2 million as of December 31, 2024, indicating a significant increase in liquidity [14] - R&D expenses for Q2 2025 were $38.3 million, a slight decrease from $39.3 million in Q2 2024, primarily due to reduced preclinical and clinical costs [15] - G&A expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024, driven by higher compensation and professional fees [16] - The net loss for Q2 2025 was $43.3 million, compared to $41.0 million in Q2 2024, reflecting increased expenses [17] Business Line Data and Key Metrics Changes - The company is focused on developing aldosterone synthase inhibitors (ASIs) for hypertension and related conditions, with promising clinical data from trials such as LAUNCH HTN and ADVANCE HTN [6][10] - A survey indicated that 95% of clinicians would likely prescribe lorundrostat if approved, highlighting strong interest in the product [7] Market Data and Key Metrics Changes - Uncontrolled and resistant hypertension affects over 20 million patients in the U.S., representing a significant unmet medical need [8] - The company has identified nearly 9 million patients who started new treatments in the third line or later position in 2024, reflecting dissatisfaction with current options [7] Company Strategy and Development Direction - The company aims to enhance the profile of lorundrostat in treating hypertension with comorbid conditions like chronic kidney disease (CKD) and obstructive sleep apnea (OSA) [10][12] - A pre-NDA meeting with the FDA is scheduled for 2025, indicating progress towards regulatory approval [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data supporting lorundrostat's efficacy and safety, emphasizing the unmet need in the market [21][34] - The company is exploring partnership opportunities, particularly outside the U.S., to maximize the reach of lorundrostat [24] Other Important Information - The company is expanding its medical communications team to raise awareness and interest in lorundrostat ahead of its potential launch [9] - The EXPLORER OSA trial is expected to provide top-line data in 2026, focusing on the effects of lorundrostat on nighttime blood pressure [12] Q&A Session Summary Question: Thoughts on AstraZeneca's Phase III Vax HTN data - Management refrained from speculating on AstraZeneca's data but expressed confidence in lorundrostat's safety and efficacy based on their own trials [21][22] Question: Opportunities for lorundrostat beyond hypertension - Management indicated potential for lorundrostat in treating related comorbidities like CKD and OSA, emphasizing its role in managing dysregulated aldosterone [30] Question: Payer strategies and market access - Management does not anticipate a step edit through spironolactone, expecting payers to navigate access through generic classes instead [55] Question: Commercial strategy and market entry - The company is currently focused on payer strategy and medical affairs to build awareness for lorundrostat, with specific commercial strategies still in development [59][60] Question: Pre-NDA meeting expectations - Management is confident in the comprehensive data package prepared for the FDA, which includes insights from various clinical trials [62] Question: Concerns about drug-drug interactions - Management clarified that PPI use is allowed in trials, and the focus is on ensuring adequate blood pressure control rather than safety concerns [41] Question: Future data releases from ongoing trials - Management confirmed plans to publish data from the open-label extension trial, TRANSFORM HDN, as it becomes available [74]

Financial Data and Key Metrics Changes - Revenue in the second quarter was $600,000, reflecting ongoing progress in partner programs [19] - Research and development expenses increased to $20.5 million from $15.3 million in the prior year, driven by advancements in internal programs and increased personnel costs [20] - Selling, general and administrative expenses decreased to $8.5 million from $9.3 million in the prior year, primarily due to a reduction in stock compensation expense [20] - Cash, cash equivalents, and short-term investments as of June 30, 2025, were $117.5 million, down from $134 million as of March 31, 2025 [21] - The company raised approximately $64 million in gross proceeds post-quarter, enhancing its balance sheet and funding operations into 2028 [21][22] Business Line Data and Key Metrics Changes - The company initiated phase one clinical trials for AVS-101, a potential best-in-class anti-T1A antibody, with interim results expected later this year [6][7] - ABS-201, an innovative anti-prolactin receptor antibody for androgenetic alopecia, is on track for a phase one 2A trial initiation in early 2026, with interim efficacy data anticipated later that year [9][24] - The company continues to progress on several additional programs, including ABS-301 and AVS-501, targeting difficult-to-drug indications [10] Market Data and Key Metrics Changes - The ABS-201 program targets a market of approximately 80 million adults in the US affected by androgenetic alopecia, with no significant therapeutic innovation in nearly 30 years [8] - The company is engaged with multiple interested parties regarding potential transactions for ABS-101 following positive clinical data readouts [16] Company Strategy and Development Direction - The company aims to out-license or sell internal and co-developed programs following value inflection points, focusing on maximizing shareholder value [15][16] - The strategy includes developing ABS-201 through later stages of clinical development and potentially commercialization, given its straightforward clinical development pathway [18] - The company is also focused on advancing its AI-integrated drug creation platform, which enhances its pipeline and offers a differentiated value proposition for potential partners [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strengthened financial position and the ability to advance internal programs, including ABS-201 [22][23] - The company anticipates multiple major catalysts over the next 18 months, including interim readouts for ABS-101 and ABS-201 [23][24] - Management highlighted the importance of partnerships and ongoing discussions with large pharma companies, expecting to sign at least one partnership this year [66] Other Important Information - AMD made a $20 million strategic investment in the company, reflecting confidence in its AI-driven drug creation platform [12] - The company plans to provide updates on additional early-stage programs at a later date [11] Q&A Session Summary Question: What kind of data can be expected from the first TL1A data readout later this year? - Approximately 40 healthy volunteers will be dosed for the AVS-101 Phase I study, with pharmacokinetic and immunogenicity data expected at the interim readout [26][28] Question: What is the current plan for ABS-201 in terms of formulation and dosing? - The plan includes a subcutaneous formulation with a six-month treatment cycle, potentially involving two or three doses [31][34] Question: What is the long-term vision to remain competitive in AI-based drug discovery? - The focus is on de novo antibody creation targeting difficult-to-drug targets, with successful partnerships indicating strong capabilities [40][42] Question: What are the next preclinical milestones for ABS-301 and ABS-501? - Additional in vivo work is required to complete the drug development package, with plans to partner these programs early [52][55] Question: Will there be revenue recognition from partners? - Yes, revenue will be milestone-oriented and may be lumpy, with expectations of large upfront and milestone payments [60][63] Question: What is the development plan for ABS-201? - After the Phase I, 2A trial, a worldwide Phase II, III trial is planned, with potential approval anticipated around 2030-2031 [78][81]

GRAIL (GRAL) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0Good day, ladies and gentlemen, and welcome to the GRAIL Second Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.Speaker1Thanks, operator, and thanks, everyone, for joining us today. On the call are Bob Ragusa ...

Financial Data and Key Metrics Changes - The company generated $38.6 million in adjusted EBITDA for Q2 2025, representing over a 600% increase quarter over quarter [11][12] - Net income for the quarter totaled $35.7 million, reflecting disciplined capital deployment [12] - Total revenue for the quarter was $68.1 million, supported by realized prices of $65.66 per barrel of oil, $8.7 per barrel for natural gas liquids, and $1.8 per Mcf for natural gas [12][13] - Total operating expenses were $25.66 per BOE, including lease operating expenses of $5.92 per BOE and general and administrative expenses of $8.58 per BOE [13][14] Business Line Data and Key Metrics Changes - The company achieved record production of 21,052 barrels of oil equivalent per day, with approximately 50% being oil, marking a 540% increase quarter over quarter [6][12] - Capital expenditures totaled $56.6 million for the quarter, aligned with the one rig development program targeting approximately 60 wells per year [5][14] Market Data and Key Metrics Changes - The company has a robust pipeline of accretive acquisition targets and is in the process of closing two additional acquisitions, adding approximately 18,000 net acres expected to close in Q3 [7][9] - The company’s hedging program covers approximately 85% of proved developed production, securing pricing of $68.04 per barrel of oil through 2025 [9][15] Company Strategy and Development Direction - The company focuses on delivering long-term sustainable value through disciplined growth, strong capital efficiency, and opportunistic portfolio expansion [4][29] - The strategy includes both organic growth and continued consolidation through acquisitions, with a commitment to capital efficiency and operational excellence [7][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving corporate cash flow breakeven and emphasized the importance of returning capital to shareholders through dividends [10][29] - The company revised its full-year production guidance from 7,000-8,000 BOE per day to 24,000-26,000 BOE per day, reflecting enhanced visibility and successful integration of recent acquisitions [28][29] Other Important Information - The company ended the quarter with total proved reserves of approximately 100 million BOE, with 55 million BOE classified as proved developed producing [16][17] - The integration of recently acquired assets has been seamless, with a focus on operational efficiency and cost control [17][18] Q&A Session Summary Question: Thoughts on M&A market and measuring returns on development locations - Management highlighted a disciplined approach to acquisitions, focusing on accretive deals at lower multiples compared to peers [35][36] Question: Key components to reduce well costs - Management discussed strategies to reduce well costs from $5.6 million to $5 million, emphasizing cost discipline and competitive vendor processes [38][39] Question: Learning curve with Bayswater assets and current production levels - Management noted that production from Bayswater assets was impacted by timing of the acquisition and expected to ramp up steadily [45][46] Question: Update on Rush Pad completions - Management confirmed that completions are on schedule and expressed excitement about the potential production rates [48][49] Question: Clarification on production numbers from Bayswater - Management clarified that the reported production numbers were accurate based on the effective date of the acquisition [56][57] Question: Guidance on future production and capital expenditures - Management indicated a significant ramp in production expected in Q3 and Q4, with capital expenditures aligned with guidance [59][61]

Financial Data and Key Metrics Changes - The net loss for Q2 2025 was $27.9 million, compared to $17.2 million in Q2 2024, primarily due to changes in non-cash fair value of notes and warrants and increased operating expenses [20] - R&D expenses for the quarter were $21.2 million, up from $16.8 million in the same quarter last year, reflecting continued advancement in clinical studies [19] - SG&A expenses decreased to $4.9 million from $6.2 million in the same quarter last year, mainly due to lower stock-based compensation [19] Business Line Data and Key Metrics Changes - The Revita program is emerging as a foundational therapy for resetting the body's metabolic set point in obesity and type 2 diabetes, with new data showing up to two years of benefit in weight maintenance and blood sugar control following a single treatment [7][8] - The Rejuva program has completed preclinical efficacy, toxicity, and biodistribution studies, with plans for a phase one/two clinical study to evaluate safety and preliminary efficacy in adults with inadequately controlled type 2 diabetes [16][17] Market Data and Key Metrics Changes - The company is addressing the significant unmet need for weight regain after GLP-1 discontinuation, with a focus on patients who have lost weight through GLP-1 therapy but struggle to maintain it after stopping [4][5] - Insights from key stakeholders indicate a shift in patient and prescriber attitudes, with a growing desire for alternatives to long-term GLP-1 therapy [36] Company Strategy and Development Direction - The company has strengthened its financial position through a $23 million public offering, which could provide up to $69 million in total proceeds, positioning it to capture the value of clinical and strategic progress [6] - A nonbinding letter of intent with Bariendo aims to prepare for potential adoption of Revita pending FDA approval, focusing on pre-commercial preparation and distribution channels [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about upcoming data readouts and the potential for Revita to serve as a long-term solution for weight maintenance after GLP-1 therapy [10][22] - The company anticipates a transformational second half of the year, with multiple clinical milestones ahead, including randomized data from the REMAIN one midpoint cohort [21][22] Other Important Information - The company has been granted two new US patents, reinforcing its position as an innovation leader in gut-targeted metabolic therapy, with over 100 granted patents worldwide [14] - The company aims to redefine the risk-benefit profile of long-term GLP-1 therapy with Rejuva, potentially offering a durable solution for chronic metabolic disease [17] Q&A Session Summary Question: What additional data points will be shared in the midpoint update? - Management indicated that the update will focus on safety, tolerability, and effectiveness of weight loss maintenance, with visibility into the overall population's behavior [27][28] Question: What is the status of Rejuva IND clearance? - Management reported significant progress and expects to see the lot release of the GMP product soon, with preliminary data anticipated in 2026 [30] Question: What trends are observed in the GLP-1 market? - There is a growing desire among patients to stop long-term GLP-1 therapy, highlighting the need for better real-world outcomes, which bodes well for Revita and Rejuva [36] Question: How does GLP-1 therapy impact observed outcomes? - Management believes that the contribution from GLP-1 to weight loss in patients is minimal, as consistent signals of weight loss have been observed across various studies [42] Question: Will patients in the REMAIN one cohort be tracked longer for durability? - Management confirmed that patients will be followed for a year, with incremental data updates expected over time [48][49] Question: What are the expectations for DEXA scans in the REVEAL trial? - DEXA scans will not be included in the open-label REVEAL study, and historical comparators for body composition upon tirzepatide discontinuation are lacking [70]

Financial Data and Key Metrics Changes - The company has extended its cash runway guidance into 2027, positioning itself to achieve multiple value-enhancing data milestones in the upcoming years [6][38] - The financials reflect a significant decline in clinical trial spending as multiple legacy trials are closing out, which will positively impact cash flow [38] Business Line Data and Key Metrics Changes - The analysis of the ASPEN six trial indicates that CD47 expression is a key predictive biomarker for clinical response, with a notable increase in overall response rates (ORR) for patients with high CD47 expression [3][8] - The company is modifying its Phase II clinical trial in breast cancer to pursue a CD47 and HER2 biomarker-driven strategy, enhancing the potential for targeted oncology approaches [4][12] Market Data and Key Metrics Changes - Approximately 20,000 patients are identified as addressable in the HER2 positive and CD47 high segment, representing a market opportunity estimated between $2 billion to $4 billion [30] - The company anticipates that CD47 overexpression is found in roughly 50% to 70% of HER2 positive breast cancer patients, indicating a significant commercial opportunity [13][30] Company Strategy and Development Direction - The company is focused on advancing its HER2 positive breast cancer program with a CD47 biomarker-driven approach, which has been derisked by positive data from two different HER2 positive cancers [22][36] - The development strategy includes pursuing a targeted IO breakthrough with EVO, aiming to replicate successful results across various tumor types [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the potential of CD47 as a predictive biomarker, which could facilitate smaller and faster future studies, enhancing the ability to select patients effectively [40] - The management team is optimistic about the upcoming data presentations and the implications for future clinical trials, particularly in breast cancer [41] Other Important Information - The company is set to present full data from the ASPEN six trial at an upcoming medical conference in Q4 of this year, which is expected to provide further insights into the efficacy of EVO [8][20] - The clinical pipeline remains focused on the combination of evorpercept with anti-cancer antibodies, with a priority on the HER2 positive breast cancer program [36][37] Q&A Session Summary Question: Do you need to meet with FDA to finalize trial design changes for Aspen breast? - The company has submitted the amendment for the Aspen breast study to the FDA and is ready to proceed without any holdup [44] Question: Can you frame investigator feedback on the CD47 biomarker approach? - Feedback from investigators has been positive, with enthusiasm for the CD47 biomarker and its potential to address unmet needs in patients progressing on HER2 therapies [46] Question: What kind of data would give confidence to continue pursuing the biomarker approach? - The company is looking for response rates in the high 30s to 40% range to consider the data compelling enough for further development [48] Question: Will the current Phase II study support registration? - The current study is designed to inform decision-making for future registrational studies, with the potential for accelerated approval depending on the data [55][56] Question: How does the baseline characteristic compare between CD47 high and low patient groups? - The baseline characteristics are generally well balanced, and further details will be shared at a medical meeting [76] Question: Is there any data on CD47 expression post HER2 treatment? - There is evidence suggesting that CD47 levels may increase with subsequent lines of therapy, indicating a potential resistance mechanism [81]