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DISCO topline results: 64Cu-SARTATE is highly effective in detecting tumours in NET patients compared to SOC imaging. Phase III planning underway.
DISCO topline results: 64Cu-SARTATE is highly effective in detecting tumours in NET patients compared to SOC imaging. Phase III planning underway.

Yahoo

time05-06-2025

  • Health
  • Yahoo

DISCO topline results: 64Cu-SARTATE is highly effective in detecting tumours in NET patients compared to SOC imaging. Phase III planning underway.

HIGHLIGHTS Topline data from Clarity's diagnostic Phase II trial, DISCO, confirms that 64Cu-SARTATE is safe and highly effective compared to standard-of-care (SOC) imaging at detecting lesions in patients with neuroendocrine tumours (NETs). DISCO compared the diagnostic performance of 64Cu-SARTATE at an average of 4 hours (between 3 to 5 hours) and 20 hours post-administration (same-day and next-day imaging, respectively) to 68Ga-DOTATATE. 64Cu-SARTATE lesion detection substantially outperformed that of 68Ga-DOTATATE. 64Cu-SARTATE detected 393 to 488 lesions, and 68Ga-DOTATATE identified 186 to 265 lesions among 45 study participants across the readers. Out of all the lesions identified by the readers, 230-251 were deemed to be discordant (i.e. only present on one of the scans, 68Ga-DOTATATE or 64Cu-SARTATE positron emission tomography [PET] / computed tomography [CT]). Of these lesions, 93.5% (average across readers) were only detected on the 64Cu-SARTATE PET/CT scans. The number of discordant lesions detected by 64Cu-SARTATE on the same-day and next-day scans was comparable. Approximately half of all the discordant lesions had an available standard-of-truth (SOT), such as histopathology or conventional imaging. The identified discordant lesions yielded a lesion-level sensitivity of 93.4% to 95.6% (95% confidence interval [CI]: 65.1, 99.5) for 64Cu-SARTATE (across both timepoints) and only 4.4% to 6.6% (95%CI: 0.5, 34.9) for 68Ga-DOTATATE across both readers. 64Cu-SARTATE was deemed safe and well tolerated. Only 7 (15.6%) participants experienced 64Cu-SARTATE-related adverse events (AEs). No serious treatment-emergent AEs were observed in the study. Based on the exciting preliminary results of the DISCO trial, Clarity will commence next steps to conduct a registrational Phase III study of 64Cu-SARTATE in NETs with the US Food and Drug Administration's (FDA) guidance. SYDNEY, June 5, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce positive results from the diagnostic Phase II DISCO trial (NCT04438304)[1] with 64Cu-SARTATE in patients with known or suspected NETs. DISCO trial design DISCO is a "Diagnostic Imaging Study of 64COpper-SARTATE Using PET on Patients with Known or Suspected Neuroendocrine Tumours". It assessed the performance of Clarity's SARTATE imaging product as a potential new method to diagnose and manage NETs. The trial aimed to build on earlier clinical experience with 64Cu-SARTATE in patients with NETs, which demonstrated that the diagnostic has excellent imaging characteristics and suggested that 64Cu-SARTATE PET/CT provides comparable or superior lesion detection to 68Ga-DOTATATE PET/CT in all patients, especially in the liver[2]. DISCO recruited participants with Gastroenteropancreatic NETs (GEP-NETs) across 4 sites in Australia, comparing the diagnostic performance of 64Cu-SARTATE PET at an average of 4 hours (between 3 and 5 hours) and approximately 20 hours post-administration (same-day and next-day imaging, respectively) to the current SOC, 68Ga-DOTATATE PET. Participants were required to have undergone a pre-study 68Ga-DOTATATE PET/CT scan within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE as part of their routine clinical care. The trial was initially designed to enrol up to 63 patients, based on the anticipated lesion-level discordance rate between 64Cu-SARTATE and 68Ga-DOTATATE PET. Following a pre-planned early analysis of the data collected during the study, the sample size was adjusted to 45 patients, allowing for an earlier enrolment completion. Study participants were dosed with 200 MBq of 64Cu-SARTATE. Both the 64Cu-SARTATE and 68Ga-DOTATATE PET/CT scans were reviewed by 2 blinded central readers. Participants were followed for up to 12 months to complete additional investigations (e.g. biopsy and conventional imaging) and obtain the SOT used to verify discordant findings between the scan pairs. The verification of discordant findings against the SOT evidence (as true- or false-positive findings) was completed by an independent central assessor, distinct from the central readers evaluating the 64Cu-SARTATE and 68Ga-DOTATATE scans. Lesion-level sensitivity was calculated for the discordant lesions between the scan pairs, with each true-positive discordant lesion on one scan considered a false-negative lesion on the other scan, and each false-positive discordant lesion on one scan considered a true-negative lesion on the other scan. Topline results The results indicate that lesion detection by 64Cu-SARTATE (regardless of imaging timepoint) substantially outperformed that of 68Ga-DOTATATE. 64Cu-SARTATE detected 393 to 488 lesions, and 68Ga-DOTATATE identified 186 to 265 lesions among 45 participants across the readers (Figure 1). Out of all lesions identified by the readers, 230-251 were deemed to be discordant between 64Cu-SARTATE and 68Ga-DOTATATE PET/CT, with 93.5% (average across readers and imaging days) of these discordant lesions detected on the 64Cu-SARTATE scans only. A previously completed Phase I study demonstrated a 1.7 fold increase (median of 6.70 vs. 3.92, p=0.002) in contrast (i.e. lesion-to-background ratio) for 64Cu-SARTATE PET/CT performed at 4 hours post-administration compared to 68Ga-DOTATATE PET/CT2. This improvement in contrast may explain the detection of additional lesions observed in the DISCO trial. The average SUVmax, representing the highest concentration of 64Cu-SARTATE uptake in lesions, was notably high, ranging from 37.42 to 43.90 across both imaging days in the DISCO trial. Approximately half of all discordant lesions had an available SOT, which yielded a lesion-level sensitivity of 93.4% to 95.6% (95%CI: 65.1, 99.5) for 64Cu-SARTATE, including both timepoints, and only 4.4% to 6.6% (95%CI: 0.5, 34.9) for 68Ga-DOTATATE. 64Cu-SARTATE was deemed safe and well tolerated. Only 7 (15.6%) trial participants experienced 64Cu-SARTATE-related AEs, the majority of which were mild (Grade 1) gastrointestinal events, commonly observed in NET patients, and typically resolved within 2 days of onset. No serious treatment-emergent AEs were observed in the study. Based on the findings of the DISCO trial to date, Clarity will commence the next steps to conduct a registrational Phase III study of 64Cu-SARTATE in NETs with the US FDA's guidance. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "We are very excited about the initial topline data from the DISCO trial as 64Cu-SARTATE was confirmed to be safe and very effective in detecting NET lesions in patients with known or suspected disease. The DISCO trial demonstrates a significant advantage of our diagnostic over 68Ga-DOTATATE. 64Cu-SARTATE detected almost double the number of lesions compared to the SOC, and, where SOT was available, a very high lesion-level sensitivity of 93.4% - 95.6% in comparison to just 4.4% - 6.6% for 68Ga-DOTATATE for these discordant findings. In addition to identifying more lesions with our product, lesions detected by 64Cu-SARTATE also exhibited high uptake with low background on the PET scans, making it easier to identify those lesions by readers. Excellent lesion visualisation was also supported by substantial clearance from the liver. The favourable biodistribution of 64Cu-SARTATE PET enabled high-contrast diagnostic imaging for up to approximately 24 hours post-injection (Figure 1), offering greater flexibility in the scheduling of PET/CT scans. "In the DISCO trial, we continue to observe the substantial limitations of the current-generation of short half-life isotope products, what we call isotope-centric medicine. This is clearly illustrated by 68Ga-DOTATATE with imaging timepoints solely dictated by the very short isotope half-life (approximately 1 hour for gallium-68) as opposed to good science and medicine. In contrast, 64Cu-SARTATE highlights the extraordinary benefits of next-generation patient-centric medicine, where imaging is guided by the optimal timepoint to scan and detect lesions, focusing on the needs of the patients and their treating professionals. "We believe that the flexibility of imaging with 64Cu-SARTATE, in comparison to approximately 1 hour with 68Ga-DOTATATE, plays an important role in the detection benefits seen in the DISCO study. We have known this for many years and have demonstrated these advantages of optimal timepoint imaging with different products in our Targeted Copper Theranostic (TCT) platform, including SARTATE. We have seen first-hand in a number of clinical trials that once radiopharmaceutical products are administered, they take time to find the lesion whilst also needing to clear from non-target organs, providing greater contrast. This is known as signal-to-noise ratio or, in our case, tumour-to-background ratio. Having greater contrast is especially important to identify smaller or more difficult to find cancers. "The longer half-life of copper-64, combined with Clarity's proprietary SAR Technology, sets up a strong foundation for next-generation diagnostics, which could be unmatched in the radiopharmaceutical sector. In addition to clinical benefits, the opportunity for high-volume centralised manufacturing and broad, on-demand distribution of ready-to-use diagnostics translates into flexibility and reliability for patients and their treating staff, meaning that every patient with access to PET imaging, including those in underserved and broad geographic areas, may access improved cancer diagnostics. "Patients with NETs are often misdiagnosed and experience delays in receiving the correct diagnosis, which may lead to disease progression and identification of their cancer at later stages. Visualising NET lesions earlier and more accurately may have a significant impact on patient outcomes as it equips clinicians with crucial information on disease burden, helping to determine an optimal treatment plan. As such, the SSTR2 imaging market is an important focus for Clarity. We estimate the NET diagnostic market in the US alone to be around 100,000 scans per year, growing to approximately 120,000 scans per year by 2029. "Importantly, the positive results of the DISCO trial open broader opportunities for the development of 64Cu-SARTATE in additional SSTR2-expressing malignancies beyond NETs, such as certain types of breast and lung cancers, where unmet clinical needs remain high. We believe the SSTR2 market is set to grow substantially with a number of therapies in development for this target, which include large indications such as breast and lung cancers. Subject to the successful completion of these studies, we believe that the imaging market for 64Cu-SARTATE could be as large, if not larger, than the very lucrative prostate cancer imaging market where radiopharmaceuticals currently dominate the diagnostic paradigm. "We look forward to sharing additional data readouts from the trial and presenting the results at future international medical conferences. We plan to rapidly progress discussions with the FDA to initiate a diagnostic registrational Phase III study, as a first key step in expanding SARTATE into the theranostic field of NETs, as well as other SSTR2-expressing cancers, with the copper-64/copper-67 pair. If the findings from the DISCO trial are substantiated in a registrational Phase III study and lead to regulatory approval by the US FDA, 64Cu-SARTATE may play an important role in improving diagnostic accuracy, lesion detection and staging of patients with NETs. These factors could improve clinical decision-making and treatment outcomes, potentially positioning 64Cu-SARTATE as a best-in-class agent for the diagnosis of NETs." About SARTATE SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express SSTR2, such as NETs. Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE). Disclaimer 64Cu-SARTATE is an unregistered product. The safety and efficacy of 64Cu-SARTATE has not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. About NETs NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system[3]. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin[4]. NETs can either be benign or malignant, as well as non-functional and functional[5]. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon[6]. Overall, it is estimated that more than 20,000 people in the United States are diagnosed with a NET each year[7], and approximately 190,000 people are living with this diagnosis[8]. Patients with NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of more than 4 years[9]. As such, about 30-75% of NET patients have distant metastases at the time of diagnosis[10]. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%[11]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers. For more information, please contact: Clarity Pharmaceuticals Dr Alan Taylor Lisa SadetskayaExecutive Chairperson Director, Corporate Communicationsataylor@ lisa@ References [1] Identifier: NCT04438304 [2] Hicks R et al. First-in-human trial of 64Cu-SARTATE PET imaging of patients with neuroendocrine tumours demonstrates high tumor uptake and retention, potentially allowing prospective dosimetry for peptide receptor radionuclide therapy. The Journal of Nuclear Medicine. 2019. [3] Cheung VTF, Khan MS. A guide to midgut neuroendocrine tumours (NETs) and carcinoid syndrome. Frontline gastroenterology. 2015;6(4):264-269. [4] Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015;121(4):589-597. [5] Yau H, Kinaan M, Quinn SL, Moraitis AG. Octreotide long-acting repeatable in the treatment of neuroendocrine tumors: patient selection and perspectives. Biologics : targets & therapy. 2017;11:115-122. [6] Leoncini E, Boffetta P, Shafir M, Aleksovska K, Boccia S, Rindi G. Increased incidence trend of low-grade and high-grade neuroendocrine neoplasms. Endocrine. 2017 Nov;58(2):368-379. doi: 10.1007/s12020-017 1273-x. Epub 2017 Mar 16. PMID: 28303513; PMCID: PMC5671554. [7] Wu C, Song Z, Balachandra S, Dream S, Chen H, Rose JB, Bhatia S, Gillis A. Charting the Course: Insights into Neuroendocrine Tumor Dynamics in the United States. Ann Surg. 2025 Jun 1;281(6):968-975. doi: 10.1097/SLA.0000000000006331. Epub 2024 May 6. PMID: 38708616; PMCID: PMC11538379. [8] Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. PMID: 28448665; PMCID: PMC5824320. [9] Basuroy R, Bouvier C, Ramage JK, Sissons M, Srirajaskanthan R. Delays and routes to diagnosis of neuroendocrine tumours. BMC Cancer. 2018 Nov 16;18(1):1122. doi: 10.1186/s12885-018-5057-3. PMID: 30445941; PMCID: PMC6240263. [10] Aluri V. and Dillion, J.S. 2017, "Biochemical Testing in Neuroendocrine Tumors", Endocrinology & Metabolism Clinics of North America, [11] Polee, I.N. et al. 2022, "Long-term survival in patients with gastroenteropancreatic neuroendocrine neoplasms: A population-based study", European Journal of Cancer, Volume 172, 2022, Pages 252-263, ISSN 0959-8049, • Krasnovskaya et al. Recent Advances in 64Cu/67Cu-Based Radiopharmaceuticals. Int J Mol Sci. 2023 May 23;24(11):9154. doi: 10.3390/ijms24119154. This announcement has been authorised for release by the Executive Chairperson. View original content to download multimedia: SOURCE Clarity Pharmaceuticals Sign in to access your portfolio

Workshop looks at advancing coastal water sustainability
Workshop looks at advancing coastal water sustainability

Observer

time03-06-2025

  • General
  • Observer

Workshop looks at advancing coastal water sustainability

SUHAR: As part of its commitment to advancing scientific research and environmental sustainability, Sohar University hosted a high-level workshop on Monday entitled: 'Assessing the Impact of the Decision Support System for Coastal Waters (DISCO) on Stakeholders'. The event was organised in collaboration with the Directorate-General of Fisheries Research at the Ministry of Agriculture, Fisheries and Water Resources, and comes as part of the ongoing activities under the DISCO research project, which is strategically funded by the Ministry of Higher Education, Research and Innovation and receives a funding support from the National Aeronautics and Space Administration (NASA). The workshop commenced with a keynote address by Prof Kelvin Bwalya, Director of Research Development at Sohar University. He began by warmly welcoming the delegates on behalf of Vice-Chancellor Dr Hamdan al Fazari, quoting, "I extend a warm welcome to all the delegates to this prestigious event. Sohar University is always happy to host internationally recognised events to reaffirm our commitment to meaningful research that aligns with the UN Sustainable Development Goals and Oman Vision 2040." Prof Bwalya further expressed pride in the university's collaboration on a Nasa-funded research project alongside esteemed partners from the USA and Oman's Ministry of Agriculture, Fisheries and Water Resources. Dr Dawood al Yahyai, Director-General of Fisheries Research, delivered another keynote address. He emphasised the critical role of the DISCO system in advancing sustainable marine resource management and enabling data-driven environmental decision-making through cutting-edge monitoring technologies. Led by Prof Dale Kiefer, Principal Investigator from the University of Southern California, the research team presented the developmental journey of the DISCO system and its technical capabilities in monitoring oceanographic and environmental conditions of coastal waters. Presentations were also delivered by Suad al Bimani from the Marine Science and Fisheries Centre, highlighting the key challenges facing Oman's coastal ecosystems. Dr Scott Burg and Prof Rakesh Belwal from Sohar University presented the methodology used for stakeholder impact assessment, which is part of the new evaluation phase of the project supported by Nasa. The scientific programme featured six main sessions, including live demonstrations, scientific presentations and interactive discussions. The participants were divided into two parallel focus groups to evaluate user needs, provide feedback on the system's capabilities, and explore ways to enhance its adoption and impact across relevant sectors. The event brought together experts and representatives from major national institutions, including the Ministry of Agriculture, Fisheries and Water Resources, Royal Navy of Oman, OQ, Majis Industrial Services, Sultan Qaboos University, the National University of Science and Technology, the University of Technology and Applied Sciences and Sohar University.

Zimbabwean official hails Chinese-invested firm for increasing steel production
Zimbabwean official hails Chinese-invested firm for increasing steel production

The Star

time08-05-2025

  • Business
  • The Star

Zimbabwean official hails Chinese-invested firm for increasing steel production

HARARE, May 8 (Xinhua) -- Zimbabwe is witnessing the revival of its iron and steel industry following the ramp-up of steel production by the Chinese-invested Dinson Iron and Steel Company (DISCO), a senior official from Zimbabwe's ruling party said on Thursday. "We have a new product, which is the export of steel from Zimbabwe. This is also beginning to spur the regeneration of Zimbabwe's downstream steel fabrication sector," said Christopher Mutsvangwa, a politburo member and secretary for information and publicity for the Zimbabwe African National Union-Patriotic Front, while addressing journalists in Harare, the capital of Zimbabwe. DISCO, a subsidiary of China's Tsingshan Holding Group, commenced production last year with pig iron, followed by steel billets, and is now producing steel bars. The company is also expected to start producing bolts, nuts and other steel products. "The technology continues to expand, and the product diversity continues to increase," said Mutsvangwa. The local steel production is expected to support the revival of the heavy steel industry in Bulawayo, Zimbabwe's second-largest city, which was severely affected by the collapse of the domestic steel sector, he added. The closure of a major steel producer in 2008 significantly impacted Zimbabwe's local steel industry, forcing the country to rely on imports. Following the ramp-up of domestic steel production, the Zimbabwean government last Friday introduced new restrictions on the importation of certain steel products.

DISCO Announces First Quarter 2025 Financial Results
DISCO Announces First Quarter 2025 Financial Results

Business Wire

time07-05-2025

  • Business
  • Business Wire

DISCO Announces First Quarter 2025 Financial Results

AUSTIN, Texas--(BUSINESS WIRE)--CS Disco, Inc. ('DISCO') (NYSE: LAW) today announced financial results for its first quarter ended March 31, 2025. 'At DISCO, we are shaping the future of litigation and believe our industry-leading platform equips legal teams with tools not previously available to the legal world,' said Eric Friedrichsen, DISCO Chief Executive Officer. 'We are enabling customers to tackle the most complex, high-stakes matters with confidence. Together with our dynamic product platform and expert services team, we are showing our customers that we are 'with you in every case'.' First Quarter 2025 Financial Highlights: Software revenue was $30.9 million, up 3% compared to the first quarter of 2024. Total revenue was $36.7 million, up 3% compared to the first quarter of 2024. GAAP net loss was $11.4 million, compared to $10.6 million in the first quarter of 2024. Adjusted EBITDA was $(5.1) million, compared to $(5.2) million in the first quarter of 2024. Recent Business Highlights: Product Awards: DISCO was named a G2 2025 award winner in the 'Best Legal Software Products' category. Director Appointment: DISCO welcomed Tom Bogan to the Board of Directors in March 2025, bringing extensive experience in executive leadership and in developing and scaling global software and SaaS platforms. New Product Features: DISCO introduced several new capabilities, including Cecilia Definitions, which enables users to generate on-demand definitions for selected text to allow for accelerated comprehension and analysis. Second Quarter and Full Year 2025 Financial Outlook As of May 7, 2025, DISCO is issuing the following outlook for the second quarter of 2025 and increasing its outlook for fiscal year 2025: Second quarter of 2025: Software revenue in the range of $31.25 million - $32.25 million. Total revenue in the range of $36.5 million - $38.5 million. Adjusted EBITDA in the range of $(5.5) million - $(3.5) million. Fiscal year 2025: Software revenue in the range of $125.5 million - $131.5 million. Total revenue in the range of $146.0 million - $158.0 million. Adjusted EBITDA in the range of $(18.0) million - $(15.0) million. DISCO's second quarter and fiscal year 2025 financial outlook is based on assumptions that are subject to change, many of which are outside of its control. If actual results vary from these assumptions, these expectations may change. There can be no assurance that DISCO will achieve these results. Reconciliation of Adjusted EBITDA on a forward-looking basis to net loss, the most directly comparable GAAP measure, is not available without unreasonable efforts due to the high variability and complexity and low visibility with respect to the charges excluded from this non-GAAP measure; in particular, the effects of stock-based compensation expense specific to equity compensation awards that are directly impacted by unpredictable fluctuations in DISCO's stock price. DISCO expects the variability of the above charges to have a significant, and potentially unpredictable, impact on its future GAAP financial results. Conference Call Information DISCO will host a conference call and webcast at 4:00 p.m. CT (5:00 p.m. ET) today, May 7, 2025, to discuss its first quarter financial results and business highlights. The conference call can be accessed by dialing (888) 300-4030 from the United States or +1 (646) 970-1443 internationally with conference ID 8394292. The live webcast of the conference call and other materials related to DISCO's financial performance can be accessed from DISCO's investor relations website at Following the completion of the call until 10:59 p.m. CT (11:59 p.m. ET) on Wednesday, May 28, 2025, a telephone replay will be available by dialing (800) 770-2030 from the United States, or +1 (609) 800-9909 internationally with conference ID 8394292. A webcast replay will also be available at for 12 months. About DISCO DISCO (NYSE: LAW) provides comprehensive, innovative solutions for modern litigation. We create and service an intuitive, cloud-native platform at the forefront of litigation technology, backed by the partnership of expert professional services and support. Leveraging the latest in AI to help law firms and corporations achieve smarter outcomes faster, our scalable products and tools allow customers to simplify everyday tasks and tackle complex matters at every stage of litigation. References to 'DISCO,' the 'Company,' 'our' or 'we' in this press release refer to CS Disco, Inc. and its subsidiaries on a consolidated basis. Use of Non-GAAP Financial Measures DISCO uses the following non-GAAP financial measures: Adjusted EBITDA, Adjusted EBITDA margin; non-GAAP cost of revenue; non-GAAP gross profit; non-GAAP gross margin; non-GAAP research and development expense; non-GAAP research and development expense as a percentage of revenue; non-GAAP sales and marketing expense; non-GAAP sales and marketing expense as a percentage of revenue; non-GAAP general and administrative expense; non-GAAP general and administrative expense as a percentage of revenue; non-GAAP loss from operations; non-GAAP operating margin; non-GAAP net loss attributable to common stockholders, non-GAAP net loss attributable to common stockholders per share (basic and diluted) and non-GAAP net loss attributable to common stockholders as a percentage of revenue. Management believes that these non-GAAP financial measures are useful measures of operating performance because they exclude items that DISCO does not consider indicative of its core performance. In the case of Adjusted EBITDA and Adjusted EBITDA margin, DISCO adjusts net loss for such items as depreciation and amortization expense; income tax provision; interest and other, net; stock-based compensation expense; payroll tax expense on employee stock transactions; expenses associated with stockholder litigation; and other one-time, non-recurring items, when applicable. In the case of non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross margin, non-GAAP research and development expense, non-GAAP research and development expense as a percentage of revenue, non-GAAP sales and marketing expense and non-GAAP sales and marketing expense as a percentage of revenue, DISCO adjusts the respective GAAP balances for stock-based compensation expense, and other one-time, non-recurring items, when applicable. In the case of non-GAAP general and administrative expense, non-GAAP general and administrative expense as a percentage of revenue, non-GAAP loss from operations, non-GAAP operating margin, non-GAAP net loss attributable to common stockholders, non-GAAP net loss attributable to common stockholders per share (basic and diluted) and non-GAAP net loss attributable to common stockholders as a percentage of revenue, DISCO adjusts the respective GAAP balances for stock-based compensation expense, expenses associated with stockholder litigation, and other one-time, non-recurring items, when applicable. There are limitations associated with the use of these non-GAAP financial measures. These non-GAAP financial measures are not prepared in accordance with GAAP, do not reflect a comprehensive system of accounting and may not be completely comparable to similarly titled measures of other companies due to potential differences in the exact method of calculation between companies. Certain items that are excluded from these non-GAAP financial measures can have a material impact on operating loss and net loss. As a result, these non-GAAP financial measures have limitations and should be considered in addition to, not as a substitute for or superior to, the closest GAAP measures, or other financial measures prepared in accordance with GAAP. DISCO's management uses these non-GAAP measures as measures of operating performance; to prepare DISCO's annual operating budget; to allocate resources to enhance the financial performance of DISCO's business; to evaluate the effectiveness of DISCO's business strategies; to provide consistency and comparability with past financial performance; to facilitate a comparison of DISCO's results with those of other companies, many of which use similar non-GAAP financial measures to supplement their GAAP results; and in communication with DISCO's board of directors concerning financial performance. Forward-Looking Statements This press release contains forward-looking statements, including, among other things, statements regarding DISCO's future financial performance and DISCO's strategies and business initiatives. Words such as 'may,' 'should,' 'will,' 'believe,' 'expect,' 'anticipate,' 'target,' 'project,' and similar phrases that denote future expectation or intent regarding DISCO's financial results, operations, and other matters are intended to identify forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The outcome of the events described in these forward-looking statements is subject to known and unknown risks, uncertainties, and other factors that may cause DISCO's actual results, performance, or achievements to differ materially, including (i) our history of operating losses; (ii) our limited operating history; (iii) our ability to maintain and advance our innovation and brand; (iv) our ability to effectively add new customers; (v) our ability to effectively increase usage and penetration with our existing customer base; (vi) our ability to expand our sales coverage and establish a digital sales channel; (vii) our ability to expand internationally; (viii) our ability to grow our partner ecosystem and maintain existing strategic relationships with law firms, legal services providers and our other partners; (ix) our ability to expand our offering portfolio to a wider range of legal processes outside of our current core offerings; (x) our dependence on revenue from customer usage, which fluctuates based on the timing of and activity driven by legal matters for which our product offerings are used, and any shortfall of large matters on our platform; (xi) our ability to pursue strategic acquisitions and strategic investments to expand the functionality and value of our product offerings; (xii) our ability to comply or remain in compliance with laws and regulations that currently apply or become applicable to our business in the jurisdictions in which we operate; (xiii) the potential that our computer or electronic systems, applications or services, or those of any third parties on whom we depend, fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data; (xiv) our ability to compete effectively with existing competitors and new market entrants; (xv) the impact of general macroeconomic conditions, such as fluctuations in inflation and fluctuating interest rates and the potential imposition of tariffs in the United States and abroad, on our or our customers' businesses; and (xvi) the impact that global events, such as the Russia-Ukraine war and conflict in the Middle East, and any related economic downturn could have on our or our customers' businesses, financial condition and results of operations. The forward-looking statements contained in this press release are also subject to additional risks, uncertainties, and factors, including those more fully described in our filings with the Securities and Exchange Commission ('SEC'), including our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 20, 2025. Further information on potential risks that could affect actual results will be included in the subsequent periodic and current reports and other filings that we make with the SEC from time to time, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. Forward-looking statements represent DISCO's management's beliefs and assumptions only as of the date such statements are made. We undertake no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. CS DISCO, INC. Condensed Consolidated Statements of Cash Flows (in thousands) (unaudited) March 31, 2025 2024 Cash flow from operating activities: Net loss $ (11,393 ) $ (10,582 ) Adjustments to reconcile net loss to cash used in operations: Depreciation and amortization 927 1,075 Stock-based compensation 5,879 5,673 Charge to allowance for credit losses 534 564 Non-cash operating lease costs 556 265 Amortization of premium on short-term investments (828 ) — Other (142 ) — Changes in operating assets and liabilities: Accounts receivable 258 1,927 Prepaid expenses and other current assets 232 409 Other long-term assets — 17 Accounts payable 1,536 (2,838 ) Accrued expenses and other (7,159 ) (2,738 ) Deferred revenue (391 ) (784 ) Operating lease liabilities (466 ) (278 ) Other liabilities (41 ) (40 ) Net cash used in operating activities (10,498 ) (7,330 ) Cash flow from investing activities: Purchases of property, equipment and capitalized software development costs (525 ) (688 ) Purchases of short-term investments (45,436 ) — Maturities of short-term investments 38,303 — Proceeds from disposal of equipment 2 — Net cash used in investing activities (7,656 ) (688 ) Cash flow from financing activities: Proceeds from exercise of stock options 6 10 Net proceeds from issuance of common stock under Employee Stock Purchase Plan 240 360 Repurchase of common stock related to net share settlement (24 ) (39 ) Repurchase of common stock related to share repurchase program — (2,718 ) Cash paid for acquisitions (296 ) (457 ) Principal payments on finance lease obligations (10 ) (10 ) Net cash used in financing activities (84 ) (2,854 ) Net decrease in cash and cash equivalents: (18,238 ) (10,872 ) Cash and cash equivalents at beginning of period 52,771 159,551 Cash and cash equivalents at end of period $ 34,533 $ 148,679 Supplemental disclosure: Cash paid for taxes $ 285 $ 198 Non-cash investing and financing activities: Property and equipment included in accounts payable and accrued liabilities $ 86 $ 56 Expand CS DISCO, INC. Reconciliation from GAAP to Non-GAAP Results (in thousands, except for percentages and per share amounts) (unaudited) Three Months Ended March 31, 2025 2024 Net loss $ (11,393 ) $ (10,582 ) Depreciation and amortization expense 927 1,075 Income tax provision 137 86 Interest and other, net (1,354 ) (1,836 ) Stock-based compensation expense 5,879 5,673 Payroll tax expense on employee stock transactions 150 193 Expenses associated with stockholder litigation 565 199 Adjusted EBITDA $ (5,089 ) $ (5,192 ) Adjusted EBITDA margin (14 )% (15 )% Expand Three Months Ended March 31, 2025 2024 Cost of revenue $ 9,503 $ 8,852 Non-GAAP adjustments: Stock-based compensation expense (499 ) (385 ) Non-GAAP cost of revenue $ 9,004 $ 8,467 Non-GAAP gross profit $ 27,649 $ 27,104 Non-GAAP gross margin 75 % 76 % Expand Three Months Ended March 31, 2025 2024 Research and development $ 14,257 $ 12,079 Non-GAAP adjustments: Stock-based compensation expense (2,043 ) (2,092 ) Non-GAAP research and development $ 12,214 $ 9,987 Non-GAAP research and development as a % of revenue 33 % 28 % Expand Three Months Ended March 31, 2025 2024 Sales and marketing $ 14,527 $ 15,808 Non-GAAP adjustments: Stock-based compensation expense (1,344 ) (1,080 ) Non-GAAP sales and marketing $ 13,183 $ 14,728 Non-GAAP sales and marketing as a % of revenue 36 % 41 % Expand Three Months Ended March 31, 2025 2024 General and administrative $ 10,976 $ 11,164 Non-GAAP adjustments: Stock-based compensation expense (1,993 ) (2,116 ) Expenses associated with stockholder litigation (565 ) (199 ) Non-GAAP general and administrative $ 8,418 $ 8,849 Non-GAAP general and administrative as a % of revenue 23 % 25 % Expand Three Months Ended March 31, 2025 2024 Loss from operations $ (12,610 ) $ (12,332 ) Operating margin (34 )% (35 )% Non-GAAP adjustments: Stock-based compensation expense 5,879 5,673 Expenses associated with stockholder litigation 565 199 Non-GAAP loss from operations $ (6,166 ) $ (6,460 ) Non-GAAP operating margin (17 )% (18 )% Expand Three Months Ended March 31, 2025 2024 Net loss attributable to common stockholders $ (11,393 ) $ (10,582 ) Non-GAAP adjustments: Stock-based compensation expense 5,879 5,673 Expenses associated with stockholder litigation 565 199 Non-GAAP net loss attributable to common stockholders $ (4,949 ) $ (4,710 ) Non-GAAP net loss attributable to common stockholders per share, basic and diluted $ (0.08 ) $ (0.08 ) Weighted average shares used to compute basic and diluted net loss per share 60,565 61,188 Non-GAAP net loss attributable to common stockholders as a % of revenue (14 )% (13 )% Expand

DISCO to Announce First Quarter 2025 Financial Results On May 7, 2025
DISCO to Announce First Quarter 2025 Financial Results On May 7, 2025

Business Wire

time22-04-2025

  • Business
  • Business Wire

DISCO to Announce First Quarter 2025 Financial Results On May 7, 2025

AUSTIN, Texas--(BUSINESS WIRE)--CS Disco, Inc. (' DISCO ') (NYSE: LAW), a creator of industry-leading litigation technology, today announced that it will report its financial results for the first quarter ended March 31, 2025 after market close on Wednesday, May 7, 2025. The financial results and business highlights will be discussed on a conference call and webcast scheduled at 4:00 p.m. Central Time (5:00 p.m. Eastern Time) on Wednesday, May 7, 2025. The conference call can be accessed by dialing (888) 300-4030 from the United States or +1 (646) 970-1443 internationally, with conference ID 8394292. The live webcast of the conference call can be accessed from DISCO's investor relations website at Following the completion of the call until 10:59 p.m. Central Time (11:59 p.m. Eastern Time) on Wednesday, May 28, 2025, a telephone replay will be available by dialing (800) 770-2030 from the United States or +1 (609) 800-9909 internationally with conference ID 8394292. A webcast replay will also be available at for 12 months. About DISCO DISCO (NYSE: LAW) provides comprehensive, innovative solutions for modern litigation. We create and service an intuitive, cloud-native platform at the forefront of litigation technology, backed by the partnership of expert professional services and support. Leveraging the latest in AI to help law firms and corporations achieve smarter outcomes faster, our scalable products and tools allow customers to simplify everyday tasks and tackle complex matters at every stage of litigation. Learn more at References to 'DISCO,' the 'Company,' 'our' or 'we' in this press release refer to CS Disco, Inc. and its subsidiaries on a consolidated basis.

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