Announcement PDF ASX Announcement 30 October 2024 Partnership Announcement On Tuesday 29 October 2024, USA time, Cogstate Ltd (ASX:CGS) announced a partnership with Medidata, a Dassault Systèmes brand and a leading provider of clinical trial solutions. Under the partnership, Cogstate and Medidata will jointly provide a fully unified solution for the delivery and oversight of assessments in central nervous system diseases. Cogstate and Medidata are already actively marketing the joint offering and the first sales contract with a bio-pharma customer is expected to execute within the coming days. A copy of the press release is attached. Including the partnership with Medidata, Cogstate has established multiple relationships with electronic clinical outcome assessment providers to act as channel partnerships, each with different levels of integrations and capabilities. Cogstate margins from sales through channel partners are unchanged from direct sales. Medidata, with its platform capabilities, including the electronic data capture system, Rave, is the largest strategic partner in the Cogstate portfolio. At the company’s recent AGM, Cogstate CEO, Brad O’Connor, commented, “The number of opportunities that our partners are bringing to us is increasing. Over the three and a half months of FY25 year to date, the number of proposals that Cogstate has issued from opportunities brought to us by channel partners already exceeds the full FY23 year and is almost as many as the full FY24 year.” At the AGM, Cogstate also announced Clinical Trial sales contracts of US$13.9 million had been executed since 01 July 2024 – compared to US$27.0 million for the full year ended 30 June 2024. In respect of expected FY25 results, the company has provided guidance of: • Revenue: growth from US$43.4 million recorded in FY24; • Profit before tax: growth from US$7.1 million recorded in FY24; and • Operating cashflow: growth from US$5.8 million positive operating cashflow recorded in FY24. Earlier this month, Cogstate announced an on-market share buyback of up to 10% of Cogstate’s issued ordinary share capital within the next 12 months. Net cash balance at 30 June 2024 was US$29.4 million. This announcement was authorised for release by Cogstate Ltd CEO, Brad O’Connor. | Page 1 About Cogstate Cogstate Ltd (ASX:CGS) is the neuroscience technology company optimising brain health assessments to advance the development of new medicines and to enable earlier clinical insights in healthcare. Cogstate technologies provide rapid, reliable and highly sensitive computerised cognitive tests across a growing list of domains and support electronic clinical outcome assessment (eCOA) solutions to replace costly and error-prone paper assessments with real-time data capture. The company’s clinical trials solutions include quality assurance services for study endpoints that combine innovative operational approaches, advanced analytics and scientific consulting. For over 20 years, Cogstate has proudly supported the leading-edge research needs of biopharmaceutical companies and academic institutions and the clinical care needs of physicians and patients around the world. In the Healthcare market, Cogstate seeks to provide primary care physicians and consumers with brief, accurate and scientifically validated digital measures of cognition, with a focus on easy to use, self-administered tests that inform patients and save physician time. In this market, Cogstate has partnered with pharmaceutical company, Eisai, to distribute Cogstate assessments in the USA & Asia. For more information, please visit www.cogstate.com. For further information contact: Brad O’Connor, Chief Executive Officer, boconnor@cogstate.com Important Notices Past performance Past performance is given for illustrative purposes only and should not be relied upon as (and is not) an indication of Cogstate's views on its future financial performance or condition. Past performance of Cogstate cannot be relied upon as an indicator of (and provides no guidance as to) the future performance of Cogstate. Nothing contained in this announcement nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee, whether as to the past, present or future. Future performance and forward-looking statements This announcement contains certain “forward-looking statements”. The words “expect”, “anticipate”, “estimate”, “intend”, “believe”, “guidance”, “should”, “could”, “may”, “will”, “predict”, “plan” and other similar expressions are intended to identify forward-looking statements. Indications of, and guidance on, future earnings and financial position and performance are also forward-looking statements. Forward-looking statements, opinions and estimates provided in this announcement are based on assumptions and contingencies that are subject to change without notice and involve known and unknown risks and uncertainties and other factors that are beyond the control of Cogstate, its directors and management. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. Actual results, performance or achievements may differ materially from those expressed or implied in such statements and any projections and assumptions on which these statements are based. These statements may assume the success of Cogstate's business strategies, including the that the results of any of those strategies will be realised in the period for which the forwardlooking statement may have been prepared or otherwise. For example, Cogstate's performance in any one financial period is sensitive to whether or not contracts are signed in that period, or a subsequent period, and the rate of enrolment in trials of its customers which are influenced by factors that are outside of Cogstate's control. Readers are cautioned not to place undue reliance on forward-looking statements and except as required by law or regulation, none of Cogstate, its representatives or advisers assumes any obligation to update these forward-looking statements. No representation or warranty, express or implied, is made as to the accuracy, likelihood of achievement or reasonableness of any forecasts, prospects, returns or statements in relation to future matters contained in this announcement. The forward-looking statements are based on information available to Cogstate as at the date of this announcement. Except as required by law or regulation (including the ASX Listing Rules), none of Cogstate, its representatives or advisers undertakes any obligation to provide any additional or updated information, whether as a result of a change in expectations or assumptions, new information, future events or results or otherwise. Indications of, and guidance or outlook on, future earnings or financial position or performance are also forward-looking statements. | Page 2 Medidata and Cogstate Strike Strategic Partnership Transforming Clinical Trials in Neurology with Clinical Outcome Assessment (eCOA) and Clinician Solutions Powered by AI and Advanced Analytics Science-driven collaboration ameliorates neurological assessments and endpoint data quality, enhances the rater and patient experience, and integrates Medidata App innovations with Cogstate capabilities New York – October 29, 2024 – Medidata, a Dassault Systèmes brand and the leading provider of clinical trial solutions to the life sciences industry, today announced a partnership with neuroscience solutions leader Cogstate to reshape clinical trials and outcomes measurement for central nervous system (CNS) diseases across neurodegenerative, psychiatric, motor, and rare neurodevelopmental disorders, among others. Together, the companies will deliver an improved experience, supported by Medidata eCOA (electronic clinical outcome assessment) that empowers customers through faster trial starts and optimal rater experiences. This includes a streamlined rater journey through a single mobile device app and a comprehensive suite of data quality assurance solutions for central nervous system (CNS) assessments. The collaboration addresses the complexities of CNS clinical trials by delivering a fully unified platform for CNS assessment delivery and oversight. By combining Medidata’s industry-leading Medidata Platform with Cogstate’s validated digital cognitive assessments, expert rater training, and monitoring solutions, this relationship will deliver higher quality data collection with increased efficiency and accuracy. By leveraging the Medidata App, a powerful mobile, site-based solution, with Medidata Rave EDC, and Medidata eCOA features designed for CNS trials, raters will gain greater precision in managing their studies, initiating patient site visits, and completing intricate CNS assessments on the site tablet. The app will also offer upgraded data capture, including enhanced controls and navigation, uniquely flexible annotation options (keyboard text, handwriting, and image capture of external notes), and embedded audio recording with smart transcription to allow for greater scoring accuracy and reducing rater burden. Biopharmaceutical customers and raters will benefit from single device access to all the ClinRO, ePRO, and PerfO assessments—including Cogstate’s suite of validated digital assessments— offering a more holistic view of patient outcomes. Raters need only conduct a CNS assessment, with data submitted directly into Rave EDC, and connecting seamlessly to Cogstate’s rater monitoring platform for timely review and rater query management, faster trial starts, superior data quality monitoring, and a simplified rater journey. “The subjective nature of evaluating patients and the potential for data variability pose significant challenges in CNS clinical trials,” said Anthony Costello, CEO, Medidata. “Through our joint efforts, and drawing on Medidata’s deep expertise in eCOA, AI, and sensors, we are enabling the highest endpoint data quality standard, simplifying CNS trial setup, and running automated checks on patient assessment transcripts to minimize study team burden and mitigate the potential for errors.” In addition to Medidata eCOA, Medidata’s CNS Suite fuses advanced sensor technology and AI-driven analytics to address the unique issues of these trials by employing Medidata Sensor Cloud, AI, and myMedidata, enabling researchers to collect and analyze a vast array of biometric and behavioral data. As a result, they can provide deeper insights into patient outcomes while simultaneously supplying the most patient-centric clinical trial experience through their single portal for life. “The ability to deliver precise and reliable data is critical for understanding and treating complex neurological conditions,” said Brad O’Connor, CEO, Cogstate. “The strategic combination of science and technology available in the Cogstate and Medidata partnership allows us to deliver unique data quality innovations for more informed clinical trial decision-making and better patient outcomes.” Cogstate and Medidata are actively working together to create cutting-edge ways to use CNS technology, elevate data capture, and refine patient assessment tools. Leaders from Medidata and Cogstate will present a keynote and panel session at Medidata NEXT New York, sharing additional details about the partnership as well as the latest advances in CNS clinical trial optimization. About Medidata Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 34,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,200 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata. About Dassault Systèmes Dassault Systèmes is a catalyst for human progress. We provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers can redefine the creation, production and life-cycle-management processes of their offer and thus have a meaningful impact to make the world more sustainable. The beauty of the Experience Economy is that it is a human-centered economy for the benefit of all –consumers, patients and citizens. Dassault Systèmes brings value to more than 350,000 customers of all sizes, in all industries, in more than 150 countries. For more information, visit www.3ds.com © Dassault Systèmes. All rights reserved. 3DEXPERIENCE, the 3DS logo, the Compass icon, IFWE, 3DEXCITE, 3DVIA, BIOVIA, CATIA, CENTRIC PLM, DELMIA, ENOVIA, GEOVIA, MEDIDATA, NETVIBES, OUTSCALE, SIMULIA and SOLIDWORKS are commercial trademarks or registered trademarks of Dassault Systèmes, a European company (Societas Europaea) incorporated under French law, and registered with the Versailles trade and companies registry under number 322 306 440, or its subsidiaries in the United States and/or other countries. All other trademarks are owned by their respective owners. Use of any Dassault Systèmes or its subsidiaries trademarks is subject to their express written approval. About Cogstate Cogstate Ltd (ASX:CGS) is a leading neuroscience technology company optimizing brain health assessments to advance the development of new medicines and to enable earlier clinical insights in healthcare. Cogstate technologies provide rapid, reliable, and highly sensitive computerized cognitive tests and support electronic clinical outcome assessment (eCOA) solutions to replace costly and error-prone paper assessments with real-time data capture. For more than 20 years, Cogstate has proudly supported the leading-edge research needs of biopharmaceutical companies and academic institutions and the clinical care needs of physicians and patients around the world. For more information, go to Cogstate.com or follow us on LinkedIn and Twitter. Contact: Medidata PR Medidata.PR@3ds.com Analyst Relations Medidata.AR@3ds.com