- Science 37 pioneered the concept of decentralized clinical trials.
- The Covid-19 pandemic drove more demand for DCTs.
- The Company is a leader in its niche DCT market worth over $60 billion.
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Science 37 Holdings, Inc. (NASDAQ:SNCE) is an enabler of universal access to clinical research through its Science 37 Clinical Trial Operating System ('OS), pioneering the concept of decentralized Agile Clinical Trials ('ACTs). To date the Company has executed over 100 ACTs with more than 475,000 patient relationships in 21+ countries, enrolling 3x more diverse participants and 15x faster than other sites in the same study, and retaining patients 28% longer than the industry average.
The technology platform at the core of Science 37's configurable OS is a single unified system, enabling trial workflow orchestration, evidence generation, and data harmonization. The trial workflow is automated and optimized for multiple roles including investigators, patients and mobile nurses, orchestrating a simple user experience and easy data management. Collection of information from multiple sources such as eConsent, eSource - electronic clinical outcome assessments ('eCOA/ePROs), real-world evidence ('RWE), connected wearable devices, and the unique BYOD app are all unified in the OS.
(Image source: company website)
Science 37's patient centric approach enables attracting participants and enrolling them for the creation and retention of representative patient communities around the world. The Company's network of telemedicine investigators can be sourced on-demand, across any therapeutic area and geography, with patient's accessible to them from virtually anywhere. The numerous in-home procedures and data collection is provided by mobile nurses, who have completed a mandatory, comprehensive training program with remote and in-personal activities, operating on a single, unified set of standard operating procedures ('SOPs). The Company's remote coordinators have extensive trial experience to consult and support patients and study teams, coordinating care with the participant's local physician(S), procedures, lab tests, referrals through local healthcare providers, etc.
Patient communities, telemedicine investigators, mobile nurses, remote coordinators and any connected devices, all have seamless integration with open APIs and tokenization systems to ensure data harmonization with EDC systems, and to manage study dashboards, performance metrics and analytics. The Company's flexible approach allows custom configuration of studies based upon research needs, for an agile clinical trial, with activities happening anywhere - on-premises or off-premises. The Company's experts have deep understanding to navigate complex regulatory processes on behalf of its customers, across several therapeutic areas including neuroscience & pain, infectious & respiratory, cardiometabolic diseases, hepatology & NASH, oncology, hematology, and immunology. The Science 37 OS enables universal access to patients and providers across diverse audiences.
Science 37 consummated a reverse merger or business combination with LifeSci Acquisition II Corp. ('LSAQ) on 10/6/2021. The common stock of the resulting company Science 37 Holdings, Inc. is listed on The Nasdaq Stock Market under the symbol "SNCE." The Company filed a registration statement in form S-1 with the U.S. SEC on 12/23/2021, for the sale from time to time by named selling securityholders of up to 98,379,268 shares of common stock, including - "PIPE shares," founder shares, and common stock issued or issuable to certain former stockholders and other securityholders of legacy Science 37 including earn-out shares and outstanding options. The Company will not receive any proceeds from these sales. The stock last closed at $12.47, near the midpoint of its range of $8.42 to $15.10 since listing on Nasdaq.
On 11/15/2021, the Company announced its financial results for the nine months ending 9/30/2021. Revenue in the period was approximately $39.2 million. Operating expenses were approximately $37.5 million. As of 9/30/2021, the Company had cash and cash equivalent balance of approximately $243 million, which is anticipated to provide a cash runway of at least 12 months.
Science 37 is an "emerging growth company" and a "non-accelerated filer" and may take advantage of reduced public company reporting and compliance requirements. The Company has incurred losses since inception in 2014 and as of 9/30/2021, its accumulated deficit was approximately $137 million. The Company anticipates that it will continue to incur significant losses for at least the next several years while it continues to commercialize its existing products and services and seeks to develop and commercialize new products and services. The Company anticipates that additional investments in its computing infrastructure and facilities will be required to scale its operations, and to keep attracting suitable and willing investigators or patients for clinical trials on a consistent basis. A significant percentage of the Company's revenues are derived from a concentrated group of customers and the loss of one or more major customers could materially and adversely affect its business, results of operations or financial condition. The Company depends on third parties to provide products and services critical to its business, which include suppliers of drugs for use in trials; the nurses, investigators and coordinators involved in executing clinical trials, and common carriers to ship drugs and other products. Any failure by even one of these third parties in providing the required products or services, or complying with applicable regulatory requirements, could have a material adverse effect on the Company's business.
In light of the COVID-19 pandemic and recent logistical technology developments, the U.S. FDA and European Medicines Agency ('EMA) had issued guidance directing sponsors to implement DCT techniques to maintain study continuity, and endorsed DCT techniques as viable, long-term solutions for study design and evidence generation. If this guidance were to be retracted or if the FDA and/or EMA were to stop promoting the use of DCT techniques, the level of decentralized trial activity could decrease adversely affecting its business, financial condition or results of operations. The Company benefits largely from the tendency of biopharmaceutical companies to outsource clinical research projects, and any downturn in this tendency could materially adversely affect its business. As the breadth and complexity of Science 37's information systems continue to grow, it will increasingly be exposed to the risks inherent in the development, integration and ongoing operation of evolving information systems.
Science 37 pioneered the concept of decentralized clinical trials ('DCTs). The Company is disrupting a large market with approximately $195 billion spent annually in biopharmaceutical research and development, and approximately $60 billion spent annually in serviceable clinical trials. Today, Science 37 continues to be a leader in the DCT category and should be a decent investment in its niche. Four Wall Street analysts are very bullish on the stock with an average price target of $18.33.
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This article was written by
Avisol Capital Partners is made up of a team of medical experts, finance professionals and techies, all of whom invest their own money in the picks they share. They aim to help readers find the middle ground between value and growth investing, as they demystify the biopharma industry.They lead the investing group Total Pharma Tracker where they offer a monthly updated catalyst database, an investability scoring system for quick reference ideas, and direct access in chat for dialogue and questions. Learn more.
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