Market Potential On December 30, 2021, the FDA approved Recorlev for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s Syndrome for whom surgery is not an option or has not been curative and Recorlev became commercially available in January 2022. We believe approximately 8,000 Cushing’s patients are managed pharmacologically in the U.S. with a tremendous amount of unmet need since nearly 40% of patients are poorly controlled on their current medication. We believe that this values the Cushing’s market in the U.S. at approximately $2 billion annually. Cushing’s Syndrome is a complex disease, and we believe that patients could significantly benefit from additional support services and educational resources in conjunction with therapy. For this reason, we have partnered with a specialty pharmacy to provide a customized support and product distribution program, Xeris CareConnection™, for members of the Recorlev ecosystem, including appropriate patients, caregivers, physicians, and payors. Xeris CareConnection provides support services throughout the entire treatment journey to patients and healthcare professionals with direct access to pharmacists, reimbursement specialists and access managers. The comprehensive patient support program includes welcome information, therapy onboarding, at-home delivery of medication, a discreet courier service for urinary free cortisol (UFC) test collection, automatic monthly refill shipments, financial assistance programs, one-on-one support, and ongoing educational resources. Our Product Candidates Ready-to-Use Glucagon (XP-9164) for Gastroenterology We are currently in Phase 1 development with product candidate XP-9164, an early-stage compound for gastroenterology. XP-9164 is intended to address unmet needs in the growing procedural gastroenterology market. Glucagon transiently decreases peristalsis of smooth muscle in the gastrointestinal tract. Glucagon administration during gastrointestinal imaging permits more precise visualization for studies and procedures. It is also used in abdominal vascular procedures such as treating esophageal varices and other GI bleeds. Glucagon is also utilized in biopsies, abscess drainage, GI stenting, gastrostomy tube placement and colonoscopies. In 2019 there were ~17M colonoscopies performed in the U.S. A ready-to-use glucagon may potentially address a number of areas of needed improvement: improved operational efficiency, no reconstitution (and thus fewer reconstitution errors), room temperature stable liquid, faster preparation and possibly less waste. Ready-to-Use Glucagon for Exercise-Induced Hypoglycemia(EIH) in Diabetes Exercise-induced (or exercise-associated) hypoglycemia and the complexity of management aimed at its prevention represent major barriers to the adoption of regular physical activity for many individuals with diabetes treated with insulin. Although carbohydrate ingestion, including oral glucose tablets, can help ameliorate hypoglycemia, patients’ carbohydrate requirements can be as high as 1 gram per minute of exercise, which can be counterproductive to weight management. Aerobic exercise, in particular, often results in a significant drop in blood glucose concentrations. Qualitative feedback has shown that the challenges in current exercise management strategies and the need to consume carbohydrates are frustrating and may lead to minimized or complete omission of exercise for many patients. People with diabetes who are on intensive insulin regimens are at risk of EIH. We believe there is a subset of these individuals that exercises at least three times per week per current guidelines who could potentially use a mini-dose of ready-to-use glucagon each time they exercise. Xeris Offering—Mini-doses of Ready-to-Use Glucagon for Treatment of EIH We are developing a mini-dose of our ready-to-use, liquid-stable glucagon and have observed appropriate dose-dependent PK and PD responses when administered subcutaneously at doses of 75, 150 and 300 μg in adults with T1D. A proof-of-concept study further demonstrated that a mini-dose of 150 μg of glucagon prevented non-severe hypoglycemia to a substantially similar degree as oral glucose tablets that are commonly used during exercise to prevent or correct non-severe hypoglycemia in adults with T1D. As such, the use of mini-dose glucagon enabled patients to avoid the unnecessary caloric intake inherent in glucose tablets or other types of carbohydrates. There currently are no FDA-approved glucagon products that enable individuals to modestly increase glucagon levels at the start of exercise. Glucagon rescue kits exist as a lyophilized powder that must be reconstituted in diluent immediately prior to injection as they are unstable in aqueous solutions for extended periods of time. Despite the challenging reconstitution process, there has been significant documented off-label use, in which patients with T1D mini-dose glucagon using the traditional glucagon kits. Clinical Experience We have successfully completed a number of preclinical studies in multiple species to support the safety of mini-dose glucagon, as well as Phase 2 safety and efficacy clinical trials in subjects with T1D. Phase 2 Clinical Trials XSMP-203: The Use of Mini-Dose Glucagon to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes Based on previous dose-finding trials (XSMP-201 and XSMP-202), we collaborated on a third Phase 2 clinical trial of mini-dose glucagon for EIH in the first quarter of 2016. The primary analysis of this trial was comparison of the glycemic response of 150 μg mini-dose glucagon against current standards of care, including basal insulin reduction and glucose tablet consumption, to mitigate EIH. 15
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