RAPT Therapeutics Inc 2024年度报告

April 2025 Dear Stockholders, I am pleased to report on our vision for significant growth and momentum as we advance clinicaldevelopment of our lead drug candidate, RPT904, a novel half-life extended monoclonalantibody designed to bind immunoglobin E (IgE), a key driver of several allergic diseases.1 Pursuing Large Markets and Unmet Needs in Allergy 2024 was a transitional year for RAPT, which culminated in the acquisition of worldwide rights(excluding mainland China, Hong Kong, Macau and Taiwan) to develop and commercializeRPT904 through an exclusive license agreement with Jemincare Pharmaceutical Co., Ltd., aleading pharmaceutical company in China. We believe RPT904 has potential as a best-in-classtherapeutic option compared to omalizumab (marketed as Xolair®), an anti-IgE monoclonalantibody approved for several allergic disorders. Our initial focus will be food allergy and weplan to initiate a Phase 2b clinical trial of RPT904 in food allergy later in 2025. Separately,Jemincare is conducting Phase 2 clinical trials of this promising asset in China in asthma andchronic spontaneous urticaria (CSU). Should these mid-stage trials prove successful, they wouldsolidify our belief in the pipeline-in-a-product potential of RPT904 across multiple indicationsand its potential to address the significant unmet needs of patients with those inflammatoryconditions. Our confidence in RPT904 is based on two key factors: 1)RPT904 targets the same clinically validated binding site (epitope) as omalizumab,but utilizes an innovative design for extended half-life and improved affinity. Thisallows for the potential of RPT904 to reduce dosing frequency and improvecompliance and patient outcomes. 2)Data from Jemincare’s randomized, double-blinded, Phase 1 single-dose dose-escalation study in 56 healthy volunteers in China confirmed the median half-life ofRPT904 was more than two times that of omalizumab at the same dose. In addition,the pharmacokinetics of RPT904 were approximately dose-proportional andpharmacodynamic analysis showed deeper and more sustained reduction of free IgE and higher total IgE accumulation by RPT904 compared to omalizumab at the samedose. Reduction of free IgE by omalizumab is associated with efficacy across a rangeof indications including food allergy and asthma. Prioritizing Food Allergy Although there are broad opportunities for RPT904, we are prioritizing development in foodallergy, which is a significant and growing health problem in the United States, Europe andthroughout the developed world and an area of high unmet medical need. According to FoodAllergy Research & Education (FARE), an organization dedicated to improving the lives ofpeople with food allergy through research, education and advocacy, over 17 million people in theUnited States have been diagnosed with a food allergy, including approximately six millionchildren. Furthermore, FARE notes that approximately 40% of people with a food allergy areallergic to more than one food and approximately half of food-allergic people in the UnitedStates have had a severe reaction from their food allergy. Traditional treatments include food avoidance, which does not eliminate risk, and oralimmunotherapy, which is burdensome, treats a single allergen and is associated with side effects,including anaphylaxis. Despite these approaches, 3.4 million patients per year in the US require avisit to the emergency room for food allergy-related reactions. This places a large burden on thehealthcare system and has a negative socioeconomic and quality of life impact on patients andtheir families. The approval of omalizumab last year as a treatment for food allergy was well received withRoche reporting over 40,000 patients prescribed in the first three quarters after launch.Compared to traditional therapies, omalizumab’s main advantages include its high response rateand ability to treat multiple food allergies simultaneously. With an extended half-life, we believeRPT904 has the potential to be dosed much less frequently than omalizumab (every 8 or 12weeks compared to every 2 to 4 weeks) and has the potential to treat patients with high IgE orhigh body weight who are not eligible to be treated with omalizumab. This profile should behighly attractive to patients, prescribers and payers and should position RPT904 as the preferredtreatment option for food allergy. Chronic Spontaneous Urticaria We have also identified CSU as a priority indication for RPT904 right behind food allergy.Omalizumab is the standard of care for the estimated 400 thousand CSU patients whose diseaseis inadequately controlled with high-dose antihistamines. We believe that RPT904, with its less-frequent dosing, would successfully compete with omalizumab and become the preferredtreatment option in this indication. Our partner Jemincare is currently conducting a Phase 2 trialin CSU in China, which is expected to read out later this year. This Phase 2 trial, if successful, would support o