Gossamer Bio(US:GOSS)2019-05-14 20:21Financial Data and Key Metrics Changes - Gossamer Bio ended Q1 2019 with $492.5 million in cash and cash equivalents, which included an $11 million interest in securities receivable [36] - The company reported a net loss of $32.6 million for the quarter, equating to $0.90 per share [37] - Research and development expenses were approximately $25 million, reflecting a ramp-up for GB001, GB002, and GB004 [37] Business Line Data and Key Metrics Changes - GB001, an oral DP2 antagonist, is in a Phase 2b trial for eosinophilic asthma, with an interim analysis expected in the first half of 2020 [7][9] - GB002, an inhaled PDGFR inhibitor for Pulmonary Arterial Hypertension (PAH), completed Phase 1 safety studies and is set to begin Phase 1b trials later in Q2 2019 [21][22] - GB004, an oral HIF-1 stabilizer for Inflammatory Bowel Disease, has begun a Phase 1b trial in patients with active mild to moderate ulcerative colitis [26][27] - GB1275, an oral CD11b modulator for cancer treatment, is expected to enter Phase 1/2 studies in advanced solid tumors in the second half of 2019 [29][30] Market Data and Key Metrics Changes - The company aims to position GB001 in the moderate persistent asthma market, targeting patients who are not adequately controlled on current therapies [77][80] - Gossamer Bio is focusing on chronic rhinosinusitis and chronic spontaneous urticaria, with no significant competitors in the oral treatment space [58][66] Company Strategy and Development Direction - Gossamer Bio is focused on becoming a leader in immunology, inflammation, and oncology, with multiple data readouts expected in 2020 [6] - The company is actively pursuing business development opportunities in late-stage research programs that align with its existing pipeline [94][95] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the momentum generated in developing multiple product candidates that could significantly improve patient lives [39] - The strong financial position allows the company to continue advancing its scientific efforts [39] Other Important Information - Gossamer Bio closed its IPO in February 2019, raising over $291 million in net proceeds, and secured a $150 million debt facility [34][35] - The company will host a fireside chat at the Bank of America/Merrill Lynch Healthcare Conference [33] Q&A Session Summary Question: What is the significance of Novartis' Phase 3 trial results for GB001? - Management anticipates that positive results from Novartis' trials would validate the mechanism of DP2 antagonism, benefiting GB001 [45][49] Question: What were the findings from the Phase 1 trial for GB002? - The Phase 1 trial showed a favorable PK profile with rapid absorption and fast clearance, confirming the inhaled formulation's tolerability [50][53] Question: What biomarkers will be evaluated in the Phase 2 trial for GB002? - Key biomarkers include NT-proBNP levels and imaging measures like cardiac MRIs to assess right heart function [86][87] Question: How will GB004's clinical activity be measured? - Clinical activity will be assessed through HIF-1 alpha levels and histopathology indices in ulcerative colitis patients [90][91] Question: What is the company's approach to market positioning for GB001? - The company is focusing on the moderate persistent asthma market, targeting patients who are not adequately controlled by existing therapies [77][80]