Protagonist Therapeutics(US:PTGX)2022-08-04 20:58Financial Performance - The company reported a net loss of $41.0 million and $62.0 million for the three and six months ended June 30, 2022, respectively, compared to a net loss of $30.8 million and $54.8 million for the same periods in 2021[133]. - The accumulated deficit stood at $471.3 million as of June 30, 2022[175]. - Loss from operations increased by $10.6 million, or 34%, from $30.9 million in Q2 2021 to $41.4 million in Q2 2022[146]. - Total operating expenses rose by $25.8 million, or 41%, from $63.4 million for the six months ended June 30, 2021, to $89.1 million for the same period in 2022[156]. - General and administrative expenses increased by $5.5 million, or 44%, from $12.7 million for the six months ended June 30, 2021, to $18.2 million for the same period in 2022[165]. - License and collaboration revenue decreased by $1.4 million, or 62%, from $2.3 million in Q2 2021 to $0.9 million in Q2 2022, primarily due to reduced services under the Restated Agreement with Janssen[148]. - License and collaboration revenue increased by $18.1 million, or 214%, from $8.5 million for the six months ended June 30, 2021, to $26.6 million for the same period in 2022[159]. Research and Development - The company expects to continue incurring significant research and development expenses as it seeks regulatory approval for its product candidates[133]. - Total research and development expenses increased by $20.3 million, or 40%, from $50.7 million for the six months ended June 30, 2021, to $70.9 million for the same period in 2022[163]. - Clinical and development expenses for PN-943 rose by $5.9 million, or 76%, from $7.8 million in Q2 2021 to $13.6 million in Q2 2022[151]. - The Phase 2 trial of PN-943 for ulcerative colitis (UC) achieved clinical proof of concept, with the 150 mg BID dose arm showing a 27.5% clinical remission rate, a 13% delta versus placebo[124]. - The company is currently conducting a global Phase 3 clinical trial of rusfertide for polycythemia vera (PV) with a target enrollment of approximately 250 patients, aiming to complete enrollment by the end of the first half of 2023[117]. - The FDA granted orphan drug designation for rusfertide for the treatment of PV in June 2020, and Fast Track designation in December 2020, although the Breakthrough Therapy Designation was voluntarily withdrawn in June 2022[122]. Cash Flow and Funding - The company had $291.9 million in cash, cash equivalents, and marketable securities as of June 30, 2022[175]. - Cash used in operating activities for the six months ended June 30, 2022, was $51.3 million, a decrease of $1.2 million compared to the same period in 2021[181]. - Cash provided by investing activities for the six months ended June 30, 2022, was $30.3 million, an increase of $29.3 million compared to the same period in 2021[182]. - Cash provided by financing activities for the six months ended June 30, 2022, was $17.6 million, a decrease of $108.8 million compared to the same period in 2021[185]. - The company anticipates needing to raise substantial additional funding to advance product candidates through clinical development[176]. Economic and Market Conditions - The ongoing COVID-19 pandemic has caused delays in clinical trials and may continue to impact future operations and liquidity[130]. - The company is facing economic uncertainty due to inflationary pressures and geopolitical instability, which may affect operating results and costs[131]. - Inflation is expected to remain elevated, potentially increasing costs related to labor and research and development[190]. - The company is exposed to market risks, including interest rate sensitivities and inflation[187]. - An immediate 100 basis point increase in interest rates would increase the company's interest income by approximately $2.4 million[188]. Employee and Administrative Costs - General and administrative expenses increased by $1.0 million, or 15%, from $6.7 million in Q2 2021 to $7.7 million in Q2 2022, mainly due to higher personnel costs[153]. - The company had 101 full-time equivalent research and development employees as of June 30, 2022, up from 81 in the previous year[152]. - Research and development expenses included increases of $2.0 million in stock-based compensation and $1.6 million in other personnel-related expenses compared to Q2 2021[152]. - Stock-based compensation expense for the six months ended June 30, 2022, was $12.7 million, up from $6.6 million in the same period in 2021[181].