 SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 GLOBE NEWSWIRE -- Principia Biopharma Inc. Nasdaq: PRNB, a late-stage biopharmaceutical company focused on developing treatments for immune mediated diseases, today announced financial results for the second quarter ended June 30, 2020. We are very pleased with the progress the company made on each program in the first half of the year despite the ongoing COVID-19 pandemic challenges. Our investigators were able to present additional positive data for both ITP and pemphigus and Sanofi announced positive Phase 2 data in multiple sclerosis, said Martin Babler, president and chief executive officer of Principia. With the initiation of a Phase 3 trial in patients with relapsing multiple sclerosis, we received a 50 million milestone payment from Sanofi which enhances our balance sheet and allows us to continue strong execution on our programs. Six-month and year-to date program highlights Rilzabrutinib for the treatment of pemphigus Announced full data set from the Phase 2 Part B pemphigus BELIEVE PV trial during the virtual late-breaker research session of the American Academy of Dermatology Results to date demonstrate a positive riskbenefit profile while decreasing daily corticosteroid usage Enrollment of the PEGASUS Phase 3 trial continues to be on target Rilzabrutinib for the treatment of ITP Announced updated positive data from an ongoing Phase 12 trial in 47 heavily pre-treated patients during the virtual session of the European Hematology Association Interim results demonstrate rilzabrutinib reaches primary endpoint in 50 percent of patients treated 12 weeks with 400 mg twice-daily dose; demonstrated fast onset and durable responses Granted orphan drug designation by the European Commission EC Anticipate initiating a pivotal Phase 3 trial by the end of 2020, assuming no COVID-19 related impact Rilzabrutinib for the treatment of IgG4-RD Announced the expansion of development of rilzabrutinib into IgG4-RD Anticipate initiating a Phase 2 trial in the second half of 2020 PRN473 Topical for the treatment of immune mediated diseases of the skin Announced expansion of its BTK franchise with PRN473 Topical Initiated two Phase 1 trials in Australia -- a single ascending dosemultiple dose trial in healthy volunteers and a challenge study Anticipate Phase 1 single ascending dosemultiple dose trial results in the second half of 2020 PRN2246SAR442168 for the treatment of multiple sclerosis Demonstrated a significant reduction in disease activity in partner Sanofis Phase 2 relapsing multiple sclerosis MS trial Met primary and secondary objectives with 85 percent or greater relative reduction achieved in the number of new gadolinium-enhancing T1 and new or enlarging T2 hyperintense lesions First patient dosed in Sanofis Phase 3 trial in relapsing MS, triggering a 50 million milestone payment in the third quarter of 2020 Immunoproteasome Inhibitor Selected a candidate molecule to move forward into the preclinical development phase General Corporate Highlights Hosted a virtual Analyst Event highlighting BTK inhibitors significant potential beyond B cells, how rilzabrutinib is differentiated from other BTKs due to its reversible covalent binding as well the companys maturing pipeline and research focus The company has hired key employees to meet the expanded development programs and expected organizational growthSecond Quarter 2020 Financial Results Cash Position: Cash, cash equivalents, and marketable securities were 316.5 million as of June 30, 2020, compared to 367.8 million as of December 31, 2019. In addition, the company received an additional 50.0 million milestone payment from Sanofi in the third quarter of 2020. Revenues: Collaboration revenues were 50.0 million for the three months ended June 30, 2020, compared to 30.0 million for the same period in 2019, for the achievement of clinical development milestones in our Sanofi collaboration. RD Expenses: Total research and development expenses were 30.9 million for the three months ended June 30, 2020, including stock-based compensation expense of 3.9 million, compared to 18.7 million for the same period in 2019, including stock-based compensation expense of 1.8 million. The increase in total research and development expenses was mainly driven by an increase in rilzabrutinib program costs, due to the progression of our global Phase 3 trial in pemphigus, ongoing Phase 2 trial in ITP and certain manufacturing campaigns to supply drug products for our rilzabrutinib clinical trials, the initiation of our Phase 1 trial for PRN473 Topical in March 2020 and an increase in employee-related expenses. GA Expenses: General and administrative expenses were 9.2 million for the three months ended June 30, 2020, including stock-based compensation expense of 3.1 million, compared to 5.2 million for the same period in 2019, including stock-based compensation expense of 1.7 million. The increase in total general and administrative expenses was primarily driven by increased employee-related expenses and costs related to operating as a public company. Net Income Loss: For the three months ended June 30, 2020, net income was 10.8 million compared to net income of 7.1 million for the same period in 2019. About Principia Biopharma Principia is a late-stage biopharmaceutical company dedicated to bringing transformative therapies to patients with significant unmet medical needs in immune mediated diseases. Through Principias proprietary Tailored Covalency platform, our strategy is to build and advance a pipeline of best-in-class drug candidates with significant therapeutic benefits, limit unintended side effects, improve quality of life and over time modify the course of disease. This highly reproducible approach enables the company to pursue multiple programs efficiently, having discovered three drug candidates. Rilzabrutinib, a reversible covalent BTK inhibitor, is being evaluated in a global Phase 3 clinical trial in participants with pemphigus, a Phase 12 clinical trial in participants with immune thrombocytopenia ITP, and the company plans to initiate a Phase 2 clinical trial in participants with IgG4-Related Diseases and a Phase 3 trial in ITP. PRN2246SAR442168 is a covalent BTK inhibitor which crosses the blood-brain barrier and is partnered with Sanofi. Sanofi has announced that SAR442168 will be evaluated in four Phase 3 clinical trials in participants with relapsing and progressive forms of multiple sclerosis. PRN473 Topical, a topical reversible covalent BTK inhibitor designed for immune-mediated diseases that could benefit from localized application to the skin, is being evaluated in Phase 1 trials. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Principias expectations regarding the Principia pipeline of product candidates, and the initiation, timing, scope and success of additional clinical trials and results. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Principias actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. For a description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Principias business in general, see the risk factors set forth in Principias reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Principia specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Principia Biopharma Inc.Condensed Consolidated Statements of OperationsUnaudited In thousands, except share and per share amounts Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Revenue 50,000 30,000 50,000 35,160 Operating expenses: Research and development 30,888 18,718 57,630 34,241 General and administrative 9,231 5,233 16,600 9,740 Total operating expenses 40,119 23,951 74,230 43,981 Income loss from operations 9,881 6,049 24,230 8,821 Other income expense, net 199 42 199 41 Interest income 730 1,108 2,342 2,290 Net income loss 10,810 7,115 21,689 6,572 Net income loss per share Basic 0.33 0.30 0.66 0.28 Diluted 0.31 0.28 0.66 0.28 Weighted-average shares used to calculate net income loss per share Basic 33,087,340 23,927,172 33,040,547 23,896,788 Diluted 35,311,938 25,792,101 33,040,547 23,896,788 Principia Biopharma Inc.Summary Consolidated Balance Sheet DataUnauditedIn thousands June 30, 2020 December 31, 2019 Cash, cash equivalents and marketable securities 316,533 367,837 Total assets 385,954 382,736 Stockholders equity 351,440 358,978 CONTACT: Investor Contact Christopher Chai, CFO Media Contact Paul Laland 415.519.6610 