Principia Biopharma Reports Second Quarter 2020 Financial Results

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Principia Biopharma Inc.A (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.
a??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,a?? said Martin Babler, president and chief executive officer of Principia. a??With the initiation of a Phase 3 trial in patients with relapsing multiple sclerosis, we received a $50 million milestone payment from SanofiA which enhances our balance sheet and allows us to continue strong execution on our programs.a??
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 risk/benefit 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 1/2 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 EuropeanA 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 dose/multiple dose trial in healthy volunteers and a challenge study

Anticipate Phase 1 single ascending dose/multiple dose trial results in the second half of 2020

PRN2246/SAR442168 for the treatment of multiple sclerosis

Demonstrated a significant reduction in disease activity in partner Sanofia??s 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 Sanofia??s 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 inhibitorsa?? significant potential beyond B cells, how rilzabrutinib is differentiated from other BTKs due to its reversible covalent binding as well the companya??s maturing pipeline and research focus

The company has hired key employees to meet the expanded development programs and expected organizational growth

Second 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. A In addition, the company received an additional $50.0 million milestone payment from Sanofi in the third quarter of 2020.
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