On August 6, 2020 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune mediated diseases, reported financial results for the second quarter ended June 30, 2020 (Press release, Principia Biopharma, AUG 6, 2020, View Source [SID1234563097]).
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"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 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 (EHA) (Free EHA Whitepaper)
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
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 Sanofi’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 Sanofi’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 inhibitors’ significant potential beyond B cells, how rilzabrutinib is differentiated from other BTKs due to its reversible covalent binding as well the company’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. 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.
R&D 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
Anticipate initiating a Phase 2 trial in the second half of 2020
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.
G&A 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.