On August 8, 2019 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported financial results for the second quarter ended June 30, 2019 (Press release, Principia Biopharma, AUG 8, 2019, View Source [SID1234538436]).
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"During the second quarter we continued to execute on our clinical programs, including the global PEGASUS Phase 3 trial and a Phase 2 extension trial in patients with pemphigus, as well as our Phase 2 clinical trial in patients with immune thrombocytopenia," said Martin Babler, president and chief executive officer of Principia Biopharma. "For SAR442168, formerly known as PRN2246, we reached an important milestone with our partner Sanofi when the first patient was dosed in their Phase 2b dose-finding trial in patients with relapsing multiple sclerosis, triggering a $30 million payment."
2019 program highlights include:
PRN1008 for the treatment of pemphigus
Announced positive Phase 2 data during the late-breaking session at the annual meeting of the American Academy of Dermatology (AAD) in Washington, D.C.
Continued enrollment of patients in the global PEGASUS Phase 3 clinical trial
Completed enrollment of patients in the Believe-PV Phase 2 extension trial
Anticipating Phase 2 extension trial topline data by fourth quarter 2019
PRN1008 for the treatment of immune thrombocytopenia
Continued enrollment of patients in the global Phase 2 clinical trial
Anticipating Phase 2 trial topline data by fourth quarter 2019
SAR442168/PRN2246 for the treatment of multiple sclerosis
The first patient was dosed in Sanofi’s Phase 2b trial in patients with relapsing multiple sclerosis, which triggered a $30 million milestone payment
PRN1371 for the treatment of metastatic bladder cancer
Presented Phase 1 data at AACR (Free AACR Whitepaper) Bladder Cancer conference: Transforming the Field meeting in Denver, Colorado; PRN1371 was well tolerated in 36 patients in dose-escalation phase
Continued enrollment of patients in the dose expansion trial in metastatic urothelial carcinoma
General Corporate Highlights
Appointed two industry veterans, Shao Lee Lin, MD, Ph.D. and Patrick Machado, to our Board of Directors
Second Quarter 2019 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were $178.5 million as of June 30, 2019, compared to $180.6 million as of December 31, 2018.
Revenues: Collaboration revenue was $30.0 million for the three months ended June 30, 2019, compared to $13.0 million for the same period in 2018. The $30.0 million revenue recognized for the three months ended June 30, 2019 was for the achievement of a milestone in our Sanofi collaboration. The $13.0 million revenue recognized for the same period in 2018 consists of a portion of upfront fees from our Sanofi and AbbVie collaborations, as well as a portion of a milestone we achieved in the three months ended June 30, 2018.
R&D Expenses: Total research and development expenses were $18.7 million for the three months ended June 30, 2019, including stock-based compensation expense of $1.8 million, compared to $8.9 million for the same period in 2018, including stock-based compensation expense of $0.2 million. The increase in total research and development expenses was mainly driven by an increase in personnel-related expenses as we build out our R&D team, and an increase in PRN1008 program costs, due to the initiation of a global Phase 3 trial in patients with pemphigus in November 2018 and certain manufacturing campaigns to supply drug products for our PRN1008 clinical trials.
G&A Expenses: General and administrative expenses were $5.2 million for the three months ended June 30, 2019, including stock-based compensation expense of $1.7 million, compared to $2.2 million for the same period in 2018, including stock-based compensation expense of $0.2 million. The increase in total general and administrative expenses was primarily driven by increased personnel-related expenses and headcount costs related to operating as a public company. The increased personnel-related expenses were attributable to increased stock-based compensation expenses due to a higher valuation of options granted in 2019.
Net Income (Loss): For the three months ended June 30, 2019, net income was $7.1 million compared to a net income of $1.8 million for the same period in 2018.