PRNB Principia Biopharma

Principia Biopharma Reports Third Quarter Financial Results

Principia Biopharma Reports Third Quarter Financial Results

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing novel therapies for immune mediated diseases, today announced financial results for the third quarter ended September 30, 2019.

“With our focus on execution, we made significant progress on our clinical programs during the third quarter. We also recently reported preliminary positive data from our ongoing Phase 2 pemphigus and Phase 1/2 immune thrombocytopenia (ITP) clinical trials with PRN1008. Following these announcements, we were able to execute a successful follow-on offering of common stock with gross proceeds of $241.5 million,” said Martin Babler, president and chief executive officer of Principia Biopharma. “We are also pleased industry veteran Shawn Tomasello joined our Board of Directors as she brings an extensive track record in commercializing novel pharmaceutical products.”

Third Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $161.2 million as of September 30, 2019, compared to $180.6 million as of December 31, 2018. In addition, in October 2019, we completed a follow-on public offering which resulted in net proceeds of $226.5 million after deducting underwriting discounts and commissions and estimated offering expenses.

Revenues: We did not recognize any collaboration revenue for the three months ended September 30, 2019, compared to $18.6 million for the same period in 2018. The $18.6 million recognized for the three months ended September 30, 2018 consisted of a portion of upfront fees and milestone payments from our Sanofi and AbbVie collaborations.

R&D Expenses: Total research and development expenses were $18.4 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.8 million, compared to $9.2 million for the same period in 2018, including stock-based compensation expense of $0.3 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 $5.0 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.5 million, compared to $2.9 million for the same period in 2018, including stock-based compensation expense of $0.4 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.

Net Income (Loss): For the three months ended September 30, 2019, net loss was $22.3 million compared to a net income of $6.7 million for the same period in 2018, as we did not recognize any collaboration revenue for the three months ended September 30, 2019.  

About Principia Biopharma

Principia is a late-stage biopharmaceutical company focused on developing novel therapies for immune mediated diseases. Principia’s proprietary Tailored Covalency® platform differentiates the company’s investigational therapies from traditional small molecules and provides the potential to deliver the potency, selectivity and safety of injectable drugs while maintaining the convenience of a pill. This highly reproducible approach enables the company to pursue multiple programs efficiently. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 1/2 clinical trial in patients with ITP. PRN2246/SAR442168, a covalent BTK inhibitor that crosses the blood-brain barrier, is being evaluated in a Phase 2 clinical trial in patients with multiple sclerosis, and has been partnered with Sanofi. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor (FGFR) is being evaluated in a Phase 1 trial in patients with bladder cancer. 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, Principia’s expectations regarding the Principia pipeline of product candidates,  and the timing, scope and success of additional clinical results (including, without limitation,  the final results from Part B of the Phase 2 trial of PRN1008 in patients with pemphigus, and the Phase 1/2 clinical trial of PRN1008 in patients with immune thrombocytopenia). Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Principia’s 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 Principia’s business in general, see the risk factors set forth in Principia’s 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.

Investor Contact

Christopher Chai, CFO

Media Contact

Paul Laland

415.519.6610

Principia Biopharma Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share amounts)

  Three Months Ended

September 30,
 Nine Months Ended

September 30,
   2019   2018   2019   2018 
Revenue $  $18,564  $35,160  $43,000 
Operating expenses:        
Research and development  18,368   9,200   52,609   26,855 
General and administrative  4,965   2,887   14,705   7,265 
Total operating expenses  23,333   12,087   67,314   34,120 
Income (loss) from operations  (23,333)  6,477   (32,154)  8,880 
Other income (expense), net  3   (133)  (38)  (655)
Interest income  1,034   339   3,324   565 
Net income (loss) $(22,296) $6,683  $(28,868) $8,790 
Net income (loss) attributable to common stockholders $(22,296) $  $(28,868) $ 
Net income (loss) per share attributable to common stockholders        
Basic $(0.93) $  $(1.21) $ 
Diluted $(0.93) $  $(1.21) $ 
Weighted-average shares used to calculate net income (loss) per share attributable to common stockholders        
Basic  24,018,192   5,087,792   23,937,701   2,149,583 
Diluted  24,018,192   6,144,492   23,937,701   3,096,952 
                 



Principia Biopharma Inc.

Summary Consolidated Balance Sheet Data

 (Unaudited)

 (In thousands)

  September 30,

2019
 December 31,

2018
Cash, cash equivalents and marketable securities $161,217 $180,637
Total assets  174,087  195,521
Stockholders’ equity  152,675  169,860

EN
05/11/2019

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Principia Biopharma

 PRESS RELEASE

Patient Enrollment Concluded Early in PEGASUS Phase 3 Pemphigus Trial ...

Patient Enrollment Concluded Early in PEGASUS Phase 3 Pemphigus Trial for Rilzabrutinib Trial enrolled patients ahead of originally anticipated timeline despite COVID-19 pandemic SOUTH SAN FRANCISCO, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Principia Biopharma Inc., a Sanofi company, focused on developing treatments for immune mediated diseases, today announced it has completed patient enrollment into the global Phase 3 PEGASUS trial for rilzabrutinib, an oral investigational Bruton tyrosine kinase (BTK) inhibitor.  “We are pleased with the speed of recruitment and would like to thank...

 PRESS RELEASE

Principia Biopharma Reports Second Quarter 2020 Financial Results

Principia Biopharma Reports Second Quarter 2020 Financial Results 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 a...

 PRESS RELEASE

Principia Announces First Patient Enrolled in Sanofi’s Phase 3 Trial...

Principia Announces First Patient Enrolled in Sanofi’s Phase 3 Trial of SAR442168 in Relapsing Multiple Sclerosis Dosing of Patient Will Trigger $50 Million Milestone Payment SOUTH SAN FRANCISCO, Calif., June 23, 2020 (GLOBE NEWSWIRE) -- Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, today announced that the first patient has been enrolled in its partner Sanofi’s Phase 3 clinical trial of SAR442168 in patients with relapsing multiple sclerosis (RMS). Upon dosing, Principia will be entitled to...

 PRESS RELEASE

Principia Announces Positive Data from its Phase 2 Part B Trial in Pem...

Principia Announces Positive Data from its Phase 2 Part B Trial in Pemphigus Clear dose-response combined with decreased daily corticosteroid usage Response rate increased with extended duration of treatment to six months while maintaining a favorable safety profile SOUTH SAN FRANCISCO, Calif., June 12, 2020 (GLOBE NEWSWIRE) -- Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, today announced positive data from its Phase 2 Part B open-label trial in pemphigus, BELIEVE-PV. The full data set w...

 PRESS RELEASE

Principia Presents Updated Positive Data of Rilzabrutinib for Immune T...

Principia Presents Updated Positive Data of Rilzabrutinib for Immune Thrombocytopenia in Ongoing Phase 1/2 Trial Oral BTK inhibitor reaches primary endpoint in 50 percent of patients treated > 12 weeks; demonstrates fast onset and durable responses Principia to initiate pivotal Phase 3 trial in ITP SOUTH SAN FRANCISCO, Calif., June 12, 2020 (GLOBE NEWSWIRE) -- Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune mediated diseases, today announced positive data on durability of response from an ongoing Phase 1...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch