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Portola Pharmaceuticals Reports Third Quarter 2015 Financial Results and Provides Corporate Update
Initiated Rolling BLA submission to
--Conference Call Today at
“We achieved a number of significant clinical, regulatory and manufacturing milestones over the past quarter,” said
Other Recent Achievements, Upcoming Events and Milestones
- Completed APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) study enrollment.
- Successfully completed a sixth and final review of the APEX study Data and Safety Monitoring Committee, to correspond with an increase in sample size from 6,850 to 7,500 patients.
- Received Fast Track designation from the
FDAfor prevention of VTE in acute medically ill patients.
- APEX Study metrics, including pooled blinded aggregate event rates, remain on target.
- Plan to report topline APEX study data late in the first quarter of 2016.
- Plan to submit a New Drug Application to the
FDAin 2016, subject to positive data.
- Initiated rolling submission of BLA; we expect the application to be complete by the end of 2015 under Accelerated Approval pathway.
- Completed commercial manufacturing process validation at CMC Biologics to support the BLA and commercial launch at 2,500 liter scale.
- Successfully scaled up our first Generation 2, 10,000 liter batch product at
- Announced topline data from the second part of the Phase 3 ANNEXATM-R study, which demonstrated that andexanet alfa administered as an intravenous bolus followed by a continuous two-hour infusion produced rapid reversal of the anticoagulant effect of rivaroxaban and sustained it for the duration of the infusion. The full data set from Part 2 of the study will be presented during a Late-Breaking Clinical Trial session at the American Heart Association’s Scientific Sessions 2015 on
November 11in Orlando.
- Enrollment remains on track in ANNEXA-4, a Phase 4 confirmatory study of patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed.
- Initiated a Phase 2 proof-of-concept study in healthy volunteers to evaluate the safety and efficacy of andexanet alfa in reversing the anticoagulant effect of betrixaban, and define the dose of betrixaban required for inclusion in ANNEXA-4.
- Plan to present two abstracts at the
American Society of Hematology(ASH) Annual Meeting in December in Orlando.
Cerdulatinib – Oral, dual Syk/JAK kinase inhibitor for hematologic cancers
- Continued to dose-escalate in the Phase 1 part of the ongoing Phase 1/2a study in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies to determine the maximum tolerated dose. Exploring alternate dosing regiments and formulations to get to a higher exposure. Cerdulatinib continues to show activity and is well tolerated.
- Plan to present three abstracts at the ASH Annual Meeting in December in
David C. Stump, M.D., former executive vice president, research and development, at Human Genome Sciences, Inc., to Portola’s board of directors.
Third Quarter Financial Results
Collaboration revenue earned under Portola's collaborations with
Total operating expenses for the third quarter of 2015 were
Portola reported a net loss of
Conference Call Details
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Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and ability to achieve the milestones and events described under the section "Planned Upcoming Events and Milestones," our goal of becoming a fully commercialized biopharmaceutical company, the projected timing of our product launches, the occurrence and timing of planned filings with the
|PORTOLA PHARMACEUTICALS, INC.|
|Unaudited Condensed Statements of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended
|Nine Months Ended
|Collaboration and license revenue||$||2,912||$||2,427||$||7,656||$||7,213|
|Research and development||48,405||31,780||140,563||88,918|
|Selling, general and administrative||10,071||6,424||27,987||16,601|
|Total operating expenses||58,476||38,204||168,550||105,519|
|Loss from operations||(55,564||)||(35,777||)||(160,894||)||(98,306||)|
|Interest and other income (expense), net||406||(16||)||495||437|
|Net loss attributable to common stockholders||$||(55,158||)||$||(35,793||)||$||(160,399||)||$||(97,869||)|
|Shares used to compute net loss per share attributable to common stockholders:|
|Basic and diluted||52,576,005||41,402,037||51,428,117||41,233,206|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(1.05||)||$||(0.86||)||$||(3.12||)||$||(2.37||)|
|PORTOLA PHARMACEUTICALS, INC.
|Unaudited Condensed Balance Sheet Data
|September 30,||December 31,|
|Cash, cash equivalents and investments||$||355,968||$||392,303|
|Total current assets||376,467||315,077|
|Property and equipment, net||5,406||2,776|
|Accrued research and development and accrued and other liabilities||27,439||13,966|
|Deferred revenue (current portion and long-term)||29,431||36,585|
|Total current liabilities||49,158||41,131|
|Total stockholders’ equity||322,908||347,802|
Ana Kapor Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com