Blueprint Technologies Inc (NASDAQ:BPMC), a leader in discovering and developing highly selective kinase medicines for patients with genomically defined diseases, today reported financial results and provided a business update for the first quarter ended March 31, 2016.
- Initiated third Phase 1 clinical trial: In March 2016, Blueprint Medicinesenrolled the first patient in its Phase 1 clinical trial of BLU-285 for the treatment of advanced systemic mastocytosis (SM).
- FDA granted orphan drug designation for BLU-285 for gastrointestinal stromal tumors (GIST) and SM: In January 2016, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to BLU-285 for the treatment of GIST and SM. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
- Presented preclinical data highlighting the identification of potent and selective RET inhibitors, including BLU-667: In April 2016, at theAmerican Association for Cancer Research (AACR) Annual Meeting,Blueprint Medicines presented new preclinical data demonstrating that its RET inhibitors, including its drug candidate BLU-667, showed potent inhibition of RET activity and tumor regression in RET fusion or mutation positive lung adenocarcinoma, papillary and medullary thyroid cancer cell lines and in vivo models, at well tolerated doses.Blueprint Medicines plans to file an IND for BLU-667 by the end of 2016.
- Entered into a worldwide collaboration with Roche: In March 2016,Blueprint Medicines entered into a collaboration and exclusive license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc.(collectively, Roche) for the discovery, development and commercialization of up to five small molecule therapeutics targeting kinases believed to be important in cancer immunotherapy. Under the terms of the agreement, Blueprint Medicines received an upfront cash payment of $45 million and will be eligible to receive up to an additional approximately $965 million in contingent option fees and milestone payments related to specified research, preclinical, clinical, regulatory and sales-based milestones across all five programs. Of the total contingent payments, up to approximately $215 million are for option fees and milestone payments for research, preclinical and clinical development events prior to licensing across all five potential programs.
- Strengthened executive leadership team and board of directors: InJanuary 2016, Blueprint Medicines announced the appointment ofKate Haviland as Chief Business Officer and the promotion of Andy Boral, M.D., Ph.D., to Chief Medical Officer. In February and April 2016, respectively, Blueprint Medicines appointed Lonnel Coats and Dr. Lynn Seely to its board of directors.
Clinical Program Updates and Upcoming Milestones:
Blueprint Medicines’ lead drug candidates are BLU-285, a selective inhibitor of both Exon 17 mutant KIT and D842V mutant PDGFRα, and BLU-554 a selective inhibitor of the FGFR4 receptor. Enrollment is progressing in the dose escalation portion of Blueprint Medicines’ Phase 1 clinical trials for BLU-285 in unresectable, treatment-resistant GIST and advanced SM and BLU-554 in advanced hepatocellular carcinoma (HCC).
- The dose escalation portion of each Phase 1 clinical trial is designed to enroll three patients in each cohort with the goal of establishing a maximum tolerated dose (MTD) or a recommended dose if the MTD is not achieved. As of May 9, 2016, the Phase 1 clinical trials for BLU-285 in GIST and BLU-554 in HCC are each enrolling the fifth dose cohort, and the Phase 1 clinical trial for BLU-285 in SM is enrolling the second dose cohort.
- Blueprint Medicines expects to share preliminary data from the dose escalation portion of each of these Phase 1 clinical trials by the end of 2016. For each Phase 1 clinical trial, Blueprint Medicines anticipates that this preliminary data will include safety, pharmacokinetics and pharmacodynamic measures across a range of dose levels and any initial assessments of clinical activity that may be available.
First Quarter 2016 Financial Results:
- Cash Position: As of March 31, 2016, cash, cash equivalents, and investments were $191.5 million, as compared to $162.7 million as ofDecember 31, 2015. This increase was primarily due to the $45.0 million upfront payment received in March 2016 under the Rochecollaboration, offset by cash used in operating activities.
- Collaboration Revenue: Collaboration revenues were $6.9 million for the first quarter of 2016, as compared to $0.7 million for the first quarter of 2015. This increase was due to Blueprint Medicines entering into a rare genetic disease collaboration with Alexion Pharma Holding(Alexion) in March 2015 and a cancer immunotherapy collaboration with Roche in March 2016. Collaboration revenues for the first quarter of 2016 reflected reimbursement from Alexion for work conducted byBlueprint Medicines in the first quarter under the parties’ collaboration and a $0.8 million milestone payment from Alexion, which was recognized upon achievement in the first quarter. In addition, collaboration revenues for the first quarter of 2016 reflected a portion of the $15.0 million upfront payment under the Alexion collaboration, a portion of a $1.8 million milestone payment previously received under the Alexion collaboration and a portion of the $45.0 million upfront payment under the Roche collaboration, all of which will be amortized over the period of the applicable research term.
- R&D Expenses: Research and development expenses were $17.6 million for the first quarter of 2016, as compared to $9.2 million for the same period in 2015. This increase was primarily attributable to approximately $2.6 million in increased expenses associated with clinical manufacturing activities, approximately $2.4 million in increased expenses associated with continuing to build Blueprint Medicines’ platform and advance its discovery pipeline, approximately$1.7 million in increased personnel expense and approximately $1.4 million in increased expenses for external clinical activities associated with advancing Blueprint Medicines’ two lead programs into clinical trials.
- G&A Expenses: General and administrative expenses were $4.6 millionfor the first quarter of 2016, as compared to $2.8 million for the same period in 2015. This increase was primarily attributable to approximately $0.8 million in increased personnel costs and approximately $0.7 million in increased professional fees.
- Net Loss: Net loss was $15.5 million for the first quarter of 2016, or a basic and diluted net loss per share available to common stockholders of $0.57, as compared to a net loss of $11.6 million for the same period in 2015, or a basic and diluted net loss per share available to common stockholders of $8.23.
Blueprint Medicines expects that its cash, cash equivalents and investments balance will be at least $120 million at December 31, 2016. In addition,Blueprint Medicines expects that its existing cash, cash equivalents and investments will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into late 2017. (Original Source)
Shares of Blueprint Medicines closed yesterday at $15.45, up $1.80 or 13.19%. BPMC has a 1-year high of $37.17 and a 1-year low of $13.04. The stock’s 50-day moving average is $17.59 and its 200-day moving average is $19.34.