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At this juncture, below is a list of our clients attending JP Morgan this year. Please email us at
cknoll@bplifescience.com or call (415) 375-3340 Ext. 4 with any meeting requests.
JP Morgan 2017 Blueprint Client Profiles
 | Cerus Corporation (NASDAQ: CERS) - Commercial stage biomedical products developer focused on blood safety and a global leader in blood pathogen inactivation. Marketing the INTERCEPT Blood system in the U.S. and abroad for platelets and plasma which is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood.
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Profile: INTERCEPT blood system is FDA approved for plasma and platelets, and commercialized in over 150 centers in 25 countries, with 17 U.S. blood centers in routine use, including the American Red Cross. The Company continues to make progress in positioning INTERCEPT to become the standard of care in the U.S. which was recently bolstered by the FDA’s revised guidance with respect to the Zika virus, whereby the Agency now mandates the use of screening tests or pathogen reduction for all U.S. blood centers. Furthermore, this past March, the FDA included pathogen reduction technology in its revised guidance document on bacterial safety standards for platelets, whereby the INTERCEPT Blood system is currently the only FDA approved pathogen reduction technology.
2016 Highlights: Received FDA approval for the use of the INTERCEPT Blood system for platelets suspended in 100% plasma. Announced a $181 million BARDA contract to support clinical development of INTERCEPT Red Blood Cell System in the U.S. Primary endpoints successfully met for EU Phase III and US Phase II red blood cell studies. First 17 U.S. blood center customers initiated production of INTERCEPT-treated platelets, including the American Red Cross. First U.S. blood centers submitted biologics license applications to the FDA to allow for interstate export of INTERCEPT platelet components.
Market Cap: $524M (as of Dec 12, 2016)
Cash: $81.2M (at Sept 30, 2016)
2016 Revenues: 27.1M (at Sept 30, 2016) |
Key Upcoming Milestones
- Submission of application seeking CE Mark approval for the INTERCEPT Red Blood Cell System in Europe.
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 | Nexvet (NASDAQ: NVET) - A late stage veterinary biologics developer transforming the therapeutic market for companion animals, such as dogs and cats, by developing novel, species-specific biologics products via its proprietary PETization™ platform. PETization rapidly designs monoclonal antibodies (“mAbs”) that are recognized as “self” or “native” by an animal’s immune system. Pivotal efficacy trial completed for lead program (ranevetmab/NV-01) and pilot stage concluded for second program (frunevetmab/NV-02), which are anti-nerve growth factor (NGF) mAb therapies in development as monthly subcutaneous injectables for the control of pain associated with osteoarthritis in dogs and cats, respectively. |
Profile: Nexvet's injectible canine and feline mAb's have the potential to revolutionize veterinary medicine by providing veterinarians and pet owners with the first ever monthly injectable chronic pain products, obviating significant treatment compliance challenges seen with owner-administered medicines and providing vets with regular patient visits. Nexvet’s product candidates build upon the safety and efficacy data from clinically tested human biologics, thereby reducing clinical risk and development cost. Successful completion of the pivotal efficacy and field safety study for ranevetmab, which enrolled 262 dogs with osteoarthritis, was announced in November 2015. Successful completion of a pilot field study of frunevetmab, which enrolled 126 cats with osteoarthritis, was announced in May 2016. Both studies were randomized, placebo-controlled, double-blinded field studies. In both studies, statistically significant efficacy endpoints were met, and the therapies were seen to be safe and well-tolerated, with no significant adverse safety signals detected.
2016 Highlights: Initiated pivotal field efficacy and safety study of frunevetmab. Publication of two peer-reviewed articles regarding frunevetmab in the Journal of Veterinary Internal Medicine. Presented expanded data from the ranevetmab pivotal efficacy and field safety study, and the recently completed frunevetmab pilot field study at a Nexvet-hosted seminar at the American College of Veterinary Internal Medicine (ACVIM) Forum in Denver, Colorado. Filed the effectiveness technical section for ranevetmab with the FDA. Opened its veterinary biologics manufacturing facility in Tullamore, Ireland, and announced a collaboration with Zenoaq, for an anti-PD-1 program for canine cancer under United States Department of Agriculture (USDA) jurisdiction, with new candidates showing binding and potent inhibition of canine PD-1.
Market Cap: $51.07M (as of Dec 12, 2016)
Cash: $24.6M (at Sept. 30, 2016)
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Key Upcoming Milestones
- H1 2017 - Commencement of a pivotal safety study of ranevetmab
- Q4 2017 - Report data from pivotal field efficacy and safety study of frunevetmab
- FY 2017 - Further data from PD-1 and TNF programs
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 | Nohla Therapeutics (Private) - Clinical stage developer of universal donor cellular therapies for the treatment of patients with life threatening hematological disorders. Leveraging technology platform developed at Fred Hutchinson Cancer Research Center and spun-out in December 2015. |
Profile: Technology enables the ex vivo expansion and directed differentiation of cord blood stem/progenitor cells derived from umbilical cord blood that is used clinically resulting in “off-the-shelf” universal donor cellular therapies developed bench to bedside with funding from BARDA and NHLBI. It has demonstrated reduced time to neutrophil and platelet engraftment, decreased rates of severe acute graft versus host disease, decreased transplant related mortality, and best-in-class improvements in overall survival. Two lead programs are NLA-101, which consists of expanded off-the-shelf universal donor stem and progenitor cell therapy for hematological malignancies, and NLA-102, expanded universal donor cell therapy for Chemotherapy Induced Neutropenia. NLA-101 is being evaluated in a Phase IIb Trial in Cord Blood Transplantation.
2016 Highlights: Closed $43.5M Series A financing round led by new investor ARCH Venture Partners with participation from 5AM Ventures and existing investor, Jagen. Announced exclusive supply agreement with LifeSouth Community Blood Centers in Gainesville, Florida, which will provide Nohla with fully qualified clinical grade cord blood units for the Company’s expanded hematopoietic stem and progenitor cell products. NLA-101’s Phase IIb Trial in Cord Blood Transplantation enrolled its 80th patient (of 160) in July 2016.
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Key Upcoming Milestones
- Q1 2017 - Interim DSMB analysis for P2b HSCT Study
- Q1 2017 - Initiate P2 CIN trial in AML Patients
- H2 2017 - Initiate Single Unit CBT (sCBT) study
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 | Opthea (ASX: OPT) - Developing novel biologic therapies for the treatment of eye diseases. Lead compound, OPT-302 (ongoing Phase 1/2A in wet AMD), blocks two members of the vascular endothelial growth factor family, namely VEGF-C and VEGF-D, which cause blood vessels to grow and leak. Also, it can be synergistic with any VEGF-A targeting agent- Lucentis, Avastin or Eylea. |
Profile: OPT-302’s Phase 1/2A clinical trial is being conducted at sites across the US. In September 2016, the company presented phase I data supporting the safety and efficacy of OPT-302 administered as a monotherapy and in combination with Lucentis in naive and pretreated wet AMD patients at the EU Retina conference at Copenhagen. The company just announced in November enrolment completion of a Phase 2A clinical trial, which is underway to study additional expansion cohorts of high dose in combination with Lucentis.
2016 Highlights: Announced positive data from Phase 1 Wet AMD Clinical Trial for OPT-302 (met all efficacy and safety objectives). Completed patient enrolment and dosed first patient in Phase 2A dose expansion study for OPT-302 in Wet AMD. Presented data from Phase 1 clinical trial of OPT-302 was presented at the European Society of Retina Specialists (EURETINA) Congress.
Market Cap: $102.2M (as of Dec 12, 2016)
Cash: $14.5M (at June 30, 2016)
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Key Upcoming Milestones
- 1Q 17 – Phase 2A primary data analyses
- 2017 – Initiate Phase 2B clinical trial
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 | Prolacta Bioscience (Private) - Commercial stage developer of human milk-based neonatal nutritional products that meet the needs of critically ill, premature infants in the NICU. Commenced commercialization in the US in 2009 and the company has been cash flow positive since 2011. Net revenues for 2015 were $63.5 million (+40% y/y). |
Profile: Company is a pioneer in the space of milk-fractionation and development of human milk-based neonatal nutritional products and is building a broad therapeutic pipeline by leveraging plasma expertise. Lead product, Prolact+ Fortifier, is the market leader in the US with 15-18% current market share of a growing of $382 –$573 million US market opportunity. The Company truly leads the industry in the quality and safety of nutritional products made from breast milk and operates the first and only pharmaceutical-grade manufacturing facility for the processing of human breast milk. New human milk based products such as Infant Cardiac and Pediatric are in in clinical development. The company is also investing in R&D of Human milk fractionated biologics such as Human Milk Oligosaccharides (HMO.)
2016 Highlights: Announced on December 2016 the closing of a $35 million mezz round, which was led by Essex Woodlands and included new investor, Aisling Capital, along with existing shareholder, Health Evolution Partners.
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Key Upcoming Milestones
- 2017 - Setting up commercial infrastructure for geographic expansion in EU
- 2017 - Concluding clinical trials for existing products in new indication both in and out of the NICU
- 2017 - Initiating new clinical trials to evaluate the role human milk oligosaccharides (another product derived from milk fractionation) in maintenance of the gut microbiome
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 | Zosano (Nasdaq: ZSAN) - Turn around CNS opportunity led by Konstantinos Alataris, founder/former CEO of Nevro (Nasdaq: NVRO). Company is leveraging its proprietary intracutaneous delivery system to provide rapid symptom relief to patients. Lead program is M207, a zolmitriptan-coated microneedle patch that is designed to rapidly deliver zolmitriptan during a migraine attack (Phase III trial called Zotrip). |
Profile: M207 has demonstrated significantly more rapid onset of action and high Cmax and AUC than the standard of care for acute migraine-oral, Sumatriptan. The pivotal efficacy trial (Zotrip) is a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0 mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. 360 patients were recruited and enrolled in the Zotrip trial at 36 centers across the United States. Subjects recruited into the Zotrip trial had a history of at least one year of episodic, acute migraines with or without aura. Upon recruitment, the subjects enter a run-in period that ensures they meet the key eligibility criteria of 2-8 migraine attacks per month, which is documented using an electronic diary. Successfully screened subjects are then randomized into the treatment/dosing period in which they have 8 weeks to confirm and receive blinded treatment for a single migraine attack.
2016 Highlights: Appointed Konstantinos Alataris, Ph.D. as President and CEO. Presented Phase I trial for M207 at American Headache Society 2016 and demonstrated safety and rapid onset of their product. Initiated phase 2/3 registrational trial of M207 under 505B2. Announced the completion of enrollment for Zotrip (October).
Market Cap: $13.8M (as of Dec 12, 2016)
Cash: $23.1M (at Sept 30, 2015)
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Key Upcoming Milestones
- 1Q 17 – Zotrip Phase III efficacy results
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