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IVERIC bio, Inc. (ISEE)
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6.59-0.23 (-3.37%)
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“It has been a landmark year as we have achieved several major milestones for Zimura,” stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. “Over the past year, we announced positive 12-month and 18-month results from our GATHER1 Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration. We initiated patient enrollment in GATHER2, our second Phase 3 clinical trial for the treatment of GA secondary to AMD. Additionally, we strengthened our balance sheet, advanced our two lead gene therapy product candidates to be on track to enter into the clinic next year and identified a lead compound for our HtrA1 inhibitor program.”
Pravin U. Dugel, M.D., Chief Strategy and Business Officer of IVERIC bio added, “We are excited about the momentum generated with Zimura as a potential treatment for GA and, based on scientific data, Zimura‘s potential impact in wet (neovascular) AMD and in earlier stages of dry AMD. We are also encouraged by our HtrA1 inhibitor, IC-500, which we believe could be another important target in the treatment of AMD. Looking forward, our goal is to expand our footprint in multiple stages and types of AMD, dry and wet. We intend to do this by potentially studying Zimura in additional indications and by advancing the development of IC-500. We expect to make great strides in 2021, as we continue to move our pipeline of therapeutics and gene therapy product candidates forward.”
read the article of Stonepipe Capital and their interest on ISEE. One day this could be a $60 stock
Wedbush’s David Nierengarten initiated coverage of Iveric Bio with an Outperform rating and a price target of $13.
The Thesis
Geographic atrophy is estimated to represent a market opportunity of over $1 billion, with the current patient population at more than 1 million, Nierengarten said in the note.
In October, Iveric Bio had announced Zimura showed positive results in slowing the growth of lesions in its Phase 2 study. The company’s lead asset is also being investigated in Stargardt disease and data from this study could come as early as in the back half of 2002, the analyst noted.
Nierengarten expects more details of the trial design for Zimura’s pivotal study to be disclosed at Iveric Bio’s R&D investor symposium on Jan. 14.
He further wrote, “The company is also building a portfolio of gene therapy candidates, with the first program in autosomal dominant retinitis pigmentosa (adRP) likely to enter the clinic late this year.”
6:36 AM ET, 02/27/2018 - Briefing.com
Reports Q4 (Dec) loss of $0.26 per share, $0.29 better than the two analyst estimate of ($0.55).Pipeline Update:During the second half of 2017, the Company modified its on-going Zimura (avacincaptad pegol) clinical trial for the treatment of geographic atrophy (GA) secondary to dry age related macular degeneration (AMD). The modification of the trial design accelerates the anticipated timeline for obtaining top-line data. Initial top-line data is expected to be available during the second half of 2019. The scientific details of the GA secondary to dry AMD clinical trial were presented at the 41st Annual Macula Society Meeting in Beverly Hills, California, February 21-24, 2018. During the third quarter of 2017, the Company initiated a dose-ranging, open-label Phase 2a clinical trial of Zimura in combination with the anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis (ranibizumab) in patients with wet AMD who have not been previously treated with any anti-VEGF agents. Based on the current enrollment rate, the Company expects initial top-line data from this trial to be available by the end of 2018. As of December 31, 2017, the Company had $167 million in cash and cash equivalents. Based on the Company's current 2018 business plan, including continuation of its development programs for Zimura and initiation of its collaborative gene therapy research programs, the Company expects the cash required to fund its operations and capital expenditures for 2018 will range between $50 million and $55 million. This estimate does not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies or associated development that the Company may pursue.The co also announced today that the Company has initiated an innovative gene therapy research collaboration focused on applying novel gene therapy technology to discover and develop next-generation therapies for the treatment of ocular diseases. As part of Ophthotech's strategy, the Company has entered into a series of sponsored research agreements with the University of Massachusetts Medical School and its Horae Gene Therapy Center to utilize their "minigene" therapy approach and other novel gene delivery technologies to target retinal diseases.