Le Lézard
Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Iveric Bio Reports Fourth Quarter and Year End 2020 Operational Highlights and Financial Results


IVERIC bio, Inc. (Nasdaq: ISEE) today announced financial and operating results for the fourth quarter and full year ended December 31, 2020 and provided a general business update.

The Company also announced that patient enrollment and retention for GATHER2, its second Phase 3 clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) are progressing well with enrollment ahead of schedule. The Company is accelerating the timeline for when it expects to complete enrollment in GATHER2 to the third quarter of 2021. If the prespecified 12-month results from GATHER2 are positive, the Company plans to file applications with the results from GATHER1 and GATHER2 to the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA.

"We start 2021 with significant momentum as we continue to enroll patients into our Zimura GATHER2 clinical trial and now expect to complete enrollment in the third quarter of this year," stated Glenn P. Sblendorio, Chief Executive Officer and President of Iveric Bio. "We are extremely encouraged by the progress of our clinical trial sites to enroll and retain patients. We continue to work with our investigators to provide a safe environment for patients, which we believe increases the patients' comfort and confidence to participate in the GATHER2 clinical trial. We are committed to continuing patient enrollment and retention aggressively in the GATHER2 clinical trial while prioritizing patient safety."

Pravin U. Dugel, M.D., Chief Strategy and Business Officer of Iveric Bio added, "Although bringing Zimura to patients suffering from geographic atrophy secondary to age-related macular degeneration remains our top priority, in 2021 and thereafter we will continue to explore the potential development of Zimura in earlier stages of age-related macular degeneration as well as neovascular (wet) macular degeneration. Additionally, in our IC-500 program, we are pursuing HtrA1 inhibition as a target in the treatment of GA and potentially earlier stages of AMD. We are focused on advancing our pipeline of both therapeutic and gene therapy product candidates for treating retinal diseases with the potential to create long-term shareholder value."

Therapeutics Programs Targeting Age-Related Macular Degeneration

Zimura® (avacincaptad pegol): Complement C5 Inhibitor

IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor

Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

Corporate Highlights

During 2020, the Company expanded its Board of Directors and management by adding a number of leading industry experts. Mark S. Blumenkranz, M.D., M.M.S., HJ Smead Professor Emeritus, Department of Ophthalmology, Stanford University joined the Company's board of directors in July 2020. Pravin U. Dugel, M.D. joined the Company as Chief Strategy and Business Officer in March 2020. Dr. Dugel was previously Managing Partner, Retinal Consultants of Arizona and the Retinal Research Institute; Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California; and Founding Member, Spectra Eye Institute in Sun City, Arizona. Dhaval Desai, PharmD, joined the Company as Chief of Staff in August 2020. Previously, Mr. Desai served as Medical Unit Head at Novartis Eye Care.

In June 2020, the Company raised approximately $150 million in net proceeds in an underwritten public offering of common stock, and pre-funded warrants in lieu of common stock, and a concurrent private placement of common stock.

Fourth Quarter and Year End 2020 Operational Update and 2021 Cash Guidance

2020 Financial Highlights

Conference Call/Web Cast Information

Iveric Bio will host a conference call/webcast to discuss the Company's financial and operating results and provide a business update. The call is scheduled for March 3, 2021 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-221-3881 (USA) or 323-794-2590 (International), passcode 9597743. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the Iveric Bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA), passcode 9597743.

About Iveric Bio

Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. The Company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases. Vision is Our Mission. For more information on the Company, please visit www.ivericbio.com.

Forward-looking Statements

Any statements in this press release about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company's strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "seek," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. In this press release, the Company's forward looking statements include statements about its expectations regarding patient enrollment and patient retention in its second Phase 3 trial (GATHER2) of Zimura in geographic atrophy secondary to AMD and use of the results from its completed clinical trial of Zimura for the treatment of geographic atrophy secondary to AMD (GATHER1) as a Phase 3 trial, its development and regulatory strategy for Zimura and its other product candidates, including additional indications that the Company may pursue for the development of Zimura and IC-500, the implementation of its business plan, its expectations regarding expected cash, cash equivalents and available for sale securities and the sufficiency of its cash resources, the timing, progress and results of clinical trials and other research and development activities and regulatory submissions, the potential utility of its product candidates, the potential for its business development strategy and its personnel and human capital resources. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the progression and duration of the COVID-19 pandemic and responsive measures thereto and related effects on the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, including enrollment and retention in clinical trials, availability of data from these programs, reliance on contract development and manufacturing organizations, university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, developments from the Company's competitors and the marketplace for the Company's products, need for additional financing and negotiation and consummation of business development transactions and other factors discussed in the "Risk Factors" section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company's views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

ISEE-G

 
IVERIC bio, Inc.
Selected Financial Data (unaudited)
(in thousands, except per share data)
 

 Three Months Ended December 31, 

 

 Year Ended December 31, 

2020

 

2019

 

2020

 

2019

 
Statements of Operations Data:                
Operating expenses:
Research and development  

 $

                       17,473

 

 

 $

                       11,567

 

 

 $

                       62,784

 

 

 $

                       39,644

 

General and administrative

 

                            8,022

 

 

                            6,275

 

 

                          25,952

 

 

                          21,628

 

Total operating expenses  

 

                          25,495

 

 

 

                          17,842

 

 

 

                          88,736

 

 

 

                          61,272

 

Loss from operations

 

                        (25,495

)

 

                        (17,842

)

 

                        (88,736

)

 

                        (61,272

)

Interest income  

 

                                 63

 

 

 

                               369

 

 

 

                               500

 

 

 

                            2,151

 

Other income (expense), net

 

                                 -

 

 

                                 -

 

 

                                 (6

)

 

                               151

 

Loss before income tax provision (benefit)  

 

                        (25,432

)

 

 

                        (17,473

)

 

 

                        (88,242

)

 

 

                        (58,970

)

Income tax provision (benefit)

 

                                 -

 

 

                                   5

 

 

                          (3,695

)

 

                             (111

)

Net loss  

 $

                     (25,432

)

 

 $

                     (17,478

)

 

 $

                     (84,547

)

 

 $

                     (58,859

)

Net loss per common share:
Basic and diluted  

 $

                         (0.27

)

 

 $

                         (0.39

)

 

 $

                         (1.14

)

 

 $

                         (1.39

)

Weighted average common shares outstanding:
Basic and diluted  

 

                          92,810

 

 

 

                          44,413

 

 

 

                          74,185

 

 

 

                          42,224

 

December 31, 2020 December 31, 2019
(in thousands)
Balance Sheets Data:        
Cash, cash equivalents and marketable securities

 $

                     210,047

 

 $

                     125,699

 

Total assets  

 $

                     216,754

 

 

 $

                     130,187

 

Total liabilities

 $

                       25,191

 

 $

                       12,984

 

Additional paid-in capital  

 $

                     756,543

 

 

 $

                     597,679

 

Accumulated deficit

 $

                   (565,073

)

 $

                   (480,526

)

Total stockholders' equity  

 $

                     191,563

 

 

 $

                     117,203

 

 


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