1. - Patient Enrollment for GATHER2 Clinical Trial of Zimura® for the Treatment of Geographic Atrophy Secondary to Age-related Macular Degeneration Ahead of Target and Progressing Well; Completion of Enrollment Expected in 3Q of this Year -

    - Conference Call and Webcast Today, March 3, 2021, at 8:00 a.m. ET -

    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…

    - Patient Enrollment for GATHER2 Clinical Trial of Zimura® for the Treatment of Geographic Atrophy Secondary to Age-related Macular Degeneration Ahead of Target and Progressing Well; Completion of Enrollment Expected in 3Q of this Year -

    - Conference Call and Webcast Today, March 3, 2021, at 8:00 a.m. ET -

    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

    • In April 2020, the U.S. FDA granted Fast Track designation for Zimura for the treatment of GA secondary to dry AMD.
    • In June 2020, the Company announced positive 18-month results from GATHER1, its first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. The 18-month data supports the previously announced 12-month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. Zimura was generally well tolerated after 18 months of administration.
    • In late June 2020, the Company announced that the first patient had been dosed in the GATHER2 clinical trial.
    • In September 2020, the Company announced that the positive 12-month Phase 3 results from its GATHER1 clinical trial with Zimura were published in Ophthalmology®, the Journal of the American Academy of Ophthalmology.
    • In February 2021, Dr. Dugel presented the positive results from GATHER1 at the Angiogenesis, Exudation, Degeneration 2021 – Virtual Edition meeting.
    • The Company increased the enrollment target in its ongoing Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease. After initially enrolling 95 patients in this trial, the Company plans to enroll approximately 25 additional patients, with the goal of enrolling a total of 120 patients.

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

    • The Company recently revised its development plans for IC-500 to include plans to investigate multiple dosing schedules for this product candidate. Based on current timelines, the Company expects to submit an IND to the FDA for IC-500 in GA secondary to AMD in the second half of 2022.

    Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)

      The Company is preparing an IND for IC-100 and plans to meet with regulatory authorities to discuss its selected doses for a first-in-human clinical trial prior to the submission. The Company plans to file an IND for IC-100 with the FDA and begin enrolling patients in a Phase 1/2 clinical trial for IC-100 in the second half of 2021.
    • IC-200: BEST1-Related IRDs

      The Company is completing IND-enabling activities for IC-200 and plans to file an IND for IC-200 with the FDA and begin enrolling patients in a Phase 1/2 clinical trial for IC-200 in the second half of 2021.
    • Minigene Programs

      The Company, in collaboration with the University of Massachusetts Medical School (UMMS), continues to advance its minigene programs for Leber Congenital Amaurosis Type 10 (LCA10), autosomal recessive Stargardt Disease (ABCA4), and USH2A-related IRDs. The Company expects to select a lead construct for its LCA10 minigene program in the second quarter of 2021. The Company expects to obtain additional results from its Stargardt Disease minigene program in the first half of 2021. The Company expects to obtain preliminary results from its USH2A minigene program in the first half 2021.

    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

    • As of December 31, 2020, the Company had $210 million in cash, cash equivalents and available for sale securities.
    • The Company estimates its year-end 2021 cash, cash equivalents and available for sale securities will range between $130 and $140 million. The Company also estimates that its cash, cash equivalents and available for sale securities will be sufficient to fund its planned capital expenditure requirements and operating expenses, excluding any potential approval or sales milestones payable to Archemix Corp. or any commercialization expenses for Zimura, into 2024. These estimates are based on the Company's current business plan, including the continuation of its ongoing clinical development programs for Zimura, the progression of its IC-100 and IC-200 programs into the clinic, and the advancement of its IC-500 development program. These estimates also assume that the Company will enroll approximately 400 patients in the GATHER2 trial. These estimates do not reflect any additional expenditures related to potentially studying Zimura in other indications or resulting from the potential in-licensing or acquisition of additional product candidates or technologies or commencement of new sponsored research programs, and any associated development the Company may pursue.

    2020 Financial Highlights

    • R&D Expenses: Research and development expenses were $17.5 million for the quarter ended December 31, 2020, compared to $11.6 million for the same period in 2019. For the year ended December 31, 2020, research and development expenses were $62.8 million compared to $39.6 million for 2019. Research and development expenses increased primarily due to the initiation of GATHER2 and increased manufacturing activities for Zimura, increased manufacturing and preclinical development activities associated with the Company's IC-100 and IC-200 gene therapy programs and the progression of its IC-500 development program.
    • G&A Expenses: General and administrative expenses were $8.0 million for the quarter ended December 31, 2020, compared to $6.3 million for the same period in 2019. For the year ended December 31, 2020 general and administrative expenses were $26.0 million compared to $21.6 million for 2019. General and administration expenses increased primarily due to increases in general consulting costs and professional fees.
    • Income Tax (Benefit): Income tax benefits of $3.7 million and $0.1 million for the years ended December 31, 2020 and 2019, respectively, were recognized to reflect the favorable settlement of local tax audits.
    • Net Income: The Company reported a net loss for the quarter ended December 31, 2020 of $25.4 million, or ($0.27) per diluted share, compared to a net loss of $17.5 million, or ($0.39) per diluted share, for the same period in 2019. For the year ended December 31, 2020, the Company reported a net loss of $84.5 million or ($1.14) per diluted share, compared to a net loss of $58.9 million or ($1.39) for the same period in 2019.

    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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  2. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on March 1, 2021, the Company granted non-statutory stock options to purchase an aggregate of 41,500 shares of the Company's common stock to 2 newly hired, non-executive employees. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock options have an exercise price of $6.49 per share, equal to the closing price of Iveric Bio's common…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on March 1, 2021, the Company granted non-statutory stock options to purchase an aggregate of 41,500 shares of the Company's common stock to 2 newly hired, non-executive employees. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock options have an exercise price of $6.49 per share, equal to the closing price of Iveric Bio's common stock on March 1, 2021. Each stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on March 1, 2022 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The vesting of each grant is subject to the employee's continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    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.

    ISEE-G

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  3. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President, and Pravin U. Dugel, M.D., Chief Strategy and Business Officer, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference virtually on Thursday, March 4 at 9:50 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About Iveric Bio

    Iveric Bio is a science-driven biopharmaceutical company focused on…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President, and Pravin U. Dugel, M.D., Chief Strategy and Business Officer, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference virtually on Thursday, March 4 at 9:50 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    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 Iveric Bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent Iveric Bio's views only as of the date of this press release. Iveric Bio anticipates that subsequent events and developments will cause its views to change. While Iveric Bio may elect to update these forward-looking statements at some point in the future, Iveric Bio specifically disclaims any obligation to do so.

    ISEE-G

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  4. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its fourth quarter and full year 2020 financial and operating results on Wednesday, March 3, 2021. Following the announcement, the Iveric Bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    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…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its fourth quarter and full year 2020 financial and operating results on Wednesday, March 3, 2021. Following the announcement, the Iveric Bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    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 Toll Free), 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 Iveric Bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent Iveric Bio's views only as of the date of this press release. Iveric Bio anticipates that subsequent events and developments will cause its views to change. While Iveric Bio may elect to update these forward-looking statements at some point in the future, Iveric Bio specifically disclaims any obligation to do so.

    ISEE-G

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  5. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on January 4, 2021, the Company granted non-statutory stock options to purchase an aggregate of 28,000 shares of the Company's common stock to two newly hired, non-executive employees. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock options have an exercise price of $6.895 per share, equal to the closing price of IVERIC bio's common…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on January 4, 2021, the Company granted non-statutory stock options to purchase an aggregate of 28,000 shares of the Company's common stock to two newly hired, non-executive employees. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock options have an exercise price of $6.895 per share, equal to the closing price of IVERIC bio's common stock on January 4, 2021. Each stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on January 4, 2022 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The vesting of each grant is subject to the employee's continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    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.

    ISEE-G

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  6. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President, will present an overview of the Company at the 39th Annual J.P. Morgan Healthcare Conference in a virtual session on Thursday, January 14, 2021 at 2:50 p.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio

    IVERIC bio is a science-driven biopharmaceutical company focused on the discovery and development of novel…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President, will present an overview of the Company at the 39th Annual J.P. Morgan Healthcare Conference in a virtual session on Thursday, January 14, 2021 at 2:50 p.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  7. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on December 3, 2020, the Company granted a newly hired employee equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan. The inducement grants were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors and were made as a material inducement to the employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of the employee's employment compensation.

    The inducement grants consisted of a non-statutory option to purchase 34,000 shares of the Company's common stock, a grant of 7,000 restricted stock units for shares of the Company's common stock.

    The stock…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on December 3, 2020, the Company granted a newly hired employee equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan. The inducement grants were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors and were made as a material inducement to the employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of the employee's employment compensation.

    The inducement grants consisted of a non-statutory option to purchase 34,000 shares of the Company's common stock, a grant of 7,000 restricted stock units for shares of the Company's common stock.

    The stock option has an exercise price of $6.37 per share, equal to the closing price of IVERIC bio's common stock on December 3, 2020. The stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on December 3, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The grant of 7,000 restricted stock units for shares of the Company's common stock vests with respect to 100% of the shares underlying the grant on December 3, 2021. The vesting of each grant is subject to the employees continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    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.

    ISEE-G

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  8. - Conference Call and Webcast Today, November 2, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fiscal quarter ended September 30, 2020 and provided a general business update.

    "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…

    - Conference Call and Webcast Today, November 2, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fiscal quarter ended September 30, 2020 and provided a general business update.

    "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."

    Therapeutics Programs Targeting Age-Related Macular Degeneration

    • Zimura® (avacincaptad pegol): Complement C5 Inhibitor

      In September 2020, the Company announced that the positive Phase 3 results from its GATHER1 clinical trial with Zimura were published in Ophthalmology®, the Journal of the American Academy of Ophthalmology. The published article is available online at https://www.aaojournal.org/article/S0161-6420(20)30845-9/fulltext.
    • Today, the Company announced that the positive GATHER1 data from the first Zimura Phase 3 clinical trial will be presented at the 2020 American Academy of Ophthalmology - Retina Subspecialty Day Virtual Annual Meeting, November 13, 2020 at 6:10pm ET by Dr. Donald J. D'Amico, Professor and Chairman of Ophthalmology at Weill Cornell Medical College and Ophthalmologist-in-Chief at the New York Presbyterian Hospital.

    The GATHER1 data were recently presented at the following virtual conferences:

    • Virtual EURETINA Annual Meeting, by Dr. Frank G. Holz, Professor and Chair of the Department of Ophthalmology, University of Bonn, Germany;
    • Retina Society Annual Meeting, by Dr. Carl D. Regillo, Chief, Retina Services at Wills Eye Hospital;
    • Meeting of the Club Jules Gonin, by Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology and a member of the Vitreoretinal Faculty at Duke University Eye; and
    • American Society of Retina Specialists Annual Meeting, by Dr. Baruch D. Kuppermann, Chairman of the Department of Ophthalmology at UC Irvine.
    • In late June 2020, the Company announced that the first patient had been dosed in GATHER2, its second Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. If 12-month results from GATHER2 are positive, the Company plans to file applications with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA.

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

    • The Company selected a lead product candidate from its HtrA1 inhibitor program, which it will refer to as IC-500. Based on current timelines, the Company is planning to submit an IND to the FDA for IC-500 in GA secondary to AMD in the second half of 2021.

    Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) and IC-200: BEST1-Related IRDs

      IND-enabling activities for IC-100 and IC-200, and natural history studies for IC-200, are ongoing. The Company plans to file an IND for IC-100 with the FDA in early 2021 and begin enrolling patients in a Phase 1/2 clinical trial for IC-100 during the first half of 2021. The Company plans to file an IND for IC-200 with the FDA in the middle of 2021 and begin enrolling patients in a Phase 1/2 clinical trial for IC-200 in the second half of 2021.
    • Minigene Programs

      The Company, in collaboration with the University of Massachusetts Medical School, continues to advance its minigene programs for Leber Congenital Amaurosis Type 10 (LCA10), autosomal recessive Stargardt Disease (ABCA4), and USH2A-related IRDs. The Company expects to select a lead construct for its LCA10 minigene program in the fourth quarter of 2020 or early 2021. The Company expects to obtain additional results from its Stargardt Disease minigene program in early 2021. The Company expects to obtain preliminary results from its USH2A minigene program in early 2021.

    Corporate Update

    In July 2020, Mark S. Blumenkranz, M.D., M.M.S., joined the Company's board of directors. Dr. Blumenkranz is a biotechnology industry leader and internationally known Vitreo-Retinal Specialist with notable expertise in pharmaceuticals for age-related macular degeneration and ocular gene therapy.

    Third Quarter 2020 Operational Update and Cash Guidance

    As of September 30, 2020, the Company had $231.1 million in cash, cash equivalents and available for sale securities. The Company has revised its estimated year-end 2020 cash, cash equivalents and available for sale securities to range between $210 million and $215 million, reflecting the impact of a fourth quarter $6.0 million milestone payment to Archemix Corp. The Company also estimates that its cash, cash equivalents and available for sale securities will be sufficient to fund its planned capital expenditure requirements and operating expenses, excluding any potential approval or sales milestones payable to Archemix Corp. or any commercialization expenses for Zimura, through at least mid-2024. These estimates are based on the Company's current business plan, including the continuation of its ongoing clinical development programs for Zimura, the progression of its IC-100 and IC-200 programs into the clinic, and the advancement of its IC-500 development program. These estimates also assume that the Company will enroll approximately 400 patients in the GATHER2 trial. These estimates do not reflect any additional expenditures related to potentially studying Zimura in other indications or resulting from the potential in-licensing or acquisition of additional product candidates or technologies or commencement of new sponsored research programs, and any associated development the Company may pursue.

    2020 Q3 Financial Highlights

    • R&D Expenses: Research and development expenses were $18.8 million for the quarter ended September 30, 2020, compared to $10.4 million for the same period in 2019. For the nine months ended September 30, 2020, research and development expenses were $45.3 million compared to $28.1 million for the same period in 2019. Research and development expenses increased primarily due to increased manufacturing and preclinical development activities associated with the Company's IC-100 and IC-200 gene therapy programs, the completion of its GATHER1 clinical trial, the initiation of its GATHER2 clinical trial and the progression of its IC-500 development program.
    • G&A Expenses: General and administrative expenses were $6.6 million for the quarter ended September 30, 2020, compared to $4.7 million for the same period in 2019. For the nine months ended September 30, 2020, general and administrative expenses were $17.9 million compared to $15.4 million for the same period in 2019. General and administration expenses increased primarily due to increases in general consulting costs and professional fees.
    • Net Income: The Company reported a net loss for the quarter ended September 30, 2020 of $25.5 million, or ($0.27) per diluted share, compared to net loss of $14.4 million, or ($0.35) per diluted share, for the same period in 2019. For the nine months ended September 30, 2020, the Company reported a net loss of $59.1 million or ($0.87) per diluted share, compared to a net loss of $41.4 million or ($1.00) for the same period in 2019.

    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 November 2, 2020 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 866-575-6539 (USA) or 323-794-2575 (International), passcode 6339331. 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 6339331.

    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.

    Website Disclaimer

    We have included website addresses in this press release solely as inactive references. The information contained on, or that can be accessed through, such websites is not a part of this press release.

    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 to use the results of 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, 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, and the potential for its business development strategy. 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, 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, 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.

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

    Three Months Ended September 30,

     

    Nine Months Ended September 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

     
    Statements of Operations Data:
    Operating expenses:
    Research and development

    $

    18,841

     

    $

    10,383

     

    $

    45,311

     

    $

    28,077

     

    General and administrative

     

    6,643

     

     

    4,674

     

     

    17,930

     

     

    15,353

     

    Total operating expenses

     

    25,484

     

     

    15,057

     

     

    63,241

     

     

    43,430

     

    Loss from operations

     

    (25,484

    )

     

    (15,057

    )

     

    (63,241

    )

     

    (43,430

    )

    Interest income

     

    33

     

     

    495

     

     

    437

     

     

    1,782

     

    Other income (expense)

     

    1

     

     

    -

     

     

    (6

    )

     

    151

     

    Loss before income tax benefit

     

    (25,450

    )

     

    (14,562

    )

     

    (62,810

    )

     

    (41,497

    )

    Income tax benefit

     

    -

     

     

    (125

    )

     

    (3,695

    )

     

    (116

    )

    Net loss

    $

    (25,450

    )

    $

    (14,437

    )

    $

    (59,115

    )

    $

    (41,381

    )

    Net loss per common share:
    Basic and diluted

    $

    (0.27

    )

    $

    (0.35

    )

    $

    (0.87

    )

    $

    (1.00

    )

    Weighted average common shares outstanding:
    Basic and diluted

    $

    92,675

     

    $

    41,552

     

    $

    67,931

     

    $

    41,486

     

     
    September 30, 2020 December 31, 2019
    (in thousands)
    Balance Sheets Data:
    Cash, cash equivalents and marketable securities

    $

    231,122

     

    $

    125,699

     

    Total assets

    $

    234,595

     

    $

    130,187

     

    Total liabilities

    $

    20,009

     

    $

    12,984

     

    Additional paid-in capital

    $

    754,136

     

    $

    597,679

     

    Accumulated deficit

    $

    (539,641

    )

    $

    (480,526

    )

    Total stockholders' equity

    $

    214,586

     

    $

    117,203

     

     

    ISEE-G

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  9. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the Company will participate in the following, upcoming, virtual investor conferences in November:

    • 29th Annual Credit Suisse Virtual Healthcare Conference
      Glenn P. Sblendorio, Chief Executive Officer and President and Pravin U. Dugel, M.D., Executive Vice President and Chief Strategy and Business Officer will participate in a fireside chat on Tuesday, November 10, 2020, at 8:00 a.m. ET.
    • Stifel 2020 Virtual Healthcare Conference
      Dr. Dugel will present an overview of the Company on Monday, November 16, 2020 at 11:20 a.m. ET.

    Investors and the general public are invited to listen to the live webcasts available on the Investors / Events section of the IVERIC bio website at www.ivericbio.com

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the Company will participate in the following, upcoming, virtual investor conferences in November:

    • 29th Annual Credit Suisse Virtual Healthcare Conference

      Glenn P. Sblendorio, Chief Executive Officer and President and Pravin U. Dugel, M.D., Executive Vice President and Chief Strategy and Business Officer will participate in a fireside chat on Tuesday, November 10, 2020, at 8:00 a.m. ET.
    • Stifel 2020 Virtual Healthcare Conference

      Dr. Dugel will present an overview of the Company on Monday, November 16, 2020 at 11:20 a.m. ET.

    Investors and the general public are invited to listen to the live webcasts available on the Investors / Events section of the IVERIC bio website at www.ivericbio.com. An archived replay will be available on the Company's website immediately following the conferences and for at least two weeks thereafter.

    The Company will also participate in the following industry conference:

    • Eyecelerator 2020 Virtual Conference

      Dr. Dugel will present an overview of the Company and participate in a panel discussion titled, "Modulating Senescence, Complement and Cell Death Pathways to Save Vision. Endpoints and Regulatory Considerations. Current, GA Trials, Compare and Contrast. Combination Therapy to Inhibit CNV and Geographic Atrophy. The Patients' Perspective." during the Eyecelerator Retina Livestream on Friday, October 30, 2020 between 12:00 p.m. – 2:00 p.m. ET. To listen to the livestream visit https://www.eyecelerator.com/live-stream-october-2020. He will also participate in a panel discussion titled, "Opportunities and Challenges for Medium-Sized Companies" on November 6, 2020 at 4:00 p.m. ET.
    • OIS Drug Delivery Innovation Showcase on November 5, 2020 between 1:00 p.m. – 4:00 p.m. ET Dr. Dugel will present an overview of the Company. To listen to the presentation visit https://ois.net/ois-drug-delivery-showcase.

    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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  10. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its third quarter 2020 financial and operating results on Monday, November 2, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 866-575-6539 (USA) or 323-794-2575 (International), passcode 6339331. 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…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its third quarter 2020 financial and operating results on Monday, November 2, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 866-575-6539 (USA) or 323-794-2575 (International), passcode 6339331. 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 6339331.

    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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

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  11. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on October 1, 2020, the Company granted a newly hired employee a non-statutory option to purchase 14,000 shares of the Company's common stock. This grant was made pursuant to the Company's 2019 Inducement Stock Incentive Plan (as amended), was approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and was made as a material inducement to such employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of the employee's employment compensation.

    The stock option has an exercise price of $5.98 per share, equal to the closing price of IVERIC bio's common stock on October 1, 2020. The…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on October 1, 2020, the Company granted a newly hired employee a non-statutory option to purchase 14,000 shares of the Company's common stock. This grant was made pursuant to the Company's 2019 Inducement Stock Incentive Plan (as amended), was approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and was made as a material inducement to such employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of the employee's employment compensation.

    The stock option has an exercise price of $5.98 per share, equal to the closing price of IVERIC bio's common stock on October 1, 2020. The stock option has a ten-year term and vests over four years, with 25% of the shares underlying the option vesting on October 1, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The vesting of the option is subject to the employee's continued service with the Company through the applicable vesting date. The inducement grant is subject to the terms and conditions of the award agreement covering the grant and the Company's 2019 Inducement Stock Incentive Plan (as amended).

    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.

    ISEE-G

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  12. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the Company will participate in the following upcoming virtual investor conferences in September:

    • Citi 15th Annual BioPharma Virtual Conference 2020 on Wednesday, September 9 and Thursday, September 10, 2020, IVERIC bio will host meetings with investors.
    • Cantor Virtual Global Healthcare Conference 2020 on Wednesday, September 16, 2020 at 8:00 a.m. ET, investors and the general public are invited to listen to a live webcast of a fireside chat with Glenn P. Sblendorio, Chief Executive Officer and President and Pravin U. Dugel, M.D., Chief Strategy and Business Officer, available on the Investors / Events section of the IVERIC bio website at www.ivericbio.com. An archived replay will be available…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the Company will participate in the following upcoming virtual investor conferences in September:

    • Citi 15th Annual BioPharma Virtual Conference 2020 on Wednesday, September 9 and Thursday, September 10, 2020, IVERIC bio will host meetings with investors.
    • Cantor Virtual Global Healthcare Conference 2020 on Wednesday, September 16, 2020 at 8:00 a.m. ET, investors and the general public are invited to listen to a live webcast of a fireside chat with Glenn P. Sblendorio, Chief Executive Officer and President and Pravin U. Dugel, M.D., Chief Strategy and Business Officer, available on the Investors / Events section of the IVERIC bio website at www.ivericbio.com. An archived replay will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    The Company will also participate in the following retina showcase:

    • Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase on Thursday, September 10, 2020 at 1:36 p.m. ET. Dr. Dugel will present an overview of the Company. To listen to the presentation visit the Investors / Events section of the IVERIC bio website at www.ivericbio.com.

    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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

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  13. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on September 1, 2020, the Company granted non-statutory stock options to purchase an aggregate of 34,000 shares of the Company's common stock to two newly hired, non-executive employees. In addition, on September 1, 2020 the Company granted a newly hired employee a grant of 3,000 restricted stock units for shares of the Company's common stock. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on September 1, 2020, the Company granted non-statutory stock options to purchase an aggregate of 34,000 shares of the Company's common stock to two newly hired, non-executive employees. In addition, on September 1, 2020 the Company granted a newly hired employee a grant of 3,000 restricted stock units for shares of the Company's common stock. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock options have an exercise price of $4.53 per share, equal to the closing price of IVERIC bio's common stock on September 1, 2020. Each stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on September 1, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The restricted stock unit grant vests with respect to 100% of the shares underlying the grant on September 1, 2021. The vesting of each grant is subject to the employee's continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    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.

    ISEE-G

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  14. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the positive Phase 3 results from its GATHER1 clinical trial with Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) were published in Ophthalmology®, the Journal of the American Academy of Ophthalmology. Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in GATHER1, which was an international, multicenter, randomized, double masked, sham controlled clinical trial. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the positive Phase 3 results from its GATHER1 clinical trial with Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) were published in Ophthalmology®, the Journal of the American Academy of Ophthalmology. Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in GATHER1, which was an international, multicenter, randomized, double masked, sham controlled clinical trial. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared to the corresponding sham control group. The data for both dose groups were statistically significant. Zimura was generally well tolerated in the GATHER1 clinical trial.

    The published article, entitled "C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial," is now available online at https://www.aaojournal.org/article/S0161-6420(20)30845-9/fulltext?dgcid=raven_jbs_aip_email.

    "These published data bring Zimura one step closer as a potential treatment for patients with GA secondary to AMD, who currently do not have any treatment options available to them," said Glenn Jaffe, M.D., lead author and Robert Machemer Professor of Ophthalmology, Chief of the Department of Ophthalmology Retina Division, Duke University. "Because Zimura inhibits C5 which is downstream in the complement cascade, upstream homeostatic complement activities including C3 are preserved. Zimura had a favorable safety profile. A treatment effect for the Zimura 2 mg and 4 mg groups was observed as early as 6 months. GATHER1 is currently the only Phase 3 clinical trial I am aware of showing early suppression of GA growth which continued throughout the trial with continuous treatment out to 18 months."

    "We are privileged to have the positive results of the Zimura GATHER1 clinical trial published in Ophthalmology, the highly-respected and peer-review publication of the American Academy of Ophthalmology," stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio. "Our second Phase 3 clinical trial, GATHER2, is currently underway to further evaluate the efficacy and safety of Zimura in patients with geographic atrophy. If the primary efficacy endpoint is met at 12 months in the GATHER 2 trial, we plan to file for registration with the US and European regulatory authorities following receipt of that data. The absence of treatment options for geographic atrophy represents an area of urgent unmet medical need and a major public health concern for the expanding aging population."

    "We want to thank all the patients, clinical trial investigators and their staffs for their support and participation in this well conducted trial. We believe these robust, published, Phase 3 clinical data should further increase the enthusiasm for our ongoing GATHER2 clinical trial," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio.

    In the Company's second Phase 3 clinical trial for Zimura in GA secondary to AMD, known as GATHER2, approximately 400 patients will be randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth at 12 months will be performed. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. The final evaluation will take place at month 24.

    Geographic Atrophy

    Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

    Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. Zimura is designed to inhibit complement factor C5 cleavage into C5a and C5b. By inhibiting the formation of complement C5 terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC). This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial (RPE) cells and slow down the progression of GA.

    GATHER1 Clinical Trial

    286 patients were enrolled in the GATHER1 clinical trial, with patients receiving Zimura 1 mg, Zimura 2 mg, Zimura 4 mg or a sham injection monthly for 18 months. Efficacy data from patients receiving Zimura 1 mg was not part of the prespecified primary statistical analysis.

    In June 2018, IVERIC bio announced 18-month data from GATHER1 supporting the published 12 month data from this trial. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control group. The pre-specified efficacy analysis for the primary endpoint was performed at month 12 using all of the power in the trial to detect a statistically significant difference. Therefore, the p-values for the 18 month statistical analyses are descriptive in nature. The descriptive p-values for the treatment effects at month 18 were p=0.0014 for the Zimura 2 mg group and p=0.0021 for the Zimura 4 mg group.

    There was no Zimura-related inflammation, no Zimura-related discontinuations from the trial, no cases of endophthalmitis and no Zimura-related adverse events reported by investigators in the trial. Through month 18, the investigator reported incidence of choroidal neovascularization (CNV) in the untreated fellow eye was 11 patients (3.8%), and in the study eye was 3 patients (2.7%) in the sham control group, 2 patients (7.7%) in the Zimura 1 mg group, 8 patients (11.9%) in the Zimura 2 mg group, and 13 patients (15.7%) in the Zimura 4 mg group. The most frequently reported ocular adverse events were related to the injection procedure.

    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 the Company's expectations regarding its second Phase 3 trial (GATHER2) of Zimura in geographic atrophy secondary to AMD and to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy (GATHER1) as a Phase 3 trial, its development and regulatory strategy for Zimura, the potential clinical meaningfulness of the results of clinical trials, the Company's hypotheses regarding complement inhibition as a mechanism of action for the treatment of geographic atrophy, the implementation of its business plan, the timing, progress and results of clinical trials and other research and development activities and regulatory submissions, and the potential utility of its product candidates. 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, availability of data from these programs, reliance on collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters and need for additional financing 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

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  15. - Conference Call and Webcast Today, August 5, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fiscal quarter ended June 30, 2020 and provided a general business update.

    "Following the positive results from our GATHER1 Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration, our main priority is to aggressively drive patient recruitment and retention in GATHER2, our second Phase 3 clinical trial for the treatment of GA secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We believe GATHER1 is currently the only Phase 3 clinical trial showing early suppression of GA growth…

    - Conference Call and Webcast Today, August 5, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fiscal quarter ended June 30, 2020 and provided a general business update.

    "Following the positive results from our GATHER1 Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration, our main priority is to aggressively drive patient recruitment and retention in GATHER2, our second Phase 3 clinical trial for the treatment of GA secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We believe GATHER1 is currently the only Phase 3 clinical trial showing early suppression of GA growth which continued for 18 months with continuous treatment. The enthusiasm, resiliency and dedication of patients, physicians and their staffs fueled by their confidence in the GATHER1 Phase 3 results are exceeding our expectations."

    Mr. Sblendorio added, "During the second quarter, we strengthened our balance sheet with a public offering and a concurrent private placement. We believe this enables us to further execute on our strategy to develop and deliver retinal treatments through our Zimura, gene therapy and HtrA1 inhibitor programs, with the potential to create long-term shareholder value."

    Age-Related Macular Degeneration Programs

    Zimura® (avacincaptad pegol): Complement C5 Inhibitor

    • In June 2020, the Company announced positive 18 month results from GATHER1, its first Phase 3 clinical trial for Zimura, a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The 18 month data supports the previously announced 12 month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. Zimura was generally well tolerated after 18 months of administration.
    • The GATHER1 data was presented at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, May 3 – 7, 2020 by Karl G. Csaky, MD, T. Boone Pickens Senior Scientist and Director of the Molecular Ophthalmology Laboratory at the Retina Foundation of the Southwest, and was also presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting, July 24 – 26, 2020 by Baruch D. Kuppermann, MD, Chairman of the Department of Ophthalmology at UC Irvine.
    • In late June 2020, the Company announced that the first patient had been dosed in GATHER2, its second Phase 3 clinical trial for Zimura in development for the treatment of GA secondary to AMD. If 12 month results from GATHER2 are positive, the Company plans to file an application with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA.
    • In April 2020, the U.S. FDA granted Fast Track designation for Zimura for the treatment of GA secondary to AMD. Fast Track designation offers important benefits, including frequent interactions with the FDA and the potential eligibility for rolling submission and priority review of a New Drug Application, if relevant criteria are met.
    • The Company increased the enrollment target in its ongoing Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease. After initially enrolling 95 patients in this trial, the Company plans to enroll approximately 25 additional patients, with the goal of enrolling a total of 120 patients as was initially intended in the protocol for this trial.

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

    • The Company selected a lead product candidate from its HtrA1 inhibitor program, which it will refer to as IC-500. Based on current timelines, the Company is planning to submit an IND with the U.S. FDA for IC-500 in GA secondary to AMD in 2021.

    Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) and IC-200: BEST1-Related IRDs

      Natural history studies and IND-enabling activities for IC-100 and IC-200 are ongoing. The Company plans to begin enrolling patients in Phase 1/2 clinical trials for IC-100 during the first half of 2021 and for IC-200 in 2021.
    • Minigene Programs

      The Company, in collaboration with the University of Massachusetts Medical School, continues to advance its minigene program for Leber Congenital Amaurosis Type 10 (LCA10), autosomal recessive Stargardt Disease (ABCA4), and USH2A-related IRDs. The Company expects to select a lead construct for its LCA10 minigene program and obtain additional results for its Stargardt Disease minigene program by the end of 2020. The Company expects to obtain preliminary results from its USH2A minigene program in late 2020 or early 2021.

    Corporate Update

    In April 2020, the Company appointed Pravin U. Dugel, MD as Executive Vice President and Chief Strategy and Business Officer. In July 2020, Mark S. Blumenkranz, MD, MMS, joined its board of directors.

    Second Quarter 2020 Operational Update and Cash Guidance

    As of June 30, 2020, the Company had $245.7 million in cash and cash equivalents. 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. The Company now estimates that its year-end 2020 cash and cash equivalents will range between $215 million and $220 million. The Company also estimates that its cash and cash equivalents will be sufficient to fund its currently planned capital expenditure requirements and operating expenses, excluding any potential approval or sales milestones payable to Archemix Corp. or any commercialization expenses for Zimura, through at least mid-2024. These estimates are based on the Company's current business plan, which includes the continuation of the Company's clinical development programs for Zimura, the progression of the Company's IC-100 and IC-200 programs into the clinic, and the advancement of the Company's IC-500 development program. These estimates assume that the Company will enroll approximately 400 patients in the GATHER2 trial. These estimates do not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies, commencement of any new sponsored research programs, or any associated develop that the Company may pursue.

    2020 Q2 Financial Highlights

    • R&D Expenses: Research and development expenses were $12.7 million for the quarter ended June 30, 2020, compared to $10.0 million for the same period in 2019. For the six months ended June 30, 2020, research and development expenses were $26.5 million compared to $17.7 million for the same period in 2019. Research and development expenses increased primarily due to increased manufacturing and preclinical development costs associated with the Company's IC-100 and IC-200 gene therapy programs, the initiation and start-up activities for its GATHER2 clinical trial, manufacturing activities for Zimura and the progression of its HtrA1 inhibitor program.
    • G&A Expenses: General and administrative expenses were $6.3 million for the quarter ended June 30, 2020, compared to $5.2 million for the same period in 2019. For the six months ended June 30, 2020, general and administrative expenses were $11.3 million compared to $10.7 million for the same period in 2019. General and administration expenses increased primarily due to increases in professional fees and general consulting costs.
    • Income Tax (Benefit): Income tax benefits of $0.4 million and $3.7 million for the three and six months ended June 30, 2020, respectively, were recognized to reflect a favorable settlement of a state corporate income tax audit.
    • Net Income: The Company reported a net loss for the quarter ended June 30, 2020 of $18.6 million, or ($0.32) per diluted share, compared to a net loss of $14.4 million, or ($0.35) per diluted share, for the same period in 2019. For the six months ended June 30, 2020, the Company reported a net loss of $33.7 million or ($0.61) per diluted share, compared to a net loss of $26.9 million or ($0.65) for the same period in 2019.

    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 August 5, 2020 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-220-8451 (USA) or 323-794-2588 (International), passcode 2738321. 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 2738321.

    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 the impact of the COVID-19 pandemic on the Company's research and development programs, operations and financial position, its expectations regarding patient enrollment and patient retention in its second Phase 3 trial (GATHER2) of Zimura in geographic atrophy secondary to AMD and to use the results of its completed clinical trial of Zimura for the treatment of geographic atrophy secondary to AMD (GATHER1) as a Phase 3 trial, expectations regarding patient enrollment and patient retention in its Phase 2b screening trial of Zimura for autosomal recessive Stargardt disease, its development and regulatory strategy for Zimura and its other product candidates, the implementation of its business plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities and regulatory submissions, the potential utility of its product candidates, and the potential for its business development strategy. 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, 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, 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.

    IVERIC bio, Inc.

    Selected Financial Data (unaudited)

    (in thousands, except per share data)
     
    Three Months Ended June 30, Six Months Ended June 30,

    2020

    2019

    2020

    2019

     
    Statements of Operations Data:
    Operating expenses:
    Research and development

    $

    12,720

     

    $

    10,009

     

    $

    26,470

     

    $

    17,694

     

    General and administrative

     

    6,289

     

     

    5,198

     

     

    11,287

     

     

    10,679

     

    Total operating expenses

     

    19,009

     

     

    15,207

     

     

    37,757

     

     

    28,373

     

    Loss from operations

     

    (19,009

    )

     

    (15,207

    )

     

    (37,757

    )

     

    (28,373

    )

    Interest income

     

    46

     

     

    617

     

     

    404

     

     

    1,287

     

    Other income (expense)

     

    (12

    )

     

    151

     

     

    (7

    )

     

    151

     

    Loss before income tax provision (benefit)

     

    (18,975

    )

     

    (14,439

    )

     

    (37,360

    )

     

    (26,935

    )

    Income tax provision (benefit)

     

    (386

    )

     

    4

     

     

    (3,695

    )

     

    9

     

    Net loss

    $

    (18,589

    )

    $

    (14,443

    )

    $

    (33,665

    )

    $

    (26,944

    )

    Net loss per common share:
    Basic and diluted

    $

    (0.32

    )

    $

    (0.35

    )

    $

    (0.61

    )

    $

    (0.65

    )

    Weighted average common shares outstanding:
    Basic and diluted

    $

    57,421

     

    $

    41,477

     

    $

    55,424

     

    $

    41,452

     

    June 30, 2020 December 31, 2019
    (in thousands)
    Balance Sheets Data:
    Cash and cash equivalents

    $

    245,735

     

    $

    125,699

     

    Total assets

    $

    249,950

     

    $

    130,187

     

    Total liabilities

    $

    11,909

     

    $

    12,984

     

    Additional paid-in capital

    $

    752,143

     

    $

    597,679

     

    Accumulated deficit

    $

    (514,191

    )

    $

    (480,526

    )

    Total stockholders' equity

    $

    238,041

     

    $

    117,203

     

    ISEE-G

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  16. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, MD, Executive Vice President and Chief Strategy and Business Officer, will present an overview of the Company at the Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 9:10 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation available on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio
    IVERIC bio is a science-driven biopharmaceutical company focused on the discovery and development…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, MD, Executive Vice President and Chief Strategy and Business Officer, will present an overview of the Company at the Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 9:10 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation available on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  17. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on August 3, 2020, the Company granted Dhaval Desai, the Company's newly hired Chief of Staff, equity based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan. The inducement grants were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors and were made as a material inducement to the employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation.

    The inducement grants consisted of a non-statutory option to purchase 160,000 shares of the Company's common stock, a grant of 75,000 restricted stock units for shares of the Company's…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on August 3, 2020, the Company granted Dhaval Desai, the Company's newly hired Chief of Staff, equity based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan. The inducement grants were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors and were made as a material inducement to the employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation.

    The inducement grants consisted of a non-statutory option to purchase 160,000 shares of the Company's common stock, a grant of 75,000 restricted stock units for shares of the Company's common stock and a grant of 15,000 restricted stock units for shares of the Company's common stock.

    The stock option has an exercise price of $4.29 per share, equal to the closing price of IVERIC bio's common stock on August 3, 2020. The stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on August 3, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The grant of 75,000 restricted stock units for shares of the Company's common stock vests with respect to 25% of the shares underlying the grant on each of August 3, 2021, August 3, 2022, August 3, 2023 and August 3, 2024. The grant of 15,000 restricted stock units for shares of the Company's common stock vests with respect to 100% of the shares underlying the grant on August 3, 2021. The vesting of each grant is subject to Mr. Desai's continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    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.

    ISEE-G

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  18. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its second quarter 2020 financial and operating results on Wednesday, August 5, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 888-220-8451 (USA) or 323-794-2588 (International), passcode 2738321. 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…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its second quarter 2020 financial and operating results on Wednesday, August 5, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 888-220-8451 (USA) or 323-794-2588 (International), passcode 2738321. 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 2738321.

    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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  19. A Biotechnology Industry Leader and Internationally Known Vitreo-Retinal Specialist with Notable Expertise in Pharmaceuticals for Age-Related Macular Degeneration and Ocular Gene Therapy –

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the election of Mark S. Blumenkranz, M.D., M.M.S., HJ Smead Professor Emeritus of Ophthalmology at Stanford University, to its Board of Directors, effective as of July 15, 2020. Dr. Blumenkranz is an internationally known vitreo-retinal specialist, with notable contributions in the area of novel pharmaceuticals for macular diseases, ocular gene therapy, new laser systems, and ophthalmic tele-health and technology development.

    "As a highly-recognized retinal specialist and co-founder of multiple biotechnology…

    A Biotechnology Industry Leader and Internationally Known Vitreo-Retinal Specialist with Notable Expertise in Pharmaceuticals for Age-Related Macular Degeneration and Ocular Gene Therapy –

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the election of Mark S. Blumenkranz, M.D., M.M.S., HJ Smead Professor Emeritus of Ophthalmology at Stanford University, to its Board of Directors, effective as of July 15, 2020. Dr. Blumenkranz is an internationally known vitreo-retinal specialist, with notable contributions in the area of novel pharmaceuticals for macular diseases, ocular gene therapy, new laser systems, and ophthalmic tele-health and technology development.

    "As a highly-recognized retinal specialist and co-founder of multiple biotechnology and medical technology companies, Mark's ophthalmic expertise and extensive business experience will be of tremendous value as we continue to advance our pipeline of therapeutics for age-related retinal diseases and gene therapy product candidates for inherited retinal diseases," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio.

    "IVERIC bio has created an exceptional retinal focused pipeline that has the potential to deliver breakthrough solutions for patients," stated Dr. Blumenkranz. "It is exciting to see the advances that the Company has made in its retinal pipeline including Zimura and the new gene therapy programs. I am thrilled to join the board of directors of IVERIC bio as the Company advances to the next stage of its development."

    "Mark's experience in leading and building biotechnology companies, further strengthens our board and represents a valuable addition to the Company," stated David R. Guyer, M.D., Executive Chairman of IVERIC bio. "We welcome Mark as a board member and look forward to his contributions to IVERIC bio's future successes."

    Mark S. Blumenkranz, M.D., M.M.S.

    Mark S. Blumenkranz, M.D., M.M.S., is HJ Smead Professor Emeritus in the Department of Ophthalmology at Stanford University, where he is the co-director of the Ophthalmic Innovation Program. Dr. Blumenkranz is a co-founder and the Chief Executive Officer and Chairman of Kedalion Therapeutics and currently serves as a director of Verana Health, BVI Visitec, Combangio Corporation, and One Medical (ONEM:NASDAQ). Dr. Blumenkranz is also a Managing Director of Lagunita Biosciences, an early stage biotechnology and medical investment company and incubator.

    He was a co-founder and served on the Boards of Optimedica Corporation (acquired by AMO), Peak Surgical (acquired by Medtronics), Adverum Biotechnologies (ADVM:NASDAQ), and Oculeve (acquired by Allergan). He also co-founded Verana Health (formerly Digisight Technologies) and Combangio Corporation, both clinical-stage privately held venture backed companies in Silicon Valley, and continues to serve on their Boards. In the past he served as an independent Director at Oculex Pharmaceuticals (acquired by Allergan), and Presbia.

    Dr. Blumenkranz has a longstanding interest and expertise in university corporate technology transfer and early stage biomedical company formation and is the author of more than 160 peer reviewed articles and more than 18 issued patents including the Pascal and Catalys lasers. He is a past President of the American University Professors of Ophthalmology, the Retina Society, the Macula Society, and a Fellow Emeritus of the Corporation of Brown University, where he served as the Chair of the Medical School Committee.

    Dr. Blumenkranz received his undergraduate, graduate and medical degrees at Brown, his ophthalmic residency training at Stanford and a fellowship in vitreo-retinal diseases at the Bascom Palmer Eye Institute. He served as the Chair of the Ophthalmology Department at Stanford from 1997 until 2015 and played a leading role in the planning, fundraising and construction of the Byers Eye Institute there.

    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.

    IVERIC bio 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 the implementation of its strategic plan. 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, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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

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  20. IVERIC bio, Inc. (NASDAQ:ISEE) today announced the first patient has been dosed in GATHER2, also known as ISEE2008, the second Phase 3 clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company announced previously that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in GATHER1, also known as OPH2003, the first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. There are no U.S. Food and Drug Administration or European Medicines Agency approved treatments available for patients with GA secondary to AMD.

    "The absence of treatment…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced the first patient has been dosed in GATHER2, also known as ISEE2008, the second Phase 3 clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company announced previously that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in GATHER1, also known as OPH2003, the first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. There are no U.S. Food and Drug Administration or European Medicines Agency approved treatments available for patients with GA secondary to AMD.

    "The absence of treatment options for geographic atrophy represents an area of urgent unmet medical need and a major public health concern for the expanding aging population," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "The initiation of enrollment in GATHER2, brings us another step closer to potentially delivering a clinically meaningful therapy to patients with GA. The GATHER2 clinical trial, if positive, marks the second Phase 3 clinical trial needed to seek regulatory approval for Zimura."

    "We believe GATHER1 is currently the only Phase 3 clinical trial showing early suppression of GA growth which continued for 18 months with continuous treatment," stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio. "We have experienced impressive enthusiasm by our investigators to initiate the second Phase 3 trial, GATHER2, based on the robustness of efficacy, the strength of the statistical evidence, and the favorable safety profile of Zimura in the GATHER1 Phase 3 trial. We believe that these robust data increase comfort and confidence in our investigators to expedite recruitment and retain patients in our GATHER2 clinical trial."

    In the GATHER2 clinical trial, approximately 400 patients will be randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth at 12 months will be performed. If the 12 month results are positive, the Company plans to file an application with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA following receipt of that data. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. The final evaluation will take place at month 24.

    Geographic Atrophy

    Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

    Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. Zimura is designed to inhibit complement factor C5 cleavage into C5a and C5b. By inhibiting the formation of complement C5 terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC). This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial (RPE) cells and slow down the progression of GA.

    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 the impact of the COVID-19 pandemic on the Company's research and development programs, operations and financial position, its expectations to initiate enrollment in its second Phase 3 trial (GATHER2) of Zimura in geographic atrophy secondary to AMD and to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy (GATHER1) as a Phase 3 trial, its development and regulatory strategy for Zimura, the potential clinical meaningfulness of the results of clinical trials, the Company's hypotheses regarding complement inhibition as a mechanism of action for the treatment of geographic atrophy, the implementation of its business plan, the timing, progress and results of clinical trials and other research and development activities and the potential utility of its product candidates. 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, availability of data from these programs, reliance on collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters and need for additional financing 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

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  21. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the closing of its underwritten public offering of 28,503,220 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case, before underwriting discounts and commissions. The shares of common stock issued and sold in the public offering at the closing include 3,967,500 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discount. All of the shares and warrants in the public…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the closing of its underwritten public offering of 28,503,220 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case, before underwriting discounts and commissions. The shares of common stock issued and sold in the public offering at the closing include 3,967,500 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discount. All of the shares and warrants in the public offering were sold by the Company.

    In addition, the Company announced the closing of its concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 8,649,453 shares of its common stock to affiliates of Vivo Capital, LLC and Samsara BioCapital, LP, at a sale price equal to the price to the public in the public offering.

    The Company received net proceeds of approximately $116.9 million from the public offering, after deducting underwriting discounts and commissions and estimated offering expenses, and approximately $33.1 million from the concurrent private placement, after deducting placement agent fees and estimated offering expenses.

    Cowen and Credit Suisse acted as book-running managers for the public offering and as the placement agents for the concurrent private placement. Wedbush PacGrow acted as lead manager for the public offering.

    The public offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of an effective registration statement. A final prospectus supplement related to the public offering was filed with the Securities and Exchange Commission (the "SEC") and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing , or by telephone: (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, or by telephone: (800) 221-1037, or by emailing .

    The securities sold in the concurrent private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    ISEE-G

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  22. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an upsized underwritten public offering of 24,535,720 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case less underwriting discounts and commissions. The purchase price of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.001 per share exercise price of such pre-funded warrant. In addition, in connection with the public offering, the Company has granted the underwriters an option for a period of 30…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an upsized underwritten public offering of 24,535,720 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case less underwriting discounts and commissions. The purchase price of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.001 per share exercise price of such pre-funded warrant. In addition, in connection with the public offering, the Company has granted the underwriters an option for a period of 30 days to purchase up to an additional 3,967,500 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by the Company.

    Concurrent with the public offering, the Company has agreed to sell, subject to the consummation of the public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), 8,649,453 additional shares of its common stock to affiliates of Vivo Capital, LLC and Samsara BioCapital, LP, at a sale price equal to the price to the public in the public offering.

    The aggregate gross proceeds from the public offering and the concurrent private placement are expected to be approximately $143.9 million, before underwriting discounts and commissions, placement agent fees and offering expenses payable by the Company, and without giving effect to any exercise by the underwriters of their option to purchase additional shares.

    Cowen and Credit Suisse are acting as the book-running managers for the public offering and as placement agents for the concurrent private placement. Wedbush PacGrow is acting as lead manager for the public offering. The public offering and the concurrent private placement are expected to close on or about June 22, 2020, subject to customary closing conditions.

    The public offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of an effective registration statement. A final prospectus supplement related to the public offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained, when available, by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing , or by telephone: (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, or by telephone: (800) 221-1037, or by emailing .

    The securities to be sold in the concurrent private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the public offering and the concurrent private placement, 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," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. 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 satisfaction of customary closing conditions related to the public offering and the concurrent private placement, the progression and duration of the novel coronavirus (COVID-19) pandemic and responsive measures thereto and related effects on the financial markets and the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions, whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements on its expected timelines, and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement and the reports that the Company files with the SEC. 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

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  23. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of $50.0 million of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of $50.0 million of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares are to be offered by the Company.

    Concurrent with the public offering, the Company has agreed to sell, subject to the consummation of the public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), $35 million of its common stock to affiliates of Vivo Capital, LLC and Samsara BioCapital, LP at a sale price equal to the price of the common stock sold to the public in the public offering. The consummation of the public offering is not contingent on the consummation of the concurrent private placement.

    Cowen and Credit Suisse are acting as the book-running managers for the public offering and as placement agents for the concurrent private placement. Wedbush PacGrow is acting as lead manager for the public offering.

    A shelf registration statement on Form S-3 (File No. 333-226497) relating to the shares of common stock to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on August 15, 2018. The public offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the public offering is being filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the public offering may also be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing , or by telephone: (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, or by telephone: (800) 221-1037, or by emailing .

    The securities to be sold in the concurrent private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the proposed public offering and the concurrent private placement, 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," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. 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 market and other financial conditions, the potential completion of the proposed public offering and the concurrent private placement or the size or terms thereof, satisfaction of customary closing conditions related to the proposed public offering and the concurrent private placement, the progression and duration of the novel coronavirus (COVID-19) pandemic and responsive measures thereto and related effects on the financial markets and the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions, whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital requirements on its expected timelines, and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement and the reports that the Company files with the SEC. 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

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  24. NEW YORK, June 15, 2020 /PRNewswire/ -- IVERIC bio, Inc. (NASDAQ:ISEE) today announced positive 18 month results from the Company's first Phase 3 clinical trial (OPH2003) for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The 18 month data supports the previously announced 12 month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control…

    NEW YORK, June 15, 2020 /PRNewswire/ -- IVERIC bio, Inc. (NASDAQ:ISEE) today announced positive 18 month results from the Company's first Phase 3 clinical trial (OPH2003) for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The 18 month data supports the previously announced 12 month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control group. The pre-specified efficacy analysis for the primary endpoint was performed at month 12 using all of the power in the trial to detect a statistically significant difference. Therefore, the p-values for the 18 month statistical analyses are descriptive in nature. The descriptive p-values for the treatment effects at month 18 were p=0.0014 for the Zimura 2 mg group and p=0.0021 for the Zimura 4 mg group.



    In this trial, the treatment effect was observed as early as 6 months, with an increase in the absolute difference of the mean change in GA growth for treatment with either Zimura 2 mg or Zimura 4 mg, as compared to sham, at each subsequent time point, suggesting the progressive benefit of continuous treatment with Zimura. Zimura maintained its favorable safety profile at 18 months with no reported Zimura related adverse events, no cases of endophthalmitis and a lower rate of choroidal neovascularization (CNV) than reported for C3 inhibition. The overall 18 month data may suggest a dose response relationship. 



    "We are extremely excited by the new 18 month data from this Phase 3 clinical trial, both with respect to efficacy and safety," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "In the OPH2003 clinical trial, the 18 month results indicated continuous Zimura treatment benefit with a favorable safety profile in patients with GA secondary to AMD. This is an impressive achievement since we believe OPH2003 is currently the only Phase 3 clinical trial showing suppression of GA growth with continuous treatment for 18 months."



    "We are one step closer to potentially bringing a clinically meaningful therapy to patients with GA who currently do not have any FDA or EMA approved treatments available to them," stated Kourous A. Rezaei, MD, Chief Medical Officer of IVERIC bio. "We believe the robust 18 month efficacy data further validates the potential role of complement C5 inhibition in GA secondary to AMD and has the potential to differentiate Zimura from other product candidates in development. We are poised to initiate our second pivotal trial, ISEE2008, comparing Zimura 2 mg with sham later this month. We want to thank our patients, our clinical trial investigators and their staffs for their support and participation in this trial."



    The Company previously announced that in the OPH2003 clinical trial, Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in the international, multicenter, randomized, double masked, sham controlled clinical trial in GA secondary to AMD. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared to the corresponding sham control group. The data for both dose groups were statistically significant. 



    "I am excited about the efficacy and favorable safety profile observed in the 12 month Zimura Phase 3 data, and now the long term 18 month efficacy and safety data further confirm my belief in the role of complement C5 inhibition in the treatment of GA," stated Peter K. Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research, Cole Eye Institute and Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine. "The delta between the Zimura 2 mg and Zimura 4 mg treatment groups and the corresponding sham control groups occurred early in the study and continued over 18 months which means my patients may benefit after only a few injections and maintain this with additional treatments. Moreover, the safety profile remained favorable after 18 months of treatment."



    "We are excited by these 18 month results," stated Pravin U. Dugel, MD, Executive Vice President and Chief Strategy and Business Officer of IVERIC bio. "In the challenging COVID-19 pandemic era, we believe that we are in an advantageous position as the OPH2003 data is the only positive Phase 3 clinical data in GA secondary to AMD that we are aware of that has been reported to date. We believe that these robust data should increase investigator enthusiasm and confidence for patient recruitment and retention in our ISEE2008 clinical trial."



    OPH2003 18 Month Data



    A total of 286 patients were enrolled in this trial.



    Mean rate of change in GA growth over 18 months, was measured by fundus autofluorescence (FAF) based on readings at four time points (baseline, month 6, month 12 and month 18) and was calculated using the square root transformation of the GA area. The FAF images were assessed by an independent masked reading center. The prespecified statistical analysis plan used a model of repeated measures (MRM) to compare data for the Zimura 2 mg and Zimura 4 mg groups to the corresponding sham groups. Detailed data are shown below:

    Mean Rate of Change in Geographic Atrophy (GA) Area from Baseline to Month 18

    (Square Root Transformation)



    Cohort

    Zimura 2 mg

    (N = 67)

    Sham

    (N = 110)

    Difference

    % Difference

    P-Value

    (Descriptive)

    Mean Change in GAa (mm)

    0.430

    0.599

    0.168

    28.11%

    0.0014













    Cohort

    Zimura 4 mg

    (N = 83)

    Sham

    (N = 84)

    Difference

    % Difference

    P-Value

    (Descriptive)

    Mean Change in GAb (mm)

    0.391

    0.559

    0.167

    29.97%

    0.0021



    a Based on least squares means from MRM model, these least square means are from the MRM model, drawing on all available data at the month 18 time point, including data from groups with different randomization ratios in Part 1 and Part 2, and should not be interpreted as directly observed data.

    b These least squares means are estimates of the MRM model, drawing on all available data, at the month 18 time point.

    The graphs below illustrate the observed difference in mean rate of GA growth between each of the Zimura 2 mg and Zimura 4 mg treatment groups and their corresponding sham control groups based on the MRM analysis at both 12 months (which was previously reported) and 18 months. 

    ITT Population; Based on the least squares means from MRM Model drawing on all available data at the respective 12 month and 18 month analysis time points, including data from groups with different randomization ratios in Part 1 and Part 2, and should not be interpreted as directly observed data; Hochberg procedure used for significance testing for 12 month data. *Previously reported (PRNewsfoto/IVERIC bio, Inc.)

     

    ITT Population; Based on the least squares means from the MRM Model drawing on all available data at the respective 12 month and 18 month analysis time points; Hochberg procedure used for significance testing for 12 months data. *Previously reported (PRNewsfoto/IVERIC bio, Inc.)

    Zimura was generally well tolerated after 18 months of administration. There was no Zimura-related inflammation, no Zimura-related discontinuations from the trial, no cases of endophthalmitis and no Zimura-related adverse events. Through month 18, the reported incidence of CNV in the untreated fellow eye was 11 patients (3.8%), and in the study eye was 3 patients (2.7%) in the sham control group, 8 patients (11.9%) in the Zimura 2 mg group, and 13 patients (15.7%) in the Zimura 4 mg group. The most frequently reported ocular adverse events were related to the injection procedure. 

    The Company plans to make additional supportive information regarding the 18 month results available in its public filings with the Securities and Exchange Commission.

    Geographic Atrophy

    Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

    Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. Zimura is designed to inhibit complement factor C5 cleavage into C5a and C5b. By inhibiting the formation of complement C5 terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC). This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial (RPE) cells and slow down the progression of GA.

    Conference Call/Web Cast Information

    IVERIC bio's management team will host a conference call/webcast today at 8:00 a.m. Eastern Time to discuss the positive 18 month Zimura data. To participate in the conference call, dial 800-367-2403 (USA) or 334-777-6978 (International), passcode 7075082. 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 Toll Free), passcode 7075082.

    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 the impact of the COVID-19 pandemic on the Company's research and development programs, operations and financial position, its expectations to initiate enrollment in its second Phase 3 trial (ISEE2008) of Zimura in geographic atrophy secondary to AMD and to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy (OPH2003) as a Phase 3 trial, its development and regulatory strategy for Zimura, the potential clinical meaningfulness of the results of clinical trials, the implementation of its business plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. 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, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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

    (PRNewsfoto/IVERIC bio, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/iveric-bio-announces-positive-zimura-18-month-data-supporting-the-12-month-efficacy-findings-continuous-positive-treatment-effect-with-favorable-safety-profile-in-geographic-atrophy-secondary-to-age-related-macular-degeneration-i-301076622.html

    SOURCE IVERIC bio, Inc.

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  25. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report 18 month data from the Zimura® (avacincaptad pegol) OPH2003 Phase 3 randomized, controlled clinical trial in geographic atrophy secondary to age-related macular degeneration on Monday, June 15, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the results.

    To participate in this conference call, dial 800-367-2403 (USA) or 334-777-6978 (International), passcode 7075082. 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…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report 18 month data from the Zimura® (avacincaptad pegol) OPH2003 Phase 3 randomized, controlled clinical trial in geographic atrophy secondary to age-related macular degeneration on Monday, June 15, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the results.

    To participate in this conference call, dial 800-367-2403 (USA) or 334-777-6978 (International), passcode 7075082. 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 Toll Free), passcode 7075082.

    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 IVERIC bio's future expectations, plans and prospects, including statements regarding IVERIC bio's expectations to use its previously announced OPH2003 clinical trial of Zimura for the treatment of geographic atrophy as a Phase 3 trial, constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including expectations for regulatory matters. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  26. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on June 1, 2020, the Company granted non-statutory stock options to purchase an aggregate of 34,000 shares of the Company's common stock to two newly hired, non-executive employees. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock options have an exercise price of $4.02 per share, equal to the closing price of IVERIC bio's common…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on June 1, 2020, the Company granted non-statutory stock options to purchase an aggregate of 34,000 shares of the Company's common stock to two newly hired, non-executive employees. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock options have an exercise price of $4.02 per share, equal to the closing price of IVERIC bio's common stock on June 1, 2020. The stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on June 1, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter, subject to each employee's continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of an award agreement covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    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.

    ISEE-G

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  27. - Conference Call and Webcast Today, May 6, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fiscal quarter ended March 31, 2020 and provided a general business update.

    "From the onset of this terrible coronavirus (COVID-19) pandemic, our main priority has been the health and safety of patients and their caregivers, physicians and their staffs, and our employees and collaborators," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "The first quarter brought unprecedented times, so we chose to pause the initiation of patient enrollment in our second Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related…

    - Conference Call and Webcast Today, May 6, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fiscal quarter ended March 31, 2020 and provided a general business update.

    "From the onset of this terrible coronavirus (COVID-19) pandemic, our main priority has been the health and safety of patients and their caregivers, physicians and their staffs, and our employees and collaborators," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "The first quarter brought unprecedented times, so we chose to pause the initiation of patient enrollment in our second Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration. Due to the dedication and unwavering support of our clinical investigators and their staffs along with our experienced clinical operations team, we put into place an aggressive strategy for Zimura and continue to activate additional sites and progress other trial startup activities, including identification of potential patients, so that we can be in a position to expeditiously begin enrolling patients as soon as we determine the appropriate time to do so. We are excited that Zimura has received Fast Track designation from the U.S. FDA."

    Mr. Sblendorio added, "Following the positive efficacy results and favorable safety profile observed in our initial Phase 3 clinical trial of Zimura and along with advancing our inherited retinal disease gene therapy programs, now is the ideal time to welcome Dr. Pravin Dugel to our executive management team. Pravin brings an extensive network and long-standing relationships with the retinal medical community and the biotech/pharma ophthalmic industry. He will help lead the Company's strategy and build alliances with potential collaborators, investors and other stakeholders."

    Zimura® (avacincaptad pegol): Complement C5 Inhibitor

    • In January 2020, the Company announced the design of its second Phase 3 clinical trial of Zimura in geographic atrophy secondary to AMD, ISEE2008. The Company plans to enroll approximately 400 patients in this international, multicenter, double masked, sham controlled clinical trial. Patients will be randomized to receive either monthly administration of Zimura 2mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth over 12 months will be performed. If the primary efficacy endpoint is met at month 12, the Company plans to file applications with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. Patients who were initially randomized to the sham control arm will continue with monthly administration of sham. The final evaluation will take place at month 24.
    • On March 18, 2020, the Company announced that due to the COVID-19 pandemic, it had decided to delay the initiation of patient enrollment in the ISEE2008 trial, which was otherwise on track to begin in March 2020. The Company continues to monitor the situation closely in the United States and abroad to determine when enrollment should begin.
    • In April 2020, the U.S. FDA granted Fast Track designation for Zimura for the treatment of GA secondary to AMD. Fast Track designation offers important benefits, including frequent interactions with the FDA and the potential eligibility for Rolling Submission and Priority Review of a New Drug Application, if relevant criteria are met.
    • The Company expects topline 18-month data from its first Phase 3 clinical trial evaluating Zimura for the treatment of GA secondary to AMD, OPH2003, will be available by the end of the second quarter of 2020. The primary purpose of the 18-month timepoint is to gather additional safety data.
    • The Company's ongoing Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease, an orphan inherited retinal disease, is on track for top-line data to be available during the second half of 2020.

    Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)

    Natural history studies and IND-enabling activities for IC-100 are ongoing. The Company plans to file an IND for IC-100 by the end of 2020 or early 2021 and to begin enrolling patients in a Phase 1/2 clinical trial during the first half of 2021.

    • IC-200: BEST1-Related IRDs

    Natural history studies and IND-enabling activities for IC-200 are ongoing. The Company plans to initiate a Phase 1/2 clinical trial for IC-200 during the first half of 2021.

    • miniCEP290: Leber Congenital Amaurosis Type 10 (LCA10)

    IVERIC bio, in collaboration with the University of Massachusetts Medical School (UMass Medical School), is continuing to optimize the minigene constructs for this program with the goal of identifying a lead construct during the second half of 2020.

    • miniABCA4 Program for Stargardt Disease (STGD1)

    IVERIC bio, through its collaborative sponsored research agreement with UMass Medical School, is evaluating several ABCA4 minigene constructs in both in vitro and in vivo experiments. The Company has received preliminary results and expects to receive additional results for the miniABCA4 program during the second half of 2020.

    • miniUSH2A: USH2A-Related IRDs Including Usher Syndrome Type 2A (Usher 2A) and USH2A-Associated Nonsyndromic Autosomal Recessive Retinitis Pigmentosa

    This research program targets IRDs associated with mutations in the USH2A gene, including Usher 2A and USH2A-associated nonsyndromic autosomal recessive retinitis pigmentosa. The Company expects to receive preliminary results by late 2020.

    Corporate Update

    On April 1, 2020, IVERIC bio appointed Pravin U. Dugel, MD as Executive Vice President and Chief Strategy and Business Officer. Dr. Dugel reports to Glenn Sblendorio.

    First Quarter Financial Results and 2020 Cash Guidance

    As of March 31, 2020, the Company had $108.4 million in cash and cash equivalents. The Company now estimates that its year-end 2020 cash and cash equivalents will range between $65 million and $70 million. The Company also estimates that its cash and cash equivalents will be sufficient to fund its operations and capital expenditure requirements as currently planned into the beginning of 2022. These estimates are based on the Company's current 2020 business plan, including the initiation of the Zimura ISEE2008 Phase 3 clinical trial and the continuation of the Company's other on-going research and development programs. This estimate does not reflect any additional expenditures, including associated development costs, in the event the Company in-licenses or acquires any new product candidates or commences any new sponsored research programs.

    2020 Q1 Financial Highlights

    • R&D Expenses: Research and development expenses were $13.8 million for the quarter ended March 31, 2020, compared to $7.7 million for the same period in 2019. Research and development expenses increased primarily due to increased manufacturing and preclinical development costs associated with the Company's IC-100 and IC-200 gene therapy programs, the initiation and start-up activities for its ISEE2008 clinical trial and progression of its HtrA1 inhibitor program.
    • G&A Expenses: General and administrative expenses were $5.0 million for the quarter ended March 31, 2020, compared to $5.5 million for the same period in 2019. General and administrative expenses decreased primarily due to a decline in general consulting costs and professional fees.
    • Income Tax (benefit): An income tax benefit of $3.3 million was recognized in the quarter ended March 31, 2020 to reflect a favorable settlement of a state corporate income tax audit.
    • Net loss: The Company reported a net loss for the quarter ended March 31, 2020 of $15.1 million, or ($0.28) per diluted share, compared to a net loss of $12.5 million, or $(0.30) per diluted share, for the same period in 2019.

    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 May 6, 2020 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4148 (USA) or 323-794-2598 (International), passcode 6273033. 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 Toll Free), passcode 6273033.

    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 the impact of the COVID-19 pandemic on the Company's research and development programs, operations and financial position, its expectations to initiate enrollment in its second Phase 3 trial (ISEE2008) of Zimura in geographic atrophy secondary to AMD and to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy (OPH2003) as a Phase 3 trial, its development and regulatory strategy for Zimura, the implementation of its business plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. 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, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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 March 31,

     

    2020

     

     

    2019

     

     
    Statements of Operations Data:
    Operating expenses:
    Research and development

    $

    13,750

     

    $

    7,685

     

    General and administrative

     

    4,998

     

     

    5,481

     

    Total operating expenses

     

    18,748

     

     

    13,166

     

    Loss from operations

     

    (18,748

    )

     

    (13,166

    )

    Interest income

     

    358

     

     

    670

     

    Other income

     

    5

     

     

    -

     

    Loss before income tax provision (benefit)

     

    (18,385

    )

     

    (12,496

    )

    Income tax provision (benefit)

     

    (3,309

    )

     

    5

     

    Net Income (loss)

    $

    (15,076

    )

    $

    (12,501

    )

    Net loss per common share:
    Basic and diluted

    $

    (0.28

    )

    $

    (0.30

    )

    Weighted average common shares outstanding:
    Basic and diluted

    $

    53,426

     

    $

    41,427

     

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

    $

    108,352

     

    $

    125,699

     

    Total assets

    $

    115,714

     

    $

    130,187

     

    Total liabilities

    $

    11,084

     

    $

    12,984

     

    Additional paid-in capital

    $

    600,182

     

    $

    597,679

     

    Accumulated deficit

    $

    (495,602

    )

    $

    (480,526

    )

    Total stockholders' equity

    $

    104,630

     

    $

    117,203

     

     

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  28. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on May 1, 2020, the Company granted a newly hired, non-executive employee a non-statutory stock option to purchase 33,000 shares of the Company's common stock. This grant was made pursuant to the Company's 2019 Inducement Stock Incentive Plan, was approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and was made as a material inducement to this employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock option has an exercise price of $3.62 per share, equal to the closing price of IVERIC bio's common stock on May 1, 2020. The…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on May 1, 2020, the Company granted a newly hired, non-executive employee a non-statutory stock option to purchase 33,000 shares of the Company's common stock. This grant was made pursuant to the Company's 2019 Inducement Stock Incentive Plan, was approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and was made as a material inducement to this employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock option has an exercise price of $3.62 per share, equal to the closing price of IVERIC bio's common stock on May 1, 2020. The stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on May 1, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter, subject to the employee's continued service with the Company through the applicable vesting date. The inducement grant is subject to the terms and conditions of an award agreement covering the grant and the Company's 2019 Inducement Stock Incentive Plan.

    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.

    ISEE-G

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  29. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its first quarter 2020 financial and operating results on Wednesday, May 6, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 800-458-4148 (USA) or 323-794-2598 (International), passcode 6273033. 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…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its first quarter 2020 financial and operating results on Wednesday, May 6, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 800-458-4148 (USA) or 323-794-2598 (International), passcode 6273033. 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 Toll Free), passcode 6273033.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  30. SEC Form 4
    FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549

    STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

    Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934
    or Section 30(h) of the Investment Company Act of 1940
    OMB APPROVAL
    OMB Number: 3235-0287
    Estimated average burden
    hours per response: 0.5
      
    Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
    1. Name and Address of Reporting Person*
    SBLENDORIO GLENN

    (Last) (First) (Middle)
    C/O IVERIC BIO, INC.
    ONE PENN PLAZA, 35TH FLOOR

    (Street)
    NEW YORK NY 10119

    (City) (State) (Zip)
    2. Issuer Name and Ticker or Trading Symbol
    IVERIC bio, Inc. [ ISEE ]
    5. Relationship
    SEC Form 4
    FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549

    STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

    Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934
    or Section 30(h) of the Investment Company Act of 1940
    OMB APPROVAL
    OMB Number: 3235-0287
    Estimated average burden
    hours per response: 0.5
      
    Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
    1. Name and Address of Reporting Person*
    SBLENDORIO GLENN

    (Last) (First) (Middle)
    C/O IVERIC BIO, INC.
    ONE PENN PLAZA, 35TH FLOOR

    (Street)
    NEW YORK NY 10119

    (City) (State) (Zip)
    2. Issuer Name and Ticker or Trading Symbol
    IVERIC bio, Inc. [ ISEE ]
    5. Relationship of Reporting Person(s) to Issuer
    (Check all applicable)
    X Director 10% Owner
    X Officer (give title below) Other (specify below)
    President and CEO
    3. Date of Earliest Transaction (Month/Day/Year)
    04/01/2020
    4. If Amendment, Date of Original Filed (Month/Day/Year)
    6. Individual or Joint/Group Filing (Check Applicable Line)
    X Form filed by One Reporting Person
    Form filed by More than One Reporting Person
    Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
    1. Title of Security (Instr. 3) 2. Transaction Date (Month/Day/Year) 2A. Deemed Execution Date, if any (Month/Day/Year) 3. Transaction Code (Instr. 8) 4. Securities Acquired (A) or Disposed Of (D) (Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
    Code V Amount (A) or (D) Price
    Common Stock 04/01/2020 M 18,750 A (1) 225,061(2) D
    Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
    (e.g., puts, calls, warrants, options, convertible securities)
    1. Title of Derivative Security (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date (Month/Day/Year) 7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4) 8. Price of Derivative Security (Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
    Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
    Restricted Stock Units (1) 04/01/2020 M 18,750 (3) (3) Common Stock 18,750 $0 0 D
    Explanation of Responses:
    1. Restricted stock units converted into common stock on a one-for-one basis upon vesting of the units.
    2. This total includes 6,507 shares acquired by the Reporting Person on March 16, 2020 under the Registrant's 2016 Employee Stock Purchase Plan.
    3. On April 1, 2016, the Reporting Person was granted an award of 75,000 restricted stock units, which vests with respect to 25% of the shares subject to the award on each of the first, second, third and fourth anniversaries of the grant date, subject to continued employment with the Registrant and the other terms and conditions under the Registrant's 2013 Stock Incentive Plan. In December 2019, the Reporting Person terminated an automatic sale instruction under the Restricted Stock Unit Agreement that was intended to trigger sales of stock to satisfy the Reporting Person's minimum statutory withholding tax obligations with respect to the income recognized by the Reporting Person upon the vesting of the restricted stock units. The Reporting Person has opted to satisfy such withholding tax obligations in cash, in lieu of automatic sales of vested stock.
    /s/ Todd Anderman, as Attorney-in-Fact for Glenn P. Sblendorio 04/03/2020
    ** Signature of Reporting Person Date
    Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
    * If the form is filed by more than one reporting person, see Instruction 4 (b)(v).
    ** Intentional misstatements or omissions of facts constitute Federal Criminal Violations See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
    Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
    Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB Number.
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  31. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions, which have the potential to fill an unmet medical need. Fast Track designation offers important benefits, including frequent interactions with the FDA and the potential eligibility for Rolling Submission and Priority Review of a New Drug Application, if relevant criteria are…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions, which have the potential to fill an unmet medical need. Fast Track designation offers important benefits, including frequent interactions with the FDA and the potential eligibility for Rolling Submission and Priority Review of a New Drug Application, if relevant criteria are met. Currently, there is no FDA or EMA approved treatment option available for patients with GA secondary to dry AMD.

    "With no treatment options available for patients with geographic atrophy secondary to dry age-related macular degeneration the FDA's Fast Track designation recognizes the potential of Zimura to address this unmet medical need," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "Should the positive results from our initial Zimura pivotal clinical trial be confirmed by our second pivotal clinical trial, we believe this important designation may help expedite the registration of Zimura as a treatment option for our patients. We look forward to working closely with the FDA."

    On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in an international, multicenter, randomized, double masked, sham controlled clinical trial in GA secondary to dry AMD, referred to as the OPH2003 trial. Zimura was generally well tolerated after 12 months of administration. IVERIC bio provided further details supporting the positive results from this pivotal trial in its Annual Report on Form 10-K filed on February 27, 2020.

    Geographic Atrophy

    Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

    Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of dry AMD. Zimura is designed to target and inhibit complement factor C5. Zimura binds to C5 and inhibits its cleavage into the terminal fragments, C5a and C5b. By inhibiting the formation of complement system terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC), which occur at the end of the complement cascade. This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial (RPE) cells providing the potential therapeutic rationale in GA secondary to dry AMD.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 the potential future benefits of Fast Track designation, its expectations to use OPH2003 trial of Zimura for the treatment of geographic atrophy as a pivotal trial, its development strategy for Zimura, the implementation of its business plan, the timing, progress and results of clinical trials and other research and development activities and the potential utility of its product candidates. 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 initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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

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  32. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on April 1, 2020, the Company granted newly hired employees equity-based awards. The grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan (as amended), were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation. The Company granted:

    • Pravin Dugel, MD, the Company's Executive Vice President, Chief Strategy and Business Officer, a non-statutory option to purchase 300,000 shares of the Company's common stock, a…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on April 1, 2020, the Company granted newly hired employees equity-based awards. The grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan (as amended), were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to each employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation. The Company granted:

    • Pravin Dugel, MD, the Company's Executive Vice President, Chief Strategy and Business Officer, a non-statutory option to purchase 300,000 shares of the Company's common stock, a grant of 200,000 restricted stock units for shares of the Company's common stock and a grant of 20,000 restricted stock units for shares of the Company's common stock;
    • Doug Brooks, PhD, the Company's Vice President, CMC Lead Zimura, a non-statutory option to purchase 50,000 shares of the Company's common stock and a grant of 10,000 restricted stock units for shares of the Company's common stock; and
    • four other employees, non-statutory options to purchase an aggregate of 75,000 shares of the Company's common stock and a grant to one employee of 3,000 restricted stock units for shares of the Company's common stock.

    Each of the granted stock options has an exercise price of $3.16 per share, equal to the closing price of IVERIC bio's common stock on April 1, 2020. The stock options have a ten year term and vest over four years, with 25% of the shares underlying each option vesting on April 1, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The restricted stock unit grants of 200,000 shares to Dr. Dugel and 10,000 shares to Dr. Brooks each vest with respect to 25% of the shares underlying the grant on each of April 1, 2021, April 1, 2022, April 1, 2023 and April 1, 2024. The other restricted stock unit grants each vest with respect to 100% of the shares underlying the grant on April 1, 2021. The vesting of each grant is subject to the applicable employee's continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company's 2019 Inducement Stock Incentive Plan (as amended).

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission. For more information on the Company please visit www.ivericbio.com.

    ISEE-G

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  33. - A Retinal Expert Recognized Globally in both the Medical Community and Biotech/Pharma Ophthalmic Industry -

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the appointment of Pravin U. Dugel, MD, as Executive Vice President and Chief Strategy and Business Officer, effective April 1, 2020. In this role, Dr. Dugel will help shape IVERIC bio's business development strategy going forward. Dr. Dugel brings more than 25 years' experience in the treatment of retinal diseases. He will report to Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio.

    "We are excited to add Pravin to our management team," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "In addition to being a globally recognized…

    - A Retinal Expert Recognized Globally in both the Medical Community and Biotech/Pharma Ophthalmic Industry -

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the appointment of Pravin U. Dugel, MD, as Executive Vice President and Chief Strategy and Business Officer, effective April 1, 2020. In this role, Dr. Dugel will help shape IVERIC bio's business development strategy going forward. Dr. Dugel brings more than 25 years' experience in the treatment of retinal diseases. He will report to Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio.

    "We are excited to add Pravin to our management team," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "In addition to being a globally recognized retinal specialist, Pravin brings an extensive network and long-standing relationships with the biotech/pharma ophthalmic industry. With IVERIC bio's portfolio of multiple ongoing retinal disease therapeutic and gene therapy R&D programs, Pravin's experience will be instrumental in helping us build alliances with potential future collaborators and other stakeholders. We look forward to Pravin's input and perspective as we move the Company forward."

    "I am thrilled to join IVERIC bio," stated Dr. Dugel. "I am particularly excited about Zimura®'s potential to positively impact and transform the lives of patients with geographic atrophy secondary to dry age-related macular degeneration who currently do not have treatment options available, as well as the potential to bring the Company's gene therapies to patients with orphan inherited retinal diseases who also do not have treatment options available. I am eager to work with Glenn, Kourous and the experienced management team at IVERIC bio and to contribute to the Company's strategy."

    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. Dr. Dugel has authored more than 200 papers, 35 book chapters and has been invited to lecture at several marquis medical meetings and to serve as a visiting professor at universities worldwide, including in Japan, India, China, Malaysia, Egypt, the United Kingdom, France, Germany, Austria, Italy, Poland, Denmark, Norway, Czechoslovakia, Canada and Australia. He is on the Editorial Board of several major medical journals. Dr. Dugel is internationally recognized as a major clinical researcher and has been a principal investigator in over 100 multicenter clinical trials. His research and educational contributions earned him the prestigious Senior Honor Award from the American Academy of Ophthalmology (AAO). He has been elected and previously served as the Retina Subspecialty Day Board Chairman for the American Academy of Ophthalmology Annual Meeting, as a member of the Board of Directors of the largest retina society in the United States, the American Society of Retina Specialists (ASRS), and the largest retina society in Europe, EURETINA.

    Dr. Dugel is a member of the Board of Directors and current Chair of Orbis International's Medical Advisory Board/Medical Strategic Committee. Orbis International is a non-profit organization focused on ophthalmology training and education in the developing world. With Orbis, Dr. Dugel travels to developing countries to teach surgical techniques to local ophthalmologists and provide free surgery for those suffering from preventable blindness.

    Dr. Dugel graduated summa cum laude from Columbia University in New York City. He then attended UCLA School of Medicine. He completed his residency in ophthalmology at the USC Eye Institute, Keck School of Medicine. Thereafter, he completed his medical retina fellowship at the Bascom Palmer Eye Institute and his surgical retina fellowship at the USC Eye Institute, where he was elected to serve on the faculty as the Resident Director.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 development strategy for Zimura, the implementation of its business plan, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. 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 initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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

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  34. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that due to the threat of the coronavirus (COVID-19) global pandemic, the Company has decided to delay the initiation of enrollment of patients in the second pivotal clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

    "In light of the COVID-19 pandemic and out of an abundance of caution for the safety and well-being of our elderly patients and participating physicians and their staffs, we have decided to delay the initiation of enrollment in our second pivotal trial of Zimura in geographic atrophy secondary to dry AMD, the ISEE2008 trial, which was…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that due to the threat of the coronavirus (COVID-19) global pandemic, the Company has decided to delay the initiation of enrollment of patients in the second pivotal clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

    "In light of the COVID-19 pandemic and out of an abundance of caution for the safety and well-being of our elderly patients and participating physicians and their staffs, we have decided to delay the initiation of enrollment in our second pivotal trial of Zimura in geographic atrophy secondary to dry AMD, the ISEE2008 trial, which was on track to begin this month," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "It is critically important that we heed the warnings from the U.S. Centers for Disease Control, World Health Organization and national, state and local governments during this time of uncertainty. We will continue to closely monitor the situation in the United States and abroad to determine when enrollment should begin."

    "Our first priority is to ensure the best interest of our patients, caregivers, and physicians," stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio. "We want to thank clinical investigators and their teams for their enthusiasm and support in completing the activities necessary to begin enrolling patients at a number of clinical sites, including identification of potential patients for this trial. We will continue our efforts to prepare additional clinical sites, so that we can begin enrolling patients expeditiously, once the COVID-19 threat dissipates."

    Zimura Pivotal Program

    The Company plans to enroll approximately 400 patients in the ISEE2008 trial, which is an international, multicenter, double masked, sham controlled clinical trial. Patients will be randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth at 12 months will be performed. If the 12 month results are positive, the Company plans to file an application with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA following receipt of that data. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. All the patients who were initially randomized to the sham control arm will continue with monthly administration of sham. The final evaluation will take place at month 24.

    On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in an international, multicenter, randomized, double masked, sham controlled clinical trial in GA secondary to dry AMD, referred to as the OPH2003 trial. Zimura was generally well tolerated after 12 months of administration. IVERIC bio provided further details supporting the positive results from this trial, which the Company plans to use as a pivotal trial, in its Annual Report on Form 10-K filed on February 27, 2020.

    Dry AMD / Geographic Atrophy

    Dry AMD is a significant cause of moderate and severe loss of central vision in older adults, affecting both eyes in the majority of patients. Although dry AMD is the most common form of AMD, there are no U.S. Food and Drug Administration or European Medicines Agency approved therapies to treat this condition. In dry AMD, thinning of the retinal pigment epithelial (RPE) cells in the central portion of the retina, or the macula, develops, along with other age-related changes to the adjacent retinal and choroidal tissue layers. Geographic atrophy, the advanced stage of dry AMD, is a disease characterized by degeneration of retinal tissue leading to further loss of vision.

    About Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of dry AMD. Zimura is designed to target and inhibit complement factor C5. Zimura binds to C5 and inhibits its cleavage into the terminal fragments, C5a and C5b. By inhibiting the formation of complement system terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC), which occur at the end of the complement cascade. This mechanism of action could potentially prevent or slow down the degeneration of RPE cells providing the potential therapeutic rationale in GA secondary to dry AMD.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 to initiate enrollment in its second pivotal trial of Zimura in geographic atrophy secondary to dry AMD and to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy as a pivotal trial, its development strategy for Zimura, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities and the potential utility of its product candidates. 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 initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on third parties, establishment of manufacturing capabilities, expectations for regulatory matters, need for additional financing 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

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  35. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on March 2, 2020, the Company granted a newly hired, non-executive employee a non-statutory stock option to purchase 18,500 shares of the Company's common stock. In addition, on March 2, 2020, the Company granted this employee a grant of 9,250 restricted stock units for shares of the Company's common stock. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to this employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on March 2, 2020, the Company granted a newly hired, non-executive employee a non-statutory stock option to purchase 18,500 shares of the Company's common stock. In addition, on March 2, 2020, the Company granted this employee a grant of 9,250 restricted stock units for shares of the Company's common stock. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as a material inducement to this employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his or her employment compensation.

    The stock option has an exercise price of $5.61 per share, equal to the closing price of IVERIC bio's common stock on March 2, 2020. The stock option has a ten year term and vests over four years, with 25% of the shares underlying the option vesting on March 2, 2021 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The restricted stock unit grant vests with respect to 25% of the shares underlying the grant on each of March 2, 2021, March 2, 2022, March 2, 2023 and March 2, 2024. The vesting of each grant is subject to the employee's continued service with the Company through the applicable vesting date. The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission. For more information on the Company please visit www.ivericbio.com.

    ISEE-G

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  36. - Conference Call and Webcast Today, February 27, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fourth quarter and full year ended December 31, 2019 and provided a general business update.

    "We made tremendous progress last year as we build a diversified portfolio in retinal diseases that includes both therapeutics and gene therapy, setting the stage for IVERIC bio to be a leader in developing transformative therapies to treat retinal diseases," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We achieved a major milestone with our positive Zimura pivotal clinical trial results in geographic atrophy secondary to dry AMD. Our goal is to continue…

    - Conference Call and Webcast Today, February 27, 2020, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the fourth quarter and full year ended December 31, 2019 and provided a general business update.

    "We made tremendous progress last year as we build a diversified portfolio in retinal diseases that includes both therapeutics and gene therapy, setting the stage for IVERIC bio to be a leader in developing transformative therapies to treat retinal diseases," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We achieved a major milestone with our positive Zimura pivotal clinical trial results in geographic atrophy secondary to dry AMD. Our goal is to continue to build on this momentum. Following the positive data, our team quickly started working on our second Zimura pivotal clinical trial in GA with plans to enroll the first patient next month. Our lead gene therapy programs in rhodopsin mediated adRP and BEST1 related retinal diseases continue to advance towards Phase 1/2 clinical trials and we expect to identify our lead minigene construct for LCA10 later in the year."

    Therapeutics Programs

    Zimura® (avacincaptad pegol): Complement C5 Inhibitor

    • On October 28, 2019, the Company announced that Zimura® (avacincaptad pegol) met its pre-specified primary efficacy endpoint and reached statistical significance in an international, multicenter, randomized, double masked, sham controlled clinical trial in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), referred to as the OPH2003 trial. Zimura was generally well tolerated after 12 months of administration. The Company believes that the safety and efficacy results from this trial could meet regulatory agencies' requirements to serve as one of the two pivotal clinical trials typically required for marketing approval.
    • In January 2020, the Company announced the design of its second pivotal clinical trial of Zimura in GA secondary to dry AMD, ISEE2008. The Company plans to enroll approximately 400 patients in this international, multicenter, double masked, sham controlled clinical trial. Patients will be randomized to receive either monthly administration of Zimura 2mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth at 12 months will be performed. If the 12 month results are positive, the Company plans to file an application with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA following receipt of that data. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. All the patients who were initially randomized to the sham control arm will continue with monthly administration of sham. The final evaluation will take place at month 24.
    • The Company plans and is on track to enroll the first patient in the ISEE2008 trial next month.
    • The Company's ongoing Phase 2b clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease, an orphan inherited retinal disease, is on track for top-line data to be available during the second half of 2020.

    HtrA1 Inhibitor

    • The Company has identified a lead compound in this preclinical program to address GA secondary to dry AMD and is developing the formulation and manufacturing process with the goal of filing an IND during 2021.

    Gene Therapy Programs in Orphan Inherited Retinal Diseases

    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)

      Natural history studies and IND-enabling activities for IC-100 are ongoing. The Company plans to initiate a Phase 1/2 clinical trial for IC-100 in patients with rhodopsin mediated adRP during the fourth quarter of 2020.
    • IC-200: BEST1-Related IRDs

      Natural history studies and IND-enabling activities for IC-200 are ongoing. The Company plans to initiate a Phase 1/2 clinical trial for IC-200 in patients with BEST1 related retinal diseases during the first half of 2021.
    • miniCEP290: Leber Congenital Amaurosis Type 10 (LCA10)

      IVERIC bio, in collaboration with the University of Massachusetts Medical School (UMass Medical School), is continuing to optimize the minigene constructs with the goal of identifying a lead construct by mid-year 2020.
    • miniABCA4 Program for Stargardt Disease (STGD1)

      IVERIC bio, through its collaborative sponsored research agreement with UMass Medical School, is evaluating several ABCA4 minigene constructs in both in vitro and in vivo experiments. The Company has received preliminary results and expects to receive additional results for the miniABCA4 program during the second half of 2020.
    • miniUSH2A: USH2A-Related IRDs Including Usher Syndrome Type 2A (Usher 2A) and USH2A-Associated Nonsyndromatic Autosomal Recessive Retinitis Pigmentosa

      This research program targets IRDs associated with mutations in the USH2A gene, including Usher 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa. The Company expects to receive preliminary results during the second half of 2020.

    Corporate Update

    In December 2019, the Company completed an underwritten public offering in which it sold 7,750,000 shares of its common stock at a price of $4.00 per share, and it also sold to certain investors pre-funded warrants to purchase 3,750,000 shares of its common stock at a price of $3.999 per share underlying each warrant. The Company raised approximately $42.6 million in net proceeds from this offering.

    During the fourth quarter of 2019, IVERIC bio appointed Guangping Gao, PhD as Chief Strategist, Gene Therapy, and Abraham Scaria, PhD as Chief Scientific Officer.

    Fourth Quarter and Year End 2019 Financial Results and 2020 Cash Guidance

    As of December 31, 2019, the Company had $125.7 million in cash and cash equivalents. The Company estimates that its year-end 2020 cash and cash equivalents will range between $60 million and $70 million. The Company also estimates that its cash and cash equivalents will be sufficient to fund its operations and capital expenditure requirements as currently planned into the beginning of 2022. These estimates are based on the Company's current business plan, including initiation of the Zimura ISEE2008 trial and the continuation of the Company's other on-going research and development programs. These estimates do not reflect any additional expenditures, including associated development costs, in the event the Company in-licenses or acquires any new product candidates or commences any new sponsored research programs.

    2019 Financial Highlights

    • R&D Expenses: Research and development expenses were $11.6 million for the quarter ended December 31, 2019, compared to $16.1 million for the same period in 2018. For the year ended December 31, 2019, research and development expenses were $39.6 million compared to $41.7 million for the same period in 2018. Research and development expenses decreased primarily due to decreased costs associated with the Company's Zimura OPH2003 clinical trial in GA and OPH2005 clinical trial in Stargardt disease, as earlier-enrolled patients completed those trials, and decreased costs related to the Company's acquisition of Inception 4 and its HtrA1 inhibitor program during 2018. These decreases were offset by increases in costs associated with the Company's gene therapy programs.
    • G&A Expenses: General and administrative expenses were $6.3 million for the quarter ended December 31, 2019, compared to $5.7 million for the same period in 2018. For the year ended December 31, 2019, general and administrative expenses were $21.6 million compared to $23.6 million for the same period in 2018. General and administrative expenses decreased primarily due to decreases in costs to support the Company's operations and infrastructure.
    • Net Income (loss): The Company reported a net loss for the quarter ended December 31, 2019 of $17.5 million, or ($0.39) per diluted share, compared to a net income of $104.1 million, or $2.62 per diluted share, for the same period in 2018. In the quarter and year ended December 31, 2018, the Company recognized a gain on extinguishment of a royalty purchase liability of $125 million due to its December 2018 termination of a royalty and sales agreement with Novo Holdings A/S. For the year ended December 31, 2019, the Company reported a net loss of $58.9 million or ($1.39) per diluted share, compared to a net income of $63.1 million or $1.70 for the same period in 2018.

    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 February 27, 2020 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2598 (International), passcode 6010573. 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 Toll Free), passcode 6010573.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy as a pivotal trial, its development strategy for Zimura, including its plans and expectations regarding a second, pivotal clinical trial evaluating Zimura for the treatment of geographic atrophy, the implementation of its business plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. 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 initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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,  

     

    2019

     

     

    2018

     

     

    2019

     

     

    2018

     

     
    Statements of Operations Data:                
    Operating expenses:
    Research and development  

     $

                              11,567

     

     

     $

                              16,128

     

     

     $

                              39,644

     

     

     $

                              41,737

     

    General and administrative

     

                                   6,275

     

     

                                   5,667

     

     

                                 21,628

     

     

                                 23,612

     

    Total operating expenses  

     

                                 17,842

     

     

     

                                 21,795

     

     

     

                                 61,272

     

     

     

                                 65,349

     

    Loss from operations

     

                               (17,842

    )

     

                               (21,795

    )

     

                               (61,272

    )

     

                               (65,349

    )

    Interest income  

     

                                      369

     

     

     

                                      677

     

     

     

                                   2,151

     

     

     

                                   2,389

     

    Gain on extinguishment of Royalty Purchase Liability

     

                                         -  

     

     

                               125,000

     

     

                                         -  

     

     

                               125,000

     

    Other income (expense)  

     

                                         -  

     

     

     

                                          1

     

     

     

                                      151

     

     

     

                                      (16

    )

    Income (loss) before income tax provision (benefit)

     

                               (17,473

    )

     

                               103,883

     

     

                               (58,970

    )

     

                                 62,024

     

    Income tax provision (benefit)  

     

                                          5

     

     

     

                                    (231

    )

     

     

                                    (111

    )

     

     

                                 (1,063

    )

    Net Income (loss)

     $

                            (17,478

    )

     $

                            104,114

     

     $

                            (58,859

    )

     $

                              63,087

     

    Net loss per common share:                
    Basic 

     $

                                (0.39

    )

     $

                                  2.62

     

     $

                                (1.39

    )

     $

                                  1.70

     

    Diluted  

     $

                                (0.39

    )

     

     $

                                  2.62

     

     

     $

                                (1.39

    )

     

     $

                                  1.70

     

    Weighted average common shares outstanding:
    Basic   

     $

                              44,413

     

     

     $

                              39,673

     

     

     $

                              42,224

     

     

     $

                              37,061

     

    Diluted

     

                                 44,413

     

     

                                 39,687

     

     

                                 42,224

     

     

                                 37,088

     

     

    December 31, 2019

    December 31, 2018

    (in thousands)
    Balance Sheets Data:          
    Cash and cash equivalents

     $

                            125,699

     

     $

                            131,201

     

    Total assets  

     

                               130,187

     

     

     

                               137,165

     

     
    Total liabilities

     

                                 12,984

     

     

                                 13,206

     

     
    Additional paid-in capital  

     

                               597,679

     

     

     

                               545,585

     

     
    Accumulated deficit

     

                             (480,526

    )

     

                             (421,667

    )

    Total stockholders' equity  

     $

                            117,203

     

     

     $

                            123,959

     

     
     

     

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  37. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Kourous A. Rezaei, M.D., Chief Medical Officer, will present an overview of the Company at the Cowen and Company 40th Annual Health Care Conference in Boston, MA, on Wednesday, March 4 at 9:20 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Kourous A. Rezaei, M.D., Chief Medical Officer, will present an overview of the Company at the Cowen and Company 40th Annual Health Care Conference in Boston, MA, on Wednesday, March 4 at 9:20 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  38. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its fourth quarter and full year 2019 financial and operating results on Thursday, February 27, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2598 (International), passcode 6010573. 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…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its fourth quarter and full year 2019 financial and operating results on Thursday, February 27, 2020. Following the announcement, the IVERIC bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company's financial results and provide a general business update.

    To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2598 (International), passcode 6010573. 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 Toll Free), passcode 6010573.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  39.  - On-Track for First Patient Enrollment in 1Q 2020–

    -Company to Host R&D Symposium for Investors/Analysts on Tuesday January 14, 2020 in San Francisco, CA from 6:30 to 8:00 am (Pacific Time) -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced the design of the second pivotal clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). This second pivotal trial will be an international, multicenter, double masked, sham controlled clinical trial. The Company plans to enroll approximately 400 patients to be randomized to receive monthly administration of Zimura 2 mg or sham during the first 12 months of the…

     - On-Track for First Patient Enrollment in 1Q 2020–

    -Company to Host R&D Symposium for Investors/Analysts on Tuesday January 14, 2020 in San Francisco, CA from 6:30 to 8:00 am (Pacific Time) -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced the design of the second pivotal clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). This second pivotal trial will be an international, multicenter, double masked, sham controlled clinical trial. The Company plans to enroll approximately 400 patients to be randomized to receive monthly administration of Zimura 2 mg or sham during the first 12 months of the trial. The prespecified primary endpoint, mean rate of change in GA growth over 12 months, will be measured by fundus autofluorescence (FAF) based on readings at three time points (baseline, month 6, and month 12) consistent with the previous Zimura pivotal clinical trial design. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. The final evaluation will take place at month 24.

    "This trial is our top priority and we are working to address this major unmet medical need where there are no approved treatment options available for the approximately 1.5 million patients living with geographic atrophy in the US alone," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio.

    "Based on the positive 12-month results from our first pivotal trial for Zimura in GA we are looking forward to enrolling our first patient in our second pivotal clinical trial," stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio. "In the first trial, both the Zimura 2 mg and Zimura 4 mg doses met the primary efficacy endpoint at month 12 with statistical significance and similar efficacy as compared to sham. Since Zimura 2 mg is administered as a single intravitreal injection, as compared to two intravitreal injections for Zimura 4 mg, the upcoming trial will compare the safety and efficacy of the Zimura 2 mg dose to sham control in patients with GA. Our goal is to enroll the first patient in the first quarter of 2020."

    On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in an international, multicenter, randomized, double masked, sham-controlled clinical trial in GA secondary to dry AMD. Zimura was generally well tolerated after 12 months of administration. IVERIC bio provided further details supporting the positive results from this trial, which the Company plans to use as a pivotal trial, in its Quarterly Report on Form 10-Q filed on November 12, 2019.

    R&D Symposium for Investors/Analysts

    The Company will host an R&D Symposium for Investors/Analysts on Tuesday, January 14, 2020 from 6:30a.m. to 8:00a.m. Pacific Time in San Francisco, CA. The event will feature a presentation on the Zimura pivotal program in GA secondary to dry AMD with details on the design followed by additional presentations on statistical analysis and the primary endpoint for the program.

    The event will be accessible via webcast on the IVERIC bio website at www.ivericbio.com. For more information, please contact Kathy Galante at or 212-845-8231.

    Geographic Atrophy

    Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

    Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of dry AMD. Zimura is designed to target and inhibit complement factor C5. Zimura binds to C5 and inhibits its cleavage into the terminal fragments, C5a and C5b. By inhibiting the formation of complement system terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC), which occur at the end of the complement cascade. This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial (RPE) cells providing the potential therapeutic rationale in GA secondary to dry AMD.

    IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy as a pivotal trial, its development strategy for Zimura, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, estimates regarding the number of patients affected by the diseases and indications the Company's product candidates are intended to treat and the potential for its business development strategy. 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 initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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

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  40. - Featuring Zimura® Pivotal Program in Geographic Atrophy, Including the Design of the Second Pivotal Trial in GA -

    - Live Webcast to Begin at 6:30 a.m. Pacific Time -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced details for its R&D Investor Symposium being held in San Francisco on Tuesday, January 14, 2020, from 6:30 a.m. to 8:00 a.m. Pacific Time.

    The event presentations feature the design of the second pivotal trial of Zimura® (avacincaptad pegol) in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), the previously announced results of the first Zimura pivotal trial in GA, and the Company's progress in its gene therapy portfolio for orphan inherited retinal diseases. The symposium will include discussions…

    - Featuring Zimura® Pivotal Program in Geographic Atrophy, Including the Design of the Second Pivotal Trial in GA -

    - Live Webcast to Begin at 6:30 a.m. Pacific Time -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced details for its R&D Investor Symposium being held in San Francisco on Tuesday, January 14, 2020, from 6:30 a.m. to 8:00 a.m. Pacific Time.

    The event presentations feature the design of the second pivotal trial of Zimura® (avacincaptad pegol) in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), the previously announced results of the first Zimura pivotal trial in GA, and the Company's progress in its gene therapy portfolio for orphan inherited retinal diseases. The symposium will include discussions with management and retinal specialists and key opinion leaders in both dry AMD and gene therapy including:

    • William A. Beltran, DVM, PhD, University of Pennsylvania
    • Marc Buyse, ScD, IDDI
    • Karl G. Csaky, MD, PhD, Texas Retina Associates, Retina Foundation of the Southwest
    • Guangping Gao, PhD, University of Massachusetts Medical School
    • Karina E. Guziewicz, PhD, University of Pennsylvania
    • Glenn Jaffe, MD, Duke University
    • Hemant Khanna, PhD, University of Massachusetts Medical School
    • Bart P. Leroy, MD, PhD, Ghent University and Children's Hospital of Philadelphia
    • Kourous A. Rezaei, MD, Chief Medical Officer, IVERIC bio
    • Glenn P. Sblendorio, Chief Executive Officer, IVERIC bio

    A live webcast will be available under "Events & Presentations" in the Investors section of the IVERIC bio website at https://investors.ivericbio.com. A replay of the webcast will be archived on IVERIC bio's website for at least 30 days following the presentation.

    For more information, please contact Kathy Galante at or 212-845-8231.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  41. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio, will present an overview of the Company at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 11:30 a.m. Pacific Time at the Westin St. Francis Hotel in San Francisco.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio, will present an overview of the Company at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 11:30 a.m. Pacific Time at the Westin St. Francis Hotel in San Francisco.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  42. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an underwritten public offering of 6,250,000 shares of its common stock at a price to the public of $4.000 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 3,750,000 shares of its common stock at a price to the public of $3.999 per pre-funded warrant, in each case less underwriting discounts and commissions. The purchase price of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.001 per share exercise price of such pre-funded warrant. The aggregate gross proceeds from the offering are expected to be approximately $40.0 million before underwriting discounts and commissions…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an underwritten public offering of 6,250,000 shares of its common stock at a price to the public of $4.000 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 3,750,000 shares of its common stock at a price to the public of $3.999 per pre-funded warrant, in each case less underwriting discounts and commissions. The purchase price of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.001 per share exercise price of such pre-funded warrant. The aggregate gross proceeds from the offering are expected to be approximately $40.0 million before underwriting discounts and commissions and offering expenses payable by the Company. In addition, in connection with the offering, the Company has granted the underwriters an option for a period of 30 days to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by the Company.

    Cowen is acting as the sole book-running manager for the offering. Wedbush Securities is acting as the lead manager for the offering. The offering is expected to close on or about December 10, 2019, subject to customary closing conditions.

    A shelf registration statement on Form S-3 (File No. 333-226497) relating to the shares of common stock offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on August 15, 2018. The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at , or by telephone at (833) 297-2926 or Wedbush Securities Inc., Two Embarcadero Center, Suite 600, San Francisco, CA 94111, Attn: ECM Prospectus Department, by email at , or by telephone at (415) 274-7800.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About IVERIC bio, Inc.

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the public offering, 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," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. 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 satisfaction of customary closing conditions related to the public offering, the design, initiation, conduct and outcomes of research programs and clinical trials, establishment of manufacturing capabilities, availability of data from these programs, reliance on university collaborators and other third parties, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions, whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements on its expected timelines, and other factors discussed in the "Risk Factors" section contained in the quarterly and annual reports that the Company files with the SEC. 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

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  43. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying the pre-funded warrants sold in connection with the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by the Company.

    Cowen…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying the pre-funded warrants sold in connection with the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by the Company.

    Cowen is acting as the book-running manager for the offering.

    A shelf registration statement on Form S-3 (File No. 333-226497) relating to the shares of common stock to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on August 15, 2018. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the offering is being filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at , or by telephone at (833) 297-2926.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About IVERIC bio, Inc.

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the proposed public offering, 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," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. 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 market and other financial conditions, the potential completion of the proposed public offering or the size or terms thereof, satisfaction of customary closing conditions related to the proposed public offering, the design, initiation, conduct and outcomes of research programs and clinical trials, establishment of manufacturing capabilities, availability of data from these programs, reliance on university collaborators and other third parties, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions, whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements on its expected timelines, and other factors discussed in the "Risk Factors" section contained in the quarterly and annual reports that the Company files with the SEC. 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

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  44. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio, will present an overview of the Company at the Evercore ISI 2nd Annual HealthCONx Conference in Boston on Tuesday, December 3, 2019 at 9:50 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio, will present an overview of the Company at the Evercore ISI 2nd Annual HealthCONx Conference in Boston on Tuesday, December 3, 2019 at 9:50 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast of the presentation on the Investor / Events & Presentations section of the IVERIC bio website at www.ivericbio.com. An archived replay of the webcast will be available on the Company's website immediately following the conference and for at least two weeks thereafter.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  45. - Globally Recognized Innovator Played a Key Role in the Discovery and Vector Development of New AAV Serotypes -

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the appointment of Guangping Gao, PhD, as Chief Strategist, Gene Therapy. Dr. Gao brings over 30 years of scientific research experience in gene-based treatments. As one of the world's leading gene therapy experts, Dr. Gao's highly distinguished career includes major contributions to the development of adeno-associated virus (AAV) gene delivery technology. Dr. Gao is the current President of the American Society of Gene and Cell Therapy (ASGCT). In his advisory role, Dr. Gao will help shape IVERIC bio's gene therapy strategy going forward.

    "On behalf of the Board of Directors and…

    - Globally Recognized Innovator Played a Key Role in the Discovery and Vector Development of New AAV Serotypes -

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the appointment of Guangping Gao, PhD, as Chief Strategist, Gene Therapy. Dr. Gao brings over 30 years of scientific research experience in gene-based treatments. As one of the world's leading gene therapy experts, Dr. Gao's highly distinguished career includes major contributions to the development of adeno-associated virus (AAV) gene delivery technology. Dr. Gao is the current President of the American Society of Gene and Cell Therapy (ASGCT). In his advisory role, Dr. Gao will help shape IVERIC bio's gene therapy strategy going forward.

    "On behalf of the Board of Directors and management team at IVERIC bio, we are extremely excited to welcome Dr. Gao to IVERIC bio," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "Our goal at IVERIC bio is to become a leading retina company with a diversified portfolio addressing significant unmet medical needs in large market age-related retinal indications and inherited retinal diseases by utilizing both therapeutics and gene therapies. Dr. Gao's extensive background in gene therapy will be instrumental in shaping the direction of our gene therapy portfolio. It is a true privilege to work with him closely and benefit from his extensive expertise during these exciting times at our company."

    "I am delighted to have the opportunity to be a part of the IVERIC bio team," stated Dr. Gao. "I am impressed with the progress that IVERIC bio had made with their diverse pipeline of novel gene therapy solutions to treat orphan inherited retinal diseases (IRDs). I look forward to working closely with the team to help build and maximize the potential of the Company's gene therapy programs."

    "Dr. Gao is a world-renowned scientist and researcher who is a pioneer in AAV gene delivery technology," stated Kourous A. Rezaei, MD, Chief Medical Officer of IVERIC bio. "We believe that the combination of Dr. Gao's expertise in gene therapy and our knowledge and experience in drug development for retinal diseases will help set the stage for the proficient execution of our gene therapy strategy, advancing it to the next stage of evolution. We will also continue to move forward our Zimura, complement C5 inhibitor, programs as expeditiously as possible."

    About Guangping Gao, PhD

    Dr. Gao is the Co-Director, Li Weibo Institute for Rare Diseases Research, Director, Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems and Penelope Booth Rockwell Professor in Biomedical Research, at the University of Massachusetts Medical School; an elected fellow of both the US National Academy of Inventors (NAI) and the American Academy of Microbiology; and the current President of the American Society of Gene and Cell Therapy.

    Dr. Gao is an internationally recognized gene therapy researcher who has played a key role in the discovery and characterization of a new family of adeno-associated virus (AAV) serotypes, which was instrumental in reviving the gene therapy field, providing technology to enable potential treatments for many currently untreatable human diseases. For nearly 30 years of his scientific research career, Dr. Gao has primarily focused on molecular genetics and viral vector gene therapy for rare genetic diseases, with research encompassing disease gene cloning, causative mutation identification, pathomechanism investigation, animal modeling, novel viral vector discovery and engineering for in vivo gene delivery, vector biology, preclinical and clinical gene therapy product development, and viral vector manufacturing for preclinical and clinical gene therapy applications, as well as development of technology platforms for novel approaches for human gene therapy.

    Dr. Gao has published 267 research papers, 6 book chapters, and 5 edited books and serves as Editor of Human Gene Therapy, Senior Editor of the Gene and Cell Therapy book series, Associate Editor of Signal Transduction and Targeted Therapy, and on the editorial boards of several other gene therapy and virology journals. Dr. Gao holds 135 patents with 239 additional patent applications pending. Dr. Gao's inventions have been licensed to and are currently in development by over ten pharmaceutical companies. Recently, Dr. Gao was ranked as #4 on Nature Biotechnology's list of the World's Top 20 Translational Researchers for 2017.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission. For more information on the Company please visit www.ivericbio.com.

    IVERIC bio 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," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. In this press release, the Company's forward looking statements include statements about the implementation of its strategic plan to seek to address significant unmet medical needs in large market age-related retinal indications and inherited retinal diseases by utilizing both therapeutics and gene therapies, the timing, progress and results of clinical trials and other research and development activities, including manufacturing activities, the potential utility of its product candidates and the potential for its business development strategy. 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 initiation and the conduct and design of research programs and clinical trials, establishment of manufacturing capabilities, availability of data from these programs, reliance on university collaborators and other third parties, expectations for regulatory matters, 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

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  46. - Live Webcast to Begin at 8:00 a.m. Eastern Time -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced details for its previously announced Zimura® R&D Symposium for Investors being held in New York, NY on Wednesday, November 20, 2019, from 8:00 a.m. to 10:00 a.m. ET.

    The event will feature a presentation of the previously announced clinical trial results from the Company's Zimura® (avacincaptad pegol) program in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) and will include discussions with retinal specialists and key opinion leaders in dry AMD. On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in a randomized, controlled…

    - Live Webcast to Begin at 8:00 a.m. Eastern Time -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced details for its previously announced Zimura® R&D Symposium for Investors being held in New York, NY on Wednesday, November 20, 2019, from 8:00 a.m. to 10:00 a.m. ET.

    The event will feature a presentation of the previously announced clinical trial results from the Company's Zimura® (avacincaptad pegol) program in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) and will include discussions with retinal specialists and key opinion leaders in dry AMD. On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in a randomized, controlled clinical trial in GA secondary to dry AMD.

    A live webcast will be available under "Events & Presentations" in the Investors section of the IVERIC bio website at https://investors.ivericbio.com. A replay of the webcast will be archived on IVERIC bio's website for at least 30 days following the presentation.

    For more information, please contact Kathy Galante at or 212-845-8231.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  47. - Conference Call and Webcast Today, November 12, 2019, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today provided further details of the recently announced clinical trial results for the Company's Zimura®(avacincaptad pegol) program in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), reviewed the Company's financial results for the third quarter 2019 and provided a general business update.

    Zimura® (avacincaptad pegol) Highlights

    On October 28, 2019, IVERIC bio provided topline data confirming that Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the mean rate of geographic atrophy (GA) growth in patients with dry age-related…

    - Conference Call and Webcast Today, November 12, 2019, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today provided further details of the recently announced clinical trial results for the Company's Zimura®(avacincaptad pegol) program in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), reviewed the Company's financial results for the third quarter 2019 and provided a general business update.

    Zimura® (avacincaptad pegol) Highlights

    On October 28, 2019, IVERIC bio provided topline data confirming that Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the mean rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD). Today, the Company provided further clinical details and the development strategy for Zimura in GA secondary to AMD. These announcements will be discussed during today's conference call/webcast (also see the second press release issued earlier today and the press release issued on October 28, 2019.)

    "We are excited to have achieved a major milestone with our recent Zimura clinical trial results in geographic atrophy secondary to dry AMD and we look forward to start enrolling patients in a second pivotal clinical trial in the first quarter of 2020. We believe these events have the potential to be a catalyst for our company," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "IVERIC bio is now in a strong position, with a diversified, retina-focused portfolio, including both a late stage clinical program for a large market retinal disease and early stage gene therapy programs in inherited retinal diseases. We are committed to efficiently progressing these programs with the goal of continuing to create value for our shareholders."

    Gene Therapy Highlights

    Orphan IRD Gene Therapy Programs

    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)

      Natural history studies and IND-enabling activities for IC-100 are on track. The Company expects to initiate a Phase 1/2 clinical trial for IC-100 in patients with rhodopsin mediated adRP in the second half of 2020.
    • IC-200: BEST1-Related IRDs

      Natural history studies and IND-enabling activities for IC-200 are on track.

      The Company expects to initiate a Phase 1/2 clinical trial for IC-200 in patients with BEST1 related retinal diseases during the first half of 2021.
    • miniCEP290: Leber Congenital Amaurosis Type 10 (LCA10)

      Encouraging results from the Company's collaboration with the University of Massachusetts Medical School (UMass Medical School) in its miniCEP290 program led the Company to exercise its option and, in July 2019, the Company entered into an exclusive global license agreement with the University of Massachusetts for rights to develop and commercialize mutation independent novel AAV minigene therapy product candidates for the treatment of LCA10, which is due to mutations in the CEP290 gene and is the most common type of LCA. The Company plans to provide an update on the lead minigene construct in early 2020.
    • miniABCA4 Program for Stargardt Disease (STGD1)

      The Company, through its collaborative sponsored research agreement with UMass Medical School, is evaluating several ABCA4 minigene constructs in both in vitro and in vivo experiments. The Company expects to have results from the miniABCA4 program in 2020.
    • miniUSH2A: USH2A-Related IRDs Including Usher Syndrome Type 2A and USH2A-Associated Nonsyndromatic Autosomal Recessive Retinitis Pigmentosa

      In July 2019, the Company entered into a sponsored research agreement with UMass Medical School and an exclusive option agreement with the University of Massachusetts for rights to develop and commercialize novel AAV gene therapy product candidates utilizing a mutation independent minigene therapy approach for the treatment of USH2A-related IRDs. This group of orphan IRDs include Usher syndrome Type 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa.

    On October 29, 2019, Abraham Scaria, PhD was appointed to the position of Chief Scientific Officer. Dr. Scaria will lead the Company's research and pre-clinical gene therapy activities. Dr. Scaria's extensive experience includes positions at Genzyme, Sanofi and most recently at Casebia Therapeutics, leading multiple ocular gene therapy programs.

    Second Quarter 2019 Financial Results

    Operational Update

    As of September 30, 2019, the Company had $94.9 million in cash and cash equivalents. The Company reaffirms its estimate that year-end 2019 cash and cash equivalents will range between $80 million and $85 million. With the initiation of enrollment for the Company's second pivotal clinical trial for Zimura in GA planned for the first quarter of 2020, the Company estimates that its cash and cash equivalents will be sufficient to fund its operations and capital expenditure requirements as currently planned through the first half of 2021. These estimates are based on the Company's current business plan, including the continuation of its current research and development programs. This estimate does not reflect any additional expenditures in the event the Company were to in-license or acquire any new product candidates or commences any new sponsored research programs.

    • R&D Expenses: Research and development expenses were $10.4 million for the quarter ended September 30, 2019, compared to $9.4 million for the same period in 2018. For the nine months ended September 30, 2019, research and development expenses were $28.1 million compared to $25.6 million for the same period in 2018. Research and development expenses increased primarily due to increases in costs associated with the Company's gene therapy programs and HtrA1 inhibitor program, offset by decreases in costs associated with the Company's Zimura programs.
    • G&A Expenses: General and administrative expenses were $4.7 million for the quarter ended September 30, 2019, compared to $6.0 million for the same period in 2018. For the nine months ended September 30, 2019, general and administrative expenses were $15.4 million compared to $17.9 million for the same period in 2018. General and administrative expenses decreased primarily due to decreases in costs to support the Company's operations and infrastructure.
    • Net Income: The Company reported a net loss for the quarter ended September 30, 2019 of $14.4 million, or ($0.35) per diluted share, compared to a net loss of $14.7 million, or ($0.41) per diluted share, for the same period in 2018. For the nine months ended September 30, 2019, the Company reported a net loss of $41.4 million or ($1.00) per diluted share, compared to a net loss of $41.0 million or ($1.13) for the same period in 2018.

    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 November 12, 2019 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-208-1711 (USA) or 323-994-2082 (International), passcode 5526863. 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 Toll Free), passcode 5526863.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy as a pivotal trial, its development strategy for Zimura, the implementation of its business plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. 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 initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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 September 30,       Nine Months Ended September 30,  
       

    2019

       

    2018

       

    2019

       

    2018

                     
    Statements of Operations Data:                                
    Operating expenses:                
    Research and development      

     $                          10,383

         

     $                            9,407

         

     $                          28,077

         

     $                          25,609

    General and administrative    

                                   4,674

       

                                   5,968

       

                                 15,353

       

                                 17,945

    Total operating expenses      

                                 15,057

         

                                 15,375

         

                                 43,430

         

                                 43,554

    Loss from operations    

                               (15,057)

       

                               (15,375)

       

                               (43,430)

       

                               (43,554)

    Interest income      

                                      495

         

                                      637

         

                                   1,782

         

                                   1,711

    Other income (expense)    

                                         -  

       

                                        (1)

       

                                      151

       

                                      (17)

    Loss before income tax provision (benefit)      

                               (14,562)

         

                               (14,739)

         

                               (41,497)

         

                               (41,860)

    Income tax provision (benefit)    

                                    (125)

       

                                          6

       

                                    (116)

       

                                    (833)

    Net loss      

     $                        (14,437)

         

     $                        (14,745)

         

     $                        (41,381)

         

     $                        (41,027)

    Net loss per common share:                
    Basic and diluted      

     $                            (0.35)

         

     $                            (0.41)

         

     $                            (1.00)

         

     $                            (1.13)

    Weighted average common shares outstanding:                
    Basic and diluted      

                                 41,552

         

                                 36,202

         

                                 41,486

         

                                 36,181

        September 30, 2019     December 31, 2018
        (in thousands)
    Balance Sheets Data:                
    Cash and cash equivalents    

     $                          94,851

       

     $                        131,201

    Total assets      

                                 98,823

         

                               137,165

    Total liabilities    

                                   9,361

       

                                 13,206

    Additional paid-in capital      

                               552,468

         

                               545,585

    Accumulated deficit    

                             (463,048)

       

                             (421,667)

    Total stockholders' equity      

     $                          89,462

         

     $                        123,959

     

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  48. - Company Plans to Use Previously Announced Positive Zimura Clinical Trial as One of Two Pivotal Trials -

    - Zimura R&D Symposium for Investors/Analysts to be Held on November 20, 2019 -

    - Conference Call and Webcast Today, November 12, 2019, at 8:00 a.m. ET –

    IVERIC bio, Inc. (NASDAQ:ISEE) today provided further clinical details and its development strategy for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). Based on the study design and the robustness of the recently announced topline data from a randomized, double masked, sham controlled Zimura clinical trial, the Company believes that only one additional pivotal, randomized…

    - Company Plans to Use Previously Announced Positive Zimura Clinical Trial as One of Two Pivotal Trials -

    - Zimura R&D Symposium for Investors/Analysts to be Held on November 20, 2019 -

    - Conference Call and Webcast Today, November 12, 2019, at 8:00 a.m. ET –

    IVERIC bio, Inc. (NASDAQ:ISEE) today provided further clinical details and its development strategy for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). Based on the study design and the robustness of the recently announced topline data from a randomized, double masked, sham controlled Zimura clinical trial, the Company believes that only one additional pivotal, randomized, double masked, sham controlled clinical trial would potentially be needed to demonstrate the safety and efficacy of Zimura in GA secondary to dry AMD in a manner sufficient to support regulatory approval, assuming that Zimura's safety and efficacy profile remains consistent with the findings observed to date and subject to regulatory review.

    The Company also announced that it has begun to identify U.S. and international clinical trial sites for the second pivotal clinical trial in GA secondary to dry AMD and plans to start enrolling patients in the first quarter of 2020.

    On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in a randomized, double masked, sham controlled clinical trial in GA secondary to dry AMD. Zimura was generally well tolerated after 12 months of administration. IVERIC bio provided further details supporting the positive results from the clinical trial in the Company's Quarterly Report on Form 10-Q filed on November 12, 2019.

    "This is an exciting milestone for IVERIC bio as we are moving Zimura forward for GA secondary to dry AMD expeditiously," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We are extremely pleased with the totality of the Zimura data to date and the potential for providing a treatment option to patients and their physicians, where there is an urgent unmet medical need. We are initiating the second pivotal clinical trial with the goal of enrolling our first patient in the first quarter of 2020. We plan to continue to explore all options for the future development and potential commercialization of Zimura, including potential collaboration and out-licensing opportunities, while we commence Phase 3 activities."

    "AMD is a leading cause of vision loss in people over the age of 50, typically affecting both eyes. Dry AMD is reported to account for 85% to 90% of all AMD cases. Although we have various anti-VEGF treatment options available for wet AMD, which represents approximately 10% to 15% of AMD cases, we currently have no U.S. Food and Drug Administration or European Medicines Agency approved treatment options available for patients with dry AMD or GA, which is the advanced stage of dry AMD," stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio. "The Zimura clinical data to date in GA secondary to dry AMD are very encouraging and we will seek to leverage our efficient execution and deep expertise in retinal drug development with the goal of bringing Zimura to patients as soon as feasibly possible."

    Zimura R&D Symposium for Investors

    The Company will host a Zimura R&D Symposium for Investors on Wednesday, November 20, 2019 from 8:00 a.m. to 10:00 a.m. Eastern Time in New York. The event will feature a presentation of the previously announced clinical trial results from the Company's Zimura program in GA secondary to dry AMD and will include discussions with retina specialists and key opinion leaders in dry AMD. On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in a randomized, double masked, sham, controlled clinical trial in GA secondary to dry AMD.

    The event will be accessible via webcast on the IVERIC bio website at www.ivericbio.com. For more information, please contact Kathy Galante at or 212-845-8231.

    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 November 12, 2019 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-208-1711 (USA) or 323-994-2082 (International), passcode 5526863. 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 Toll Free), passcode 5526863.

    About Dry AMD / Geographic Atrophy

    Dry AMD is a significant cause of moderate and severe loss of central vision in older adults, affecting both eyes in the majority of patients. Although dry AMD is the most common form of AMD, there are no U.S. Food and Drug Administration or European Medicines Agency approved therapies to treat this condition. In dry AMD, thinning of the retinal pigment epithelial (RPE) cells in the central portion of the retina, or the macula, develops, along with other age-related changes to the adjacent retinal and choroidal tissue layers. Geographic atrophy, the advanced stage of dry AMD, is a disease characterized by degeneration of retinal tissue leading to further loss of vision.

    About Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of dry AMD. Zimura is designed to target and inhibit complement factor C5. Zimura binds to C5 and inhibits its cleavage into the terminal fragments, C5a and C5b. By inhibiting the formation of complement system terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC), which occur at the end of the complement cascade. This mechanism of action could potentially prevent or slow down the degeneration of RPE cells providing the potential therapeutic rationale for GA secondary to dry AMD.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy as a pivotal trial, its development strategy for Zimura, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. 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 initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, 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

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  49. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on November 1, 2019, the Company granted Dr. Abraham Scaria a non-statutory stock option to purchase 300,000 shares of the Company's common stock. In addition, on November 1, 2019, the Company granted Dr. Scaria 50,000 restricted stock units for shares of the Company's common stock. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as an inducement material to Dr. Scaria's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation.

    The stock option…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on November 1, 2019, the Company granted Dr. Abraham Scaria a non-statutory stock option to purchase 300,000 shares of the Company's common stock. In addition, on November 1, 2019, the Company granted Dr. Scaria 50,000 restricted stock units for shares of the Company's common stock. These grants were made pursuant to the Company's 2019 Inducement Stock Incentive Plan, were approved by the Company's compensation committee pursuant to a delegation by the Company's board of directors, and were made as an inducement material to Dr. Scaria's acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation.

    The stock option granted to Dr. Scaria has an exercise price of $3.80 per share, equal to the closing price of IVERIC bio's common stock on November 1, 2019. The stock option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on November 1, 2020 and an additional 2.0833% of the original number of shares vesting at the end of each successive month thereafter. The restricted stock unit award granted to Dr. Scaria vests with respect to 25% of the shares underlying the award on each of November 1, 2020, November 1, 2021, November 1, 2022 and November 1, 2023. The vesting of each award is subject to Dr. Scaria's continued service with the Company through the applicable vesting date. The stock options and restricted stock units are subject to the terms and conditions of a stock option agreement and restricted stock unit agreement covering the grants and the Company's 2019 Inducement Stock Incentive Plan.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission. For more information on the Company please visit www.ivericbio.com.

    ISEE-G

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  50. - Company to Host a Zimura® R&D Symposium for Investors on November 20, 2019 -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its third quarter 2019 financial and operating results on Tuesday, November 12, 2019. Following the announcement, IVERIC bio's management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss further details of the clinical trial results previously announced by the Company for its Zimura® (avacincaptad pegol) program in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), review the Company's financial results, and provide a general business update.

    To participate in this conference call, dial 888-208-1711 (USA) or 323-994-2082 (International…

    - Company to Host a Zimura® R&D Symposium for Investors on November 20, 2019 -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its third quarter 2019 financial and operating results on Tuesday, November 12, 2019. Following the announcement, IVERIC bio's management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss further details of the clinical trial results previously announced by the Company for its Zimura® (avacincaptad pegol) program in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), review the Company's financial results, and provide a general business update.

    To participate in this conference call, dial 888-208-1711 (USA) or 323-994-2082 (International), passcode 5526863. 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 Toll Free), passcode 5526863.

    Zimura R&D Symposium for Investors

    The Company also announced that it will host a Zimura R&D Symposium for Investors on Wednesday, November 20, 2019 from 8:00 a.m. to 10:00 a.m. Eastern Time in New York. The event will feature a presentation of the previously announced clinical trial results from the Company's Zimura program on GA secondary to dry AMD and will include discussions with retinal specialists and key opinion leaders in dry AMD. On October 28, 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in a Phase 2b randomized, controlled clinical trial in GA secondary to dry AMD.

    The event will be accessible via webcast on the IVERIC bio website at www.ivericbio.com. For more information, please contact Kathy Galante at or 212-845-8231.

    About IVERIC bio

    IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. 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 IVERIC bio'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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent IVERIC bio's views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so.

    ISEE-G

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  51. - Overall Data Suggest a Dose Response Relationship Across Treatment Groups -

    - Conference Call and Webcast Today, October 28, 2019 at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced initial topline data confirming that Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD) in a randomized, controlled Phase 2b clinical trial. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared…

    - Overall Data Suggest a Dose Response Relationship Across Treatment Groups -

    - Conference Call and Webcast Today, October 28, 2019 at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced initial topline data confirming that Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD) in a randomized, controlled Phase 2b clinical trial. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared to the corresponding sham control group. These data for both dose groups were statistically significant. Although efficacy data from patients receiving Zimura 1 mg was not part of the prespecified statistical analysis, preliminary descriptive analysis indicated that, on average, the percent GA growth from baseline to month 12 for Zimura 1 mg group was less than for the corresponding sham control group. The overall data suggest a dose response relationship across treatment groups.

    Zimura was generally well tolerated after 12 months of administration. There was no Zimura-related inflammation and there were no Zimura-related discontinuations from the trial. Further, there have been no ocular serious adverse events and no cases of endophthalmitis reported in the study eye in this ongoing clinical trial. During the first 12 months of the trial, the incidence of choroidal neovascularization (CNV) in the untreated fellow eye was 10 patients (3.5%), and in the study eye was 3 patients (2.7%) in the sham control group, 6 patients (9.0%) in the Zimura 2 mg group, and 8 patients (9.6%) in the Zimura 4 mg group. The most frequently reported ocular adverse events were related to the injection procedure.

    "IVERIC bio's unwavering commitment to science has resulted in compelling Phase 2b data in GA secondary to dry AMD, a major public health problem that has devastating effects on our patients," stated Marco A. Zarbin, M.D., Ph.D., FACS, Professor and Chair, Institute of Ophthalmology and Visual Science, Rutgers-New Jersey Medical School, Newark, New Jersey. "As a retina specialist, Zimura's impressive efficacy results and favorable safety profile observed to date in this trial indicate its potential as a future treatment for this growing patient population, which represents an urgent unmet medical need."