1. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, M.D., President, will present an overview of the Company at the H.C. Wainwright 23rd Annual Global Investment Conference, being held virtually from September 13-15, 2021.

    The on-demand presentation will be available for viewing beginning September 13 at 7:00 a.m. ET and can be accessed on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the presentation will be available on the Company's website immediately following the conference and for at least 30 days thereafter.

    About Iveric Bio

    Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, M.D., President, will present an overview of the Company at the H.C. Wainwright 23rd Annual Global Investment Conference, being held virtually from September 13-15, 2021.

    The on-demand presentation will be available for viewing beginning September 13 at 7:00 a.m. ET and can be accessed on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the presentation will be available on the Company's website immediately following the conference and for at least 30 days 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. For more information on the Company, please visit www.ivericbio.com.

    Forward-looking Statements

    Any statements in this press release or made during the presentation referenced herein 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, including those described in the "Risk Factors" section of public filings made by Iveric Bio with the U.S. Securities and Exchange Commission. Any forward-looking statements represent Iveric Bio's views only as of the date of this press release or the presentation, as applicable. Iveric Bio anticipates that subsequent events and developments may 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 unless required by law.

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  2. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on September 1, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to three newly-hired, non-executive employees. The inducement grants were approved by the Company's compensation and talent strategy 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 or her employment compensation.

    The inducement grants consisted of a non-statutory option to purchase an aggregate of 155,000 shares of the Company's common stock, and two grants of an aggregate of…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on September 1, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to three newly-hired, non-executive employees. The inducement grants were approved by the Company's compensation and talent strategy 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 or her employment compensation.

    The inducement grants consisted of a non-statutory option to purchase an aggregate of 155,000 shares of the Company's common stock, and two grants of an aggregate of 12,500 restricted stock units for shares of the Company's common stock.

    The stock options each have an exercise price of $10.45 per share, equal to the closing price of Iveric Bio's common stock on September 1, 2021. The stock options each have a ten-year term and vest over four years, with 25% of the shares underlying each option vesting on September 1, 2022 and an additional 2.0833% of the shares underlying each option vesting at the end of each successive month thereafter. The two grants of restricted stock units for shares of the Company's common stock each vest with respect to 100% of the shares underlying the grant on September 1, 2022. 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.

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  3. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, M.D., President, will present an overview of the Company at the H.C. Wainwright Ophthalmology Virtual Conference on Tuesday, August 17, 2021. This on-demand presentation will be available at 7:00 a.m. Eastern Time on August 17, 2021. Dr. Dugel will also participate in Addressing Unmet Medical Needs in Macular Degeneration – Dry AMD and Stargardt Disease, a one-time, live-only panel discussion, on August 17 at 11:00 a.m. Eastern Time.

    Investors and the general public are invited to listen to both the on-demand and live webcasts on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the on-demand presentation will…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, M.D., President, will present an overview of the Company at the H.C. Wainwright Ophthalmology Virtual Conference on Tuesday, August 17, 2021. This on-demand presentation will be available at 7:00 a.m. Eastern Time on August 17, 2021. Dr. Dugel will also participate in Addressing Unmet Medical Needs in Macular Degeneration – Dry AMD and Stargardt Disease, a one-time, live-only panel discussion, on August 17 at 11:00 a.m. Eastern Time.

    Investors and the general public are invited to listen to both the on-demand and live webcasts on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the on-demand presentation will be available on the Company's website immediately following the conference and for at least 30 days 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. For more information on the Company, please visit www.ivericbio.com.

    Forward-looking Statements

    Any statements in this press release or made during the presentation referenced herein 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, including those described in the "Risk Factors" section of public filings made by Iveric Bio with the U.S. Securities and Exchange Commission. Any forward-looking statements represent Iveric Bio's views only as of the date of this press release or the presentation, as applicable. Iveric Bio anticipates that subsequent events and developments may 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 unless required by law.

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  4. IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, M.D., President, will participate in the panel discussion, "Only Have Eyes For You - Ophthalmic Gene Therapy," at the 2021 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 11 at 8:00 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the on-demand panel discussion will be available on the Company's website immediately following the conference and for at least 30 days thereafter.

    About Iveric Bio

    Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of…

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today that Pravin U. Dugel, M.D., President, will participate in the panel discussion, "Only Have Eyes For You - Ophthalmic Gene Therapy," at the 2021 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 11 at 8:00 a.m. Eastern Time.

    Investors and the general public are invited to listen to a live webcast on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com. An archived replay of the on-demand panel discussion will be available on the Company's website immediately following the conference and for at least 30 days 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. 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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  5. - FDA Agreement Under Special Protocol Assessment (SPA) Received for GATHER2 Phase 3 Clinical Trial of Zimura® in Geographic Atrophy Secondary to Age-Related Macular Degeneration –

    - Zimura GATHER2 Enrollment Complete; Retention Exceeding Expectations, with Injection Fidelity Rate Target of Greater than 90% -

    - GATHER1 18 Month Post-Hoc Analyses Show Zimura 2 mg Has the Potential to Have an Impact on Earlier Stages of Dry AMD Prior to Geographic Atrophy -

    - Conference Call and Webcast Today, August 4, 2021, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the quarter ended June 30, 2021 and provided a general business update.

    "This is an exciting time for the Company as we have delivered…

    - FDA Agreement Under Special Protocol Assessment (SPA) Received for GATHER2 Phase 3 Clinical Trial of Zimura® in Geographic Atrophy Secondary to Age-Related Macular Degeneration –

    - Zimura GATHER2 Enrollment Complete; Retention Exceeding Expectations, with Injection Fidelity Rate Target of Greater than 90% -

    - GATHER1 18 Month Post-Hoc Analyses Show Zimura 2 mg Has the Potential to Have an Impact on Earlier Stages of Dry AMD Prior to Geographic Atrophy -

    - Conference Call and Webcast Today, August 4, 2021, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the quarter ended June 30, 2021 and provided a general business update.

    "This is an exciting time for the Company as we have delivered on several transformational milestones, particularly with regard to the execution of our Zimura pivotal program," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "For GATHER2, our second Zimura Phase 3 clinical trial for geographic atrophy secondary to age-related macular degeneration, we received a Special Protocol Assessment agreement from the FDA, we completed enrollment four months ahead of schedule, and patient retention, as measured by the injection fidelity rate, continues to exceed expectations and we are targeting the 12-month rate to be greater than 90%. In addition, the results of post-hoc analyses from GATHER1, our first Zimura Phase 3 clinical trial in GA secondary to AMD, indicate that Zimura may have a therapeutic benefit in earlier stages of GA."

    "We are extremely proud of the momentum that we have created," stated Pravin U. Dugel, President of Iveric Bio. "During July 2021, we strengthened our balance sheet with a public offering. We believe this enables us to further support the impressive recruitment with superb retention in our Zimura GATHER2 Phase 3 trial, prepare and potentially file a New Drug Application for Zimura in GA secondary to AMD, begin preparations for a potential commercial launch of Zimura in GA secondary to AMD, initiate a drusen clinical development program, and invest in sustained release delivery technologies for Zimura. We are committed to execute on our strategy to develop and deliver treatments for diseases of the retina through our Zimura, HtrA1 inhibitor and gene therapy programs, with the potential to create long-term shareholder value."

    Therapeutics Programs Targeting Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

    Zimura® (avacincaptad pegol): Complement C5 Inhibitor

    • Special Protocol Assessment (SPA) for GATHER2

      The Company announced on July 6, 2021, that it received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2, the Company's second pivotal clinical trial of Zimura in development for the treatment of GA secondary to AMD. The agreement further solidifies the Company's plans to file an application with the FDA for marketing approval of Zimura for GA secondary to AMD, if the ongoing GATHER2 clinical trial meets its primary endpoint at 12 months. Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in the previously completed GATHER1 pivotal clinical trial.



      In parallel discussions with those for the GATHER2 SPA, the FDA indicated to the Company that, as part of a future NDA submission for Zimura, the GATHER1 results will be considered using the original prespecified primary efficacy endpoint analysis, together with a post-hoc analysis using the same FDA preferred method that will be used for the GATHER2 trial (mean rate of growth (slope) estimated based on GA area measured by fundus autofluorescence (FAF) in the relevant timepoints). The GATHER 1 results as analyzed by the FDA preferred analysis is highly consistent with and strongly supportive of the results from the original prespecified analysis. The complete results of both analyses for GATHER1 have been presented in the Company's July 6, 2021 press release and Form 8-K filing.
    • GATHER2 Enrollment, Retention, and Injection Fidelity Rate

      On July 26, 2021, the Company announced completion of enrollment in GATHER2, four months ahead of the Company's original schedule. Based on this timeline, the Company expects topline GATHER2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis.



      In June 2021, the Company announced that it is targeting patient retention for the GATHER2 trial, as measured by injection fidelity rate through month 12, of greater than 90%. The injection fidelity rate continues to exceed the Company's expectations. Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections based on the number of enrolled patients. The Company considers injection fidelity to be the most important and stringent measure of patient retention because it reflects the timely administration of the drug into the patient's eye.
    • Earlier Stages of Dry AMD Prior to Geographic Atrophy

      In June 2021, Vas Sadda, MD, of Doheny Eye Institute at UCLA, presented new post-hoc analyses from the GATHER1 trial on progression of drusen and nascent GA (iRORA/cRORA), which are earlier forms of dry AMD, in patients treated with Zimura 2 mg as compared to patients in the sham group. These post-hoc analyses suggest that Zimura may have the potential to impact AMD even before atrophy occurs, thereby changing the natural course of the disease. The Company expects to initiate a drusen clinical development program in 2022.
    • Autosomal Recessive Stargardt Disease

      Patient enrollment in the Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease, referred to as the STAR trial, is ongoing with the goal of enrolling approximately 25 new patients for a total of approximately 120 patients.

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

    During the second quarter of 2021, the Company commenced its first preclinical tolerability study for IC-500 and is currently planning additional preclinical studies, including pharmacokinetic and target engagement studies. Formulation optimization and other manufacturing activities are also ongoing. The Company expects to submit an investigational new drug application (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-200: BEST1-Related IRDs

      The Company has completed an IND-enabling preclinical toxicology study of IC-200, in a naturally occurring canine disease model of Best disease. Subject to regulatory review, the Company plans to initiate a Phase 1/2 clinical trial of IC-200 during the fourth quarter of 2021. The first IC-200 clinical trial will focus on patients with the autosomal recessive form of the disease, autosomal recessive bestrophinopathy.
    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)

      As previously disclosed, the Company was planning to discuss with the FDA the results from its toxicology studies of IC-100, and the design of its first-in-human clinical trial, before submitting an IND. The FDA advised, in lieu of this meeting, additional discussion should be conducted during the 30-day IND review period following IND submission. The Company is currently considering its development options for this product candidate.
    • Minigene Programs

      The Company, through its minigene collaboration with the University of Massachusetts Medical School (UMMS), has identified a lead construct for its Leber Congenital Amaurosis Type 10 (LCA10) miniCEP290 program and is currently planning preclinical development for this program. The Company is evaluating preclinical data from its Stargardt Disease (ABCA4) program and expects to obtain preliminary results from its USH2A-related inherited retinal diseases (USH2A) program in the first half of 2022.



      The Company recently hired four individuals who were previously at UMMS, including Hemant Khanna, Ph.D., the principal investigator for the Company's miniCEP290, miniABCA4 and miniUSH2A sponsored research programs. Dr. Khanna joined the Company as Vice President, Pre-Clinical Ocular Research. The Company is working to transition the research and preclinical development activities for these programs from UMMS to the Company. The Company is also preparing to establish laboratory space for these employees to continue working on these programs and other preclinical research and development activities for the Company.

    Management Updates

    • In August 2021, Christopher Simms joined Iveric Bio as Senior Vice President and Chief Commercial Officer. Mr. Simms is an accomplished healthcare leader with more than 20 years of diverse commercial leadership experience at Johnson & Johnson, Genentech, and Novartis, including focused experience in retina, ophthalmology, and optometry.

    Second Quarter Financial Results and 2021 Cash Guidance

    • As of June 30, 2021, the Company had $159.9 million in cash and cash equivalents.
    • In July 2021, the Company raised approximately $108 million in net proceeds in an underwritten public offering of common stock. The Company sold 13,397,500 shares of its common stock in this public offering.
    • The Company now estimates its year-end 2021 cash, cash equivalents and available for sale securities to range between $215 million and $225 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 through at least mid-year 2024. These estimates are based on the Company's current business plan including the continuation of its ongoing clinical development programs for Zimura, preparation and potential filing of a New Drug Application and a Marketing Authorization Application for Zimura in GA secondary to AMD, beginning preparations for a potential commercial launch of Zimura in GA secondary to AMD, initiating a drusen clinical development program, and investing in sustained release delivery technologies for Zimura, the progression of its IC-200 and IC-100 programs into the clinic, and the advancement of its IC-500 development program. Excluded from these estimates are any potential approval or sales milestones payable to Archemix Corp. and potential expenses for actual commercial launch of Zimura, any additional expenditures related to potentially studying Zimura in indications outside of GA and drusen or resulting from the potential in-licensing or acquisition of additional product candidates or technologies, and any associated development the Company may pursue.

    2021 Q2 Financial Highlights

    • R&D Expenses: Research and development expenses were $23.5 million for the quarter ended June 30, 2021, compared to $12.7 million for the same period in 2020. For the six months ended June 30, 2021, research and development expenses were $42.0 million compared to $26.5 million for the same period in 2020. Research and development expenses increased primarily due to the commencement of patient enrollment and ongoing progress of the GATHER2 clinical trial, increased manufacturing activities for Zimura and increases in research and development personnel.
    • G&A Expenses: General and administrative expenses were $6.7 million for the quarter ended June 30, 2021, compared to $6.3 million for the same period in 2020. For the six months ended June 30, 2021, general and administration expenses were $15.0 million compared to $11.3 million for the same period in 2020. General and administration expenses increased primarily due to legal costs associated with continued litigation efforts.
    • Income Tax Benefit: The Company recorded no income tax benefit for the three and six months ended June 30, 2021. 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 Loss: The Company reported a net loss for the quarter ended June 30, 2021 of $30.1 million, or ($0.32) per diluted share, compared to a net loss of $18.6 million, or $(0.32) per diluted share, for the same period in 2020. For the six months ended June 30, 2021, the Company reported a net loss of $56.9 million or ($0.61) per diluted share, compared to a net loss of $33.7 million or ($0.61) for the same period in 2020.

    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 4, 2021 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 7257034 . 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 1-877-344-7529 (USA) or 1-412-317-0088 , passcode 10158843.

    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. 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 the availability of topline data from 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 its plans to submit a new drug application to the U.S. Food and Drug Administration and a marketing authorization application to the European Medicines Agency for Zimura if the results from GATHER2 are positive and its plans to initiate clinical development in drusen, the implementation of its business plan, its projected use of 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, expectations for regulatory matters, 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 clinical trial sites, contract development and manufacturing organizations, university collaborators and other third parties, establishment of manufacturing capabilities, developments from the Company's competitors and the marketplace for the Company's products, human capital 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 may 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,

    2021

     

    2020

     

    2021

     

    2020

     
    Statements of Operations Data:
    Operating expenses:
    Research and development

    $

    23,488

     

    $

    12,720

     

    $

    42,037

     

    $

    26,470

     

    General and administrative

     

    6,718

     

     

    6,289

     

     

    15,040

     

     

    11,287

     

    Total operating expenses

     

    30,206

     

     

    19,009

     

     

    57,077

     

     

    37,757

     

    Loss from operations

     

    (30,206

    )

     

    (19,009

    )

     

    (57,077

    )

     

    (37,757

    )

    Interest income

     

    65

     

     

    46

     

     

    142

     

     

    404

     

    Other income (expense), net

     

    (2

    )

     

    (12

    )

     

    (3

    )

     

    (7

    )

    Loss before income benefit

     

    (30,143

    )

     

    (18,975

    )

     

    (56,938

    )

     

    (37,360

    )

    Income tax benefit

     

    -

     

     

    386

     

     

    -

     

     

    3,695

     

    Net loss

    $

    (30,143

    )

    $

    (18,589

    )

    $

    (56,938

    )

    $

    (33,665

    )

    Net loss per common share:
    Basic and diluted

    $

    (0.32

    )

    $

    (0.32

    )

    $

    (0.61

    )

    $

    (0.61

    )

    Weighted average common shares outstanding:
    Basic and diluted

     

    93,409

     

     

    57,421

     

     

    93,382

     

     

    55,424

     

     

    June 30, 2021

    December 31, 2020

    (in thousands)

    Balance Sheets Data:
    Cash, cash equivalents and marketable securities

    $

    159,882

     

    $

    210,047

     

    Total assets

    $

    165,667

     

    $

    216,754

     

    Total liabilities

    $

    26,094

     

    $

    25,191

     

    Additional paid-in capital

    $

    761,491

     

    $

    756,543

     

    Accumulated deficit

    $

    (622,011

    )

    $

    (565,073

    )

    Total stockholders' equity

    $

    139,573

     

    $

    191,563

     

    ISEE-G

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  6. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on August 2, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to five newly hired employees. The inducement grants were approved by the Company's compensation and talent strategy 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:

    • to Christopher Simms, the Company's Senior Vice President, Chief Commercial Officer, a non-statutory option to purchase 160,000 shares of the Company's common stock…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on August 2, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to five newly hired employees. The inducement grants were approved by the Company's compensation and talent strategy 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:

    • to Christopher Simms, the Company's Senior Vice President, Chief Commercial Officer, 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 separate grant of 15,000 restricted stock units for shares of the Company's common stock; and
    • to four other non-executive employees, non-statutory options to purchase an aggregate of 64,400 shares of the Company's common stock.

    Each of the granted stock options has an exercise price of $8.64 per share, equal to the closing price of Iveric Bio's common stock on August 2, 2021. The stock options each have a ten-year term and vest over four years, with 25% of the shares underlying each option vesting on August 2, 2022 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 of 75,000 shares to Mr. Simms vests with respect to 25% of the shares underlying the grant on each of August 2, 2022, August 2, 2023, August 2, 2024 and August 2, 2025. The other restricted stock unit grant to Mr. Simms of 15,000 shares vests with respect to 100% of the shares underlying the grant on August 2, 2022. 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.

    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. For more information on the Company, please visit www.ivericbio.com.

    ISEE-G

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  7. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its second quarter 2021 financial and operating results on Wednesday, August 4, 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 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 7257034. 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 1-877-344-7529…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its second quarter 2021 financial and operating results on Wednesday, August 4, 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 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 7257034. 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 1-877-344-7529 (USA Toll Free), passcode 10158843.

    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. 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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  8. - Topline Data Expected in 2H 2022; if Positive, New Drug Application Expected -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced the early completion of patient enrollment of GATHER2, the Company's second pivotal clinical trial of Zimura® (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company expects topline GATHER2 data to be become available during the second half of 2022, approximately one year after the enrollment of the last patient, plus the time needed for database lock and analysis.

    "The time to complete enrollment in the Zimura GATHER2 clinical trial was four months ahead of our original timeline. That we were able to accomplish this during…

    - Topline Data Expected in 2H 2022; if Positive, New Drug Application Expected -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced the early completion of patient enrollment of GATHER2, the Company's second pivotal clinical trial of Zimura® (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company expects topline GATHER2 data to be become available during the second half of 2022, approximately one year after the enrollment of the last patient, plus the time needed for database lock and analysis.

    "The time to complete enrollment in the Zimura GATHER2 clinical trial was four months ahead of our original timeline. That we were able to accomplish this during the unprecedented challenges stemming from the global COVID-19 pandemic, we believe highlights the unmet need of patients and physicians for a treatment of GA secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "Patient retention continues to exceed our expectations in GATHER2. We look forward to sharing the topline results of GATHER2 in the second half of 2022 and to the potential opportunity to bring Zimura therapy to GA secondary to AMD patients around the world."

    In June 2021, the Company announced that it is targeting patient retention for the trial, as measured by the injection fidelity rate through month 12, of greater than 90%. Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections based on the number of enrolled patients. The Company considers injection fidelity to be the most important component of patient retention because it reflects the timely administration of the drug into the patient's eye.

    The Company also announced earlier this month that it received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2. The agreement further solidifies the Company's plans to file an application with the FDA for marketing approval of Zimura for GA secondary to AMD, if the ongoing GATHER2 clinical trial meets its primary endpoint at 12 months. Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in the previously completed GATHER1 pivotal clinical trial.

    "The successful completion of enrollment ahead of schedule and on-going patient retention in GATHER2 reflect the tremendous work and innovative programs our clinical team has executed and are a tribute to our patients, investigators and their study staff," stated Pravin U. Dugel, President of Iveric Bio. "This milestone would have been impressive at any time however it is more impressive during a global pandemic. We continue to focus on retention, not only to protect the integrity of our data, but also with the goal of demonstrating Zimura's early and continuous treatment effect over time, similar to what we observed previously in GATHER1."

    In GATHER2, 448 patients were 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 (slope) 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.

    About Zimura

    Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy secondary to age-related macular degeneration.

    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. 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 development and regulatory strategy for Zimura, including its strategy to seek marketing approval from the FDA and EMA for Zimura for the treatment of GA secondary to AMD if the ongoing GATHER2 clinical trial meets its primary endpoint at 12 months, the timing, progress and results of clinical trials, including expectations regarding patient retention in, and the availability of topline data from, GATHER2, and other research and development activities and the potential utility of Zimura. 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 expectations for regulatory matters, 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 clinical trial sites, contract research organizations and other third parties, establishment of manufacturing capabilities, 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 may 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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  9. – Former U.S. Franchise Head of Ophthalmics at Novartis Brings a Proven Track Record in Major Retinal Product Launches –

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the appointment of Christopher Simms to Senior Vice President and Chief Commercial Officer, effective August 2, 2021. Mr. Simms joins Iveric Bio from Novartis, where he successfully managed commercial operations for the U.S. Ophthalmics Franchise, launching BEOUV® (brolucizumab injection) for wet age-related macular degeneration (AMD). Before Novartis, he served as marketing lead for the Genentech ophthalmology business which included creating a new brand positioning and launching a new campaign for Lucentis® (ranibizumab injection).

    "In this newly created position, Chris's…

    – Former U.S. Franchise Head of Ophthalmics at Novartis Brings a Proven Track Record in Major Retinal Product Launches –

    IVERIC bio, Inc. (NASDAQ:ISEE) announced today the appointment of Christopher Simms to Senior Vice President and Chief Commercial Officer, effective August 2, 2021. Mr. Simms joins Iveric Bio from Novartis, where he successfully managed commercial operations for the U.S. Ophthalmics Franchise, launching BEOUV® (brolucizumab injection) for wet age-related macular degeneration (AMD). Before Novartis, he served as marketing lead for the Genentech ophthalmology business which included creating a new brand positioning and launching a new campaign for Lucentis® (ranibizumab injection).

    "In this newly created position, Chris's responsibilities include developing and implementing the Company's commercial strategy and establishing our commercial infrastructure as we complete our GATHER2 clinical trial, prepare for a potential new drug application (NDA) and begin to prepare for a potential launch of Zimura® (avacincaptad pegol) for the treatment of geographic atrophy secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited about a potential launch of Zimura and our strategy to develop multiple, complementary assets to establish an AMD franchise. We believe Chris's deep understanding of the retinal space and highly accomplished commercial experience with launching retinal products of blockbuster potential will serve us well."

    "It is exciting to see the advances that Iveric Bio has made," stated Mr. Simms. "I believe the Company is well positioned as it begins to pivot to a commercial organization that brings treatments to patients suffering from devastating sight threatening diseases. I am thrilled to join the management team at Iveric Bio and look forward to building and leading a commercial organization that has a positive impact on patients and the development of our products."

    Christopher Simms

    Mr. Simms is an accomplished healthcare leader with more than 20 years of diverse commercial leadership experience at Johnson & Johnson, Genentech and Novartis, including focused experience in retina, ophthalmology and optometry. Most recently, he was the Vice President and Head of the Novartis US Ophthalmics business unit which includes the brands BEOVU® and Xiidra®. He joined Novartis in 2017 to build the commercial launch strategy for BEOUV® after leading commercial efforts on Lucentis® at Genentech. Prior to Genentech, he spent 16 years at Johnson & Johnson working with leading brands across their vision care, diabetes and consumer goods businesses in Canada, Japan and the US.

    Mr. Simms has a Bachelor of Commerce from Memorial University of Newfoundland and an MBA from York University, Toronto, Canada.

    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. 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, including establishing a commercial strategy and infrastructure for the potential launch of Zimura and the Company's expectations regarding completion of the GATHER2 trial and preparation of a potential new drug application for Zimura for geographic atrophy secondary to dry age-related macular degeneration. 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 progress and results of research and development programs and clinical trials, including the ongoing GATHER2 clinical trial, availability of data from these programs, expectations for regulatory matters, establishment of manufacturing capabilities, developments from the marketplace and competitors for the Company's product candidates, human capital and personnel requirements, 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 may 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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  10. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an underwritten public offering of 11,650,000 shares of its common stock at a price to the public of $8.60 per share, less underwriting discounts and commissions. 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 1,747,500 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by the Company.

    The gross proceeds from the offering are expected to be approximately $100.2 million, before underwriting discounts and commissions and offering expenses payable by the Company, and without giving…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an underwritten public offering of 11,650,000 shares of its common stock at a price to the public of $8.60 per share, less underwriting discounts and commissions. 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 1,747,500 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by the Company.

    The gross proceeds from the offering are expected to be approximately $100.2 million, before underwriting discounts and commissions 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, Credit Suisse and Stifel are acting as the book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering. The offering is expected to close on or about July 15, 2021, subject to customary closing conditions.

    The 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 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 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 PostSaleManualRequests@broadridge.com, or by telephone: (833) 297-2926; Credit Suisse Securities (USA) LLC, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, Attn: Prospectus Department, or by emailing usa.prospectus@credit-suisse.com, or by telephone: (800) 221-1037; or Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attention: Prospectus Department, or by emailing syndprospectus@stifel.com, or by telephone: (415) 364-2720.

    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

    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.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the 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," "future", "may", "might," "plan," "predict," "project," "seek," "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, the potential completion of the offering, satisfaction of customary closing conditions related to the offering, those related to expectations for regulatory matters, 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 clinical trial sites, contract research organizations and other third parties, establishment of manufacturing capabilities, developments from the Company's competitors and the marketplace for its products, 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 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 may 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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  11. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of shares of its common stock. 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. 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, Credit Suisse and Stifel are acting as the book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

    A shelf registration statement…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of shares of its common stock. 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. 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, Credit Suisse and Stifel are acting as the book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

    A shelf registration statement on Form S-3 (File No. 333-253897) relating to the shares of common stock to be offered was filed with the Securities and Exchange Commission (the "SEC") on March 5, 2021 and was declared effective on April 9, 2021. 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, New York 11717, Attn: Prospectus Department, or by emailing PostSaleManualRequests@broadridge.com, or by telephone: (833) 297-2926; Credit Suisse Securities (USA) LLC, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, Attn: Prospectus Department, or by emailing usa.prospectus@credit-suisse.com, or by telephone: (800) 221-1037; or Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attention: Prospectus Department, or by emailing syndprospectus@stifel.com, or by telephone: (415) 364-2720.

    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

    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.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the proposed 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," "future", "may", "might," "plan," "predict," "project," "seek," "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 offering or the size or terms thereof, satisfaction of customary closing conditions related to the proposed offering, those related to expectations for regulatory matters, 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 clinical trial sites, contract research organizations and other third parties, establishment of manufacturing capabilities, developments from the Company's competitors and the marketplace for its products, 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 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 may 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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  12. - GATHER2 Enrollment and Retention Continue to Exceed Expectations; Completion of Enrollment Expected Late July of this Year and Topline Data Expected Second Half of 2022 -

    - Conference Call and Webcast Today, July 6, 2021, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the Company received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2, the Company's pivotal clinical trial of Zimura® (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As previously announced, the Company expects to complete enrollment in GATHER2 in late July of this year. Based…

    - GATHER2 Enrollment and Retention Continue to Exceed Expectations; Completion of Enrollment Expected Late July of this Year and Topline Data Expected Second Half of 2022 -

    - Conference Call and Webcast Today, July 6, 2021, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the Company received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2, the Company's pivotal clinical trial of Zimura® (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As previously announced, the Company expects to complete enrollment in GATHER2 in late July of this year. Based on this timeline, the Company expects topline GATHER2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210706005200/en/

    Zimura 2 mg vs. Sham: Mean Rate of Change in GA Area (Prespecified) Over 12 Months (Graphic: Business Wire)

    Zimura 2 mg vs. Sham: Mean Rate of Change in GA Area (Prespecified) Over 12 Months (Graphic: Business Wire)

    Similar to the Company's completed GATHER1 clinical trial, GATHER2 is designed to be an adequate and well-controlled clinical trial which, if positive, would support a New Drug Application (NDA) for Zimura in the treatment of GA secondary to AMD. The SPA agreement further solidifies the Company's plans to file an application with the FDA if the ongoing GATHER2 clinical trial meets its primary efficacy endpoint at 12 months.

    In connection with the SPA, the FDA recommended, and the Company accepted, modifying the primary efficacy endpoint for the GATHER2 trial from the mean rate of change in GA area over 12 months measured by fundus autofluorescence (FAF) at three timepoints: baseline, month 6 and month 12, to the mean rate of growth (slope) estimated based on GA area measured by FAF in at least three timepoints: baseline, month 6 and month 12. In connection with the SPA, the Company submitted, and the FDA reviewed, a revised clinical trial protocol and statistical analysis plan (SAP) for the GATHER2 trial reflecting the revised primary efficacy endpoint and agreed upon statistical analysis method. The original primary efficacy endpoint estimated the mean rate of change in GA area from baseline to month 12, as measured by FAF readings at three time points (baseline, month 6 and month 12), without assuming a constant rate of growth over the period. Using the same raw data, the FDA preferred method estimates the mean rate of growth of GA area from baseline to month 12, based on FAF readings at the same three time points (baseline, month 6 and month 12), assuming a constant rate of growth over the period, essentially fitting a straight line based on the data.

    "We are excited to receive this SPA agreement from the FDA," stated Pravin U. Dugel, MD, President of Iveric Bio. "We thank the FDA for their collaborative interactions and valuable input on the primary efficacy endpoint for the GATHER2 trial, which we believe reflects the FDA's current thinking. The modification of the primary efficacy endpoint does not require collecting any new data but instead reflects a change in how the data are analyzed. We look forward to continuing to work with the FDA and following their guidance as we work toward preparing the eventual NDA submission for Zimura."

    In parallel discussions with those for the GATHER2 SPA, the FDA indicated to the Company that, as part of a future NDA submission for Zimura, the GATHER1 results will be considered using the original prespecified primary efficacy endpoint analysis, together with a post-hoc analysis using the same FDA preferred method that will be used for the GATHER2 trial (mean rate of growth (slope) estimated based on GA area measured by FAF in the relevant timepoints).

    Dr. Dugel stated, "We are pleased that the FDA agrees the design and planned analysis of GATHER2 as modified adequately address the objectives necessary to support an NDA submission. We are also pleased that as part of a future NDA submission, the FDA has indicated that it will consider the GATHER1 data using the original prespecified primary efficacy endpoint analysis, together with the new FDA preferred method that we are using for GATHER2. The data from GATHER1, when analyzed on a post-hoc basis using the FDA's preferred method, show results that are highly consistent with and strongly supportive of the results we originally reported for GATHER1. We continue to believe GATHER1 will serve as one of the two adequate and well-controlled pivotal clinical trials required for purposes of obtaining marketing approval of Zimura in GA."

    Below are the month 12 and month 18 results for both analyses for the GATHER1 trial:

    Zimura 2 mg vs. Sham

    Mean Rate of Change in GA Area (prespecified) & Mean Rate of GA Growth (Slope) (FDA)

    The accompanying graphs illustrate the 12-month results for the Zimura 2 mg group as compared to the corresponding sham group, using both the original prespecified primary efficacy endpoint analysis and the new FDA preferred method that will be used for the GATHER2 trial.

    Below are the month 12 and month 18 results for both analyses for the GATHER1 trial, for the Zimura 2 mg group as compared to its corresponding sham group:

    MRM Analysis

    Zimura 2 mg

    (N = 67)

    Sham

    (N = 110)

    Difference

    % Difference

    P-Value

    12 Month Sq. Rt. Transformation:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm)

    0.292

    0.402

    0.110

    27.38%

    0.0072(a)

    Mean Rate of GA Growth (Slope) (mm)

    0.283

    0.392

    0.109

    27.73%

    0.0063(b)

    12 Month Observed Data:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm2)

    1.592

    2.290

    0.697

    30.45%

    0.0059(b)

    Mean Rate of GA Growth (Slope) (mm2)

    1.221

    1.889

    0.668

    35.37%

    0.0050(b)

    18 Month Sq. Rt. Transformation:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm)

    0.430

    0.599

    0.168

    28.11%

    0.0014(b)

    Mean Rate of GA Growth (Slope) (mm)

    0.451

    0.607

    0.156

    25.75%

    0.0027(b)

    18 Month Observed Data:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm2)

    2.431

    3.587

    1.156

    32.24%

    0.0009(b)

    Mean Rate of GA Growth (Slope) (mm2)

    1.914

    2.951

    1.037

    35.13%

    0.0023(b)

    The estimates for the Zimura 2 mg group vs. sham are from the MRM model, drawing on all available data, including data from groups with different randomization ratios in Part 1 and Part 2 of the trial, and should not be interpreted as directly observed data.

    (a) Prespecified primary endpoint; statistically significant

    (b) Descriptive p-value

    Zimura 4 mg vs. Sham

    Mean Rate of Change in GA Area (prespecified) & Mean Rate of GA Growth (Slope) (FDA)

    The accompanying graphs illustrate the 12-month results for the Zimura 4 mg group as compared to the corresponding sham group, using both the original prespecified primary efficacy endpoint analysis and the new FDA preferred method that will be used for the GATHER2 trial.

    Below are the month 12 and month 18 results for both analyses for the GATHER1 trial, for the Zimura 4 mg group as compared to its corresponding sham group:

    MRM Analysis

    Zimura 4 mg

    (N = 83)

    Sham

    (N = 84)

    Difference

    % Difference

    P-Value

    12 Month Sq. Rt. Transformation:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm)

    0.321

    0.444

    0.124

    27.81%

    0.0051(a)

    Mean Rate of GA Growth (Slope) (mm)

    0.307

    0.416

    0.109

    26.31%

    0.0100(b)

    12 Month Observed Data:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm2)

    2.061

    2.770

    0.709

    25.59%

    0.0082(b)

    Mean Rate of GA Growth (Slope) (mm2)

    1.674

    2.273

    0.599

    26.34%

    0.0147(b)

    18 Month Sq. Rt. Transformation:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm)

    0.391

    0.559

    0.167

    29.97%

    0.0021(b)

    Mean Rate of GA Growth (Slope) (mm)

    0.373

    0.512

    0.139

    27.11%

    0.0086(b)

    18 Month Observed Data:

     

     

     

     

     

    Mean Rate of Change in GA Area (mm2)

    2.460

    3.486

    1.026

    29.44%

    0.0034(b)

    Mean Rate of GA Growth (Slope) (mm2)

    2.142

    3.010

    0.868

    28.82%

    0.0106(b)

    (a) Prespecified primary endpoint; statistically significant

    (b) Descriptive p-value

    Safety results from GATHER1 were not impacted as part of this analysis. As previously reported, the most frequently reported ocular adverse events were related to the injection procedure. The investigator-reported incidence of choroidal neovascularization (CNV) in the sham group was 3 patients (2.7%) at 12 months and 18 months, in the Zimura 2 mg group was 6 patients (9%) at 12 months and 8 patients (11.9%) at 18 months and in the Zimura 4 mg group was 8 patients (9.6%) at 12 months and 13 patients (15.7%) at 18 months.

    As previously announced, the Company is only advancing the Zimura 2 mg dose in the GATHER2 clinical trial.

    The Company plans to make additional supportive information regarding the GATHER1 post-hoc analysis available in its public filings with the Securities and Exchange Commission.

    "This written agreement from the FDA is consistent with our clinical and regulatory strategy and, we believe, reaffirms our planned approval pathway for Zimura for the treatment of GA secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "With patient enrollment and retention exceeding our expectations, we are poised to complete enrollment in the ongoing GATHER2 clinical trial in late July of this year. We believe we are on track for initial, topline data from GATHER2 to be available approximately one year after the enrollment of the last patient in the trial, plus the time needed for database closure and analysis."

    About Special Protocol Assessments

    The SPA process is a procedure by which the FDA provides a clinical trial sponsor with an official evaluation and written guidance on the design of a proposed protocol intended to form the basis for a new drug application.

    A SPA does not ensure the receipt of marketing approval or that the approval process will be faster than conventional regulatory procedures. Final marketing approval depends on efficacy and safety results and an evaluation of the overall benefits and risks of treatment after review of the data from the development program in its totality.

    The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessments, please visit: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-protocol-assessment-guidance-industry.

    About Zimura

    Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy secondary to age-related macular degeneration.

    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 today's announcement. To participate in the conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 9482414 . 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 1-877-344-7529 (USA Toll Free), passcode 10158299.

    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. 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," "future", "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 development and regulatory strategy for Zimura, including its strategy to submit an NDA to and seek marketing approval from the FDA for Zimura for the treatment of GA secondary to AMD if the ongoing GATHER2 clinical trial meets its primary efficacy endpoint at 12 months, the timing, progress and results of clinical trials, including expectations regarding patient enrollment and retention in GATHER2 and the availability of topline data from that trial, and other research and development activities and the potential utility of Zimura. 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 expectations for regulatory matters, 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 clinical trial sites, contract research organizations and other third parties, establishment of manufacturing capabilities, developments from the Company's competitors and the marketplace for its 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 may 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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  13. - GATHER2 Enrollment Nears Completion; Timeline Accelerated to Late July of this Year -

    - GATHER2 Retention Exceeding Expectations; with Injection Fidelity Rate Target for GATHER2 Greater than 90% -

    - GATHER1 18 Month Post-Hoc Analyses Show that Zimura 2 mg Has the Potential to Have an Impact on Earlier Stages of Dry AMD Prior to Geographic Atrophy -

    - 19.6% Reduction in Rate of Progression from Drusen to iRORA/cRORA as Compared to Sham at 18 Months Representing a Relative Risk Reduction of 72% -

    - 21.8% Reduction in Rate of Progression from iRORA to cRORA as Compared to Sham at 18 Months Representing a Relative Risk Reduction of 52% -

    - Webcast Today, June 18, 2021 to Begin at 10:00 a.m. Eastern Time -

    IVERIC bio, Inc. (NASDAQ:ISEE

    - GATHER2 Enrollment Nears Completion; Timeline Accelerated to Late July of this Year -

    - GATHER2 Retention Exceeding Expectations; with Injection Fidelity Rate Target for GATHER2 Greater than 90% -

    - GATHER1 18 Month Post-Hoc Analyses Show that Zimura 2 mg Has the Potential to Have an Impact on Earlier Stages of Dry AMD Prior to Geographic Atrophy -

    - 19.6% Reduction in Rate of Progression from Drusen to iRORA/cRORA as Compared to Sham at 18 Months Representing a Relative Risk Reduction of 72% -

    - 21.8% Reduction in Rate of Progression from iRORA to cRORA as Compared to Sham at 18 Months Representing a Relative Risk Reduction of 52% -

    - Webcast Today, June 18, 2021 to Begin at 10:00 a.m. Eastern Time -

    IVERIC bio, Inc. (NASDAQ:ISEE) announced that today at the Company's Virtual Symposium for Investors and Analysts, Arshad M. Khanani, MD, MA, of Sierra Eye Associates and Chairman of the GATHER2 Steering Committee, will discuss an accelerated enrollment timeline and patient retention, including injection fidelity, for GATHER2, the Company's pivotal clinical trial of Zimura® (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company expects to complete enrollment in GATHER2 in late July of this year. Based on this timeline, the Company expects topline GATHER2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis. The Company also announced that GATHER2 is exceeding patient retention expectations. The Company is targeting patient retention for the trial, as measured by injection fidelity rate through month 12, of greater than 90%. Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections based on the number of enrolled patients.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210618005081/en/

    Proportion of Patients that progress from drusen to iRORA or cRORA (Zimura 2 mg vs. Sham)

    Proportion of Patients that progress from drusen to iRORA or cRORA (Zimura 2 mg vs. Sham)

    "Since the initiation of GATHER2, Iveric Bio has implemented a patient centric strategy with multiple initiatives to tackle the many challenges that the COVID-19 pandemic brought to conducting clinical trials," stated Dr. Khanani. "It is exciting to be a part of a clinical trial that is exceeding enrollment and retention targets and timelines in the midst of a global pandemic. I believe that the positive results from GATHER1, including the early and continuous treatment effect demonstrated, is a key motivator for the recruitment and retention in the GATHER2 clinical trial."

    "We are thrilled to have world leading retinal specialists participate in our symposium and to share the new post-hoc analyses of GATHER1 and the progress of GATHER2," stated Dhaval Desai, PharmD, Chief Development Officer of Iveric Bio. "Thus far we have seen an injection fidelity rate well above our target goal of greater than 90% and ahead of our expectations. We consider injection fidelity to be the most important component of patient retention because it reflects the timely administration of the drug into the patient's eye. We continue to focus as much on retention as recruitment, not only to protect the integrity of our data, but also to potentially demonstrate the early and continuous treatment effect observed in GATHER1."

    The Company also announced that at today's event, Vas Sadda, MD, of Doheny Eye Institute at UCLA, will present new post-hoc analyses from the GATHER1 clinical trial on progression of drusen and nascent GA (iRORA*/cRORA**), which are earlier forms of dry AMD, in patients treated with Zimura 2 mg as compared to patients in the sham group. The accompanying graphs illustrate the data that Dr. Sadda will discuss today.

    Dr. Sadda stated, "I am excited to present these encouraging data. Dry AMD is the most common cause of blindness in the US, but we have no approved treatments for this devastating disease. Some drugs, including Zimura, are being studied to decrease the rate of growth of geographic atrophy, which is very important. However, the significance of these post-hoc analyses suggest that Zimura may have the potential to impact the disease even before atrophy occurs. Given the compelling results, I believe prospective, randomized studies with Zimura on patients with earlier stages of dry AMD are warranted."

    Pravin Dugel, MD, President of Iveric Bio, stated, "In the GATHER1 post-hoc analyses, we reported decreased conversion of iRORA to cRORA and a decreased conversion of drusen to iRORA or cRORA. Both rates showed an increasing effect over time, consistent with Zimura's effect on geographic atrophy in GATHER1. While the former shows that Zimura may have a therapeutic benefit in earlier stages of geographic atrophy, the latter suggests that Zimura may have the potential to prevent progression to geographic atrophy altogether in patients with drusen. These post-hoc analyses should be considered hypothesis seeking. Nonetheless, if these results are substantiated with prospective, randomized studies, the potentially sight-saving impact of Zimura on millions of high-risk patients could be a massive leap forward in treating this disease. Our intent is to study Zimura in earlier stages of dry AMD."

    "The impressive data presented today are consistent with our stated goal to build a franchise to treat all stages of AMD, with the expansion of Zimura's footprint and the continued development of our HtrA-1 inhibitor, IC-500," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio.

    Webcast Information

    A live webcast of the event will be available today, June 18, 2021 from 10:00am to 12:00pm ET under the "Events & Presentations" in the Investors section of the Iveric Bio website at https://investors.ivericbio.com. A replay of the webcast will be posted on Iveric Bio's website following the presentation and available for at least 30 days.

    About Zimura

    Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy secondary to age-related macular degeneration.

    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. 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," "future", "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 timing, progress and results of clinical trials, including expectations regarding patient enrollment and retention in GATHER2 and the availability of topline data from that trial, the Company's development and regulatory strategy for Zimura, including its potential development in other forms or stages of dry age-related macular degeneration, , and the potential utility of Zimura and its other research and development programs. 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, expectations for regulatory matters, reliance on clinical trial sites, contract research organizations and other third parties, establishment of manufacturing capabilities, developments from the Company's competitors and the marketplace for its 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 may 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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  14. - To Provide Updates on Zimura® GATHER2 Enrollment and Retention -

    - Post-Hoc Analyses from GATHER1 on Progression of Drusen and Nascent Geographic Atrophy to be Presented for the First Time –

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced details for its Dry Age-Related Macular Degeneration Virtual Symposium for investors and analysts being held on Friday, June 18, 2021, from 10:00 a.m. to 12:00 p.m. Eastern Time. The symposium will include presentations on the Company's Zimura® (avacincaptad pegol) pivotal program in geographic atrophy (GA) secondary to Age-related Macular Degeneration (AMD) with an update on patient enrollment and retention in the Zimura GATHER2 clinical trial, the dry AMD landscape, and highlights on the Company's HtrA1…

    - To Provide Updates on Zimura® GATHER2 Enrollment and Retention -

    - Post-Hoc Analyses from GATHER1 on Progression of Drusen and Nascent Geographic Atrophy to be Presented for the First Time –

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced details for its Dry Age-Related Macular Degeneration Virtual Symposium for investors and analysts being held on Friday, June 18, 2021, from 10:00 a.m. to 12:00 p.m. Eastern Time. The symposium will include presentations on the Company's Zimura® (avacincaptad pegol) pivotal program in geographic atrophy (GA) secondary to Age-related Macular Degeneration (AMD) with an update on patient enrollment and retention in the Zimura GATHER2 clinical trial, the dry AMD landscape, and highlights on the Company's HtrA1 inhibitor, IC-500, in AMD.

    The Company also announced that a presentation by Vas Sadda, MD, Doheny Eye Institute UCLA, will feature new post-hoc analyses from the GATHER1 clinical trial on progression of drusen and nascent GA, which are earlier forms of dry AMD, in patients treated with Zimura as compared to patients in the sham group.

    The Company will host discussions with retinal specialists and key opinion leaders. Participants include:

    • Frank Holz, FEBO, FARVO, University of Bonn
    • Peter Kaiser, MD, Cole Eye Institute
    • Arshad Khanani, MD, MA, Sierra Eye Associates
    • Anat Loewenstein, MD, Tel Aviv University
    • Vas Sadda, MD, Doheny Eye Institute UCLA
    • Trent Woodruff, PhD, The University of Queensland
    • Charles Wykoff, MD, PhD, Retina Consultants of Texas
    • Dhaval Desai, PharmD, Chief Development Officer, Iveric Bio
    • Pravin Dugel, MD, President, Iveric Bio
    • Glenn 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 kathy.galante@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. 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, including those listed in the Risk Factors sections of annual and quarterly reports Iveric Bio files with the Securities and Exchange Commission. 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 except if required by law.

    ISEE-G

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  15. - GATHER2 On-Track to Complete Enrollment in 3Q of this Year -

    - Conference Call and Webcast Today, May 5, 2021, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the quarter ended March 31, 2021 and provided a general business update.

    "Iveric Bio is entering an important period as we remain focused on the execution of our ongoing Zimura GATHER2 clinical trial, which is our second Phase 3 clinical trial for Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration. We are committed to completing recruitment for the GATHER2 trial in the third quarter of this year," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "To date, both the recruitment…

    - GATHER2 On-Track to Complete Enrollment in 3Q of this Year -

    - Conference Call and Webcast Today, May 5, 2021, at 8:00 a.m. ET -

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced financial and operating results for the quarter ended March 31, 2021 and provided a general business update.

    "Iveric Bio is entering an important period as we remain focused on the execution of our ongoing Zimura GATHER2 clinical trial, which is our second Phase 3 clinical trial for Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration. We are committed to completing recruitment for the GATHER2 trial in the third quarter of this year," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "To date, both the recruitment and retention of patients in GATHER2 have exceeded our expectations. We are on track for initial, topline data from GATHER2 to be available approximately one year after the recruitment of the last patient in the GATHER2 clinical trial, plus the time needed for database closure and analysis of the initial, topline data."

    "A key goal of ours is to expand and advance our footprint in multiple stages and types of AMD," stated Pravin U. Dugel, M.D., President of Iveric Bio. "We are excited by the opportunity to potentially expand the reach of Zimura beyond GA and to continue the development of IC-500, our HtrA1 inhibitor, which we expect could be complementary to Zimura in treating AMD patients. We remain committed to developing safe and effective therapeutic and gene therapy treatment options for retinal diseases with significant unmet medical needs."

    Therapeutics Programs Targeting Geographic Atrophy Secondary to Age-Related Macular Degeneration

    Zimura® (avacincaptad pegol): Complement C5 Inhibitor

    • Enrollment and retention for GATHER2, the Company's pivotal clinical trial of Zimura in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), are progressing well with enrollment on target. In March 2021, the Company announced it accelerated the timeline for when it expects to complete enrollment in GATHER2 to the third quarter of 2021.
    • The Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease, referred to as the STAR trial, is ongoing with the goal of enrolling approximately 120 patients.

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

    • During the first quarter of 2021, the Company revised its development plans for IC-500 to include plans to investigate multiple dosing schedules for this product candidate. In April 2021, the Company commenced its first preclinical tolerability study for IC-500 and is currently planning additional preclinical studies, including pharmacokinetic and target engagement studies. Formulation optimization and other manufacturing activities are also ongoing. The Company expects to submit an IND to the FDA for IC-500 in GA secondary to AMD in the second half of 2022.

    Iveric Bio to Host Dry AMD Virtual Symposium for Investors/Analysts

    The Company will host a dry AMD Virtual Symposium for investors and analysts on Friday, June 18, 2021 from 10:00am – 12:00pm Eastern Time. The event will include presentations and discussions with retinal specialists and key opinion leaders on the dry AMD landscape, Zimura pivotal program in GA and highlights from the Company's IC-500 program in 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 kathy.galante@ivericbio.com.

    Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

    • IC-200: BEST1-Related IRDs

      The Company is completing a preclinical efficacy and toxicology study for IC-200, in the naturally occurring canine model of Best disease. Published data have demonstrated long-term rescue in this model following a single sub-retinal injection. The Company is on track to release the recently manufactured cGMP batch of IC-200 in preparation for the planned IND filing and plans to move IC-200 into the clinic, in a Phase 1/2 trial in the second half of 2021.
    • IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP).

      The Company continues to evaluate the results of preclinical toxicology studies for IC-100. In the Company's preclinical efficacy and toxicology study in a naturally occurring canine model of RHO-adRP, efficacy was demonstrated at all three doses tested. The Company also tested the same three doses in a GLP toxicology study in non-human primates. Ocular inflammation on clinical exam was observed in the high dose group in canines and to varying degrees at different dosing levels tested in non-human primates. Due to the different findings in the two different species, and the Company's high commitment to the safety of its patients, the Company is planning to discuss with regulators the design of its planned first-in-human clinical trial for IC-100 prior to submitting an IND. The Company now believes that IC-100 will likely be delayed from entering into a Phase 1/2 clinical trial this year.
    • Minigene Programs

      The Company, in its minigene collaboration with the University of Massachusetts Medical School, has identified a lead construct for its Leber Congenital Amaurosis Type 10 (LCA10) program and is currently considering development plans for this program. The Company expects to obtain additional results from its Stargardt Disease (ABCA4) program in the second quarter of 2021, and expects to obtain preliminary results from its USH2A-related inherited retinal diseases program in the second half of 2021.

    The Company announced today the formation of its Gene Therapy Inherited Retina Disease Scientific Advisory Committee that will work closely with senior management as the Company advances its gene therapy inherited retinal disease programs. The members of the advisory committee include:

    • Elias Traboulsi, MD, MEd

      Head of the Department of Pediatric Ophthalmology

      Director of the Center for Genetic Eye Diseases

      Cole Eye Institute

      Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine,

      Cleveland Clinic
    • Andreas K. Lauer, MD

      Chair, Department of Ophthalmology, Casey Eye Institute

      Professor of Ophthalmology, School of Medicine
    • Bart P. Leroy, MD, PhD

      Head, Department of Ophthalmology, Ghent University Hospital

      Senior Staff Member, Center for Medical Genetics Ghent, Ghent University Hospital

      Professor of Ophthalmology & Ophthalmic Genetics, Ghent University

      Director of the Retinal Degenerations Clinic Children's Hospital of Philadelphia
    • Mark Pennesi, MD, PhD

      Division Chief, Ophthalmic Genetics

      Associate Professor in Ophthalmology, Oregon Health & Science University
    • Eleonora Lad, MD, PhD

      Director of Grading, Duke Reading Center

      Associate Professor of Ophthalmology, Duke University Medical Center

    Board of Directors and Management

    • Today the Company announced the promotions of Pravin U. Dugel, MD, to President, and Kathy Galante to Senior Vice President, Investor Relations, both effective as of May 1.
    • In April 2021, the Company announced that David R. Guyer, MD, was stepping down from the Iveric Bio Board of Directors after 14 years, effective following Iveric Bio's 2021 Annual Stockholder Meeting scheduled to be held on May 19, 2021.

    First Quarter Financial Results and 2021 Cash Guidance

    • As of March 31, 2021, the Company had $180.2 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 to range between $125 and $135 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.

    2021 Q1 Financial Highlights

    • R&D Expenses: Research and development expenses were $18.5 million for the quarter ended March 31, 2021, compared to $13.8 million for the same period in 2020. Research and development expenses increased primarily due to the initiation of our GATHER2 trial and commencement of patient enrollment 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 $8.3 million for the quarter ended March 31, 2021, compared to $5.0 million for the same period in 2020. General and administration expenses increased primarily due to legal costs associated with ongoing litigation.
    • Income Tax Benefit: For the quarter ended March 31, 2021, the Company recorded no 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, 2021 of $26.8 million, or ($0.29) per diluted share, compared to a net loss of $15.1 million, or $(0.28) per diluted share, for the same period in 2020.

    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 5, 2021 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-317-6003 (USA) or 412-317-6061 (International), passcode 5841649. 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 877-344-7529 (USA) or 412-317-0088, passcode 10153477.

    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, advisory committee members 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.

    IVERIC bio, Inc.
    Selected Financial Data (unaudited)
    (in thousands, except per share data)
     
    Three Months Ended March 31,

    2021

    2020

     
    Statements of Operations Data:
    Operating expenses:
    Research and development

    $

    18,549

     

    $

    13,750

     

    General and administrative

     

    8,322

     

     

    4,998

     

    Total operating expenses

     

    26,871

     

     

    18,748

     

    Loss from operations

     

    (26,871

    )

     

    (18,748

    )

    Interest income

     

    77

     

     

    358

     

    Other income (expense), net

     

    (1

    )

     

    5

     

    Loss before income benefit

     

    (26,795

    )

     

    (18,385

    )

    Income tax benefit

     

    -

     

     

    3,309

     

    Net loss

    $

    (26,795

    )

    $

    (15,076

    )

    Net loss per common share:
    Basic and diluted

    $

    (0.29

    )

    $

    (0.28

    )

    Weighted average common shares outstanding:
    Basic and diluted

     

    93,311

     

     

    53,426

     

     
    March 31, 2021 December 31, 2020
    (in thousands)
    Balance Sheets Data:
    Cash, cash equivalents and marketable securities

    $

    180,201

     

    $

    210,047

     

    Total assets

    $

    187,402

     

    $

    216,754

     

    Total liabilities

    $

    20,214

     

    $

    25,191

     

    Additional paid-in capital

    $

    758,964

     

    $

    756,543

     

    Accumulated deficit

    $

    (591,868

    )

    $

    (565,073

    )

    Total stockholders' equity

    $

    167,188

     

    $

    191,563

     

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  16. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on May 3, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to four newly hired, non-executive employees. The inducement grants were approved by the Company's compensation and talent strategy 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 inducement grants consisted of four non-statutory stock options to purchase an aggregate of 95,450 shares of the Company's common stock, and two grants of an aggregate…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on May 3, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to four newly hired, non-executive employees. The inducement grants were approved by the Company's compensation and talent strategy 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 inducement grants consisted of four non-statutory stock options to purchase an aggregate of 95,450 shares of the Company's common stock, and two grants of an aggregate of 7,000 restricted stock units for shares of the Company's common stock.

    The stock options each have an exercise price of $7.17 per share, equal to the closing price of Iveric Bio's common stock on May 3, 2021. The stock options each have a 10-year term and vest over four years, with 25% of the shares underlying each option vesting on May 3, 2022 and an additional 2.0833% of the shares underlying each option vesting at the end of each successive month thereafter. The two grants of restricted stock units for shares of the Company's common stock each vest with respect to 100% of the shares underlying the grant on May 3, 2022. 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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  17. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its first quarter 2021 financial and operating results on Wednesday, May 5, 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 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 5841649. 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 1-877-344-7529…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that it will report its first quarter 2021 financial and operating results on Wednesday, May 5, 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 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 5841649. 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 1-877-344-7529 (USA Toll Free), passcode 10153477.

    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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  18. IVERIC bio, Inc. (NASDAQ:ISEE) today announced that David R. Guyer, MD, co-founder and Executive Chairman, is stepping down from the Iveric Bio Board after 14 years, effective following Iveric Bio's 2021 Annual Stockholder Meeting scheduled to be held on May 19, 2021. Dr. Guyer has served as the Chairman of Iveric's Board of Directors since its founding. During Dr. Guyer's tenure he led the Company from its initial public offering to being a late-stage clinical company focused on the discovery and development of both therapeutic and gene therapy treatment options for retinal diseases. Dr. Guyer will rejoin SV Health Investors as a Venture Partner having previously been both a Venture Partner and Partner at SV.

    "As a co-founder, former Chief…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced that David R. Guyer, MD, co-founder and Executive Chairman, is stepping down from the Iveric Bio Board after 14 years, effective following Iveric Bio's 2021 Annual Stockholder Meeting scheduled to be held on May 19, 2021. Dr. Guyer has served as the Chairman of Iveric's Board of Directors since its founding. During Dr. Guyer's tenure he led the Company from its initial public offering to being a late-stage clinical company focused on the discovery and development of both therapeutic and gene therapy treatment options for retinal diseases. Dr. Guyer will rejoin SV Health Investors as a Venture Partner having previously been both a Venture Partner and Partner at SV.

    "As a co-founder, former Chief Executive Officer and most recently Executive Chair, David has been an integral part of Iveric Bio's leadership, a trusted advisor and visionary in retinal medicine, and I sincerely thank him for his hard work and significant contributions to the Company," stated Glenn P. Sblendorio, Chief Executive Officer and President of Iveric Bio. "On behalf of the entire Company, we are grateful to have had the opportunity to work closely with David over the years and we wish him continued success."

    "Iveric Bio's strong management team has evolved to the point where there is no longer a need for an Executive Chair," stated Dr. Guyer. "After more than 14 years on the Board, I feel that this is a good departure point such that I can return to my passion as a venture capitalist. I will rejoin SV Health Investors where I will be able to focus on new company generation and board service. I am very excited about Iveric's Phase 3 program of Zimura® for the treatment of geographic atrophy secondary to age-related macular degeneration and look forward to continuing to serve the Company as a Senior Advisor."

    "David's contributions to Iveric Bio have been significant," stated Axel Bolte, Member of the Board of Iveric Bio. "After having worked with David throughout most of his tenure with the Company, it will be hard to imagine board meetings without David's presence and clinical insights. We are grateful that David agreed to the Board's request that he serve as a senior advisor so that we can continue to work with him even if in a different role."

    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 future development of its product candidates and Dr. Guyer's future role as senior advisor to the Company. 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.

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  19. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on April 1, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to a newly-hired, non-executive employee. The inducement grants were approved by the Company's compensation and talent strategy 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 60,000 shares of the Company's common stock, and two separate grants of 10,000 restricted stock units for shares…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on April 1, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to a newly-hired, non-executive employee. The inducement grants were approved by the Company's compensation and talent strategy 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 60,000 shares of the Company's common stock, and two separate grants of 10,000 restricted stock units for shares of the Company's common stock.

    The stock option has an exercise price of $6.49 per share, equal to the closing price of Iveric Bio's common stock on April 1, 2021. The stock option has a ten-year term and vests over four years, with 25% of the shares underlying the option vesting on April 1, 2022 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The first grant of 10,000 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 April 1, 2022, April 1, 2023, April 1, 2024 and April 1, 2025. The second grant of 10,000 restricted stock units for shares of the Company's common stock vests with respect to 100% of the shares underlying the grant on April 1, 2022. 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.

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  20. IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on March 15, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to a newly-hired, non-executive employee. The inducement grants were approved by the Company's compensation and talent strategy 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 125,000 shares of the Company's common stock, a grant of 60,000 restricted stock units for shares of the Company's…

    IVERIC bio, Inc. (NASDAQ:ISEE) today reported that on March 15, 2021, the Company granted equity-based awards pursuant to the Company's 2019 Inducement Stock Incentive Plan to a newly-hired, non-executive employee. The inducement grants were approved by the Company's compensation and talent strategy 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 125,000 shares of the Company's common stock, a grant of 60,000 restricted stock units for shares of the Company's common stock and a grant of 10,000 restricted stock units for shares of the Company's common stock.

    The stock option has an exercise price of $6.425 per share, equal to the closing price of Iveric Bio's common stock on March 15, 2021. The stock option has a ten-year term and vests over four years, with 25% of the shares underlying the option vesting on March 15, 2022 and an additional 2.0833% of the shares underlying the option vesting at the end of each successive month thereafter. The grant of 60,000 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 March 15, 2022, March 15, 2023, March 15, 2024 and March 15, 2025. The grant of 10,000 restricted stock units for shares of the Company's common stock vests with respect to 100% of the shares underlying the grant on March 15, 2022. 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.

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  21. - 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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  22. 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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  23. 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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  24. 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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  25. 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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  26. 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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  27. 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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  28. - 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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  29. 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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  30. 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.

    ISEE-G

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  31. 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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  32. 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.

    ISEE-G

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  33. 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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  34. 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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  35. - 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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  36. 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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  37. 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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  38. 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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  39. 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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  40. 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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  41. 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 PostSaleManualRequests@broadridge.com, 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 usa.prospectus@credit-suisse.com.

    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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  42. 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 PostSaleManualRequests@broadridge.com, 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 usa.prospectus@credit-suisse.com.

    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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  43. 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 PostSaleManualRequests@broadridge.com, 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 usa.prospectus@credit-suisse.com.

    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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  44. 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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  45. 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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  46. 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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  47. - 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