ISEE IVERIC bio Inc.

5.64
+0.24  (+4%)
Previous Close 5.4
Open 5.41
52 Week Low 0.9059
52 Week High 8.97
Market Cap $504,796,379
Shares 89,502,904
Float 78,793,166
Enterprise Value $229,669,420
Volume 1,614,414
Av. Daily Volume 826,149
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Upcoming Catalysts

Drug Stage Catalyst Date
Zimura
Autosomal Recessive Stargardt Disease
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
IC-200
BEST1 related retinal diseases
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated in 2021.
IC-100
Rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP)
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated 1H 2021.
Zimura - GATHER2
Geographic atrophy
Phase 3
Phase 3
Phase 3 trial met primary endpoint. Initiation of second trial announced June 30, 2020.
Zimura
Wet age-related macular degeneration (Wet-AMD)
Phase 2a
Phase 2a
Phase 2a top-line data released November 12, 2018 noted that treatment was generally well tolerated.
Fovista
Wet age-related macular degeneration (Wet-AMD)
Phase 3
Phase 3
Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial released August 14, 2017- primary endpoint not met.

Latest News

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

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

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

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

    The Company will also participate in the following retina showcase:

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

    About IVERIC bio

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

    Forward-looking Statements

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

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  2. 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.

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  3. 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.

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  4. - 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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  5. 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.

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