ISEE IVERIC bio Inc.

8.63
-0.05  -1%
Previous Close 8.68
Open 8.69
52 Week Low 3.97
52 Week High 10.25
Market Cap $778,901,651
Shares 90,255,116
Float 103,273,753
Enterprise Value $720,752,463
Volume 570,747
Av. Daily Volume 1,932,372
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Upcoming Catalysts

Drug Stage Catalyst Date
Zimura - GATHER2
Geographic atrophy
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
IC-100
Rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP)
Phase 1/2
Phase 1/2
Phase 1/2 trial planned - will likely be delayed from entering trials in 2021.
IC-200
BEST1 related retinal diseases
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated 2H 2021.
Zimura
Autosomal Recessive Stargardt Disease
Phase 2b
Phase 2b
Phase 2b trial ongoing.
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 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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  2. - 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.

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  3. – 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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  4. 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 , 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 , 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 , 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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  5. 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 , 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 , 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 , 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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