On May 6, 2020 Bonnie J Addario Lung Cancer Foundation reported that the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test (Press release, Bonnie J Addario Lung Cancer Foundation, MAY 6, 2020, View Source [SID1234557257]).

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Today, FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib.

Efficacy was demonstrated in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multicohort study enrolling 97 patients with metastatic NSCLC with confirmed MET exon 14 skipping. Patients received capmatinib 400 mg orally twice daily until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate (ORR) determined by a blinded independent review committee using RECIST 1.1 and response duration. Among the 28 treatment-naïve patients, the ORR was 68% (95% CI: 48, 84) with a response duration of 12.6 months (95% CI: 5.5, 25.3). Among the 69 previously treated patients, the ORR was 41% (95% CI: 29, 53) with a response duration of 9.7 months (95% CI: 5.5, 13.0).

The most common adverse reactions (≥ 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Capmatinib can also cause interstitial lung disease, hepatotoxicity, photosensitivity, and embryo-fetal toxicity. Based on a clear positive signal for phototoxicity in early laboratory studies in cells, patients may be more sensitive to sunlight and should be advised to take precautions to cover their skin, use sunscreen, and not tan while taking capmatinib.

The recommended capmatinib dose is 400 mg orally twice daily with or without food.

View full prescribing information for TABRECTA.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. The FDA approved this application 3 months ahead of the FDA goal date.

FDA granted capmatinib orphan drug and breakthrough therapy designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

On May 6, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 25,000,002 of the Company’s ordinary shares represented by American Depositary Shares (ADSs), at a purchase price of $0.40 per ADS, in a registered direct offering, for aggregate gross proceeds of approximately $10 million (Press release, Kitov Pharmaceuticals , MAY 6, 2020, View Source [SID1234557202]). Kitov has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 25,000,002 ADSs. Each ADS represents one ordinary share, no par value, of Kitov. The offering is expected to close on or about May 8, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $0.40 per ADS and will be exercisable at any time upon issuance and will expire five and one-half years from the date of issuance.

Kitov intends to use the net proceeds of this offering to fund the development of its oncology drug candidates, acquisition of new assets and for general working capital purposes.

The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by Kitov pursuant to a "shelf" registration statement on Form F-3 (File No. 333- 235327) previously filed with the U.S. Securities and Exchange Commission (the "SEC") on December 2, 2019 and declared effective by the SEC on December 13, 2019. The offering of the ADSs will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

On May 6, 2020 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported recent business highlights and financial results for the first quarter ended March 31, 2020 (Press release, Pain Therapeutics, MAY 6, 2020, View Source [SID1234557201]). Net loss was $1.2 million, or $0.05 per share, compared to a net loss of $1.4 million, or $0.08 per share, for the same period in 2019. Net cash used in operations was $1.2 million during the first quarter of 2020. Net cash use in full-year 2020 is expected to be approximately $5 million. Cash and cash equivalents were $25.6 million as of March 31, 2020, with no debt.

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"Cassava Sciences had a productive quarter with its research programs in Alzheimer’s disease," said Remi Barbier, President & CEO. "As a result, we anticipate having top-line results for our Phase 2b study of PTI-125, our lead drug candidate for Alzheimer’s, earlier than mid-2020."

Phase 2b Study – Early data readout on effects of PTI-125 on tau protein anticipated
In March 2020, Cassava Sciences announced the completion of a double-blind, randomized, placebo-controlled study of PTI-125 in 64 patients with mild-to-moderate Alzheimer’s disease, 50-85 years of age, with 16 ≤ MMSE ≤ 26. Study participants received PTI-125 100 mg, 50 mg or matching placebo, twice-daily, for 28 continuous days. The primary efficacy endpoint is the effect of PTI-125 vs placebo on CSF levels of tau protein, and other biomarker assessments.

Open-label Study – Initiated in March, approximately 20% enrolled
In March 2020, Cassava Sciences announced the initiation of an open-label, multi-center study of PTI-125 at 100 mg twice-daily for 12 months. Every study participant receives drug treatment in an open-label design. This on-going study has a target enrollment of approximately 100 patients with mild-to-moderate Alzheimer’s disease. The study is approximately 20% enrolled.

Finance Update – $2.9 million of new NIH research grant awards announced in 2020
Cassava Sciences’ scientific programs continue to be supported by research grant awards from the National Institutes of Health (NIH), the nation’s foremost medical research agency. In April 2020, the Company announced it had been awarded a new $2,500,000 research grant from NIH. In March 2020, NIH awarded the Company supplemental research funding in the amount of $374,000. The NIH’s National Institute on Aging awarded the Company these research grant award following an in-depth, peer review of PTI-125. Peer review, one of the gold standards of science, is a process where independent, outside scientists evaluate the merits of new research.

Operations Update – No major disruptions to date
In these times of pandemic, Cassava Sciences’ top priorities are to protect the health, well-being, and safety of its employees and partners, while still focusing on the key drivers of its business. The company believes it remains on-track to achieve its major strategic objectives for 2020. The Company has not experienced major disruptions across its drug manufacturing operations or supply of materials. Its broad spectrum of technical consultants, scientific advisors and service providers continue to provide timely services. The Company has adapted flexible business practices, such as remote work arrangements and temporary travel restrictions, to insure it continues to operate safety and cautiously while meeting its public health responsibilities.

Cassava Sciences recognizes the on-going pandemic has created an unstable and uncertain situation in the national economy. The Company continues to closely monitor the latest information to make timely, informed business decisions and public disclosures regarding the potential impact of pandemic on its operations. However, the scope of this pandemic is unprecedented and its long-term impact on the Company’s operations and financial condition cannot be reasonably estimated at this time.

Financial Highlights for First Quarter 2020

At March 31, 2020, cash and cash equivalents were $25.6 million, compared to $23.1 million at December 31, 2019, with no debt.
Cash balance included $3.6 million in proceeds from exercise of warrants in the first quarter of 2020. Approximately 1.6 million warrants remain outstanding, each with an exercise price of $1.25 per share. All warrants expire February 2021.
Net cash used in operations during the quarter ended March 31, 2020 was $1.2 million, net of reimbursements received from NIH grant awards.

Net cash use for full year 2020 is expected to be approximately $5.0 million, consistent with previous financial guidance.
Research grant funding reimbursements of $1.3 million were received from NIH and recorded as a reduction in research and development (R&D) expenses. This compared to $0.8 million of NIH grant receipts received for the same period in 2019.
R&D expenses were $0.5 million. This compared to $0.6 million for the same period in 2019, representing a 5% decrease. While Phase 2 clinical program expenses were higher in Q1 2020, overall expense was reduced by greater NIH reimbursement.
General and administrative (G&A) expenses were $0.8 million. This compared to $0.9 million for the same period in 2019, representing a 11% decrease. The decrease was due primarily to lower stock-based compensation expense compared to 2019.
About PTI-125
Cassava Sciences’ lead therapeutic product candidate is for the treatment of Alzheimer’s disease. PTI-125 is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science is published in peer-reviewed scientific journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry and Journal of Prevention of Alzheimer’s Disease. The Company is also developing an investigational diagnostic, called SavaDx, to detect Alzheimer’s disease with a simple blood test.

About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older developed Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, resulting in a growing social and economic burden.2

On May 6, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported first quarter 2020 financial results for the quarter ended March 31, 2020 (Press release, Allogene, MAY 6, 2020, View Source [SID1234557200]).

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"While the COVID-19 pandemic has created a challenging situation across the world, we are grateful to the employees of Allogene, the investigators and patients participating in our trials, and our countless partners and suppliers who have helped us to progress development of our AlloCAR T therapies," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "This collective determination has brought us one step closer to making AlloCAR T a reality for patients. We look forward to presenting our initial clinical data from the ALPHA Phase 1 study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma later this month and the continued advancement of our AlloCAR T pipeline with programs in other hematological malignancies and solid tumors."

Recent Highlights

ALLO-501/ALLO-501A (anti-CD19 AlloCAR T)
•Initial data from the Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) was selected for an oral presentation at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting on May 29, 2020. The ALPHA trial utilizes ALLO-647, the Company’s anti-CD52 monoclonal antibody (mAb) as a part of the lymphodepletion regimen. The Phase 1 trial is designed to assess the safety of ALLO-501 and ALLO-647 and establish appropriate doses for further study.
◦The ASCO (Free ASCO Whitepaper) abstract will be released May 13, 2020 and will include preliminary data from the first nine patients treated in this study. The virtual presentation will include additional patients, including patients treated with a higher dose of ALLO-647.
•The Company expects to initiate enrollment in ALPHA2, an abbreviated Phase 1 trial for ALLO-501A, in Q2 2020. ALLO-501A is a next generation anti-CD19 AlloCAR T that is intended for Phase 2 development.

ALLO-715 (anti-BCMA AlloCAR T)
•The Company continues to progress its robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).
•The ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM, which utilizes ALLO-647 as part of the lymphodepletion platform, is enrolling patients with initial data anticipated in Q4 2020.
•A trial to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM is on track to begin in the second half of 2020.

•Preclinical data on the Company’s internally developed TurboCAR technology will be presented in a poster session at the virtual American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 23rd Annual Meeting on May 12, 2020. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells. TurboCAR has the potential to improve efficacy, overcome the potential for exhaustion, and reduce cell dose requirements of AlloCAR T therapy.
•The Company plans to submit an Investigational New Drug (IND) application for its first TurboCAR candidate, ALLO-605, a BCMA-directed AlloCAR T therapy for MM, in 2021.

Other Portfolio Updates
•The Company has continued to progress pre-clinical work on ALLO-316, its anti-CD70 AlloCAR T clinical candidate. ALLO-316 has potential application in both hematologic malignancies and solid tumors. The initial focus for this investigational therapy will be renal cell carcinoma. The Company plans to submit an IND by the end of 2020.

Manufacturing Updates
•Construction of the Company’s cGMP cell manufacturing facility in Newark, California, has resumed following interruption due to the COVID-19 pandemic. The Company continues to expect to initiate cGMP manufacturing in 2021.
First Quarter Financial Results
•As of March 31, 2020, Allogene had $553.0 million in cash, cash equivalents, and investments.
•Research and development expenses were $42.0 million for the first quarter of 2020, which includes $6.6 million of non-cash stock-based compensation expense.
•General and administrative expenses were $15.6 million for the first quarter of 2020, which includes $7.6 million of non-cash stock-based compensation expense.
•Net loss for the first quarter of 2020 was $54.5 million, or $0.50 per share, including non-cash stock-based compensation expense of $14.2 million.

2020 Financial Guidance
•Allogene continues to expect full year GAAP net losses to be between $260 million and $280 million including estimated non-cash stock-based compensation expense of $70 million to $75 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 3788179. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On May 6, 2020 IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the fiscal quarter ended March 31, 2020 and provided a general business update (Press release, Ophthotech, MAY 6, 2020, View Source [SID1234557199]).

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"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.