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Exhibit 99.1
Clearside Biomedical Announces First Quarter 2019 Financial Results and Provides Corporate Update
- Scientific Presentations Support Broad Applicability of Clearside Delivery Platform -
- XIPERE™ under review for October 19, 2019 PDUFA Date -
- Management to Host Webcast and Conference Call Today at 8:30 A.M. ET -
ALPHARETTA, Ga., May 8, 2019 -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today reported financial results for the first quarter of 2019 and provided a corporate update.
“Clearside has a compelling opportunity to leverage our innovative, non-surgical suprachoroidal space (SCS) delivery platform to make a difference for patients with sight-threatening diseases in the U.S. and around the world,” said George Lasezkay, Pharm.D., J.D., Clearside’s Interim Chief Executive Officer. “We believe our proprietary approach and strong intellectual property in the suprachoroidal space are broadly applicable across a range of serious ophthalmic diseases.”
Dr. Lasezkay continued, “We are validating our platform with the potential approval of our first product candidate, XIPERE™ (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis, a condition that currently has no approved therapies. Uveitis is a leading cause of vision impairment and blindness in the developed world, and treating the associated macular edema is particularly important as it is an underserved patient population often affecting younger people and can result in numerous years of lost visual function.”
“We have a highly experienced team that developed XIPERE, submitted our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), and is now focused on achieving the successful approval and launch of our first commercial product. We are also committed to maximizing our SCS injection platform to expand our product pipeline and create future value through select strategic partnerships. As indicated in recent medical meeting presentations, the potential of our SCS injection platform includes small molecule therapeutics and may extend to gene-based therapies for inherited retinal diseases,” concluded Dr. Lasezkay.
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Clearside Biomedical, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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We have suffered recurring losses and negative cash flows from operations since inception and anticipate incurring additional losses until such time, if ever, that we can obtain FDA approval to market, and then generate significant sales of XIPERE.
The increase was primarily attributable to a $0.6 million increase in employee-related costs and an increase of $0.6 million in marketing-related expenses as we prepare for potential commercialization of XIPERE.
Research and development expense decreased by $2.4 million, from $13.4 million for the three months ended March 31, 2018 to $11.0 million for the three months ended March 31, 2019.
The net cash provided by financing activities for the three months ended March 31, 2018 was comprised of the net proceeds of $79.6 million received from our March 2018 public offering of common stock, the net proceeds of $10.0 million from the second amended and restated loan and security agreement, offset by $8.3 million paid to satisfy our obligations under the prior loan agreement, and $0.4 million of proceeds from the exercise of stock options.
The registration statement on Form S-3 includes a prospectus supplement covering the offering up to $18.5 million of shares of common stock over the 12 months ending March 15, 2020 in accordance with the ATM agreement.
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Financial Statements, Disclosures and Schedules
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Clearside Biomedical, Inc. provided additional information to their SEC Filing as exhibits
Ticker: CLSD
CIK: 1539029
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-19-018552
Submitted to the SEC: Fri May 10 2019 12:16:21 PM EST
Accepted by the SEC: Fri May 10 2019
Period: Sunday, March 31, 2019
Industry: Pharmaceutical Preparations