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Clearside Biomedical, Inc. (CLSD) SEC Filing 10-Q Quarterly report for the period ending Tuesday, June 30, 2020

Clearside Biomedical, Inc.

CIK: 1539029 Ticker: CLSD

Exhibit 99.1

 

 

Clearside Biomedical Announces First Quarter 2020 Financial Results

ALPHARETTA, Ga., May 8, 2020 -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today

reported financial results for the first quarter ended March 31, 2020.

 

“Our team remains focused on progressing our programs as we navigate the evolving business and regulatory environment,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “We are committed to advancing our first product candidate, XIPERE, to the U.S. regulatory finish line as quickly as possible to maximize its commercial potential. Our Investigational New Drug application remains on track for submission in mid-2020 for CLS-AX (axitinib injectable suspension) in wet age-related macular degeneration, which would potentially enable us to initiate a Phase 1/2a clinical trial before the end of this year. Additionally, we continue to support our clinical development partners in gene therapy and ocular cancer as they move their programs forward using our SCS Microinjector®.”

 

Key Highlights

Clearside and Bausch Health Companies Inc. and its leading global eye health business, Bausch + Lomb, amended their licensing agreement for the commercialization and development of XIPERE in the U.S. and Canada. Clearside granted Bausch + Lomb an exclusive option for the right to commercialize and develop XIPERE in (i) Europe and the United Kingdom, (ii) Australia and New Zealand, and/or (iii) South America and Mexico; and Bausch + Lomb extended the time allowed for Clearside to obtain regulatory approval for XIPERE in the U.S.   

NDA resubmission timeline for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension) is currently targeted for the fourth quarter of 2020 based on recent manufacturing updates.

Clearside received an upfront payment of $4.0 million from Arctic Vision pursuant to a license agreement for the commercialization and development of XIPERE in China, Hong Kong, Macau, Taiwan and South Korea.

Experienced research and development executive, Nancy J. Hutson, Ph.D., was appointed to Clearside’s Board of Directors.

Clearside established a Scientific Advisory Board with highly experienced retinal physicians who will provide input on program and clinical development.

Multiple presentations featuring Clearside’s suprachoroidal injection platform in a range of indications, including wet AMD, uveitis, diabetic macular edema and ocular gene therapy, were highlighted at global conferences, including the Annual Meeting

 


The following information was filed by Clearside Biomedical, Inc. (CLSD) on Friday, May 8, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Clearside Biomedical, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Balance Sheets
Balance Sheets (Parenthetical)
Statements Of Cash Flows
Statements Of Operations
Statements Of Stockholders' Equity
Accrued Liabilities
Accrued Liabilities (Tables)
Accrued Liabilities - Schedule Of Accrued Liabilities (Details)
Cares Act Paycheck Protection Program Loan
Cares Act Paycheck Protection Program Loan - Additional Information (Details)
Commitment And Contingencies
Commitment And Contingencies (Tables)
Commitment And Contingencies - Additional Information (Details)
Commitment And Contingencies - Future Minimum Commitments Due Under Non-Cancelable Operating Leases (Details)
Commitment And Contingencies - Operating Leases Included On The Balance Sheet (Details)
Common Stock
Common Stock - Additional Information (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Details)
Fair Value Measurements - Summary Of Assets Measured At Fair Value (Details)
License And Other Agreements
License And Other Agreements - Additional Information (Detail)
Long-Term Debt
Long-Term Debt - Additional Information (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Potential Common Stock Equivalents Excluded From Computation Of Diluted Net Loss Per Share (Details)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Schedule Of Property And Equipment, Net (Details)
Share-Based Compensation
Share-Based Compensation (Tables)
Share-Based Compensation - Additional Information (Details)
Share-Based Compensation - Summary Of Activity Related To Stock Options (Details)
Share-Based Compensation - Summary Of Share-Based Compensation Expense (Details)
Share-Based Compensation - Summary Of The Activity Related To Rsus (Details)
Significant Accounting Policies
Significant Accounting Policies (Policies)
Stock Purchase Warrants
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The Company
The Company - Additional Information (Details)
Ticker: CLSD
CIK: 1539029
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-20-038893
Submitted to the SEC: Mon Aug 10 2020 4:00:38 PM EST
Accepted by the SEC: Mon Aug 10 2020
Period: Tuesday, June 30, 2020
Industry: Pharmaceutical Preparations

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