Clearside Biomedical, Inc. (CLSD) 10-Q Quarterly Report Fri May 08 2020

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 - Cash Flow Highlight
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 revenue from XIPERE.

Financial - Expense Highlight
The three months ended March 31, 2020 also included a net cash outflow of $1.1 million from the decrease in our accrued liabilities balance, which was the result of payments we made in connection with accrued employee costs.
Financial - Expense Highlight
Additionally, there was a $0.2 million decrease in expenses related to completion of the PEACHTREE trial, a $0.4 million decrease in costs related to device and drug manufacturing and a $0.6 million decrease in employee-related costs.
Financial - Expense Highlight
If XIPERE is approved by the FDA, Bausch will be responsible for all expenses following such approval; provided that we will be responsible for the CRL-related expenses and for half of the costs of any post-approval clinical trials required by the FDA, up to a specified maximum amount.
Financial - Expense Highlight
Research and development expense decreased by $7.2 million, from $11.0 million for the three months ended March 31, 2019 to $3.8 million for the three months ended March 31, 2020.
Financial - Expense
Clinical costs are recognized based...Read more
Financial - Expense
The decrease from 2019 to...Read more
Other - Other
We borrowed an initial tranche...Read more
Other - Other
Factors that could cause or...Read more
Revenue - Product
If we raise funds through...Read more
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Our clinical trial expenses have...Read more
Financial - Expense
General and administrative expenses decreased...Read more
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Revenue - Product
On June 30, 2017, we...Read more
Financial - Expense
Expenses related to activities that...Read more
Other - Other
Our clinical development partners, including...Read more
Other - Other
We will determine which programs...Read more
Financial - Expense
The following table shows our...Read more
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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Clearside Biomedical, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.1: Material Contract

Exhibit 10.2: Material Contract

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: CLSD
CIK: 1539029
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-20-023620
Submitted to the SEC: Fri May 08 2020 4:47:35 PM EST
Accepted by the SEC: Fri May 08 2020
Period: Tuesday, March 31, 2020
Industry: Pharmaceutical Preparations

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Clearside Biomedical, Inc. (CLSD) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

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