Clearside Biomedical, Inc. (CLSD) 10-Q Quarterly Report Mon Aug 10 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.

Please wait while we load the requested 10-Q report or click the link below:

https://last10k.com/sec-filings/report/1539029/000156459020038893/clsd-10q_20200630.htm

View differences made from one quarter to another to evaluate Clearside Biomedical, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ) — *Sample 10-K Year-over-Year (YoY) Comparison*

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were ~~removed~~ , added and changed by Clearside Biomedical, Inc..

Continue

Assess how Clearside Biomedical, Inc.'s management team is paid from their Annual Proxy

Clearside Biomedical, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2020 10-K Annual Report includes:

Voting Procedures
Board Members
Executive Team
Salaries, Bonuses, Perks
Peers / Competitors

Continue

Rating
Learn More

Filter by Sentiment:

All

Positive

Negative

Filter by Category:

All

Financial

Revenue

Other

Filter by Subcategory:

All

Cash Flow

Expense

Product

Other

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
Additionally, there was a $0.7 million decrease in expenses in costs for preclinical work on potential product candidates and a $0.3 million decrease in employee-related costs.
Financial - Expense Highlight
Research and development expense decreased by $4.5 million, from $11.6 million for the six months ended June 30, 2019 to $7.1 million for the six months ended June 30, 2020.
Financial - Expense Highlight
Clinical costs are recognized based on the terms of underlying agreements, as well as an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations and additional information provided to us by our vendors about their actual costs occurred.
Financial - Expense Highlight
This decrease was primarily attributable to a $2.5 million reduction in marketing-related expenses related to the change of our business strategy to seek partners for XIPERE rather than commercializing XIPERE on our own and a decrease of $1.2 million of employee-related costs due to expenses incurred in the prior year related to the departure of our former chief executive officer.
Other - Other
Factors that could cause or...Read more
Revenue - Product
If we raise funds through...Read more
Financial - Expense
Additionally, there was a $0.8...Read more
Financial - Expense
Our clinical trial expenses have...Read more
Financial - Expense
General and administrative expenses decreased...Read more
Financial - Expense
General and administrative expenses decreased...Read more
Financial - Expense
This was primarily attributable to...Read more
Revenue - Product
This amount includes an upfront...Read more
Other - Other
However, we have based this...Read more
Financial - Expense
The decrease in net loss...Read more
Other - Other
As of June 30, 2020,...Read more
Revenue - Product
We have entered into an...Read more
Revenue - Product
During the six months ended...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
Financial - Expense
This decrease was primarily attributable...Read more
Financial - Expense
These costs include preclinical activities,...Read more

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: 0001564590-20-038893
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

External Resources:
Stock Quote
Social Media

Bookmark the Permalink:
https://last10k.com/sec-filings/clsd/0001564590-20-038893.htm

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

SEC Filings

CLSD Valuations

CLSD Annual Reports

CLSD Quarterly Reports

CLSD Corporate News