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Clearside Biomedical, Inc. (CLSD) SEC Filing 10-K Annual Report for the fiscal year ending Friday, December 31, 2021

Clearside Biomedical, Inc.

CIK: 1539029 Ticker: CLSD

 

Exhibit 99.1

img171462827_0.jpg 

 

Clearside Biomedical Announces Fourth Quarter and Full Year 2021
Financial Results and Provides Corporate Update
 

- XIPERE® -Related Milestones Generated $20 Million in Non-Dilutive Funding in Q4 2021 -

- Continued Progress in CLS-AX OASIS Wet AMD Phase 1/2a Trial
with Cohort 3 Results Expected Mid-2022 -

- New Cohort 4 Planned in Q2 2022 to Expand CLS-AX Dose Escalation in OASIS Trial-

- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

 

ALPHARETTA, Ga., March 10, 2022 -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS

®), today reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update.

 

“Our suprachoroidal injection platform is a proven approach for ocular drug delivery that offers potential advantages over other types of administration,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “Following the approval and launch of XIPERE™, the first product approved for suprachoroidal delivery, there is a growing base of retinal specialists trained to use our proprietary SCS Microinjector®. With more than 1,200 clinical injections to date and six clinical trials underway using our technology, we have established our leadership in this space.”

 

Dr. Lasezkay continued, “Our lead development asset, CLS-AX, combines the targeting, compartmentalization and potential durability of suprachoroidal delivery with the pan-VEGF inhibition of a potent tyrosine kinase inhibitor. We are making progress in OASIS, our ongoing Phase 1/2a trial of CLS-AX in patients with wet AMD. In the first two cohorts of OASIS, CLS-AX was well tolerated with no serious adverse events."

 

“Based on this positive safety profile to date and input from our scientific and clinical advisors, we are planning to add a fourth cohort in this trial to explore a broad range of doses to take into a Phase 2b clinical trial. Prior to moving forward with a higher dose in Cohort 4, we will review preliminary one-month safety data from Cohort 3. Unless we see dose limiting toxicities, we plan to initiate Cohort 4 promptly after this safety data review. We expect this review to occur in the second quarter of this year and that Cohorts 3 and

 


The following information was filed by Clearside Biomedical, Inc. (CLSD) on Thursday, March 10, 2022 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-K Annual 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-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Balance Sheets
Balance Sheets (Parenthetical)
Statement Of Stockholders' Equity (Deflicit)
Statements Of Cash Flows
Statements Of Cash Flows (Parenthetical)
Statements Of Operations
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 Warrants
Common Stock Warrants - Additional Information (Details)
Fair Value Measurements
Fair Value Measurements - Additional Information (Details)
Income Tax - Additional Information (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Schedule Of Net Deferred Tax Assets (Detail)
License And Other Agreements
License And Other Agreements - Additional Information (Detail)
Long-Term Debt
Long-Term Debt - Additional Information (Details)
Net Income (Loss) Per Share
Net Income (Loss) Per Share (Tables)
Net Income (Loss) Per Share - Schedule Of Earnings Per Share, Basic And Diluted (Details)
Net Loss Per Share - Potential Common Stock Equivalents Excluded From Computation Of Diluted Net Loss Per Share (Details)
Preferred And Common Stock
Preferred And Common Stock - Additional Information (Detail)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Schedule Of Property And Equipment, Net (Details)
Schedule Of Statutory And Effective Income Tax Rate Reconciliation (Detail)
Share-Based Compensation
Share-Based Compensation (Tables)
Share-Based Compensation - Additional Information (Details)
Share-Based Compensation - Additional Information About The Stock Option Outstanding And Exercisable (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)
Share-Based Compensation - Weighted Average Assumptions Used In Black-Scholes Option Pricing Model To Calculate Fair Value Of Underlying Common Stock (Details)
Significant Accounting Policies
Significant Accounting Policies (Policies)
Significant Accounting Policies - Additional Information (Detail)
Summary Of Activity Related To Uncertain Tax Positions (Detail)
The Company
The Company - Additional Information (Details)
Ticker: CLSD
CIK: 1539029
Form Type: 10-K Annual Report
Accession Number: 0000950170-22-003468
Submitted to the SEC: Fri Mar 11 2022 4:34:56 PM EST
Accepted by the SEC: Fri Mar 11 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations

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