Please wait while we load the requested 10-K report or click the link below:
https://last10k.com/sec-filings/report/1539029/000095017022003468/clsd-20211231.htm
June 2022
May 2022
March 2022
March 2022
December 2021
November 2021
October 2021
August 2021
June 2021
June 2021
Exhibit 99.1
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
Please wait while we load the requested 10-K report or click the link below:
https://last10k.com/sec-filings/report/1539029/000095017022003468/clsd-20211231.htm
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Clearside Biomedical, Inc..
Clearside Biomedical, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:
Rating
Learn More![]()
Outlook 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 generate significant milestone payments and royalties from XIPERE and other licensing arrangements or revenues from other product candidates.
The decrease in other expense for the year ended December 31, 2020 as compared to the year ended December 31, 2019 is primarily due to lower costs on our loan agreement that we prepaid in full in May 2020.
Due to our three-year cumulative loss position, history of operating losses and losses expected to be incurred in the foreseeable future, we considered it necessary to provide for a full valuation allowance against our net deferred tax assets.
Research and development expense decreased by $0.6 million, from $15.7 million for the year ended December 31, 2019 to $15.1 million for the year ended December 31, 2020.
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.
We expect clinical trial expenses...Read more
The losses were partially offset...Read more
The net cash provided by...Read more
If we raise funds through...Read more
Additionally, there was a $0.9...Read more
This decrease was primarily attributable...Read more
This is partially offset by...Read more
The net cash provided by...Read more
The net cash provided by...Read more
To determine revenue recognition for...Read more
This increase was primarily due...Read more
General and administrative expenses decreased...Read more
Royalties: For arrangements that include...Read more
The financial terms of these...Read more
General and administrative expenses increased...Read more
Other Income (Expense) Other income...Read more
The transaction price is then...Read more
Expenses related to activities that...Read more
Factors that could cause or...Read more
These other variables include the...Read more
We provided a full valuation...Read more
We will determine which programs...Read more
In addition, Arctic Vision has...Read more
Research and development expense increased...Read more
These costs include preclinical activities,...Read more
While our significant accounting policies...Read more
Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
Material Contracts, Statements, Certifications & more
Clearside Biomedical, Inc. provided additional information to their SEC Filing as exhibits
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