After U.S. markets closed Thursday, biopharmaceutical company Clearside Biomedical Inc. (CLSD:NASDAQ), which is engaged in developing treatments to preserve, improve and restore vision for individuals with serious back of the eye diseases by administering therapies directly through the suprachoroidal space (SCS®), announced financial results for the fourth quarter and full year of 2021 ended December 31, 2021.
Clearside Biomedical's President and CEO George Lasezkay, Pharm.D., J.D. commented, "Our suprachoroidal injection platform is a proven approach for ocular drug delivery that offers potential advantages over other types of administration…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."
"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," Dr. Lasezkay added.
Dr. Lasezkay explained that based upon the positive safety data observed so far in the OASIS wet AMD study, the company will add a fourth cohort to the trial to explore a wider range of doses (dose escalation) to take into a Phase 2b clinical trial. The company expects to report results from Cohort 3 and Cohort 4 within this year and indicated that it has begun planning for its Phase 2b clinical trial with the goal of opening recruitment for the study by year-end 2022.
Clearside noted that a significant recent development at the company was the U.S. Food and Drug Administration's (FDA) approval of on XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis in October 2021.
The company stated that it received a total of about $20 million in Q4/21 in non-dilutive funding related to development, approval and pre-launch milestones from its XIPERE commercialization partners, Bausch + Lomb and Arctic Vision, with Bausch + Lomb commercially launching sales in the U.S. in Q1/22.
The firm added that its partner Arctic Vision commenced with dosing patients in its Phase 3 study of ARVN001 for the treatment of macular edema associated with uveitis and reported that this month it also began dosing patients with diabetic macular edema in a Phase 1 trial which is also being conducted in China.
The company stated in Q4/21 it posted license and other revenue of $25.7 million, compared with just $11,000 in Q4/20. The firm noted that the increase was mostly due to milestone payments earned from its XIPERE licensing partners in Q4/21 and included $5 million in deferred revenue from prior upfront payments received under its contract with Bausch + Lomb.
The firm advised that in Q4/21 it earned net income of $18.7 million, or $0.31 per share, versus a net loss of $7.1 million, or $0.14 per share in Q4/20. The company attributed the substantial increase in net income to higher license revenue received in Q4/21.
The company stated that for FY/21 license and other revenue increased by $21.7 million to $29.6 million, compared to $7.9 million in FY/20. The company mentioned that the substantial increase was the result of the milestone payments received from XIPERE licensing partners.
The firm indicated that its overall spending on R&D in FY/21 increased by $3.5 million to $18.5 million, compared to $15.1 million during FY/20. Clearside noted that the additional expenses were attributed to costs associated with the company's CLS-AX Phase 1/2a clinical trial.
The company reported that for FY/21 it earned net income of $376,000, or $0.01 per share, versus a net loss of $18.2 million, or $0.39 per share during FY/20.
The firm indicated that had $30.4 million in cash on its balance sheet as of December 31, 2021, and that together with another $10 million collected in Q1/22 from an XIPERE pre-launch milestone payment it is well funded into Q2/23.
Clearside is a biopharmaceutical company headquartered in Alpharetta, Ga. that focuses on the development of treatments via the suprachoroidal space (SCS®) that preserve and restore vision in those with serious back of the eye diseases. The firm explained that "its SCS injection platform utilizes the company's proprietary SCS Microinjector®, which enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases." The firm states on its website that "it believes it proprietary suprachoroidal administration platform has the potential to become a standard for delivery of therapies intended to treat chorioretinal diseases."
The FDA approved Clearside's XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use in October of 2021. The company's development, commercial and collaborative pipeline includes treatments for Wet AMD, Diabetic Macular Edema, Therapeutic Biofactory / Inherited Retinal Disease, and Ocular Oncology / Choroidal Melanoma.
Clearside Biomedical started the day with a market cap of around $80.6 million with approximately 59.7 million shares outstanding and a short interest of about 2.1%. CLSD shares opened 37% higher Friday at $1.85 (+$0.50, +37.04%) over Thursday's $1.35 closing price. The stock traded between $1.71 and $2.14 per share and closed trading at $1.92 (+$0.57, +42.59%).
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