Clearside Biomedical Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
Clearside Biomedical (NASDAQ:CLSD) reported a significant milestone of $20 million in non-dilutive funding in Q4 2021, primarily from XIPERE commercialization partners. The company's license revenue for Q4 2021 soared to $25.7 million compared to just $11,000 in Q4 2020. A net income of $18.7 million was achieved, reflecting a marked improvement over the prior year's loss. The ongoing Phase 1/2a OASIS trial of CLS-AX for wet AMD is progressing, with results from Cohort 3 anticipated mid-2022 and a new Cohort 4 planned. Management will provide updates through a conference call today.
- Generated $20 million in non-dilutive funding in Q4 2021.
- License revenue rose to $25.7 million in Q4 2021, a significant increase from $11,000 in Q4 2020.
- Achieved net income of $18.7 million for Q4 2021, compared to a net loss of $7.1 million in Q4 2020.
- Planning to initiate Cohort 4 of the CLS-AX trial to explore broader dosing.
- General and administrative expenses increased by $0.5 million, mainly due to higher salary costs.
- XIPERE® -Related Milestones Generated
- 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 (GLOBE NEWSWIRE) -- 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 4 will overlap. We remain on track to report results from Cohort 3 mid-year and we expect to report results from Cohort 4 later this year. We have begun planning for our Phase 2b clinical trial, and we are targeting to open recruitment for this trial by the end of this year,” concluded Dr. Lasezkay.
Key Highlights
- XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis launched by Bausch + Lomb in Q1 2022 for commercial sale in the U.S., following approval by the U.S. Food and Drug Administration in October 2021.
- Total of
$20 million generated in Q4 2021 in non-dilutive funding related to development, approval and pre-launch milestones from XIPERE commercialization partners, Bausch + Lomb and Arctic Vision. - Cohort 3 enrollment ongoing with results expected mid-2022 in OASIS, Clearside’s U.S. based, open-label, dose-escalation Phase 1/2a trial in patients with wet AMD, to assess the safety and tolerability of a 0.5 mg dose of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector.
- New Cohort 4 planned in OASIS to enable exploration of a broad range of doses in preparation for Phase 2b clinical trial.
- Arctic Vision began dosing patients in China in its Phase 3 study of ARVN001 for the treatment of macular edema associated with uveitis. Arctic Vision also announced in March 2022 that they began dosing patients with diabetic macular edema in a Phase 1 trial in China.
- REGENXBIO presented positive interim data from two Phase 2 clinical trials testing RGX-314 using suprachoroidal delivery for the treatment of wet AMD and diabetic retinopathy.
- Aura Biosciences presented interim Phase 2 safety data evaluating suprachoroidal administration of AU-011 in patients with choroidal melanoma, reporting that there have been no related serious adverse events, dose limiting toxicities, or grade 3 adverse events observed during the trial and that suprachoroidal administration may improve the therapeutic index and optimize treatment parameters.
- Multiple presentations featuring the use of Clearside’s proprietary suprachoroidal space injection platform were highlighted at global conferences, including the Angiogenesis, Exudation, and Degeneration Virtual Conference, American Academy of Ophthalmology, American Uveitis Society Meeting, American Society of Retina Specialists Annual Meeting, Retina Society Annual Scientific Meeting, OIS Retina Summit and Ophthalmology Futures European 2021 Virtual Retina Forum.
Fourth Quarter 2021 Financial Results
Clearside’s license and other revenue for the fourth quarter of 2021 was
Research and development expenses for the fourth quarter of 2021 were
General and administrative expenses for the fourth quarter of 2021 were
Net income for the fourth quarter of 2021 was
Full Year 2021 Financial Results
Clearside’s license and other revenue for the year ended December 31, 2021 was
Research and development expenses for the year ended December 31, 2021 were
General and administrative expenses for the year ended December 31, 2021 were
Net income for the year ended December 31, 2021 was
As of December 31, 2021, Clearside’s cash and cash equivalents totaled
Conference Call & Webcast Details
Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 6354534. An archive of the webcast will be available for three months.
About Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s proprietary SCS Microinjector®, 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. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector and strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. Clearside’s first product, XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the U.S. Food and Drug Administration in October 2021. For more information, please visit www.clearsidebio.com.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX, including the expected timing of data from the OASIS clinical trial and our plans for the Phase 2b trial, the potential benefits of CLS-AX and product candidates using Clearside’s SCS Microinjector® and Clearside’s ability to fund its operations into the second quarter of 2023. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2021, and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
(678) 430-8206
-Financial Tables Follow-
| CLEARSIDE BIOMEDICAL, INC. Selected Financial Data (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
| Statements of Operations Data | Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| License and other revenue | $ | 25,687 | $ | 11 | $ | 29,575 | $ | 7,894 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,840 | 4,472 | 18,537 | 15,073 | ||||||||||||
| General and administrative | 3,140 | 2,649 | 11,665 | 10,756 | ||||||||||||
| Total operating expenses | 6,980 | 7,121 | 30,202 | 25,829 | ||||||||||||
| Income (loss) from operations | 18,707 | (7,110 | ) | (627 | ) | (17,935 | ) | |||||||||
| Other income | 2 | ̶— | 1,003 | — | ||||||||||||
| Other expense | — | (2 | ) | — | (275 | ) | ||||||||||
| Net income (loss) | $ | 18,709 | $ | (7,112 | ) | $ | 376 | $ | (18,210 | ) | ||||||
| Net income (loss) per share of common stock — | ||||||||||||||||
| basic and diluted | $ | 0.31 | $ | (0.14 | ) | $ | 0.01 | $ | (0.39 | ) | ||||||
| Weighted average shares outstanding — basic | 59,669,759 | 49,048,402 | 58,491,986 | 46,506,540 | ||||||||||||
| Weighted average shares outstanding — diluted | 61,182,414 | 49,048,402 | 59,906,602 | 46,506,540 | ||||||||||||
| Balance Sheet Data | December 31, | December 31, | |||||
| 2021 | 2020 | ||||||
| Cash and cash equivalents | $ | 30,436 | $ | 17,287 | |||
| Accounts receivable | 10,000 | — | |||||
| Total assets | 42,903 | 19,322 | |||||
| Deferred revenue | — | 5,000 | |||||
| Long-term debt (including current portion) | — | 991 | |||||
| Total liabilities | 4,928 | 10,559 | |||||
| Total stockholders’ equity | 37,975 | 8,763 | |||||
Source: Clearside Biomedical, Inc.
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