UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 10, 2021, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended September 30, 2021, as well as information regarding a conference call to discuss these financial results and the Registrant’s recent corporate highlights. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit |
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Exhibit Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded with the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Clearside Biomedical, Inc. |
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Date: |
November 10, 2021 |
By: |
/s/Charles A. Deignan |
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Charles A. Deignan |
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Chief Financial Officer |
Exhibit 99.1
Clearside Biomedical Announces Third Quarter 2021
Financial Results and Provides Corporate Update
- XIPERE™ is First FDA-Approved Product for Injection into the Suprachoroidal Space -
- Approval-Related Milestones to Provide $19 Million in Non-Dilutive Funding -
- Continued Progress in CLS-AX Wet AMD Phase 1/2a Trial -
- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -
ALPHARETTA, Ga., November 10, 2021 -- 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 third quarter ended September 30, 2021.
“The approval of XIPERE™ marks a significant milestone for Clearside as we enter a new era in delivering therapies to the back of the eye via the suprachoroidal space using our proprietary platform,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “It is always an exciting moment when you are able to develop a truly innovative pharmaceutical treatment option for patients that addresses an important unmet medical need. XIPERE is now the first product approved for injection into the suprachoroidal space, and the first therapy approved for macular edema associated with uveitis. By utilizing our SCS Microinjector®, retina physicians will now have a differentiated route of administration that provides a targeted treatment for their patients suffering from this sight-threatening disease.”
Dr. Lasezkay continued, “I am proud of the work completed by our team to advance our first clinical product, XIPERE, to final FDA approval, validating our ability to successfully develop ophthalmic therapies for suprachoroidal administration. We also continue to work closely and cooperatively with Bausch + Lomb as they prepare to launch XIPERE in the U.S. in the first quarter of 2022.”
“With the approval of XIPERE, we expect to receive a total of $19 million in non-dilutive funding for approval and pre-launch milestones from our commercialization partners. This additional capital will be utilized to advance our clinical development pipeline led by CLS-AX (axitinib injectable suspension) for suprachoroidal administration. In September 2021, we completed dosing in Cohort 2 of OASIS, our ongoing Phase 1/2a clinical trial of
CLS-AX in patients with neovascular age-related macular degeneration (wet AMD). We look forward to reporting the safety and tolerability results from Cohort 2 by the end of this year,” concluded Dr. Lasezkay.
Key Highlights
Third Quarter 2021 Financial Results
Clearside’s license and other revenue for the third quarter of 2021 was $3.1 million, compared to $3.4 million for the third quarter of 2020. This decrease was primarily attributable to higher revenue from partner licensing agreements in the third quarter of 2020.
Research and development expenses for the third quarter of 2021 were $5.1 million, compared to $3.5 million for the third quarter of 2020. This increase was primarily attributable to increased costs for continued development of CLS-AX and other pipeline programs and employee-related expenses.
General and administrative expenses for the third quarter of 2021 were $2.8 million, compared to $2.4 million for the third quarter of 2020. This increase was primarily attributable to an increase in employee-related expenses.
Net loss for the third quarter of 2021 was $4.9 million, or $0.08 per share of common stock, compared to a net loss of $2.4 million, or $0.05 per share of common stock, for the third quarter of 2020. This increase in net loss was primarily attributable to higher research and development expenses in the third quarter of 2021.
As of September 30, 2021, Clearside’s cash and cash equivalents totaled $25.2 million. With the anticipated XIPERE approval related milestone payments of $19 million from Clearside’s commercialization partners, the Company believes it will have sufficient resources to fund its planned operations into 2023.
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: 1698586. An archive of the webcast will be available for three months.
Important Safety Information about XIPERE™
Indication
XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.
IMPORTANT SAFETY INFORMATION
Patients should be monitored following injection for elevated intraocular pressure. See Dosage and Administration instructions in full Prescribing Information.
The most common non-ocular adverse event was headache (5%).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information.
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, including the timing of data from the OASIS clinical trial, the potential benefits of XIPERE, CLS-AX and therapies using Clearside’s SCS Microinjector®, the timing of commercial launch of XIPERE by Bausch + Lomb and Clearside’s ability to fund its operations into 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
XIPERE™, suprachoroidal space (SCS®), and SCS Microinjector® are trademarks of Clearside Biomedical.
AAVIATE® and ALTITUDE™ are trademarks of REGENXBIO Inc.
-Financial Tables Follow-
CLEARSIDE BIOMEDICAL, INC.
Selected Financial Data
(in thousands, except share and per share data)
(unaudited)
Statements of Operations Data |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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License and other revenue |
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$ |
3,074 |
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$ |
3,432 |
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$ |
3,888 |
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$ |
7,883 |
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Operating expenses: |
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Research and development |
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5,147 |
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3,490 |
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14,697 |
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10,601 |
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General and administrative |
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2,816 |
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2,374 |
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8,525 |
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8,107 |
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Total operating expenses |
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7,963 |
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5,864 |
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23,222 |
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18,708 |
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Loss from operations |
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(4,889 |
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(2,432 |
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(19,334 |
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(10,825 |
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Other income |
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2 |
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̶— |
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1,001 |
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— |
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Other expense |
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— |
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(1 |
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— |
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(273 |
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Net loss |
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$ |
(4,887 |
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$ |
(2,433 |
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$ |
(18,333 |
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$ |
(11,098 |
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Net loss per share of common stock — basic and diluted |
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$ |
(0.08 |
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$ |
(0.05 |
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$ |
(0.32 |
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$ |
(0.24 |
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Weighted average shares outstanding — basic and diluted |
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59,474,346 |
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46,976,649 |
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58,095,080 |
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45,653,068 |
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Balance Sheet Data |
September 30, |
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December 31, |
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2021 |
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2020 |
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Cash and cash equivalents |
$ |
25,217 |
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$ |
17,287 |
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Total assets |
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27,378 |
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19,322 |
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Deferred revenue |
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5,000 |
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5,000 |
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Long-term debt (including current portion) |
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— |
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991 |
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Total liabilities |
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9,530 |
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10,559 |
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Total stockholders’ equity |
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17,848 |
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8,763 |
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Source: Clearside Biomedical, Inc.