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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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 August 9, 2022, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended June 30, 2022, 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: |
August 9, 2022 |
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 Second Quarter 2022 Financial Results and Provides Corporate Update
- CLS-AX OASIS Phase 1/2a Trial Data from Cohorts 3 & 4 Expected in November 2022 -
- Non-Dilutive Financing Agreement with HealthCare Royalty Supports Progression of CLS-AX Clinical Program -
- Management to Host Webcast and Conference Call Today at 8:30 A.M. ET -
ALPHARETTA, Ga., August 9, 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 second quarter ended June 30, 2022 and provided a corporate update.
“We are building significant momentum through our internal and partnered programs leveraging our proprietary SCS platform technology,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “We have created a new paradigm in retinal drug delivery with XIPERE® for suprachoroidal use. It is the first product approved by the U.S. FDA for suprachoroidal injection and is now being used by physicians across the U.S. to treat patients with macular edema associated with uveitis.”
Dr. Lasezkay continued, “There are multiple upcoming anticipated catalysts related to our internal CLS-AX program and from our development and commercialization partners. We successfully completed dosing in Cohorts 3 and 4 of OASIS, our Phase 1/2a clinical trial of CLS-AX in patients with neovascular age-related macular degeneration (wet AMD). We expect to report the OASIS data for all four cohorts in November of this year, which we believe will provide more insight into the potential benefits of combining pan-VEGF inhibition from the highly potent tyrosine kinase inhibitor, axitinib, with targeted delivery to affected chorioretinal tissues utilizing our proprietary SCS Microinjector.”
Key Highlights
Second Quarter 2022 Financial Results
Clearside’s license and other revenue for the second quarter of 2022 was $384,000, compared to $780,000 for the second quarter of 2021.
Research and development expenses for the second quarter of 2022 were $5.4 million, compared to $4.1 million for the second quarter of 2021. The $1.3 million increase was primarily attributable to CLS-AX Phase 1/2a clinical trial costs.
General and administrative expenses for the second quarter of 2022 were $2.8 million, compared to $2.8 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $7.8 million, or $0.13 per share of common stock, compared to a net loss of $6.1 million, or $0.11 per share of common stock, for the second quarter of 2021.
On August 8, 2022 (Closing Date), Clearside entered into a non-dilutive financing agreement with HealthCare Royalty Partners for up to $65 million. Under the terms of the agreement,
Clearside will receive an initial payment of $32.5 million, less certain expenses, within 15 business days of the Closing Date. At the same time, an additional $12.5 million will be deposited in an escrow account to be released to Clearside upon attainment of a pre-specified sales milestone for XIPERE. The terms of the agreement also provide for an additional milestone payment of $20 million to Clearside upon attainment of a second pre-specified 2024 sales milestone for XIPERE.
As of June 30, 2022, Clearside’s cash and cash equivalents totaled $29.0 million. The initial royalty agreement payment of $32.5 million combined with the second quarter-end cash balance is expected to provide financial runway into 2024.
Conference Call & Webcast Details
Clearside’s management will host a webcast and conference call today at 8:30 a.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 Company suggests participants log in 15 minutes in advance of the event.
About XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use
XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration to the suprachoroidal space for the treatment of macular edema associated with uveitis. Bausch + Lomb, a leading global eye health company dedicated to helping people see better to live better, has the exclusive license for the commercialization and development of XIPERE in the United States and Canada. Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE, which they refer to as Arcatus™, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. XIPERE was approved by the U.S. Food and Drug Administration in October 2021 and is commercially available in the U.S.
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, is commercially available in the U.S. 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, the potential benefits of CLS-AX and product candidates using Clearside’s SCS Microinjector®, the anticipated use of proceeds from the agreement with HealthCare Royalty Partners, potential future payments under the agreement with HealthCare Royalty Partners and Clearside’s ability to fund its operations into 2024. 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, 2021, filed with the U.S. Securities and Exchange Commission (SEC) on March 11, 2022, 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 |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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License and other revenue |
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$ |
384 |
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$ |
780 |
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$ |
731 |
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$ |
814 |
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Operating expenses: |
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Research and development |
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5,430 |
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4,060 |
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9,966 |
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9,550 |
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General and administrative |
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2,791 |
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2,816 |
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6,248 |
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5,709 |
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Total operating expenses |
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8,221 |
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6,876 |
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16,214 |
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15,259 |
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Loss from operations |
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(7,837 |
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(6,096 |
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(15,483 |
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(14,445 |
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Other income |
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24 |
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1 |
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26 |
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999 |
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Net loss |
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$ |
(7,813 |
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$ |
(6,095 |
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$ |
(15,457 |
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$ |
(13,446 |
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Net loss per share of common stock — basic and diluted |
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$ |
(0.13 |
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$ |
(0.11 |
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$ |
(0.26 |
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$ |
(0.23 |
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Weighted average shares outstanding — basic and diluted |
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60,150,348 |
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57,745,465 |
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60,107,517 |
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57,394,017 |
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Balance Sheet Data |
June 30, |
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December 31, |
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2022 |
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2021 |
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Cash and cash equivalents |
$ |
29,033 |
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$ |
30,436 |
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Accounts receivable |
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123 |
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10,000 |
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Total assets |
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30,746 |
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42,903 |
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Total liabilities |
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5,498 |
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4,928 |
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Total stockholders’ equity |
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25,248 |
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37,975 |
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Source: Clearside Biomedical, Inc.