0000950170-23-020831.txt : 20230511 0000950170-23-020831.hdr.sgml : 20230511 20230511071524 ACCESSION NUMBER: 0000950170-23-020831 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230511 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230511 DATE AS OF CHANGE: 20230511 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Clearside Biomedical, Inc. CENTRAL INDEX KEY: 0001539029 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 452437375 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37783 FILM NUMBER: 23908795 BUSINESS ADDRESS: STREET 1: 900 NORTH POINT PARKWAY STREET 2: SUITE 200 CITY: ALPHARETTA STATE: GA ZIP: 30005 BUSINESS PHONE: 678-270-3631 MAIL ADDRESS: STREET 1: 900 NORTH POINT PARKWAY STREET 2: SUITE 200 CITY: ALPHARETTA STATE: GA ZIP: 30005 8-K 1 clsd-20230511.htm 8-K 8-K
0001539029false00015390292023-05-112023-05-11

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 11, 2023

 

 

Clearside Biomedical, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-37783

45-2437375

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

900 North Point Parkway

Suite 200

 

Alpharetta, Georgia

 

30005

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 678 270-3631

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

CLSD

 

The Nasdaq Stock Market LLC

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 May 11, 2023, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended March 31, 2023, 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

Exhibit

Number

Exhibit Description

99.1

Press Release, dated May 11, 2023

104

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 hereunto duly authorized.

Clearside Biomedical, Inc.

Date:

May 11, 2023

By:

/s/Charles A. Deignan

Charles A. Deignan

Chief Financial Officer

 

 EX-99 2 clsd-ex99_1.htm EX-99.1 EX-99

Exhibit 99.1

 

img171462827_0.jpg 

 

Clearside Biomedical Announces First Quarter 2023
Financial Results and Provides Corporate Update
 

- Phase 2b ODYSSEY Trial of CLS-AX in Wet AMD Expected to Open Enrollment in Q2 2023 -

- Positive Safety Data, Duration and Biologic Effect of CLS-AX Over 6 Months in OASIS Phase 1/2a Extension Study Highlighted in Presentations at Recent Medical Meetings -

- Management to Host Webcast and Conference Call Today at 8:30 A.M. ET -

 

ALPHARETTA, Ga., May 11, 2023 -- 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 first quarter ended March 31, 2023 and provided a corporate update.

 

“We have delivered a productive start to 2023 as we continue executing on our near-term plan to advance CLS-AX (axitinib injectable suspension) for the treatment of wet AMD,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “In February, we announced positive data from the OASIS Phase 1/2a Extension Study demonstrating an excellent safety profile for CLS-AX with promising duration and biologic effect over 6 months in treatment-experienced, anti-VEGF sub-responder wet AMD participants. This data was recently presented at the ARVO Annual Meeting in New Orleans.”

 

“We are now looking to build upon the OASIS results in ODYSSEY, our Phase 2b clinical trial of CLS-AX in wet AMD patients, which will open for enrollment this quarter, with topline results expected in Q3 2024. The recently announced ODYSSEY trial design was based on input from our enhanced Scientific Advisory Board and other experienced retinal physicians, while taking into account the recent FDA draft guidance for wet AMD drug development. In conducting the ODYSSEY trial, we believe that CLS-AX has the potential to demonstrate an important reduction in treatment burden while maintaining stable visual acuity in patients with wet AMD. Importantly, we also believe that the number of participants, the duration, and the outcome measures of the ODYSSEY trial will provide the necessary clinical data to inform the design of a CLS-AX Phase 3 program,” concluded Dr. Lasezkay.

 

 

 

 

Key Highlights

•
Clearside announced plans for ODYSSEY, its randomized, double-masked, parallel-group, active-controlled, multi-center Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) using suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD).
•
Favorable safety data, duration and biologic effect over 6 months in treatment-experienced anti-VEGF sub-responders was reported from Cohorts 3 and 4 of the Extension Study of OASIS, Clearside’s U.S.-based, open-label, dose-escalation Phase 1/2a clinical trial of CLS-AX in wet AMD.
•
Clearside’s Scientific Advisory Board (SAB) was enhanced with the additions of Thomas A. Ciulla, M.D., M.B.A. as Chair, Arshad M. Khanani, M.D., M.A. and Lejla Vajzovic, M.D. The SAB is comprised of industry leading retinal physicians who provide medical and scientific expertise and input on the Company’s research and development programs.
•
Clinical data was presented at The Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting, which highlighted that SCS delivery of small molecule suspensions offered targeted, compartmentalized, and durable drug delivery to the chorioretina. In addition, a poster presentation based on OASIS Phase 1/2a trial data showed that CLS-AX had an excellent safety profile and that Extension Study participants with wet AMD maintained visual acuity while experiencing a meaningful reduction in treatment burden over 6 months.
•
Presentations featuring Clearside’s proprietary suprachoroidal space injection platform were highlighted at the Macula Society Annual Meeting and the Angiogenesis, Exudation, and Degeneration Virtual Conference.

 

First Quarter 2023 Financial Results

 

•
License Revenue: Clearside’s license and other revenue for the first quarter of 2023 was $4,000, compared to $347,000 for the first quarter of 2022.
•
Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2023 and the first quarter of 2002 were $4.5 million.
•
General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2023 were $3.2 million, compared to $3.5 million for the first quarter of 2022.
•
Other Income: Other income for the first quarter of 2023 was $492,000, compared to $2,000 for the first quarter of 2022. Other income in both periods was comprised of interest income from cash and cash equivalents.

 

 

•
Other Expense: Non-cash interest expense for the first quarter of 2023 was $2.2 million, compared to $0 in the first quarter of 2022. Non-cash interest expense was comprised of imputed interest on the liability related to the sales of future royalties and the amortization of the associated issuance costs.
•
Net Loss: Net loss for the first quarter of 2023 was $9.3 million, or $0.15 per share of common stock, compared to net loss of $7.6 million, or $0.13 per share of common stock, for the first quarter of 2022.
•
Cash Position: As of March 31, 2023, Clearside’s cash and cash equivalents totaled $41.4 million. The Company believes it will have sufficient resources to fund its planned operations into the second quarter of 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. Registration for the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. To participate via telephone, please register in advance using the link provided in the event listing. The Company suggests participants log in 15 minutes in advance of the event.

 

About Clearside Biomedical, Inc.

 

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. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2 clinical testing. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. 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, timeline for initiating the ODYSSEY Phase 2b clinical trial for CLS-AX, the expected timing of topline results from the ODYSSEY clinical trial, the potential benefits of CLS-AX and other product candidates using Clearside’s SCS Microinjector® and Clearside’s ability to fund its operations into the second quarter of 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 and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC) on March 14, 2023 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

March 31,

2023

2022

License and other revenue

$

4

$

347

Operating expenses:

Research and development

4,451

4,536

General and administrative

3,158

3,457

Total operating expenses

7,609

7,993

Loss from operations

(7,605

)

(7,646

)

Other income

 

 

492

 

 

 

2

 

Non-cash interest expense on liability

   related to the sales of future royalties

 

 

(2,167

)

 

 

—

 

Net loss

$

(9,280

)

$

(7,644

)

Net loss per share of common stock — basic and diluted

$

(0.15

)

$

(0.13

)

Weighted average shares outstanding — basic and diluted

61,169,486

60,064,209

 

Balance Sheet Data

March 31,

 

 

December 31,

 

 

2023

 

 

2022

 

 

 

Cash and cash equivalents

$

41,419

$

48,258

Total assets

 

44,695

 

51,303

Liabilities related to the sales of future royalties, net

 

36,144

 

 

 

33,977

 

Total liabilities

41,995

40,696

Total stockholders’ equity

2,700

10,607

 

 

 

Source: Clearside Biomedical, Inc.

 

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Document And Entity Information
May 11, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 11, 2023
Entity Registrant Name Clearside Biomedical, Inc.
Entity Central Index Key 0001539029
Entity Emerging Growth Company false
Securities Act File Number 001-37783
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 45-2437375
Entity Address, Address Line One 900 North Point Parkway
Entity Address, Address Line Two Suite 200
Entity Address, City or Town Alpharetta
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30005
City Area Code 678
Local Phone Number 270-3631
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol CLSD
Security Exchange Name NASDAQ
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