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
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(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:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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 12, 2024, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report.
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 |
|
|
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: |
November 12, 2024 |
By: |
/s/ Charles A. Deignan |
|
|
|
Charles A. Deignan |
|
|
|
Chief Financial Officer |
Exhibit 99.1
Clearside Biomedical Announces Third Quarter 2024 Financial Results and Provides Corporate Update
- Recent ODYSSEY Phase 2b Trial of Suprachoroidal CLS-AX in Wet AMD Achieved All Primary and Secondary Outcomes -
- Positive Topline Results Support Advancing CLS-AX to Phase 3 Targeting a Differentiated Flexible Dosing Approach Similar to a Biologic with the Potential Extended Duration of a Tyrosine Kinase Inhibitor (TKI) -
- Recent Commercial Licensing Agreement for China by a Global Ophthalmic Pharmaceutical Company Provides Strategic Validation of
Clearside’s Suprachoroidal Platform -
- Compelling Data Presentations at AAO Demonstrated Potential Safety and Efficacy Benefits of Suprachoroidal Delivery Using Clearside’s Proprietary SCS Microinjector®
in Multiple Clinical Programs -
- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -
ALPHARETTA, Ga., November 12, 2024 -- 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, 2024, and provided a corporate update.
“We are making outstanding progress advancing our differentiated suprachoroidal delivery pipeline,” said George Lasezkay, PharmD, JD, President and Chief Executive Officer. “The recent positive results from our ODYSSEY trial establish CLS-AX as a Phase 3 ready asset in the large and growing wet AMD market. We are positioning CLS-AX for real-world success by focusing on a Phase 3 program in wet AMD designed to evaluate extended efficacy duration compared to current standard of care intravitreal products and produce data supportive of a prescribing label that enables physicians to take advantage of flexible maintenance dosing between 3 and 6 months. We look forward to conducting an End-of-Phase 2 meeting with the FDA in early 2025 to align on the essential components of our Phase 3 program.”
“As we work to expand the overall value of our suprachoroidal drug delivery platform, we are seeing significant interest among the retinal specialist community and from leading
biopharmaceutical companies in applying our innovative approach to treating serious retinal diseases. The recent commercial collaboration announced by Santen Pharmaceutical Co. and our Asia-Pacific partner, Arctic Vision, is a compelling validation of our suprachoroidal platform from a well-respected leader in the global ophthalmic industry. The licensing of ARVN001, branded as XIPERE® in the U.S., is part of Santen’s commitment to bringing innovative eyecare solutions to patients in China,” concluded Dr. Lasezkay.
Victor Chong, M.D., MBA, Chief Medical Officer and EVP, Head of Research & Development, added, “In addition to our partners’ promising programs, our research team is currently evaluating various small molecules through in vivo models for the potential treatment of geographic atrophy (GA), with a market size valued at over $20 billion in sales. We believe that GA is primarily a choroidal disease. Delivery of small molecules via suprachoroidal injection enables comprehensive drug coverage of both the retina and choroid, while potentially minimizing systemic and anterior segment side effects.”
Key Highlights
Third Quarter 2024 Financial Results
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 (877) 545-0523 (domestic) or (973) 528-0016 (international) and entering conference code: 756568. The Company suggests participants join 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®) to improve patient outcomes. Clearside’s SCS injection platform, utilizing the Company’s patented 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), recently completed a Phase 2b clinical trial, and planning for a Phase 3 program is underway. 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 clearsidebio.com or follow us on LinkedIn and X.
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, the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector® and
Clearside’s ability to fund its operations into the third quarter of 2025. 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, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, Clearside’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 filed with the SEC on August 12, 2024 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.
*References
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 September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
License and other revenue |
|
$ |
1,038 |
|
|
$ |
859 |
|
|
$ |
1,358 |
|
|
$ |
1,881 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
— |
|
|
|
142 |
|
|
|
— |
|
|
|
355 |
|
Research and development |
|
|
4,128 |
|
|
|
5,134 |
|
|
|
14,346 |
|
|
|
14,533 |
|
General and administrative |
|
|
2,844 |
|
|
|
2,637 |
|
|
|
8,745 |
|
|
|
8,922 |
|
Total operating expenses |
|
|
6,972 |
|
|
|
7,913 |
|
|
|
23,091 |
|
|
|
23,810 |
|
Loss from operations |
|
|
(5,934 |
) |
|
|
(7,054 |
) |
|
|
(21,733 |
) |
|
|
(21,929 |
) |
Interest income |
|
|
338 |
|
|
|
409 |
|
|
|
1,104 |
|
|
|
1,359 |
|
Other income, net |
|
|
365 |
|
|
|
— |
|
|
|
783 |
|
|
|
— |
|
Non-cash interest expense on liability related to |
|
|
(2,457 |
) |
|
|
(2,622 |
) |
|
|
(7,200 |
) |
|
|
(7,083 |
) |
Net loss |
|
$ |
(7,688 |
) |
|
$ |
(9,267 |
) |
|
$ |
(27,046 |
) |
|
$ |
(27,653 |
) |
Net loss per share of common stock — basic |
|
$ |
(0.10 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.45 |
) |
Weighted average shares outstanding — basic |
|
|
74,745,415 |
|
|
|
61,983,987 |
|
|
|
73,115,896 |
|
|
|
61,605,648 |
|
Balance Sheet Data |
September 30, |
|
|
December 31, |
|
||
|
2024 |
|
|
2023 |
|
||
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
13,888 |
|
|
$ |
28,920 |
|
Short-term investments |
|
9,703 |
|
|
|
— |
|
Total assets |
|
29,161 |
|
|
|
34,018 |
|
Liabilities related to the sales of future royalties, net |
|
49,188 |
|
|
|
41,988 |
|
Warrant liabilities |
|
8,757 |
|
|
|
— |
|
Total liabilities |
|
63,950 |
|
|
|
49,930 |
|
Total stockholders’ deficit |
|
(34,789 |
) |
|
|
(15,912 |
) |
Source: Clearside Biomedical, Inc.