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 13, 2023, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended September 30, 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
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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 hereunto duly authorized.
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Clearside Biomedical, Inc. |
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Date: |
November 13, 2023 |
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 2023 Financial Results and Provides Corporate Update
- New Licensing Partnership with BioCryst Pharmaceuticals Expands Clearside’s Proprietary Suprachoroidal Injection Platform to Plasma Kallikrein Inhibitor -
- BioCryst Collaboration Provides $5 Million Upfront, the Potential for Additional $77.5 Million in Clinical, Regulatory, and Sales Based Milestone Payments, Plus Royalties -
- Recruitment Completed in CLS-AX Phase 2b ODYSSEY Wet AMD Trial
with Topline Data Expected in Q3 2024 -
- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -
ALPHARETTA, Ga., November 13, 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 third quarter ended September 30, 2023, and provided a corporate update.
“We are successfully delivering on our two-pronged strategy of advancing our internal pipeline and expanding the use of our SCS delivery platform through external collaborations,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “With the completion of recruitment in our ODYSSEY Phase 2b wet AMD trial, we expect to report topline data in the third quarter of 2024. In addition, we signed a promising new licensing partnership with BioCryst Pharmaceuticals, which enhances our external development pipeline, and expands the utility and versatility of our proprietary SCS injection platform with a new molecule specifically targeting diabetic macular edema (DME).”
Dr. Lasezkay continued, “We are partnering with BioCryst to develop their proprietary plasma kallikrein inhibitor, avoralstat, in combination with our patented SCS Microinjector® for patients with DME, the most common cause of vision loss in individuals with diabetes. Avoralstat has high potency and low solubility, characteristics that are ideal for suprachoroidal administration and important to achieving potential efficacy with reduced dosing frequency. Delivering avoralstat into the SCS and behind the visual field could allow avoralstat to inhibit plasma kallikrein directly at the site of edema formation. We believe there is a significant market opportunity in DME utilizing suprachoroidal administration.”
“We are excited about the progress all of our partners have reported over the last few weeks utilizing our SCS Microinjector. Bausch + Lomb announced that XIPERE® has been granted a new CPT code to help facilitate better access and adoption of the product, and Arctic Vision completed enrollment in their Phase 3 trial in uveitic macular edema. At AAO, REGENXBIO and AURA presented clinically meaningful data in diabetic retinopathy and choroidal melanoma, respectively. These results, combined with the internal progress on our CLS-AX program in wet AMD, reinforce our leadership in suprachoroidal delivery to treat multiple serious retinal diseases,” concluded Dr. Lasezkay.
Key Highlights
Third Quarter 2023 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 888-506-0062 (U.S.) or 973-528-0011 (international) and entering conference code: 971200. 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®). Clearside’s SCS injection platform utilizes its patented SCS Microinjector®, the first and only FDA-approved way to access the suprachoroidal space. Clearside’s 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 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 is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. Clearside’s lead suprachoroidal development program, CLS-AX (axitinib injectable suspension), is in Phase 2b clinical testing for the treatment of neovascular age-related macular degeneration (wet AMD). Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit clearsidebio.com and follow us on LinkedIn and TwitterX.
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 expected timing of topline results from the ODYSSEY clinical trial, 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 fourth 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, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 13, 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 |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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License and other revenue |
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$ |
859 |
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$ |
266 |
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$ |
1,881 |
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$ |
997 |
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Operating expenses: |
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Cost of goods sold |
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142 |
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— |
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355 |
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— |
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Research and development |
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5,134 |
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4,637 |
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14,533 |
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14,603 |
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General and administrative |
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2,637 |
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2,353 |
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8,922 |
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8,601 |
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Total operating expenses |
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7,913 |
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6,990 |
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23,810 |
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23,204 |
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Loss from operations |
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(7,054 |
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(6,724 |
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(21,929 |
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(22,207 |
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Other income |
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409 |
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194 |
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1,359 |
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220 |
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Non-cash interest expense on liability related to |
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(2,622 |
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(1,297 |
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(7,083 |
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(1,297 |
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Net loss |
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$ |
(9,267 |
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$ |
(7,827) |
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$ |
(27,653 |
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$ |
(23,284 |
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Net loss per share of common stock — basic |
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$ |
(0.15 |
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$ |
(0.13 |
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$ |
(0.45 |
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$ |
(0.39 |
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Weighted average shares outstanding — basic |
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61,983,987 |
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60,188,541 |
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61,605,648 |
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60,134,821 |
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Balance Sheet Data |
September 30, |
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December 31, |
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2023 |
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2022 |
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Cash and cash equivalents |
$ |
28,802 |
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$ |
48,258 |
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Accounts receivable |
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882 |
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91 |
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Total assets |
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34,420 |
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51,303 |
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Liabilities related to the sales of future royalties, net |
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40,710 |
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33,977 |
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Total liabilities |
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47,269 |
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40,696 |
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Total stockholders’ (deficit) equity |
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(12,849 |
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10,607 |
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Source: Clearside Biomedical, Inc.