0000950170-24-029956.txt : 20240312 0000950170-24-029956.hdr.sgml : 20240312 20240312161643 ACCESSION NUMBER: 0000950170-24-029956 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240312 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240312 DATE AS OF CHANGE: 20240312 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Clearside Biomedical, Inc. CENTRAL INDEX KEY: 0001539029 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences 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: 24742281 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-20240312.htm 8-K 8-K
0001539029false00015390292024-03-122024-03-12

 

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): March 12, 2024

 

 

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 March 12, 2024, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter and year ended December 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 March 12, 2024

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:

March 12, 2024

By:

/s/Charles A. Deignan

Charles A. Deignan

Chief Financial Officer

 

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

Exhibit 99.1

 

img171462827_0.jpg 

 

Clearside Biomedical Announces Fourth Quarter and Full Year 2023
Financial Results and Provides Corporate Update
 

- Phase 2b ODYSSEY Wet AMD Trial Remains on Track
with Topline Data Expected in Q3 2024 -

- Partner Programs Continue to Report Positive Clinical Data
Utilizing SCS Microinjector® -

- Strengthened Capital Position from Registered Direct Equity Offering
and Recent SCS Microinjector License Agreement -

- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

 

ALPHARETTA, Ga., March 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 fourth quarter and year ended December 31, 2023, and provided a corporate update.

 

“This is an exciting time for Clearside with substantial progress in our tyrosine kinase inhibitor (TKI) program and expanded use of our injection device technology for drug delivery into the suprachoroidal space,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “We are laser focused on completing our ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in wet AMD and expect to report topline data in the third quarter of this year.”

 

Dr. Lasezkay continued, “Our proprietary SCS Microinjector® enables reliable, simple, in-office, non-surgical drug delivery into the suprachoroidal space targeted directly to the site of disease in the back of the eye. This trusted delivery method, combined with axitinib’s differentiated mechanism of action and high potency, offers the potential for CLS-AX to be a best-in-class product for long-term maintenance therapy for wet AMD patients. In ODYSSEY, we are looking to replicate the excellent safety profile, stable vision, and reduced frequency of injections over 6 months that we observed in our OASIS Phase 1/2a and Extension Study.”

 

“In addition, our development and commercialization partners continue to report positive safety and efficacy results utilizing our SCS Microinjector. We are very excited to begin

 

working closely with our newest licensing partner, BioCryst Pharmaceuticals, on their program targeting diabetic macular edema (DME) exclusively using suprachoroidal delivery of their proprietary plasma kallikrein inhibitor, avoralstat. With the upfront licensing fee from BioCryst combined with our recently completed equity financing, we expect our existing cash and cash equivalents will enable us to fund our operating expenses into the third quarter of 2025,” concluded Dr. Lasezkay.

 

Key Highlights

•
Completion of a registered direct offering in February 2024, which generated $15.0 million in gross proceeds to Clearside.
•
On January 1, 2024, a new permanent Category 1 Current Procedural Terminology (CPT) code for XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use became available for physician use.
•
Completion of participant randomization in December 2023 in ODYSSEY, Clearside’s Phase 2b clinical trial of CLS-AX using suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD), with topline data expected in the third quarter of 2024.
•
Entered into an exclusive, worldwide license with BioCryst Pharmaceuticals in November 2023 to use Clearside’s SCS Microinjector for the delivery of BioCryst’s proprietary plasma kallikrein inhibitor, avoralstat, for the treatment of DME. The terms of the agreement include an upfront license fee from BioCryst of $5.0 million and an additional $77.5 million in potential clinical, regulatory and post-approval sales-based milestone payments plus tiered mid-single digit royalties on annual global net product sales.
•
Multiple data presentations on the use of Clearside’s suprachoroidal delivery platform were featured at prominent medical meetings, including American Academy of Ophthalmology (AAO), American Society of Retina Specialists, The Retina Society, Macula Society and Hawaiian Eye and Retina.
‒
Presentations of data on CLS-AX in wet AMD highlighted the excellent safety profile, stable vision and reduced frequency of injections observed for up to 6-months in the OASIS® Phase 1/2a clinical trial and Extension Study.
‒
Positive data was presented on the extended treatment duration of XIPERE utilizing suprachoroidal delivery. Real-world data showed excellent durability in which more than 75% of eyes did not require retreatment for 6 months after a single dose of XIPERE, supporting Clearside’s approach to extended drug release and reduced treatment burden for patients by delivering drug directly to the back of the eye via suprachoroidal administration with the SCS Microinjector.

 

‒
REGENXBIO’s ABBV-RGX-314 gene therapy using suprachoroidal delivery continues to be well tolerated in the Phase 2 ALTITUDE® trial for treatment of diabetic retinopathy and the Phase 2 AAVIATE® trial for treatment of wet AMD.
‒
Aura Biosciences presented positive clinical safety and efficacy updates of bel-sar for early-stage choroidal melanoma from its ongoing Phase 2 clinical trial with suprachoroidal administration. Additionally, in November 2023, Aura received FDA Agreement under a Special Protocol Assessment (SPA) for its CoMpass Phase 3 clinical trial of belzupacap sarotalocan (bel-sar) in early-stage choroidal melanoma. Aura dosed the first patient in the CoMpass trial in December 2023.

 

Fourth Quarter 2023 Financial Results

 

•
License Revenue: License and other revenue for the fourth quarter of 2023 was $6.3 million, compared to $0.3 million for the fourth quarter of 2022. The $6.0 million increase was primarily attributable to the receipt of $5.0 million in an upfront license fee from BioCryst and $1.0 million in a milestone payment from Aura Biosciences.
•
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $6.3 million, compared to $5.0 million for the fourth quarter of 2022. The increase was primarily due to ODYSSEY clinical trial costs.
•
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $2.9 million, compared to $3.2 million for the fourth quarter of 2022. The decrease was primarily due to lower insurance premiums and timing of patent-related costs.
•
Other Expense: Non-cash interest expense for the fourth quarter of 2023 was $2.3 million, compared to $2.0 million for the fourth 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 fourth quarter of 2023 was $4.8 million, or $0.08 per share of common stock, compared to net loss of $9.7 million, or $0.16 per share of common stock, for the fourth quarter of 2022. The decrease in net loss was primarily attributable to the receipt of $5.0 million in an upfront license fee from BioCryst in the fourth quarter of 2023.
•
Cash Position: As of December 31, 2023, Clearside’s cash and cash equivalents totaled $28.9 million. Subsequent to the quarter end, in February 2024, Clearside completed a registered direct offering of stock and warrants which generated $15.0 million in gross proceeds. The Company believes that with the inclusion of the net proceeds from this offering, it will have sufficient resources to fund its planned operations into the third quarter of 2025.

 

 

 

 

Full Year 2023 Financial Results

 

•
License Revenue: License and other revenue for the year ended December 31, 2023 was $8.2 million, compared to $1.3 million for the year ended December 31, 2022. The $6.9 million increase was primarily attributable to the receipt of $5.0 million in an upfront license fee from BioCryst and $1.4 million in milestone payments from Aura Biosciences.
•
R&D Expenses: R&D expenses for the year ended December 31, 2023 were $20.8 million, compared to $19.6 million for the year ended December 31, 2022. The increase was primarily due to ODYSSEY clinical trial costs, offset by decreases in other miscellaneous expenses.
•
G&A Expenses: G&A expenses for the year ended December 31, 2023 were $11.9 million, compared to $11.8 million for the year ended December 31, 2022.
•
Other Income: Other income for the year ended December 31, 2023 was $1.7 million, compared to $0.7 million for the year ended December 31, 2022. The increase was due to higher interest rates earned on cash and cash equivalents.
•
Other Expense: Non-cash interest expense for the year ended December 31, 2023 was $9.4 million, compared to $3.3 million for the year ended December 31, 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 year ended December 31, 2023 was $32.5 million, or $0.53 per share of common stock, compared to net loss of $32.9 million, or $0.55 per share of common stock, for the year ended December 31, 2022.

 

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: 694916. 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, 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), is in Phase 2b 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 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 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 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

December 31,

Twelve Months Ended

December 31,

2023

2022

2023

2022

License and other revenue

$

6,345

$

330

$

8,226

$

1,327

Operating expenses:

Cost of goods sold

 

 

—

 

 

 

204

 

 

 

355

 

 

 

204

 

Research and development

6,313

5,027

20,846

19,630

General and administrative

2,947

3,169

11,869

11,770

Total operating expenses

9,260

8,400

33,070

31,604

Loss from operations

(2,915

)

(8,070

)

(24,844

)

(30,277

)

Other income

 

 

360

 

 

 

449

 

 

 

1,719

 

 

 

669

 

Non-cash interest expense on liability related to
 the sales of future royalties

(2,277

)

(2,042

)

 

(9,360

)

(3,339

)

Net loss

 

$

(4,832

)

 

$

(9,663

)

 

$

(32,485

)

 

$

(32,947

)

Net loss per share of common stock — basic
 and diluted

 

$

(0.08

)

 

$

(0.16

)

 

$

(0.53

)

 

$

(0.55

)

Weighted average shares outstanding — basic
 and diluted

 

 

62,404,329

 

 

 

60,412,700

 

 

 

61,806,959

 

 

 

60,204,862

 

 

 

 

Balance Sheet Data

December 31,

 

 

December 31,

 

 

2023

 

 

2022

 

 

Cash and cash equivalents

$

28,920

$

48,258

Total assets

 

34,018

 

51,303

Liabilities related to the sales of future royalties, net

41,988

33,977

Total liabilities

49,930

40,696

Total stockholders’ (deficit) equity

(15,912

)

10,607

 

 

Source: Clearside Biomedical, Inc.

 

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Document And Entity Information
Mar. 12, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 12, 2024
Entity Registrant Name Clearside Biomedical, Inc.
Entity Central Index Key 0001539029
Entity Emerging Growth Company false
Entity 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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