8-K: Clearside Biomedical Announces Positive Phase 3 Plans for CLS-AX in Wet AMD Following FDA Meeting

Clearside Biomedical reports alignment with the FDA on Phase 3 plans for CLS-AX in wet AMD, along with financial results for Q4 and full-year 2024 and a corporate update.

Summary

• Clearside Biomedical announced its Q4 and full-year 2024 financial results and provided a corporate update on March 27, 2025.
• The company completed an End-of-Phase 2 meeting with the FDA and reached an agreement on Phase 3 plans for suprachoroidal CLS-AX in wet AMD.
• Clearside's Asia-Pacific partner, Arctic Vision, had its New Drug Application (NDA) for ARCATUS (XIPERE) for uveitic macular edema (UME) accepted for review in China.
• REGENXBIO, in collaboration with AbbVie, plans a Phase 3 clinical program for sura-vec (ABBV-RGX-314) using suprachoroidal delivery for diabetic retinopathy.
• Aura Biosciences is enrolling patients in its global Phase 3 CoMpass trial evaluating belzupacap sarotalocan (bel-sar) for choroidal melanoma.
• BioCryst Pharmaceuticals plans to initiate clinical testing of avoralstat for diabetic macular edema in 2025.
• License and other revenue for Q4 2024 was $0.3 million, compared to $6.3 million in Q4 2023.
• Research and development (R&D) expenses for Q4 2024 were $4.2 million, compared to $6.3 million in Q4 2023.
• General and administrative (G&A) expenses for Q4 2024 were $3.1 million, compared to $2.9 million in Q4 2023.
• Net loss for Q4 2024 was $7.3 million, or $0.10 per share, compared to a net loss of $4.8 million, or $0.08 per share, for Q4 2023.
• As of December 31, 2024, Clearside's cash and cash equivalents totaled $20.0 million, which is expected to fund operations into the fourth quarter of 2025.
• License and other revenue for the year ended December 31, 2024, was $1.7 million, compared to $8.2 million for the year ended December 31, 2023.
• R&D expenses for the year ended December 31, 2024, were $18.6 million, compared to $20.8 million for the year ended December 31, 2023.
• Net loss for the year ended December 31, 2024, was $34.4 million, or $0.47 per share, compared to a net loss of $32.5 million, or $0.53 per share, for the year ended December 31, 2023.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the progress in clinical development, particularly the alignment with the FDA on Phase 3 plans for CLS-AX. However, the decreased revenue and increased net loss temper the overall positive outlook.

Positives

• Successful End-of-Phase 2 meeting with the FDA, leading to alignment on Phase 3 plans for CLS-AX in wet AMD.
• Arctic Vision's NDA for ARCATUS (XIPERE) accepted for review in China.
• Multiple partnerships advancing suprachoroidal drug candidates into Phase 3 clinical trials.
• Positive safety profile demonstrated in the ODYSSEY Phase 2b trial.
• Appointment of Tony Gibney as Chair of Clearside's Board of Directors.

Negatives

• License and other revenue decreased to $0.3 million in Q4 2024 from $6.3 million in Q4 2023.
• Net loss increased to $7.3 million in Q4 2024 from $4.8 million in Q4 2023.
• License and other revenue for the year ended December 31, 2024, decreased to $1.7 million from $8.2 million in the previous year.
• Net loss for the year ended December 31, 2024, increased to $34.4 million from $32.5 million in the previous year.

Risks

• The company's ability to raise additional capital is a risk factor.
• Uncertainties inherent in the conduct of clinical trials could impact results.
• Reliance on third parties over which Clearside may not always have full control poses a risk.
• The company's ability to obtain and maintain regulatory approvals for its product candidates is uncertain.

Future Outlook

Clearside believes it will have sufficient resources to fund its planned operations into the fourth quarter of 2025, and is planning for a Phase 3 program for CLS-AX.

Management Comments

• George Lasezkay, PharmD, JD, President and Chief Executive Officer, stated that Clearside is redefining the delivery of therapeutics to the retina through the suprachoroidal space.
• Dr. Lasezkay highlighted the differentiated platform of early and later stage SCS assets, multiple validating SCS collaborations, and potential for pipeline expansion opportunities.

Industry Context

The announcement highlights the growing interest in suprachoroidal drug delivery as a method for treating retinal diseases, with multiple companies partnering with Clearside to utilize its SCS Microinjector technology. The focus on wet AMD, diabetic retinopathy, and geographic atrophy reflects the significant unmet needs in these large and growing markets.

Comparison to Industry Standards

• The planned Phase 3 program for CLS-AX aims to compete with established treatments like EYLEA and VABYSMO in the wet AMD market.
• The flexible dosing regimen being explored for CLS-AX is similar to that of VABYSMO and EYLEA HD, potentially offering a competitive advantage.
• Other companies like Ocular Therapeutix (OTX-TKI) and EyePoint Pharmaceuticals (EYP-1901) are also developing treatments for wet AMD, but Clearside believes its approach has several advantages, including a more potent API and a lower risk of endophthalmitis.
• REGENXBIO's sura-vec (ABBV-RGX-314) is a gene therapy for diabetic retinopathy, similar to other gene therapy programs in development for retinal diseases.

Management Changes

Stakeholder Impact

• Shareholders: The Phase 3 plans for CLS-AX and the advancement of partner programs could positively impact shareholder value.
• Employees: Continued progress in clinical development and potential pipeline expansion could provide job security and growth opportunities.
• Patients: Successful development and approval of CLS-AX and other suprachoroidal therapies could provide new treatment options for sight-threatening eye diseases.
• Partners: Clearside's continued innovation and development of its SCS Microinjector platform could benefit its partners in their own drug development efforts.

Next Steps

• Clearside will continue preparations for the Phase 3 program for CLS-AX in wet AMD.
• The company will support its partners in advancing their suprachoroidal drug candidates through clinical development.
• Clearside will continue evaluating small molecules for the potential long-acting treatment of geographic atrophy (GA).

Key Dates

Keywords

CLS-AX, suprachoroidal, wet AMD, XIPERE, ARCATUS, uveitic macular edema, SCS Microinjector, clinical trials, financial results, Clearside Biomedical