Clearside Biomedical Announces Second Quarter 2024 Financial Results and Provides Corporate Update
Clearside Biomedical (Nasdaq: CLSD) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Phase 2b ODYSSEY trial for CLS-AX in wet AMD on track with topline data expected in late Q3 2024.
2. Safety Review Committee recommended trial continuation with no serious adverse events observed.
3. Q2 2024 financial results: Revenue $90,000, net loss $7.6 million ($0.10 per share).
4. Cash position of $29.4 million, expected to fund operations into Q3 2025.
5. Progress in XIPERE commercialization and positive results from partner Arctic Vision's Phase 3 trial in China.
6. Advancements in suprachoroidal delivery platform and partnerships.
Clearside Biomedical (Nasdaq: CLSD) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. Il trial ODYSSEY di fase 2b per CLS-AX nella degenerazione maculare umida è in linea con le aspettative, con i dati preliminari previsti per la fine del terzo trimestre 2024.
2. Il Comitato di revisione sulla sicurezza ha raccomandato la continuazione dello studio senza eventi avversi gravi osservati.
3. Risultati finanziari del secondo trimestre 2024: Ricavi di 90.000 dollari, perdita netta di 7,6 milioni di dollari (0,10 dollari per azione).
4. Posizione di cassa di 29,4 milioni di dollari, previsto per finanziare le operazioni fino al terzo trimestre 2025.
5. Progressi nella commercializzazione di XIPERE e risultati positivi dal trial di fase 3 del partner Arctic Vision in Cina.
6. Sviluppi nella piattaforma di consegna suprachoroidale e nelle collaborazioni.
Clearside Biomedical (Nasdaq: CLSD) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los aspectos más destacados incluyen:
1. El ensayo ODYSSEY de fase 2b para CLS-AX en la DMAE húmeda está en marcha, con datos preliminares esperados a finales del tercer trimestre de 2024.
2. El Comité de Revisión de Seguridad recomendó la continuación del ensayo sin eventos adversos graves observados.
3. Resultados financieros del segundo trimestre de 2024: Ingresos de 90,000 dólares, pérdida neta de 7,6 millones de dólares (0,10 dólares por acción).
4. Posición de efectivo de 29,4 millones de dólares, previsto para financiar operaciones hasta el tercer trimestre de 2025.
5. Avances en la comercialización de XIPERE y resultados positivos del ensayo de fase 3 de su socio Arctic Vision en China.
6. Progresos en la plataforma de entrega suprachoroidea y en asociaciones.
클리어사이드 바이오메디컬(Clearside Biomedical) (Nasdaq: CLSD)는 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. 습성 황반변성(AMD) 치료를 위한 CLS-AX의 ODYSSEY 2b 시험이 순조롭게 진행 중이며, 2024년 3분기 말에 주요 데이터가 예상됩니다.
2. 안전성 검토 위원회가 심각한 부작용이 관찰되지 않은 채 시험의 지속을 추천했습니다.
3. 2024년 2분기 재무 결과: 수익 90,000달러, 순손실 760만 달러(주당 0.10달러).
4. 2940만 달러의 현금 보유액이 있으며, 2025년 3분기까지 운영자금으로 사용될 것으로 예상됩니다.
5. XIPERE 상용화와 중국에서 파트너 Arctic Vision의 3상 시험 결과가 긍정적입니다.
6. 맥락막 상측 전달 플랫폼 및 파트너십의 진전을 이루었습니다.
Clearside Biomedical (Nasdaq: CLSD) a publié les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour sur l'entreprise. Les points clés comprennent :
1. L'essai ODYSSEY de phase 2b pour CLS-AX dans la DMLA humide est en bonne voie, avec des données préliminaires attendues à la fin du troisième trimestre 2024.
2. Le Comité de révision de la sécurité a recommandé de poursuivre l'essai, aucun événement indésirable grave n'ayant été observé.
3. Résultats financiers du deuxième trimestre 2024 : Revenus de 90 000 dollars, perte nette de 7,6 millions de dollars (0,10 dollar par action).
4. Position de liquidités de 29,4 millions de dollars, prévue pour financer les opérations jusqu'au troisième trimestre 2025.
5. Progrès dans la commercialisation de XIPERE et résultats positifs de l'essai de phase 3 du partenaire Arctic Vision en Chine.
6. Progrès dans la plateforme de délivrance suprachoroïdale et dans les partenariats.
Clearside Biomedical (Nasdaq: CLSD) hat die finanziellen Ergebnisse des zweiten Quartals 2024 bekannt gegeben und ein Unternehmensupdate bereitgestellt. Zu den wichtigsten Punkten gehören:
1. Die ODYSSEY-Studie der Phase 2b für CLS-AX bei feuchter AMD verläuft planmäßig, mit ersten Ergebnissen, die für Ende Q3 2024 erwartet werden.
2. Das Sicherheitsüberprüfungskomitee empfahl die Fortsetzung der Studie, da keine schwerwiegenden unerwünschten Ereignisse beobachtet wurden.
3. Ergebnisse für das zweite Quartal 2024: Einnahmen von 90.000 US-Dollar, Nettoverlust von 7,6 Millionen US-Dollar (0,10 US-Dollar pro Aktie).
4. Liquiditätsposition von 29,4 Millionen US-Dollar, voraussichtlich zur Finanzierung der Betriebe bis zum dritten Quartal 2025.
5. Fortschritte bei der Kommerzialisierung von XIPERE und positive Ergebnisse aus der Phase-3-Studie des Partners Arctic Vision in China.
6. Fortschritte bei der suprachoroidalen Abgab plattform und Partnerschaften.
- Phase 2b ODYSSEY trial for CLS-AX in wet AMD progressing on schedule
- Safety Review Committee recommended trial continuation with no serious adverse events
- XIPERE showing excellent durability in real-world use with 87.7% of eyes not requiring additional treatment for 6 months
- Partner Arctic Vision reported positive Phase 3 results for XIPERE (ARCATUS) in China
- NDAs for ARCATUS accepted for review in Australia and Singapore
- Publication of consensus guidelines for suprachoroidal drug delivery in RETINA journal
- Gene therapy partner REGENXBIO advancing programs using Clearside's SCS Microinjector
- Revenue decreased from $1.0 million in Q2 2023 to $90,000 in Q2 2024
- Net loss of $7.6 million in Q2 2024
- Cash position of $29.4 million only expected to fund operations into Q3 2025
Insights
Clearside Biomedical's Q2 2024 results show a mixed financial picture. Revenue decreased to
The company's cash position of
Investors should note the positive developments in partnerships, particularly Arctic Vision's progress in Asia-Pacific markets, which could lead to future revenue streams. However, the current financial situation suggests Clearside may need additional funding in the near future to support its pipeline development and potential commercialization efforts.
The progress of Clearside's Phase 2b ODYSSEY trial for CLS-AX in wet AMD is encouraging. The Safety Review Committee's recommendation to continue the trial without modification, noting no drug-related Serious Adverse Events, is a positive signal for the drug's safety profile. The completion of six months of treatment, including re-dosing, is a critical milestone that will provide valuable data for evaluating CLS-AX's efficacy in this chronic condition.
The real-world data from XIPERE, showing
The addition of Dr. Glenn Yiu to the Scientific Advisory Board brings valuable expertise in retinal diseases and ocular imaging technologies, which could enhance Clearside's research capabilities. Overall, these developments strengthen the company's position in the ophthalmology space and support the potential of its suprachoroidal delivery platform.
- Phase 2b ODYSSEY Trial in Wet AMD Remains on Track with Topline Data Expected in Late Q3 2024 -
- ODYSSEY Safety Review Committee Recommends Trial Continue as Planned with no Serious Adverse Events Observed -
- Recent Key Opinion Leader Webinar Highlighted the Broad Applicability and Real-World Experience of Suprachoroidal Drug Delivery -
ALPHARETTA, Ga., Aug. 12, 2024 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2024, and provided a corporate update.
“Our Phase 2b ODYSSEY clinical trial utilizing CLS-AX (axitinib injectable suspension) in patients with wet AMD continues to advance on track and on time with topline data expected in late Q3 2024,” said George Lasezkay, PharmD, JD, President and Chief Executive Officer. “In July, the Safety Review Committee reviewed masked safety data and noted that there have been no drug-related Serious Adverse Events (SAEs), including no endophthalmitis or retinal vasculitis, and recommended the trial continue as planned without modifying the protocol. Both arms of the ODYSSEY trial have completed six months of treatment, with CLS-AX being re-dosed per protocol in the CLS-AX arm. Re-dosing with CLS-AX is an important and differentiating feature of the ODYSSEY trial, and the re-dosing data will be valuable as we evaluate the effects of CLS-AX in this chronic disease and plan our Phase 3 clinical development program.”
Dr. Lasezkay continued, “Several noteworthy events have also occurred featuring our commercial product, XIPERE®1, for the treatment of patients with macular edema associated with uveitis. Most importantly, our Asia-Pacific partner, Arctic Vision, reported positive results from their Phase 3 trial for XIPERE, known as ARCATUS in China, and announced that new drug applications (NDAs) for ARCATUS have been accepted for review in Australia and Singapore. In addition, data presented on the real-world use of XIPERE in the United States has shown the product has excellent durability as
“In May 2024, consensus guidelines for drug delivery by suprachoroidal administration, co-authored by 16 practicing retinal physicians, were published in the prominent journal, RETINA®. The article describes the physicians’ best practices for injection into the suprachoroidal space. These valuable guidelines, combined with our progress with CLS-AX and the promising real-world and Phase 3 data from XIPERE continue to demonstrate the advantages of suprachoroidal administration utilizing our proprietary SCS Microinjector® to deliver therapies to the back of the eye for the treatment of a variety of retinal diseases,” concluded, Dr. Lasezkay,
Key Highlights
- Topline data expected in late third quarter of 2024 from Phase 2b ODYSSEY clinical trial of CLS-AX using suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD).
- Clearside’s Asia-Pacific partner, Arctic Vision, reported positive topline results from its Phase 3 clinical trial of ARCATUS® for the treatment of uveitic macular edema in China and announced that NDAs for ARCATUS have been officially accepted in Australia and Singapore.
- Clearside hosted its Suprachoroidal Delivery Key Opinion Leader webinar highlighting broad applicability and real-world experience with suprachoroidal drug delivery and SCS development opportunities, including wet AMD and geographic atrophy. The replay of this event is available on the Clearside website under the Investors section: Events and Presentations.
- Ophthalmology Science published an article summarizing safety and tolerability data from OASIS, Clearside’s Phase 1/2a Open-Label, Dose-Escalation trial of CLS-AX (axitinib injectable suspension) in wet AMD. The full publication can be accessed here.
- RETINA®, The Journal of Retinal and Vitreous Diseases published consensus guidelines for drug delivery via Suprachoroidal Space (SCS®) injection. The full publication can be accessed here.
- Clearside’s gene therapy partner, REGENXBIO, reported progress on their ABBV-RGX-314 programs delivered via suprachoroidal injection with Clearside’s SCS Microinjector®. REGENEXBIO announced that they expect to initiate a global pivotal trial in the first half of 2025 for the treatment of diabetic retinopathy, and that their Phase 2 ALTITUDE® trial is now enrolling a new cohort of patients with center-involved diabetic macular edema (DME). In addition, REGENEXBIO announced their AAVIATE® Phase 2 trial in wet AMD is initiating enrollment in a new cohort at dose level 4.3
- Multiple data presentations on the use of Clearside’s suprachoroidal delivery platform were featured at prominent medical meetings, including the Association for Research in Vision and Ophthalmology (ARVO), Clinical Trials at the Summit and Retinal Imaging Biomarkers and Endpoints Summit.
- Glenn Yiu, MD, PhD, Professor of Ophthalmology at the University of California, Davis, was appointed to Clearside’s Scientific Advisory Board (SAB) in July 2024. Dr. Yiu, a board-certified vitreoretinal surgeon, leads the translational research program at UC Davis studying AMD and other retinal diseases, with focus on ocular imaging technologies, gene editing and delivery, and animal models of retinal disease.
- Tony Gibney was appointed to Clearside’s Board of Directors in April 2024. Mr. Gibney is an experienced biotechnology executive and former investment banker who brings over 25 years of experience dedicated to advising biotechnology companies on business strategy, collaborations, financings, and mergers and acquisitions.
Second Quarter 2024 Financial Results
- License and other revenue for the second quarter of 2024 was
$90,000 , compared to$1.0 million for the second quarter of 2023. The revenue primarily related to payments pursuant to Clearside’s license agreements and revenue for services and the sales of SCS Microinjector kits to licensees. - Research and development expenses for the second quarter of 2024 were
$4.6 million , compared to$4.9 million for the second quarter of 2023. The decrease was primarily related to the CLS-AX program ($0.2 million ), development of the SCS Microinjector ($0.2 million ), and preclinical work ($0.1 million ). This was partially offset by a$0.2 million increase in employee related costs. - General and administrative expenses remained constant at
$3.1 million in the second quarter of 2024 and 2023. - Interest income for the second quarter of 2024 was
$0.4 million compared to$0.5 million for the second quarter of 2023. The decrease was due to the lower balance of cash, cash equivalents and short-term investments. - Other income for the second quarter of 2024 was
$1.9 million , compared to$0 for the second quarter of 2023. Other income for the second quarter of 2024 was due to the change in fair value of the warrant liabilities from the prior March 31, 2024 valuation date. - Non-cash interest expense remained constant at
$2.3 million in the second quarter of 2024 and 2023. 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 for the second quarter of 2024 was
$7.6 million , or$0.10 per share of common stock, compared to net loss of$9.1 million , or$0.15 per share of common stock, for the second quarter of 2023. - As of June 30, 2024, Clearside’s cash, cash equivalents and short-term investments totaled
$29.4 million . The Company believes it will have sufficient resources to fund its planned operations into the third quarter of 2025.
Additional Information
In lieu of a second quarter 2024 conference call, the Company hosted a Suprachoroidal Delivery Key Opinion Leader Webinar on Wednesday, July 24, 2024. The replay of this event is available on the Clearside website under the Investors section: Events and Presentations. Quarterly earnings conference calls are expected to resume with the third quarter 2024 financial results.
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 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 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.
1XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use is being commercialized by Bausch + Lomb who has the exclusive license for the commercialization and development of XIPERE in the United States and Canada. Arctic Vision has the exclusive license for the commercialization and development of XIPERE, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. XIPERE was approved by the U.S. Food and Drug Administration in October 2021 and is commercially available in the U.S. A link to the full prescribing information is available at https://www.xipere.com/hcp/#isi.
2Yiu, Glen, “Suprachoroidal Drug Delivery in the Real World”, Clinical Trials at the Summit Meeting, June 2024
3ALTITUDE® and AAVIATE® are registered trademarks of REGENXBIO, Inc.
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 June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| License and other revenue | $ | 90 | $ | 1,018 | $ | 320 | $ | 1,022 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | — | 213 | — | 213 | ||||||||||||
| Research and development | 4,603 | 4,948 | 10,218 | 9,399 | ||||||||||||
| General and administrative | 3,077 | 3,127 | 5,901 | 6,285 | ||||||||||||
| Total operating expenses | 7,680 | 8,288 | 16,119 | 15,897 | ||||||||||||
| Loss from operations | (7,590 | ) | (7,270 | ) | (15,799 | ) | (14,875 | ) | ||||||||
| Interest income | 419 | 458 | 767 | 950 | ||||||||||||
| Other income, net | 1,917 | — | 418 | — | ||||||||||||
| Non-cash interest expense on liability related to the sales of future royalties | (2,340 | ) | (2,294 | ) | (4,743 | ) | (4,461 | ) | ||||||||
| Net loss | $ | (7,594 | ) | $ | (9,106 | ) | $ | (19,357 | ) | $ | (18,386 | ) | ||||
| Net loss per share of common stock — basic and diluted | $ | (0.10 | ) | $ | (0.15 | ) | $ | (0.27 | ) | $ | (0.30 | ) | ||||
| Weighted average shares outstanding — basic and diluted | 74,731,139 | 61,654,520 | 72,292,183 | 61,413,343 | ||||||||||||
| Balance Sheet Data | June 30, | December 31, | |||||
| 2024 | 2023 | ||||||
| Cash and cash equivalents | $ | 18,238 | $ | 28,920 | |||
| Short-term investments | 11,122 | — | |||||
| Total assets | 33,934 | 34,018 | |||||
| Liabilities related to the sales of future royalties, net | 46,731 | 41,988 | |||||
| Warrant liabilities | 9,121 | — | |||||
| Total liabilities | 62,219 | 49,930 | |||||
| Total stockholders’ deficit | (28,285 | ) | (15,912 | ) | |||
Source: Clearside Biomedical, Inc.
FAQ
When is Clearside Biomedical (CLSD) expecting topline data from the ODYSSEY trial?
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