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Clearside Biomedical Announces Third Quarter 2024 Financial Results and Provides Corporate Update

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Clearside Biomedical (Nasdaq: CLSD) announced its Q3 2024 financial results and provided a corporate update. Key highlights include the successful completion of the ODYSSEY Phase 2b trial for CLS-AX in wet AMD, achieving all primary and secondary outcomes. The positive results support advancing CLS-AX to Phase 3 with a flexible dosing approach. Clearside also secured a commercial licensing agreement with Santen Pharmaceutical for rights in China, validating its suprachoroidal platform. Financially, Clearside reported a Q3 2024 net loss of $7.7 million, or $0.10 per share, compared to a $9.3 million net loss in Q3 2023. Revenue for Q3 2024 was $1.0 million, up from $0.9 million in Q3 2023. As of September 30, 2024, the company had $23.6 million in cash and equivalents, sufficient to fund operations into Q3 2025. The webcast and conference call are scheduled for today at 4:30 PM ET.

Clearside Biomedical (Nasdaq: CLSD) ha annunciato i risultati finanziari per il terzo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono il completamento con successo del trial ODYSSEY di fase 2b per CLS-AX nell'AMD umida, raggiungendo tutti gli obiettivi primari e secondari. I risultati positivi supportano l'avanzamento di CLS-AX alla fase 3 con un approccio di dosaggio flessibile. Clearside ha inoltre stipulato un accordo di licenza commerciale con Santen Pharmaceutical per i diritti in Cina, confermando la validità della sua piattaforma suprachoroidale. A livello finanziario, Clearside ha riportato una perdita netta di 7,7 milioni di dollari nel terzo trimestre del 2024, ovvero 0,10 dollari per azione, rispetto a una perdita netta di 9,3 milioni di dollari nel terzo trimestre del 2023. I ricavi per il terzo trimestre del 2024 sono stati di 1,0 milioni di dollari, in aumento rispetto ai 0,9 milioni di dollari del terzo trimestre del 2023. Al 30 settembre 2024, la società possedeva 23,6 milioni di dollari in contante e equivalenti, sufficienti a finanziare le operazioni fino al terzo trimestre del 2025. La diretta streaming e la conferenza telefonica sono programmate per oggi alle 16:30 ET.

Clearside Biomedical (Nasdaq: CLSD) anunció sus resultados financieros para el tercer trimestre de 2024 y proporcionó una actualización corporativa. Los puntos destacados incluyen la finalización exitosa del ensayo ODYSSEY de fase 2b para CLS-AX en AMD húmeda, logrando todos los resultados primarios y secundarios. Los resultados positivos respaldan el avance de CLS-AX a la fase 3 con un enfoque de dosificación flexible. Clearside también aseguró un acuerdo de licencia comercial con Santen Pharmaceutical para los derechos en China, validando su plataforma suprachoroidal. Financieramente, Clearside reportó una pérdida neta de 7,7 millones de dólares en el tercer trimestre de 2024, o 0,10 dólares por acción, en comparación con una pérdida neta de 9,3 millones de dólares en el tercer trimestre de 2023. Los ingresos para el tercer trimestre de 2024 fueron de 1,0 millones de dólares, en comparación con 0,9 millones de dólares en el tercer trimestre de 2023. A fecha del 30 de septiembre de 2024, la compañía tenía 23,6 millones de dólares en efectivo y equivalentes, suficientes para financiar operaciones hasta el tercer trimestre de 2025. La transmisión web y la llamada de conferencia están programadas para hoy a las 4:30 PM ET.

Clearside Biomedical (Nasdaq: CLSD)는 2024년 3분기 재무 결과를 발표하고 회사 업데이트를 제공했습니다. 주요 하이라이트로는 습성 황반변성(Wet AMD) 치료를 위한 CLS-AX의 ODYSSEY 2b 시험을 성공적으로 완료하여 모든 주요 및 부차적 결과를 달성한 것이 포함됩니다. 긍정적인 결과는 CLS-AX를 3상으로 진행하는 데 따른 유연한 투여 접근 방식을 지지합니다. Clearside는 또한 중국에서의 권리를 위한 Santen Pharmaceutical과 상업적 라이선스 계약을 체결하여 그들의 초안막 플랫폼을 검증했습니다. 재무적으로, Clearside는 2024년 3분기에 770만 달러의 순손실을 기록했으며, 주당 0.10달러입니다. 이는 2023년 3분기의 930만 달러 순손실과 비교됩니다. 2024년 3분기 매출은 100만 달러로, 2023년 3분기의 90만 달러에서 증가했습니다. 2024년 9월 30일 기준으로 회사는 2360만 달러의 현금 및 현금성 자산을 보유하고 있으며, 이는 2025년 3분기까지 운영을 지원하기에 충분합니다. 웹캐스트와 컨퍼런스 콜은 오늘 오후 4시 30분(ET)에 예정되어 있습니다.

Clearside Biomedical (Nasdaq: CLSD) a annoncé ses résultats financiers pour le troisième trimestre de 2024 et a fourni une mise à jour de l'entreprise. Les faits saillants incluent l'achèvement réussi de l'essai ODYSSEY de phase 2b pour CLS-AX dans l'AMD humide, atteignant tous les résultats primaires et secondaires. Les résultats positifs soutiennent l'avancement de CLS-AX vers la phase 3 avec une approche de dosage flexible. Clearside a également conclu un accord de licence commerciale avec Santen Pharmaceutical pour les droits en Chine, validant ainsi sa plateforme suprachoroidale. Sur le plan financier, Clearside a rapporté une perte nette de 7,7 millions de dollars au troisième trimestre de 2024, soit 0,10 dollar par action, contre une perte nette de 9,3 millions de dollars au troisième trimestre de 2023. Les revenus pour le troisième trimestre de 2024 s'élevaient à 1,0 million de dollars, contre 0,9 million de dollars au troisième trimestre de 2023. Au 30 septembre 2024, la société avait 23,6 millions de dollars en liquidités et équivalents, suffisants pour financer ses opérations jusqu'au troisième trimestre de 2025. Le webinaire et la conférence téléphonique sont prévus pour aujourd'hui à 16h30 ET.

Clearside Biomedical (Nasdaq: CLSD) hat seine Finanzzahlen für das dritte Quartal 2024 bekannt gegeben und ein Unternehmensupdate bereitgestellt. Zu den wichtigsten Ergebnissen gehört der erfolgreiche Abschluss der ODYSSEY Phase 2b Studie für CLS-AX bei feuchter AMD, bei dem alle primären und sekundären Ziele erreicht wurden. Die positiven Ergebnisse unterstützen den Übergang von CLS-AX zur Phase 3 mit einem flexiblen Dosierungsansatz. Clearside sicherte sich auch einen kommerziellen Lizenzvertrag mit Santen Pharmaceutical für die Rechte in China, was die Gültigkeit seiner suprachoroidalen Plattform bestätigt. Finanzielle Zahlen zeigen, dass Clearside im dritten Quartal 2024 einen Nettoverlust von 7,7 Millionen US-Dollar, beziehungsweise 0,10 US-Dollar pro Aktie, im Vergleich zu einem Nettoverlust von 9,3 Millionen US-Dollar im dritten Quartal 2023 verzeichnete. Der Umsatz für das dritte Quartal 2024 betrug 1,0 Millionen US-Dollar, im Vergleich zu 0,9 Millionen US-Dollar im dritten Quartal 2023. Zum 30. September 2024 hatte das Unternehmen 23,6 Millionen US-Dollar in bar und Äquivalenten, was ausreicht, um die Betriebstätigkeit bis ins dritte Quartal 2025 zu finanzieren. Die Webcast- und Telefonkonferenz sind für heute um 16:30 Uhr ET geplant.

Positive
  • ODYSSEY Phase 2b trial for CLS-AX in wet AMD achieved all primary and secondary outcomes.
  • CLS-AX advancing to Phase 3 with a flexible dosing approach.
  • Commercial licensing agreement with Santen Pharmaceutical for China.
  • Q3 2024 net loss decreased to $7.7 million from $9.3 million in Q3 2023.
  • Revenue increased to $1.0 million from $0.9 million in Q3 2023.
  • Cash and equivalents of $23.6 million, sufficient to fund operations into Q3 2025.
Negative
  • Net loss of $7.7 million in Q3 2024.
  • Increased general and administrative expenses to $2.8 million from $2.6 million in Q3 2023.

Insights

The Q3 results highlight significant financial challenges despite clinical progress. $23.6M cash position only provides runway into Q3 2025, suggesting potential need for additional financing. Net loss of $7.7M ($0.10 per share) shows modest improvement from $9.3M loss year-over-year, primarily due to reduced R&D expenses. Revenue remains minimal at $1.0M, mainly from licensing agreements.

The ODYSSEY trial success and potential Phase 3 advancement represent significant catalysts, particularly in the wet AMD market. The recent Santen-Arctic Vision deal validates the platform technology, potentially leading to future revenue streams. However, the company's burn rate and cash runway warrant careful monitoring.

The ODYSSEY Phase 2b trial results mark a important milestone for CLS-AX in wet AMD treatment. The achievement of both primary and secondary endpoints, coupled with extended duration potential, positions the therapy competitively against current standards of care. The flexible dosing approach (3-6 months) could provide significant advantages over existing treatments requiring more frequent administration.

The expansion into geographic atrophy (GA) represents a strategic move into a $20B market. The suprachoroidal delivery mechanism's ability to target both retinal and choroidal tissue while minimizing side effects could provide a compelling advantage in this space.

- 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., Nov. 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 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

  • The ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD) achieved its primary and secondary outcomes, demonstrated extended duration, stable vision and anatomic measures and a well-tolerated safety profile.
  • Clearside’s Asia-Pacific partner, Arctic Vision, signed a new commercial collaboration with Santen Pharmaceutical Co., Ltd. for commercial rights in China to ARVN001, Arctic Vision’s triamcinolone acetonide injectable suspension for suprachoroidal use, in the treatment of uveitic macular edema (UME) and certain other ophthalmic indications under development. ARVN001 is branded as XIPERE in the U.S. and ARCATUS® in China.
  • Arctic Vision reported positive topline results from its Phase 3 clinical trial of ARCATUS for the treatment of UME in China and announced that New Drug Applications for ARCATUS are under review by regulators in Australia and Singapore.
  • Tony Gibney was appointed Chair of Clearside’s Board of Directors, effective November 1, 2024, succeeding Clay Thorp, who will continue serving as a member of the Board. Mr. Gibney joined Clearside’s Board as an independent director in April 2024 and is an experienced biotechnology executive and former investment banker, most recently serving as Executive Vice President, Chief Business & Strategy Officer, of Iveric Bio, Inc. until the company’s acquisition by Astellas Pharma Inc. in July 2023.
  • Glenn Yiu, MD, PhD, Professor of Ophthalmology at the University of California, Davis, was appointed to Clearside’s Scientific Advisory Board 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 a focus on ocular imaging technologies, gene editing and delivery, and animal models of retinal disease.
  • An article was published titled “Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection for UME: A Physician Survey” by Christopher R. Henry et al. that summarizes physicians’ “real-world” perspectives on early experiences with XIPERE for the treatment of patients with UME. Findings from this survey indicate that the suprachoroidal injection technique was easy to learn (92% found the injection procedure relatively easy post-training) and resulted in favorable patient outcomes consistent with clinical trial data. The full publication can be accessed here.
  • Clearside’s gene therapy partner, REGENXBIO, reported on both of their programs administering ABBV-RGX-314 via Clearside’s SCS Microinjector. Based on positive interim results to date from the Phase 2 ALTITUDE® trial in diabetic retinopathy (DR), AbbVie and REGENXBIO announced that they have accelerated a planned End-of-Phase 2 meeting with the FDA expected this quarter. REGENXBIO expects to initiate the first global pivotal trial in DR in the first half of 2025. In addition, the ALTITUDE trial is enrolling a new cohort of patients with center-involved diabetic macular edema. In wet AMD, based on a favorable safety profile and to evaluate dose levels for a planned pivotal program, the Phase 2 AAVIATE® trial is enrolling a new cohort.
  • In September 2024, Clearside’s ocular oncology partner, Aura Biosciences, presented positive Phase 2 end-of-study results evaluating bel-sar (AU-011) for the first-line treatment of early-stage choroidal melanoma at The Retina Society Annual Meeting. Bel-sar is being administered via Clearside’s SCS Microinjector.
  • Multiple presentations were delivered at the 2024 Annual Meeting of the American Academy of Ophthalmology (AAO) and preceding events that highlighted encouraging safety and efficacy data from clinical trials of therapies utilizing Clearside’s SCS Microinjector to deliver drugs into the suprachoroidal space to treat a variety of retinal diseases.

Third Quarter 2024 Financial Results

  • License and other revenue for the third quarter of 2024 was $1.0 million, compared to $0.9 million for the third 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 third quarter of 2024 were $4.1 million, compared to $5.1 million for the third quarter of 2023. This decrease was primarily due to a $1.9 million decrease in costs related to the CLS-AX program, which was partially offset by increases in employee-related costs and device development and a research and development tax credit received in the prior year.
  • General and administrative expenses were $2.8 million for the third quarter of 2024, compared to $2.6 million for the third quarter of 2023. This increase was primarily due to an increase in patent-related expenses and consulting fees.
  • Net loss for the third quarter of 2024 was $7.7 million, or $0.10 per share of common stock, compared to net loss of $9.3 million, or $0.15 per share of common stock, for the third quarter of 2023.
  • As of September 30, 2024, Clearside’s cash, cash equivalents and short-term investments totaled $23.6 million. The Company believes it will have sufficient resources to fund its planned operations into the third quarter of 2025.

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

  • XIPERE® (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 is approved by the U.S. Food and Drug Administration and is commercially available in the U.S. A link to the full prescribing information is available at https://www.xipere.com/hcp/#isi.
  • Source: IMARC Geographic Atrophy Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034
  • ALTITUDE® 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
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 the sales of future royalties  (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 and diluted $(0.10) $(0.15) $(0.37) $(0.45)
Weighted average shares outstanding — basic and diluted  74,745,415   61,983,987   73,115,896   61,605,648 
                 


      
Balance Sheet DataSeptember 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.


FAQ

What were Clearside Biomedical's Q3 2024 financial results?

Clearside Biomedical reported a net loss of $7.7 million, or $0.10 per share, and revenue of $1.0 million for Q3 2024.

What is the status of the ODYSSEY Phase 2b trial for CLS-AX in wet AMD?

The ODYSSEY Phase 2b trial achieved all primary and secondary outcomes, supporting the advancement of CLS-AX to Phase 3.

What is the significance of the commercial licensing agreement with Santen Pharmaceutical?

The agreement provides commercial rights in China for Clearside's suprachoroidal platform, validating its technology.

How much cash does Clearside Biomedical have as of September 30, 2024?

Clearside Biomedical has $23.6 million in cash, cash equivalents, and short-term investments as of September 30, 2024.

When is Clearside Biomedical's conference call and webcast for Q3 2024 results?

The conference call and webcast are scheduled for today at 4:30 PM ET.

Clearside Biomedical, Inc.

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