Clearside Biomedical, Inc. (CLSD) Business Model Canvas

Clearside Biomedical, Inc. (CLSD): Business Model Canvas [Dec-2025 Updated]

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You're digging into Clearside Biomedical, Inc. right now, and honestly, the story isn't just about their unique Suprachoroidal Space (SCS®) Microinjector® platform; it's about survival and monetization. With only $13.6 million in cash as of March 31, 2025, and burning through about $4.5 million on Research and Development (R&D) in Q1 alone, the clock is ticking. Their whole model hinges on turning their patented delivery tech-which already has XIPERE® out with Bausch + Lomb-into a massive payday, likely through a strategic sale or a major milestone hit with their lead asset, CLS-AX. It's a classic biotech pivot point, and we need to see the whole structure to know if the value is there, defintely. Let's look at the full Business Model Canvas below.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Key Partnerships

You're looking at the core of Clearside Biomedical, Inc.'s (CLSD) strategy: using its patented SCS Microinjector® technology to enable partners to deliver their own drugs to the back of the eye. This platform approach is what drove their revenue, even as they navigated financial challenges leading up to late 2025.

As of the November 2025 Chapter 11 filing announcement, Clearside Biomedical, Inc. confirmed its SCS injection platform was being used in commercial products and clinical development programs by all the key players you listed. The financial performance in early 2025 clearly showed the value derived from these relationships.

For the first quarter ended March 31, 2025, Clearside Biomedical, Inc. reported License and other revenue of $2.3 million, a significant jump from $0.2 million in Q1 2024. This revenue was directly tied to partner activity:

  • The revenue included $1.5 million in milestones from Arctic Vision.
  • An additional $0.8 million came from other revenue sources like training, services, and sales of SCS Microinjector kits to licensees.

The company reported cash and cash equivalents of $13.6 million as of March 31, 2025, which management believed was sufficient to fund operations into the fourth quarter of 2025.

Here is a breakdown of the key licensing and development partnerships that form the backbone of this segment of the business model:

Partner Product/Program Territory/Focus Key 2025 Status/Financial Data
Bausch + Lomb XIPERE® (triamcinolone acetonide injectable suspension) US and Canada commercialization XIPERE® is commercially available in the U.S..
Arctic Vision XIPERE® (branded as ARCATUS® or ARVN001) Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries Received $1.5 million in milestones in Q1 2025. NDA for ARCATUS® accepted for review in China as of February 2025. Approved in Australia and Singapore as of July 2025.
REGENXBIO and AbbVie ABBV-RGX-314 (gene therapy) SCS delivery for Diabetic Retinopathy (DR); also used for wet AMD Planned a global Phase 3 clinical program in DR utilizing the SCS Microinjector® in January 2025. Initial 2021 deal included an upfront payment of $370 million to REGENXBIO.
BioCryst Pharmaceuticals Avoralstat Diabetic Macular Edema (DME) BioCryst initiated its first clinical trial in Australia with avoralstat delivered via SCS Microinjector®; expected initial data in 2025. The deal structure includes up to $82.5 million in total milestones plus tiered royalties.
Aura Biosciences Proprietary anti-tumor agents Ocular cancers, including choroidal melanoma Worldwide licensing agreement for SCS Microinjector® use; eligible for development, regulatory, and sales milestones plus royalties.

The agreements for the SCS Microinjector® technology itself are structured to provide Clearside Biomedical, Inc. with upfront payments, development/regulatory milestones, and ongoing royalties on product sales, which is evident in the Q1 2025 revenue figures.

Specifically regarding the gene therapy programs involving REGENXBIO and its partner AbbVie:

  • REGENXBIO holds exclusive worldwide rights to use the SCS Microinjector® for delivery of adeno-associated virus (AAV)-based gene therapy for wet AMD and diabetic retinopathy.
  • AbbVie and REGENXBIO will share equally in profits from net sales of RGX-314 in the U.S..
  • REGENXBIO is responsible for completing ongoing trials, while AbbVie leads global clinical development and commercialization.

The BioCryst Pharmaceuticals collaboration for avoralstat in DME was set up for Clearside Biomedical, Inc. to receive a $5 million upfront license fee. The potential total consideration, excluding royalties, is substantial, broken down as:

  • Up to an additional $30 million in clinical and regulatory milestone payments.
  • Up to a total of $47.5 million in three post-approval sales-based milestone payments as annual global net sales reach $2 billion.

For the Aura Biosciences deal, the financial structure centers on Clearside Biomedical, Inc. being eligible to receive payments upon reaching pre-specified development, regulatory, and sales milestones, along with royalties on product sales that incorporate the SCS Microinjector®.

Finance: review Q2 2025 partner milestone receipts against cash burn rate by next Tuesday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Key Activities

You're looking at the core actions Clearside Biomedical, Inc. (CLSD) had to take to keep its platform moving, especially given the tough capital markets leading into late 2025. Honestly, the key activities shifted dramatically after the July 2025 announcement.

Developing the internal pipeline, primarily CLS-AX for wet AMD

The internal focus was definitely on advancing CLS-AX, the axitinib injectable suspension for wet AMD, which is a TKI (tyrosine kinase inhibitor) designed for durability. As of the first quarter of 2025, Research and Development (R&D) expenses were $4.5 million, a decrease from $5.6 million in Q1 2024, largely because the ODYSSEY Phase 2b trial was completed. The company was also evaluating preclinical data on two approaches targeting Geographic Atrophy (GA).

Here's a look at the pipeline focus:

  • CLS-AX for wet AMD: Lead program, Phase 3 planning underway as of July 2025.
  • Geographic Atrophy (GA): Evaluating preclinical data on improving choroidal perfusion and modulating pro-inflammatory cells.
  • Diabetic Macular Edema (DME): Evaluating preclinical data on the combination of a steroid plus a TKI (axitinib formulation).

Managing and supporting global licensing and collaboration agreements

Managing the external partnerships was a major revenue driver, especially as internal funding became constrained. License and other revenue for the first quarter of 2025 hit $2.3 million, a big jump from $0.2 million in Q1 2024. This revenue included $1.5 million in milestones from Arctic Vision and $0.8 million from training, services, and SCS Microinjector kit sales to licensees.

Clearside Biomedical, Inc. supported five commercial and late-stage development suprachoroidal licensing collaborations as of early 2025. These partners use the SCS injection platform with their own therapeutic agents.

Partner Therapeutic/Product Status/Activity (as of Q1 2025)
Arctic Vision (partner Santen) ARCATUS® (XIPERE® equivalent) NDA accepted for review in China; Approved in Australia and Singapore.
BioCryst Pharmaceuticals Avoralstat (for DME) Received authorization to start clinical trials in Australia; Initial data expected in 2025.
REGENXBIO (partner AbbVie) Gene therapies Utilizing the SCS Microinjector platform.
Aura Biosciences Anti-tumor agents Utilizing the SCS Microinjector platform.
Bausch + Lomb Various Utilizing the SCS Microinjector platform.

Manufacturing and quality control of the proprietary SCS Microinjector®

The SCS Microinjector® itself is a core asset, representing the proven delivery system. Clearside Biomedical, Inc. maintained commercial scale manufacturing capability for this device, which includes ISO certification (specifically EN ISO 13485:2016). The platform is validated by its use in the first FDA-approved product for suprachoroidal use, XIPERE®. To date, thousands of suprachoroidal injections have been performed, with over 15,000 injections cited as of early 2025.

Conducting Phase 3-ready clinical trials and regulatory filings

The company achieved a significant milestone by completing a successful End-of-Phase 2 meeting with the FDA, resulting in alignment on the Phase 3 program design for CLS-AX in wet AMD. The plan targeted a commercially attractive profile with a flexible three-to-six-month maintenance dosing label. Management confirmed plans for two pivotal Phase 3 trials for CLS-AX, aiming for treatment initiation in the second half of 2025. Each trial is designed to compare CLS-AX 1mg against aflibercept 2mg.

Regulatory progress on partner products also falls here:

  • ARCATUS® (XIPERE®): NDA under regulatory review in China and Canada as of July 2025.
  • XIPERE® (Uveitic Macular Edema): Approved in Australia and Singapore.

Exploring strategic alternatives, including a potential sale of the business

This became the overriding key activity in the second half of 2025. On July 17, 2025, Clearside Biomedical, Inc. announced it retained Piper Sandler to explore a full range of strategic alternatives to maximize stockholder value. These alternatives included the sale, license, monetization, divestiture of assets, partnership, merger, acquisition, or joint ventures. To conserve cash, all internal R&D programs were paused, and all employees, including the CEO, CFO, and CMO, transitioned into consulting roles that same week in July 2025. The workforce reduction was projected to incur charges of approximately $3.4 million in the third quarter of 2025. By November 24, 2025, the company filed a voluntary petition under Chapter 11 of the U.S. Bankruptcy Code to pursue an auction and sale process under Section 363 of the U.S. Bankruptcy Code.

The cash position as of March 31, 2025, was $13.6 million, which the company believed was sufficient to fund operations into the fourth quarter of 2025, but the strategic review was initiated to address this limited runway.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Key Resources

You're looking at the core assets Clearside Biomedical, Inc. (CLSD) relies on to execute its strategy as of late 2025. These aren't just concepts; they are tangible and proprietary elements that anchor their value proposition in the back-of-the-eye drug delivery space.

The foundation of Clearside Biomedical, Inc.'s resources is definitely its Patented Suprachoroidal Space (SCS®) Microinjector® technology. This is the delivery mechanism that allows for targeted, in-office, repeatable, non-surgical drug administration to the macula, retina, or choroid. This patented platform is the engine for their entire pipeline and partnership strategy.

This technology is backed by an Extensive intellectual property portfolio covering SCS drug delivery. While I don't have a specific count of patents, the strength of this portfolio is evidenced by its use across multiple collaborations. Clearside Biomedical, Inc. strategically partners this SCS injection platform with companies developing other ophthalmic therapeutic innovations.

A critical internal resource is the Formulation expertise for suprachoroidal drug suspensions. This expertise is necessary to create the proprietary suspensions that allow for longer-acting therapy delivery via the SCS Microinjector®.

The lead asset leveraging these resources is CLS-AX (axitinib injectable suspension), a Phase 3-ready asset. Following a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the company has alignment on the proposed Phase 3 program for wet Age-related Macular Degeneration (AMD). This asset is positioned to potentially offer a best-in-class product profile with flexible maintenance dosing every three-to-six months.

Here are the concrete details of the proposed Phase 3 program for CLS-AX, which you need to factor into any near-term valuation assessment:

Trial Component Specification
Number of Trials Two concurrent, pivotal non-inferiority trials
Primary Endpoint Average change in best-corrected visual acuity (BCVA) from baseline at Week 52
Arms per Trial 2 arms per trial
Comparison Group CLS-AX (1 mg) to aflibercept (2 mg)
Patient Population Treatment-naïve participants
Safety Follow-up One-year safety follow up period

Finally, the immediate financial resource supporting these efforts is the balance sheet strength as of the first quarter. As of March 31, 2025, Clearside Biomedical, Inc. reported Cash and equivalents of $13.6 million. Honestly, the management stated this level of cash was believed to be sufficient to fund planned operations into the fourth quarter of 2025.

To summarize the operational implications of these resources, consider what they enable:

  • Targeted drug delivery behind the retina.
  • Potential for a three-to-six month flexible maintenance dosing label for CLS-AX.
  • Commercial product (XIPERE®) approved in the U.S. via a commercial partner.
  • Development of other pipeline candidates, like those for geographic atrophy (GA).
  • Partnerships advancing programs, such as BioCryst Pharmaceuticals' DME program.

Finance: draft 13-week cash view by Friday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Value Propositions

You're looking at the core value Clearside Biomedical, Inc. delivers through its proprietary suprachoroidal space (SCS®) delivery platform. This isn't just about a new drug; it's about a fundamentally different way to get medicine where it needs to go in the eye, which changes the treatment dynamic for patients and practices.

Targeted, Compartmentalized Drug Delivery to the Macula and Retina

The primary value is achieving unprecedented access to the back of the eye where sight-threatening diseases take hold. This approach is designed for targeted and compartmentalized delivery, meaning the drug goes right to the macula and retina, potentially minimizing harm to surrounding healthy tissue. For preclinical programs targeting Geographic Atrophy (GA), this delivery method allows for comprehensive drug coverage of both the retina and choroid.

Non-Surgical, Repeatable, In-Office Procedure Using the SCS Microinjector®

The delivery mechanism itself is a key value driver. Clearside Biomedical's patented SCS Microinjector® facilitates an in-office, repeatable, non-surgical procedure. This contrasts with more invasive methods, offering a better experience for the patient and better resource management for the clinic. The platform has seen significant use, with thousands of suprachoroidal injections performed across various retinal disorders. Furthermore, the physical device is designed for ease of use, with the needle size being equivalent to most commonly used intravitreal injections.

The commercialization of the platform is evidenced by revenue generation through partners:

Metric Value (Q1 2025)
License and Other Revenue (from partners) $2.3 million
SCS Microinjector Kit Sales/Training Revenue Component $0.8 million
R&D Expenses (Reflecting platform advancement) $4.5 million

Potential for Longer-Lasting Treatment Durability (e.g., CLS-AX)

The suprachoroidal space allows for drug retention that can extend treatment intervals, directly addressing the high treatment burden of current standards of care. This is best illustrated by the data from the CLS-AX ODYSSEY Phase 2b trial for wet Age-related Macular Degeneration (AMD).

  • 67% of CLS-AX participants did not require aflibercept rescue or CLS-AX re-dosing for 6 months after the initial dose.
  • 100% of CLS-AX participants showed intervention-free rates up to 3 months.
  • Injection frequency was reduced by approximately 84% compared to the average monthly injections in the 24 weeks prior to screening for CLS-AX.
  • The planned Phase 3 program for CLS-AX is targeting a flexible three-to-six-month dosing label.

This potential durability is a major shift; current standard anti-VEGF therapies often require monthly or bi-monthly injections. The company's Q3 2025 trailing twelve-month net loss was $34.35 million, underscoring the capital required to bring these longer-acting candidates to market.

Platform Flexibility for Small Molecules, Biologics, and Gene Therapies

The SCS Microinjector® is inherently flexible, designed to deliver a wide variety of drug candidates, not just one specific type. This versatility is validated by the number of external collaborations utilizing the platform:

  • Small Molecules: BioCryst Pharmaceuticals is using it for avoralstat in diabetic macular edema (DME), with initial data expected in 2025.
  • Biologics/Gene Therapies: REGENXBIO and AbbVie are planning a Phase 3 program for sura-vec (ABBV-RGX-314) for diabetic retinopathy using suprachoroidal delivery.
  • Other Agents: The platform is being used in commercial products and clinical programs for anti-tumor agents.

This platform approach means Clearside Biomedical, Inc. can generate revenue through milestone payments, such as the $1.5 million in milestones received from Arctic Vision in Q1 2025, and through the sale of SCS Microinjector kits to licensees.

First FDA-Approved Product (XIPERE®) for Suprachoroidal Use

XIPERE® (triamcinolone acetonide injectable suspension) represents the platform's first commercial validation, being the first FDA approved therapeutic delivered into the suprachoroidal space. This established use provides a benchmark for safety and procedure adoption. To facilitate adoption, a new permanent Category 1 CPT code for XIPERE® for suprachoroidal use became effective on January 1, 2024. Real-world data for XIPERE® showed excellent durability, with more than 75% of eyes not requiring retreatment for 6 months after a single dose. Furthermore, partner Arctic Vision saw its NDA for ARCATUS® (XIPERE® in China) accepted for review in China as of Q1 2025.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Customer Relationships

High-touch, strategic B2B relationships with pharmaceutical licensees

Clearside Biomedical, Inc. maintains relationships with key industry players who utilize the proprietary SCS Microinjector® platform for their own drug candidates. As of late 2025, the Company anchored its platform with five commercial and late-stage development suprachoroidal licensing collaborations. These strategic partners include Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen.

The commercial success of partner products drives direct revenue through license fees. For the first quarter ended March 31, 2025, License and other revenue reached $2.3 million, a significant increase from $0.2 million in the first quarter of 2024. This revenue stream directly impacted the bottom line, contributing to a reduction in net loss to $8.2 million in Q1 2025 from $11.8 million in Q1 2024.

Progress within these partnerships is a key relationship metric:

  • ARCATUS® (XIPERE® in the U.S.) is approved in both Australia and Singapore.
  • The New Drug Application (NDA) for ARCATUS® in China was accepted for regulatory review, with Arctic Vision responsible for clinical development there.
  • BioCryst Pharmaceuticals is advancing its diabetic macula edema program, with initial data from DME patients expected in 2025.
  • REGENXBIO and AbbVie announced plans to initiate a Phase 3 clinical program for sura-vec (ABBV-RGX-314) using suprachoroidal delivery for diabetic retinopathy.

Clinical support and training for retinal specialists using the SCS Microinjector®

The SCS Microinjector® itself is a core relationship touchpoint, representing a proven in-office, repeatable, non-surgical procedure for targeted delivery. The platform's validation is demonstrated through its presence at major scientific forums, which serves as indirect support and education for the specialist community. In 2025, the use of the SCS delivery platform was featured in Over 15 Presentations at Major Ophthalmic Medical Meetings. Specifically, six presentations occurred at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting.

The SCS Microinjector® is used in commercial products and development programs targeting various indications:

Product/Program Indication Status/Partner
XIPERE® (triamcinolone acetonide injectable suspension) Uveitic Macular Edema Commercialized by Bausch + Lomb in the U.S.
ARCATUS™ (triamcinolone acetonide injectable suspension) Uveitic Macular Edema Approved in Australia and Singapore; under review in China.
ABBV-RGX-314 Diabetic Retinopathy/Wet AMD Phase 3 program planned with REGENXBIO/AbbVie.
Avoralstat Diabetic Macular Edema (DME) Clinical trial initiated in Australia with BioCryst Pharmaceuticals.

Investor relations focused on pipeline progress and strategic value

Investor communications center on advancing the pipeline, particularly the lead asset, CLS-AX, and the platform's overall validation. The Company reported its Q1 2025 financial results on May 14, 2025, though it did not host a conference call that quarter. As of March 31, 2025, Clearside Biomedical's cash and cash equivalents totaled $13.6 million, with management believing this was sufficient to fund planned operations into the fourth quarter of 2025.

Key financial and operational data points communicated to investors included:

  • Q1 2025 Net Loss: $8.2 million (or $0.11 per share).
  • Q1 2024 Net Loss: $11.8 million (or $0.17 per share).
  • R&D expenses for Q1 2025 were $4.5 million, down from $5.6 million in Q1 2024.
  • General and administrative expenses remained constant at $2.8 million for Q1 2025 and Q1 2024.

Regulatory engagement with agencies like the FDA for CLS-AX Phase 3 alignment

A critical recent milestone involved regulatory alignment for the lead internal asset, CLS-AX, targeting the $12+ billion wet AMD market. Clearside Biomedical announced a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), confirming alignment on the Phase 3 program design in March 2025. This alignment supports a flexible maintenance dosing label for CLS-AX for every 3 to 6 months as needed.

The proposed pivotal Phase 3 program includes:

  • Two concurrent, pivotal non-inferiority trials.
  • Each trial will have 2 arms, comparing CLS-AX (1 mg) to aflibercept (2 mg).
  • Approximately ~225 participants per arm are planned for enrollment.
  • Primary endpoint is average change in best corrected visual acuity (BCVA) from baseline at Week 52.

The Company also developed a streamlined Phase 2b/3 clinical trial design for CLS-AX in diabetic retinopathy.

Seeking new partners to fund and maximize program value

Following the FDA alignment and in light of the cash runway extending into the fourth quarter of 2025, Clearside Biomedical announced on July 17, 2025, plans to explore a full range of strategic alternatives to maximize stockholder value. This process is designed to advance the SCS platform and pipeline, which includes the Phase 3-ready CLS-AX asset and IND-ready programs for Geographic Atrophy (GA) and Diabetic Macula Edema. The Company retained Piper Sandler, a leading investment bank, to support this strategic evaluation process. Alternatives under consideration include the sale, license, monetization, and/or divestiture of one or more assets, or other strategic transactions like a merger or joint venture.

The company's financial standing as of March 31, 2025, was $13.6 million in cash and cash equivalents. The exploration of strategic alternatives was a direct response to the need to fund future operations beyond the projected Q4 2025 cash runway.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Channels

You're looking at the distribution and outreach methods for Clearside Biomedical, Inc. as of late 2025. This is heavily weighted toward partnerships, which is typical for a platform technology company, though the November 2025 Chapter 11 filing adds a layer of complexity regarding future commercialization rights.

The channels rely on leveraging third-party infrastructure for market access, supplemented by direct engagement for platform validation and device sales to those partners.

Out-licensing Agreements and Partner Reach

Clearside Biomedical's primary channel for getting its technology into the market is through out-licensing agreements. As of July 2025, the company reported having five commercial and late-stage development suprachoroidal licensing collaborations. These agreements extend the reach of the SCS Microinjector® platform globally.

The financial flow from these channels was evident in Q1 2025, where License and other revenue reached $2.3 million, a significant jump from $0.2 million in Q1 2024. This Q1 2025 revenue included $1.5 million in milestones from Arctic Vision alone. For the BioCryst Pharmaceuticals collaboration, Clearside Biomedical is eligible to receive tiered mid-single digit royalties on annual global net product sales. However, as of the November 24, 2025, Chapter 11 filing, rights linked to a royalty sub with a $106.5M revenue cap were listed as a key asset intended for sale via a Section 363 auction.

Direct Sales of the SCS Microinjector® Kits

The proprietary SCS Microinjector® device itself is a channel component, sold directly to licensees for their clinical and commercial use. In Q1 2025, revenue attributed to training, services, and the sales of SCS Microinjector kits to licensees was $0.8 million. The platform has a history of clinical use, with well over 10,000 injections performed to date with the patented device. Furthermore, Clearside Biomedical maintains commercial scale manufacturing capability for the SCS Microinjector, which includes ISO certification and CE mark certification.

Commercial Partner Sales Force for XIPERE®

The commercialization of XIPERE® (triamcinolone acetonide injectable suspension) relies on the established sales forces of its partners. Bausch + Lomb holds the exclusive license for commercialization and development in the United States and Canada, where XIPERE® is approved. Arctic Vision handles commercialization in Greater China (as ARCATUS®), South Korea, Australia, New Zealand, India, and the ASEAN Countries. XIPERE® is approved in the U.S., Canada, Australia, and Singapore.

Partner/Region Product/License Scope Approval Status (as of late 2025)
Bausch + Lomb (U.S. & Canada) XIPERE® Commercialization/Development Approved in U.S. and Canada
Arctic Vision (Asia-Pacific) XIPERE® (ARCATUS®) Commercialization/Development Approved in Australia, Singapore; NDA under review in China
BioCryst Pharmaceuticals SCS Microinjector for avoralstat (DME) First clinical trial in Australia authorized to initiate in 2025

Clinical Trial Sites and Key Opinion Leaders (KOLs)

Clinical trial sites serve as crucial early channels for platform validation and data generation. The CLS-AX ODYSSEY trial, evaluating suprachoroidal CLS-AX for wet AMD, was a multicenter, 36-week trial. KOLs are engaged to present data and shape adoption. For example, data from the ODYSSEY trial was presented by Roger Goldberg, MD, MBA, of Bay Area Retinal Associates Medical Group. Victor Chong, MD, MBA, the company's Chief Medical Officer, is also a key figure in presenting platform advancements.

Medical Conferences and Scientific Publications

Scientific dissemination is a key channel for establishing the credibility of the SCS Microinjector® platform. In 2025, Clearside Biomedical highlighted its technology through numerous presentations. The company featured six presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. Other prominent venues in 2025 included the Angiogenesis, Exudation, and Degeneration meeting, Retina Unplugged, and the Macula Society Annual Meeting. The platform's advancements were also set to be featured at the 25th EURETINA Congress in September 2025.

  • Presentations at ARVO 2025: 6
  • Total known 2025 medical meetings featuring data: 8 (ARVO + 7 others)
  • EURETINA Congress 2025 dates: September 4 - 7

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Customer Segments

You're looking at the customer landscape for Clearside Biomedical, Inc. as of late 2025. Given the Chapter 11 filing in November 2025, the immediate focus shifts to asset monetization, but the underlying customer base for the platform technology remains the foundation.

Global pharmaceutical and biotech companies seeking novel ocular delivery

These partners license the SCS platform for their own therapeutic agents. As of July 2025, Clearside Biomedical had five commercial and late-stage development suprachoroidal licensing collaborations anchored to the SCS Microinjector platform. Specific partners utilizing the SCS Microinjector in commercial products or clinical development programs include Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO (with its global partner AbbVie), and Arctic Vision (with its commercial partner Santen). For instance, BioCryst Pharmaceuticals is advancing its diabetic macular edema program using the SCS Microinjector, with initial data expected in 2025. Revenue from these partners was a key component of the Q1 2025 results, with license fees contributing $1.5 million in milestones from Arctic Vision and other revenue streams totaling $0.8 million.

Retinal specialists and ophthalmologists performing in-office injections

This segment comprises the clinical users of the SCS Microinjector for repeatable, non-surgical delivery. The company's expertise in this area is evidenced by the fact that over 15,000 injections have been completed to date using the clinically validated suprachoroidal injection training program with the SCS Microinjector. The platform supports the delivery of Clearside's own pipeline, such as CLS-AX, which is designed for a flexible three-to-six month dosing label, aiming to fit seamlessly into physician practices. The approved product, XIPERE (triamcinolone acetonide injectable suspension), is available in the U.S. through a commercial partner for treating macular edema associated with uveitis.

Patients with sight-threatening back-of-the-eye diseases (e.g., wet AMD, uveitis)

These are the ultimate beneficiaries of the technology, suffering from conditions like neovascular age-related macular degeneration (wet AMD), uveitic macular edema (UME), and geographic atrophy (GA). Clearside's lead internal program, CLS-AX, targets wet AMD and is Phase 3-ready following alignment with the FDA on the pivotal trial program. The company is also evaluating small molecules for the potential long-acting treatment of geographic atrophy (GA). The commercial product, XIPERE, treats macular edema associated with uveitis, and its Asia-Pacific version, ARCATUS, is approved in Australia and Singapore.

Investors and potential acquirers interested in platform technology monetization

This segment became acutely relevant in late 2025. On November 24, 2025, Clearside Biomedical filed for voluntary Chapter 11 bankruptcy to pursue an auction and sale process of its assets. The company retained Piper Sandler to support the strategic evaluation process, which considers the sale, license, or divestiture of assets. Financially, the company reported a net loss of $19.36 million for Q2 2025, translating to a loss of $0.27 per share. The EBIT for the current year (2025) was reported at -16.69 M USD. Cash and cash equivalents stood at $13.6 million as of March 31, 2025, which was sufficient to fund operations into Q4 2025.

Academic and clinical researchers utilizing the SCS platform

The scientific community validates the platform through presentations and data sharing. Clearside Biomedical data was featured in six presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. In total, the use of suprachoroidal drug delivery was featured in over 15 presentations at major ophthalmic medical meetings in 2025. The company's internal R&D expenses for Q2 2025 were $10.22 million, while Q1 2025 R&D expenses were $4.5 million.

Here's a quick look at key financial metrics leading up to the strategic review:

Metric Q1 2025 Value Q2 2025 Value
Total Revenue $2.3 million $320,000
Net Loss $8.2 million $19.36 million
EPS (Diluted) -$0.11 -$0.27
Cash & Equivalents (End of Period) $13.6 million (as of 3/31/2025) Not specified

The company's operating expenses for Q2 2025 included $5.9 million in SG&A costs.

The platform's reach is quantified by the following:

  • Number of SCS Microinjector injections completed to date: over 15,000.
  • Number of licensing collaborations: five.
  • Number of ARVO 2025 presentations featuring data: six.

Finance: review the cash burn rate implied by the Q2 2025 loss of $19.78 million operating loss against the Q1 cash balance by Monday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Cost Structure

You're looking at the cost structure for Clearside Biomedical, Inc. (CLSD) right as the company entered a major restructuring phase in late 2025. The primary ongoing costs revolve around advancing the pipeline and maintaining the corporate structure, but the immediate, significant costs are tied to the Chapter 11 filing and the subsequent sale process.

The core operational expenses leading up to the filing show a focus on Research and Development (R&D) to push the CLS-AX program forward, though R&D spending had actually decreased in the first quarter of 2025 compared to the prior year, reflecting lower clinical trial costs after the ODYSSEY Phase 2b trial completion. General and Administrative (G&A) costs remained steady, covering essential overhead like legal and patent maintenance for the suprachoroidal delivery platform.

Here's a quick look at the reported Q1 2025 operational expenses:

Cost Category Q1 2025 Expense Amount Comparison Point
Research and Development (R&D) $4.5 million Down from $5.6 million in Q1 2024
General and Administrative (G&A) $2.8 million Constant compared to Q1 2024

The most significant cost driver as of November 2025 is the Chapter 11 restructuring itself. When Clearside Biomedical filed for Chapter 11 bankruptcy protection on November 24, 2025, it immediately incurred substantial professional fees related to the process. These costs are necessary to manage the structured auction and sale of its business and assets, which is intended to maximize stakeholder value.

The costs associated with this strategic shift include fees for specialized advisors retained to navigate the bankruptcy court proceedings. You should track these carefully, as they are non-recurring but material expenses that impact the final recovery value. The company estimated its liabilities to be between $50 million and $100 million at the time of filing, against assets estimated between $1 million and $10 million.

The key professional services engaged for this process represent a major, albeit temporary, cost component:

  • Legal counsel retained: Cooley LLP and Richards, Layton & Finger, P.A.
  • Financial restructuring advisor retained: Berkeley Research Group LLC (BRG)
  • The process involves pursuing a sale under Section 363 of the U.S. Bankruptcy Code.

To be fair, even before the bankruptcy filing, the company was managing costs while planning for a potential Phase 3 program for CLS-AX. The net loss for Q1 2025 was $8.2 million, an improvement from the $11.8 million net loss in Q1 2024, largely due to increased license fees offsetting these operational costs.

Finance: draft 13-week cash view by Friday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Clearside Biomedical, Inc. as of late 2025, which is heavily influenced by its strategic partnerships and, critically, its recent filing for Chapter 11 protection to facilitate an asset sale.

The primary ongoing revenue streams for Clearside Biomedical, Inc. flow from its intellectual property licensing agreements for the suprachoroidal space (SCS) delivery platform.

License fees and milestone payments from strategic partners form a key component of the top line. For the first quarter ended March 31, 2025, the total License and other revenue was reported as $2.3 million. This Q1 2025 figure significantly surpassed the analyst estimate of $0.17 million.

Specifically within that Q1 2025 revenue, milestone payments were a major driver. This included $1.5 million in milestones received from Arctic Vision.

Sales of the SCS Microinjector® kits to licensees also contribute to the revenue base. This was grouped into the 'other revenue' category for Q1 2025, which amounted to $0.8 million, alongside training and services.

Royalties on commercial sales of licensed products, such as XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, represent another expected stream. However, the rights to these Royalties, along with milestone payments under existing license agreements, were largely sold in a prior transaction. As of late 2025, the assets available for sale related to the Royalty Sub included the equity in Clearside Royalty LLC and the right to revenue from the Royalties only after reaching a revenue cap of $106.5 million purchased by HCR.

The late 2025 focus is dominated by potential one-time proceeds from the sale or divestiture of assets. On November 24, 2025, Clearside Biomedical, Inc. filed for Chapter 11 bankruptcy with the intention to pursue a structured auction and sale process under Section 363 of the U.S. Bankruptcy Code to maximize stakeholder value. The key assets slated for this sale include the commercial SCS Microinjector platform, the Phase 3-ready CLS-AX program, and the existing suprachoroidal licensing collaborations.

Here's a look at some key financial figures impacting the revenue and asset valuation context:

Financial Metric Amount/Value Period/Context
License and other revenue $2.3 million Q1 2025
Q1 2025 Arctic Vision Milestone $1.5 million Q1 2025
Q1 2025 Training, Services, Kit Sales $0.8 million Q1 2025
Royalty Revenue Cap $106.5 million Related to Royalty Sub sale
Cash and Cash Equivalents $13.6 million As of March 31, 2025

The assets intended for sale via the Section 363 auction include:

  • The commercial SCS Microinjector platform and associated intellectual property.
  • The CLS-AX program, which is Phase 3 ready for wet AMD.
  • IND-ready programs for Geographic Atrophy (GA) and Diabetic Macular Edema (DME).
  • Rights linked to the royalty sub with the $106.5M revenue cap.

The company noted that the assets are attractive based on its clinically proven SCS Microinjector® platform and multiple suprachoroidal licensing agreements. The Chapter 11 filing was intended to maximize stakeholder value through this structured process.

Finance: draft asset sale timeline based on Section 363 process by Monday.


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