Clene Inc. (CLNN): Business Model Canvas [Dec-2025 Updated]

You're looking at Clene Inc.'s business model right at the razor's edge, and honestly, it's a classic biotech pivot story: heavy spending now for a potential blockbuster payoff later. As your analyst, I see a company burning through capital-like the $3.5 million in R&D during Q3 2025-while banking on its proprietary CNM-Au8 technology to secure an accelerated FDA approval for ALS patients, which is the key to unlocking future product sales. With cash reserves sitting at $7.9 million as of September 30, 2025, the near-term focus is entirely on executing that confirmatory Phase 3 RESTORE-ALS trial and managing regulatory discussions, making the Key Activities and Cost Structure the most critical sections to review below. Dive into the full canvas to see exactly how Clene Inc. is structuring its partnerships and managing the path to commercialization.

Clene Inc. (CLNN) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Clene Inc. relies on to push CNM-Au8 through late-stage development and toward potential market entry as of late 2025. These aren't just vendors; they are crucial collaborators in clinical execution and regulatory navigation.

National Institutes of Health (NIH) for Expanded Access Program funding

The partnership with the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS), under the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS), is foundational for patient access and data generation outside of formal trials.

Clene Nanomedicine, Inc. secured a significant financial commitment here. Subaward Amendment 1, filed with the SEC on January 28, 2025, provided up to $8 million in additional funding for the second year of the ALS Expanded Access Program (ACT-EAP), covering the period from September 1, 2024, to August 31, 2025. This builds upon the initial four-year grant totaling $45.1 million announced in October 2023.

This collaboration has directly impacted patient access. The ACT-EAP capacity was expanded by 80% to accommodate a maximum of 180 participants. This program supports nearly 200 people living with ALS receiving compassionate use of CNM-Au8®. The financial structure means grant revenue recognized related to Year 2 (September 2024 through March 2025) offset research and development expense in the first quarter of 2025. Furthermore, Clene Inc. was planning to conduct the analysis of this NfL biomarker data from the EAP early in the fourth Quarter of 2025, following supportive feedback from the FDA on the statistical analysis plan in June 2025.

HEALEY ALS Platform Trial consortium for clinical data and trial execution

The HEALEY ALS Platform Trial consortium provides critical, comparative clinical data that informs regulatory strategy. Clene is using post hoc analysis from this trial to support its potential accelerated approval pathway for CNM-Au8.

The data comparisons are stark, showing a clear survival signal when CNM-Au8 30 mg is compared to the concurrently enrolled control group (Regimen A).

Here's a look at the survival data derived from up to 48 months of follow-up:

To be fair, 78% of patients in both comparison groups were also receiving standard ALS treatments like riluzole and edaravone. Still, these figures are what Clene Inc. is using as it prepares to submit a New Drug Application (NDA) by the end of 2025.

Contract Research Organizations (CROs) for global Phase 3 trial management

Managing the confirmatory Phase 3 RESTORE-ALS trial, planned to launch in mid-2025, requires robust external execution partners. These CROs are essential for managing the complexity of modern global trials.

The RESTORE-ALS trial itself is structured with a 108-week double-blind treatment period, utilizing a 2:1 randomization ratio favoring active treatment. The financial stakes in selecting the right CRO are high; in the industry, poor selection can lead to delays costing over $500,000 daily in lost revenue. Clene's success hinges on these strategic alliances to accelerate enrollment and maintain data quality for this pivotal study.

Key Opinion Leaders (KOLs) and academic neurologists for clinical advocacy

Clinical advocacy from leading neurologists is vital for trial recruitment, KOL endorsement, and shaping the regulatory dialogue. This network is deeply integrated into Clene's ongoing programs.

The NIH-funded EAP leadership team exemplifies this integration, featuring:

• Jinsy A. Andrews, MD, MSc, FAAN, of Columbia University
• Eric Anderson, MD, PhD, MBA, FAAN, of Synapticure
• Benjamin Greenberg, MD, MHS, FAAN, Head of Medical of Clene

Clene Inc. actively engages the broader scientific community. Management presented a corporate update at the Emerging Growth Conference on October 23, 2025. Furthermore, the company held key regulatory discussions with the FDA in the third quarter of 2025, including a Type B meeting on the VISIONARY-MS trial and a second Type C meeting to review the ALS survival data.

Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Key Activities

You're looking at the core engine driving Clene Inc. (CLNN) right now-the day-to-day, high-stakes work required to push CNM-Au8 through the final regulatory gauntlet for ALS. Honestly, for a late clinical-stage company, Key Activities are where the cash is spent and the value is either created or lost. Here's the breakdown based on what Clene Inc. was executing as of late 2025.

Executing FDA-requested biomarker analyses for CNM-Au8 in ALS

The primary activity here was completing the specific data analyses the FDA requested to bolster the case for accelerated approval. Clene Inc. announced the completion of these FDA-recommended biomarker analyses for CNM-Au8 in people living with ALS on December 3, 2025. This work was designed to support the persuasiveness of the original neurofilament light (NfL) findings from the HEALEY ALS Platform Trial by extending the analysis to the NIH-sponsored Expanded Access Protocol (EAP).

The FDA, in late 2024, recommended three specific analyses to strengthen the case for the drug's effect on NfL and its link to clinical benefit, which is survival. These activities directly impacted the Research and Development spending.

The key analytical components included:

• NfL change in the NIH-EAP, supporting nearly 200 people treated with CNM-Au8®.
• Evaluation of additional disease-relevant biomarkers, showing statistically significant reductions in glial fibrillary acidic protein (GFAP).
• Evaluation of NfL trajectory in HEALEY placebo participants who later switched to CNM-Au8 in the open-label extension (OLE).

The NfL change was analyzed following 9 months of treatment (primary analysis) and after 6 months of treatment (supportive analysis). To be fair, this scientific heavy lifting comes with a financial footprint. Research and development expenses were reported as $3.5 million for the quarter ended September 30, 2025, down from $4.5 million for the same period in 2024.

Planning and initiating the confirmatory Phase 3 RESTORE-ALS trial in 2026

While the immediate focus was on the NDA submission, Clene Inc. was simultaneously executing the planning necessary to dose the first patient in the confirmatory Phase 3 RESTORE-ALS trial in the first half of 2026. This trial is designed to confirm the effects of CNM-Au8 on improved survival and delayed clinical worsening. Planning activities for this trial were noted as an expense driver in the third quarter of 2025.

Developing and manufacturing the nanocatalytic gold crystal oral suspension

This activity centers on the actual product: CNM-Au8, which is an oral suspension of gold nanocrystals. The company's R&D and manufacturing operations are located in Maryland. The core function of this manufacturing is to produce the catalytically active nanocrystals that drive critical cellular energy reactions, aiming for neuroprotection and remyelination. Financial reporting shows that manufacturing personnel expenses decreased, partly due to the conclusion of various clinical programs.

Here's a snapshot of the financial context surrounding these operational activities as of late 2025:

Engaging in regulatory discussions with the FDA for accelerated approval pathway

This is arguably the most critical near-term activity. Clene Inc. is actively engaging the FDA to secure an NDA submission for CNM-Au8 in ALS under the accelerated approval pathway. Following the successful completion of the biomarker analyses, the next step was to request a Type C meeting with the FDA to review those data, which was expected in the first quarter of 2026. The company's target for the NDA submission itself was the first quarter of 2026.

The company had other key regulatory touchpoints in 2025:

• A Type C meeting occurred on June 30, 2025, where the FDA provided supportive feedback on the statistical analysis plan.
• Two additional FDA meetings were confirmed for the third quarter of 2025 to discuss ALS survival data and the MS clinical development program.
• The FDA acceptance of the NDA would unlock access to an additional $130.8 million in funding.

If onboarding takes 14+ days for the next regulatory step, cash burn risk rises.

Clene Inc. (CLNN) - Canvas Business Model: Key Resources

You're looking at the core assets Clene Inc. (CLNN) relies on to push CNM-Au8 through late-stage clinical development and toward potential regulatory approval. These aren't just line items on a balance sheet; they are the specific, hard-to-replicate components that underpin their entire value proposition.

The most fundamental asset is the Proprietary CNM-Au8 nanocatalytic gold crystal technology platform. This isn't a standard small molecule; it's an oral suspension of gold nanocrystals engineered to restore neuronal health and function. The mechanism centers on increasing energy production and utilization within central nervous system cells. The catalytically active nanocrystals are designed to drive essential cellular energy reactions, which in turn enable neuroprotection and remyelination by boosting the resilience of neuronal and glial cells against disease stressors.

This technology is protected by Intellectual Property (IP), including the federally registered trademark CNM-Au8® held by Clene Nanomedicine, Inc.. The IP covers the drug formulation and its unique mechanism of action targeting mitochondrial function and the NAD pathway. The commitment to defending and advancing this IP is reflected in past spending, with legal fees related to regulatory activities and intellectual property increasing in the 2024 fiscal year.

Financially, the immediate resource strength is measured by liquidity. As of September 30, 2025, Clene Inc. reported cash and equivalents of $7.9 million. This figure represents a reduction from the $12.2 million held at the close of 2024. To maintain operations, the company supplemented this with $1.2 million raised after the third quarter close, extending the expected cash runway into the second quarter of 2026.

The investment in human capital, the Specialized R&D and regulatory personnel focused on neurodegenerative diseases, is evidenced by operational spending. You can see the quarterly commitment to this team below, noting the cost-saving measures implemented:

The reduction in both R&D and G&A expenses year-over-year for the third quarter of 2025 reflects active cost management. The personnel component of G&A saw lower costs, alongside lower legal fees.

Key operational milestones tied to these resources include:

• Completion of analyses of ALS biomarker data, including NfL analysis from the NIH-sponsored Expanded Access Program (EAP).
• Planning for a New Drug Application (NDA) submission in the first quarter of 2026 under an accelerated approval pathway.
• Progress in the Multiple Sclerosis (MS) program following a Type B end-of-Phase 2 meeting with the FDA in the third quarter of 2025.

Honestly, the cash position is tight, but the runway extension into Q2 2026 gives them a defined window to execute the planned NDA submission. Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Value Propositions

You're looking at the core promises Clene Inc. (CLNN) makes to its customers-the patients and healthcare providers dealing with devastating neurodegenerative conditions. These propositions are built on the potential of their lead candidate, CNM-Au8.

First-in-class oral therapy for neurodegenerative diseases like ALS and MS

• CNM-Au8 is an oral suspension of gold nanocrystals.
• Designed to treat amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).
• The company is advancing toward a planned New Drug Application (NDA) submission for ALS under the accelerated approval pathway, with the target now set for the first quarter of 2026.
• The confirmatory Phase 3 RESTORE-ALS trial is expected to dose its first patient in the first half of 2026.

Potential to significantly extend survival in ALS patients (post-hoc analysis data)

The value proposition here centers on survival data derived from analyses of the HEALEY ALS Platform Trial and the NIH-sponsored Expanded Access Program (EAP). Here's a look at the key survival metrics reported as of late 2025:

The strongest observed benefit in a subset of patients meeting RESTORE-ALS trial criteria showed a 49% reduction in mortality risk. Another analysis indicated an overall survival improvement of 4.1 months for treated patients.

Restoring neuronal health by improving mitochondrial function and energy metabolism

The mechanism of action supports the therapeutic value proposition by targeting fundamental cellular processes:

• CNM-Au8 drives critical cellular energy producing reactions.
• Data from the Phase 2 REPAIR-MS trial showed CNM-Au8 improved brain energy metabolism, evidenced by improvements to the NAD+/NADH ratio.
• Preclinical data in a Parkinson's disease model showed CNM-Au8 improved mitochondrial health and restored cellular metabolism.

Oral suspension formulation offers ease of administration for chronic conditions

The delivery method is a key differentiator for chronic disease management, where adherence is vital. CNM-Au8 is formulated as an oral suspension of gold nanocrystals.

For context on the operational scale supporting these value propositions as of September 30, 2025, Clene Inc. reported cash and cash equivalents of $7.9 million, with an expected cash runway extending into the second quarter of 2026. The company recorded a net loss of $8.8 million for the third quarter of 2025 on revenue of $15,000.

Clene Inc. (CLNN) - Canvas Business Model: Customer Relationships

You're looking at how Clene Inc. manages its critical relationships with regulatory bodies, patient communities, the scientific community, and the capital markets as of late 2025. This is the core of their near-term value realization, especially with the ALS New Drug Application (NDA) timeline shifting.

High-touch engagement with the FDA for regulatory pathway alignment

Engagement with the U.S. Food and Drug Administration (FDA) is intense, focusing on securing an accelerated approval for CNM-Au8 in Amyotrophic Lateral Sclerosis (ALS). The company has been working through specific biomarker data analyses as directed by the agency.

The planned ALS accelerated-approval NDA submission was adjusted to the first quarter of 2026 from the previous fourth quarter of 2025 target. To support this, Clene Inc. held a second Type C meeting with the FDA in the third quarter of 2025 to review long-term survival benefit data from the HEALEY ALS Platform Trial regimen. Furthermore, the company requested a Type C meeting in the first quarter of 2026 to present newly completed analyses supporting the planned NDA. For the Multiple Sclerosis (MS) program, an end-of-Phase 2 Type B meeting occurred in the third quarter of 2025, where the FDA expressed openness to cognition-focused endpoints beyond the standard EDSS measure.

Here are the key statistical outcomes from the completed FDA-recommended biomarker analyses:

The FDA's focus remains on demonstrated improvements in ALS disease-specific biomarkers to support the accelerated filing path. Clene Inc. expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial in the first half of 2026.

Direct communication with patient advocacy groups (e.g., ALS Association)

Clene Inc. maintains communication with the patient community, which is vital for a late-stage neurodegenerative disease therapy. The company's commitment to the ALS community is stated as unwavering as they pursue therapeutic development.

While specific interaction metrics with the ALS Association aren't public, the company's commitment to transparency is shown through investor updates. For instance, Clene Inc. planned an investor call and webcast for December 3, 2025, to provide an update on the CNM-Au8 program in ALS, demonstrating ongoing dialogue with stakeholders.

General industry context shows that 97% of 372 surveyed US patient groups in 2024 reported having a working relationship with at least one pharmaceutical company, and 83% mentioned benefiting from financial support from pharma in 2024.

Scientific and clinical data dissemination to specialist neurologists

Dissemination to specialist neurologists centers on presenting robust clinical and scientific data across their target indications: ALS, Parkinson's Disease (PD), and MS. This builds the necessary scientific consensus for adoption.

Key data dissemination events in 2025 included:

• Presenting data from the long-term extension of the VISIONARY-MS trial at the American Academy of Neurology meeting in April 2025.
• Presenting survival data from the HEALEY ALS Platform Trial analysis in the fourth quarter of 2025.
• Presenting biomarker results at the December 3, 2025, investor webcast.

The company is focused on showing physiological and anatomical evidence of neuronal repair and remyelination from the MS program data.

Investor relations and capital raising to fund operations into Q2 2026

Managing investor relations is crucial, given the cash burn rate and the critical regulatory milestones ahead. The focus here is on extending the operating runway to support the Q1 2026 NDA submission.

Here is the financial snapshot supporting the operational runway:

In terms of investor activity during the third quarter of 2025, 19 institutional investors added shares of CLNN to their portfolio, while 6 decreased their positions. This capital structure, including the $1.2 million raised post-quarter, is what management projects will sustain operations until the second quarter of 2026. Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Channels

You're looking at how Clene Inc. (CLNN) gets its value proposition-the potential for neuronal health improvement via CNM-Au8-to the market and stakeholders. This is all about the pathways to the FDA, the medical community, and eventually, the patient.

Regulatory Submission Process (NDA) to the U.S. Food and Drug Administration

The primary channel for commercialization hinges on the New Drug Application (NDA) for CNM-Au8 in Amyotrophic Lateral Sclerosis (ALS). Clene Inc. planned to submit this NDA under the accelerated approval pathway by the end of 2025. This process involved critical interactions with the FDA; for instance, the company had scheduled Type C meetings in the third quarter of 2025 to discuss ALS survival benefit data and Multiple Sclerosis (MS) development plans. Furthermore, the company was finalizing the analysis of Neurofilament light (NfL) biomarker data from the NIH-sponsored Expanded Access Program (EAP), with results expected in early fourth quarter of 2025. To be fair, subsequent updates suggest the NDA submission might shift to the first quarter of 2026, pending a requested Type C meeting in the first quarter of 2026 to present the final supporting data.

Global Network of Clinical Trial Sites and Investigators

The clinical evidence supporting the NDA is channeled through a network of trial sites. The NIH-sponsored Expanded Access Protocol (EAP) for ALS, a collaborative effort involving Clene Nanomedicine, NYU, and Synapticure, enrolled 183 participants across eight sites located in the United States. This network is key for generating the data required for regulatory review. For the confirmatory Phase 3 RESTORE-ALS trial, Clene anticipates dosing the first patient in the first half of 2026. The MS program also utilized a network, presenting data from the long-term extension of its Phase 2 VISIONARY-MS trial.

Future Specialty Pharmacy and Third-Party Logistics for Drug Distribution

As of late 2025, Clene Inc. is in the preparatory phase for commercial launch, contingent on regulatory approval. The company is focused on the necessary steps for distribution post-approval. While the company is actively planning for the future, specific financial commitments or contracts for a specialty pharmacy network or third-party logistics (3PL) providers have not been publicly detailed with concrete dollar amounts or partner names in the latest reports. The focus remains on the near-term goal of the NDA submission, which precedes the execution of the distribution channel strategy.

Scientific Publications and Medical Conferences for Data Presentation

Presenting clinical and preclinical data is a vital channel for communicating value to Key Opinion Leaders (KOLs) and the broader scientific community. Clene Inc. actively used major medical forums in 2025 to disseminate findings on CNM-Au8. Here's a snapshot of their recent engagement:

These presentations are the direct channel used to build scientific consensus around the drug's mechanism of action, which is improving mitochondrial health and protecting neuronal function.

Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Clene Inc. (CLNN) as of late 2025. Since Clene Inc. is a late clinical-stage biopharmaceutical company, its primary customer segments are currently defined by their participation in clinical development or their potential as future commercial patients, which is heavily influenced by the company's current financial standing.

The financial reality as of the third quarter of 2025 definitely frames how Clene Inc. can engage these segments. The company reported a net loss of $8.8 million for the quarter ended September 30, 2025. Cash and cash equivalents stood at $7.9 million on that date, down from $12.2 million at the end of 2024. Honestly, this cash position, even with $1.2 million raised subsequently, only extends the cash runway into the second quarter of 2026. This near-term liquidity constraint means that the immediate focus is on hitting critical regulatory milestones to unlock future financing or commercial revenue.

Here is a breakdown of the segments Clene Inc. is targeting, mapped against the most relevant available data points:

• Patients with Amyotrophic Lateral Sclerosis (ALS) seeking disease-modifying therapy: The immediate focus is on regulatory submission, with a planned New Drug Application (NDA) for accelerated approval in Q1 2026.
• Patients with Multiple Sclerosis (MS) and Parkinson's Disease (PD) in clinical trials: MS Phase 2 REPAIR-MS results were presented in September 2025. PD development is supported by new preclinical data from September 2025.
• Specialist neurologists and prescribers in the US and global markets: These are the key opinion leaders and trial investigators who influence adoption, evidenced by presentations at ECTRIMS in September 2025.
• Government and commercial payers (insurance companies) for reimbursement: Reimbursement strategy is contingent on regulatory success, but the company's R&D spending for the nine months ending September 30, 2025, was a significant investment area, with Q3 2025 R&D expenses at $3.5 million.

The company's operational expenses in Q3 2025 were $3.5 million for Research and Development and $2.2 million for General and Administrative expenses. Total other expense for the quarter was $3.1 million. These figures show where capital is being deployed to advance the product toward these customer segments.

The following table summarizes the key clinical and financial metrics tied to engaging these customer segments as of late 2025:

The path to commercial segments for ALS is set with a target NDA submission in Q1 2026, but the company needs to secure financing beyond Q2 2026.

Clene Inc. (CLNN) - Canvas Business Model: Cost Structure

You're looking at the core spending that keeps Clene Inc. running as it pushes CNM-Au8 toward potential regulatory submissions. The cost structure is heavily weighted toward the science, which is typical for a late clinical-stage biopharma company. Honestly, the biggest line items reflect the pursuit of FDA approval for their lead candidate.

The Research and Development (R&D) investment is a primary driver of cash burn. For the third quarter of 2025, Clene Inc. reported R&D expenses totaling $3.5 million. This figure reflects ongoing study operations, including enrollment and activities for the NIH-sponsored Expanded Access Program (EAP), alongside the necessary planning for the upcoming Phase 3 RESTORE-ALS clinical trial. The company expects to dose the first patient in that confirmatory trial in the first half of 2026, so these planning costs are front-loaded.

Clinical trial expenses, specifically for the planned Phase 3 RESTORE-ALS trial, are a major future cost component, though the Q3 2025 R&D number already includes initial planning activities. Beyond ALS, costs are also tied to ongoing development plans for Multiple Sclerosis (MS), following their Type B end of Phase 2 meeting with the FDA in Q3 2025.

General and Administrative (G&A) overhead was reported at $2.2 million for the third quarter of 2025. This was actually a decrease year-over-year, driven by lower legal fees, reduced public and investor relations expenses, and lower personnel costs. Still, maintaining the corporate structure and supporting the clinical programs requires this baseline spending.

A significant, non-operating cost impacting the bottom line is the non-cash expense related to the valuation of financial instruments. Total other expense for Q3 2025 surged to $3.1 million, which the company attributed primarily to losses from the changes in fair value of common stock warrant liabilities and derivative liabilities. This is a key volatility factor you need to model, as it's not tied to day-to-day operations.

Here's a quick look at the key expense and loss components for the third quarter of 2025:

The net result of these costs, against minimal revenue of only $15,000 in the quarter, was a net loss. You should keep an eye on the cash position, as that dictates the operational runway. As of September 30, 2025, Clene Inc. reported cash and cash equivalents of $7.9 million.

The cost structure is further defined by specific activities driving the R&D spend:

• Enrollment and study operations in the NIH-sponsored EAP.
• Planning activities for the Phase 3 RESTORE-ALS clinical trial.
• Costs related to ongoing EAPs.
• Expenses for regulatory activities related to FDA discussions.

The company's cash runway, supported by the Q3 cash balance plus $1.2 million raised shortly after the quarter's end, is projected to sustain operations into the second quarter of 2026. Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Clene Inc. (CLNN) as of late 2025, and honestly, it's a picture dominated by non-sales income while they push for commercialization. The current revenue base is thin, which is typical for a late clinical-stage biopharma company, but the structure shows a clear path toward product sales.

For the third quarter of 2025, the realized revenue was minimal, which you'd expect given the focus on clinical development. Clene Inc.'s third quarter financials revealed total revenue of $0.02 million. Specifically, the royalty income component met your minimum threshold, coming in at $15,000 for Q3 2025. This is down from $87,000 in royalty income for the same period last year.

Another key non-sales revenue component is the non-dilutive grant funding tied to the ongoing work with the National Institutes of Health (NIH). This grant revenue directly supports the Expanded Access Program (EAP) for Amyotrophic Lateral Sclerosis (ALS) patients. You'll see this recorded as an offset, meaning it reduces operating expenses rather than being booked as top-line revenue, but it's crucial cash flow. Specifically, grant revenue increased related to Year 2 of the ongoing ALS EAP funded by the NIH, which is recorded as an offset to general and administrative expense or research and development expense.

Here's a quick look at the financial context around this revenue base as of the end of Q3 2025:

Looking ahead, the revenue picture is entirely dependent on the success of the CNM-Au8 regulatory pathway. The primary future revenue driver is potential product sales following an accelerated FDA approval for ALS. Clene Inc. is planning to submit a New Drug Application (NDA) for CNM-Au8 in ALS under an accelerated approval pathway in the first quarter of 2026. This is a shift from a prior expectation of a Q4 2025 submission.

The market opportunity is substantial, which underpins the value of any future commercialization or licensing deals that would generate milestone payments. The ALS treatment market is projected to reach $1.3 billion by 2034.

The potential future revenue streams Clene Inc. is positioned to capture include:

• Potential product sales of CNM-Au8 following anticipated accelerated FDA approval in 2026.
• Future milestone payments contingent upon securing licensing or commercialization partnerships for CNM-Au8 in ALS or Multiple Sclerosis (MS).
• Revenue from the MS clinical development program, which progressed with an end-of-Phase 2 meeting with the FDA in Q3 2025.

If onboarding takes 14+ days, churn risk rises, but for Clene Inc., if the Q1 2026 NDA submission is successful, the revenue profile shifts from grant/royalty offsets to potential product sales. Finance: draft 13-week cash view by Friday.