Tiziana Life Sciences Ltd (TLSA): Business Model Canvas [Dec-2025 Updated]

You're analyzing a clinical-stage play, and for Tiziana Life Sciences Ltd (TLSA), the entire business model hinges on a single, high-stakes asset: intranasal foralumab, which promises non-invasive CNS targeting. Honestly, this is a pure development bet; their revenue streams are currently just non-core interest income of $0.71 million for H1 2025, funding significant R&D costs that hit $5.9 million in the same period. With cash on hand at $7.3 million as of June 30, 2025, understanding the key partnerships and the unique value proposition-immunomodulation via direct CNS delivery-is defintely crucial to assessing their runway and ultimate upside. Dive into the full canvas below to see exactly how they plan to de-risk this journey.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Key Partnerships

You're looking at the core external relationships Tiziana Life Sciences Ltd (TLSA) relies on to advance its intranasal foralumab program, which is a critical component of its business model as of late 2025. These partnerships de-risk development by outsourcing specialized functions and accelerating clinical validation.

Renaissance Lakewood LLC for Nasal Drug Formulation and Scalable Manufacturing

Tiziana Life Sciences executed a product development services agreement with Renaissance Lakewood LLC on February 21, 2025. Renaissance Lakewood is designated as a leading Contract Development and Manufacturing Organization (CDMO) specializing in nasal drug delivery. The primary goal of this collaboration is to optimize the current formulation of intranasal foralumab and establish a comprehensive plan for scaling up its production specifically for use in a nasal device. This move is a direct step to expedite clinical development and potential commercialization, which is vital given the company's financial position.

Here's a quick look at Tiziana Life Sciences' financial standing around the time of this key manufacturing agreement, based on the interim results filed for the first half of 2025:

The company also noted that its Executive Chairman, Gabriele Cerrone, held over 36.28% of the issued share capital as of September 5, 2025, showing strong insider conviction.

Academic Medical Centers for Multi-Center Clinical Trials

Tiziana Life Sciences Ltd (TLSA) engages academic medical centers through established clinical research networks to execute its multi-center trials for intranasal foralumab.

• The Phase 2 clinical trial for amyotrophic lateral sclerosis (ALS) is being conducted within the Network of Excellence for ALS (NEALS) Consortium.
• The NEALS Consortium brings together several trial-ready, high-enrolling ALS research centers.
• For the Multiple Sclerosis (MS) Phase 2a trial, Tiziana Life Sciences added the Weill Cornell Medicine MS Center (NYC) as a site beginning in mid-2025.
• The company is also pursuing trials in other areas, including ongoing expanded access for moderate Alzheimer's disease.

Healey ALS MyMatch Program for Phase 2 Trial Acceptance

A significant validation of the intranasal foralumab science came on November 25, 2025, when Tiziana Life Sciences announced acceptance into the Healey ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham. This acceptance means the company's Phase 2 ALS trial is now part of a coordinated clinical research framework.

The study is specifically supported by a grant from the ALS Association following a rigorous peer review process. This program is designed so that successful investigational products may advance to future regimens of the HEALEY ALS Platform Trial-a perpetual, late-phase efficacy study-or move directly to standalone Phase 3 trials. The trial is set to be led by Principal Investigators at Mass General Brigham.

Contract Research Organizations (CROs) to Manage Global Clinical Operations

While Tiziana Life Sciences Ltd (TLSA) has not publicly detailed specific contracts with external Contract Research Organizations (CROs) for managing global clinical operations in the latest disclosures, the structure of its accepted ALS trial implies reliance on established clinical management infrastructure.

• The Healey ALS MyMatch Program itself is described as a multi-site, collaborative initiative.
• The ALS trial enrollment is set to occur at multiple rapid-enrolling U.S. centers within the NEALS Consortium.
• The agreement with Renaissance Lakewood LLC covers manufacturing and formulation scale-up, which is a key operational function often outsourced to specialized CDMOs, distinct from clinical trial management CROs.

The company's strategy relies on leveraging these established, high-enrolling networks to manage the operational complexity of its multi-site studies.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Key Activities

You're looking at the core engine of Tiziana Life Sciences Ltd (TLSA) right now, which is heavily focused on advancing intranasal foralumab through critical clinical stages. The key activities are all about execution on the clinical and strategic fronts, given the company's pipeline focus.

Conducting Phase 2/2a clinical trials for foralumab in neurodegenerative diseases

The primary activity centers on moving foralumab, the fully human anti-CD3 monoclonal antibody, through late-stage trials using its unique intranasal delivery platform. You see activity across several high-need indications as of late 2025.

For Multiple System Atrophy (MSA), Tiziana Life Sciences Ltd (TLSA) announced that the first participant was enrolled and dosed in its Phase 2a clinical trial in August 2025. This interventional study, NCT06868628, involves a subsequent 6-month open-label treatment phase with eight 3-week dosing cycles, and primary completion was expected by September 2025.

The company is also pushing forward with other neurodegenerative targets:

• Phase 2 trial for non-active secondary progressive multiple sclerosis (na-SPMS) began patient screening in November 2023.
• Phase 2 trial for Mild Alzheimer's Disease is planned to begin in 2H 2025.
• Phase 2 trial for ALS is also planned to begin in 2H 2025.
• The ALS Phase 2 trial was accepted into the Healey ALS MyMatch Program on November 25, 2025.

Data from the Expanded Access Program for Moderate Alzheimer's Disease, which began dosing in December 2024, showed improvement or stability of disease in all 14 patients treated within 6 months. The next catalyst update for the na-SPMS Phase 2 trial is expected in December 2025.

Research and Development (R&D) to expand foralumab's pipeline applications

R&D activity is focused on maximizing the potential of foralumab across various neuroinflammatory and neurodegenerative conditions, essentially a pipeline-in-a-drug strategy. While specific 2025 R&D expense figures aren't explicitly stated here, the pipeline expansion itself is a key activity.

Tiziana Life Sciences Ltd (TLSA) is actively pursuing multiple indications with foralumab, which is the world's only fully human anti-CD3 monoclonal antibody currently in clinical development.

Here's a look at the clinical stage of the foralumab pipeline as of late 2025:

Also, Tiziana Life Sciences Ltd (TLSA) has 3 unlicensed products looking for licensing opportunities.

Manufacturing process optimization and scale-up for commercial readiness

For a clinical-stage company, manufacturing key supplies for ongoing and upcoming trials is a critical activity. However, the most recent specific manufacturing data relates to a prior asset.

Manufacturing of clinical supplies for the Phase 1 study of the Anti IL-6 Receptor mAb (TZLS-501) was anticipated to be completed in 4Q 2022. You'll want to check the latest filings for any updates on the scale-up capacity for intranasal foralumab, which is the current lead candidate.

Strategic business development for future out-licensing or commercial partnerships

This involves high-level executive engagement to secure funding, partnerships, or strategic alignment for the pipeline assets. The company has been active in presenting its pipeline to potential partners and investors.

A major strategic move announced on December 2, 2025, was the intention to spin out the anti-IL-6 receptor monoclonal antibody, TZLS-501, into a separately listed public company.

Executive engagement for business development included:

• CEO Ivor Elrifi and COO/CFO Keeren Shah presenting at the Jefferies London Healthcare Conference on November 19, 2025.
• The company presenting intranasal foralumab to potential investors and strategic partners at the J.P. Morgan Asset Management Life Science Innovation Forum (LSIF) 2025 on October 1-2, 2025.

On the financial strategy side, Tiziana Life Sciences Ltd (TLSA) announced its intention not to engage in capital raising activities for the immediate future on January 23, 2025. Insider conviction remains high, as Executive Chairman Gabriele Cerrone purchased 25,000 common shares at $1.60 per share on September 5, 2025, bringing his total holdings to 36.28% of the issued share capital, which consists of over 105 million ordinary shares.

Finance: draft 13-week cash view by Friday.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Key Resources

You're looking at the core assets Tiziana Life Sciences Ltd (TLSA) relies on to execute its strategy, especially given the cash position typical for a clinical-stage biotech. These resources are what back the entire value proposition.

The most critical tangible resource is the capital base. As of the six months ended June 30, 2025, Tiziana Life Sciences Ltd reported $7.3 million in cash and cash equivalents. That figure was up from $3.7 million on December 31, 2024, partly due to an additional $2 million raised post-period end from ATM issuances and investment share sales. To be fair, this cash position needs careful management against the operating burn; for the first half of 2025, the total comprehensive loss was $5.3 million.

The primary intellectual property centers around the lead candidate, Foralumab. This is the sole fully human anti-CD3 monoclonal antibody currently in clinical development, which is a significant differentiator. This asset is being pushed through several indications using a unique delivery method.

The technology underpinning this is the nasal administration platform. Tiziana Life Sciences Ltd has secured its technology for alternative routes of immunotherapy through patents, with several applications pending globally. This exclusive license and patent portfolio is a non-replicable resource for their targeted approach to immunomodulation in the Central Nervous System (CNS) diseases.

The human capital-the specialized scientific and regulatory expertise-is essential for navigating the FDA and other bodies for these complex neuroinflammatory and CNS programs. This team is driving Foralumab through multiple advanced trials:

• Phase 2 trial in non-active Secondary Progressive Multiple Sclerosis (na-SPMS) is ongoing, with cohorts of 18 patients per treatment arm at 50 µg and 100 µg doses for a 12-week duration.
• Phase 2a trial for Multiple System Atrophy (MSA) began dosing in March 2025.
• The company is progressing towards opening a Phase 2 trial for early Alzheimer's Disease (AD).

Here's a quick look at the balance sheet snapshot around that key resource date:

The potential market opportunity for one of these indications, like ALS, is estimated to be valued at $790 million globally, with a projected CAGR of 5.8% until 2030. That potential upside is what this specialized team and IP are designed to capture.

Finance: draft 13-week cash view by Friday.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Tiziana Life Sciences Ltd (TLSA) believes its lead asset, intranasal foralumab, is a significant step forward in treating tough neuroinflammatory diseases. The value proposition hinges on a novel delivery method for their fully human anti-CD3 monoclonal antibody (mAb).

The primary value is the non-invasive intranasal delivery for direct CNS targeting, bypassing the blood-brain barrier. This method is key to their strategy, moving away from systemic injections. As of late 2025, this lead product is in Phase II development, with the next catalyst update anticipated in December 2025.

Next, consider the potential for improved safety and tolerability versus traditional intravenous (IV) anti-CD3 mAbs. The intranasal route is designed to reduce systemic toxicity. In the Expanded Access (EA) program for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), which treated 10 patients for a minimum of six months, there were no serious or severe treatment-related adverse events reported.

Tiziana Life Sciences Ltd is squarely targeting high-unmet-need conditions like non-active Secondary Progressive MS (na-SPMS) and MSA. These are areas where current therapeutic innovation has been limited. The company is advancing clinical programs in both areas, with the Phase 2a na-SPMS trial (NCT06292923) expecting top-line data readout by the end of 2025. The Multiple System Atrophy (MSA) Phase 2a study (NCT06868628) is a six-month, open-label trial.

Here's a quick look at the target patient populations for these high-unmet-need indications:

The mechanism of action provides the final piece of the value puzzle: immunomodulation via regulatory T-cell (Treg) induction to reduce neuroinflammation. This is where the clinical observations come into play. In the na-SPMS Expanded Access study, all 10 patients experienced stabilization of their Expanded Disability Status Scale (EDSS) scores. Furthermore, TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). One report indicated 80% of participants in an Expanded Access Program showed a qualitative reduction in microglial activity after six months of treatment. This focus on immune regulation is what Tiziana Life Sciences Ltd believes will differentiate its therapy.

Financially, the company is investing heavily to realize this value. For the six months ended June 30, 2025, Tiziana Life Sciences Ltd reported a total comprehensive loss of $5.3 million, up from $4.7 million in the prior year period. Cash on hand was $7.3 million as of June 30, 2025, an increase from $3.7 million on December 31, 2024, with an additional $2 million raised post-period end. The Executive Chairman, Mr. Gabriele Cerrone, showed conviction by purchasing 25,000 common shares at $1.60 per share on September 5, 2025, bringing his total holdings to over 43.27 million shares, representing 36.28% of the issued share capital.

You can see the commitment to the pipeline through the company's structure; its issued share capital consists of over 105 million ordinary shares.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Customer Relationships

You're looking at how Tiziana Life Sciences Ltd (TLSA) manages its relationships with the key groups that drive its clinical and financial progress. For a clinical-stage biotech, these relationships are the lifeblood, moving science from the lab bench to the patient bedside and, eventually, to the market.

Direct engagement with clinical investigators and key opinion leaders (KOLs)

Tiziana Life Sciences Ltd builds relationships directly with the medical centers running its trials. This engagement is crucial for data integrity and future adoption of foralumab. The Phase 2a clinical trial for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), which began patient screening in November 2023, expanded its network throughout 2025.

By June 13, 2025, dosing commenced at the Weill Cornell Medicine Multiple Sclerosis Center in New York City, marking the fifth site for this trial. This site joined established institutions:

• Yale University
• Johns Hopkins University
• Brigham and Women's Hospital
• University of Massachusetts

Furthermore, Tiziana Life Sciences Ltd initiated a Phase 2a study for Multiple System Atrophy (MSA) in August 2025, with primary completion expected by September 2025. The company also planned for its Phase 2 Clinical Trial for ALS and its Phase 2 Clinical Trial for Mild Alzheimer's Disease to begin in the 2H 2025.

Regulatory interaction via the FDA's Expanded Access Program (EAP) for patients

The relationship with the FDA, facilitated through the Expanded Access Program (EAP), provides a direct channel to patients with unmet needs. As of February 20, 2025, 14 patients had been enrolled in the na-SPMS EAP for intranasal foralumab. The FDA had recently allowed an expansion of this program to include an additional 20 patients. The initial cohort of 10 patients in this EAP showed either improvement or stability of disease within 6 months of starting treatment. Separately, the EAP for Moderate Alzheimer's Disease began dosing patients in December 2024.

Here's a snapshot of the EAP engagement metrics:

Investor relations and corporate presentations at major healthcare conferences

Managing investor perception is a key relationship focus, especially for a clinical-stage company. A strong signal of internal confidence came from the Executive Chairman and Founder, Mr. Gabriele Cerrone. On September 5, 2025, he purchased 25,000 common shares at $1.60 per share. This action increased his total holdings to over 43.27 million common shares, representing 36.28% of the company's issued share capital as of that date.

Tiziana Life Sciences Ltd actively engaged the financial community through presentations:

• Presentation scheduled at Jefferies Global Healthcare Conference on November 13, 2025.
• Announcement of plans to spin out the IL-6 Asset on December 2, 2025.

Scientific publications and data dissemination to the medical community

The medical community relationship is maintained by sharing clinical data. The company's progress is highlighted by key trial milestones, which serve as the basis for future scientific dissemination. For the initial 10 patients in the na-SPMS EAP, 70% saw a measurable improvement in fatigue, based on data reported in April 2024, which supports ongoing data sharing efforts. The progression of multiple Phase 2a trials across different indications-na-SPMS, MSA, ALS, and Mild Alzheimer's Disease-provides a steady stream of data points for scientific engagement throughout 2025.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Channels

The Channels component for Tiziana Life Sciences Ltd focuses on the physical and strategic avenues used to move their drug candidates, intranasal foralumab primarily, through development and toward commercialization.

Clinical Trial Sites for Patient Recruitment and Drug Delivery

Tiziana Life Sciences Ltd utilizes a network of prestigious academic medical centers to execute its clinical development programs. The Phase 2 clinical trial for intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS) is a key focus, with dosing commencing at the Weill Cornell Medicine Multiple Sclerosis Center in New York City on June 13, 2025. This site represents the fifth location for this trial. The trial, NCT06292923, began patient screening in November 2023.

The clinical site network for the na-SPMS trial includes, or has included, the following esteemed institutions:

• Yale University
• Johns Hopkins University
• Brigham and Women's Hospital
• University of Massachusetts (UMass)
• Weill Cornell Medicine Multiple Sclerosis Center
• Cornell University
• University at Buffalo (SUNY)
• Thomas Jefferson University

For the MS program, all participants receive PET scans at a single imaging site, Invicro, located at New Haven, Connecticut, to maintain data consistency. Beyond MS, Tiziana Life Sciences Ltd is advancing other programs through these channels:

• Multiple System Atrophy (MSA) Phase 2a trial began dosing in August 2025.
• Mild Alzheimer's Disease Phase 2 Clinical Trial is planned to begin in 2H 2025.
• The Expanded Access Program for moderate Alzheimer's Disease began dosing in December 2024.
• The Phase 2 Clinical Trial for ALS was accepted into the Healey ALS MyMatch Program on November 25, 2025.

Regulatory Pathways for Drug Approval and Market Access

The regulatory channel is critical for Tiziana Life Sciences Ltd, with intranasal foralumab having previously received Fast Track designation from the FDA. The company navigates both the US and European regulatory environments.

In the European Union, new Health Technology Assessment (HTA) Regulation became effective in January 2025, requiring joint clinical assessments for therapies like oncology, gene, and cell therapies, which influences pricing and reimbursement decisions. The EMA's proposed revisions aim to reduce the assessment time for new medicines to 180 days (or 150 days for medicines of major public health interest) from the current 210 days. As of late November 2025, the FDA's Center for Drug Evaluation and Research (CDER) had approved 38 new molecular entities and new therapeutic biologicals year-to-date, compared to 50 approvals in 2024.

Strategic Partnering Conferences for Potential Commercial Deals

Tiziana Life Sciences Ltd actively uses industry conferences to engage with potential strategic partners and investors. The company presented its pipeline, including intranasal foralumab, at the BIO International Convention 2025. Furthermore, the CEO presented at JP Morgan's Life Science Innovation Forum (LSIF) in Riyadh on October 1-2, 2025. The company was also scheduled to present at the Jefferies Global Healthcare Conference on November 13, 2025. As of December 2, 2025, Tiziana Life Sciences Ltd had a market capitalization of approximately $211.51 million.

Contract Development and Manufacturing Organizations (CDMOs) for Product Supply

While specific CDMO contracts for foralumab are not detailed, the company has a history of managing clinical supply manufacturing. Manufacturing of clinical supplies for the anti-IL-6 receptor mAb, TZLS-501, was anticipated to be completed in 4Q 2022. Tiziana Life Sciences Ltd is planning to spin off the TZLS-501 asset into a separate publicly traded entity. The company's financial status as of June 30, 2025, showed cash of $7.3 million and a total comprehensive loss of $5.3 million for the preceding six months.

The following table summarizes key financial and operational metrics relevant to the business structure as of the reporting period:

The company is also advancing its pipeline by prioritizing intranasal foralumab, which is the world's only fully human anti-CD3 monoclonal antibody currently in clinical development.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Customer Segments

You're looking at the customer base for Tiziana Life Sciences Ltd (TLSA) as of late 2025, which is almost entirely focused on high-unmet-need Central Nervous System (CNS) and neuroinflammatory diseases. The value proposition is built around intranasal foralumab, the world's only fully human anti-CD3 monoclonal antibody in clinical development for these indications, delivered via a novel route that aims for better safety and tolerability than traditional intravenous methods. This focus means the customer segments are highly specialized.

Patients suffering from severe neurodegenerative diseases with limited treatment options (na-SPMS, MSA, AD, ALS).

This group represents the direct end-users who stand to benefit from the company's lead asset. You see Tiziana Life Sciences Ltd targeting specific, progressive conditions where current standards of care are inadequate. For instance, in the non-active Secondary Progressive Multiple Sclerosis (na-SPMS) indication, an Expanded Access (EA) program treated 10 patients, where all 10 showed improvement or stability of disease within six months of treatment. Another report noted positive early data from the MS EA program showing improvement or stability in all 14 patients treated within six months. The Phase 2a trial for na-SPMS actually began dosing in the fourth quarter of 2023.

The pipeline extends to other severe conditions:

• Multiple System Atrophy (MSA): Phase 2a dosing commenced in August 2025.
• Alzheimer's Disease (AD): The Expanded Access Program for moderate AD started dosing in December 2024. The Phase 2 trial for mild AD is slated to begin in the second half of 2025.
• Amyotrophic Lateral Sclerosis (ALS): A Phase 2 trial is scheduled to begin in the second half of 2025, supported by a grant from the ALS Association. This program also gained acceptance into the Healey ALS MyMatch Program as of November 25, 2025.

The company's market valuation reflects this high-risk, high-reward patient focus; as of December 4, 2025, Tiziana Life Sciences Ltd had a market capitalization of $207.94 million.

Large pharmaceutical companies seeking late-stage, de-risked CNS assets for licensing.

These are the potential acquirers or major partners. They look for assets that have successfully navigated early-stage hurdles, which is exactly what Tiziana Life Sciences Ltd is trying to achieve with its lead candidate. The company's strategy, often described as a pipeline-in-a-drug approach, creates multiple potential licensing milestones. The fact that Tiziana Life Sciences Ltd announced on December 2, 2025, plans to spin out its IL-6 asset into a separate listed company suggests a strategy to potentially unlock value from non-core assets, making the remaining CNS pipeline more focused and perhaps more attractive to a large partner seeking a specific neurodegenerative asset. The overall antibody market context, which was historically projected to grow from $150 billion in 2019 to $300 billion by 2025, shows the scale of the prize these large companies are hunting for.

You can see the internal conviction supporting this strategy:

• Executive Chairman Gabriele Cerrone held over 43.27 million common shares, representing 36.28% of issued share capital as of September 5, 2025.
• The total issued share capital is over 105 million ordinary shares.

This level of insider ownership signals strong belief in the asset's future licensing potential.

Clinical researchers and neurologists focused on neuroinflammation and T-cell therapy.

This segment includes the investigators, Key Opinion Leaders (KOLs), and academic centers running the trials. They are customers in the sense that they utilize the drug supply and the clinical trial infrastructure provided by Tiziana Life Sciences Ltd. The company's focus on intranasal delivery of foralumab, a fully human anti-CD3 monoclonal antibody, directly appeals to researchers looking for novel immunomodulation routes that bypass systemic exposure. The company has been presenting its clinical findings, such as at the Jefferies London Healthcare Conference on November 19, 2025. Financially, the company reported a total comprehensive loss of $5.3 million for the first six months of 2025, which is funded by its cash position of $7.3 million as of June 30, 2025, supplemented by a $2 million raise post-period end. This operational spend directly supports the research activities that engage this customer segment.

Here is a snapshot of the pipeline targets engaging these researchers:

The FDA's previous Fast Track designation for intranasal foralumab in na-SPMS also validates the scientific approach for this segment.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Tiziana Life Sciences Ltd (TLSA) as of late 2025. For a biotech firm deep in clinical development, the cost structure is almost entirely driven by the pipeline. It's not about inventory; it's about burning cash to generate data and regulatory milestones. Here's the quick math on the major expenses we see in the latest interim results.

The most significant outlay, as expected for a company advancing intranasal foralumab through multiple indications, is Research and Development (R&D). This is where the money goes for trials, lab work, and discovery efforts. To be fair, this is the engine of the business, but also its biggest drain.

The General and Administrative (G&A) expenses, which we see here as Selling, General & Admin (SG&A), were reported at $12.58 million for the trailing twelve months (TTM) ending June 30, 2025. This covers the corporate overhead-salaries for non-R&D staff, legal, accounting, and general operational upkeep. It's a substantial fixed cost base that needs to be covered while the R&D engine runs.

Beyond those headline numbers, the structure includes several critical, often variable, cost drivers tied directly to the clinical strategy. These costs are essential for moving the lead asset, intranasal foralumab, toward potential commercialization.

• High Research and Development (R&D) costs, approximately $5.9 million for H1 2025.
• General and Administrative (G&A) expenses, around $12.58 million for the TTM ended June 30, 2025.
• Clinical trial execution and regulatory submission costs.
• Manufacturing and formulation optimization expenses with CDMOs.

Clinical trial execution and regulatory submission costs are a major component embedded within the R&D spend, but they represent distinct, large-scale expenditures. You're looking at site activation fees, patient recruitment costs for the Phase 2 trials in Multiple Sclerosis (MS) and Multiple System Atrophy (MSA), and the preparation of documentation for regulatory bodies like the FDA. For example, advancing the IND (Investigational New Drug) submission for ALS requires significant external consulting and data compilation fees.

Also, Tiziana Life Sciences Ltd (TLSA) incurs expenses related to Manufacturing and formulation optimization with Contract Development and Manufacturing Organizations (CDMOs). Since the lead candidate uses a novel intranasal delivery method, optimizing the formulation for stability, scalability, and consistent dosing is a non-trivial, ongoing expense. These costs ensure the drug product used in trials, and eventually for market, meets all quality standards. Finance: draft 13-week cash view by Friday.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Tiziana Life Sciences Ltd as of late 2025. Honestly, for a clinical-stage biotech focused on advancing intranasal foralumab, the current revenue picture is exactly what you'd expect: it's almost entirely non-operational income and financing, not product sales.

The core business of selling a commercial product is not yet generating top-line revenue. As of the trailing twelve months ending June 30, 2025, Tiziana Life Sciences Ltd reported $0.00 in revenue, which is typical for a pre-commercial biotech firm. The company is still deep in the development and clinical trial phase for its lead candidate.

What keeps the lights on right now is non-core income. For the first half of 2025 (H1 2025), the company recorded $0.71 million from non-core Interest and Investment Income. This is the money earned from holding cash reserves, not from drug development or sales.

To fund the ongoing Phase 2a clinical trial for intranasal foralumab in non-active secondary progressive multiple sclerosis and other general corporate purposes, Tiziana Life Sciences relies on capital markets. While the company announced in January 2025 its intention not to engage in capital raising activities for the immediate future, the most recent concrete financing event was a registered direct offering late in 2024 to bolster its cash position.

Here's a look at that recent financing activity:

This capital is earmarked for specific clinical and development goals. Here are the intended uses of those net proceeds from the offering:

• Funding the Phase 2a clinical trial for intranasal foralumab in non-active secondary progressive multiple sclerosis.
• Expediting the clinical development of foralumab in Alzheimer's disease.
• Developing foralumab for other indications.
• Working capital and other general corporate purposes.

Looking ahead, the major potential revenue streams are tied entirely to the success of foralumab and its platform technology. These are contingent events, not guaranteed income streams right now. The company is advancing intranasal foralumab, the only fully human anti-CD3 mAb in clinical development, for conditions like multiple sclerosis, Alzheimer's disease, and multiple system atrophy.

Future potential revenue streams include:

• Milestone payments upon achieving specific clinical or regulatory success points.
• Upfront and ongoing licensing fees from a commercial partner.
• Potential royalties on future net sales, should a drug gain approval.

Finance: draft 13-week cash view by Friday.