Tiziana Life Sciences Plans to Spinout IL-6 Asset into Separate Listed Company

Rhea-AI Summary

Tiziana Life Sciences (Nasdaq: TLSA) intends to spin out its fully human anti-IL-6 receptor program TZLS-501 into a separately listed, immunology-focused company and will distribute shares in specie to Tiziana shareholders at a record date to be announced. TZLS-501 targets both membrane-bound and soluble IL-6R and was advanced for development due to heightened industry interest in IL-6 therapeutics, noted alongside Novartis' $1.4 billion acquisition of Tourmaline Bio.

The transaction requires shareholder approval and meeting listing criteria; TZLS-501 remains a Tiziana asset until approvals are obtained.

Positive

• Spin-out planned to create a dedicated TZLS-501 public company
• In specie distribution means existing shareholders will retain TZLS-501 value
• Dual-action IL-6R asset targets membrane-bound and soluble IL-6R
• Market validation cited by Novartis $1.4B IL-6 acquisition

Negative

• No certainty the transaction will proceed; subject to approvals
• Listing risk requires meeting listing criteria before an IPO
• Timing unknown record date and shareholder vote timing to be announced

Insights

Corporate Strategy Analyst

Planned spin-out aims to isolate the IL-6 asset to sharpen focus and preserve shareholder value, but approval and listing remain uncertain.

Tiziana Life Sciences proposes to separate its IL-6 receptor asset TZLS-501 into a publicly listed company via an in specie distribution, enabling shareholders to hold the new entity directly. The mechanism creates two focused businesses: one continuing development of TZLS-501 and the parent remaining focused on intranasal foralumab. A distribution in specie preserves direct shareholder exposure rather than an outright sale.

The outcome depends on multiple gating items. Shareholder approval and meeting listing criteria must occur before the spin-out completes, so execution risk is material. The announcement cites a comparable industry transaction ($1.4 billion) as context but does not disclose valuation, financing, or a timeline beyond saying a record date will be set in the coming weeks. These missing specifics limit near-term information value.

Watch for three concrete signals over the next quarters: the formal shareholder vote and the announced record date, any disclosed capital structure or valuation for the spun entity, and listing approval documentation. Each item will materially change the transaction's investor impact within a short to medium timeframe.

BOSTON, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together “TZLS-501”) via a spinout into a separate publicly traded company, to enhance the strategic focus of each company and to drive value for shareholders. Tiziana shareholders at the record date will retain value from TZLS-501 through the distribution in specie of shares in the new TZLS-501 listed entity.

The Company recently announced that it would advance development of TZLS-501, a dual-action IL-6R monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R. This decision was based in part on heightened industry interest in the IL-6 pathway—underscored by Novartis' recent $1.4 billion acquisition of Tourmaline Bio for its IL-6 inhibitor pacibekitug. The Company considers TZLS-501 as having the potential to be a standalone business. Accordingly, the Company intends to proceed with steps for a publicly listed immunology-focused spin-out company, centered on the IL-6 market. The record date for this proposed transaction will be announced in the coming weeks, and the transaction will formally be put to shareholders of Tiziana for approval. TZLS-501 will remain an asset of Tiziana Life Sciences until such time as shareholders formally approve proposals for the spin-out entity.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “The recent Novartis acquisition of Tourmaline Bio for $1.4 billion highlights the tremendous value and strategic importance of IL-6 pathway therapeutics in addressing systemic inflammation and related diseases. Building on our September announcement to advance TZLS-501, we believe now is the ideal time to position this promising asset as a standalone entity. TZLS-501's unique dual mechanism—blocking IL-6R signaling while reducing circulating IL-6 cytokines—offers significant potential as a monotherapy or in combination with other agents. This spin-out will unlock dedicated resources for its development, while allowing us to maintain focus on intranasal foralumab as our lead program.”

There can be no certainty that the transaction will proceed and any listing will be subject to meeting the required listing criteria.

About TZLS-501

TZLS-501, a fully human mAb, was licensed from Novimmune, SA, (Geneva, CH) in 2017. IL-6 is a cytokine that binds to its receptor subunit IL-6Rα on the cell membrane and is a major determinant in priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases. TZLS-501 acts via a dual mechanism by inhibiting IL-6R signaling and depleting circulating levels of IL-6.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Tiziana's Annual Report on Form 20-F for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

FAQ

What is Tiziana announcing about TZLS-501 and TLSA on December 2, 2025?

Tiziana announced intent to spin out TZLS-501 into a separately listed company and to distribute shares in specie to TLSA shareholders at a record date to be announced.

How will TLSA shareholders keep value from the TZLS-501 spin-out?

Shareholders will retain value via an in specie distribution of shares in the new TZLS-501 listed entity at the record date.

What is TZLS-501 and why is TLSA spinning it out (TLSA)?

TZLS-501 is a fully human dual-action anti-IL-6 receptor antibody targeting membrane-bound and soluble IL-6R; TLSA plans a spin-out to create a focused immunology company for that asset.

Will the TZLS-501 spin-out definitely happen for TLSA and when?

No; the company said there is no certainty the transaction will proceed—it requires meeting listing criteria and shareholder approval.

Does industry activity support TLSA's TZLS-501 spin-out thesis?

The company referenced industry interest, citing Novartis' $1.4 billion acquisition of Tourmaline Bio for an IL-6 inhibitor as supportive market validation.

When will TLSA announce the record date and shareholder vote for the spin-out?

The company said the record date will be announced in the coming weeks and the transaction will be put to shareholders for approval.