Zacks Small-Cap Research has started coverage on drug developer Tiziana Life Sciences PLC (NASDAQ:TLSA) (LON:TILS), which is advancing three candidates for a variety of indications in autoimmune disease, cancer and coronavirus (COVID-19).

Zacks has placed a valuation of US$7.50 per ADR share compared to a current price of US$3 in New York (up over 12% on the day).

Zacks said its value was based on its probability adjusted estimates for successful Phase III confirmatory trials in progressive Multiple Sclerosis (pMS) with nasally administered foralumab ( the company’s lead candidate) and Crohn’s Disease (CD) with orally administered foralumab, which Zacks expects to yield registrational results in 2026.

Phase II study

Tiziana is also starting a Phase II study in COVID patients with nasally administered foralumab, analysts noted.

The company is also developing an anti-IL6 monoclonal antibody called TZLS-501 as a treatment for inflammatory pulmonary diseases such as acute respiratory distress syndrome (ARDS), COVID and interstitial lung disease (ILD).  It is also planning a Phase II study with its candidate milciclib in solid cancer tumors.

Phase 2 foralumab clinical trials for MS and CD are targeted for this year, while Phase 2 combination trials for milciclib with a tyrosine kinase inhibitor (TKI) are expected in coming quarters, said Zacks.

“The candidates’ mechanism of action in Tiziana’s portfolio and their methods of administration bring new approaches to the table which are expected to work upstream of current standard of care, produce fewer side effects, enlist more precise activity and allow for targeted administration to the sites that present the disease.”

Substantial demand

In progressive MS there is only one other disease modifying therapy available that has limited effectiveness, providing substantial demand for an improved treatment, said Zacks, which estimates a market of about 100,000 patients in the United States and almost twice that number outside the USA.

Zacks valuation assumes a 2026 regulatory approval and 2027 commercialization of foralumab for both progressive Multiple Sclerosis (pMS) and CD in conjunction with partners.

“We anticipate that the foralumab programs will complete Phase II work and advance into Phase III efforts in 2023, assuming successful Phase II results. If safety and efficacy endpoints are met in Phase III trials, Tiziana can make BLA, MAA and other regulatory submissions to obtain marketing approval for pMS and CD by 2027 and 2028.”

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