Shares of Tiziana Life Sciences jumped 16% in Monday’s pre-market trading after the biotech company announced the completion of the Brazil clinical trial of its nasally administered foralumab for the treatment of COVID-19.
Preliminary findings of the trial showed that the response from patients treated with foralumab was positive and well-tolerated. Topline data from the trial results are expected to be released later this month.
Foralumab is Tiziana Life’s (TLSA) exclusive fully human anti-CD3 monoclonal antibody. The proprietary nasal formulation and nasal delivery of foralumab promises an immediate relief to COVID-19 patients as the virus enters through the nasal and respiratory passage.
The clinical study enrolled 39 patients with moderate to severe COVID-19 who did not require the use of a ventilator at the start of the study. The primary endpoint of the study was safety of the treatment, and secondary endpoints were to assess the impact of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression. The pharmacokinetics of Foralumab was also be assessed.
The trial was completed in partnership with scientific teams at Boston’s Harvard Medical School, Brazil’s Santa Casa de Misericórdia de Santos Hospital and Brazil’s CRO [contract research organization] INTRIALS. The last patients in the trial received their final dose on Dec. 21, 2020.
Tiziana’s pipeline of drugs against validated autoimmune and cancer targets, prompted B. Riley analyst Mayank Mamtani to initiate coverage on the stock with a Buy rating on Dec. 22.
Mamtani, who set a price target of $8 (296% upside potential), commented “Our projections of free cash flow to the firm from sales of oral foralumab for moderate to severe Crohn’s disease and nasal foralumab for non-active SPMS are adjusted and weighted based on historical regulatory approval rates of similar treatments at similar stages of development.”
The analyst sees potential near-term upside from read-throughs of two COVID-19 programs including the intranasal foralumab additive to oral dexamethasone and the inhaled proprietary anti-IL-6R monoclonal antibody TZLS-501.
Further, the company’s cash in hand of over $60 million has convinced Mamtani that “2021 could be a year of successful pipeline execution with a busy clinical data catalyst flow consisting of an intranasal foralumab C-19 therapeutic study in early 2021E, followed by MS and Crohn’s disease in 2H21E,” (See TLSA stock analysis on TipRanks)
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