What are the recent developments announced by Tiziana Life Sciences on its Covid-19 vaccine clinical trial?

  • January 11, 2021 04:31 PM GMT
  • Hina Chowdhary
    Director, Equities Research Hina Chowdhary
    1378 Posts

    Hina Chowdhary is the Director, Equity Research at Kalkine and has an extensive experience of about 15 years in the area of Research, which includes 5+ years in Equities Research particularly.She has earned a Master of Science degree from the renowne...

What are the recent developments announced by Tiziana Life Sciences on its Covid-19 vaccine clinical trial?

Summary

  • Tiziana Life Sciences had not reported any revenue since its inception.
  • The Company had announced the completion of its clinical study in Brazil investigating nasally administered Foralumab.
  • The Company had completed the demerger of StemPrintER Sciences Limited on 30 October 2020.
  • The Company was having a cash balance of £7.2 million as of 30 June 2020.

Tiziana Life Sciences Plc (LON: TILS) is the LSE listed Biotechnology company, having its focus on developing drugs to cure diseases in oncology and immunology. The Company had reported a net loss in the range from £5 million to £9 million consistently from last five years. Based on its 1-year performance, shares of TILS have generated a return of about 156.47%.

Key Products

The Company is focused on the following products –

Milciclib (TZLS-201) - Milciclib can be defined as orally bioavailable, small molecule broad-spectrum inhibitor of CDKs (CDKs): 1, 2, 4, 5 and 7 and Src family kinases. CDKs are a family of highly conserved enzymes that regulates cell cycle through a series of activities that occurs in cells directing towards division and duplication of its DNA to generate two daughter cells. Src family kinases perform regulation of cell growth and potential transformation of normal cells to cancer cells.

 

Foralumab (TZLS-401) - Foralumab is the only fully human anti-CD3 mAb in clinical development. It is different from the previous non-human or humanized anti- CD3 mAbs. Foralumab picks out the CD3 epsilon (CD3ε) receptor, which is an accepted method for modulating T-Cell response and achieving immunosuppression. The Company believed Foralumab could have broad application to autoimmune and inflammatory diseases, such as NASH, Crohn’s disease, MS, type-1 diabetes, or T1D, inflammatory bowel disease, psoriasis and rheumatoid arthritis, where T-cell response modulation is preferred.

Anti-IL6r (TZLS-501) - TZLS-501 is a fully human mAb targeting the IL-6R. The Company had licensed the intellectual property from Novimmune in January 2017. This fully human mAb has a unique method of action depleting circulating levels of the IL-6 in the blood.  

Development Pipeline

The development pipeline for all the three products Milciclib (TZLS-201), Foralumab (TZLS-401), Anti-IL6r (TZLS-501) is shown below -

(Source: Company presentation)

Recent News

On 04 January 2021, the Company had announced that it had completed the clinical study encapsulating details of the investigation of nasally administered Foralumab to treat Covid-19 patients in Brazil. It is a proprietary human monoclonal antibody which exists standalone or in combination with orally administered dexamethasone in COVID-19 patients. The Company had reported the final dose of the trial on 21 December 2020. The topline data from this trial would be available by January 2021. The nasal delivery of Foralumab would provide immediate relief to COVID-19 patients as COVID-19 enters through the nasal and respiratory passage.

On 11 November 2020, the Company had announced its association with Parexel Biotech to conduct phase 1b/2 clinical trial in patients regarding Crohn's Disease.

On 02 November 2020, the Company had updated regarding the initiation of a collaborative clinical study investigating COVID-19 patients in Brazil regarding nasally administered Foralumab either alone or in combination with orally administered dexamethasone.

On 29 October 2020, the Company had updated regarding the demerger of StemPrintER Sciences Limited and mention regarding its allotment of Accustem Sciences Limited shares to shareholders had been sanctioned by the Court on 27 October 2020. The completion date of the demerger was 30 October 2020. On 16 September 2020, the Company had decided to dissolve its StemPrintER asset into a segregate public company, Accustem Sciences Limited and the Company would provide the new entity with USD 1.3 million in cash. Accustem Sciences is projected to list on the London Stock Exchange (LSE) by late Q4 2020.

Financial Highlights (for six months ended 30 June 2020, as reported on 30 September 2020)

(Source: Company result)

  • The Company had not reported any revenue for H1 FY20 ended on 30 June 2020.
  • The total comprehensive loss of the Company went up from negative £3.57 million in H1 FY19 to negative £3.91 million in H1 FY20.
  • With regards to its financial position, the Company was having a cash balance of £7.2 million as of 30 June 2020 in comparison to £153,000 as of 31 December 2019.
  • The Company had raised £12.9 million of funds for the six months ended on 30 June 2020. £8.1 million was raised through a public offering on NASDAQ, £2.8 million was raised through ‘At the market’ sales agreement and remaining £2.0 million was raised through options and warrants.
  • Subsequently, the Company also raised USD 57.25 million through the American Depository shares on NASDAQ in August 2020.
  • The funds raised would be used in the development of clinical trials of Milciclib and Foralumab. 

Share Price Performance Analysis of Tiziana Life Sciences Plc

(Source: Refinitiv, chart created by Kalkine group)

Shares of Tiziana Life Sciences Plc were trading at GBX 113.50 and were up by close to 4.13% against the previous closing price as on 11 January 2021, (before the market close at 10:00 AM GMT). TILS's 52-week High and Low were GBX 264.83 and GBX 20.74, respectively. Tiziana Life Sciences Plc had a market capitalization of around £212.13 million.

Business Outlook

The Company had updated regarding the completion of its clinical study in Brazil investigating nasally administered Foralumab, its proprietary human monoclonal antibody, and final data of this clinical study would be available by January 2021. The Company had completed various fundraising activities to smoothen the process of developing clinical trials of Milciclib and Foralumab. The activity pipeline of the Company is shown below -

(Source: Company presentation)

 


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