Tiziana announces financial results for year ending 31 December 2018

4th April 2019

Tiziana Life Sciences PLC
(“Tiziana” or the “Company”)

Financial Results for the Year Ended 31 December 2018

London, 4 April 2019 – Tiziana Life Sciences plc
(AIM: TILS), the clinical stage biotechnology company focused on
targeted drugs to treat diseases in oncology and immunology, today
announces its financial results for the year ended 31 December 2018.

Highlights of the period:


  • Foralumab
    • Following the exclusive licence agreement entered into with The
      Brigham and Women’s Hospital, Inc. relating to a novel formulation of
      Foralumab in a medical device for nasal administration, the Company
      filed an investigational new drug application (IND) for the
      first-in-human evaluation of the nasal administration of Foralumab.
    • Initiated Phase 1 trial to evaluate biomarkers of immunomodulation
      of clinical responses of the nasal administration of Foralumab in
      healthy volunteers.
    • Completed cGMP manufacturing of clinical trial materials for a
      Phase 1 study in preparation of an IND for the first-in-human evaluation
      of the oral administration of Foralumab.
  • Milciclib
    • In May 2018, the Independent Data Monitor committee (IDMC)
      completed an interim analysis of tolerability data from the first eleven
      treated patients and recommended expansion of the initial cohort to an
      additional 20 patients to complete the trial enrolment, which was
      completed in December 2018. Top-line data is expected in the second
      quarter of 2019.
    • Expects to initiate a Phase 2b trial (TZLS (201)-125a-011) dosing
      Milciclib in combination with Sorafenib (the standard of care) in
      patients with HCC in 2019.
  • TZLS-501 (Anti-IL6R)
    • In preclinical studies, TZLS-501 demonstrated the potential to overcome limitations of other IL-6 blocking pathway drugs
    • TZLS-501 also demonstrated the potential to block or reduce IL-6 signaling in mouse models of inflammation.


  • On 4th April 2018, the Group announced the addition of Mr Leopoldo
    Zambeletti as a non-executive director with responsibility for strategic
    development. Mr Zambeletti will also chair the Nomination Committee.


  • In the period January to October 2018, the Company raised a total of £2,811,363 through issue of new ordinary shares.
  • In November 2018, the Company announced pricing of its initial
    public offering of American Depositary Shares (“ADSs”) raising gross
    proceeds of £3.42 million.
  • On 20 November 2018, in addition to the £3.42 million raised in the
    US IPO, the Company announced the issue of 607,500 Ordinary Shares
    totalling £1.09 million.
  • On 20 November 2018, the Company also announced the issue of
    2,137,625 Ordinary Shares at a price of 60p each to certain persons who
    had made loans to the Company on terms that the loans would be converted
    (without interest) into Ordinary Shares in the Company completing a
    qualifying public offering on Nasdaq, equating to the extinguishment of
    £1.39 million.


  • On 7 February 2019, the Company announced that Riccardo
    Dalla-Favera MD had resigned from his role as Non-Executive Director of
    the Company.
  • On 20 March 2019, the Company announced that it had submitted an
    IND to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1
    clinical trial of enteric-coated capsules of Foralumab in healthy
    volunteers. This single-site clinical study is expected to enrol 36
    subjects and it will be conducted at the Brigham and Women’s Hospital
    (BWH), Harvard Medical School.


Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder

+44 (0)20 7493 2853

Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner / Richard Nash

+44 (0)20 7213 0880

About Tiziana

Tiziana is a UK biotechnology company that focuses on the discovery
and development of novel molecules that treat human disease in oncology
and immunology. The Company is focused on its lead compound milciclib.
The Company is also in clinical development of foralumab. Foralumab is
the only fully human engineered human anti-CD3 antibody in clinical
development. This phase II compound has potential application in a wide
range of autoimmune and inflammatory diseases, such as nonalcoholic
steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative
colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel
disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a
T-cell response is desirable.

For more information go to http://www.tizianalifesciences.com

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.