UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
June 2021
Commission File Number: 0001723069
Tiziana Life Sciences plc
(Exact Name of Registrant as Specified in Its Charter)
3rd Floor,
11-12 St James’s Square
London SW1Y 4LB
United Kingdom
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On June 21, 2021, Tiziana Life Sciences plc (the “Company”) issued a regulatory news service announcement in the United Kingdom announcing the appointment of Dr. Kevin Schutz as Vice-President of Regulatory Affairs. (the “RNS Announcement”).
The RNS Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| TIZIANA LIFE SCIENCES PLC | |||
| Date: June 21, 2021 | By: | /s/ Kunwar Shailubhai | |
| Name: | Kunwar Shailubhai | ||
| Title: | Chief Executive Officer | ||
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EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Regulatory News Service Announcement, dated June 21, 2021 |
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Exhibit 99.1
Tiziana Appoints Dr. Kevin Schutz as Vice-President of Regulatory Affairs
NEW YORK & LONDON, June 21, 2021 — Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, is pleased to announce the appointment of Dr. Kevin Schutz, PharmD, as Vice-President of Regulatory Affairs. Dr. Schutz will lead regulatory interactions related to clinical studies in the United States, Europe and Asian countries.
Dr. Schutz has over 19 years of pharmaceutical industry experience including 14 years of Regulatory Affairs experience. He has focused on disease indications with high unmet medical needs, in Neurology (including multiple sclerosis), Pulmonology (including infectious disease), and other potential disease indications, which the Company is currently developing products for or is planning to pursue. Specifically, Foralumab (an intranasally delivered, next generation, fully human anti-CD3 monoclonal antibody) for Secondary Progressive Multiple Sclerosis (SPMS) and COVID-19 with Pulmonary Inflammation as lead indications.
“Dr. Schutz brings extensive hands-on experience working with regulatory agencies including the FDA (USA), EMA (Europe), and PMDA (Japan), among others. His background will greatly strengthen Tiziana’s global development capabilities in regions where the Company is actively pursuing clinical development. We are pleased to have him on our team to lead this important role in global development of our pipeline” commented Dr. Neil Graham, Chief Medical Officer of Tiziana Life Sciences
“I am excited to join the Tiziana team to further the development of products which aim to help patients manage diseases with an unmet medical need. Tiziana’s lead pipeline candidate, Foralumab, is promising with multiple potential indications in multiple sclerosis and pulmonary diseases and I look forward to contributing to its development” said Dr. Schutz.
About Tiziana Life Sciences
Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohns Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn’s disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.
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. 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 enquiries:
United Kingdom:
Tiziana Life Sciences plc
| Gabriele Cerrone, Chairman and founder | +44 (0)20 7495 2379 |
United States:
Investors:
Dave Gentry, CEO
| RedChip Companies Inc. | 407-491-4498 |
dave@redchip.com