# EDGAR Filing Document

**Accession Number:** 0001723069
**File Stem:** 0001213900-23-000668
**Filing Date:** 2023-1
**Character Count:** 6477
**Document Hash:** f8c7168a2906ad3d29d522966f97dd9e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-000668.hdr.sgml**: 20230104

**ACCESSION NUMBER**: 0001213900-23-000668

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 2

**CONFORMED PERIOD OF REPORT**: 20230104

**FILED AS OF DATE**: 20230104

**DATE AS OF CHANGE**: 20230104

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Tiziana Life Sciences Ltd
- **CENTRAL INDEX KEY:** 0001723069
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** D0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38723
- **FILM NUMBER:** 23504326

**BUSINESS ADDRESS:**
- **STREET 1:** 3RD FLOOR, 11-12 ST. JAMES'S SQUARE
- **CITY:** LONDON, ENGLAND
- **STATE:** X0
- **ZIP:** SW1Y 4LB
- **BUSINESS PHONE:** 0044(0) 207-495-2379

**MAIL ADDRESS:**
- **STREET 1:** 3RD FLOOR, 11-12 ST. JAMES'S SQUARE
- **CITY:** LONDON, ENGLAND
- **STATE:** X0
- **ZIP:** SW1Y 4LB

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Tiziana Life Sciences plc
- **DATE OF NAME CHANGE:** 20171116

**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**

**January 2023**

**Commission File Number: 001-38723**

**Tiziana Life Sciences LTD**

(Exact Name of Registrant as Specified in Its Charter)

**9<sup>th</sup> Floor**

**107 Cheapside**

**London** 

**EC2V 6DN**

(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 January 4, 2023, Tiziana Life Sciences LTD (the "<u>Company</u>") issued a press release, announcing the IND for Phase 2 Study of Milciclib in Combination with Gemcitabine for Non-Small Cell Lung Cancer has been filed.

The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 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.

**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 LTD** | **TIZIANA LIFE SCIENCES LTD** | **TIZIANA LIFE SCIENCES LTD** |
| Date: January 4, 2023 | By: | /s/ Keeren Shah | /s/ Keeren Shah |
|  |  | Name: | Keeren Shah |
|  |  | Title: | Chief Financial Officer |

---

**EXHIBIT INDEX**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [News Service Announcement, dated January 4, 2023](ea171195ex99-1_tizianalife.htm) |

---

## Exhibit 99.1

**Exhibit 99.1**

Tiziana Life Sciences Announces IND filed for Phase 2 Study of Milciclib in Combination with Gemcitabine for Non-Small Cell Lung Cancer

NEW YORK, January 4, 2023 -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced the Investigational New Drug (IND) application filing for milciclib in combination with gemcitabine for non-small cell lung cancer (NSCLC).

"This Phase 2 IND filing, which was achieved with minimal additional resource deployment, enhances the asset value and Tiziana's optionality for milciclib," commented Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana. "Milciclib previously showed encouraging results in several cancer clinical studies - both as a monotherapy and in combination with gemcitabine. We believe that there could be an important role for a pan-CDK inhibitor in the oncologist's toolbox. At the same time, we are highly focused on advancing our leading CNS-focused programs with intranasal foralumab, which continues to generate encouraging data in our expanded access trial of secondary progressive multiple sclerosis."

**About Milciclib**

Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomyosin receptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety in 316 patients with advanced solid cancers in Phase 1 and 2 studies and shown indications of efficacy. In two completed Phase 2 thymic cancer trials, milciclib successfully increased overall survival and met both primary and secondary endpoints.

**About Tiziana Life Sciences**

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For further inquiries:

**Tiziana Life Sciences Ltd**

Hana Malik, Business Development and Investor Relations Manager<br> +44 (0) 207 495 2379<br> email: info@tizianalifesciences.com

**Investors:**<br> Irina Koffler<br> LifeSci Advisors, LLC<br> 646.970.4681<br> ikoffler@lifesciadvisors.com