TLSA Tiziana Life Sciences Ltd

 

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

 

August 2023

 

 

Commission File Number:  001-38723

 

 

Tiziana Life Sciences LTD

(Exact Name of Registrant as Specified in Its Charter)

 

 

9^th 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 ☐

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

 

On August 23, 2023, Tiziana Life Sciences LTD (the “Company”) issued a press release, announcing Appointment of William A. Clementi as Chief Development Officer

 

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
Date: August 23, 2023	By:	/s/ Keeren Shah
		Name:	Keeren Shah
		Title:	Chief Financial Officer

 

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		News Service Announcement, dated August 23, 2023

 

 

3

Exhibit 99.1

 

 

 

Tiziana Life Sciences Announces Appointment of William A. Clementi as Chief Development Officer

 

●

Leadership Addition Strengthens Company’s Commitment to Advancing Innovative Therapies

 

NEW YORK, August 23, 2023 -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, is pleased to announce that it has appointed William A. Clementi, Pharm.D., FCP as Chief Development Officer. Dr. Clementi will formally take up the CDO role effective September 1, 2023. In this role, Dr. Clementi will be responsible for overseeing the company’s development strategies and advancing its portfolio of groundbreaking therapeutic candidates.

 

Dr. Clementi brings with him a wealth of experience in the biopharmaceutical industry, having held leadership roles at several prominent companies. He has a proven track record of successfully guiding development programs from early stages through clinical trials, regulatory approval, and commercialization. His deep understanding of drug development and his strategic insights will be invaluable as Tiziana continues to advance its pipeline.

 

Dr. Clementi has followed a science-driven career path since completing his NIH Training Fellowship (under John L. McNay M.D. and Thomas M. Ludden Ph.D.)  Upon completing his Fellowship research in drug metabolism and vascular smooth muscle relaxation, Dr. Clementi joined the University of Texas Graduate School of Biomedical Sciences (UTGBS) faculty and the College of Pharmacy faculty in Austin, Tx, in the Departments of Medicine and Pharmacology at the Health Sciences Center in San Antonio.  His primary responsibilities were interdisciplinary, and he led innovative programs in the Colleges with teaching, research, and clinical commitments. Dr. Clementi directed the Clinical Pharmacokinetic Consultation Service, providing novel computer-based drug dosing to the acute care settings at two major teaching hospitals.

 

Dr. Clementi continued his career in the pharmaceutical industry, joining Synthelabo and the U.S. affiliate Lorex Pharmaceuticals, where he held the Worldwide Director of Market Development position. Lorex and Synthelabo launched three EMA and FDA-approved products (betaxolol, zolpidem, and alfuzosin).

 

 

In 1991 Dr. Clementi established a regulatory consulting company, Clementi & Associates, Ltd. (dba as Clementi Ltd).  Clementi Ltd. provides regulatory and clinical consultation to small companies developing drugs, biologics, cell-based therapies, organ sustainability products and contrast media for medical imaging.  Clementi Ltd. has experience with required regulatory submission standards and processes, including orphan designation, exploratory INDs, expanded access INDs, and combination drug-drug and device-drug products. Clementi Ltd also provides high-level cGMP and GCP oversight.

 

Dr. Clementi is a graduate of Boston University and the University of Texas and the College of Pharmacy.

 

Commenting on his new role, William A. Clementi said, “I am excited to join Tiziana Life Sciences and contribute to the advancement of its innovative therapeutic candidates. I am excited to apply my regulatory and drug development experience and skills to Tiziana and contribute to the leadership team. The company’s commitment to addressing unmet medical needs and its dedication to scientific excellence are truly inspiring. I look forward to working closely with the talented team at Tiziana to drive the development of novel treatments that have the potential to make a meaningful impact on patients’ lives.”

 

Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, expressed his enthusiasm about the appointment, stating, “We are delighted to welcome William to Tiziana as our Chief Development Officer. His extensive experience and leadership in drug development align perfectly with our company’s vision to bring transformative therapies to patients in need. As Tiziana enters a critical phase of growth and development, William’s expertise will undoubtedly contribute to our success.”

 

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 approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favourable 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

 

Paul Spencer, Business Development and Investor Relations

+44 (0) 207 495 2379

email: info@tizianalifesciences.com

 

Investors:

 

Irina Koffler

LifeSci Advisors, LLC

+1 646 970 4681

ikoffler@lifesciadvisors.com

 

 

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