XTL Biopharmaceuticals Stock

XTL Biopharmaceuticals Ltd., a biopharmaceutical company, engages in the acquisition and development of pharmaceutical drugs for the treatment of autoimmune diseases.

The company's drug, hCDR1, is a potential treatment for systemic lupus erythematosus (SLE) and Sjogren's syndrome (SS). The company's sole drug candidate is hCDR1, a Phase II-ready asset for the treatment of SLE, the most prominent type of lupus.

hCDR1 is a peptide (short protein) that is administered subcutaneously and acts as a disease-specific treatment to modify the SLE-related autoimmune process.

Two placebo controlled Phase I trials and a placebo controlled Phase 2 trial, or the PRELUDE trial, were conducted on patients with SLE by Teva Pharmaceutical Industries, Ltd. (Teva), which had previously in-licensed hCDR1 from Yeda Research and Development (Yeda). Subsequent to Teva's return of the program to Yeda, the Food and Drug Administration (FDA) directed that the primary endpoint in future trials for Lupus therapies, including those for hCDR1, should be based on either the British Isles Lupus Activity Group index (BILAG) index or the SLE Responder Index (SRI). The FDA has provided the company with written guidance confirming the acceptability of BILAG as the primary endpoint in its planned study. The company has decided to reduce its research and development expenditures in connection with the execution of clinical trials relating to hCDR1 until full funding for the trials or cooperation with a strategic partner is secured.

hCDR1 is also Phase II-ready for the treatment of SS. In preclinical studies, blood mononuclear cells obtained from blood samples of patients with primary SS (pSS) were incubated in vitro in the presence of hCDR1 and a control peptide.

The company is exploring the expansion of its IP portfolio surrounding hCDR1 and at the same time has decided to reduce its research and development expenditures in connection with execution of its clinical trials. In parallel, the company searches to identify additional assets to add to its portfolio.

Licensing Agreements and Collaborations

hCDR1

The company has a license agreement with Yeda, which grants it the exclusive worldwide right to research, develop, and commercialize hCDR1 for all indications.

Strategy

As part of the company's business strategy, its policy is to file patent applications in the U.S. and internationally to cover methods of use, new chemical compounds, pharmaceutical compositions and dosing of the compounds and compositions and improvements in each of these.

The company is expanding its IP portfolio surrounding hCDR1 and has decided to reduce its research and development expenditures in connection with execution of its clinical trials until full funding for the trials or cooperation with a strategic partner is secured. In parallel, the company will look to identify additional assets to add to its portfolio.

Intellectual Property

hCDR1 for the Treatment of SLE and SS

The company has exclusively licensed from Yeda, families of patents relating to hCDR1.

A patent family for the formulation entitled 'Parenteral Formulations of Peptides for the Treatment of Systemic Lupus Erythematosus' that covers a very specific pharmaceutical composition, including Edratide. It has been granted in the U.S., Europe (Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, the Netherlands, and Sweden), China, India, Israel, Japan, Mexico, and Canada. The patent expires on January 14, 2024.

A patent family for the treatment of Sjögren's syndrome with Edratide and similar peptides was filed in 2018. A patent was issued in UAS and the application was allowed in Japan and a patent is expected to be granted shortly. A patent application is pending in Europe, Australia, Canada, China, Hong Kong, and Israel.

Research and Development

For the year ended December 31, 2022, the company's research and development expenses were approximately $30 thousand.

Government and Industry Regulation

Numerous governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies, impose substantial regulations upon the clinical development, manufacture and marketing of the company's drug candidates and technologies, as well as its ongoing research and development activities.

Before marketing in the U.S., any drug that the company develops must undergo rigorous pre-clinical testing and clinical trials and an extensive regulatory approval process implemented by the FDA, under the Federal Food, Drug and Cosmetic Act of 1938, as amended.

The company is required to submit extensive pre-clinical and clinical data and supporting information to the FDA for each indication or use to establish a drug candidate's safety and efficacy before it can secure FDA approval. According to the FDA, before commencing clinical trials in humans, the company must submit an Investigational New Drug (IND) to the FDA containing, among other things, pre-clinical data, chemistry, manufacturing and control information, and an investigative plan.

History

The company was founded in 1993. It was incorporated under the Israeli Companies Law in March 1993 under the name Xenograft Technologies Ltd. The company was re-registered as a public company in June 1993 in Israel and changed its name to XTL Biopharmaceuticals Ltd. in 1995.