AIM Rule 26
The following information is provided by Tiziana Life Sciences plc (the "Company") in accordance with Rule 26 of the AIM Rules. Until 23rd April 2014 the company’s name was Alexander David Investments Plc.
1. Description of Business
Tiziana Life Sciences plc (“Company”) is a biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology.
On 24 April 2014 the Company acquired Tiziana Pharma Limited (“TPL”) via a reverse takeover (as defined in the AIM Rules). TPL was formed in November 2013 as a vehicle to acquire and exploit certain intellectual property in biotechnology, specifically a programme focussed on metastatic breast cancer. TPL’s research team has discovered that Bcl-3 has a prominent role in the metastasis of mammary cancers, and has elucidated the mechanism of Bcl-3 action to be a regulator of cancer cell motility. TPL has also determined that Bcl-3 inhibition suppresses cell motility in triple-negative, HER-2-positive PR- and ER-positive breast cancer sub-types, suggesting that Bcl-3 may be a master regulator of this metastatic property not only in aggressive breast cancers, but across the clinical spectrum of breast disease.
On 22 December 2014, the Company in-licensed the molecule foralumab, the only fully human engineered anti-human CD3 antibody in clinical development, from Novimmune SA. Foralumab targets the CD3 epsilon (CD3ε) receptor, which is a recognised approach for modulating T-Cell response and achieving immunosuppression. Foralumab is a phase II asset with potential application in a wide range of autoimmune and inflammatory disease, such as multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
On 20 January 2015, the Company in-licensed milciclib from Nerviano Medical Sciences. The compound milciclib blocks the action of a specific set of enzymes known as cyclin-dependent kinases (CDKs), which are involved in the process of cell division, as well as a number of other protein kinases. Milciclib has an unusual kinase inhibitory profile making it active against other receptors such as, tyrosine kinase, src family and splicing kinases. Milciclib is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy. Milciclib has demonstrated that is well tolerated in over 263 patients in phase I and II clinical trials and has been granted orphan designation by the European Commission and by the US Food and Drug Administration (FDA) for the treatment of malignant thymoma / thymic epithelial tumours. Nerviano has demonstrated, in preclinical studies, that milciclib has potential in other cancer indications, specifically liver and breast cancer. For more information please see “About Us”.
2. Details of Directors
Gabriele Cerrone MBA Executive Chairman (aged 46)
Mr Cerrone has a successful track record and extensive experience in the financing and restructuring of micro-cap biotechnology companies. He has founded nine biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has taken six of these companies to the Nasdaq Market and one to the AIM Market in London. Mr Cerrone co-founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman; he was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) and Callisto Pharmaceuticals, Inc. (OTCMKTS: CLSP), and was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA). Mr Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the Board until its merger in September 2007 with Inhibitex, Inc. Mr Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn sale to Bristol Myers Squibb Co in 2012. Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Founder of Tiziana Life Sciences plc (AIM: TILS) an oncology focused therapeutics company; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV); and founder of BioVitas Capital Ltd.
Dr. Riccardo Dalla-Favera Non-Executive Director (aged 65)
Riccardo has provided key leadership to the cancer research community at Columbia University Medical Center, particularly in his roles as founding Director of the Institute for Cancer Genetics, and from 2005-2011, as Director of the Herbert Irving Comprehensive Cancer Center. As a researcher, he has contributed much of the current knowledge on the genetic lesions responsible for human B cell lymphoma. The molecular lesions identified by Riccardo have led to the development of diagnostic tests and are being tested as targets in clinical trials with lymphoma patients. His work is widely quoted in scientific publications and in medicine and oncology textbooks. Riccardo has been recognized with several national awards, including the 2006 William Dameshek Prize for Outstanding Contribution to Hematology from The American Society of Hematology. In 2011 he was elected to the Institute of Medicine of the National Academy of Sciences, USA.
Willy Simon Non-Executive Director (aged 67)
Willy Jules Simon is a banker and worked at Kredietbank N.V. and Citibank London before serving as an executive member of the Board of Generale Bank NL from 1997 to 1999 and as the chief executive of Fortis Investment Management from 1999 to 2002. He acted as chairman of Bank Oyens & van Eeghen from 2002 to 2004. From 2004 until 2012, he served as a non-executive director of Redi & Partners Ltd., a fund of funds. He was previously chairman of AIM-traded Velox3 plc (formerly 24/7 Gaming Group Holdings plc) until 2015 and had been a director of Playlogic Entertainment Inc., a NASDAQ OTC listed company.
Kunwar Shailubhai PhD MBA Executive Director, CEO & CSO (aged 61)
Dr. Shailubhai is a Co-Founder and Chief Scientific Officer of Synergy Pharmaceuticals, Inc., a NASDAQ-listed biotechnology company focusing on innovative therapeutics for treatment of GI disorders, diseases and colon cancer. He also currently serves as CEO of Rasna Therapeutics, Inc., a developer of therapeutics to address the high unmet need that exists for AML and other forms of leukemia. Dr. Shailubhai has held leadership positions at Monsanto Life Sciences Company (St. Louis, MO), Callisto Pharmaceuticals, and Synergy Pharmaceuticals Inc. At Monsanto Company Dr. Shailubhai worked on a number of projects in inflammatory diseases and cancer, and eventually headed the cancer prevention group where he initiated research programs focusing on prevention of breast, prostate, and colon cancer in humans. He also initiated discovery projects to explore the therapeutic potential of uroguanylin, a physiological agonist of guanylate cyclase-C (GC-C), in GI disorders, diseases and colon cancer. These pioneering research efforts opened a novel avenue for therapeutic applications of uroguanylin and other GC-C agonists, not only in colon cancer but also in other GI diseases such as irritable bowel syndrome-constipation (IBS-C), chronic idiopathic constipation (CIC), and inflammatory bowel disease (IBD). Dr. Shailubhai discovered several other proprietary GC-C agonists as part of the development of Synergy’s discovery portfolio. Dr. Shailubhai has 17 issued patents, several pending patent applications, and 40 research publications in journals of international repute. Dr. Shailubhai also holds joint appointments as Professor at Bharuch S. Blumberg Institute, Doylestown, PA and as an Adjunct Professor at Drexel University School of Medicine, Philadelphia. Dr. Shailubhai received his M.B.A. degree in 2002 from University of Missouri at St. Louis.
Leopoldo Zambeletti Non-Executive Director (aged 50)
During a 19 year career as an investment banker, Mr. Zambeletti led the European Healthcare Investment team at J.P. Morgan for eight years before taking up the same position at Credit Suisse for a further five years. Since 2013 he has been an independent strategic advisor to life science companies on merger and acquisitions, out-licensing deals and financing strategy. He is a non-executive director at Advanced Accelerator Applications, Qardio, Summit Therapeutics plc, Nogra Pharma and Faron Pharmaceuticals OY. Mr. Zambeletti started his career at KPMG as an auditor.
Mr. Zambeletti received a B.A. in Business from Bocconi University in Milan, Italy. He serves as a trustee to Barts and the London Charity, which helps to fund the hospitals of the Barts NHS Trust including St Bartholomew, the Royal London and the London Chest Hospitals. He is the founder of the cultural initiative 5x5 Italy.
3. Corporate Governance
The Directors recognise the importance of sound corporate governance and the Enlarged Group will comply with the provisions of the Corporate Governance Code for Small and Mid-Size Quoted Companies (QCA Code), as published by the Quoted Companies Alliance. The Enlarged Group has also established a remuneration committee, an audit committee and an AIM Rules compliance committee with formally delegated duties and responsibilities.
The Remuneration Committee is chaired by Riccardo Dalla-Favera and includes members Leopoldo Zambeletti and Willy Simon, will meet not less than twice each year. The committee will be responsible for the review and recommendation of the scale and structure of remuneration for senior management, including any bonus arrangements or the award of share options with due regard to the interests of the Shareholders and the performance of the Enlarged Group.
The Audit, Risk and Disclosure Committee comprises Willy Simon as Chairman and members Riccardo Dalla-Favera and Leopoldo Zambeletti, will meet not less than three times a year. The committee will be responsible for making recommendations to the New Board on the appointment of auditors and the audit fee and for ensuring that the financial performance of the Enlarged Group is properly monitored and reported. In addition, the Audit Committee will receive and review reports from management and the auditors relating to the interim report, the annual report and accounts and the internal control systems of the Enlarged Group.
The Nomination Committee, comprises Leopoldo Zambeletti as Chairman and Willy Simon as a member, will meet not less than two times a year. The committee will lead the process for Board appointments and make recommendations to the Board.
Further details in relation to QCA compliance is set out in point 13 (QCA Compliance Statement) below.
4. Country of Incorporation and Operation
Tiziana Life Sciences plc was incorporated in England and Wales. The Company’s registered number is 08942956 and its registered office is: 3rd Floor, 11-12 St. James's Square, London, SW1Y 4LB, United Kingdom. The Company's principal country of operations is the United Kingdom.
Private investors are encouraged to participate in the Company’s Annual General Meeting, at which Directors, including the Executive Chair and the chairs of the Audit, Remuneration and Nominating Committees are available to review the results, comment on current business activity and answer questions. Shareholders are also reminded that they may contact the Company at any time to request a one-to-one meeting with the Chief Executive Officer, via the details listed in the ‘Contact Us’ section of the website, available here.
The Company acknowledges that transparent and timely communication is key to employee engagement and the Company endeavours to update employees regularly via its website (see the ‘News and Events’ section of the website, available here). Employees are encouraged to relay feedback to the Board by using one of the methods listed in the ‘Contact’ section of the website, available here.
Communities and the Environment
The Company strives to act as a good corporate citizen. It is conscious of the basic tenets of conservation: reduce, reuse, recycle, and is aware of the impact its business activities have on the communities in which it operates.
7. Exchanges and Trading Platforms
All of the Company's shares are traded on the AIM Market of the London Stock Exchange plc. The Company's shares are not traded on any other exchange or trading platform.
The Company is subject to the UK City Code on Takeovers and Mergers.
8. AIM Securities in Issue
- The Company's issued share capital comprises 136,409,818 ordinary shares at 3p each.
- The percentage of securities not in public hands is 50.07%.
- The Company has granted options over a total of 18,617,403 ordinary shares of which 5,086,166 are vested at exercise prices between 15p and £1.925p per share and 13,531,237 remain subject to vesting conditions (at potential exercise prices ranging from 15p to £1.925 per share). In addition warrants to subscribe for a total of 3,330,239 ordinary shares at exercise prices between 50p and £2.50 are outstanding.
- There are no restrictions on the transfer of securities.
9. Significant Shareholders
*Gabriele Cerrone, Executive Chairman, is considered to have a beneficial interest in the shares and voting rights held Planwise Group Limited and Panetta Partners Limited, giving him an aggregate interest in share and voting rights equal to 47.05%
14. Key Advisors
Cairn Financial Advisers LLP
Cheyne House, Crown Court
62-63 Cheapside, London EC2V 6AX
T +44 (0)20 7213 0880
Link Asset Services
65 Gresham Street, London EC2V 7NQ
T +44 (0)20 7397 6283