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Tiziana Life Sciences #TILS Announces Proposed U.S. Public Offering of ADSs

New York and London, February 17, 2020 – Tiziana Life Sciences plc (NASDAQ: TLSA; AIM: TILS) (the “Company” or “Tiziana”), a U.S. and U.K. biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today announces the commencement of an underwritten public offering in the United States of  American Depositary Shares (“ADSs”), representing ordinary shares of nominal value £0.03 each in the capital of the Company (“Ordinary Shares”) on the NASDAQ Global Market.  Each ADS represents five (5) Ordinary Shares.  Tiziana expects to grant the underwriters a 45-day option to purchase additional ADSs offered in the public offering.  There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The price for the Offering has not yet been determined.

All ADSs to be sold in the Offering will be offered by the Company. The number of Ordinary Shares represented by ADSs comprised in the Offering will be within existing shareholder authorities.

Tiziana intends to use the net proceeds from the proposed offering to advance the clinical development of Foralumab, and its other research and development programs, working capital and other general corporate purposes.

ThinkEquity (“ThinkEquity”), a division of Fordham Financial Management, Inc., is acting as the representative of the underwriters in the Offering.

The Offering is being made only by means of a prospectus supplement, which, for the avoidance of doubt, will not constitute a “prospectus” for the purposes of the Prospectus Regulation (as defined below) and has not been reviewed by any competent authority in any Member State (as defined below).

A shelf registration statement on Form F-3 (File No. 333-236013) relating to the ADSs to be issued in the proposed offering was previously filed with the Securities and Exchange Commission (SEC) and was declared effective on February 6, 2020.  This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 

A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at prospectus@think-equity.com. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

The person who arranged for the release of this announcement on behalf of the Company was Tiziano Lazzaretti, Chief Financial Officer of Tiziana.

About Tiziana Life Sciences plc

Tiziana Life Sciences is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. We believe Foralumab is the only fully human anti-CD3 mAb in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as NASH, primary biliary cholangitis (PBS), ulcerative colitis, MS, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

For readers in the European Economic Area

In any member state in the European Economic Area (each, a “Member State”) that has implemented the Prospectus Regulation (as defined below), this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Regulation. The term “Prospectus Regulation” means Regulation (EU) 2017/1129.

For readers in the United Kingdom

This announcement, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (“Investment professionals”) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (“High net worth companies, unincorporated associations etc.”) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). The ADSs offered in the Offering are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements including with respect to the creation of a trading market for ADSs representing the Ordinary Shares in the United States. 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.

END

For further enquiries:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder 

+44 (0)20 7493 2853

 

Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner 

 

+44 (0)20 7213 0883

Tiziana Life Sciences #TILS – Filing of SEC Form F-3

New York/London, 23 January 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, announces the Company has today filed a Form F-3 with the Securities Exchange Commission. An F-3 filing is a shelf registration statement for securities which may enable the Company to potentially conduct a future fundraising (but absent any specific terms at the current time).

Contacts:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder

+44 (0)20 7495 2379

 

Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner

+ 44 (0)20 7213 0880

 

Shore Capital (Broker)

Antonio Bossi / Fiona Conroy

+44 (0)20 7601 6125

 

 

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences

Tiziana Life Sciences #TILS Appoints Gregor MacRae to strengthen the Board

New York/London, 21 January 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, is pleased to announce appointment of Mr. Gregor MacRae to its Board as a Non-executive Director.

Mr. Gregor MacRae holds a Law degree (LLB Hons) from the University of Birmingham. He is a qualified Chartered Accountant (ICAEW) and has been a financial and business strategy adviser to multiple companies. Presently, Gregor is the Senior Partner of Appledore Wealth Management LLP, a London-based high net worth business advisory partnership. Gregor also served as a director of Chiltern Group Plc, an international trust company.

“I am delighted to join the Board of Tiziana and I am looking forward to working with the Company. I believe my experience as an advisor to several international companies over the last 25 years will compliment Tiziana and I am more than happy to join the Company at this exciting time”, said Gregor MacRae.

“We are delighted to have Gregor join our team as he brings rich experience to help and advise companies in their financial and business strategies. His appointment is a step towards reshaping the Board ahead of the Company’s intention to become a solely NASDAQ listed company” said Dr. Shailubhai, CEO & CSO of Tiziana Life Sciences.

Tiziana Life Sciences previously announced that it has appointed advisers in relation to an intended redomicile of the Company to Bermuda, to delist the Company’s ordinary shares from its AIM listing and to cancel its ADR program in order to facilitate listing of its Bermuda common shares on NASDAQ. As a result, Tiziana Life Sciences will only be listed on NASDAQ and all current ADRs and AIM shares will be replaced by NASDAQ shares.

In 2019 Tiziana announced the successful completion of three clinical studies, a phase 2a clinical trial with milciclib in sorafenib-resistant hepatocellular carcinoma, a phase 1 study with nasal administration of Foralumab, a fully human anti-CD3 monoclonal antibody, and a phase 1 clinical trial with oral administration of Foralumab.

Pursuant to Rule 17 and Schedule 2(g) of the AIM Rules for Companies, the following information is disclosed in respect of Gregor Charles William MacRae (aged 57):

Current Appointments

Appointments in the last five years

OKYO Pharma Limited

Elysium Golf Limited

Appledore Sports Management Limited

Opskic Group Limited

Appledore Property Management Limited

Amorim Partners Limited

Appledore Bleu des Mers Limited

Sorino Limited

Appledore Consulting Limited

Sorino (UK) Limited

Appledore Wealth Management LLP

Sidero Limited

B C Estates Limited

Mayze Services Limited

Clarges Consultancy Limited

Pretzi Limited

Hampton Resources Limited

Semolin Limited

Triple 8 Holdings Limited

Pinta Consultancy Limited

Crazele Properties Limited

 

There is no further information to be disclosed in relation to the appointments of Mr MacRae pursuant to AIM Rule 17 and Schedule 2 (g) of the AIM Rules for Companies. 

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

About Tiziana Life Sciences

Tiziana Life Sciences plc 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, the Company is also developing Foralumab for liver diseases. Foralumab is the only 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. 

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.

Contacts:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder

+44 (0)20 7495 2379

 

Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner

+ 44 (0)20 7213 0880

 

Shore Capital (Broker)

Antonio Bossi / Fiona Conroy

+44 (0)20 7601 6125

 

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences

Tiziana Life Sciences #TILS – Exec Chairman Gabriele Cerrone purchases more shares

New York/London, 14 January 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, announces that on the 13 January 2020 it was informed that on that date, Panetta Partners Limited, an entity closely associated with Gabriele Cerrone, Executive Chairman, bought 28,500 Ordinary Shares at a price of 43 pence per Ordinary Share, as set out below.

The information set out below is provided in accordance with the requirements of Regulation 19(3) of the EU Market Abuse Regulation No 596/2014:

1. Details of PDMR / person closely associated
a) Name Gabriele Cerrone/Panetta Partners Limited
2. Reason for the notification: On market acquisition
a) Position / status Executive Chairman
b) Initial notification /amendment Initial notification
3. Details of the issuer
a) Name Tiziana Life Sciences plc
b) LEI 213800CED47HI8PIOB36
4. Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a) Description of the financial instrument Ordinary Shares
b) Identification code of the Financial Instrument GB00BKWNZY55
c) Nature of the transaction On market acquisition of ordinary shares
d) Price(s) and volume(s)
Price: 43 pence; Volume: 28,500
e) Aggregated information

– Aggregated volume

 

– Price

 

N/A

 

N/A

f) Date of the transaction 13 January 2020
g) Place of the transaction AIM

 

As a result of this transaction Mr Cerrone’s interests in the underlying ordinary shares of the Company increases from 64,318,425 (47.066%) to 64,346,925 (47.087%). Mr Cerrone’s interests in the ordinary shares of the Company are based on a holding of 63,680,404 ordinary shares held by Planwise Limited and voting rights in respect of 666,521 ordinary shares held by Panetta Partners Limited (as shares and via ADSs). Mr Cerrone is considered beneficially interested in the holdings of Panetta Partners Limited and Planwise Limited.

 

For more information go to http://www.tizianalifesciences.com

 

Contacts:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder

+44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner

+44 (0)20 7213 0883
Shore Capital (Broker)

Antonio Bossi / Fiona Conroy

+44 (0)20 7408 4050

Tiziana Life Science (Nasdaq: TLSA / AIM: TILS) – Proposed Cancellation from AIM

New York/London, 13 January 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, announces that it has appointed advisers in relation to an intended redomicile of the Company to Bermuda which is anticipated to occur by Q2-2020, as a consequence of the redomicile the Company will not be seeking to re-admit its ordinary shares on AIM and will therefore seek shareholder consent for its shares to be cancelled from AIM when the redomicile occurs.  A further announcement will be made in due course.

Furthermore, the Company intends to cancel its ADR program and have its Bermuda common shares listed on Nasdaq.

The Company is today attending the J.P. Morgan Healthcare Conference in San Francisco, a copy of the investor presentation that is being used by the Company is available for download from its website at www.tizianalifesciences.com.

About Tiziana Life Sciences

Tiziana 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, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 mAbs in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as crohn’s disease (CD), nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

For more information go to http://www.tizianalifesciences.com

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for the release of this announcement on behalf of the Company was Kunwar Shailubhai, CEO of Tiziana.

 

Contacts:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder                                    +44 (0)20 7495 2379

 

Cairn Financial Advisers LLP (Nominated adviser)                   +44 (0)20 7213 0883

Liam Murray / Jo Turner

 

Shore Capital (Broker)                                                                +44 (0)20 7408 4050

Antonio Bossi / Fiona Conroy

Tiziana Life Sciences #TILS – Phase 1 Clinical Data Demonstrating Oral Treatment with Foralumab is Well-tolerated in Healthy Volunteers

New York/London, 9 January 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to report completion of Phase 1 clinical study of Foralumab, a fully human anti-CD3 monoclonal antibody (“mAb”), in healthy subjects. The proprietary oral formulation, comprising the lyophilized and stabilized free-flowing powder of formulated Foralumab encapsulated in an enteric-coated capsule, was well-tolerated at all doses tested and there were no drug-related safety issues even at the highest dose of 5 mg in this trial.

This Phase 1 trial, conducted at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, was a single-site, double-blind, placebo-controlled, single ascending dose (“SAD”) study in healthy subjects in which Foralumab was orally administered at 1.25, 2.5 and 5.0 mg per dose as enteric-coated capsules. Each cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule. All subjects completed the trial without any safety concerns at any of the doses.

It has previously been shown that orally administered Foralumab to NOD/SCID IL2γc-/- mice (which have human immune systems) with skin xenografts was well-tolerated up to 15 µg/day (n=20; human equivalent dose of 3.66 mg/dose in a 60 kg human) for 5 days then weekly, prevented skin xenograft rejection indefinitely. Clinical studies conducted by other researchers have also shown that oral administration of OKT3, a murine anti-CD3 mAb, was well-tolerated up to 5 mg/day for 5 days to healthy subjects, to patients with nonalcoholic steatohepatitis (“NASH”) for 30 days and to hepatitis C virus (“HCV”) non-responders for 30 days. Data from a recently completed clinical study indicated that oral administration of OKT3 was well tolerated at 1 mg/day for 30 consecutive doses in patients with moderate-to-severe ulcerative colitis. Importantly, the treatment resulted in clinical responses in 3 out of 6 patients, including one patient with complete clinical response.

“This is the first-ever study demonstrating that orally administered Foralumab is well-tolerated at all doses up to 5.0 mg/dose. This ground breaking study opens a novel avenue for future development of oral mAb therapeutics “commented Dr. Howard L. Weiner, a member of the scientific advisory board of Tiziana Life Sciences. “Recently, we also successfully demonstrated that nasally administered Foralumab is not only well-tolerated but also produced the desirable immunological responses. He added that “both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits.”

“We are very pleased with the tolerability of both oral and nasally administered Foralumab added Dr. Tanuja Chitnis, Professor of Neurology at Harvard Medical School, and study Principal Investigator (“PI”).

“Successful completion of this study is a significant milestone to validate our proprietary technologies of oral and nasal administration of mAbs, which we believe could potentially be transformational for future development of mAbs therapeutics.  We are excited to note that oral administration was well-tolerated and that the treatment did not result in severe toxicities that are commonly observed with intravenous (IV) administration of anti-CD3 mAbs. These findings provide the scientific rationale for our core technologies of oral and nasal formulations of mAb therapeutics”, said Dr. Shailubhai, CEO & CSO of Tiziana Life Sciences.

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

 

About Foralumab

Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, demonstrated a reduced release of cytokines after IV administration in patients with Crohn’s disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improved overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy. Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs. 

Preclinical studies on oral and nasal administration with Anti-CD3 mAbs

Preclinical and clinical studies have shown that mucosal induction of Tregs by oral or nasal administration of anti-CD3 mAbs is an innovative approach to treat autoimmune and anti-inflammatory diseases (Kuhn and Weiner 2016). Administration of anti-CD3 antibody orally in SLJ mice was shown to suppress autoimmune encephalomyelitis and nasally administered anti-CD3 mAbs were shown to ameliorate disease in an animal model of multiple sclerosis by inducing IL-10+LAP+ (“latency-associated peptide”) T cells, demonstrating oral and nasal anti-CD3 mAbs as a new approach to treat progressive forms of multiple sclerosis and other types of chronic CNS inflammation. Additionally, mucosal administered anti-CD3 mAbs suppressed lupus in lupus-prone mice (“BWF1”) by inducing IL-10 and TGF-β (“Transforming Growth Factor”) dependent mechanisms associated with a suppression of IL-17 and IL-21 pro-inflammatory cytokines.

About Tiziana Life Sciences

Tiziana Life Sciences plc 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, the Company is also developing Foralumab for liver diseases. Foralumab is the only 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.

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.

Contacts:

 

Tiziana Life Sciences plc 

Gabriele Cerrone, Chairman and founder 

+44 (0)20 7495 2379

Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner

+ 44 (0)20 7213 0883

 

Shore Capital (Broker)

Antonio Bossi / Fiona Conroy

+44 (0)20 7601 6125

 

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences.com

Tiziana Life Sciences #TILS – Director Dealing, Exec Chairman Gabriele Cerrone purchases 12,500 ADSs

New York/London, 2 January 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, announces that on 31 December 2019, Panetta Partners Limited, an entity closely associated with Gabriele Cerrone, Executive Chairman, bought 12,500 ADSs each representing 5 ordinary shares of nominal value 3p each in the capital of the Company at a price of US$2.79 per ADS, as set out below.

The information set out below is provided in accordance with the requirements of Regulation 19(3) of the EU Market Abuse Regulation No 596/2014:

1. Details of PDMR / person closely associated
a) Name Gabriele Cerrone/Panetta Partners Limited
2. Reason for the notification: On market acquisition
a) Position / status Executive Chairman
b) Initial notification /amendment Initial notification
3. Details of the issuer
a) Name Tiziana Life Sciences plc
b) LEI 213800CED47HI8PIOB36
4. Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a) Description of the financial instrument ADS representing 5 Ordinary Shares of nominal value 3p each
b) Identification code of the Financial Instrument 88875G101
c) Nature of the transaction On market acquisition of ordinary shares
d) Price(s) and volume(s)
Price: US$2.79; Volume: 12,500
e) Aggregated information

– Aggregated volume

 

– Price

 

12,500

 

US$34,875

f) Date of the transaction 31 December 2019
g) Place of the transaction NASDAQ

As a result of this transaction Mr Cerrone’s interests in the underlying ordinary shares of the Company increases from 64,255,925 (47.020%) to 64,318,425 (47.066%). Mr Cerrone’s interests in the ordinary shares of the Company are based on a holding of 63,680,404 ordinary shares held by Planwise Limited and voting rights in respect of 638,021 ordinary shares held by Panetta Partners Limited (as shares and via ADSs). Mr Cerrone is considered beneficially interested in the holdings of Panetta Partners Limited and Planwise Limited.

For more information go to http://www.tizianalifesciences.com

Contacts:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder

+44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner

+44 (0)20 7213 0883
Shore Capital (Broker)

Antonio Bossi / Fiona Conroy

+44 (0)20 7408 4050

Alan Green talks Santa Rally, Funds, JD Sports #JD, Tiziana Life Sciences #TILS & Itaconix #ITX on Vox Markets podcast

Alan Green discusses Santa Rally, funds, JD Sports #JD, Tiziana Life Sciences #TILS & Itaconix #ITX with Justin Waite on the Vox Markets podcast. The interview is 19 minutes 13 seconds in.

Tiziana Life Sciences #TILS – Initiates Phase 1 Clinical Trial with Orally Administered Foralumab, a Fully Human anti-CD3 monoclonal antibody, in Healthy Volunteers

London/New York, 4 December 2019 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a clinical-stage biotechnology company focused on developing innovative therapeutics for inflammatory diseases and cancersis pleased to announce initiation of a Phase I clinical trial in healthy volunteers with a proprietary oral formulation of Foralumab encapsulated in enteric-coated capsules. The primary objective of this single ascending dose (SAD) phase 1 study, being led by Dr. Tanuja Chitnis at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA USA, is to determine safety and tolerability of orally administered Foralumab. The clinical protocol also includes evaluation of pharmacokinetics to determine if there is any systemic absorption of Foralumab following oral administration. 

“Oral administration of Foralumab in enteric-coated capsules is a novel approach to upregulate T regulatory cells (Tregs) that have the capability to cross-through blood brain barrier and provide clinical benefits. Successful demonstration of safety in this study will facilitate immediate evaluation of orally administered Foralumab in a phase 2 clinical study in patients with progressive multiple sclerosis, a neurodegenerative disease for which there are limited treatment options”, said Dr. Howard Weiner 

“We are excited to initiate this trial because this is the first-ever clinical study with orally administered Foralumab in enteric-coated capsules. The oral route of administration is expected to minimize toxicities associated with intravenous administration of anti-CD3 mAbs and it may also improve the clinical outcome through activation of gut mucosal immunity. Our proprietary oral formulation technology has the potential to be useful for treatment of neurodegenerative and gastrointestinal diseases,” commented Kunwar Shailubhai, CEO and CSO of Tiziana. 

About Dr. Howard Weiner

Dr. Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women’s Hospital in Boston. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer’s disease, amyotrophic lateral sclerosis, stroke and brain tumors. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce Tregs for the treatment of these diseases. 

About Dr. Tanuja Chitnis

Dr. Tanuja Chitnis is a Professor of Neurology at the Harvard Medical School, and Director of the Translational Neuroimmunology Research Center at Brigham & Women’s Hospital in Boston. She has led studies including the testing of nasal Foralumab in healthy volunteers and a study of fingolimod in pediatric MS that led to FDA approval.

About Harvard Medical Centre

Brigham and Women’s Hospital (BWH) is located adjacent to Harvard Medical School, of which it is the second largest teaching affiliate. It is the largest hospital of the Longwood Medical and Academic Area in Boston, Massachusetts, USA. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare, the largest healthcare provider in Massachusetts. BWH conducts the second largest hospital-based research program in the world, with an annual research budget of more than $630 million. Pioneering milestones include the world’s first successful heart valve operation and the world’s first solid organ transplant. 

About Neurodegenerative diseases  

Neurodegenerative diseases include Alzheimer’s, multiple sclerosis, Huntington’s disease, Parkinson’s disease, ALS and others. Among these, Alzheimer’s is the most prevalent disease. In 2013 the global market for AD was 4.9 billion and expected to rise to 13 billion by the end of 2023. Current treatments for neurodegenerative diseases are mainly symptomatic, but new disease-modifying drugs to slow or stop the progression of the disease are now emergingThree AChE inhibitors are currently in use for AD, i.e. donepezil (Aricept), rivastigmine (Exelon) and galantamine (Reminyl) and cladribine (Mavenclad) for MS. It is recognized that inflammation plays a critical role in neurodegenerative diseases of the CNS.  Immune-directed therapies for neurodegenerative diseases target immune system cells such as the T cells that cause inflammatory and autoimmune disease in MS and microglia in ALS and show promise. It has been shown in animal models of progressive MS that anti-CD3 antibody targeting T cells ameliorates disease. These effects were shown to be IL-10 dependent, mediated by regulatory T cells leading to suppression of the disease. There is great promise in ongoing studies of inflammation-targeted neuroprotective strategies, which may ultimately be used across neurodegenerative diseases.

About Tiziana Life Sciences

Tiziana 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, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 mAbs in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as crohn’s disease (CD), nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

For more information go to http://www.tizianalifesciences.com

The person who arranged for the release of this announcement on behalf of the Company was Kunwar Shailubhai, CEO of Tiziana. 

Contacts:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder

+44 (0)20 7495 2379

Cairn Financial Advisers LLP (Nominated adviser)              

Liam Murray / Jo Turner

+44 (0)20 7213 0883

Shore Capital (Broker)

Antonio Bossi / Fiona Conroy

Tiziana Life Sciences #TILS – Issue of convertible unsecured loan notes with warrants to raise £1,434,000

New York/London, 1 November 2019 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, announces that it has raised £1,434,000 of finance by way of the issue of convertible unsecured loan notes (the “Loan Notes”), with warrants attached, for working capital purposes.

The Company previously announced its intention to raise additional equity share capital by way of an offering of its NASDAQ listed ADSs in the US. However, the Directors decided that given current market conditions, such an equity fundraise would be on dilutive terms which would be punitive to existing shareholders particularly in light of the recent positive news from the Company’s scientific programs. Accordingly, the Company has decided to raise convertible debt finance from supportive existing shareholders.

The Loan Notes are expected to be short term instruments and carry a coupon of 16% per annum and are convertible (together with all accrued interest) into ordinary shares of nominal value £0.03 each in the capital of the Company (“Ordinary Shares”) at a conversion price of 42p. The warrants issued in connection with the Loan Notes entitle the holders to subscribe for one additional share per conversion share at the same price of 42p. The warrants may be exercised for a period of up to 5 years from their issue.

The person who arranged for release of this announcement on behalf of the Company was Tiziano Lazzaretti, Chief Financial Officer of Tiziana.

About Tiziana Life Sciences

Tiziana Life Sciences plc 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, the Company is also developing foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody known to the company in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

For further enquiries:

Contact:

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder                               +44 (0)20 7495 2379

Cairn Financial Advisers LLP (Nominated adviser)                  +44 (0)20 7213 0883

Liam Murray / Jo Turner

Shore Capital (Broker)                                                             +44 (0)20 7408 4050

Antonio Bossi / Fiona Conroy

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