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Mail on Sunday Market Watchlist – Tiziana Life Sciences #TILS
There has been a scramble among AIM biotech companies to come up with a potential treatments for Coronavirus. One of the firms is Tiziana Life Sciences #TILS, listed on AIM and Nasdaq.
The shares were in demand on Thursday when it said it had developed new technology to treat COVID-19 infections.
Tiziana Life Sciences #TILS – Develops Novel Investigational Treatment For Patients Infected with COVID-19
New York/London — April 9, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announced today that it has developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer. Development of this novel technology is a step forward toward expediting development of TZLS-501, a fully-human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus. The Company believes the technology could also be applicable for use with other FDA approved mAbs and drugs. The Company has submitted a provisional patent application for the delivery technology.
“Direct delivery of anti-IL-6R mAb to the lungs using a portable handheld inhaler or nebulizer is a rapid and immediate therapy for children and adults infected with COVID-19. Importantly, this treatment with our fully human anti-IL-6R mAb (TZLS-501) has the potential to be a long-term therapy to halt progression and reduce mortality in patients with COVID-19, as a portion of the population may not opt to utilize a vaccine,” said Gabriele Cerrone, Chairman of Tiziana Lifesciences.
Patients infected with COVID-19 are known to develop an uncontrolled immune response (“cytokine storm”), which results in excessisive production of pro-inflammatory cytokines and other proteins such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a) and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which in turn causes severe damage to lung tissue resulting in respiratory failure and eventually death. Among these cytokines, IL-6 seems to be one of the major culprits underlying coronavirus-mediated respiratory failure. Early clinical studies conducted by doctors in China suggest that anti-IL6R mAbs may be used in clinical practice for treatment of COVID-19. Consequently, China’s National Health Commission has recommended the use of Roche’s blockbuster drug, Actemra® and Sanofi’s Kevzera® for treatment of patients infected with COVID-19.
Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with the severe lung damage commonly observed with COVID-19 infections and acute respiratory distress syndrome (ARDS). Tiziana believes TZLS-501 (anti-IL6R) combined with this newly introduced inhalation technology may rapidly inhibit inflammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death.
“The filing of this comprehensive provisional patent application covering treatment with our anti-IL-6R mAb, as well as prophylactic intervention with a vaccine candidate, designed from Spike (S) protein of COVID-19, is an important step in finding a solution to the current pandemic. We look forward to providing updates on the development of this product candidate and its introduction into clinical trials in a real-world setting,” said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.
About TZLS-501
TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα can be shed as a soluble sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from which sIL-6R is implicated mediates pro-inflammatory effect underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, which is the major cause of lung damage, provides this mAb with distinct advantages for treatment of COVD-19. The Company licensed TZLS-501 from Novimmune, a Swiss biotechnology company, in 2017.
The person who arranged for the release of this information was Dr Kunwar Shailubhai, the Chief Executive Officer of the Company.
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.
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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
United Kingdom:
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
United States:
Investors
Scott Gordon
CORE IR
(516) 222-2560
scottg@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Tiziana Life Sciences #TILS – Announces Closing of Offering and Resulting Total Voting Rights
London, New York 16 March 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 closing of its underwritten follow-on public offering (the “Offering”) of American Depositary Shares (“ADSs”) on the NASDAQ Global Market. Tiziana issued 3,333,333 ADSs (representing 16,666,665 new ordinary shares of nominal value £0.03 each in the capital of the Company (“Ordinary Shares”)) at a price to the public of $3.00 per ADS raising gross proceeds of approximately $10 million (before deducting underwriting discount, commissions and offering expenses). Each ADS offered represents five (5) Ordinary Shares. In addition, Tiziana has granted the underwriters a 45-day option to purchase up to an additional 499,999 ADSs on the same terms and conditions (the “Option”). All ADSs sold in the Offering were offered by the Company. The number of Ordinary Shares represented by ADSs comprised in the Offering (including by way of the exercise of the Option) were within existing shareholder authorities.
ThinkEquity, a division of Fordham Financial Management, Inc., acted as the sole book-running manager for the Offering.
Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab, (ii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and (iii) for working capital and other general corporate purposes.
Tiziana’s Ordinary Shares are admitted to trading on AIM, a market of the London Stock Exchange plc (“AIM”), under the symbol “TILS”. The ADSs are listed for trading on the Nasdaq Global Market under the symbol “TLSA”.
This Offering was being made pursuant to a registration statement on Form F-3, as amended (File No. 333-236013), previously filed with the U.S. Securities and Exchange Commission (the “SEC”), which became effective on February 6, 2020.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 base prospectus relating to this offering have been filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Before investing in Tiziana’s securities, you should read the preliminary prospectus supplement and the accompanying base prospectus and the documents incorporated by reference therein for information about Tiziana and this Offering. A final prospectus supplement related to the Offering will also be filed with the SEC.
Copies of the final prospectus supplement and accompanying prospectus relating to the offering 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, by email at prospectus@think-equity.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC’s website at http://www.sec.gov.
Total Voting Rights
In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the total number of Ordinary Shares in issue is 153,321,181. There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.
The figure of 153,321,181 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.
Admission of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option) is expected to occur on 17 March 2020.
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”), 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.
For distributors
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the ADSs offered in the Offering have been subject to a product approval process, which has determined that the ADSs offered in the Offering are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors should note that: the price of the ADSs offered in the Offering may decline and investors could lose all or part of their investment; the ADSs offered in the Offering offer no guaranteed income and no capital protection; and an investment in the ADSs offered in the Offering is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering. Furthermore, it is noted that, notwithstanding the Target Market Assessment, ThinkEquity will only procure investors who meet the criteria of professional clients and eligible counterparties.
For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to, the ADSs offered in the Offering.
ThinkEquity, a division of Fordham Financial Management, Inc., is responsible for undertaking its own Target Market Assessment in respect of the ADSs offered in the Offering and determining appropriate distribution channels.
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 and the intended use of proceeds from the Offering. 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 and include statements regarding the anticipated use of proceeds and the anticipated closing. 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 including market conditions, whether the proposed offering is completed and the satisfaction of customary closing conditions related to the proposed offering. 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 2379 |
ThinkEquity, a division of Fordham Financial Management, Inc. Ramnarain Jaigobind / Priyanka Mahajan |
+001 (877) 436-3673 |
Cairn Financial Advisers LLP (Nominated adviser) Liam Murray / Jo Turner
|
+44 (0)20 7213 0883 |
Alan Green & Sarah Lowther discuss the market crash, lessons from China, plus an array of stocks including Tiziana Life #TILS & Open Orphan #ORPH on the Total Market Solutions podcast
Alan Green Joins Sarah Lowther To Talk All Things Markets
During this weekend podcast, and in the wake of a colossal fall, we look at markets which ended the week on Friday the 13th, so far we’ve witnessed an emergency rate cut by the bank of England as the FTSE had its worst day in 33yrs.
Alan Green shares some insight on the most recent events surrounding Corona Virus, as he extrapolates what he can from the lessons in China, the initiative adopted by the UK plus an array of market opportunities, on the assumption one assumes a strong stomach and constitution toward volatility!
Stocks covered include #AZN #GSK #TILS #ORPH #RDSB #TSCO #SBRY #OCDO #JDW
Tiziana Life Sciences (Nasdaq: TSLA / AIM: TILS) Announces Pricing of U.S. Follow-On Offering of ADSs Raising $10 million
New York and London, March 12, 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 announced the pricing of its underwritten follow-on public offering (the “Offering”) of American Depositary Shares (“ADSs”) on the NASDAQ Global Market. Tiziana will issue 3,333,333 ADSs (representing 16,666,665 new ordinary shares of nominal value £0.03 each in the capital of the Company (“Ordinary Shares”)) at a price to the public of $3.00 per ADS raising gross proceeds of approximately $10 million (before deducting underwriting discount, commissions and offering expenses). Each ADS offered represents five (5) Ordinary Shares. In addition, Tiziana has granted the underwriters a 45-day option to purchase up to an additional 500,000 ADSs on the same terms and conditions (the “Option”). 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 (including by way of the exercise of the Option) will be within existing shareholder authorities.
ThinkEquity, a division of Fordham Financial Management, Inc., is acting as the sole book-running manager for the Offering.
The closing of the Offering is expected to occur on March 16, 2020, subject to customary closing conditions.
Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab for Crohn’s Disease and progressive multiple sclerosis, (ii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and (iii) for working capital and other general corporate purposes.
Tiziana’s Ordinary Shares are admitted to trading on AIM, a market of the London Stock Exchange plc (“AIM”), under the symbol “TILS”. The ADSs are listed for trading on the Nasdaq Global Market under the symbol “TLSA”.
This Offering is being made pursuant to a registration statement on Form F-3, as amended (File No. 333-236013), previously filed with the U.S. Securities and Exchange Commission (the “SEC”), which became effective on February 6, 2020.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 base prospectus relating to this offering have been filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Before investing in Tiziana’s securities, you should read the preliminary prospectus supplement and the accompanying base prospectus and the documents incorporated by reference therein for information about Tiziana and this Offering. A final prospectus supplement related to the Offering will also be filed with the SEC.
Copies of the final prospectus supplement and accompanying prospectus relating to the offering, when available, 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, by email at prospectus@think-equity.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC’s website at http://www.sec.gov.
In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the total number of Ordinary Shares in issue will be 153,321,181. There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.
Application will be made to the London Stock Exchange for the Ordinary Shares to be admitted to trading on AIM (“Admission”). Admission is expected to occur on or around 17 March 2020.
The figure of 153,321,181 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.
Following admission of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the fully diluted issued share capital of the Company will consist of 179,148,059 Ordinary Shares.
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”), 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.
For distributors
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the ADSs offered in the Offering have been subject to a product approval process, which has determined that the ADSs offered in the Offering are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors should note that: the price of the ADSs offered in the Offering may decline and investors could lose all or part of their investment; the ADSs offered in the Offering offer no guaranteed income and no capital protection; and an investment in the ADSs offered in the Offering is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering. Furthermore, it is noted that, notwithstanding the Target Market Assessment, ThinkEquity will only procure investors who meet the criteria of professional clients and eligible counterparties.
For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to, the ADSs offered in the Offering.
ThinkEquity, a division of Fordham Financial Management, Inc., is responsible for undertaking its own Target Market Assessment in respect of the ADSs offered in the Offering and determining appropriate distribution channels.
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 and the intended use of proceeds from the Offering. 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 and include statements regarding the anticipated use of proceeds and the anticipated closing. 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 including market conditions, whether the proposed offering is completed and the satisfaction of customary closing conditions related to the proposed offering. 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 7495 2379 |
ThinkEquity, a division of Fordham Financial Management, Inc. Ramnarain Jaigobind / Priyanka Mahajan |
|
Cairn Financial Advisers LLP (Nominated adviser) Liam Murray / Jo Turner
|
+44 (0)20 7213 0883 |
Tiziana Life Sciences developing TZLS-501 as a potential treatment for Coronavirus patients
Nasdaq and AIM listed Tiziana Life Sciences plc (Nasdaq: TSLA / AIM: TILS) has today announced that its TZLS-501 treatment could be a potential treatment for patients infected with coronavirus (COVID-19) who are at risk of respiratory failure.
Tiziana, a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, is expediting development of TZLS-501, with Novimmune, SA, a Swiss biotechnology company with whom it entered into a world-wide license for composition-of-matter in 2017.
Tiziana plans to administer TZLS-501 using a proprietary formulation technology. Tests have already shown that the treatment rapidly depletes circulating levels of IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness.
Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences said; “We are excited to move forward with our clinical development plan to expedite evaluation in patients as soon as possible.”
by Alan Green
Tiziana Life Sciences (Nasdaq: TLSA; AIM: TILS) – TZLS-501 Potential Treatment of Certain Patients Infected with Coronavirus COVID-19
New York/London, March 11, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA; AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announced today that it is expediting development of TZLS-501, a novel, fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with coronavirus COVID-19 (SARS-CoV-2). Tiziana plans to administer TZLS-501 using a proprietary formulation technology. The Company entered into a world-wide license for composition-of-matter of TZLS-501, a fully human mAb targeting IL-6R, with Novimmune, SA, a Swiss biotechnology company in 2017.
Certain patients infected with coronavirus COVID-19 may develop an uncontrolled immune response (“cytokine storm”) resulting in severe damage to lung tissue which could lead to respiratory failure (see Note 1, below). Early clinical studies conducted by doctors in China suggest that anti-IL6R mAbs may be used in clinical practice for treatment of COVID-19. Consequently, China’s National Health Commission has recommended the use of Roche’s blockbuster drug, Actemra® for treatment of patients infected with COVID-19, with serious lung damage and elevated IL-6 levels. Actemra was first approved by the FDA in 2010 for rheumatoid arthritis. Besides Actemra®, Sanofi and Regeneron are currently exploring Kevzara®, an FDA-approved anti-IL-6 receptor therapy for rheumatoid arthritis, for treatment of severe COVID-19.
Tiziana’s anti-IL-6R mAb binds to both the membrane-bound and soluble forms of IL-6R and rapidly depletes circulating levels of IL-6 in the blood (see Note 2, below). An excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness. A recent Chinese study also reported that COVID-19 infection caused clusters of severe respiratory illness such as severe acute respiratory distress syndrome (ARDS) (see Note 3, below).
“We believe that the features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptors along with rapid depletion of circulating IL-6 cytokine, a major cause of lung damage, provides TZLS-501 with distinct advantages for treatment of COVID-19 over other anti-IL-6R mAbs such as Actemra® and Kevzara® for treatment of COVID-19. The recent decision by researchers in China to add Actemra® to treatment guidelines for coronavirus patients with serious lung damage confirms the utility of anti-IL6R mAb. We are excited to move forward with our clinical development plan to expedite evaluation in patients as soon as possible”, said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.
Notes
Reference is made above to the following third-party publications:
- Chaolin Huang, et al., Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. The Lancet, volume 395, pages 497-506. 2020. Published online January 24, 2020.
- Lacroix, M. et al., Novel Insights into Interleukin 6 (IL-6) Cis- and Trans-signaling Pathways by Differentially Manipulating the Assembly of the IL-6 Signaling Complex. J Biol Chem. 2015 Nov 6; 290(45): 26943-26953.
- Chan, Jasper Fuk-woo et. al., A familiar cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. The Lancet, volume 395, pages 514-523. 2020. Published online January 24, 2020.
The person who arranged for the release of this announcement was Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.
About TZLS-501
TZLS-501, a fully human mAb, was acquired from Novimmune, SA, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, a major cause of lung damage, provides TZLS-501 with distinct advantages for treatment of COVID-19.
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 monoclonal antibody 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 |
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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 |