Home » Posts tagged 'TILS'
Tag Archives: TILS
Andrew Hore – Quoted Micro 25 January 2021
AQUIS STOCK EXCHANGE
Rutherford Health (RUTH) has signed contracts with the NHS that underpin a significant proportion of its fixed costs. More cash will be required in order to take advantage of the potential for the cancer care clinics. The cash will be needed in the next few months and could be raised at the same time as moving to AIM. Capacity of the Cardiff site could be fully utilised in 2021 and patients have been booked in at three other sites.
Broadband services provider Rural Broadband Solutions (RBBS) has grown its number of connections to 2,500 by the start of January and is signing up 25 a month. Digital marketing is being increased to attract clients that have access to the Rural Gigabit voucher funding scheme. There is interest from 300 households so the company can apply for £1m of government funding. The target is 5,000 monthly paying customers by October 2023.
S-Ventures (SVEN) has acquired 75.1% of We Love Purely Ltd by issuing 1.53 million shares at 9p a share, which is equivalent to £137,600 and paying off a loan of £30,000. We Love Purely is a snacks supplier and it sells Purely plantain chips. Under new ownership the product range will be expanded. Two S-Ventures directors held shares in the acquired company.
Investment company Gledhow Investments (GDH) raised £1.69m from investment disposals in the year to September 2020. That generated a profit of £508,000 after admin expenses. NAV increased from £884,000 to £1.3m. That includes £382,000 of cash compared with a market capitalisation of £539,000.
Coinsilium Group Ltd (COIN) says that the value of its crypto currency position has increased by two-fifths. On 21 January, there was cash of $1.5m, which is mainly crypto currencies. There are also $164,000 of RIF tokens that will vest over 22 months.
Gunsynd (GUN) has converted part of its loan to Rogue Baron at 3.97p a share and that gives it a 19.7% stake in the drinks company. Once Rogue Baron joins Aquis Stock Exchange the rest of the loan stock will be converted. Warrants have been exercised that raised £200,000 for Gunsynd.
Engineer Vulcan Industries (VULC) says third quarter trading was in line with expectations. Third quarter revenues were 14% higher the second quarter at £1.6m. Order books are strong. The proposed acquisition of E Lowe will not happen.
Capital for Colleagues (CFCP) has maintained its NAV at 52.75p a share at the end of November 2020. There are 16 investments in the portfolio.
NQ Minerals (NQMI) has filed a draft prospectus for its move to the standard list.
Dozens Savings has issued just over £1m of retail bonds and demand is outstripping supply.
AIM
Business restructuring company Begbies Traynor (LSE: BEG) has acquired rival CVR Global for up to £20.8m, which is its largest acquisition. CVR’s annual profit was £1.2m and there are potential cost savings of £750,000 a year.
Beximco Pharmaceuticals (BXP) is acquiring Sanofi Bangladesh for £35.5m. The deal is still subject to regulatory approval. This will broaden the product range and helps the group move into new sectors. It will also add more manufacturing capacity. The deal should be earnings enhancing. Sanofi made a pre-tax profit of £4.3m in 2019.
Ground engineering contractor Van Elle (VANL) made a loss in the first half of 2020-21 and trading remains mixed. Interim revenues fell by 21% due to the original lockdown and delayed rail work, but there should be a recovery in the second half. Cost reductions are coming through and helping to stem the loss. This puts Van Elle in a stronger position for the next financial year. Improving utilisation of equipment will help the company return to profit and start paying dividends again.
Acoustic materials supplier Autins (AUTG) would have reported halved second-hand revenues without the contribution from PPE. Full year revenues fell from £26.9m to £21.5m as one major automotive customer was hit by production problems. The loss increased from £1.54m to £1.76m. The high depreciation charge means that £1.48m of cash was generated from operations during the year. The Neptune product is gaining new contracts, particularly for electric vehicles.
Flexible printed circuit technology developer Trackwise Designs (TWD) disappointed the market with its trading statement. Growth in revenues has been slower than expected due to short-term problems, but finnCap has maintained its 2021 forecast, which predicts a rise in revenues from £6.2m to £14.2m. That would be enough to make the company profitable.
Alumasc (LSE: ALU) traded ahead of expectations in the six months to December 2020 and this has led to a large upgrade in the full year pre-tax profit forecast to £8.9m. There has been a bounce back in building and construction activity.
Trans-Siberian Gold (TSG) produced 15,217 ounces of gold at the Asacha mine in the fourth quarter, taking the total for the year to 45,066 ounces. Annual revenues were $81m. Production has stopped at Vein 25 because of an accident that killed two people. Mining in the main zone continues.
CCTV equipment supplier UniVision Engineering Ltd (UVEL) has signed a supplementary agreement with MTR Corp in Hong Kong for an additional £1.53m of work.
Jade Road Investments (JADE) is the new name for Adamas Finance Asia.
MAIN MARKET
LED lighting and wiring accessories supplier Luceco (LUCE) traded at the top of expectations in 2020, helped by a strong second half. Pre-tax profit will be around £29m, up from £15.8m in 2019. Cash generation is strong and net debt has declined to £18.3m.
Castillo Copper (CCZ) is considering selling its Broken Hill Alliance (BHA) project. This will enable the company to focus on the Mt Oxide project in Queensland, where there have been positive drilling results. Plans are being made to accelerate the development of this project. There should be more news about the other assays from the drilling and there will be modelling of a JORC resource. It makes sense to focus on this asset. BHA has is highly prospective for silver, zinc and lead in the west zone and iron oxide copper gold in the east zone. There should be interest from companies operating in the region. BHA could be sold or spun off into a quoted vehicle.
Personal care products supplier InnovaDerma (IDP) is raising £4m from a placing with up to £500,000 more to come from an open offer. This cash will finance investment in ecommerce and improve the balance sheet. The business continues to lose money. It could be profitable in 2021-22.
Argo Blockchain (ARB) has raised £22.4m at 80p a share and the cash will be invested in more crypto currency mining equipment. This will be installed between February and June. Capacity will be increased by nearly three-fifths.
Strong footwear sales helped Zotefoams (ZTF) to achieve slightly higher revenues in 2020 with pre-tax profit at the top end of expectations.
Flavour ingredients supplier Treatt (TET) continues to perform strongly in the first four months of the financial year. Drinks volumes have increased despite Covid-19 restrictions and this has helped Treatt. Forecasts have been raised with the 2020-21 pre-tax profit figure increased from £15.2m to £18.2m.
Tiziana Life Sciences (TILS) has switched from AIM to the Main Market.
Pensana Rare Earths (PRE) will drop the ASX listing on 24 February.
Andrew Hore
Tiziana Life Sciences #TILS – Appoints Optiva Securities Limited as Broker
Tiziana Life Sciences plc (AIM:TILS) is pleased to announce the appointment of Optiva Securities Limited as its broker with immediate effect.
Enquiries:
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
Optiva Securities Limited
Robert Emmet + 44 (0)20 3981 4173
For further information, please visit the Company’s website at www.tizianalifesciences.com .
Tiziana Life Sciences #TILS presents StemPrintER, a superior prognostic test compared to Oncotype DX to predict breast cancer
Tiziana Life Sciences announces presentation of StemPrintER, a superior prognostic test as compared to Oncotype DX to predict breast cancer
· StemPrintER Outperforms Oncotype DX in analysis with 800+ samples from ER+/HER2- postmenopausal breast cancer patients
· SPARE Model is up to 40-50% more accurate than standard clinical markers in analysis with 1800+ samples for prediction of distant metastasis
New York/London – May 29, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today results, from a poster selected for discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference, demonstrating the superiority of StemPrintER stem cell based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2- postmenopausal breast cancer patients. A second poster describing results on prediction of distant recurrence using a next generation StemPrintER model, named SPARE, presented in a separate ASCO session, showed even more refined accuracy than standard clinicopathological markers in predicting risk of distant recurrence. Both posters were authored by a team of scientists from the European Institute of Oncology in Milan, and the head-to-head comparison of StemPrintER with Oncotype DX was conducted in collaboration with the Royal Marsden Hospital and Queen Mary University in London.
As announced previously, the Company intends to demerge its StemPrintER and SPARE (together “StemPrintER”) genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity.
Major Highlights of Results
1. The first poster, which was also part of a discussion session, “Comparison of StemPrintER, a Novel Biology-based Genomic Predictor of Distant Recurrence in Breast Cancer, with Oncotype DX in the TransATAC cohort,” shows that StemPrintER
· Outperforms Oncotype DX in 10-year risk prediction in more than 800 ER+/HER2- postmenopausal breast cancer patients in the analysis, including in lymph node-negative (N0) and 1 to 3 lymph node-positive (N1-3) patients1
· Significantly (p<0.0001) stratifies high vs. low risk groups when adjusted for clinical parameters as expressed by clinical treatment scores (CTS)
2. The second poster, “Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer patients,” demonstrates that the next-generation StemPrintER Risk Score (SPARE) model
· Shows approximately 20% superiority to the traditional clinicopathological parameters, as expressed by the CTS, in providing prognostic information for the more than 1,800 patients analyzed and in certain populations was demonstrated to be up to 40-50% more accurate.
· Investigators found that SPARE added substantial prognostic information to CTS, but the inverse was not proven to be the case.
__________________________
1 N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) might describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.
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 information is Dr Kunwar Shailubhai, the Company’s Chief Executive Officer and Chief Scientific Officer.
About ER+/Her2- breast cancer
Endocrine receptor-positive (ER+) breast cancers constitute the majority of breast cancer cases (~75-80%) and display remarkable variability in clinical behaviour. This heterogeneity makes prognosis and therapy response often challenging to predict using the standard clinicopathological features of the tumor. Although the overall prognosis for this group of patients is good, a significant proportion (>20%) of these women will experience distant recurrence in the first 10 years post-surgery. For ER+ patients who also have a negative HER2 status (HER2-), the standard of care is endocrine therapy with the addition of adjuvant chemotherapy in those patients considered to be at risk of recurrence according to clinicopathological parameters. However, it has become apparent that these parameters are often insufficient to predict risk of recurrence in ER+/HER2- BC patients, and, as a consequence, a significant proportion of these patients are either over- or under-treated. Multigene prognostic tests can assist decision making on treatments, differentiating low risk patients who could be safely SPARE chemotherapy from higher risk patients who might benefit from chemotherapy.
About StemPrintER/SPARE
StemPrintER, and its next generation derivative SPARE that combines StemPrintER with two clinical markers, namely lymph nodal status and tumor size, in a more refined risk model, is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, ER+/HER2- breast cancer patients, based on the detection of 20 cancer stem cell markers normalized to 4 housekeeping genes. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn’s Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.
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
CORE IR
ir@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Andrew Hore – Quoted Micro 25 May 2020
AQUIS STOCK EXCHANGE
Daniel Thwaites (THW) closed its pubs and hotels on 20 May and it will not pay a final dividend for 2019-20. Net debt was £65.4m at the end of March 2020 and there are £16.6m of spare bank facilities. Trading had been strong, and the predominance of freehold properties means that rent payments is not as big a concern as it is for some pub operators.
Housebuilder St Mark Homes (SMAP) had a NAV of 127p a share at the end of 2019. The share price is 87.5p. There is cash of £4.8m and the company intends to pay off its bond, which has a 6% coupon. In 2019, pre-tax profit dipped from £117,000 to £114,000.
KR1 (KR1) has raised $353,000 from the sale of RPL tokens, relating to the Rocket Pool, which is developing a proof-of-stake infrastructure service using Ethereum 2.0. The tokens were acquired for $0.21 each and sold at $1.67 each. The majority of the RPL tokens acquired are still held by KR1 even though there was a buyer for all of them. The takeover of digital asset custodian Volt Ltd has generated a further $244,000.
Rutherford Health (RUTH) has signed a framework agreement that will enable it to provide cancer treatment services to NHS trusts. The deal lasts an initial period of two years.
Altona Energy (ANR) has cancelled its open offer because the minimum amount was not raised. Instead, management is in discussions with three companies that could reverse into Altona. Cash will be required to cover the costs of a reverse takeover.
Trading has resumed in Lombard Capital (LCAP) shares. Lombard’s waste and recycling subsidiary is acquiring land in Preston for £1.08m. Lombard needs to issue more bonds in order to fully fund the purchase. Existing bond holders are swapping £507,000 worth into shares at 25p each and £320,000 has been raised from the exercise of warrants at 10p each. The current share price is 27.5p and it is more than five times the level it was two months ago. The site was previously used for recycling and Lombard will reapply for an environmental licence. It will be used for a waste to energy project and a plastic recovering plant.
Coinsilium Group Ltd (COIN) has been appointed as adviser to Kesholabs, a Kenya-based blockchain technology developer. Kesholabs is developing three applications that could be launched within 12 months.
Clean Invest Africa (CIA) says that CASA is set to resume limited operations after the lockdown in South Africa. CASA will produce test work and production of anthracite samples.
Ananda Developments (ANA) subsidiary DJT plants has met with the MHRA to discuss its plans to grow strains of cannabis. This is part of the licence application to grow medicinal cannabis. There will be further consultation with the UK authorities.
World High Life (LIFE) says that subsidiary Love Hemp has increased capacity for its LH Botanicals business.
IWEP is swapping part of its loan to Eight Capital Partners (ECP) into a 29.8% stake at 0.025p a share. Shares have also been issued to creditors to satisfy money owed.
First Sentinel (FSEN) has invested £270,000 in Stabiltech Biopharma as part of a £6m fundraising. The corporate finance subsidiary is advising the investee company on further fundraisings. The vaccine developer is developing a potential vaccine for COVID-19. Clinical trials should start in June.
Secured Property Developments (SPD) is still seeking property investments. There is £514,000 in the bank and net assets of £470,000.
All Star Minerals (ASMO0 has raised £80,000 at 0.02p a share and a further £170,000 is being sought. Ian Harebottle and Richard Lloyd, who both have mining experience, are joining the board.
NQ Minerals (NQMI) has raised £189,500 in placings at 7p a share and 7.5p a share. NQ has raised £340,000 in the past fortnight.
Shareholders have passed the resolution to consolidate 100 existing Wheelsure Holdings (WHLP) shares into one new share.
Sport Capital Group (SCG) has appointed Peterhouse as joint broker.
Engineering businesses consolidator Vulcan Industries is seeking admittance to the Aquis Stock Exchange. The focus is profitable metal fabrication and precision engineering businesses. First Sentinel is corporate adviser. The expected admission date is 1 June.
AIM
Renalytix AI (RENX) plans to gain a Nasdaq listing. The renal diagnostics company has not decided how much money it wants to raise. Renalytix AI has launched a joint venture to develop and produce COVID-19 antibody test kits.
STM (STM) subsidiary Carey has won a court case brought by a client. Adams v Carey related to a non-advisory SIPP taken out by Adams and an investment that he asked to be put in the SIPP. The investment performed poorly, and Adams claimed for loss of value. This case has been going on for more than two years.
Employee background checks provider ClearStar (CLSU) has launched a COVID-19 testing service that will help employers with back to work planning. That could attract additional clients for ClearStar’s services.
Imaging services provider IXICO (IXI) increased interim revenues from £3.43m to £4.56m and that helped to more than double profit from £215,000 to £475,000. There was cash of £6.66m at the end of March 2020. The order book is strong. It was £15.3m at the end of the interim period and more has been added since then. Data analysis from existing trials is continuing during the lockdown.
Tiziana Life Science (TILS) intends to demerge its genomics-based personalised medicine businesses into a separate quoted vehicle. This will enable the business to raise cash to develop the StemPrintER technology for the prediction of disease recurrence in breast cancer patients.
Tissue products developer Tissue Regenix (TRX) raised £14.6m at a share price of 0.25p. This was much-needed cash because existing funds were about to run out.
A share placing by Open Orphan (ORPH) at 11p a share raised £12m after expenses. This will help to finance services for COVID-19 vaccines and tests, as well as more laboratory facilities.
Digital TV technology provider Mirada (MIRA) has extended the term for its revolving credit facility by 12 months to the end of November 2021. Earlier this month, Mirada launched a lower cost version of its technology. Iris in Swift Mode is a pre-packaged platform.
Eddie Stobart Logistics (ESL) has acquired the Eddie Stobart brand from Stobart Group (STOB), which will have to change its name, for £10m. An annual fee of £3m was payable for the brand. This will be saved from now on. There have been some reductions in activity due to COVID-19, but grocery and e-commerce demand remain strong.
Cash shell Summerway Capital (SWC) has £5.55m in the bank as it continues to seek an acquisition.
MAIN MARKET
Contango Holdings (CGO) has published a prospectus relating to the acquisition of the Lubu coal project. The potential deal was announced more than one year ago. A £1.4m placing at 5p a share in January will finance costs and initial investment in the Lubu project. Readmission is expected on 18 June.
The Takeover Panel Executive has denied Moss Bros (MOSB) bidder Brigadier’s attempt to lapse its offer. Brigadier has asked for the ruling to be reviewed.
Pure Gold Mining Inc (PUR) has secured a $15m investment at $1.52 a share. This will be invested in the Red Lake Mine.
Loans to Shefa Gems (SEFA) totalling £1.25m have been converted at a premium to the market price. The shares issued account for 14.5% of the enlarged share capital.
Andrew Hore
Tiziana Life Sciences #TILS – Demerger of StemPrintER Genomics-Based Personalized Medicine business as a separate listed company
New York and London, May 22, 2020 – Tiziana Life Sciences plc (NASDAQ: TLSA, AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announces that it intends to demerge its StemPrintER and SPARE (together “StemPrintER”) genomics-based personalized medicine businesses into a separate company and effect a capital reductionto facilitate the spin-out and listing of StemPrintER as an independent entity.
Following the Company’s recent announcement concerning the trial conducted by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, the Company’s Board, which has been considering options for StemPrintER for some time, is pleased to announce that they consider that the results of the trial and the progress made substantiate the viability of StemPrintER as having the potential to be a standalone business and accordingly intend to proceed with steps for a spin-out, by way of demerger, and listing on a public market of a new independent genomics-based personalized medicine company focused on the StemPrintER business.
The rationale of this decision is that, as a standalone genomics-based personalized medicine company and separate legal entity, StemPrintER could:
- Secure separate financial resources, with the goal of enabling accelerated development of the StemPrintER genomic test;
- Separate StemPrintER from Tiziana’s biotechnology and pharmaceutical businesses so it may focus on the personalized medicine market; and
- Allow Shareholders to benefit from both Tiziana’s rapidly developing drug portfolio and the standalone value of StemPrintER as it progresses through its own development milestones and the path to commercialization and allow shareholders to receive the maximum potential value from StemPrintER as a standalone entity.
The Board is taking the necessary preliminary steps in preparation for a potential spin-out, including the incorporation of a new subsidiary to hold the relevant assets. The Company will also put proposals to shareholders at the Annual General Meeting to obtain the approval necessary for a capital reduction which will be required to implement the demerger.
Notwithstanding that the required approval for the capital reduction will be sought, these considerations remain at an early stage and there can be no guarantee that the demerger will be completed. The approval of the capital reduction will enable the Board, in due course, to declare distribution in specie of shares in the new StemPrintER entity to existing Tiziana shareholders.
No record date has yet been set for the entitlement to shares in the new StemPrintER entity as a number of technical, legal and accounting processes need to be completed before the demerger can be formally put to shareholders of Tiziana for approval. For the avoidance of doubt StemPrintER will remain a group business until such time as shareholders formally approve proposals for a demerger.
For shareholder interest and information, StemPrintER will be the subject of a poster discussion session (https://meetinglibrary.asco.org/record/185144/abstract) on 29 May 2020 titled “Comparison of StemPrintER, a novel stem cell biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort” at the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20).
Further announcements will be made at the appropriate time.
About StemPrintER and SPARE
StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.
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 INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY’S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC OFFICER.
Contacts:
Tiziana Life Sciences plc
United Kingdom:
|
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 |
United States:
Investors –
CORE IR
(516) 222-2560
ir@coreir.com
Media –
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Tiziana Life Sciences #TILS – Exercise of Warrants and Issue of Equity
London, New York, 18 May 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (the “Company” or “Tiziana”), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today announces that it has allotted and issued 264,286 ordinary shares of 3 pence each (“New Ordinary Shares”) credited as fully paid in respect of the exercise of 264,286 warrants at a price of 50 pence per share, yielding £132,143 in cash proceeds for the Company.
Application has been made for the 264,286 New Ordinary Shares to be admitted to trading on AIM (“Admission”), and dealings are expected to commence on or around 22 May 2020. The New Ordinary Shares will rank pari passu with the Company’s existing Ordinary Shares.
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 New Ordinary Shares to be issued in connection with the exercise of the warrants, the total number of Ordinary Shares in issue will be 161,031,169. 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 161,031,169 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.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn’s Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
For further enquiries:
|
Tiziana Life Sciences plc Gabriele Cerrone, Chairman and founder |
+44 (0)20 7493 2379 |
|
Cairn Financial Advisers LLP (Nominated adviser) Liam Murray / Jo Turner
|
+44 (0)20 7213 0883 |
Tiziana Life Sciences #TILS – Online Publication of Two Abstracts at ASCO Reporting Clinical Activity & Safety of Milciclib in Patients with Advanced Hepatocellular Carcinoma
New York and London, May 14, 2020 – Tiziana Life Sciences plc (NASDAQ: TLSA, AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases , today announces the online publication of two abstracts on clinical studies with Milciclib, a small molecule pan-inhibitor of cyclin dependent kinases (CDKs) in the proceedings of the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20)
The first abstract reports Phase 2a clinical data with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma (HCC) patients, for which it met the primary endpoint, that oral treatment with Milciclib was well tolerated with manageable toxicities and no recorded drug-related deaths. The second abstract reports preliminary clinical data from an ongoing investigator-originated trial with a combination of orally administered Milciclib and Regorafenib in liver transplant patients with recurrent HCC. Thus far, the study has shown mean AFP levels (a common tumor biomarker) reduced by approximately 20% within one month of treatment.
MAJOR HIGHLIGHTS
Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients. First Author: Erica Villa, MD., et al.
· Phase 2a multi-centered clinical evaluation of Milciclib (100 mg once daily; 4 days on/3 days off for 4 weeks; defining each cycle) for 6-month in 28 evaluable out of 31 enrolled patients in Italy, Greece and Israel.
· The trial successfully met the primary endpoint that oral treatment with Milciclib was well tolerated with manageable toxicities and no recorded drug related deaths.
· The secondary endpoints for clinical activity assessment were based on the independent radiological review using the modified Response Evaluation Criteria in Solid Tumors (mRECIST)
· Positive demonstrated clinical activity included:
1. 50% (14 out of 28) evaluable patients completed 6-month duration of the trial.
2. 64% (9 out of 14) patients requested and were approved by their respective ethical committees to continue the treatment.
3. Both median time to progression (TTP) and progression free survival (PFS) were 5.9 months (95% Confidence Interval (“CI”) 1.5-6.7 months) out of the 6-months duration of the trial.
4. Approximately 57% of evaluable patients showed ‘Stable Disease’ (SD; met at least once in an 8-week interval) and 3.6% patients showed ‘Partial Response’ (PR).
5. Approximately 61% of patients showed ‘Clinical Benefit Rate’ defined as CBR=CR+PR+SD (with CR representing Complete Remission).
6. Five patients on compassionate use continued the treatment for a total of 9, 9, 11, 13 and 16 months, respectively. Two patients continuing the treatment have reached 16 months.
“Advance cases of patients with HCC have limited therapeutic options because of the poor safety and tolerability of existing drugs. Thus, a newer drug, preferentially with a different mechanism of action, such as Milciclib is a necessary medical need,” stated Prof. Angelo Sangiovanni, M.D. principal investigator of the study and site investigator at Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy. “ In this context, safety, and tolerability of oral treatment with Milciclib is remarkable. Results from the phase 2a clinical study demonstrating clinical activity in these advance cases of HCC are notable. The fact that many of the treated patients continued with the treatment, even after completing 6 months duration of the study, is particularly very impressive.”
Abstract #307309: Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence. First Author: Alessandro Pivetti. MD., et al.
· Seven patients enrolled to date in this ongoing study
· Combination treatment of Milciclib and Regorafenib was well tolerated with manageable toxicities
· Mean AFP levels reduced by 20% within one month of treatment
· Patients treated for longer duration had 50% reduction in AFP levels
· Currently, patients enrolled in the study are in 2 to 10 months of treatment period
“Our center has been involved with clinical evaluation of several drug candidates in advanced HCC patients and both of the above-mentioned studies were conducted at our site. The oral treatment with Milciclib is not only very well tolerated but it also showed clinical activity. Most of these patients with advance cases of HCC are exhibiting stabilization of disease and have continued the treatment under a compassionate use program, which in my opinion is very impressive,”added Prof. Erica Villa, M.D. , site Investigator at the Policlinico di Modena, Modena, Italy. “ Moreover, the positive clinical activity and impressive safety and tolerability of Milciclib in combination with Regorafenib in liver transplant patients with recurrent HCC is certainly noteworthy. Thus, clinical data from these two studies are very encouraging and warrant continued development of Milciclib, either as monotherapy or combination therapy.”
About Milciclib (TZLS-201)
Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn’s Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
About ASCO
The American Society of Clinical Oncology (ASCO) was established in 1964 with the sole purpose of improving the care of people with cancer. Membership currently stands at 40,000 physicians and scientists. ASCO is one of the premiere organizations for the advancement of cancer treatments and the annual ASCO meeting is an important forum for discussion of new cancer therapies and treatments.
For more information go to http://www.tizianalifesciences.com
THE PERSON WHO ARRANGED FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY’S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC OFFICER.
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
CORE IR
ir@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Alan Green talks markets, Tiziana Life Sciences #TILS, Blue Prism #PRSM & Tertiary Minerals #TYM on UK Investor Mag podcast
Alan Green discusses markets, Tiziana Life Sciences #TILS, Blue Prism #PRSM & Tertiary Minerals #TYM with Jonathan Roy on the UK Investor Mag podcast. Link on the image to listen.
Tiziana Life Sciences #TILS – ASCO Conference – StemPrintER Study Presentation
Tiziana Life Sciences Announces Data Demonstrating StemPrintER’s Superiority Compared to OncotypeDX in Providing Prognostic Information to Conventional Clinical Parameters in Breast Cancer Patients in Poster Discussion Session at the American Society of Clinical Oncology (ASCO) Virtual Conference
Additional data to be presented validating the SPARE Model for Distant Metastasis Prediction utilizing the Company’s StemPrintER Platform
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
New York/London – May 14, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today that a new study will be presented by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients during a poster discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference. The study demonstrates greater refinement and superiority of StemPrintER over current market leader Oncotype DX in delivering prognostic information as part of the therapeutic decision-making process in ER+/HER2- breast cancer patients. An additional abstract from the scientists at the European Institute of Oncology will be presented in a separate poster session, which details a further refined risk model, the SPARE model, based on the combination of StemPrintER with clinical parameters for distant metastasis prediction. Both abstracts, became available May 13, 2020, while the posters and discussion session will be held during The American Society of Clinical Oncology (ASCO) Virtual Conference May 29-31, 2020.
Each of these studies independently provides significant additional information on the value of StemPrintER — and its derivative SPARE (detailed below) — as clinical tools to aid personalized therapeutic decision-making in women with ER+/HER2- breast cancer. Of particular note is the comparative precision of StemPrintER over Oncotype DX in predicting the potential recurrence of certain types of breast cancer following treatment. The two studies highlight the importance of the stem cell approach to develop a potentially powerful prognostic tool to predict breast cancer prognosis.
Abstract #1020, “Comparison of StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort,” is an independent validation of the prognostic value of StemPrintER in a cohort of more than 800 luminal ER+/HER2- postmenopausal breast cancer patients from the international TransATAC study and a head-to-head comparison of the prognostic power of StemPrintER with OncotypeDx. Results provide independent validation of StemPrintER as a potentially powerful prognostic tool to stratify patients for the risk of early or late recurrence independently of other clinicopathological parameters. Importantly, the study also shows that StemPrintER is superior to OncotypeDX in the prediction of 10-year recurrence risk in all patients, as well as in N0 and N1-3 patients. The study further demonstrates that StemPrintER is capable of outperforming OncotypeDX in providing additional prognostic information to the standard clinicopathological parameters.
Abstract #1057, “Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer (BC) patients,” develops a more refined risk model for distant metastasis prediction, which combines StemPrintER with tumor size (pT) and nodal status (pN). The new model is termed SPARE (StemPrintER for Personalized Adjuvant Therapy in Endocrine Receptor-Expressing Patients) and, in the analysis of a consecutive-retrospective cohort of more that 1,800 ER+/HER2- breast cancer patients with 15-year complete follow-up from the European Institute of Oncology (IEO) in Milan, revealed to be an even more powerful tool, compared to the original StemPrintER for predicting early and late distant metastasis risk independently of standard clinical parameters.
“These data sets demonstrate that StemPrintER has the potential to become an essential prognostic tool that will help clinicians to tailor more or less aggressive therapy based on a more accurate risk assessment of disease recurrence compared to what we have seen to date,” added Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. “This product also represents an important addition to our existing therapeutic pipeline as it opens Tiziana into the area of precision medicine, creating an entirely new business line beyond our current patented technology in offering new delivery mechanisms for monoclonal antibodies.”
About StemPrintER
StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.
The person who arranged for the release of this information is Dr Kunwar Shailubhai, the Company’s Chief Executive Officer and Chief Scientific Officer.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn’s Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.
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
CORE IR
ir@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Tiziana Life Sciences #TILS to present two studies featuring StemPrintER during the American Society of Clinical Oncology (ASCO) Virtual Conference
New York/London – May 11, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announces that two abstracts on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, will be presented at the American Society of Clinical Oncology’s 2020 Virtual Conference. All abstracts, including Abstract #1020, which compares Tiziana’s product to current market leader Oncotype DX as part of a poster discussion session, will be available online beginning May 13, 2020 beginning at 5:00 PM ET at abstracts.asco.org. The American Society of Clinical Oncology (ASCO) Virtual Conference will be held from May 29-31, 2020.
In addition, the Company will publish online two e-abstracts featuring its Miliciclib compound for the treatment of hepatocellular carcinoma on 13 May 2020 but which will not be presented as part of the conference.
Abstracts include:
Poster Discussion Session, Breast Cancer, Metastatic:
· Abstract #1020: “Comparison of StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort”
Poster Session, Breast Cancer, Metastatic:
· Abstract #1057: “Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer (BC) patients”
e-Abstracts include:
· e16711: “Phase 2a safety and efficacy of Milciclib, a pan-cyclin dependent kinase inhibitor, in unresectable, sorafenib-refractory or -intolerant hepatocellular carcinoma patients”
· e16634: “Safety and clinical activity of combination treatment with regorafenib and milciclib in liver transplant patients with hepatocellular carcinoma recurrence”
“These data being presented at ASCO are significant for our oncology portfolio and highlight a complementary technology for detection of breast cancer,” said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. “Of particular note is that one of these studies was selected to be part of a poster discussion session during the meeting. We look forward to sharing these critical data on our StemPrintER clinical diagnostic for ER+/HER2- breast cancer patients and its utility in potentially optimizing therapeutic decision-making, especially in the discussion of StemPrintER relative to the current market leader, Oncotype DX.”
About StemPrintER
StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.
About Milciclib
Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycin receptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety in 316 patients with advanced solid cancers in Phase I and II studies and shown indications of efficacy. In two completed Phase II thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints. While the current standard of care for hepatocellular carcinoma (HCC), the most common liver cancer, is only effective in a small percentage of patients, Milciclib has the potential to be broadly effective because it targets the underlying cause of disease. A unique feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222, that promote the formation of blood vessels (angiogenesis) to facilitate the spread of cancer cells. Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance to treatment with Sorafenib.
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, multiple sclerosis, type-1 diabetes (“T1D”), Crohn’s disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.
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
CORE IR
ir@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com