On November 23, 2018 Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (the "Company" or "Tiziana"), a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, reported the closing of its underwritten, registered public offering in the United States (the "Offering") of 442,910 American Depositary Shares ("ADSs"), representing 4,429,100 new ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares") at a price of $9.90 per ADS, for aggregate gross proceeds of approximately £3.42 million (or $4.39 million at a GBP1 : US$1.2839 exchange rate), before deducting underwriting discounts and commissions (Press release, Tiziana Life Sciences, NOV 23, 2018, View Source [SID1234531588]). Each ADS offered represents 10 Ordinary Shares. All ADSs sold in the Offering will be offered by the Company.

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In addition, Tiziana has granted the underwriter a 30-day option to purchase up to an additional 66,437 ADSs on the same terms and conditions (the "Option"). 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.

The ADSs began trading on the Nasdaq Global Market ("Nasdaq") under the ticker "TLSA" on 20 November 2018.

Laidlaw & Company (UK) Ltd. acted as the sole book-running manager in respect of the Offering.

Following Admission, the issued share capital of the Company will be 136,409,818 Ordinary Shares (or 137,074,183 Ordinary Shares if the underwriters exercise the Option in full) and this figure may be used by shareholders as a denominator for the calculations by which they will determine if they are required to notify their interest in, or change to their interest, the Company, under the Disclosure Guidance and Transparency Rules published by the UK Financial Conduct Authority. 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 Offering was made only by means of a prospectus, which, for the avoidance of doubt, did not constitute a "prospectus" for the purposes of the Prospectus Directive (as defined below) and was not been reviewed by any competent authority in any Member State (as defined below).

Copies of the final prospectus and accompanying prospectus relating to and describing the terms of the Offering may be obtained from Laidlaw & Company Ltd., Attention: Syndicate Department, 521 Fifth Avenue, New York, NY 10175, by telephone at +01 (0)212 953 4917 or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus are also available on the website of the US Securities and Exchange Commission (the "SEC") at www.sec.gov.

A registration statement relating to these securities was declared effective by the SEC on 19 November 2018.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

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 Directive (as defined below), this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term "Prospectus Directive" means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

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 have been subject to a product approval process, which has determined that such securities 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" (for the purposes of the MiFID II Product Governance Requirements) should note that: the price of ADSs may decline and investors could lose all or part of their investment; the ADSs offer no guaranteed income and no capital protection; and an investment in ADSs 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.

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 ADSs.

On November 23, 2018 Kancera AB (publ) reported that unique blockers of the Fractal System have been patented. From the patented blockers, Kancera intends to further develop a new drug candidate, which is estimated to take about 12 months (Press release, Kancera, NOV 23, 2018, View Source;releaseID=1593528 [SID1234531596]).

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• Kancera provided an operational update for the Fractalkine project as follows •Research results show that blockade of the Fractal system can be expected to protect both heart and kidney function in inflammation

• Clinical studies focusing on cardiovascular inflammation of myocardial infarction are expected to start in the first half of 2019

• Kancera’s research in cancer continues with a focus on lymphoma (biomarker study scheduled for completion in the fourth quarter of 2018) and ovarian cancer (EU-funded preclinical research), while the Vinnova-funded study of neuroblastoma has been reported and completed.

• Kancera announced that the company is reorganizing to focus on Fractalkine projects.

• Kancera announced that results of cooperation with Karolinska Institutet were published in the journal Nature Communications under the title "Targeting PFKFB3 radiosensitizes cancer cells and suppresses homologous recombination".

SIGNIFICANT EVENTS AFTER THE END OF THE THIRD QUARTER

• Kancera has reported that the company has registered a patent application (EP18205819.8) for a third series of novel substances that selectively inhibit the enzyme HDAC6 for the treatment of inflammation and cancer

.• In the framework of EU research program Horizon 2020, Kancera has been awarded a research grant of a total of approximately 250,000 Euro for funding a doctoral student in order to explore the role of the Fractalkine system in the development of pain in arthritis.

• Kancera has announced that terms have been developed for shareholders’ investment decisions in the company by Global Corporate Finance Inc. (GCF), New York. The investment, which covers a maximum of SEK 60 million over 30 months, is intended to take place in tranches (rounds) of which Kancera determines the timing.

• Kancera hereby provides a status update for the Fractalkine project:

New effect study in animal model of myocardial infarction showed that lower doses than expected give a significant cardiovascular effectssww
Preliminary results from the GLP toxicology study showed that the calculated effective dose of KAND567 was safe (final results from this study are expected in January).
Phase 0 study in lymphoma patients will be completed in December and the analyzes are expected to be completed in January 2019
STATEMENT FROM THE CEO

In the Fractalkine project, we have strengthened our patent protection against competition and conducted a series of studies aimed at both preparing for Phase IIa cardiovascular patients and evaluating the possibility of an effect on blood cancer (lymphoma).

The protection has been further strengthened after our patenting of a new series of Fractalkine blockers that allow for the development of several independent products within the project.

Prior to the cardiac study in humans, the choice of intravenous dosing with KAND567 has been evaluated for efficacy and safety. The effect has been evaluated in a disease model of myocardial infarction and safety in a toxicological GLP study. The efficacy study showed that lower doses than expected provide a significant heart-protecting effect. Preliminary results from the toxicology study provide evidence pointing towards the safety of the calculated effective dose of KAND567 (final results from this study are expected in January). The next step in the preparation is the start of manufacturing KAND567 for intravenous treatment in clinical trials, which will occur within a few weeks. This means that the application for authorization for implementation of Fas Ib is planned to be submitted to the Medical Products Agency during the first quarter and completed during the second quarter of 2019 and that the corresponding Phase IIa application is scheduled for submission during the second quarter.

In May, we started a biomarker study (Phase 0) in lymphoma patients together with partners at Karolinska Hospital and the Institute. The aim of the study is to investigate whether there are groups of lymphoma patients in which the Fractalkine system is activated and possibly pervasive in the disease. Recruitment of patients has proceeded at a high rate in parallel with immunological analysis of blood samples. This means that sample collection can be completed in December and be analyzed in January. The results will determine whether continued evaluation of the role of the Fractalkine system in cancer continues toward lymphoma or focuses on the EU-funded solid tumor research project.

Interest in how Fractalkine affects various diseases in humans increases with continuous research progress, in the field of dementia and nerve pain amongst others. This has resulted in an invitation to participate in a further EU-funded research project with European research groups and pharmaceutical companies with the above focus. Kancera has participated in the application for this now approved EU project, starting in the spring of 2019.

The fact that Kancera is developing in the right direction we believe also forms the basis for the interest from the family-owned company GC Finance to invest in the company. The intention is to use capital injection from GC F (to be decided by an extraordinary general meeting) to expand to evaluate additional indications for the portfolio of Fractalkine blockers, expand clinical studies and for operations.

On November 22, 2018 Oncorena Holding AB reported that the company through a share issue has raised capital to build its organization and resources in preparation for clinical development with a patient study of a new treatment modality for advanced kidney (renal) cancer (Press release, Oncorena, NOV 22, 2018, View Source [SID1234531572]). The capital was raised from Oncorena’s largest shareholders P.U.L.S. AB and HealthCap, as well as other current shareholders. In addition, several new investors have made significant investments.

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The new capital will be used to build the company’s organization and resources, as well as all activities needed in preparation for the planned clinical study. In the phase I-IIa study to be conducted in patients with advanced kidney cancer on dialysis will be treated with Oncorena’s potential new drug orellanine. Orellanine is a substance that is taken up specifically by kidney cancer cells and kidney cells, pre-clinical experimental studies have shown very promising results.

"The new capital provides an important infusion to enable necessary steps in the development of orellanine into a novel treatment for patients with advanced renal cancer. The medical need is high for these patients since there is no effective treatment with good tolerability available today," says Lars Grundemar, CEO of Oncorena.

"It will be a strategically important step for Oncorena when the clinical patient study with this innovative compound can be started. I am therefore pleased to notice the great confidence in Oncorena amongst the existing shareholders as well as from new investors," says Bengt-Åke Bengtsson, chairman of Oncorena’s board.

For further information, please contact
Lars Grundemar, CEO, Oncorena Holding AB, [email protected],
phone +46 (0)76 209 5518
Bengt-Åke Bengtsson, Chairman of the Board, Oncorena Holding AB, [email protected], phone +46 (0)70 746 0000

About kidney cancer
Approximately 1 in 10,000 is afflicted with kidney cancer annually. 80% of the patients are between 40 and 69 years of age when they are diagnosed (median age 63 years). The disease can often be cured with surgery if detected in time, but unfortunately the diagnosis is often made when the tumor has already spread to other organs. The prognosis is then considerably less favorable and certain groups have a median survival of only approx. 1.5 years. Today the disease is treated with various types of drugs, often with severe side effects, and standard chemotherapy drugs have only limited effect. There is therefore a high need for new, effective and safe drugs.

On November 22, 2018 Vineti, Inc., the leading digital "platform of record" for personalized therapies, reported a new partnership with Tessa Therapeutics to advance and scale personalized cell therapies for solid tumors in Asia and world-wide (Press release, Tessa Therapeutics, NOV 22, 2018, View Source [SID1234531574]).

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Tessa Therapeutics (Tessa), an international clinical stage biopharmaceutical company focusing on cellular immunotherapy treatments for cancer, is a leading developer of personalized T cell therapies for solid tumors, including head and neck cancers and cervical cancer. Vineti provides the leading digital software platform to align and manage the complex personalized cell therapy process, safely and efficiently.

The goal of the partnership is to scale Tessa’s therapies world-wide in a safe and efficient manner, supporting both late clinical stage therapies approaching commercialization and early-phase therapies progressing through various clinical stages. Tessa, headquartered in Singapore, brings international expertise through both its Asia operations and its global treatment network.

Tessa’s Virus-Specific T cell (VST) technology is showing compelling results and an excellent safety profile in the treatment of cancer. The company is currently conducting a multi-center Phase III trial targeting nasopharyngeal cancer, and a Phase I trial targeting cervical cancer and oropharyngeal cancer, set to move into Phase II in 2019. In addition, Tessa is developing a broad pipeline of pre-clinical therapies targeting major cancers such as liver and lung using its VST platform.

"As a team of industry experts who care deeply about patient care, Tessa understands the current challenges in cell therapy and is addressing them proactively by partnering with Vineti," said Tessa Chief Business Officer Jennifer Butler. "By running our therapies on the Vineti platform, we are taking an important step towards global commercial readiness."

Vineti’s platform will support Tessa as it builds its pipeline of therapies and prepares for commercialization, with a focus on providing a digital orchestration platform to track, trace, align, and simplify the complex journey that underlies each therapy’s personalized operations and logistics chain. Vineti is now supporting patients and clinicians in more than 65 leading medical centers, and is rapidly expanding to Asia-Pacific and Europe.

"Vineti is honored to support Tessa in its work to develop transformative, critically-needed therapies," said Vineti CEO Amy DuRoss. "The Vineti platform is designed to support innovative therapies as they evolve and scale. Therapeutic advances against solid tumors will make a real difference for even more patients, and we are very excited to help Tessa scale their treatments globally."

Vineti is the first cloud-based software platform to safely and efficiently move patient-based personalized therapies into mainstream medicine at scale. The Vineti platform – configurable, cloud-based, secure and scalable – brings the best of enterprise software to next-generation pharmaceutical science. Vineti’s solution aligns, manages, integrates and simplifies all the major steps and stakeholders in the inherently complex cell and gene therapy process, helping everyone from health care providers to biopharma and manufacturers exert efficiency and control to optimize the patient’s therapy journey.

This announcement follows Tessa’s recent research collaboration with St. Jude, and Vineti’s strategic teaming agreement with Deloitte.

On November 22, 2018 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, oral, selective AXL kinase inhibitors for multiple cancer indications, is reported the appointment of Alan Barge MD as Interim Chief Medical Officer and member of the leadership team (Press release, BerGenBio, NOV 22, 2018, View Source [SID1234531625]). The Company also announces further senior organisational changes and a strengthening of its clinical operations as it prepares for the intended advancement of its lead candidate bemcentinib into the next stages of clinical development.

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Dr Barge is a board-certified oncologist and haematologist, with more than 25 years of experience in cancer drug development, spent primarily at AstraZeneca and Amgen. He spent over 12 years at AstraZeneca, where he was VP and Head Oncology and Infection, during which time he was responsible for the development of Iressa (gefitinib) for non-small cell lung cancer (NSCLC) and the translational research that resulted in the successful personalised medicine strategy for AZ. Prior to AZ, Dr Barge was European and Global Medical Director at Amgen, at which he was responsible for European approval and label extensions for several of Amgen’s cancer therapies. More recently, Dr Barge has been actively involved in the biotech sector in both CMO and non-executive positions, including CMO of Carrick Therapeutics (UK and Ireland) and SVP Oncology at ASLAN Pharmaceuticals (Singapore).

Dr Barge will work as part of BerGenBio’s leadership team on an interim basis until a permanent CMO is appointed.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are delighted to welcome Alan to the team. His vast experience from developing successful cancer drugs with AstraZeneca and Amgen will be most valuable in forming and executing the Company’s clinical and regulatory strategy for bemcentinib as we enter the next phase of development. We anticipate further results from our phase II proof-of-concept studies of bemcentinib in NSCLC and AML in the coming months, and aim to start a randomised phase 2 trial programme in these indications in 2019."

In addition, BerGenBio announces the promotion of Dr Anthony Brown to Chief Scientific Officer from Director of Research, succeeding BerGenBio co-founder Professor James Lorens, who becomes a Senior Scientific Advisor to the Company. Murray Yule, BerGenBio’s Clinical Development Officer, will leave the Company with effect from 30 November 2018. Further, as noted during the Company’s 03 2018 results presentation, Dr Tone Bjaaland has recently been appointed as Director of Clinical Operations (>25 years’ experience in clinical research) and further strengthens the team.