GlobeNewswire by notified

PCI Biotech: First half-year 2020 results

Share

Oslo (Norway), 26 August 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim first half-year and Q2 2020 results. Please find enclosed the report and presentation.


Highlights

fimaChem
*The main priorities during the COVID-19 pandemic has been identification and implementation of potential mitigating actions for progressing the RELEASE study. Screening into the RELEASE study has been severely affected in the first half of 2020 with only one patient recruited during the pandemic, and the study has yet to enrol the first US patient. The situation is still unclear and the long-term consequences of the pandemic are uncertain

*Good progress in Asia, with the first 8 RELEASE study sites recently opened. A total of 44 sites are open by mid-August 2020 across EU, US and Asia and >50 sites are planned to be included into the study

*The Asian clinical sites are located in South Korea and Taiwan, providing access to hospitals and KOL’s in a commercially interesting region with higher prevalence of bile duct cancer than in the US and EU

*Several new initiatives to recoup long-term recruitment projections are being implemented, with the aim to accelerate patient inclusion when the current constraints on clinical trials inflicted by the COVID-19 pandemic are resolved. A complete picture of the consequences for the RELEASE study and the effect of the new initiatives are not yet available, but a delay of 6-12 months may be anticipated. The expected timeline for the planned interim analysis by 1H 2022 is therefore extended to range from 2H 2022 to 1H 2023, and the current cash-position may not be sufficient to reach interim read of the RELEASE study

*An article with a case report series from the Phase I study has been accepted for publication in Endoscopy International Open. The article provides a detailed description of treatment effects in three select patients at the dose chosen for RELEASE

fimaVacc
*Two new US patents have been granted in 2020, providing broad coverage for the combination of fimaVACC with various cytokines and a new important class of adjuvants

fimaNAc
*The evaluation period under the preclinical research collaboration with AstraZeneca has been extended by 6 months and the evaluation of the potential for a further collaboration now runs to the end of 2020

*The research collaborations have recently been reviewed for progress and value to PCI Biotech, and prioritised accordingly, resulting in closure of three collaborations

Corporate
*The management team was in May 2020 strengthened by the appointment of Dr Amir Snapir as CMO and Mr Ludovic Robin as CBO

Per Walday, CEO of PCI Biotech, comments: “Our highest priority during the COVID-19 pandemic has been the safety of our patients, employees and collaborators. We have previously communicated that this pandemic will result in yet undeterminable delays and increased cost, and we now see that recruitment into the RELEASE study has been severely affected by the COVID-19 pandemic. This is probably due to several factors, including the study being done in busy tertiary hospitals often requiring patient travel, involving treatment procedures demanding key hospital resources, and CCA being a rare disease. On the other hand, we have seen good progress in the work to ensure an optimised study when the pandemic issues are resolved, with regulatory approval and sites initiated in both South Korea and Taiwan, 10 new RELEASE study sites opened since the Q1 2020 report, and good progress in our efforts to relax relevant patient eligibility criteria. We have initiated work to include Ukraine in the study and are also considering further Asian countries. We should now be well positioned to accelerate the RELEASE study when the COVID-19 pandemic subsides. Two important fimaVacc patents have been granted in the US and we are intensifying our efforts to find partners and move this programme to clinical proof-of-concept in a disease setting. With all these tasks at hand, we are very pleased to have strengthened the executive team with Dr Amir Snapir as CMO and Mr Ludovic Robin as CBO, who have both taken strong strategic and operational ownership in the work.”

***
An online presentation in English will be held today, Wednesday 26 August 2020, at 08.30am CEST (local time). The presentation can be followed as a live webcast (access through link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20200826_2) or the company’s website under “Investors – Reports and presentations – Webcasts”. It will be possible to post questions through the webcast console.

The interim report and the presentation will also be available on www.newsweb.no and on the company's webpage, www.pcibiotech.com from 07:00am (CEST) on 26 August 2020.

For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757

About PCI Biotech         
PCI Biotech is a biopharmaceutical late stage clinical development company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead programme fimaChem consists of a pivotal study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.

For further information, please visit: www.pcibiotech.com
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo                

Forward-looking statements    
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Attachments

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release

Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a

DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release

Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68

Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release

Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.

Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release

AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us

Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release

VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye