Oslo, Norway, November 17, 2021 – PCI Biotech (OSE: PCIB), a cancer biopharmaceutical company, today announced its third quarter 2021 interim results. Please find the report and presentation attached.
* The recruitment of patients in the RELASE study is always difficult and fluctuating – Covid-19 has a continued negative impact on the study and with August being a low recruitment month due to the holiday season, only five patients were recruited in the third trimester
* Three patients were included in the RELEASE study in October and the company continues to focus on recruitment, with an emphasis on regular trial management, including assessment of overall performance and replacement of the site
* Thirty patients were included in the RELEASE study at the end of October and the schedule for the interim analysis remains 2H 2023
* Proactively pursue strategies to address recruitment and retention, including interactions with the FDA and EMA regarding an alternative study design
* The program is moving towards the launch of a Phase II proof-of-concept clinical study, with product definition and study design clarified following extensive consultations with international experts
* Development plan initiated on the basis of strategic research and collaborations, targeting applications adapted to the specific strengths of PCI technology
* Significant strengthening of the organization with three highly qualified people; an experienced operational leader for RELEASE, and two key employees within clinical science and business development focusing on fimaVacc and fimaN / Avs
Per Walday, CEO of PCI Biotech, comments: “The strengthening of organization with three key employees To positively contributed To progress in all development areas, corn the RELEASE study is Unfortunately always touched by the Covid-19 panhalf. Sscheduling of the local administration of light at bile duct by endoscopy stay difficult in the RELEASE study, as clinical trial sites continue to face a backlog of patients. The situation should improve as vaccination rates increase in the future. We focus entirely on optimal study performance and progress, with particular attention to site performance and proactive management of study-specific risks. We are too pursuer strategic options to address retention and recruitment, including In progress interactions with regulatory authorities regarding a well prepared and rational study design change using external control data in RELEASE. The first responses from regulatory authorities do however suggest important challenges for use this approach in a pivotal first-line treatment trial. We are happy to provide more granularity on the next steps for fimaVacc, as product definitionnoand the study approach has been clarified after full interactions with KOLs. We look forward to bringing this exciting program with encouraging early clinical immune response results To proof of concept in a combined treatment framework with immunomodulatorIom in solid tumors. A stronger strategy the focus was on the fimaNAc program with focus on specific applications suitable for strength of the PCI Technology, and we continue to pursue new value-added collaborations Opportunities.“
The presentation will take place in English today, Wednesday, November 17, 2021, at 8:30 a.m. CET (local time). The presentation can be followed as a live webcast, accessible via the link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/2021117_3 or the company’s website under “Investors – Reports and Presentations – Webcasts “.
There will be a question-and-answer session at the end of the presentation and it will be possible to post written questions through the webcast console. The presentation will also be delivered via teleconference, primarily facilitated for investors intending to ask questions verbally during the question-and-answer session.
Dial–in detail for teleconferencing, mainly ease for verbal questions during the question-and-answer session:
If you plan to use this facility, please join the event 5-10 minutes before the scheduled start time using the phone numbers below. A line mediator will provide information on how to ask questions.
Norway +47 2350 2007 / Sweden +46 (0) 8 5033 6574 / Denmark +45 35 15 80 49 / United Kingdom +44 (0) 330 336 9125 / United States +1 929 477 0324. If your country does not is not listed, we recommend using the UK login details.
When prompted, provide the confirmation code or event title.
Confirmation code: 7356590
Title of the event: PCI Biotech
The interim report and presentation will also be available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com from 07:00 CET on November 17, 2021.
For more information, please contact:
Ronny Skuggedal, Chief Financial Officer
Email: [email protected]
Mobile: +47 9400 5757
About PCI Biotech
PCI Biotech is an advanced-stage biopharmaceutical clinical development company focused on the development and commercialization of novel therapies for the treatment of cancer through its innovative photochemical internalization (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaChemistry (reinforcement of chemotherapy for the localized treatment of cancer), fimaVacc (T cell induction technology for therapeutic vaccination), and fimaNAc (administration of therapeutic nucleic acids).
Photochemical internalization induces triggered endosomal release which is used to unleash the true potential of a wide range of therapeutic modalities. The company’s flagship program fimaChemistry consists of a pivotal study in bile duct cancer, an orphan indication with a high unmet need and no approved products. fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works synergistically with several other advanced vaccination technologies. fimaNAc uses endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and RNAi therapies, thereby addressing one of the major bottlenecks facing this emerging and promising field.
For more information, please visit: www.pcibiotech.com
Contact details: PCI Biotech Holding ASA, Ullernchaussée 64, N-0379 Oslo
This announcement may contain forward-looking statements, which as such are not historical facts, but are based on various assumptions, many of which are, in turn, based on other assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other significant factors. These risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by these forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
This information is subject to disclosure requirements in accordance with Section 5-12 of the Norwegian Securities Law.
PCI Biotech Q3 Interim Report 2021
PCI Biotech Q3 2021 presentation