PCI BIOTECH HOLDING ASA Unlocking the potential of innovative medicines
Unlocking the potential of innovative medicines
FIRST QUARTER 2020
INTERIM REPORT
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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LEVERAGING THE PCI TECHNOLOGY IN THREE DISTINCT AREAS
TRIGGERED ENDOSOMAL RELEASE
ABOUT PCI BIOTECH
PCI Biotech is an oncology-focused biopharmaceutical company headquartered in Norway and listed on the Oslo Stock Exchange. The company develops novel therapies for the treatment of cancer through its proprietary photochemical internalisation (PCI) technology originating from the world-leading research at the Oslo University Hospital - the Norwegian Radium Hospital. The PCI technology works by inducing light-triggered endosomal release which may unlock the true potential of a wide array of therapeutic modalities, such as small molecules, vaccines and nucleic acids.
PCI Biotech's lead programme is fimaCHEMwith the photosensitiser fimaporfin (Amphinex®), which entered the pivotal RELEASE study in May 2019, following the completion of a Phase I study with encouraging tumour response and survival data. The second programme fimaVACCis a vaccination technology that applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic vaccines. Successful clinical proof of concept was achieved in a Phase I study in healthy volunteers in 2019. The third programme fimaNACis a technology for intracellular delivery of nucleic acids, which is currently being evaluated in collaboration with key players in the field.
Unlocking the potential of innovative medicines
Highlights in the quarter
fimaCHEM
- The main priorities during theCOVID-19 pandemic has been identification and implementation of potential mitigating actions for the RELEASE study progress, as well as identification and removal of unnecessary recruitment hurdles in the study protocol. PCI Biotech has not yet a complete picture of the consequences for the RELEASE study, but delays in patient recruitment and increased costs are expected
- Several new initiatives to recouplong-term recruitment projections are being implemented, including potential modifications to screening parameters and further expansion into new countries. These new initiatives are being implemented to accelerate patient inclusion when the current restrictions of the COVID-19 pandemic are resolved, with the aim to reach interim analysis by Q2 2022. It is however currently not clear that the cash-position will suffice to reach interim read of the RELEASE trial, given the uncertainty surrounding long- term consequences of the unprecedented situation with the COVID-19 pandemic
- The majority of sites have halted or reduced patient screening and we are still awaiting enrolment of the first US patient. Site activations are delayed, but nonetheless 1 European and 3 US RELEASE study sites have opened since the Q4 2019 report. 34 of the 40 initially planned sites were open byend-April 2020
- Site preparations are ongoing for addition of Asian sites in 2020, to provide access to hospitals and KOL's in a region with higher prevalence of bile duct cancer and to enhance patient recruitment. So far progress has not been significantly impacted by theCOVID-19 pandemic and regulatory approval has been achieved in Taiwan
fimaVACC
- Two US patents granted in 2020 with broad coverage for the combination offimaVACCwith various cytokines and a new important class of adjuvants
- Atwo-pronged development strategy is pursued, with Phase I results being used both in direct partnering efforts and planning for clinical proof of concept in a disease setting
Corporate
- The management team has been strengthened with appointment of CMO Dr Amir Snapir and CBO Mr Ludovic Robin
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
Key figures
(In NOK 1,000) | 2020 | 2019 | 2019 |
Q1 | Q1 | FY | |
Other income | 1 929 | 2 245 | 9 392 |
Operating expenses | 17 893 | 20 354 | 98 195 |
Operating results | -15 974 | -17 929 | -88 804 |
Net financial result | 20 401 | -4 895 | 58 |
Comprehensive income | 4 427 | -22 824 | -88 746 |
Cash & cash equivalents | 258 080 | 328 757 | 261 103 |
Cash flow from operating activities | -22 866 | -16 489 | -83 471 |
Operational review and development programmes overview
Implications of the COVID-19 pandemic
PCI Biotech is closely monitoring potential implications on its short- and long-term operations following the development of the COVID-19 pandemic in 2020. PCI Biotech's overriding priority has been the safety of its staff, patients participating in the clinical trial and its collaborators. Other key priorities are now identification and implementation of potential mitigating actions for the fimaCHEMRELEASE study progress during the pandemic in collaboration with our contract research organisation, as well as identification and removal of unnecessary recruitment hurdles in the study protocol. PCI Biotech has not identified any major near-term shortage in supplies of investigational products or devices for the trial. PCI Biotech has per date of this report not a complete picture of consequences regarding timelines and costs for the RELEASE study, but delays and increased costs are expected.
PCI Biotech has a solid cash-position per Q1 2020, partly placed in EUR. It is however currently not clear that the cash-position will suffice to reach interim read of the RELEASE trial, given the uncertainty surrounding long-term consequences of the unprecedented situation with the COVID-19 pandemic.
For the fimaVACCand fimaNACprogrammes the main identified implications are transient downturn in business development activities.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
fimaCHEM
The fimaCHEMprogramme for local enhancement of cancer treatments is the most advanced of PCI Biotech's development programmes. The main focus is now to bring the lead candidate to the market through successful completion of the pivotal RELEASE trial for treatment of inoperable bile duct cancer.
RELEASE is a single randomised pivotal study with registration intent, building on encouraging results from the Phase I study. The first patient of a total of 186 patients was enrolled in May 2019 after final confirmation of the safety of up to two fimaCHEMtreatments in the Phase I extension study in April.
RELEASE will evaluate PCI Biotech's Amphinex®-the intravenous formulation of fimaporfin- in combination with the standard of care chemotherapy with gemcitabine and cisplatin.
Bile duct cancer is a rare disease with high unmet medical need and the combination of Amphinex and chemotherapy will be evaluated as a first line treatment, with orphan drug designation granted in both EU and the US.
RELEASE start-up activities and new initiatives
Start-up activities are ongoing for the RELEASE study, with site contract negotiations, regulatory and ethics approvals, site activations and final protocol harmonisation based on feedback from the different national regulatory bodies.
By date of this report, the company had received regulatory and ethics approvals for USA and 10 out of 11 planned European countries; Norway, Germany, France, Spain, Italy, Belgium, Poland, Sweden, Denmark and Finland. The remaining country is UK. The study was initially planned to be executed in approximately 40 clinical sites, of which 34 sites had opened for recruitment by end-April 2020. 5 of these sites are in the US and we are awaiting enrolment of the first US patient. In addition, regulatory approval for Taiwan was achieved in March 2020.
The RELEASE study has enthused investigators that are actively looking for patients, which is very important for clinical studies in rare patient groups such as cholangiocarcinoma. The opening of sites is however behind the original plan, and further impacted by the COVID-19 pandemic, which affects patient recruitment and study recruitment projections.
Several new initiatives to recoup long-term recruitment projections are being explored and implemented to accelerate patient inclusion when the current restrictions of the COVID-19 pandemic are resolved, with the aim to reach interim analysis by Q2 2022. These initiatives include potential modifications to screening parameters for removal of unnecessary recruitment hurdles, deployment of field-based personnel to understand patient flow and facilitate enrolment and expansion of the trial into new countries.
The design of the pivotal RELEASE study is based on regulatory interactions
The RELEASE study design has been based on the outcome of meetings with the two leading regulatory authorities, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). In the ongoing global protocol harmonisation process, the interim analysis primary endpoint has been changed from progression free survival (PFS) to objective response rate (ORR). The change is motivated by a post-investigational new drug (IND) recommendation by the FDA and the modification changes the interim read from an event driven analysis based on PFS to a recruitment driven analysis. The modification is not expected to have significant impact on the estimated timelines.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
Regular communication milestones for the RELEASE study
The planned communication milestones for the pivotal RELEASE study will be quarterly updates on the number of countries and clinical sites open for recruitment, as well as updates on expected timelines for major milestones. Other milestones and updates will be communicated as appropriate, including outcome of the IDMC reviews, as well as further details regarding timing and plan for interim analysis.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
Phase I results paved the way for the pivotal RELEASE trial with registration intent
The RELEASE study builds on the favourable safety results and encouraging early signs of efficacy in the Phase I study, with more than 80% of the patients being progression-free at 6 months.
The fimaCHEMtreatment boosts the chemotherapy effect locally in the bile duct. Local tumour response in the bile duct is important to maintain biliary drainage, and the primary tumour response may therefore be more important for survival outcome than would be the case for many other cancers.
Overview best overall response - patients with measurable disease in all cohorts (n=15)
(Cohort I, II & Extension: data from local read, Cohort III & IV: data from centralised read)
Tumour response translates into encouraging survival data
All patients have been followed-up for survival post-study and the finally confirmed median overall survival (mOS) for the full study ended on 16.1 months at final censoring, with two patients still being alive.
The group in the dose escalation study that received the RELEASE study dose (n=6, cohort IV) had a mOS of 22.8 months. Three of these patients exceeded 30 months survival, including one patient still alive more than four years after inclusion in the study. The mOS in the extension group (n=7), where patients received up to two fimaCHEMtreatments of the RELEASE dose was 16.6 months, with one patient still alive at final censoring. Five of the seven extension patients received two fimaCHEMtreatments.
Although these are small patient groups with considerable heterogeneity, PCI Biotech is pleased to see that the positive signs of tumour response seem to translate into encouraging survival data.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
Bile duct cancer and the fimaCHEMtechnology
Bile duct cancer originates in the ducts that drain bile from the liver into the small intestine. It is a rare disease with an annual incidence rate of 1-2 cases per 100,000 in the Western world but higher prevalence in most Asian countries.
There is currently no approved treatment specifically for extrahepatic bile duct cancer and the development pipeline for new potential treatments is limited. Bile duct cancer is also characterised by a remarkable resistance to common chemotherapy, leaving surgery as the only possibly curative treatment today. However, the majority of new cases are deemed inoperable upon presentation, meaning that there is a high unmet need for new drug classes, improved treatment technologies, or alternative methods in order to increase overall survival and quality of life for these patients.
The current Standard of Care (SoC) for inoperable extrahepatic bile duct cancer patients is stenting to keep the bile duct open, followed by a combination treatment with the chemotherapies gemcitabine and cisplatin. In preclinical studies, the fimaCHEMtechnology has significantly enhanced the effect of gemcitabine, which is the most studied and used chemotherapy drug in bile duct cancer treatment.
The bile duct is easily accessible for light application through routinely used endoscopic methods.
Comparator data for inoperable bile duct cancer
The median overall survival (mOS) in the studies that established the combination of gemcitabine and cisplatin as Standard of Care in bile duct cancer was 11.7 and 11.2 months respectively (Valle et al.NEJM (2010) 362:1273-81 and Okusaka et al.BJC (2010) 103:469-74).
While these results represent the best available published comparator data it should be noted that the results are not directly comparable to the data on inoperable extrahepatic bile duct cancer in the fimaCHEMPhase I study. The published studies include a wide range of different inoperable bile duct cancer patients, while the fimaCHEMtreatment is focused solely on inoperable extrahepatic bile duct cancer.
fimaVACC
The fimaVACCprogramme aims to enhance the cellular immune responses that are important for the therapeutic effect of vaccines, and the fimaVACCtechnology has proven excellent preclinical efficacy with protein- and peptide-based vaccines. The technology has shown particularly strong CD8 T-cell immune responses, which are important for therapeutic vaccination, as well as enhanced helper (CD4) T-cell and antibody responses.
Successful clinical proof-of-concept in healthy volunteers
PCI Biotech successfully translated the vaccination technology into humans through a Phase I study in healthy volunteers that was completed in May 2019. The immune results provided Proof-of-Concept and clinical support of fimaVACC's potential to enhance overall T-cell responses, by demonstrating improvement of the immunogenicity of vaccines in healthy volunteers.
fimaVACCprovides highly desired features for therapautic vaccination technologies:
- Increased number of responders
- EnhancedT-cell responses
- ImprovedT-cell functionality
The Phase I results showed a substantial increase in number of T-cell responders to HPV peptides already after two vaccinations, and a clear enhancement in the T-cell responses compared to the control
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
group. The important CD8 responses were more robust with fimaVACCand exhibited increased functionality compared to control.
More than 90 subjects were included, and tolerability of intradermal treatment with fimaVACCis established across a wide range of doses. The study results were presented at the ESMO Immuno- Oncology Congress in December 2019 and PCI Biotech aims for a publication in a relevant scientific journal in 2020.
Collaboration with international immunotherapy experts
The analysis of overall T-cell responses was done in collaboration with Oslo University Hospital, The Radium Hospital, and the analysis of CD8 T-cell responses were performed at the Department of Medical Oncology at Leiden University Medical Centre (LUMC) under the leadership of Professor Sjoerd van der Burg.
Potential COVID-19 opportunities
Significant efforts are being invested by the global health community to research and develop potential treatments against COVID-19. Most vaccine companies are currently focused on reaching the clinic with their own established technologies and may not be open for the inclusion of new technologies in the short term. PCI Biotech is nevertheless closely monitoring and exploring potential opportunities to contribute to these efforts, as the characteristics of the PCI technology may fit well with the medical needs.
New US patents granted
In January 2020, a US patent was granted providing a broad coverage for the combination of various cytokines with the fimaVACCtechnology. In March 2020, a further US patent was granted providing a broad coverage for the combination of the fimaVACCtechnology with a new important class of adjuvants, called toll like receptor agonists. These US patents secure protection until 2035, while patent applications are still pending in Europe and key Asian markets. These patents are important for PCI Biotech's development strategy, as it supplements the company's ability to potentially generate an internal future vaccine pipeline, in addition to bringing value for the fimaVACCtechnology in partnering efforts.
Research and development supported by a grant
The fimaVACCprogramme is supported by a government grant from the Research Council of Norway (BIA-programme) of up to NOK 13.8 million distributed over the course of four and a half years, 2017- 2021.
Immunotherapy with the fimaVACCtechnology
The pharmaceutical industry has long recognised the potential of therapeutic cancer vaccination, i.e. vaccines that treat cancer by inducing or strengthening the body's own immune response. The potential of combining cancer vaccination with immune checkpoint inhibitors has triggered a renewed interest in therapeutic cancer vaccines over the past years.
However, key issues remain to be solved, and the task of improving the immunogenicity of vaccine candidates is a main priority within the immunotherapy field. PCI Biotech believes the fimaVACCtechnology may play a key role in solving this challenge.
Effective induction of cytotoxic T-cells will be critical to realise the potential of therapeutic cancer vaccines, and today's vaccines often fail to generate such responses. One of the main reasons is likely insufficient delivery of vaccine antigens to the appropriate presentation pathway in the immune cells. The fimaVACCtechnology has the potential to effectively enhance vaccine presentation through these pathways.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
fimaNAC
The fimaNACprogramme provides a targeted intracellular delivery technology for nucleic acid therapeutics. It is a preclinical stage collaborative programme, with six research collaborations established with key players in the field.
The current collaboration partners include AstraZeneca and the five biotechnology companies Bavarian Nordic, BioNTech, eTheRNA immunotherapies, IMV and Phio Pharmaceuticals. All these collaboration partners are exploring synergies between their proprietary nucleic acid technologies and the fimaNACtechnology, with potential for further deepening of the partnerships.
The collaboration agreement with AstraZeneca has been extended several times and the scope of the collaboration was recently expanded to evaluate whether synergies established in oncology in vivomodels are transferrable to additional disease areas. The research collaboration ran to the end of 2019 and the companies have agreed to use the following 6 months until end of June 2020 to evaluate the potential for further collaboration.
The fimaNACtechnology and nucleic acid therapy
Several forms of nucleic acids are widely acknowledged to have significant therapeutic potential and numerous clinical trials are underway.
The therapeutic potential of compounds such as nucleic acids is however limited by the challenge of delivering sufficient amounts of large molecules into the cells. PCI Biotech believes the fimaNACtechnology may resolve this issue through enhanced delivery of the majority of nucleic acid types.
Corporate
Management changes
PCI Biotech appointed Dr Amir Snapir, MD, PhD as Chief Medical Officer (CMO), commencing from May 2020. Dr Snapir will also serve as a member of PCI Biotech's executive management team. He will lead the execution of all clinical development programmes, and be a key contributor to the identification and implementation of new opportunities and pipeline expansions. Dr Snapir brings extensive experience in global clinical development of novel therapeutics, from early clinical translation to marketing authorisation, combined with extensive international regulatory experience. Dr Snapir also brings years of experience in business collaborations, alliances and product co-developments. Since 2007 Dr Snapir has held various positions at Orion Pharma, Espoo, Finland, spanning from leader of clinical pharmacogenomics to clinical development leader in Oncology. In his most recent role, Dr Snapir held the position as Director, Rare Disease Development. Dr Snapir has a PhD from the University of Turku, Finland and an MD from the University of Tel Aviv, Israel. Dr. Snapir is the author of numerous scientific publications.
Dr. Hans Olivecrona has been CMO since autumn 2017 and has provided instrumental drive and competence to PCI Biotech's clinical projects, including design and start-up of the pivotal RELEASE study. From July 2019, the current CMO Dr. Olivecrona has operated via a consultancy agreement, and he will continue to be available for PCI Biotech on a consultancy basis to secure a smooth transition.
In April 2020, PCI Biotech announced the appointment of Mr Ludovic Robin, PharmD, MBA, as Chief Business Officer (CBO), commencing from May 2020. Mr Robin will also serve as a member of PCI Biotech's executive management team. He will lead all business and commercial development activities
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
and be a key contributor to the strategic decision making for the existing pipeline and to capture new opportunities. Over the last twenty-five years, Ludovic has held numerous international managerial positions providing leadership in the pharmaceutical industry in the areas of international research and development, business development, as well as marketing and sales. In particular, he has participated in the launch of more than fifteen original orphan drugs or specialty pharmaceuticals. Mr Robin joined Shire in 2004 serving as Marketing Manager, Business Unit Director, Marketing Director and Commercial Operations Head of France/Benelux. In 2016 he joined Advicenne, a French biotech listed on Euronext as CBO, deputy CEO, responsible for commercial strategy of the drug candidates under development/registration in EU and US. Mr Robin holds a Doctorate of Pharmacy (PharmD) from Lyon I University, a Master's in Industrial Pharmacy from Lyon Institute of Industrial Pharmacy, and an MBA from HEC Paris.
Financial review
Income Statement
(Figures in brackets = same period 2019 unless stated otherwise)
The Group has not recorded revenues for the financial year 2020 nor 2019. Grants received from public sources as the Norwegian Research Council "BIA" and "SkatteFUNN" are recorded as other income. Other income for Q1 amounted to NOK 1.9 million (NOK 2.4 million). The SkatteFUNN tax scheme has been modified by the authorities with effect from 2020, reducing the maximum benefit level. Timelines for PCI Biotech's BIA supported project has been extended with one year, until end of 2021. These changes cause reduction in other income for the quarter compared to 2019.
Research and development (R&D) expenses for Q1 ended at NOK 15.6 million (NOK 16.7 million). Operating expenses for the quarter were NOK 17.9 million (NOK 20.4 million). Operating expenses are mainly driven by the R&D activity level. The pivotal fimaCHEMtrial is the main cost driver, in both Q1 2020 and Q1 2019. For Q1 2020 the operating expenses are positively impacted by the change in estimated social security liabilities (recognised as long- and short-term liabilities) in connection with the share option scheme for employees. The net positive non-cash P&L effect for the share option scheme is NOK 2.0 million in Q1 2020 compared to Q1 2019.
Net financial results for Q1 2020 were NOK 20.4 million positive, compared to NOK 4.9 million negative in Q1 2019. The net financial results are mainly driven by exchange rate fluctuations on bank deposits placed in foreign currency, as a hedge of the foreign currency risk for the pivotal RELEASE study, and interest on bank deposits.
For the first time PCI Biotech presents a net positive result in the quarter, solely driven by the positive net financial result, which is due to positive exchange rate effects on bank deposits. Net profit for the quarter was NOK 4.4 million (net loss NOK 22.8 million).
Cash flow and balance sheet
The Group held cash and cash equivalents of NOK 258.1 million at the end of the quarter, compared to NOK 261.1 million per year-end 2019. Cash flow from operations is mainly dependent on R&D activities. Cash flow from operating activities was NOK -22.9 million in the quarter, compared to NOK -16.5 million Q1 2019, reflecting timing differences in settlement of liabilities from operational activities. All cash and cash equivalents are placed as bank deposits. Exchange rate effects on bank deposits in foreign currency was NOK 19.9 million positive in the quarter, compared to NOK 5.4 million negative in Q1 2019.
The increase in short term receivables per end of Q1 2020 compared to Q1 2019 is mainly due to advance payments during 2019 in connection with initiation of the RELEASE trial. Other long-term
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
liabilities relate to potential future social security liabilities in connection with the company's share option program, and the liability fluctuates with the share price and number of outstanding 'in-the-money' share options. Social security liabilities for share options that are vested, or may vest during the next 12 months, are disclosed as short-term liabilities.
Other
Risks and uncertainty factors for 2020
PCI Biotech is exposed to uncertainties and risk factors, which may influence some or all of the company's activities. As described in the Annual Report 2019, the most important risks the company is exposed to in 2020 are associated with progress and performance of R&D programmes, and the associated regulatory affairs and market risk. No circumstances have been identified that significantly change the uncertainties and risk factors described in the Annual Report 2019, which also covers implications of the COVID-19 pandemic.
Related party transactions
PCI Biotech is relying on services provided by third parties, including related parties, as a result of its organisational set-up. PCI Biotech considers its business relationship with The Norwegian Radium Hospital Research Foundation as the only material ordinary related party transactions per year end of March 2020. Please see note 7 Related party transactions for further details.
Post-closing events
In April 2020, PCI Biotech announced the appointment of Mr Ludovic Robin, PharmD, MBA, as Chief Business Officer (CBO), commencing from May 2020. Mr Robin will also serve as a member of PCI Biotech's executive management team. He will lead all business and corporate development activities and be a key contributor to the strategic decision making for the existing pipeline and to capture new opportunities.
PCI Biotech is not aware of any other post-closing events, which could materially influence this interim financial statement.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
Outlook
PCI Biotech believes that the proprietary PCI technology has the possibility to unlock the true potential of certain classes of innovative medicines. Supported also by external collaboration partners' opinion, the PCI technology has the opportunity to play a significant role in the realisation of several new therapeutic modalities, including immunotherapy (fimaVACC) and nucleic acid therapeutics (fimaNAC).
Although the company's focus is divided over the three programmes, most resources are currently spent on progressing the lead project of fimaCHEM, which is clinical development of fimaporfin with gemcitabine for the treatment of inoperable extrahepatic bile duct cancer; a rare disease with high unmet medical need. Based on the encouraging early signs of efficacy in Phase I, the company worked with regulators in Europe and the U.S. receiving important guidance for the design of a pivotal phase study.
The final pivotal study design has thus been determined and the first patient was enrolled in May 2019. The company its fully committed to advance the programme with the ambition of helping patients currently left without effective treatment options to achieve a good quality of life.
In parallel, the two other programmes, fimaVACCand fimaNAC, are proceeding in accordance with the established development strategy. The clinical validation of the fimaVACCtechnology is essential for PCI Biotech's role within the immunotherapy space. The Phase I study in healthy volunteers provided affirmative results on translation of the technology into humans and key data to support the programme's further development. The fimaNACprogramme continues to follow a collaborative approach, by pursuing out-licensing opportunities.
In short, the main priorities of PCI Biotech at this time are to:
- Effectively drive thefimaCHEMclinical development programme in inoperable extrahepatic bile duct cancer towards the market
- Implement the strategy for the next phase of development forfimaVACC
- Manage alliance and partnering activities across all commercially interesting areas for the PCI platform
The Board of Directors and CEO
PCI Biotech Holding ASA
Oslo, 5 May 2020
Hans Peter Bøhn | Christina Herder | Hilde Furberg |
Chairman (sign) | Director (sign) | Director (sign) |
Andrew Hughes | Lars Viksmoen | Per Walday |
Director (sign) | Director (sign) | CEO (sign) |
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
CONDENSED INTERIM CONSOLIDATED FINANCIAL INFORMATION
PROFIT AND LOSS | Note | Q1 2020 | Q1 2019 | FY 2019 | ||||
(in NOK 1,000) | ||||||||
Other income | 6 | 1 919 | 2 425 | 9 392 | ||||
Research and development | 7,9 | 15 580 | 16 739 | 83 312 | ||||
General and administrative | 2 313 | 3 615 | 14 883 | |||||
Operating expenses | 17 893 | 20 354 | 98 195 | |||||
Operating results | -15 974 | -17 929 | -88 804 | |||||
Financial income and expenses | ||||||||
Financial income | 20 700 | 659 | 2 737 | |||||
Financial expenses | 299 | 5 554 | 2 680 | |||||
Net financial result | 8 | 20 401 | -4 895 | 58 | ||||
Profit/Loss before income tax | 4 427 | -22 824 | -88 746 | |||||
Income tax | 10 | 0 | 0 | 0 | ||||
Net profit/loss | 4 427 | -22 824 | -88 746 | |||||
Other comprehensive income | 0 | 0 | 0 | |||||
Total comprehensive income | 5 | 4 427 | -22 824 | -88 746 | ||||
BALANCE SHEET | Note | 31.03 2020 | 31.03 2019 | 31.12 2019 | ||||
(in NOK 1,000) | ||||||||
Non-current assets | ||||||||
Property, plant and equipment | 17 | 5 194 | 39 | 5 072 | ||||
Right to use asset | 16 | 1 060 | 1 665 | 1 211 | ||||
Total non-current assets | 6 254 | 1 704 | 6 283 | |||||
Current assets | ||||||||
Short term receivables | 8 | 16 594 | 9 968 | 14 646 | ||||
Cash & cash equivalents | 8 | 258 080 | 328 757 | 261 103 | ||||
Total current assets | 274 673 | 338 725 | 275 749 | |||||
Total assets | 280 927 | 340 429 | 282 032 | |||||
Equity and liabilities | ||||||||
Equity | ||||||||
Paid in capital | 11,12 | 562 126 | 562 119 | 562 126 | ||||
Other reserves | -301 674 | -243 812 | -307 297 | |||||
Total equity | 260 452 | 318 308 | 254 828 | |||||
Long term liabilities | ||||||||
Other long term liabilities | 14 | 738 | 96 | 2 037 | ||||
Lease liabilities | 16 | 380 | 1 169 | 539 | ||||
Total long term liabilities | 1 119 | 1 265 | 2 576 | |||||
Short term liabilities | ||||||||
Trade debtors | 2 828 | 5 391 | 8 601 | |||||
Lease liabilities | 16 | 668 | 657 | 657 | ||||
Other short term liabilities | 7,13 | 15 862 | 14 808 | 15 370 | ||||
Total short term liabilities | 19 357 | 20 856 | 24 628 | |||||
Total liabilities | 20 476 | 22 121 | 27 204 | |||||
Total equity and liabilities | 280 927 | 340 429 | 282 032 |
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
CHANGE IN EQUITY
(in NOK '000) | 31.03 2020 | 31.03 2019 | 31.12 2019 |
Equity at beginning of period | 254 828 | 339 954 | 339 954 |
Capital increase | 0 | 839 | 1 183 |
Share option scheme | 1 195 | 339 | 2 436 |
Comprehensive income in the period | 4 427 | -22 824 | -88 746 |
Equity at end of period | 260 452 | 318 308 | 254 828 |
CASH FLOW
(in NOK '000) | Q1 2020 | Q1 2019 | FY 2019 |
Ordinary profit before taxes | 4 427 | -22 824 | -88 746 |
Depreciation, amortisation and write off | 429 | 153 | 955 |
Leasing interest cost | 19 | 9 | 37 |
Share options | 1 195 | 339 | 2 436 |
Currency gain(-)/ loss(+) not related to operations | -19 917 | 5 445 | 1 649 |
Net interest paid/received | -495 | -527 | -1 776 |
Changes in working capital and other non-cash adjustments | -8 525 | 915 | 1973 |
Cash flow from operating activities | -22 866 | -16 489 | -83 471 |
Net interest paid/received | 495 | 527 | 1 776 |
Acquisition of non-current assets | -400 | - | -5 405 |
Net cash flow from investing activities | 95 | 527 | -3 629 |
Cash flow from financial activities | |||
Payment principal portion of lease liabilities | -168 | - | -657 |
Net proceeds from share issues | - | 838 | 1 183 |
Net cash flow from financial activities | -168 | 838 | 526 |
Net change in cash during the period | -22 940 | -15 124 | -86 574 |
Exchange rate effect on bank deposits in foreign currency | 19 917 | -5 445 | -1 649 |
Cash and cash equivalents at the beginning of the period | 261 103 | 349 326 | 349 326 |
Cash and cash equivalents at the end of the period | 258 080 | 328 757 | 261 103 |
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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SELECTED EXPLANATORY NOTES:
1. Nature of operation
PCI Biotech Holding ASA (PCI Biotech) was established in 2008, and comprises PCI Biotech Holding ASA, the fully owned subsidiary PCI Biotech AS and the dormant Icelandic Branch PCI Biotech Utibu. The PCI Biotech shares have been listed on Oslo Børs since 27 April 2018 under the ticker PCIB, as a transfer of listing from Oslo Axess. The company is headquartered in Oslo, Norway.
PCI Biotech has developed a unique and patented photochemical intracellular drug delivery technology for use in cancer therapy and other diseases. The technology may also be used to enhance the immunological response of vaccines. The company collaborates closely with The Norwegian Radium Hospital in Oslo, Norway and receives substantial funding on several projects from the Research Council of Norway. The company has an extensive international collaboration network with recognised expert groups in both drug delivery and vaccination. Photochemical Internalisation (PCI) is a proprietary technology for light-directed intracellular drug delivery by triggered endosomal release.
The PCI technology has potential to improve the efficacy of both existing drugs and new classes of drugs, such as therapeutic vaccines, gene therapy and other therapies based on nanotechnology or on biotechnological principles. The company's objective is to prove the clinical usefulness of the technology with various drugs and subsequently license out the technology to partners for further development and marketing. Revenues will be generated at the time of partnering and onwards from up-front payments, milestone payments and royalties from sales. PCI Biotech works on the development of PCI products for enhanced delivery of existing cancer drugs (fimaCHEM), and as a platform that may both potentiate the effect of vaccines (fimaVACC) and delivery of nucleic acids (fimaNAC). PCI Biotech has two active clinical development programmes; one project in the fimaCHEMprogramme and the other in the fimaVACCprogramme. The fimaCHEMproject has initiated the pivotal clinical RELEASE study with registration intent for the lead candidate fimaporfin (Amphinex) in combination with the chemotherapeutic agents gemcitabine for treatment of inoperable extrahepatic bile duct cancer. The fimaVACCproject has completed a Phase I study in healthy volunteers, which has provided clinical proof- of-concept of fimaVACC'Sability to enhance and direct the response of vaccines towards a stronger cellular immune response. The fimaNACprogramme is in preclinical stage.
2. Basis of presentation
These condensed unaudited interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting. These condensed interim financial statements should be read in conjunction with the consolidated financial statements for the year ended 31 December 2019 (hereafter 'the Annual Financial Statements'), as they provide an update of previously reported information. The accounting policies used are consistent with those used in the Annual Financial Statements. The presentation of the condensed interim financial statements is consistent with the Annual Financial Statements. This interim report has not been subject to an audit. The going concern assumption has been applied when preparing this interim financial report. The board of directors approved the condensed interim financial information on 5 May 2020.
PCI Biotech has Norwegian kroner (NOK) as its functional currency and presentation currency. In the absence of any statement to the contrary, all financial information is reported in whole thousands. As a result of rounding adjustments, the figures in the condensed interim financial statements may not add up to the totals.
3. Summary of significant accounting policies
The accounting policies applied and the presentation of the interim condensed consolidated financial information for 2020 is consistent with the consolidated financial statements for the year ended 31 December 2019.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
The new standards and interpretations or amendments to published standards that were effective for the annual period beginning on January 1, 2020 or later and that could affect PCI Biotech are discussed in accounting principles, part 4, to the consolidated financial statements for 2019. In the 2019 financial statements, PCI Biotech applied the accounting standard IFRS 16 Leasesfor the first time. Please see note 16 Rights to use assets and lease liabilities for further details.
4. Important accounting valuations, estimates and assumptions
Estimates and judgments are evaluated on an on-going basis and are based on historical experience and other factors, including expectations of future events that are considered to be relevant.
In preparing these condensed interim financial statements, the significant judgements made by management in applying the group's accounting policies and the key sources of estimation uncertainty were the same as those applied to the consolidated financial statements for the year ended December 31st, 2019.
5. | Earnings per share | ||||
Earnings per share | |||||
Q1 2020 | Q1 2019 | FY 2019 | |||
Result allocated to shareholders (in NOK '000) | 4 427 | (22 824) | (88 746) | ||
Weighted average of outstanding shares | (in '000) | 37 266 | 37 185 | 37 229 | |
Earnings per share (NOK per share) | 0,12 | -0,61 | -2,38 | ||
Diluted earnings per share: | |||||
Q1 2020 | Q1 2019 | FY 2019 | |||
Result allocated to shareholders (in NOK '000) | 4 427 | (22 824) | (88 746) | ||
Weighted average of outstanding shares | (in '000) | 37 971 | 37 671 | 37 935 | |
Earnings per share (NOK per share) | 0,12 | -0,61 | -2,38 | ||
Weighted average of outstanding diluted shares is weighted number of average number of shares adjusted with share options that are in the money. Earnings per share is not affected by the dilution if negative results in the period.
6. Segment information and Other income
The Company reports only one segment and had no revenues for the reporting period. Government grants are not recognised until it is probable that the conditions attached to the contribution will be achieved. The grants are recognised in the statement of profit and loss in the same period as the related expenses, and are disclosed as other income. The Company has recognised grants from the Norwegian Research Council (BIA) and the tax incentive scheme (SkatteFUNN) in the period.
7. Related party transactions
PCI Biotech is relying on services provided by third parties, included related parties, as a result of its organisational set-up. PCI Biotech considers that its business relationship with The Norwegian Radium Hospital Research Foundation regarding research and overall PCI technology development represent related party transactions.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
The following table shows the extent of such transactions in the reported periods (all figures in NOK '000):
Purchase of services | Q1 2020 | Q1 2019 | FY 2019 |
The Norwegian Radium Hospital Research Foundation | 423 | 639 | 2 091 |
At the end of the quarter PCI Biotech had NOK 0.4 million in short-term liability to The Norwegian Radium Hospital Research Foundation.
8. Credit risk, foreign currency risk and interest risk
Credit risk
PCI Biotech has no sales for 2019 and 2020 and faces therefore no credit risk.
Maturity profile on short-term receivables at the end of the quarter (all figures in '000 NOK):
Not due | ||||||
(prepaid | Less than 3 | 3 to 12 | More than 12 | |||
expenses) | months | months | months | Total | ||
Other receivables | 7 521 | 1 261 | 6 625 | 1 188 | 16 | 594 |
Total receivables | 7 521 | 1 261 | 6 625 | 1 188 | 16 | 594 |
A majority of the short-term receivables relates to accrued, not received government grants (BIA) and tax incentive scheme (SkatteFUNN). A major part of prepaid expenses relates to the RELEASE study.
Foreign currency risk
PCI Biotech has transactional currency exposure arising from purchases in currencies other than the functional currency (NOK). In October 2018 PCI Biotech placed parts of the net proceeds from the rights issue of NOK 360 million in Euro deposits as a hedge of the foreign currency risk for the pivotal RELEASE study, which was initiated in Q2 2019. Foreign currency expenses covered by the Euro deposits have since inception been beneficial compared to spot currency exposure towards NOK. PCI Biotech has not implemented any other hedging strategy to reduce foreign currency risk.
In the quarter exchange rate fluctuation on cash deposits placed in Euro generated a positive accounting effect of NOK 19.9 million. From inception in October 2018 the Euro deposits have had a net positive accounting effect of NOK 27.4 million.
Interest risk
PCI Biotech has no interest-bearing debt. PCI Biotech faces interest risk on cash deposits.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
9. Research and Development
All figures in '000 NOK
Q1 2020 | Q1 2019 | FY 2019 | |
Clinical studies | 12 430 | 12 818 | 62 971 |
Pre-clinical studies | 1 504 | 1 990 | 6 198 |
CMC and equipment | 1 049 | 1 279 | 10 716 |
Patents | 597 | 651 | 3 427 |
Other costs | 0 | 0 | 0 |
Total | 15 580 | 16 739 | 83 312 |
PCI Biotech has no development expenditure that qualifies for recognition of an asset under IAS 38 Intangible assets. Expenditure on research activities is recognised as an expense in the period in which it was incurred and all research expenses are recorded in the profit and loss statement, in line with previous years.
10. Deferred tax and deferred tax assets
At the end of the quarter, the group held NOK 109 million in non-capitalised deferred tax assets (22% tax rate), which mainly relates to carry forward losses.
11. Share options
Share options outstanding from the company's share option program for employees have the following expiry date and exercise prices:
Number of share options | |||
Exercise price in NOK | |||
Expiry date | per share option | 31.12.2019 | 31.03.2020 |
2020 - Q3 | 7.84 | 26 000 | 26 000 |
2020 - Q3 | 3.26 | 34 500 | 34 500 |
2022 - Q3 | 21.48 | 325 000 | 325 000 |
2024 - Q3 | 25.78 | 320 000 | 320 000 |
Total | 705 500 | 705 500 |
The current authorisation, granted by the Annual General Meeting in May 2019, for the employee share option program allows for a total of 2,790,000 share options, of which 745,500 have been granted by the Board of Directors, including 40,000 share options exercised in Q3 2019.
Overview share | Total | Total | |||||
options, | holdings | holdings | |||||
Senior executives | 31.12.2019 | Allocated | Lapsed | Exercised | Expired | 31.03.2020 | |
Per Walday, CEO | 164 000 | 0 | 0 | 0 | 0 | 164 000 | |
Ronny Skuggedal, CFO | 116 000 | 0 | 0 | 0 | 0 | 116 000 | |
Anders Høgset, CSO | 106 000 | 0 | 0 | 0 | 0 | 106 000 | |
Kristin Eivindvik, PD | 73 500 | 0 | 0 | 0 | 0 | 73 500 | |
Hans Olivecrona, CMO* | 0 | 0 | 0 | 0 | 0 | 0 | |
Total | 459 500 | 0 | 0 | 0 | 0 | 459 500 | |
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
- Transitioned from an employee to a consultant position by 30 June 2019 and all unexercised share options were terminated.
12. Share capital
No. of shares | Nominal value per share | Share capital | |
in NOK | in NOK | ||
31.12.2019 | 37 265 890 | 3.00 | 111 797 670 |
Transactions | |||
31.03.2020 | 37 265 890 | 3.00 | 111 797 670 |
The annual general meeting in May 2019 authorised the board of directors to execute share capital increases by issuing up to 2,790,000 shares with a nominal value of NOK 3.00 in connection with the company's employee share option program. The authorisation is valid for one year. In addition the board of directors were authorised to execute share capital increases with up to NOK 12,004,700 in connection with private placements. The authorisation shall not be used to increase share capital by an amount in excess of 10% of the share capital, based on the share capital per date of the authorisation and potential share capital increases in relation to the employee share option program. The authorisation may be used for general corporate purposes and is valid for one year.
PCI Biotech has more than 5,100 shareholders at the end of March 2020.
10 largest shareholders per 31 March 2020:
Name | No. of shares | Ownership |
FONDSAVANSE AS | 3 760 443 | 10,09 % |
Myrlid AS | 2 465 000 | 6,61 % |
MP PENSJON PK | 2 258 206 | 6,06 % |
RADIUMHOSPITALETS FORSKNINGSSTIFT. | 1 281 415 | 3,44 % |
NORDNET LIVSFORSIKRING AS | 1 107 063 | 2,97 % |
GRESSLIEN | 721 000 | 1,93 % |
Nordnet Bank AB | 610 271 | 1,64 % |
Jandersen Kapital AS | 500 000 | 1,34 % |
BERG-LARSEN | 477 400 | 1,28 % |
ESTI AS | 386 000 | 1,04 % |
Total 10 largest shareholders | 13 566 798 | 36,41 % |
Others | 23 699 092 | 63,59 % |
Total | 37 265 890 | 100,00 % |
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
Shares owned, directly or indirectly, by members of the board, senior executives and their personally related parties per end of March 2020:
No. of shares | |||
Name | Position | 31.12.2019 | 31.03.2020 |
Hans Peter Bøhn | Chairman | 123 662 | 123 662 |
Lars Viksmoen | Board member | 12 966 | 12 966 |
Christina Herder | Board member | 10 000 | 10 000 |
Hilde Furberg (Borkenholm AS)* | Board member | 4 000 | 4 000 |
Andrew Hughes | Board member | 0 | 0 |
Per Walday | CEO | 68 300 | 68 300 |
Anders Høgset | CSO | 63 300 | 63 300 |
Ronny Skuggedal | CFO | 43 000 | 43 000 |
Kristin Eivindvik | CDO | 18 800 | 18 800 |
Hans Olivecrona** | CMO* | NA | NA |
Total | 344 028 | 344 028 |
- Hilde Furberg's shares are owned via Borkenholm AS, which is a related party to Hilde Furberg.
- Hans Olivecrona transitioned into a consultancy position from 1 July 2019 and holdings are reported to that date.
13. Other short-term liabilities
Other short-term liabilities mainly consist of accrued R&D and salary related costs and public duties.
14. Other long-term liabilities
Long term liabilities include public duties payables due in 1-4 years for potential future exercises of "in- the-money" share options per end of the quarter in PCI Biotech's employee share option scheme and lease liabilities due in 1-2 years according to IFRS 16. See note 16 for further details regarding IFRS 16 and the related long-term lease liability.
15. Financial assets and liabilities
Cash and cash equivalents are measured as financial instruments at fair value through other comprehensive income (OCI). The carrying amount of cash and cash equivalents is applied and disclosed since this approximately equals to fair value since these instruments have a short term to maturity. All other financial assets and liabilities are measured as financial instruments at amortised cost and due to short term to maturity and/or low values, non-discounted values are applied and disclosed.
16. Right of use assets and lease liabilities (IFRS 16)
IFRS 16 was adopted by PCI Biotech with effects as of 1 January 2019, applying the modified retrospective method. Office lease was identified as the only applicable right-to-use asset. The relevant non-cancellable operating lease commitment per 1 January 2019 was NOK 2.0 million for 2019-2021, not including an extension option due to not reasonable certainty about option exercise. Discounted value applying an incremental borrowing rate of 6% was NOK 1.8 million per 1 January 2019.
On transition to IFRS 16, PCI Biotech recognised NOK 1.8 million as right to use assets and a corresponding lease liability which are disclosed in the balance sheet as long- and short-term liabilities depended on maturity of the corresponding principal lease payments. Accounting principles applied are described in the annual financial statement for the year ended 31 December 2019, under accounting principles section 2.4 and see also note 24.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
The implementation effect of IFRS 16 in 2019, movements of the rights-of-use assets and lease liabilities and income statement and cash flow effects are presented below:
All figures in '000 NOK | |
Right to use asset - office lease | |
Initial recognition 01.01.2019 | 1 815 |
Acquisition costs 31.12.2019 | 1 815 |
Acquisitions Q1 2020 | 0 |
Acquisition costs 31.03.2020 | 1 815 |
Depreciation FY 2019 | 604 |
Depreciation Q1 2020 | 151 |
Accumulated depreciation and impairment as of 31.03.2020 | 755 |
Total right to use assets - office lease as of 31.03.2020 | 1 060 |
Lower of remaining lease term or economic life | 1.75 years |
Depreciation method | Linear |
Lease liabilities - office | |
Initial recognition 01.01.2019 | 1 815 |
Payments principal portion of the lease liability 2019 | -657 |
Payments principal portion of the lease liability Q1 2020 | -167 |
Interest expenses on the lease liability 2019 | 38 |
Interest expenses on the lease liability Q1 2020 | 18 |
Total lease liabilities for office as of year-end | 1 048 |
Whereof: | |
Short term lease liabilities < 1 year | 668 |
Long term lease liabilities > 1 year | 380 |
Income statement effects Q1 2020 - office lease | |
Depreciation of right to use asset | -151 |
Effect on Operating results net of tax | -151 |
Interest expenses on the lease liabilities | -18 |
Effect on Net financial result net of tax | -18 |
Comprehensive income effect net of tax | -169 |
Cash flow effects Q1 2020 - office lease | |
Payments principal portion of the lease liability Q1 2020 | -167 |
Payments of principal portion of the lease liabilities are not charged to profit and loss under IFRS 16 and will only have cash flow effects.
17. Property, plant and equipment
PCI Biotech acquired the first lots of lasers to be used in the RELEASE study during 2019. A linear depreciation method over the expected lifetime of five years for the equipment is applied.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
Equipment | 31.03 2020 | 31.03 2019 | 31.12 2019 | |
Carrying value at the beginning of the period | 5 072 | 17 | 17 | |
Acquisitions | 400 | 23 | 5 405 | |
Depreciation | 278 | 1 | 350 | |
Carrying value at the end of the period | 5 194 | 39 | 5 072 | |
18. | Subsequent events |
In April 2020, PCI Biotech announced the appointment of Mr Ludovic Robin, PharmD, MBA, as Chief Business Officer (CBO), commencing from May 2020. Mr Robin will also serve as a member of PCI Biotech's executive management team. He will lead all business and corporate development activities and be a key contributor to the strategic decision making for the existing pipeline and to capture new opportunities.
PCI Biotech is not aware of any other post-closing events, which could materially influence this interim financial statement.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
23
Unlocking the potential of innovative medicines | |
DEFINITIONS AND GLOSSARY | |
Amphinex: | Trade name of the clinical intravenous formulation of fimaporfin |
BIA: | User-drivenresearch-based innovation program by the Research Council of Norway |
CCA: | Cholangiocarcinoma - Bile duct cancer |
CRC: | Cohort Review Committee |
FDA: | US Food and Drug Administration |
Fimaporfin: | Generic name of the photosensitiser active ingredient TPCS2a |
fimaCHEM: | PCI Biotech's development program for enhancement of generic chemotherapies |
fimaNAC: | PCI Biotech's development program for delivery of nucleic acids |
fimaVACC: | PCI Biotech's development program for a vaccination technology |
HPV: | Human papillomavirus |
IDMC: | Independent Data Monitoring Committee |
IND | Investigational New Drug |
In vitro: | Studies performed with cells or biological molecules studied outside their normal |
biological context; for example proteins are examined in solution, or cells in | |
artificial culture medium. | |
In vivo: | Studies in which the effects of various biological entities are tested on whole, |
living organisms usually animals. | |
KLH | Keyhole limpet hemocyanin |
ODD: | Orphan Drug Designation |
ORR: | Overall Response Rate |
OS: | Overall Survival |
PCI: | Photochemical internalisation |
PCIB: | PCI Biotech's ticker at Oslo Børs |
PFS: | Progression Free Survival |
RELEASE: | Name of PCI Biotech's pivotal study for inoperable extrahepatic bile duct cancer |
R&D: | Research and Development |
SAC: | Scientific Advisory Committee |
SoC: | Standard of Care |
NOK: | Norwegian kroner |
FY: | Financial year (1stJanuary - 31stDecember) |
Q1: | First quarter (1stJanuary - 31stMarch) |
Q2: | Second quarter (1stApril - 30thJune) |
Q3: | Third quarter (1stJuly - 30thSeptember) |
Q4: | Fourth quarter (1stOctober - 31stDecember) |
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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Unlocking the potential of innovative medicines
FINANCIAL CALENDAR
Q2 Report 2020 | 26 August | 2020 |
Q3 Report 2020 | 11 November | 2020 |
INVESTOR CONTACT
Contact person: Ronny Skuggedal, CFO, email: rs@pcibiotech.no, mob: +47 9400 5757
FORWARD LOOKING STATEMENTS
This Report contains certain forward-looking statements relating to the business, financial performance and results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, and are sometimes identified by the words "believes", expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions. The forward-looking statements contained in this Report, including assumptions, opinions and views of the Company or cited from third party sources, are solely opinions and forecasts which are subject to risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that are expressed or implied by statements and information in the Report, including, among others, risks or uncertainties associated with the Company's business, segments, development, growth management, financing, market acceptance and relations with customers, and, more generally, general economic and business conditions, changes in domestic and foreign laws and regulations, taxes, changes in competition and pricing environments, and fluctuations in currency exchange rates and interest rates. None of the Company or any of its subsidiaries or any such person's directors, employees or advisors provide any assurance that the assumptions underlying forward-looking statements expressed in this Report are free from errors nor does any of them accept any responsibility for the future accuracy of such forward- looking statements.
PCI Biotech Holding ASA, Ullernchausséen 64, 0379 Oslo, Norway, Company no: 991036393 VAT
Phone: + 47 67 11 54 00, www.pcibiotech.com
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PCI BIOTECH HOLDING ASA
Ullernchausséen 64
N-0379 Oslo
Norway
Phone: +47 67 11 54 00
email: post@pcibiotech.com
web: www.pcibiotech.com
PCI BIOTECH AS, subsidiary
Ullernchausséen 64
N-0379 Oslo
Norway
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PCI Biotech Holding ASA published this content on 06 May 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 May 2020 07:53:15 UTC
