NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, TO UNITED STATES NEWS WIRE SERVICES OR FOR DISSEMINATION IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, HONG KONG OR SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER OF ANY OF THE SECURITIES DESCRIBED HEREIN.
PCI Biotech convenes an extraordinary general meeting to propose a fully underwritten Rights Issue of NOK 360 million
Oslo, August 24, 2018 - PCI Biotech Holding ASA's ("PCI Biotech" or the "Company") proposes to carry out a fully underwritten rights issue of NOK 360 million at a subscription price of NOK 30.00 per share, with pre-emptive subscription rights for existing shareholders (the "Rights Issue"). The Board of Directors has resolved to call for an extraordinary general meeting (the "EGM") to be held on 14 September 2018 to resolve the Rights Issue. The notice of the EGM will be distributed separately.
Per Walday, CEO of PCI Biotech, said: "We are very happy to announce this fully underwritten rights issue that provides PCI Biotech with the funds needed to perform the pivotal fimaChem study. The established underwriting syndicate shows that we both have a supportive shareholder base and significant interest from external investors, including a reputable international specialist investor. Our focus is now to bring fimaChem to the market as quickly as possible, through successful performance of the pivotal study.“
The Rights Issue is fully underwritten, subject to customary terms and conditions, by an underwriting syndicate established by ABG Sundal Collier and Arctic Securities (the "Joint Bookrunners"). The Rights Issue is supported by the Company’s largest shareholders Fondsavanse, MP Pensjon, Myrlid and Radiumhospitalets Forskningsstiftelse as significant underwriters. In addition, the international specialist investor Nyenburgh as well as other institutional investors have underwritten the remainder of the Rights Issue. The underwriters will receive an underwriting fee equal to 3.50 per cent of their respective underwriting obligations.
Stocken Invest AS, a company owned 100% by Lars Kåre Viksmoen, a member of the Board of PCI Biotech, has entered into the underwriting agreement and has underwritten NOK 1.0 million of the Rights Issue. Stocken Invest AS currently owns 4,000 shares in PCI Biotech.
The Rights Issue
Completion of the Rights Issue is subject to shareholders' approval at the EGM to be held on 14 September 2018 and that an EEA-prospectus for the Rights Issue is approved by the Financial Supervisory Authority of Norway and published in accordance with applicable laws.
Through the Rights Issue, the share capital of PCI Biotech will be increased by NOK 36,000,000 through an issue of 12,000,000 new shares, each with a nominal value of NOK 3.00. Shareholders in the Company as at close of trading on Oslo Børs on 14 September 2018 (as evidenced in the VPS shareholder register on 18 September 2018, being the "Record Date"), who may lawfully participate in the Rights Issue ("Eligible Shareholders"), will be granted subscription rights giving a preferential right to subscribe for and be allocated new shares in the Rights Issue, meaning that the share will trade exclusive of the right to receive subscription rights from and including 17 September 2018 for trades subject to ordinary T+2 settlement in the VPS. Each Eligible Shareholder will be granted approximately 0.48 subscription rights for each existing share registered as being held by such existing shareholders in the VPS as of the Record Date. The number of subscription rights issued to each Eligible Shareholder will be rounded down to the nearest whole subscription right. Each subscription right will, subject to applicable securities laws, give the right to subscribe for and be allocated one (1) new share in the Rights Issue. Over- subscription by holders of subscription rights or subscription for shares without subscription rights will be permitted. Further details of the terms of the Rights Issue will be described in the prospectus to be released in connection with commencement of the subscription period for the Rights Issue (see indicative timeline below).
The subscription rights will be tradable and listed on Oslo Børs during the subscription period for the Rights Issue. Any subscription rights not used or sold during the subscription period will lapse and cease to carry any value.
The subscription price per new share in the Rights Issue is NOK 30.00 per share. The subscription price corresponds to a discount of approximately 34 per cent to the implied Theoretical Ex-Rights Price of NOK 45.61 based on PCI Biotech's closing share price on 23 August 2018. Following completion of the Rights Issue, the share capital of PCI Biotech will be NOK 110,984,670 consisting of 36,994,890 shares, each with a nominal value of NOK 3.00. The Rights Issue will result in gross proceeds to PCI Biotech of NOK 360,000,000.
Below is an indicative time table for the Rights Issue:
14 September 2018: EGM to resolve the Rights Issue
14 September 2018: Last day of trading in PCI Biotech shares inclusive subscription rights
17 September 2018: PCI Biotech shares trade excluding rights to participate in the Rights Issue
18 September 2018: Record date for determining the right to receive subscription rights, at which date the VPS shareholders register for trades with ordinary settlement in VPS (T+2) will show shareholders of the Company as per the end of trading on 14 September 2018.
On or about 19 September 2018: Publication of prospectus and first day of subscription period for the Rights Issue
On or about 03 October 2018: Last day of subscription period for the Rights Issue
On or about 08 October 2018: Allocation of new shares
On or about 10 October 2018: Payment for new shares
On or about 11 October 2018: Registration of share capital increase in the Norwegian Register of Business Enterprises
ABG Sundal Collier and Arctic Securities are acting as Joint Bookrunners in connection with the Rights Issue. Advokatfirmaet Selmer AS is acting as the Company's legal advisor in connection with the Rights Issue.
Update on PCI Biotech’s development programmes
The emerging data from the fimaChem Phase I dose-escalation study in inoperable extrahepatic bile duct cancer continues to deliver positive early signs of efficacy. Cohort IV included six patients at the dose level selected for pivotal development and the results from this Cohort are now mature enough for presentation. Although the results are based on small patient numbers, the efficacy signs are very promising compared to the most relevant published comparator data on treatment with standard of care. Attached is a summary table with key Phase I data and references to the most relevant comparator data. The pivotal study is intended to include up to two fimaChem treatments and the safety of this regimen is studied in an extension to the Phase I study. By August 2018, four patients have passed the safety window after the second fimaChem treatment. The plan is to include an additional safety review by the Independent Data Monitoring Committee (IDMC) after eight patients. The pivotal study is expected to start early in 2019, with an interim analysis of progression free survival and objective response rate for potential accelerated/conditional approval available approx. 36 months after initiation. For further information on timelines and study design, see attachment.
The advent of effective immunotherapeutics in several disease areas have provided hope for a large number of patients, but therapeutic vaccination within oncology has faced several setbacks in late stage development due to insufficient efficacy. The fimaVacc technology has proven to be a strong inducer of the cellular immune responses needed for therapeutic effect in animal models and the initial clinical immune response results are promising. The Phase I results indicate enhanced T-cell responses, with early responses and high response rates at tolerable dose levels. There is a large commercial potential in this technology, as there is a need for improved T-cell responses in both therapeutic cancer vaccination and several infectious disease applications. The near-term focus of this programme is to further characterise the immune response.
The fimaNAc programme addresses a main challenge for the realisation of the vast opportunity in nucleic acid therapeutics – effective intracellular delivery of this class of large therapeutic molecules. Several of the key commercial players in this therapeutic area continue to show interest in the fimaNAc technology and the Company currently has six ongoing research collaborations. The most recent collaborations, with IMV and Bavarian Nordic, were established over the last couple of months. PCI Biotech intends to continue the collaborative strategy, with the aim to convert research collaborations to commercial partnerships with select companies.
Update on 2Q 2018 Financial Figures
The Company will report its full financial figures for 2Q 2018 on 30 August 2018.
Net results in 2Q 2018 amounted to NOK -7.1 million. At the end of 2Q 2018 the Company’s cash and cash equivalents amounted to NOK 28.4 million, a net change of NOK -10.2 million relative to the figures reported for 1Q 2018.
The contents of this announcement have been prepared by, and are the sole responsibility of, the Company. The Company's financial advisors are acting exclusively for the Company and no one else, and will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients, or for advice in relation to the Rights Issue, the contents of this announcement or any of the matters referred to herein.
The information in this announcement is for information purposes only and does not purport to be accurate or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness.
Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "strategy", "intends", "estimate", "will", "may", "continue", "should" and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. 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.
The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. Neither the publication and/or delivery of this announcement shall under any circumstances imply that there has been no change in the affairs of the Company or that the information contained herein is correct as of any date subsequent to the earlier of the date hereof and any earlier specified date with respect to such information.
A prospectus approved by the competent authority in Norway is expected to be published by the Company before the Rights Issue commences (if and when made) and, if and when published, can be obtained on the Company's website, subject to regulatory restrictions. Investors should not subscribe for any securities referred to in this announcement except on the basis of information contained in the prospectus.
Neither this announcement nor any copy of it may be made or transmitted directly or indirectly into the United States, Australia, Canada, Japan, Hong Kong or South Africa or any other jurisdiction where to do so would be unlawful. The Rights Issue (if made) and the distribution of this announcement and other information in connection with the Rights Issue may be restricted by law in certain jurisdictions. Any failure to comply with such restrictions may constitute a violation of applicable securities laws. Persons into whose possession this announcement or other information should come are required to inform themselves about and observe any such restrictions. The Company assumes no responsibility in the event there is a violation by any person of such restrictions.
This announcement does not in itself constitute, and should not be construed as, an offer for sale or subscription of or solicitation or invitation of any offer to subscribe for or purchase any securities of the Company or its affiliates in any jurisdiction. The Rights Issue will (if and when made) not be made in any jurisdiction or in any circumstances in which such offer or solicitation would be unlawful. No steps have been taken or will be taken relating to the Rights Issue in any jurisdiction outside of Norway in which such steps would be required.
The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or any securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with applicable state law. There will be no public offer of the securities in the United States.
This announcement is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this announcement must satisfy themselves that it is lawful to do so.
Further information regarding restrictions applicable for the Rights Issue will be set out in the prospectus prepared for the Rights Issue.
About PCI Biotech
PCI Biotech is a biopharmaceutical 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 fimaChem programme consists of a clinical Phase I/II clinical 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 more information visit: www.pcibiotech.com
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Per Walday, CEO, firstname.lastname@example.org, Mobile: +47 917 93 429
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
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.