Scandion Oncology CEO Newsletter autumn 2019

  Dear Scandion Oncology shareholder, Scandion Oncology wants to thank you for your continued trust and confidence in us and our work as we work through these challenging times together, and we hope that you and your families are safe and healthy. With the widening spread of COVID-19 across the world, we wanted to provide you with the latest updates on our activities, and, just as important, emphasize our continued commitment to bringing our drugs to the many cancer patients with untreatable drug resistant cancer disease.

Scandion Oncology A/S ("Scandion Oncology") has published that combining SCO-101 and the chemotherapy drug docetaxel, which is used in the treatment of several types of cancer, results in synergy. Based on modelling of preclinical data with docetaxel resistant cancer cells, Scandion Oncology has published that SCO-101 significantly increases the potency of docetaxel (docetaxel belongs to the group of taxane chemotherapy). Furthermore, the results provided key information regarding promising dose ratios and dose levels for future clinical studies when using  the combination of SCO-101 and taxanes.

The current Phase II clinical study with SCO-101 is treating a serious diseases with no satisfactory treatment option and therefore Scandion Oncology has together with its clinical partners at the hospitals decided to continue the colorectal cancer study with FOLFIRI resistant patients. Due to the current situation related to the COVID-19 pandemic, Scandion Oncology is not able to predict how many patients that will be included in the next couple of months. Enrolment into the study will be solely based on the discretion of the clinical investigators.

Scandion Oncology A/S ("Scandion Oncology") hereby announces that the company has been informed by the State Serum Institute in Copenhagen that conducts the animal experiments with the antibiotic-resistant bacteria and the Scandion Oncology compounds, that due to the coronavirus, the State Serum Institute must postpone the last of three animal studies until the coronavirus situation is under control. Scandion Oncology estimates that the final data will be published during April-May 2020 instead of March 2020.

Scandion Oncology A/S ("Scandion Oncology" or "the Company") today announces that the Chairman, Vice Chairman and Chief Medical Officer of the Company have bought shares in Scandion Oncology. The shares have been acquired in the daily trading on Spotlight Stock Market.

Scandion Oncology A/S ("Scandion Oncology") informs about a short delay in the clinical phase II study with SCO-101 in drug resistant colorectal cancer. The delay is due to external events outside the influence of Scandion Oncology and is unrelated to the treatment with SCO-101.

Scandion Oncology A/S ("Scandion Oncology") hereby announces that the company has published pre-clinical results with its second drug candidate, SCO-201, for reversal of drug resistance.

Scandion Oncology A/S ("Scandion Oncology" or "the Company") hereby publishes the year-end report for the period January - December 2019. The year-end report is available on the Company's website (www.scandiononcology.com). Below is a summary of the report.

Scandion Oncology A/S ("Scandion Oncology") hereby announces that the company has obtained DKK 5 million from Innovation Fund Denmark for the clinical development of SCO-101 in metastatic pancreatic cancer.

The clinical Phase II trial with drug resistant metastatic colorectal cancer patients has now been registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04247256?term=scandion+oncology&draw=2&rank=1).

CEO Nils Brünner and Chairman of the Board Peter Høngaard, have now safely returned from the JP Morgan Meeting in San Francisco. The JP Morgan meeting is the largest meeting in the world when it comes to meeting potential partners within Life Science. Prior to the meeting, Scandion Oncology had arranged face-to-face meetings with pharma companies, investors, bankers and service providers.

Scandion Oncology A/S ("Scandion Oncology") Chief Executive Officer Nils Brünner and Chairman of the Board Peter Høngaard will be attending the JP Morgan 38th Annual Healthcare Conference 13-16 January 2020 in San Francisco.

Scandion Oncology A/S ("Scandion Oncology") today announces that the company has received approval from the Ethics Committee regarding its first clinical trial for SCO-101 at hospitals in Denmark. The only change that the Ethics Committee requested was to include a one-page summary of the patient information sheet for review before the study could be started.  With this approval, Scandion Oncology follows its objectives.

Scandion Oncology A/S (“Scandion Oncology”) today announces that the company has identified novel analogues with more than tenfold higher potency against antibiotic resistant bacteria and that the in vivo animal study has been delayed from Q4 2019 until Q1 2020 due to technical issues with the control substance. This will not affect the company"s goal of finding a partner for commercializing Scandion Oncology’s drug candidate SOM-001 and analogs for antibiotic resistance in 2020. Moreover, it will not affect the company’s cash position.

Scandion Oncology A/S ("Scandion Oncology" or "the Company") today announces that the Chairman and Vice Chairman of the Company buy shares in Scandion Oncology. The shares come from a prior transaction where the CEO and CSO of Scandion Oncology bought shares from the former CEO. Below is a detailed description of the transactions being conducted. All transactions are intended to be done outside the market.

Scandion Oncology A/S (“Scandion Oncology”) today announces that the company has received final approval from the Danish Medicines Agency for start of a clinical Phase II trial with the drug candidate SCO-101 in combination with chemotherapy in patients with drug resistant metastatic colorectal cancer. The study is conducted in two parts. The first interim results from this first part   are expected in Q2 2020 and the final study is expected to be available by the end of 2020.

Dear Scandion Oncology shareholder,Being able to change drug resistance will have impact on millions of cancer patients world-wide. With the current speed of development and if everything works out, we expect to start the clinical phase II study with SCO-101 treatment by December 2019. In this newsletter, I will give a short summary of what’s to come for SCO-101, with a primary focus on the upcoming phase II clinical trial.

Scandion Oncology A/S (”Scandion Oncology” or the “Company”) hereby publishes the InterimReport for the period 1 January – 30 September 2019. The Interim Report is available on theCompany"s website (www.scandiononcology.com). Below is a summary of the report.

Scandion Oncology A/S (“Scandion Oncology”) today announces that the European Patent Office (“EPO”) has granted the company’s patent application for SCO-101 when combined with chemotherapy. Patent is valid until May 2037.

Scandion Oncology A/S (“Scandion Oncology”) today announces that the company has submitted an application to the Danish Medicines Agency for permission to conduct a clinical Phase II study in patients with metastatic colorectal cancer. Scandion Oncology is thus following the timelines presented in the prospect. The study will be initiated at hospitals in Denmark. The clinical Phase II study will be conducted in two parts, and provided that the study is approved in the fourth quarter of 2019, the first data are expected in Q2 2020 and the final study report will be released in H1 2021.

Scandion Oncology A/S (“Scandion Oncology”) today announces that the report on the in vivo animal data on antibiotic resistance SOM-001 is extended until mid-Q4 2019 due to shortage in slots at the provider. This will not affect the company"s goal of finding an overall strategy for commercializing SOM-001 in 2020.

Scandion Oncology A/S (“Scandion Oncology”) today announces that Peter Høngaard has accepted to take the role of Chairman of the Board as of October 1, 2019. With Peter Høngaard’s strong knowledge of developing life science businesses from research to commercialization Scandion Oncology is now taking full advantage of this added expertise in the Board. The current Chairman Jørgen Bardenfleth will now take the role of Vice-Chairman.

Dear Scandion Oncology shareholder, Scandion Oncology is heading towards an exciting future where we will, hopefully, deliver a new cancer treatment to the market. One that can help overcome chemotherapy resistance - an accomplishment that truly would mark a new dawn for modern cancer treatment.

Scandion Oncology A/S (”Scandion Oncology”) hereby announces that, in connection with the registration of the new share issue carried out during the second quarter 2019, the main shareholders ownership in Scandion Oncology has decreased.

Scandion Oncology A/S (”Scandion Oncology” or the “Company”) hereby publishes the Half-Year Report for the period 1 January – 30 June 2019. The Half-Year Report is available on the Company"s website (www.scandiononcology.com). Below is a summary of the report.

Scandion Oncology wishes to make aware that we have published a new Q&A on August 20, 2019. The Q&A concerns the status on a EU grant regarding endocrine treatment of breast cancer cell lines. The Q&A can be read here: https://scandiononcology.com/qa/

In June/July 2019, Scandion Oncology A/S (“Scandion Oncology”) conducted a rights issue of units in which the general public was given the opportunity to subscribe. Through the rights issue, a total of 7,144,590 shares and 2,381,530 warrants of series TO 1 were issued. First day of trading in TO 1, ISIN DK0061144078, will be on Thursday, 8 August 2019.

In June/July 2019, Scandion Oncology A/S (“Scandion Oncology”) conducted a rights issue of units in which the general public was given the opportunity to subscribe. Through the rights issue, a total of 7,144,590 shares and 2,381,530 warrants of series TO 1 were issued. The rights issue of units has now been fully registered at the Danish Business Authority. Last day of trading in BTU (paid-up for units) will be on July 30, 2019 and the stop date will be on August 1, 2019.

On July 9, 2019, the subscription period in Scandion Oncology A/S’s ("Scandion Oncology") rights issue of units ended. The interest in the rights issue was significant and the rights issue was subscribed to a total of approx. SEK 58.3 million (excl. guarantee commitments), corresponding to a subscription rate of approx. 199 percent. Through the rights issue, a total of 7,144,590 shares and 2,381,530 warrants of series TO 1 will be issued and Scandion Oncology will now be provided approx. SEK 29.3 million before issue costs. Settlement notes are expected to be sent out today, July 12, 2019. Sedermera Fondkommission is the financial advisor in connection with the rights issue and Markets & Corporate Law acts as the legal advisor.

Scandion Oncology A/S (“Scandion Oncology” or the “Company”) today announces that the Company has identified the four clinical sites where the lead candidate drug SCO–101 will be tested in combination with chemotherapy in patients with metastatic and drug resistant colorectal cancer. The first patients to enter the trial are expected to be included in December 2019. The four sites are located in Denmark in the Capital Region, Region South, Region North and Region Zealand.

Scandion Oncology A/S (”Scandion”) today announced that SCO-101 tablets have successfully been produced as a pilot production by Solural Pharma Aps, Denmark (“Solural”). Scandion is thus following the timelines for SCO-101’s clinical development. The SCO-101 raw material is produced by Cambrex in Sweden and then transferred to Solural in Denmark where it is formulated into tablets. Scandion expects to initiate its first clinical Phase II study with SCO-101 in patients with drug resistant cancer in late 2019.

Today, on the 20th of June, 2019, the subscription period for Scandion Oncology A/S ("Scandion Oncology") rights issue begins. The subscription period runs until the 9th of July 2019. A fully subscribed issue of units will initially provide Scandion Oncology with approximately MSEK 29.3 and an additional approximately MSEK 12.4 (before issue costs) in a later stage if all consideration free warrants are exercised. Ahead of the rights issue, Scandion Oncology has received subscription commitments from, among others, senior executives and board members and also entered into agreements regarding top-down guarantee. In total, the subscription commitments and the top-down guarantees corresponds to approx. 89 percent of the inital issue volume. Prospectus, teaser and subscription forms are available through the websites of Scandion Oncology (www.scandiononcology.com) and Sedermera Fondkommission (www.sedermera.se). The investment documents are also available via Spotlight’s website (www.spotlightstockmarket.com). Subscription of units can be made by submitting a subscription form to Sedermera Fondkommission or through their website (via BankID). 

Prospectus relating to the rights issue in Scandion Oncology A/S (”Scandion Oncology” or ”the Company”) has been approved and registered by the Danish Financial Supervisory Authority and is now available at Scandion Oncology’s website (www.scandiononcology.com), Sedermera Fondkommission (www.sedermera.se) and at the website of Spotlight Stock Market (www.spotlightstockmarket.com). Teaser and subscription form will be published on the webpages mentioned above at the start of the subscription period. The prospectus has also been passported to Sweden.

On June 11th, 2019, the Extraordinary General Meeting of Scandion Oncology A/S (”Scandion Oncology” or the ”Company”) was held. Below follows a summary of the established decisions. All decisions were taken with the required majority. 

Scandion Oncology A/S (“Scandion Oncology”) hereby announces that Jørgen Bardenfleth will continue as Chairman of the Board and Peter Høngaard Andersen will take over the position as Vice-Chairman of the Board.

In connection with the announcement that the Board of Directors of Scandion Oncology A/S (“Scandion Oncology”) has proposed to an Extraordinary General Meeting to conduct an issue of units, main shareholders, Board of Directors and management of Scandion Oncology have signed and prolonged so-called lock-up agreements, which means that they commit to retain 90 percent of their holdings in the company over the upcoming 12 months calculated from June 2019. In total, the lock-up agreements correspond to 53 percent of the share of votes and capital in Scandion Oncology. The following parties have entered into lock-up agreements:

On May 29th, 2019, the Annual General Meeting of Scandion Oncology A/S (”Scandion Oncology” or the“Company”) was held. Below follows a summary of the established decisions. All decisions were taken with the required majority. 

The Board of Directors of Scandion Oncology A/S (”Scandion Oncology” or the “Company”) convenes the shareholders of Scandion Oncology to an Extraordinary General Meeting, which will be held: Tuesday, June 11, 2019 at 11:00 AM, Fruebjergvej 3, 2100 København, Denmark

Scandion Oncology A/S (“Scandion Oncology” or ”the Company”) today announces that the Board of Directors has proposed to an Extraordinary General Meeting to conduct an issue of units that can provide a maximum of approximately SEK 41.7 million to the Company before issue costs. The capitalization consists of shares amounting to a maximum of approximately SEK 29.3 million and consideration free warrants of series TO 1 that can additionally provide the Company with a maximum of approximately SEK 12.4 million, provided the warrants are fully exercised. The public is also invited to subscribe for units in the rights issue. Scandion Oncology has in advance received pre-subscriptions and “top-down” guarantee commitments from institutional and private investors totaling approximately 82 percent of the issue volume. Notice of Extraordinary General Meeting will be published shortly.

Scandion Oncology A/S (”Scandion Oncology” or ”the Company”) hereby publishes the Interim report for the period 1 January – 31 March 2019. The interim report is available on the Company"s website (www.scandiononcology.com). Below is a summary of the report.

Scandion Oncology A/S would like to make use of the full window for releasing the Q1 2019-report. The company therefore releases the Q1 2019-report on May 27, 2019. The previously reported reporting date was May 23, 2019.

SCANDION ONCOLOGY A/S is pleased to announce that the company has received an “Intention to Grant” notice from the EPO regarding its European patent application 17726573.3, which includes SCO-101 in combination with specific topoisomerase I inhibitors to treat various cancers. The patent will last until 2037.

The Board of Directors of Scandion Oncology A/S (”Scandion Oncology” or the“Company”) convenes the shareholders of Scandion Oncology to the Annual General Meeting, which will be held: Wednesday, May 29, 2019 at 16:00 PM. Fruebjergvej 3, 2100 København Complete notice incl. complete proposals from the Board and appendices can be found on the website of Scandion Oncology (www.scandiononcology.com).

Scandion Oncology A/S hereby publishes the Annual Report for 2018. The Annual Report 2018 is available on the company"s website (www.scandiononcology.com).

Scandion Oncology A/S (”Scandion” or ”the Company”) announces today that the Company has signed a collaboration agreement with Department of Drug Design and Pharmacology, University of Copenhagen regarding development of a class of drugs that can revert anti-cancer drug resistance. The lead compound from this drug class, named SCO-301, complements Scandion’s drug portfolio, since it targets resistance against a large class of anti-cancer drugs that is not targeted by SCO-101 or SCO-201. Scandion has thus already fulfilled one of the milestones for 2020.