Interim Report 2017-01-01 – 2017-12-31

The Management Board and Chief Executive Officer of Oncology Venture Sweden AB hereby submit a report for the accounting year 2017. “Oncology Venture Sweden AB” refers to Oncology Venture Sweden AB with corporate identification number 559016-3290. “The Company” or “Oncology Venture” refers to the group, that is Oncology Venture Sweden AB and its subsidiary company Oncology Venture ApS (100% owned by Oncology Venture), 2X Oncology (92% by Oncology Venture) and OV-SPV2 ApS (40% owned by Oncology Venture).

Summary of communique on financial report  

Twelve months (2017-01-01 – 2017-12-31)

  • The Group’s net turnover increased to 1,996 (1,305) KSEK.
  • The Group’s result after tax decreased to -56,547 (-33,543) KSEK.
  • The Group’s cash and bank assets decreased to 11,977 (18,872) KSEK.
  • The Group’s result per share decreased to -5.20 (-1.95) SEK.
  • Its solidity increased to 82,5 (78.8) %.

Fourth quarter (2017-10-01 – 2017-12-31)

  • The Group’s net turnover increased to 0 (1,169) KSEK.
  • The Group’s result after tax increased to -22,527* (-18,618) KSEK.
  • The Group’s result per share increased to -2.07 (-1.85) SEK.

The Group’s result per share: The result for the period divided by the average number of shares. Total number of shares as of
31 December 2017 increased to 10,980,573. Average number of shares for the period is 10,944,862.30.
Amount within brackets: Comparable period in the previous year.

Solidity: Equity divided by total capital.

*The result was mainly influenced by operating costs. These mainly consisted of one-off production costs of approximately 7 000 KSEK (mainly regarding manufacturing of Irofulven), 4 000 KSEK regarding screening and clinical site costs and 3 300 KSEK regarding costs for clinical research operations, mainly regarding preparation of Phase 2 studies. 5 400 KSEK are referred to costs borne by 2X Oncology, whose accounts are incorporated into Oncology Venture’s group accounts.

Important events during 2017

-          On 22 December Oncology Venture advises that the Company has been given approval by the Danish Ethics Committee and Health Authority (DHMA) for its application to implement a phase-2 trial of Irofulven in patients with castration and docetaxel-resistant prostate cancer.

-          On 15 December, Oncology Venture advises that a publication with the title "Drug response prediction in high-risk multiple myeloma" will be published in the scientific journal "Gene". The printed version is expected to be made available in January 2018. In the publication it is demonstrated that MPI’s drug response predictor - DRP® - can predict sensitivity to melfalan (extended progression-free survival, PFS) and bortezomib (extended PFS and with a better response rate, RR).

-          On 14 December, Oncology Venture advises an updated timetable for obtaining results for the response prediction in patients for a non-publicised small molecule TKI inhibitor from Novartis Pharma AG.

-          On 30 November, Oncology Venture advises that the Company’s Board of Directors have decided, subject to the approval of an extraordinary annual general meeting, to implement a representative subscription of a maximum 2,745,143 shares at an subscription price of 16.30 SEK per share. The fully subscribed new issue will make Oncology Venture around MSEK 44.7 before issuing costs.

-          On 21 November, Oncology Venture advises that the dose of 75mg + 75mg per patient on day 1 and 8 in a three-week scheme has been confirmed as being safe and is therefore approved by the committee for safety data that had recommended the dose (RD) for future treatments with LiPlaCis®. It was also advised that the rate of the patient recruitment for the ongoing phase-2 part of the trial of metastatic breast cancer involving treatment with LiPlaCis® had been accelerated over recent months and had now been found to be adequate.

-          On 16 November, Oncology Venture advises that the Company had reached an agreement with one the major investors in OV-SPV2 ApS to extend the option to repurchase shares in OV-SPV2, which owns the rights to the TKI inhibitor from Novartis. The option will be extended by six months, up until 1 June 2018.

-          On 7 November the number of shares in Oncology Venture increase after Medical Prognosis Institute A/S ("MPI") in March 2017 used 100,000 of the 302,243 warrants that MPI acquired in payment for the expanded three-year exclusive licence for MPI’s Drug Response Prediction technology, DRP®. The new number of shares in Oncology Venture is hence 10,977,007.

-          On 27 October, the Company advises that a phase-2 protocol for Irofulven for castration and docetaxel-resistant prostate cancer had been submitted to the Danish Ethics Committee and Health Authority.

-          On 23 October the Company publishes a pipeline and business update, describing the status of its ongoing projects.

-          Oncology Venture advises on 29 September that 12 patients with metastatic breast cancer had been successfully recruited to the phase 2 part of the clinical trial of LiPlaCis® for metastatic breast cancer. Oncology Venture has previously advised that the Company was expecting to recruit between 12 and 15 patients up to and including Q3 2017.

-          On 19 September, Oncology Venture advises that early data from an ongoing phase 1/2 trial of LiPlaCis® show response and clinical effects in patients with metastatic breast cancer who are difficult to treat.

-          On 23 August, Oncology Venture publishes an update of its pipeline.

-          Oncology Venture advises on 9 August that the Company has made an accurate DRP® prediction of the results of treatment in patients treated with 2X-121, the recently licensed PARP inhibitor from Eisai Inc.

-          On 19 July Oncology Venture and Novartis Pharma AG enter into an agreement on an option for an exclusive licence for a tyrosine kinase inhibitor in clinical phase 3.

-          On 7 July Oncology Venture and Eisai Inc. enter into an exclusive global licence agreement for the clinical oncological drug candidate PARP Inhibitor E7449/2X-121. E7449 has already shown a good treatment effect in phase 1.

-          Oncology Venture advises on 6 July that the Danish Health Authority and Medicines Agency and the Ethics Committee permit the inclusion of patients with metastatic breast cancer in the phase 2 trial of LiPlaCis® as early as after the patients’ second line of treatment. A LiPlaCis® side-effects profile also enables more vulnerable patients with low levels of blood platelets and patients with an impaired liver function to be included in the trial.

-          On 27 June, Oncology Venture advises that data from the ongoing phase 1/2 trial show that the tumour response of LiPlaCis® in clinical practice can be predicted by the Company’s Drug Response Predictor (DRP®) whatever the type of tumour, which includes breast cancer.

-          On 8 June, Oncology Ventures spinout, 2X Oncology Inc., receives an American IND for 2X-111, a liposomal doxorubicin for the treatment of breast and brain cancer.

-          DRP® data for epirubicin for breast cancer are presented as a poster on the poster session “Breast Cancer – Metastatic” at ASCO’s (American Sociology of Clinical Oncology) annual meeting on 4 June 2017 in Chicago, Illinois, USA.

-          Oncology Venture advises 31 May that the first patient has been included in the phase 1/2 trial of APO010 for the treatment of multiple myeloma (MM).

-          Oncology Venture is informed on 29 May by the US Patent Office that they intend to approve a patent application for a Drug Response Predictor (DRP®) for the Company’s cancer drug Irofulven.

-          The DRP® data for epirubicin for breast cancer is published on ASCO’s (American Society of Clinical Oncology) website. DRP® was significantly associated with progression-free survival (PFS) in a cohort of 137 patients with metastatic breast cancer.

-          On 8 May the annual general meeting is held in the Company. A communique containing the decisions that were made is available on the Company’s website.

-          On 6 April, 2X Oncology expands its management group and appoints George O. Elston as CEO, while Marie Foegh continues as CMO within the company.

-          Oncology Venture advises on 5 April that the Company has implemented a representative subscription, which makes the Company approx. 33.7 MSEK before subscription costs.

-          On 28 March Oncology Venture enters into an exclusive global licence agreement for 2-BBB Medicines BV’s leading phase-2 product 2B3-101 – now called 2X-111 – for the treatment of glioblastoma (primary brain cancer).

-          On 24 March, Oncology Venture and Eisai Inc. enter into an agreement according to which Oncology Venture will develop companion diagnostics by means of its DRP™ technology for a drug candidate from Eisai Inc’s oncological portfolio. The intention is to evaluate Oncology Venture’s interest in an in-licensing of the drug for further clinical development in 2X Oncology.

-          On 21 March the Danish Medicines Agency (DHMA) approves the focused trial of APO010 in patients with multiple myeloma.

-          Oncology Venture receives on 8 March around 1,000,000 SEK by using subscription warrants of the 2019 series.

-          An extraordinary annual general meeting is held in Oncology Venture on 1 March. A communiqué from the extraordinary annual general meeting is available at the Company’s and AktieTorget’s (www.aktietorget.se) respective websites.

-          Oncology Venture advises on 21 February that the Company has developed a new version of LiPlaCis® that can be kept at 2-8°C. This product has been successfully produced and passed all quality controls.

-          Oncology Venture publishes on 31 January a status update regarding the Company’s pipeline covering three products in Oncology Venture, two signed term sheets, a term sheet under negotiation in 2X Oncology and an agreed term sheet in OV-SPV2 ApS.

-          Oncology Venture advises on 24 January that DRP® successfully predicts the effect of four breast cancer drugs from Personalized Medicine.

-          Oncology Venture advises on 19 January that the LiPlaCis® project is granted a total of approx. 963,000 euro (approx. 9.1 MSEK) via the EUROSTARS programme for the further development of the project. Moreover, the public contribution releases private investment funds of approx. 950,000 euro (approx. 9.0 MSEK) from the Company’s partner Smerud Medical Research International AS. In total, the contribution received for the LiPlaCis® programme amounts to approx. 1.9 MEUR (approx. 18 MSEK).

-          An extraordinary annual general meeting is held in Oncology Venture on 17 January. A communiqué from the extraordinary annual general meeting is available at the Company’s and AktieTorget’s (www.aktietorget.se) respective websites.

-          The Company advises on 9 January that CE labelling for Drug Response Predictor – DRP® – has undergone a technical validation and has been registered for Oncology Venture’s leading drug candidate LiPlaCis®. A CE IVD validation (In-vitro diagnostics) and registration allows the product to be marketed within the EU and enables commercialisation in 32 European countries.

-          Marie Foegh, MD, Dr.Sc., is offered on 3 January and accepts the position of CEO for 2X Oncology Inc. (“2X Oncology”).

Important events after expiry of the period

-          On 5 February 2018 Oncology Venture appoints Claus Frisenberg Pedersen as new Chief Financial Officer (CFO). Claus Frisenberg Pedersen succeeds Nikolaj Buhl Jensen, who is moving on to a position as Senior Consultant in the management company Buhl Oncology (Buhl Krone Holding APS).

-          Oncology Venture advises on 31 January 2018 the results of the other interim assessment of the phase-2 part of an ongoing phase 1/2 trial of LiPlaCis® - a targeted liposomal formulation of cisplatin - in difficult-to-treat patients with metastatic breast cancer. Clinical benefit has now been demonstrated in seven out of ten assessable patients who have been treated with LiPlaCis®, while conventional treatment with cisplatin in trials carried out previously resulted in a clinical response of only ten per cent in this patient category.

-          On 31 January, Oncology Venture advises that the Company’s representative subscription of approx. MSEK 44.7 to finance planned clinical trials with existing drugs candidates and build up a financial buffer has been over-subscribed. The representative subscription was for approx. MSEK 59.6, equivalent to a subscription level of around 133 per cent. Through the representative subscription, 2,745,143 shares were newly issued and Oncology Venture made approx. MSEK 44.7 before subscription costs.

-          On 15 January 2018, Oncology Venture publishes the initial conclusions from a DRP® trial relating to a phase 3 TKI product from Big Pharma. In the study of biopsy data from renal cancer - where the DRP® results were compared with the results from clinical trials - a consistent result could be seen. On this basis, the Company’s objective is now to further develop the drug and its DRP® commercially.

-          The subscription period for Oncology Venture’s new share issue was initiated on 11 January 2018.

-          On 8 January 2018, Oncology Venture advises that the Company’s CFO Nikolaj Buhl Jensen has used 100,000 options of the 2015/2018 series, which means that 107,000 new shares are issued at a rate of 6.88 SEK per share.

On 4 January 2018, Oncology Venture publishes a prospectus on the occasion of the company’s representative subscription which was initiated on 11 January 2018.

-          An extraordinary annual general meeting is held in Oncology Venture on 4 January 2018. A communiqué from the extraordinary annual general meeting is available at the Company’s and AktieTorget’s (www.aktietorget.se) respective websites.

Peter Buhl Jensen comments

Oncology Venture has made significant progress during 2017, which means we have been able to achieve the targets which were communicated before the start of the new year. We have entered into an agreement with the Big Pharma company on two drug candidates, and supplied early data from the ongoing phase 1/2 trial of LiPlaCis®. This result shows a good treatment effect in the selected patients, and confirms that our Drug Response Prediction (DRP®) technology works. We hope to be able to develop ourselves into a “preferred partner” for major pharmaceuticals companies as DRP® shows clinical evidence of being able to identify those patients that have the greatest chance of responding to the drug. We have already received a number of offers from the Big Pharma company for collaboration on various drug candidates, which shows that our activity is being followed with great interest.

In July 2017, we agreed on an option to in-license a phase 3 product from Novartis Pharma AG, one of the most successful developers of cancer drugs in the world. The agreement concerns a very promising small-molecular kinase inhibitor (TKI) in clinical phase 3 development, and is divided into two parts. Negotiations on both parts are completed and Oncology Venture will decide whether the final part will be signed. The first part of the agreement gives permission to check beforehand whether DRP® is able to identify which patients benefit from the treatment with TKI in a phase 3 trial of renal cancer. Biopsy data from 150 patients have been analysed with our DRP® technology and in January 2018 we were able to report a consistent result for the TKI inhibitor. The TKI product will be the strongest and most advanced in Oncology Venture’s pipeline, with a clear effect in several cancer types. I am convinced that we can develop the TKI project for commercialisation, and when we have the full data package we can continue to develop DRP® to a tool that can be used for clinical guidance to predict the drug’s benefit for patients.

The other Big Pharma agreement was also concluded in July, when we signed an exclusive global licensing agreement with Eisal Inc. on the phase 2 PARP inhibitor E7449, which we now call 2X-121. The ground-breaking science and convincing clinical results behind 2X-121, combined with DRP®, just as with the TKI product I mentioned above, provides an exceptional reduced-risks opportunity to develop effective treatments for cancer types that are difficult to treat. We were already able to announce in August that DRP® has been able to identify respondents and non-respondents for 2X-121 successfully and with statistical significance among the 13 patients examined in a phase 1 trial which had been previously carried out by Eisal. The results, based on patient biopsies, are as good as we could have hoped for. With the help of DRP®, we have taken a major step towards the PARP market.

The above-mentioned progress has been made in our two SPV companies 2X Oncology and OV-SPV2, but also Oncology Venture’s own pipeline has taken clear steps forward. In January 2018 we reported the results of the second interim assessment from the phase 2 part of an ongoing phase 1/2 trial of LiPlaCis®. Clinical benefit has now been demonstrated in seven out of ten assessable patients who have been treated with LiPlaCis®, while conventional treatment with cisplatin in trials carried out previously resulted in a clinical response of only ten per cent in this patient category. We are very happy to announce that the interim results from the phase 2 part of the trial meet our very high expectations. The effect that has been observed in patients with difficult-to-treat metastatic breast cancer, who had on average undergone previous cancer therapy on seven occasions, is remarkable. We expect to be able to present the final results during the second half of 2018, the exact time depends mainly on how long the patients will be treated. My expectations of the combination of LiPlaCis® and DRP® are high, as the focused treatment has the potential to bring new hope and better treatment for cancer patients.

The development of 2X-111, Irofulven and APO010 is also going according to plan. Our overall objective is to carry out focused phase 2 trials of DRP®, which are expected to take around 12 months. If the outcome of the trials is positive, our objective will be to either out-license and further develop the drug with a partner or to sell the products. Our pipeline has experienced a very positive development during the second half of 2017 and we are currently preparing for several meetings, including the “End of Phase 2” meetings with FDA in the USA, provided that TKI DRP® shows good prognostic capacity. The new share issue of approx. MSEK 44.7 that has recently been implemented is financing our activity throughout 2018, and gives us the opportunity to carry out the planned clinical trials and also provides us with a satisfactory financial buffer. Based on the past year’s successes of Oncology Venture’s attractive drug project, we will continue to break new ground in the development of cancer drugs during 2018.

Peter Buhl Jensen – CEO, Oncology Venture Sweden AB


Auditor’s Review

In accordance with AktieTorget’s regulations, the report has not been reviewed by The Company’s auditor.

Principles for Interim Report

The interim report has been made in accordance with Swedish jurisdiction for annual accounts, and following general advice of the Swedish National Board of Accounting 2012:01, Annual Accounts and Consolidated Accounts (”K3”and in accordance with ”BFNAR 2007:1 Voluntary Interim Reporting”). For further information on accounting principles, we refer to the Annual Accounts of Oncology Venture for 2016.

Financial Calender

Q1 Report 2018 31 May 2018
General Annual Meeting 2018         17 May 2018
Q2 Report 2018 31 August 2018
Q3 Report 2018 30 November 2018
Q4 Report 2018 28 February 2018

The Board and CEO hereby certify that the interim report gives an accurate overview of The Company’s operations.

Hoersholm, February 28, 2018

Oncology Venture Sweden AB

The Board and CEO

For further information regarding Oncology Venture, kindly contact:

Ulla Hald Buhl, COO, Manager of IR & Communications                         Peter Buhl Jensen, CEO
Phone: +45 21 70 10 49                                                                           Phone: +45 21 60 89 22
E-mail: uhb@oncologyventure.com                                                          E-mail: pbj@oncologyventure.com  

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