Rapporter Publicerat: 2017-08-29 14:51:00

Oncology Venture: Half-year Report 2017-01-01 - 2017-06-30

Published August 25, 2017

"Oncology Venture Sweden AB" refers to Oncology Venture Sweden AB, organisation no 559016-3290. "The Company", or "Oncology Venture" refers to the business group, i.e. Oncology Venture Sweden AB and subsidiaries Oncology Venture ApS (100% ownership), 2X Oncology (92 % ownership) and OV-SPV2 ApS (40 % ownership).

Summary of Half-year Report

First Half-year (2017-01-01 - 2017-06-30)

· Revenue: 1 610 KSEK (1 478 KSEK)
· Profits for the period: -22 213 KSEK (-10 056 KSEK)
· Cash at end of period: 37 545 KSEK (20 824) KSEK
· Consolidated profit per share: -2,16 (-1,08) SEK
· Solidity: 89,8 % (98,8) %

Second Quarter (2017-04-01 - 2017-06-30)

· Revenue: 1 610 KSEK (0 KSEK)
· Profits for the period: - 10 586 KSEK (-5 191 KSEK)
· Consolidated profit per share: -1,04 (-0,56) SEK

Consolidated profit per share: period result divided by average number of stock shares.

Per April 1, 2017, the total number of stock shares was 10 074 794. Total number of stock shares per June 30, 2017, amounts to 10,877,007. Average number of stock shares for the period is 10,141,276. Amounts in brackets represent the equivalent period last year. Shareholder equity ratio: equity divided by assets.

Significant Events During the Second Quarter of 2017

-          Oncology Venture carries out a rights issue, supplying the company with approximately 33,7 MSEK before emission costs.

-          2X Oncology extends its management group and appoints George O. Elston CEO while Marie Foegh continues as the company's CMO.

-          The General Annual Meeting was held on May 8, 2017. A communique of decision made at this meeting can be found at The Company's web page, www.oncologyventure.com.

-          DRP data for epirubicin in Breast Cancer treatment has been published at the web page of ASCO (American Society of Clinical Oncology). DRP was significantly associated with progression free survival, PFS, in a cohort of 137 patients suffering from metastatic Breast Cancer.

-          Oncology Venture is informed by the US Patent and Trademark Office that they intend to approve a patent application concerning a Drug Response Predictor (DRPTM) for the company's anti-cancer drug Irofulven.

-          Oncology Venture announces a first patient has been included in the phase 1/2 study of APO010 in Multiple Myeloma (MM).

-          A poster on DRP data for epirubicin in Breast Cancer treatment is presented at the poster session "Breast Cancer - Metastatic" during the annual meeting of ASCO (American Society of Clinical Oncology) on June 4, 2017, in Chicago, Illinois, USA.

-          The Oncology Venture spinout, 2X Oncology, receives an American Investigational New Drug Application (IND) for 2X-111, a liposomal doxorubin for Breast and Brain Cancer.

-          Oncology Venture announces data from the ongoing phase 1/2 study show how tumor response to LiPlaCis in clinical praxis can be predicted by the company's Drug Response Predictor (DRPTM) regardless of tumor type, including Breast Cancer.

Events After End of This Period

-          Oncology Venture announces that the Danish Medicines Agency and the Ethics Committee approve inclusion of Metastatic Breast Cancer patients in the phase 2 study of LiPlaCis already after the patient's second line of treatment. The side effect profile of LiPlaCis also allows for more vulnerable patients with low thrombocyte count and patients with decreased liver function to be included in the study.

-          Oncology Venture and Eisai Inc. sign an exclusive global license agreement for the clinical oncology drug candidate PARP Inhibitor E7449 / 2X-121. E7449 has shown good efficacy already in phase 1.

-          Oncology Venture and Novartis Pharma AG sign an option agreement regarding an exclusive license for a kinase inhibitor in clinical phase 3.

-          Oncology Venture announces the company has made a precise DRP prediction in patients treated with 2X-121, the recently in-licensed PARP inhibitor from Eisai Inc.

-          On August 23, 2017, Oncology Venture publishes a new update on their pipeline.

CEO Peter Buhl Jensen comments

The time has come for me to make a summary of a particularly eventful and value creating quarter in the development of Oncology Venture. At the inception of the Company, we promised five products in three years.  In just two years, we now have six products secured - ahead of plan - with a seventh on the horizon. We believe that our strong oncology pipeline positions us as a very strong global player in anti-cancer drug development. I am very happy with the performance of my team, and look forward to begin clinical studies in co-operation with our professional clinical research partner, Smerud Medical Research International, to further accelerate patient inclusion and progress in clinical results. In September, we expect the application for Irofulven to be submitted to the Danish authorities. Once it is approved, our three first Phase 2 products will all be under clinical development. Next in line will be 2X-111 and 2X-121, and I find this kind of progress characterising a company in formidable development. 

The Company holds the global rights for six products, and the global rights for Drug Response Predictor - DRP™, an innovative technology for developing precision medicine for cancer patients.

We started this quarter by announcing having raised around 33.7 million SEK before emission costs through our rights issue during March, 2017. I would like to thank the investors in this rights issue - the largest one in the history of Oncology Venture - for their support, injecting new working capital in the business. Since our listing at AktieTorget a little over two years ago, Oncology Venture has rapidly created substantial value within the Company through a Phase 2 pipeline of up to seven products, two spin-out companies, and the first partner agreement with Cadila is in place. With a pipeline as substantial as this, and with the prospect of value increase, there is potential of attracting institutional long-term investors. Based on this, as formerly communicated, we strive to become listed at the main stock market Nasdaq Stockholm Small Cap.

We have reached an important scientific milestone in announcing that the efficacy of chemotherapy with epirubicin, one of the most commonly used drugs for Breast Cancer treatment, can now be predicted in accordance with DRP data we presented at the Annual Meeting of ASCO (American Society of Clinical Oncology). DRP was significantly associated with progression free survival, PFS, in a cohort of 135 patients suffering from Metastatic Breast Cancer. These are good news: our patented epirubicin DRPTMis now also validated in clinical praxis, and I am convinced we can use this powerful tool to successfully develop our epirubicin based product 2X-111 for Breast Cancer, and hopefully also for Glioblastoma (Brain Cancer).

Furthermore, we could announce in June that our spin-out company 2X Oncology received a so called Investigational New Drug (IND), i.e. permission to run clinical studies in the USA, for drug candidate 2X-111. It is of great value to have an IND in the U.S. enabling us to perform clinical studies.

During this quarter, we have also strengthened our patent portfolio. In May, we announced the US Patent and Trademark Office had informed us of their intention to approve a patent application for a Drug Response Predictor (DRP™) for our anti-cancer drug Irofulven. Protecting Irofulven and its companion diagnostic DRP™ via FDA's Orange Book is a very important part of our strategy. This secures another 20 years of patent protection. In September, the application for Irofulven is expected to be submitted to the Danish authorities. We have also communicated progress in our development of drug candidate APO010. On May 31, we announced a first patient had been included in the phase 1/2 study of APO010 in Multiple Myeloma (MM). I am happy APO010 is now in clinical use for MM.

The activity within Oncology Venture is continuously high. We have six phase 2 projects in Oncology Venture, all showing good safety profiles, and we have secured funding for these projects. Beyond this, we also have two spin-out companies,

2X Oncology Inc. and OV-SPV2. For the drug candidates developed within these companies, we have signed agreements with Big Pharma companies Eisai, Inc. and Novartis Pharma AG, something we are of course very proud of.

I look forward to yet another exciting quarter for Oncology Venture!

Peter Buhl Jensen

CEO, Oncology Venture Sweden AB 

Dokument

Oncology Venture Sweden AB

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Venlighedsvej 1,
DK-2970 HOERSHOLM, Danmark
+45 21 70 10 49 http://www.oncologyventure.com