Interim Report 2017-01-01 – 2017-09-30

The Board and CEO of Oncology Venture Sweden AB hereby announce the interim report for the first three quarters of 2017. Oncology Venture Sweden ABrefers 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 Interim Report

The First Nine Months (2017-01-01 – 2017-09-30)

  • Net sales: 2 091 KSEK (2 647 KSEK)
  • Profits after tax: -34 020 KSEK (-18 159 KSEK)
  • Cash and bank: 19 053 KSEK (11 781 KSEK)
  • Consolidated profit per share: -3,13 SEK (-1,95 SEK)
  • Solidity: 88,7 % (90,2%)

Third Quarter (2017-07-01 – 2017-09-30)

  • Net sales: 481 KSEK (1 169 KSEK)
  • Profits after tax: -11 807 KSEK (-8 102 KSEK)
  • Group earnings per share: -1,09 SEK (-0,87 SEK)

Group earnings per share: period result divided by average number of shares.

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

Significant Events During the Third Quarter of 2017

-          Oncology Venture announces 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 disturbances in 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, hereby named 2X-121. The drug has shown good efficacy already in phase 1.

-          Oncology Venture and Novartis Pharma AG sign an option right 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 of their pipeline.

-          On September 19, 2017, Oncology Venture announced early data from an ongoing phase 1/2 study showing response and clinical efficacy in hard-to-treat patients suffering from Metastatic Breast Cancer.

-          On September 29, 2017, Oncology Venture announced 12 Metastatic Breast Cancer patients being successfully recruited for the phase 2 part of the clinical study of LiPlaCis® in Metastatic Breast Cancer. The company previously announced expecting to recruit 12-15 patients by Q3 2017.

Significant Events After End of This Period

-          October 23, 2017, the company published a pipeline and business update, giving the status of ongoing projects.

-          October 27, 2017, the company announced that a phase 2 protocol for Irofulven in castration and docetaxel resistant Prostate Cancer was submitted to the Danish Medicines Agency.

-          November 7, 2017 the number of shares in Oncology Venture was increased since Medical Prognosis Institute A/S ("MPI") used 100 000 out of the 302 243 warrants they received as consideration for the extended three-year exclusive licence for MPI’s Drug Response Prediction technology, DRP®. The new number of shares in Oncology Venture is thereby 10 977 007.

-          November 16, 2017, Oncology Venture announced the company had reached an agreement with one of the major investors in OV-SPV2 ApS to prolong the option of repurchasing shares in OV-SPV2, holding the rights for the TKI inhibitor from Novartis. The option will be prolonged with six (6) months through June 1, 2018.

-          November 21, 2017, Oncology Venture announced the dose 75mg + 75mg per patient on day 1 and 8 in a three-week schedule has been found safe, and is thereby approved by the Safety Data Committee recommended dose (RD) for future treatments with LiPlaCis®. The pace of patient recruitment to the ongoing phase 2 part of the LiPlaCis study in Metastatic Breast Cancer has increased during the past months.

-          November 30, 2017, Oncology Venture announced the company board made a conditional decision that if approved at the upcoming Extraordinary General Meeting, a rights issue will be made of maximum 2 745 143 shares at an issue price of 16,30 SEK per share. A fully subscribed rights issue would provide Oncology Venture around 44,7 million SEK before emission costs.

Below, you will find the pipeline of Oncology Venture. The company’s aim is performing focused phase 2 studies and when positive results can be presented, to out-license, to further co-develop with a partner, or to sell the products. 
Drug Candidate Indication Activity Activity Initiated Ownership
TKI Kidney Cancer DRP analysis of biopsies from phase 3 Tyrosinkinase inhibitor from Novartis
Planning material for meeting with FDA
Oncology Venture is currently waiting for biopsy data from Novartis, expected to be available within 6-8 weeks from October 23, 2017. Knowing by then if DRP can predict respondents, OV will communicate with the FDA (the American drug authorities) regarding an “End of phase 2 meeting request”. After this, the company can communicate the future of the TKI inhibitor.Ongoing The rights for TKI are held by SPV company OV-SPV2 ApS, whereof 40 % is owned by Oncology Venture, 10 % by MPI and 50 % by external investors. It was recently announced Oncology Venture may acquire another 35 % of the OV-SPV2 shares before June 1, 2018.
Oral PARP inhibitor – 2X-121 Metastatic Breast Cancer
Ovarian Cancer
EISAI Phase 2 PARP inhibitor (E7449)Planning material for meeting with FDA In-licensed. The company is now planning a defined phase 2 study, aimed to be financed with liquid assets from a planned rights issue. The study is expected to begin during 2018, and to be finished approximately 12 months later. After this, the company will be able to communicate the future of 2X-121. Ongoing The rights for 2X-121 are held by SPV company 2X Oncology Inc., whereof 92 % is owned by Oncology Venture and 8 % by external investors until a possible capital raise.
LiPlaCis® Breast Cancer Screening patients ( > 1400 patients) Ongoing Oncology Venture has signed an exclusive global license agreement with Liplasome Pharma, and possible future sales revenue will be divided as follows: Oncology Venture 45%, MPI 10% and Liplasome Pharma 45%. The company has also signed a development agreement with Cadila Pharmaceutical Ltd. Provided Cadila delivers according to this agreement, Oncology Venture’s part of any future LiPlaCis® income will be 29,25 %.
Phase 2 study*Planning material for meeting with FDA   Started Q3 2016. Inclusion of first 12 patients in the phase 2 part finished Q3 2017. New permit for up to 20 patients: ongoing. Last patient is expected to be included Q1 2018 and results are estimated to Q3-Q4 2018, depending on required length of patient treatment.Ongoing
Breast Cancer Randomized phase 2 study To be initiated 2018. Inclusion of first patient Q2 2018, and last patient during Q4 2019. The study, estimated to include about 80 patients, has received EUROSTARS funding in co-operation with our partner Smerud.
Skin, Head & Neck, Esophagus and Prostate Cancer,Cadila sponsored Phase 2 studies To be initiated
Breast Cancer, Cadila sponsored Pivotal/phase 3 study To be initiated
TOP2 inhibitor – 2X-111  Glioblastoma
Metastatic Breast Cancer
Liposomal doxorubicin-Glutathion phase 2 In-licensed to 2X Oncology Inc. The company is planning a defined phase 2 study, intended to be financed with liquid assets from a planned rights issue. The study is estimated to begin during 2018, and to be finished approximately 12 months later. By then, the company will be able to communicate the future of 2X-111. The rights for 2X-111 are held by SPV company 2X Oncology Inc., whereof 92 % is owned by Oncology Venture and 8 % by external investors until a possible capital raise.
Irofulven Metastatic Prostate Cancer Screening patients Ongoing Oncology Venture has acquired 75% of the rights to Irofulven from Lantern Pharma Inc. Lantern will receive 25 % of possible milestone payments, a number that may increase to 40% if Lantern makes use of their purchase option of 2 million USD when eight patients have been treated in the planned phase 2 study. Should Lantern use their option, Oncology Venture will own 60% and Lantern 40% of the rights for Irofulven.
Preparing for phase 2 Ongoing
Submit application for clinical study Submitted October 2017
Phase 2 study* 15 patients in phase 2 study. Last patient expected to be included during Q1 2019.
APO010 Immuno-oncology drugFirst indication Multiple Myeloma (Bone Marrow Cancer) Screening patients Ongoing Oncology Venture has acquired the rights for APO010 from Onxeo. At a possible market launch, Oncology Venture will receive >90 % of the sales profit.
Clinical phase 1/2 study Phase 1 dose escalation part ongoing. Total phase 1 and 2 circa 30 patients, depending on how many patients are to be included in the phase 1 dose escalation part. If about 30 patients are included, the last patient is estimated to be included during Q1 2019.
Oral TOP1 inhibitor – 2X-131 Oral TOP1 inhibitor phase 2 for development in patients suffering from Ovarian Cancer Term Sheet under negotiation. 2X Oncology Inc.’s rights for 2X-131 are currently being negotiated.
Regarding Special Purpose Vehicles (SPV) Seed investment of 3,5 million USD Secured
Series A financing Ongoing

CEO Peter Buhl Jensen comments  

On July 19, 2017, we had the joy of announcing an agreement with Novartis Pharma AG, one of the world’s biggest and most successful cancer drug developers, on exclusive in-licensing of a particularly promising small molecule kinase inhibitor (TKI), currently in clinical phase 3 development. The agreement is divided into two parts, both all the way negotiated, where Oncology Venture makes the call on the second part being signed. The first part gives permission for forehand testing of DRP® prediction on which patients will benefit from TKI treatment in a phase 3 study in Kidney Cancer. Data from biopsies from 150 patients will be analysed with our DRP technology for a blinded prediction of which patients could benefit from the drug. If DRP®can successfully do this, we obviously wish to partake in the second part of the agreement, this then providing us with an exceptionally risk reduced possibility of developing effective cancer treatments. No financial or other details on this have been published. We are of course very happy and proud of DRP®being viewed as a potential game changer for high quality Big Pharma products. Should Oncology Venture’s DRPreceive positive results, this will be the only TKI drug with a bio marker – a clear market advantage.

We started this quarter by announcing the Danish Medicines Agency and the Ethics Committee permits us to include Metastatic Breast Cancer patients in the phase 2 study of LiPlaCis® already after the patient’s second line of treatment. I am very pleased that the possibility of partaking in the phase 2 study can now be offered to the patients earlier in their treatment process. This gives more patients a potential new treatment option, and it also enables an expansion of the LiPlaCis® indication. The LiPlaCis programme has achieved a higher value through us being permitted to treat patients with symptoms from liver metastases and patients with low thrombocyte count, patients otherwise excluded from many drug treatments. With these additions, there is a need to increase the number of patients to reach statistical strength and thereby find a sufficient cut-off level for DRP® in the randomised phase 2 study. We have therefore applied for and been granted a permission to expand the study to a total of up to 20 patients.

In July, we announced Oncology Venture signed an exclusive, global license agreement with EISAI Inc. regarding their phase 2 PARP inhibitor E7449, hereby renamed 2X-121. Just as with the above mentioned TKI product, the ground-breaking science and convincing clinical data behind 2X-121 in combination with our unique DRP® bio marker technology provides an exceptionally risk reduced possibility of developing effective treatments for hard-to-treat cancer types. It was with great satisfaction that we announced in August how DRP for 2X-121 had successfully and with statistical significance identified respondents and non-respondents among the 13 patients examined in the previously conducted EISAI phase 1 study. The results from the biopsies of these 13 patients are just as good and satisfying as we could have hoped for. Through DRP, we have taken a great leap on our way to the PARP market.

In September, we published early data from an ongoing phase 1/2 study of LiPlaCis®, showing clinical efficacy in three out of five analysed Metastatic Breast Cancer patients. Published data on cisplatin alone shows response in 10%, and I am very pleased with these promising early results of the phase 2 part of the LiPlaCis® study, where screening has enabled us to handpick patients likely to respond to treatment. I am also very pleased we have been able to include patients in the LiPlaCis® study as promised, and I am thankful for the hard work of optimising the recruitment process put in by the hospital sites and by our CRO partner Smerud. I am convinced the widening of the inclusion level from 20% to 66% will render important information on the relevant limit where DRP can show response. This information is crucial for the planned randomised phase 2 study supported by EUROSTARS. My expectations for LiPlaCis® and the DRP® technology are high, since I believe focused treatment can bring new hope and better treatments for cancer patients.

I have a particularly positive view upon the future of Oncology Venture. We are being offered quality products from Big Pharma companies. Our spearhead product LiPlaCis®, where DRP technology is being used for selection to our studies now shows we can include the right patients. We have documented up-front how the DRP for PARPi can show which solid tumors patients will benefit from treatment. We are in the starting blocks for performing the same analysis for the TKI product in patients with Kidney and Liver Cancer. LiPlaCis®, 2X-121 (PARPi), 2X-111 (liposomal doxorubicin) and TKI (under analysis) are all products where DRP has given a forehand prediction on which cancer patients in clinic would benefit from treatment. Therefore, these products are prioritised in our pipeline.

Referring to the company’s high activity level, I would like to round off by saying the board recently decided on performing a rights issue of around 44,7 million. This will enable further increase of the pace of our activities in a focused way.

Peter Buhl Jensen – CEO, Oncology Venture Sweden AB

Subscribe

Documents & Links